Amazon Seller Compliance

Andrew Parshad

Andrew Parshad is President, CEO and founder of Quality Smart Solutions, a North American compliance solutions provider offering regulatory and quality assurance services to comply with FDA & Health Canada brands and ingredients regulations in the categories of dietary supplements, foods, cosmetics, OTC drugs and medical devices. Andrew started Quality Smart Solutions in 2007. Since that time he and his firm has served thousands of clients worldwide . Andrew's affiliate company, Quality IMPORT Solutions that offers import agent services into the Canadian market as a government licensed importer for foods, dietary supplements and medical devices.

Categories
Blog Medical Devices

FDA 510(k) pre-submissions vs PMA: What’s the difference?

Medical device compliance process – FDA 510k pre-submission vs PMA

Medical device compliance process – FDA 510k pre-submission vs PMA

When preparing to launch a medical device in the U.S., one of the first and most important decisions you’ll make is choosing the correct regulatory pathway. For many manufacturers, that means understanding the FDA 510(k) pre-submission process and how it compares to the Premarket Approval (PMA) route. 

These two regulatory pathways represent the most common ways to gain FDA clearance or approval, but they differ significantly in requirements, risk classification, and timelines. Choosing the right one early on can help streamline your path to market and reduce costly delays. Keep reading to discover how these processes compare and which one is the best fit for your medical device. 

Why it matters: Choosing the right FDA submission path 

Not all medical devices are created equal, and some carry more risk than others. The U.S. Food and Drug Administration (FDA) classifies medical devices into three categories based on risk: Class I, II, and III. Most Class II devices require a 510(k) submission, while Class III devices generally need a Premarket Approval (PMA) application. 

Choosing the wrong path can cost you time, money, and delay your product’s launch. Missteps in your 510(k) submission process can also result in rejections, warning letters, or costly remediation work. Using the FDA 510(k) pre-submission pathway can help reduce those risks by allowing early communication with the FDA. 

What is an FDA 510(k) pre-submission? 

A 510(k) pre-submission is part of the FDA’s Q-Submission program. It allows you to request early feedback from the FDA before formally submitting your 510(k) application. This process is voluntary but highly recommended, especially if your device involves new technology, novel indications, or unclear regulatory expectations. 

During a pre-submission, you can ask the FDA questions about data requirements, test methods, or regulatory strategy. While the feedback is non-binding, it helps reduce guesswork and can improve the quality of your final submission. 

Learn more from the FDA’s official Q-Submission guidance. 

What is a PMA? 

A PMA (Premarket Approval) is the most rigorous FDA review process for medical devices. It’s required for Class III devices, those that sustain or support life, are implanted, or present a high risk of illness or injury. 

Unlike a 510(k) submission, which shows that your device is substantially equivalent to an existing one, a PMA requires you to prove your device is safe and effective through scientific evidence, typically including clinical trials. 

This makes PMA more complex, expensive, and time-consuming. However, it’s essential for innovative or high-risk devices with no valid predicate. 

510(k) vs PMA: Key differences 

Before choosing a submission path, it’s important to understand the core differences between these two regulatory routes. A 510(k) submission is generally intended for moderate-risk devices with a valid predicate, while the PMA pathway is used for high-risk or novel products requiring clinical evidence. 

Here’s a quick comparison of FDA 510(k) submissions and PMA requirements: 

Category 

510(k) 

PMA 

Device class 

Class II 

Class III 

Evidence required 

Substantial equivalence 

Clinical data and scientific evidence 

Review time 

Shorter (typically 90 days) 

Longer (can take 6–12 months or more) 

Cost 

Lower 

Significantly higher 

Risk level 

Moderate risk 

High risk 

How we support you through the submission process 

At Quality Smart Solutions, we guide you through each step of the 510(k) or PMA pathway, starting with a sound strategy and optional FDA 510(k) pre-submissions when appropriate. Our team of experienced 510(k) consultants helps you: 

  • Determine the right regulatory pathway 
  • Prepare and submit a complete 510(k) or PMA 
  • Plan and submit Q-Sub requests (510(k) pre-submissions) 
  • Respond to FDA feedback and questions 
  • Stay compliant throughout the product lifecycle 

We’re not just regulatory experts. We’re your strategic partners in market access and compliance. 

Common questions about FDA 510(k) pre-submissions and PMA

Do I need a 510(k) if my product is brand new?

Not always. If there’s no valid predicate device, you may need a PMA or a De Novo classification request instead. 

Yes, but it’s risky. Skipping the FDA 510(k) pre-submissions process can lead to missed requirements or unclear expectations, resulting in delays or rejections. 

Generally, yes. However, certain devices may qualify for Humanitarian Device Exemptions (HDE) if they are intended for rare conditions. 

It’s not common and can be complex. It’s best to determine the correct path upfront through a regulatory assessment or pre-submission discussion with the FDA. 

Let’s get your device to market with confidence 

Whether you need help with the FDA 510(k) pre-submission process, a formal 510(k) submission, or a full PMA strategy, Quality Smart Solutions is here to support you. Our team of 510(k) consultants works closely with you to evaluate your device, prepare your submission, and communicate effectively with the FDA. 

Visit our medical device services page or contact us to get started. 

Categories
Blog Regulatory Compliance

How to Strengthen Operations with GMP Training

Professional GMP training session at a life sciences facilit

Professional GMP training session at a life sciences facilit

If you work in the life sciences industry, you’ve likely heard of GMP, Good Manufacturing Practice. It’s a fundamental part of producing safe, effective, and high-quality products. But how confident are you that your team fully understands what’s expected, and more importantly, why it matters? 

This blog breaks down what GMP compliance really involves and why professional training can make a measurable difference in your operations. We’ll explore common challenges, offer tips for staying ahead of regulatory demands, and show you how to build a culture of quality that sets your business up for long-term success. Let’s dive in. 

Why GMP compliance is getting harder to ignore 

To begin with, regulations across the life sciences sector continue to evolve, placing increasing pressure on companies to remain vigilant. Whether you manufacture pharmaceuticals, natural health products, or medical devices, failing to meet GMP standards can lead to major setbacks that affect both compliance status and brand reputation. 

For example, missed inspections, delayed approvals, costly recalls, and restricted market access are just some of the risks. On top of that, today’s consumers and business partners are holding companies to higher standards, expecting transparency, accountability, and consistent product quality. 

Clearly, understanding the GMP framework isn’t optional. It’s a foundational step toward not just regulatory success, but long-term operational resilience. 

What your business can do to meet GMP expectations 

To meet these expectations, start by equipping your team. Employees need to do more than follow SOPs, or Standard Operating Procedures, they need to understand the “why” behind each standard. 

A strong training program should cover: 

  • Risk-based approaches to quality and compliance 
  • Best practices in documentation and record-keeping 
  • Internal audits, CAPA processes, and inspection readiness 

Whether your team is new to GMP or needs a refresher, the right training builds clarity, consistency, and confidence across all departments. 

Choosing the right professional GMP training format for your team 

When planning training, it’s important to consider how your team learns best and what will create the most lasting impact. Fortunately, training doesn’t have to disrupt your workflow. Onsite sessions provide hands-on instruction that aligns closely with your facility, processes, and equipment. This makes it easier for teams to connect theory to practice in a familiar setting. 

If your operations are spread out or your team prefers more flexibility, virtual sessions are a great alternative. They reduce travel time and costs, while still giving your team access to expert-led instruction and regulatory insights. 

No matter which delivery format you choose, make sure the training offers more than just slides and lectures. A good program should encourage interaction, focus on real-world scenarios, and provide immediate takeaways your team can put into practice. That’s what transforms knowledge into action. 

How to make GMP compliance easier to manage 

Compliance gaps can happen even when teams are doing their best. As businesses grow or shift responsibilities, it becomes harder to keep GMP practices consistent.  

That’s why, at Quality Smart Solutions, we provide professional GMP training designed to fit your needs. Ultimately, our goal is to support your team, not just with information, but with real tools that build understanding and drive action. 

We work with businesses across Canada and the U.S., offering tailored training sessions that reflect both Health Canada’s GMP guidance and FDA GMP requirements. Our instructors bring industry expertise and regulatory experience, so your team gets advice grounded in reality. 

No matter which format you choose, our training helps you reduce deviations, improve inspection outcomes, and build a stronger quality culture from within. 

Common concerns (and what you can do about them)

We already have SOPs, do we still need professional GMP training?

Yes. SOPs are a great starting point, but without context, employees may miss key compliance elements. Professional GMP training helps connect procedures with regulatory intent and reinforces consistent application. 

Not at all. With flexible delivery options, this type of training can be seamlessly integrated without disrupting your day-to-day productivity. 

No. Smaller teams often benefit the most, since training fills resource gaps and strengthens accountability across roles. 

It’s recommended to revisit your training at least annually or whenever there are regulatory updates or internal process changes. 

Absolutely. Tailored sessions that align with your products, equipment, and compliance scope make it easier for teams to apply what they’ve learned immediately. 

Let’s strengthen your compliance strategy 

If you’re aiming to build a quality-driven organization, professional GMP training is one of the smartest moves you can make. Beyond passing inspections, the real value lies in building a culture that supports consistent performance and long-term growth. 

Contact us today to explore training options that match your team’s needs. Quality Smart Solutions is here to help guide you forward. 

Categories
Blog Regulatory Compliance

How Audits Help You Stay Compliant with Health Canada

Auditor reviewing compliance checklist at a licensed facility

Auditor reviewing compliance checklist at a licensed facility

When it comes to audits related to Health Canada requirements, staying compliant is about more than checking off a list. It helps you maintain your licence, protect your brand, and stay competitive in a regulated market. If you hold a Drug Establishment Licence (DEL), Medical Device Establishment Licence (MDEL), or a Natural Health Product (NHP) site licence, understanding how audits work can save you from costly compliance issues. 

At the same time, internal compliance efforts matter, but they may not catch everything. If you’re unsure whether your systems meet current expectations, you’re not alone. Keep reading to learn how audits can help uncover hidden risks and give you a clearer picture of where your compliance stands. 

Why internal audits might fall short 

Even the most dedicated internal teams can develop blind spots. For example, familiarity with routine operations may lead to oversights, especially in complex areas like documentation, traceability, and preventive controls. Without specialized training and ongoing exposure to regulatory updates, internal audits may miss key deficiencies. 

On the other hand, external audits provide fresh perspective. They focus on critical areas like validation, standard operating procedures (SOPs), CAPA systems, and recordkeeping. As a result, these reviews serve as a proactive tool to uncover non-compliances before Health Canada inspectors arrive. 

What Health Canada looks for 

To enforce GMP requirements, Health Canada conducts inspections under regulations that apply to drugs, medical devices, and natural health products, which are outlined in documents such as the Good Manufacturing Practices (GMP) Guidelines and Inspection Tracker. During these inspections, inspectors typically assess areas such as: 

  • Quality management systems and documentation 
  • Personnel training and hygiene 
  • Equipment cleaning and maintenance 
  • Material handling and storage 
  • Production controls and batch records 
  • Complaint handling and product recalls 

If gaps are found, the outcome can range from observations to more serious enforcement measures, including licence suspension. Regular audits can help confirm your readiness for inspections and avoid reactive compliance fixes. 

How the audit process works 

A proper compliance audit includes a full review of your facility, procedures, and documentation. It typically begins with a pre-audit questionnaire, followed by an on-site visit and staff interviews. The auditor then issues a detailed report outlining any non-conformances, risk level, and recommended corrective actions. 

The audit findings are usually grouped into categories based on severity, and your team is expected to implement a corrective action plan within a reasonable timeframe. Some companies choose to conduct these audits annually or ahead of licence renewals to stay on top of Health Canada expectations. 

Frequently asked questions

Should I implement an external audit program if I passed my last inspection?

Yes. Compliance is ongoing. Health Canada inspections are periodic, but requirements must be met at all times. Regulatory expectations evolve, and internal processes may shift over time, so audits are valuable tools to continuously verify that your operations remain aligned with current standards.

Finding issues is not a failure, it’s a benefit of the audit. The purpose of an audit is to uncover gaps before they escalate into compliance problems. Early detection enables your team to correct deficiencies proactively, minimizing the risk of receiving observations or sanctions during a formal Health Canada inspection.

No. Audits are useful for businesses of any size. Smaller teams often benefit from extra support, and larger companies use audits to confirm internal controls and stay compliant as they grow.

Yes. Audits are often used as a preparation step ahead of licence renewals to ensure all documentation and processes meet current standards.

Many businesses find it invaluable to hold external audits annually, as well as whenever there is a major shift in their operations. This may include licence renewals, the implementation of new equipment or processes, or the launch of a new product.

Next steps for your audit 

A professional audit helps you stay compliant, protect your licence, and reduce regulatory risk. It’s a proactive investment that strengthens your quality systems and positions your company for long-term success. 

That’s why, at Quality Smart Solutions, we support companies of all sizes with tailored audit solutions across the natural health product, drug, and medical device sectors. Our experienced auditors perform in-depth reviews of your operations, identify gaps based on current Health Canada requirements, and deliver actionable plans to help you implement corrective measures efficiently.  

We also stay up to date on evolving regulatory trends to help your business stay ahead of compliance challenges. Therefore, if you’re preparing for a Health Canada inspection or want to assess your current compliance status, we can help you take the next step. Book a free consultation with our experts. 

Categories
News Regulatory Compliance for Dietary Supplements

How to Comply with the FDA’s NDI Notification Process

FDA’s dietary supplement NDI notification guidance overview

FDA’s dietary supplement NDI notification guidance overview

If you’re planning to introduce a new ingredient into your dietary supplement formula for the U.S. market, the FDA NDI notification requirements are something you can’t afford to overlook. Failing to notify the FDA properly can result in regulatory action, rejected products, and disrupted business plans. 

To help businesses like yours navigate these rules more confidently, the FDA has just released new educational materials including a downloadable fact sheet and two YouTube videos that explain the NDI notification process in simple terms. Keep reading to understand how this update affects you and how to stay compliant. 

What is an NDI and why does it matter? 

A new dietary ingredient (NDI) is any ingredient that was not marketed in the United States as a dietary ingredient before October 15, 1994. If your supplement contains one, you’re required to submit a New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before you introduce the product to market. 

This process allows the FDA to assess the safety of the ingredient before it reaches consumers. While it’s meant to ensure public health, many businesses overlook or misunderstand the requirements, leading to avoidable regulatory trouble. 

What’s new in the FDA’s educational materials? 

To improve industry understanding and increase compliance, the FDA has released a plain-language fact sheet outlining the NDI notification process and two short videos explaining who must submit a notification and what the process involves. 

These resources aim to support small and mid-sized businesses who may not have the legal teams or regulatory expertise of larger corporations. If you’ve ever felt lost in technical documentation, these tools were made with you in mind. 

Common compliance mistakes to avoid 

Many companies mistakenly believe that if their ingredient is “natural” or used in other markets, they don’t need to notify the FDA. That’s incorrect. Even widely consumed ingredients like turmeric or collagen may require a notification if used in a new form or dosage. 

Another frequent misstep is assuming that contract manufacturers or suppliers will handle the submission. While they can assist, the brand owner is ultimately responsible for ensuring compliance. 

Finally, some businesses submit incomplete or late notifications, which can result in delays or enforcement action. 

How to meet NDI requirements correctly 

Staying compliant doesn’t have to be overwhelming. Here’s a simplified path forward: 

  • First, determine if your ingredient qualifies as an NDI. If it was not marketed in the U.S. before October 15, 1994, it likely qualifies. 
  • Prepare a complete notification. Include safety data, identity information, and a full description of the ingredient and its use. 
  • Submit at least 75 days in advance. The clock starts once the FDA confirms receipt, not when you send it. 

What if you don’t submit an NDIN? 

If you fail to submit a required NDIN, the FDA may consider your product adulterated. This could lead to warning letters, import refusals, product seizures, or even recalls. 

But the good news is: compliance is within reach. With the right guidance and support, you can meet FDA requirements and protect your business. That’s where we come in. 

How Quality Smart Solutions can help 

At Quality Smart Solutions, we provide expert advice on new dietary ingredients, full dossier preparation for New Dietary Ingredient Notifications, and fast support for FDA pre-submission meetings and responses to FDA questions. 

The FDA’s new fact sheet and videos are a welcome step toward making the NDI process more transparent and manageable. But as helpful as these materials are, regulatory submissions still require expertise and attention to detail. 

If you’re planning to launch a dietary supplement with a new ingredient, don’t take unnecessary risks. Contact us to ensure your FDA NDI notification is handled correctly so you can bring your product to market with confidence. 

Categories
Blog Regulatory Compliance

Pet Supplements or Veterinary Health Products? USA vs Canada

Pet supplements and veterinary health products comparison between the U.S. and Canada

Pet supplements and veterinary health products comparison between the U.S. and Canada

If you are planning to market animal health products, the question of pet supplements or veterinary health products will come up fast. This difference matters, especially if you’re selling in both the United States and Canada.  

What qualifies as a supplement in the U.S. might be considered a drug or a Veterinary Health Product (VHP) in Canada. Misunderstanding this can lead to product seizures, warning letters, or even a ban from entering the market. 

In this blog, we will walk you through how both countries regulate these products, why it matters for your business, and how to stay compliant across borders. Keep reading to discover the key distinctions and what they mean for your regulatory obligations. 

What are pet supplements in the U.S.? 

In the U.S., pet supplements aren’t officially recognized by the FDA. Instead, they fall under regulations for animal foods or drugs. If your product contains only approved feed ingredients and avoids therapeutic claims, it may be considered food. But if it claims to treat or prevent disease, it’s likely a drug. 

Claims like “supports mobility” may be tolerated, while “relieves joint pain” could require drug approval. You must also meet FDA manufacturing standards and, in many cases, register at the state level with AAFCO. Learn more at the FDA’s Animal & Veterinary Products page. 

What are veterinary health products in Canada? 

Canada classifies pet supplements as Veterinary Health Products (VHPs), which are low-risk products used to maintain or promote animal health, not treat disease. 

To sell a VHP, you must notify Health Canada and use only permitted ingredients. Claims must be non-therapeutic, and your label must match your submission. Bilingual packaging is required. 

This process is more flexible than a drug application but still demands accuracy. For more information, visit Health Canada’s VHP page. 

Comparing U.S. and Canadian regulations 

To help you spot the key differences faster, here’s a side-by-side look at how each system defines and regulates these products: 

Aspect United States Canada 
Regulatory Category Animal food or animal drug Veterinary Health Product (VHP) 
Recognized Term No official recognition of “pet supplements” “Pet supplements” not used; products are VHPs 
Governing Body FDA + state-level (AAFCO involvement) Health Canada 
Ingredient Approval Based on AAFCO listings or approved drug ingredients Must use substances from the VHP permitted substances list 
Claim Restrictions Cannot make disease claims without drug approval Must avoid disease-related claims 
Pre-Market Requirement No federal registration, but state registration may apply VHP Notification required before sale 
Packaging Requirements Varies by state Bilingual packaging required (English and French) 
Enforcement Risk Product seizure or warning letters Border detention or withdrawal from market 

Common mistakes to avoid 

Many companies overlook the fine print that separates a compliant product from one that might be stopped at customs or pulled from shelves. So, here are some of the most common mistakes to watch out for: 

1. Assuming U.S. rules apply in Canada

Some companies try to bring “supplements” into Canada without realizing that these are classified differently. In Canada, the word “supplement” is not typically used for animals. It is either a drug or a VHP. 

2. Making unapproved claims

Whether you are in the U.S. or Canada, therapeutic claims (like “cures skin infections”) can quickly move your product into the drug category, which has stricter requirements. 

3. Skipping notification in Canada

If you do not notify Health Canada before selling your product, it can be detained at the border or removed from store shelves. 

4. Using non-compliant ingredients

Canada has a strict list of permitted substances. Using an unapproved ingredient can delay your product launch or lead to immediate enforcement. 

5. Neglecting state registrations in the U.S.

Some companies overlook that even if their product meets federal guidelines, they still need to register in individual states, each with its own process and fees. 

How to stay compliant 

As you’ve seen, each country has its own approach. Here’s how to stay aligned: 

For the United States: 

  1. Check AAFCO ingredient approval and avoid therapeutic claims. 
  2. Review FDA guidance on marketing language. 
  3. Register with individual states where needed. 

For Canada: 

  1. Submit a VHP notification to Health Canada. 
  2. Use only permitted ingredients and non-therapeutic claims. 
  3. Ensure bilingual packaging and label consistency. 

Frequently asked questions

Can I sell the same pet product in both countries?

Not as-is. A product that is legal in the U.S. might need reformulation, new packaging, or a claim adjustment to comply with Canadian VHP rules. Even the terminology and suggested usage may need to change.

Not always, but you may need different versions of the label and accompanying literature to match local compliance requirements.

No. While there are overlaps in good manufacturing practices and safety expectations, each country has distinct pathways.

Yes. What is considered a functional benefit in the U.S. might be interpreted as a therapeutic claim in Canada. Avoid crossover language that triggers higher scrutiny.

By aligning with regulations in both the U.S. and Canada, your brand can access two of the largest pet-owning populations in North America. Cross-border compliance adds credibility and can give your brand a competitive edge.

Compliance is your competitive edge 

Navigating pet product regulations across borders takes more than good intentions. It requires precision, up-to-date knowledge, and a clear strategy tailored to each market. 

Whether you’re launching a new product or adapting an existing one, our team can help you stay compliant, save time, and avoid costly setbacks. We monitor updates from both the FDA and Health Canada,so you don’t have to. 

Need help getting started? Contact us today to ensure your products meet regulatory standards in the U.S. and Canada. 

Categories
Blog Natural Health Products (NHPs)

How to get an NPN for hydration products in Canada

Health Canada-approved hydration products with Natural Product Number (NPN)

Health Canada-approved hydration products with Natural Product Number (NPN)

Thinking of selling hydration products in Canada? If your product makes a therapeutic claim, you may need a Natural Product Number, or NPN. Health Canada requires companies to license hydration supplements, such as electrolyte powders and tablets as Natural Health Products (NHPs) when these products make health-related claims.

However, not all hydration products fall into this category, as some may be regulated as supplemented foods instead.

Not sure where to begin? You’re not alone. The process of getting an NPN can seem complicated. What ingredients are allowed? What documents do you need to demonstrate that your product is effective and safe? How do you even submit an application?

The good news is that once you understand the steps, it becomes much more manageable. So, let’s walk through it together.

What are hydration products, and why are they regulated?

Hydration products help restore fluids, electrolytes, and nutrients lost through physical activity, heat, or dehydration. You’ll find them most often in powder or tablet format. Many use ingredients like potassium or magnesium and make claims such as “helps to maintain/support normal electrolyte balance”.

Because these therapeutic claims are linked to a health benefit, Health Canada classifies hydration products as NHPs. This means they must follow specific regulations and require a Natural Product Number (NPN) before being sold legally. So, if you have a hydration mix product, your product could be a natural health product (NHP). 

What is an NPN, and why do hydration products need one?

An NPN is an eight-digit number issued by Health Canada to show that a Natural Health Product meets safety, quality, and effectiveness standards. In other words, it confirms your product has gone through a proper review process.

When your hydration product promotes electrolyte balance, fluid replenishment, or recovery, it crosses into the territory of regulated health claims. That’s why you need to go through the NPN application process, even if your product looks like a simple drink mix.

Common roadblocks to approval

Some businesses assume NPNs are only required for capsules or pills. However, that’s not the case. Products marketed as drink powders, for example, can also require licensing, depending on their ingredients and claims.

One common roadblock is the use of ingredients not found in Health Canada’s NHPID (Natural Health Products Ingredients Database). Even if the ingredient is common, if it exceeds permitted dosages or uses an unapproved form, your application could be delayed or rejected. 

What is required for a successful NPN application? 

To obtain approval, you must prepare thorough product documentation. This includes:

  • Full formulation details with ingredient source and dosage.
  • Specific health claims you plan to make and clinical evidence to support any non-monographed health claims.
  • Scientific support or evidence showing the product is safe and effective.
  • Product and ingredient testing.
  • Description of how the product is taken and how often, and any risk information.

For hydration products, scientific literature or Health Canada monographs often support these claims. Additionally, the product label must be established in accordance with the Natural Health Product Regulations and follow formatting and content guidelines, including bilingual requirements.

How to submit your application to Health Canada

Once you’ve gathered all your documentation, you’ll submit your application through the Natural and Non-prescription Health Products Directorate (NNHPD) portal. Health Canada will then review the file, assess the information provided, and issue a decision.

If your submission meets all requirements, you’ll get your NPN. But if there are issues or missing details, they’ll request clarification or reject the file. This is why having a complete, accurate application is so important. 

How long does it take to get an NPN?

Processing times depend on the application class. Class I applications, which follow a single monograph, may take about 60 days. More complex Class II or III submissions can take anywhere from 90 to 210 days, or longer.

To stay updated, you can check current timelines on the Health Canada NHP application page. 

How we help you get your NPN faster

At Quality Smart Solutions, we help clients bring hydration and wellness products to market in Canada, quickly and compliantly. Our regulatory team can: 

  • Review and provide recommendations on your formula based on adjusting formulas to align with Health Canada monographs
  • Prepare your NPN application and submits it on your behalf
  • Handle communication with Health Canada, including clarifications
  • Help design compliant bilingual product labels

We know the process inside and out. That’s why, whether you’re launching your first hydration product or expanding your line, we’ll guide you through every step to avoid delays.

Frequently asked questions

What ingredients are most commonly used for hydration products?

Ingredients such as potassium and magnesium are often used, especially when they align with Health Canada’s monographs. Still, exact forms and dosages matter, so it’s important to check the Health Canada’s NHPID (Natural Health Products Ingredients Database). 

Health Canada fees and professional services to prepare and manage your application vary depending on your formula’s complexity and application classification. 

Sometimes. International studies can be used, but they must meet Health Canada’s evidence requirements. Our team can help you determine what data is acceptable.

Don’t let compliance slow you down

With the right partner, navigating the compliance process becomes much easier. By understanding Health Canada’s expectations and collaborating with experienced regulatory advisors, you can stay compliant and reach the market more quickly.

Need help applying for an NPN? Contact us or visit our NPN Application Services page to learn more about our services.

Categories
Blog GRAS

How the GRAS Process Differs for Human Food and Animal Feed

GRAS process comparison for human food and animal feed

GRAS process comparison for human food and animal feed

When introducing a new substance into the market, one of the first questions you need to answer is whether it’s intended for human food or animal feed. This decision significantly impacts how the substance must be evaluated and documented under the GRAS (Generally Recognized as Safe) process. 

The regulatory pathway for GRAS differs depending on the target consumer. Human food GRAS notifications follow one route, while animal feed submissions involve added layers, including nutritional utility and environmental considerations. 

In this post, we’ll focus on the key differences between GRAS for human food and for animal feed, and how to ensure your submission is complete, compliant, and ready for review. Keep reading to learn more 

What is the GRAS process? 

The GRAS process allows companies to determine that a substance is safe for its intended use without submitting a full food additive petition to the FDA. Here’s how it works: 

  • For human food, a company can independently determine GRAS status with support from a panel of qualified experts. Once determined, the ingredient can be marketed without formal FDA approval. 
  • For animal feed, the process is more complex. In addition to the voluntary GRAS notification: 
  • Federal review is often required. 
  • Companies may need to file a feed additive petition. 
  • Some products may require an AAFCO ingredient definition. 
  • Others might go through the newer FDA Animal Feed Ingredient Consultation (AFIC) process. 

Each pathway depends on the ingredient’s intended use and the regulatory landscape it falls under. 

Comparing the human food vs. animal feed GRAS process 

At a glance, GRAS submissions for human food aim to prove general safety, while those for animal feed must demonstrate both safety and nutritional utility for specific species. If the ingredient is used in food-producing animals, human safety must also be considered. 

Human food GRAS notices are reviewed by the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), focusing on toxicology, dietary exposure, and historical use. They are usually transparent and less likely to involve redacted data. 

Animal feed GRAS notices go to the Center for Veterinary Medicine (CVM). These require deeper data sets, such as species-specific nutrition profiles, stability testing within feed, and sometimes environmental impact assessments. 

To help visualize these differences, the chart below outlines the main distinctions between the two GRAS pathways. 

GRAS Component Human Food Animal Feed 
FDA Review Center CFSAN CVM 
Primary Focus General safety for human population Species-specific safety and nutritional utility 
Data Transparency Mostly public with minimal redactions Often includes redacted proprietary data 
Nutritional Requirements Not always emphasized Must match AAFCO nutrient profiles 
Stability Testing Ingredient as packaged Ingredient within feed matrix and homogeneity required 
Dietary Exposure Assessment Based on national food survey data Based on average daily feed intake by species 
Environmental Assessment Not typically required Often required, especially for livestock feed 
Residue and Human Safety Not applicable Required for food-producing animals 
Regulatory Complexity Single federal pathway Federal and state layers (AAFCO, AFIC) 

Key differences in GRAS submissions 

The differences between human food and animal feed GRAS submissions go beyond just who consumes the product. They span areas like safety requirements, confidentiality, labeling, dietary exposure, and environmental impact. Below, we outline these distinctions in more detail. 

1. Use-specific safety requirements

The GRAS process is centered on intended use, not just the ingredient itself. A substance that is GRAS for human consumption may not automatically qualify as GRAS for animal feed. Intended species, dosage, and method of consumption all influence the FDA’s evaluation. 

2. Confidentiality and data presentation

Human food GRAS notifications typically include summaries of manufacturing steps and high-level safety evidence. These are often publicly accessible with little redacted content. In contrast, animal feed submissions frequently contain confidential data, such as detailed Certificates of Analysis and proprietary manufacturing information. 

3. Composition and labeling needs

Animal feed GRAS notices must include specific nutritional information like crude protein, fiber, and fat. This helps manufacturers comply with species-based dietary requirements and labeling standards set by AAFCO. Such detail is less common in human food GRAS submissions. 

4. Safety and stability testing

Both types of GRAS submissions require supporting safety data, including toxicology and genotoxicity studies. For animal feed, this data must confirm safety in the target species. If the ingredient is intended for food-producing animals, the analysis must also address potential human exposure through animal products. 

Animal feed submissions must also show that the ingredient remains stable in feed formulations and is evenly distributed. These factors help ensure consistent nutrient delivery across all servings. 

5. Dietary exposure estimates

For human food, dietary exposure is calculated using national data to determine both average and high-end consumption. Animal feed exposure estimates are simpler, relying on average feed intake data for each species. 

If an ingredient is used in livestock feed, its impact on human consumers must also be factored in. This includes evaluating potential residues in milk, eggs, or meat. 

6. Environmental and utility considerations

Environmental assessments are typically required for animal feed ingredients, especially if the ingredient or its byproducts may enter soil or water systems. These are generally not required for human food GRAS submissions. 

In addition, animal feed GRAS submissions must demonstrate utility. That means showing that the ingredient provides real nutritional or functional value to the animal. If it’s promoted as a source of omega-3s, for example, the data must confirm bioavailability. 

Need help navigating the GRAS process? 

Whether you’re preparing a GRAS notification for human food or animal feed, the regulatory requirements can be complex. At Quality Smart Solutions, our team of regulatory experts is here to guide you every step of the way, from manufacturing data to safety studies to dietary exposure assessments. 

Contact us today to ensure your next submission is accurate, complete, and aligned with FDA expectations. 

Categories
Blog

Traditional Cosmetics vs. Cosmeceuticals: What’s the Difference? 

Comparison chart showing traditional cosmetics and cosmeceutical

Comparison chart showing traditional cosmetics and cosmeceutical

Understanding the distinction between traditional cosmetics vs. cosmeceuticals is essential if you’re manufacturing or marketing skincare or beauty products in North America. While both types of products may appear similar on store shelves, they follow different regulatory pathways, and that has a direct impact on your compliance obligations. 

Whether you’re selling moisturizers, anti-aging serums, or acne treatments, knowing how your product is classified under Health Canada and the FDA can help you avoid costly enforcement issues, delays at customs, or claims that mislead consumers.  

Keep reading to learn how these categories differ, and what that means for your compliance strategy. 

What are traditional cosmetics?

In both Canada and the United States, traditional cosmetics are products intended to cleanse, beautify, or alter the appearance of the body without affecting its structure or function. These products do not claim to treat or prevent any disease and are not meant to alter bodily functions. 

Here’s a quick comparison of how traditional cosmetics are defined by regulators: 

Regulatory Body Definition Examples 
Health Canada Any substance used to cleanse, improve, or alter the complexion, skin, hair, or teeth. Lipstick, body lotion, perfume 
FDA (U.S.) Products intended for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body’s structure or functions. Shampoo, deodorant, makeup, nail polish 

Both agencies emphasize that products making only cosmetic claims (not therapeutic ones) generally fall into the traditional cosmetic category. Here are some additional insights: 

  • Health Canada defines a cosmetic as “any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth.”  
  • The FDA defines cosmetics similarly, but draws a stricter line between cosmetics and drugs. If your product makes therapeutic claims or affects the body’s structure/function, it may be regulated as a drug or both a cosmetic and drug. 

So, while makeup, shampoo, and moisturizers typically qualify as cosmetics, the moment a claim suggests treatment, healing, or bodily alteration, the classification (and even compliance path) can change significantly. 

What are cosmeceuticals?

Cosmeceuticals are often marketed as a hybrid between cosmetics and pharmaceuticals. They typically include active ingredients like peptides, retinoids, or alpha hydroxy acids that promise to improve skin health or provide anti-aging effects. 

However, here’s the catch, the term “cosmeceutical” is not officially recognized by either Health Canada or the FDA. This can create confusion, especially for businesses using the term in branding or advertising. 

In Canada, if a product makes therapeutic or drug-like claims (e.g., “reduces wrinkles” or “treats acne”), it may be regulated as a drug or a natural health product (NHP) and require additional licensing, such as a DIN or NPN. 

In the U.S., products making similar claims may fall under drug regulations, and companies must follow drug labelling and premarket approval requirements. 

Key compliance risks when misclassifying cosmeceuticals

Marketing a cosmeceutical with claims that go beyond cosmetic purposes could trigger regulatory action. These are some of the most common pitfalls: 

  • Unapproved therapeutic claims: Phrases like “heals skin” or “stimulates collagen” can reclassify your product as a drug. 
  • Missing licences: In Canada, NHPs require a product licence and a site licence. 
  • Incorrect labelling: Your product label must reflect its classification, including specific disclosures, ingredient lists, and usage instructions. 
  • Non-compliant advertising: Promoting cosmetic products with exaggerated benefits can be flagged by regulators in both countries. 

How to ensure compliance with your product 

If you’re unsure whether your product is a cosmetic, NHP, or drug, it’s important to assess your ingredients, claims, and format. Working with a regulatory partner like Quality Smart Solutions can help you navigate classification, licensing, and labelling requirements in Canada and the U.S. 

Here’s how we can support you: 

  • Regulatory classification and risk assessment 
  • Cosmetic Notification Form (CNF) submission in Canada 
  • NPN or DIN applications for therapeutic claims 
  • FDA cosmetic registration and ingredient safety 
  • Label and claims review based on product type 

Curious about how to stay compliant in both markets? Check out our tailored solutions for Canada and the U.S. under MoCRA to see how we can support your product’s success. 

Final thoughts

When it comes to traditional cosmetics vs. cosmeceuticals, the difference isn’t just in the formula, it’s in the regulatory pathway. Using the wrong classification can expose your business to fines, recalls, or costly delays. 

If you’re unsure how your product is classified or need help getting compliant, we’re here to support you. Contact us to schedule a free consultation and ensure your products are ready for market. 

Categories
Blog Regulatory Compliance

What Is an SFCR Importer of Record?

SFCR importer of record explanation for Canadian food imports

SFCR importer of record explanation for Canadian food imports

If you’re importing food into Canada, one of the key roles you’ll need to understand is that of the SFCR importer of record. To begin with, this designation comes with specific responsibilities under the Safe Food for Canadians Regulations (SFCR), and getting it right is essential for avoiding compliance headaches. 

However, the regulatory landscape is evolving. The Canada Border Services Agency (CBSA) has introduced a new system called CARM, which stands for CBSA Assessment and Revenue Management initiative. It’s designed to modernize how duties and taxes are collected, and it’s changing how businesses interact with CBSA. From registering online to posting security and submitting declarations, CARM is now a critical piece of the import process. 

In this blog, we’ll explain what an SFCR importer of record does, how CARM fits in, and what steps you need to take to stay compliant and avoid delays. Let’s dive in. 

Understanding the SFCR importer of record 

The SFCR importer of record is the entity legally responsible for ensuring that imported food products meet the Safe Food for Canadians Regulations (SFCR) and other applicable laws. This includes holding the correct food import licence, maintaining traceability records, and ensuring food safety standards are met. 

Under the SFCR, most businesses importing food for commercial sale must obtain a licence issued by the Canadian Food Inspection Agency (CFIA). In other words, this requirement applies whether you’re a distributor, broker, or manufacturer. As a result, the licence confirms your business is authorized to import food into Canada and that it maintains the necessary traceability and food safety systems. 

Whoever acts as the importer of record is responsible for meeting specific SFCR obligations, including licensing, traceability, and food safety. You can find detailed information about licensing eligibility, conditions, and the application process on the CFIA’s official food licence page. 

What is CARM and how does it affect food importers? 

CARM, or the CBSA Assessment and Revenue Management system, is a new digital platform being phased in to modernize and streamline the way duties and taxes are assessed and collected on imported goods. Once fully implemented, CARM will require all importers, including those in the food sector, to:

  • Register their business in the CARM Client Portal 
  • Post financial security (such as a surety bond) 
  • Pay duties and taxes directly through the portal 
  • Classify goods and manage accounting declarations online 

Because CARM involves customs declarations, financial posting, and accounting, it’s important for businesses to work closely with their licensed customs broker to ensure all CARM-related obligations are properly fulfilled.

For details on the CARM initiative, visit CBSA’s official CARM page.

Why accurate classification and licensing matters 

Being an SFCR importer of record isn’t just a box to check. Misclassifying goods, skipping licensing, or failing to register properly in CARM could result in: 

  • Import delays or refusals at the border 
  • Administrative Monetary Penalties (AMPs) 
  • Suspension or cancellation of your import privileges 

For this reason, many businesses choose to work with regulatory and customs experts to ensure everything is done correctly the first time. 

How regulatory experts can support you 

At Quality Smart Solutions, we help importers simplify the licensing process and avoid regulatory pitfalls. Whether you’re applying for your SFCR licence, adjusting your operations for CARM, or preparing documentation, our team is ready to guide you. 

Fortunately, you don’t need to navigate this alone. We offer tailored compliance solutions so you can focus on growing your business without worrying about setbacks at the border. 

We offer SFCR Food Licence Services designed to help you meet all regulatory requirements with clarity and confidence. Need help now? Contact us for a free consultation. 

Categories
Blog Medical Devices

How to Navigate MDL and MDEL Licensing in Canada

MDL vs MDEL explained for Health Canada compliance

MDL vs MDEL explained for Health Canada compliance

If you’re planning to sell or distribute a medical device in Canada, you’re going to hear two terms over and over again: MDL and MDEL. Understanding the difference between them is one of the first steps toward compliance with Health Canada’s medical device regulations. 

The two licences cover different parts of the process. One applies to the product itself, the other to your business. And if you get them mixed up or apply too late, you could face delays, inspection issues, or even enforcement actions. 

In this guide, you’ll learn what MDL and MDEL mean, how they apply to your operations, and how to meet Health Canada’s requirements. Whether you’re a new entrant to the Canadian market or looking to stay on track during annual renewals, this is a resource you can come back to. 

What is MDL? 

MDL stands for Medical Device Licence. This licence is issued by Health Canada to manufacturers of Class II, III, and IV medical devices. It gives formal authorization to sell those products in the Canadian market. 

To apply for an MDL, manufacturers must submit a detailed application that includes evidence related to safety, efficacy, and quality. This might involve clinical data, product testing results, and manufacturing process documentation. Health Canada reviews this information to ensure the device meets applicable standards before granting approval. 

Device classes are assigned based on risk. Class I devices pose the lowest risk and don’t require an MDL. Class II devices (e.g. contact lenses), Class III devices (e.g. ventilators), and Class IV devices (e.g. pacemakers) each require progressively more rigorous oversight. 

Once an MDL is issued, the manufacturer is expected to monitor post-market performance, report any incidents, and apply for amendments if the product is modified. 

What is MDEL? 

MDEL stands for Medical Device Establishment Licence. While the MDL is about the product, the MDEL is about the business handling that product. It applies to importers and distributors of medical devices, regardless of class. 

An MDEL shows that your business follows proper protocols for complaint handling, product recalls, storage, distribution, and recordkeeping. It’s designed to ensure that even if a company isn’t the manufacturer, it still has systems in place to protect end users. 

Unlike the MDL, which only needs to be updated when product details change, the MDEL must be renewed annually. Health Canada may conduct inspections to assess whether your quality management system and compliance practices are in place and functioning. 

Even if you deal only in Class I devices, like simple thermometers or bandages, you still need an MDEL if you’re importing or distributing them in Canada. 

Why both licences matter 

MDL and MDEL are distinct but connected. Health Canada requires that anyone involved in the medical device supply chain is traceable and accountable. This means that both the product itself and the company handling it must be reviewed and authorized. 

Failing to hold the correct licence can result in delays at customs, rejection of products, or more serious enforcement actions. For example, a foreign manufacturer trying to ship Class III devices into Canada without an MDL will not be allowed to sell.  

Similarly, a Canadian importer without an MDEL may face seizure of goods or facility inspection warnings. 

Key differences between MDL and MDEL 

MDL (Medical Device Licence) 

MDEL (Medical Device Establishment Licence) 

Required for Class II, III, IV devices 

Required for importers and distributors 

Applies to the product 

Applies to the business 

Requires safety and quality documentation 

Requires operational compliance procedures 

Valid unless cancelled or amended 

Must be renewed annually 

Reviewed by the Medical Devices Directorate 

Overseen by Health Canada’s ROEB 

Do you need both? 

Some companies only need one of the two. For example, a Class I device distributor in Canada only needs an MDEL. A foreign manufacturer of a Class III device only needs an MDL. But many companies need both. 

Let’s say you manufacture a Class II diagnostic device overseas and plan to import and sell it in Canada through your local office. You would need: 

  • An MDL for the device itself 
  • An MDEL for your Canadian establishment 

This scenario is common for global companies with regional offices. It’s also relevant to Canadian manufacturers that manage their own distribution in-house. 

Staying compliant year-round 

Holding the correct licence is not enough. You must maintain your compliance through proper documentation, training, and reporting practices. Here are some best practices: 

  • Keep records of all sales, complaints, and distribution for at least five years 
  • Maintain clear procedures for recalls and customer feedback 
  • Ensure your staff are trained on Health Canada requirements 
  • Report incidents or changes in business operations promptly 
  • Submit your MDEL renewal application before the deadline each year 

Health Canada publishes inspection summaries and issues warning letters when businesses fail to comply. Staying organized and proactive can help you avoid those outcomes. 

Where to get help 

The application process for MDL and MDEL can be complex, especially if you’re new to the Canadian market or working with limited internal resources. That’s where third-party regulatory consultants like Quality Smart Solutions can make a big difference. 

We’ve helped hundreds of companies prepare, submit, and maintain their medical device licences. Our team knows how to navigate the forms, gather the right documentation, and respond to regulatory questions. 

Contact us to get expert guidance or request a consultation. You can also visit Health Canada’s Medical Devices page for official resources and application guidelines. 

Disclaimer: This content is for informational purposes only and does not constitute legal or regulatory advice. 

Categories
Blog GRAS

Struggling With GRAS Compliance? Here’s What to Do

GRAS compliance checklist with FDA guidance

GRAS compliance checklist with FDA guidance

If you’re finding it difficult to navigate the GRAS process, you’re not alone. Whether you’re introducing a new food ingredient or formulating a novel product, understanding what it takes to meet GRAS standards can feel overwhelming. The FDA has outlined specific requirements, but without a clear plan, your submission might face delays or even rejection. 

In this guide, we’ll explain what GRAS status means, how to determine if your ingredient qualifies, and what actions you can take to move forward with confidence. If you’re unsure about the next step, this article will give you the clarity and direction you need. 

What does GRAS mean? 

GRAS stands for “Generally Recognized as Safe.” It’s a designation used by the FDA to confirm that a food ingredient is considered safe under the conditions of its intended use. According to the FDA, ingredients can achieve GRAS status through: 

  • Scientific procedures based on publicly available safety data and peer-reviewed research 
  • Common use in food prior to 1958, with a long history of safe consumption 

To meet these requirements, the evidence supporting an ingredient’s safety must be widely accepted by qualified experts and properly documented. If your ingredient doesn’t meet this standard, a food additive petition may be required instead. 

Self-affirmation or FDA notification? 

There are two main routes you can take to establish GRAS status: 

  1. Self-affirmed GRAS – You collect the data, prepare a safety dossier, and conclude internally that the ingredient is safe. No FDA review is required. 
  2. GRAS Notification – You formally notify the FDA and submit supporting documentation. The agency reviews your submission and responds with a letter, either stating they have no questions or requesting additional details. 

While self-affirmation gives you control over the process, many companies choose notification to build consumer trust and minimize regulatory risk. 

Where things can go wrong 

Even with solid scientific data, achieving GRAS status isn’t always smooth. Some common issues include: 

  • Incomplete or outdated safety data 
  • Poorly organized dossiers 
  • Limited consensus from qualified experts 
  • Gaps in toxicology or dietary exposure assessments 

Following the FDA’s expectations closely and ensuring all your documentation is current and thorough is key to moving forward successfully. 

What to do if you’re facing roadblocks 

If you’re encountering challenges with GRAS requirements, here are some practical next steps: 

1. Evaluate your ingredient carefully

Make sure your ingredient is eligible. Does it have a well-documented history of safe use? Is there reliable, peer-reviewed safety data available? 

2. Get expert support

Working with experienced consultants can make the process more efficient and reduce the risk of missteps. At Quality Smart Solutions, we help businesses build strong dossiers and prepare GRAS notifications that align with FDA standards. Contact us to learn more. 

3. Stay current on FDA guidelines

Regulatory expectations evolve. Be sure your data and approach match the FDA’s most up-to-date GRAS procedures. You can find the latest information on the FDA’s GRAS page. 

4. Be ready for audits

Even if you pursue self-affirmation, your records should be audit-ready. This includes safety studies, expert opinions, and all relevant documentation. 

Let’s get your GRAS journey on track 

GRAS is more than a checkbox. It’s the foundation for getting your product market-ready while earning consumer trust. At Quality Smart Solutions, we offer tailored support to help you move forward with clarity and confidence. Whether you’re drafting a self-affirmed GRAS dossier, submitting a GRAS notification to the FDA, or preparing for audits, our team is ready to assist. We also support: 

  • Toxicology assessments 
  • Literature reviews and safety data analysis 
  • Expert panel coordination 
  • Regulatory strategy and communication with FDA 

To explore the full range of our GRAS services, visit our GRAS Notification page. 

If you’re unsure where to start or need help refining your submission, let’s talk. Fill out our contact form to book a free consultation with one of our regulatory experts. We’ll help you chart the right path, without the guesswork. 

Categories
Food Safety News

FDA Approves Natural Food Colors for Safer Use

Natural food colors approved by FDA for use in various food categories

Natural food colors approved by FDA for use in various food categories

The FDA has officially approved three new food color additives derived from natural sources. These offer a safer alternative to petroleum-based dyes in the U.S. food supply. The approval of these natural food colors marks a big step toward cleaner labeling and healthier food options.

Moreover, this update supports the U.S. Department of Health and Human Services’ plan to phase out synthetic dyes. As part of its Make America Healthy Again campaign, the FDA is acting in response to growing demand for transparent, natural ingredients. Keep reading to learn how these newly approved colors may affect your product formulations.

What are the newly approved natural food colors?

The three FDA-approved natural color additives are: 

  • Galdieria extract blue: This blue colorant comes from red algae. It is now allowed in many products, including beverages, yogurts, smoothies, candies, cereals, dairy desserts, and whipped toppings. Fermentalg, a French biotechnology company, submitted the petition.
  • Butterfly pea flower extract: Already added to several food and drink products, its use now includes snacks like chips, cereals, and pretzels. The extract provides blue, purple, or green hues. U.S.-based Sensient Colors LLC submitted this petition. 
  • Calcium phosphate: This white colorant is now approved for ready-to-eat chicken, candy coatings, and powdered sugars. Innophos Inc. in New Jersey filed the petition. 

These approvals are especially impactful for brands seeking to eliminate artificial additives while maintaining visual appeal in their food products. 

Why this matters for your compliance strategy

Under U.S. law, manufacturers must get FDA approval before using color additives in food. This means your team needs to confirm that any new ingredient is used only in approved ways. Once approved, the colors are available for any company to use.

In addition, the FDA’s decision also signals a faster review process for future color additive petitions. According to FDA Commissioner Dr. Martin Makary, the agency is committed to expediting approvals to support a nationwide shift to safer ingredients. 

Staying ahead of regulatory change 

If your products currently use petroleum-based dyes, now is the time to start planning your transition. Reformulating with FDA-approved natural food colors not only enhances your brand’s marketability but also helps you stay ahead of potential restrictions or consumer backlash. Consider reviewing your ingredient lists and labels to determine whether your formulations may benefit from this regulatory update. 

At Quality Smart Solutions, we can support you with end-to-end regulatory services, from formulation review and label compliance to guidance on FDA submissions and ingredient approvals. Need help transitioning to natural food colorants? Contact us today to speak with our food compliance experts. 

Sources: U.S. FDA Press Release on Food Colors 

Categories
News Regulatory Updates

FDA Unannounced Inspections: What Foreign Manufacturers Need To Know 

FDA conducting surprise inspection at foreign manufacturing facility

FDA conducting surprise inspection at foreign manufacturing facility

FDA unannounced inspections are no longer limited to U.S. facilities. The U.S. Food and Drug Administration (FDA) recently announced an expansion of its unannounced inspection program to now include foreign manufacturing sites. This change will directly impact companies exporting pharmaceuticals and other regulated products into the U.S.

If you rely on international partners or operate your own facilities abroad, this update could change how you prepare for inspections. Keep reading to understand the key changes, potential risks, and how to ensure you remain compliant. 

Why is the FDA expanding unannounced inspections?

The FDA wants to strengthen oversight of global supply chains. Previously, inspections at foreign sites were usually pre-announced, which gave facilities time to prepare. However, reports of quality issues and falsified records abroad led the FDA to act. By reducing advance notice and increasing surprise visits, the agency hopes to observe day-to-day operations more accurately.

This change supports the FDA’s broader mission to protect product quality and patient safety. Because more than 70% of active pharmaceutical ingredients and many finished drugs come from outside the U.S., stronger foreign oversight is essential.

What does this mean for your business? 

If your supply chain includes foreign manufacturers, your business could feel the impact. A non-compliant facility abroad may trigger delays, import holds, or even product recalls. These outcomes can damage your brand and reduce revenue.

For companies with foreign operations, the biggest shift is the need for constant inspection readiness. Relying on advance notice is no longer safe. FDA unannounced inspections can happen at any time. If your operations fail to demonstrate consistent quality practices during a surprise visit, your company may face Form 483 observations or even stricter enforcement.

How to stay compliant

The key to managing this change is maintaining constant inspection readiness. Here’s how you can prepare: 

  • Strengthen your quality management system (QMS): Ensure your procedures are documented, up to date, and aligned with U.S. FDA expectations. 
  • Train staff regularly: Your team should understand their roles during inspections and how to respond professionally and accurately. 
  • Conduct internal audits: Regular reviews can help identify and fix gaps before the FDA does. 
  • Review supplier agreements: If you outsource manufacturing, make sure your partners are held to the same quality standards and are also prepared for unannounced inspections. 

Working with a regulatory partner can help you stay ahead of these requirements. At Quality Smart Solutions, we support companies with inspection readiness, SOP development, mock audits, and ongoing compliance strategies. 

The bottom line

The FDA’s move to expand unannounced inspections to foreign manufacturing facilities is a signal for businesses to take inspection preparedness seriously, no matter where production happens. It’s no longer a matter of if you’ll be inspected without notice, but when. 

To learn more about this update directly from the FDA, read the full press release. 

Need help preparing for potential FDA inspections or reviewing your quality systems? Contact us or fill out the form below to book a consultation with one of our regulatory experts. 

Categories
News Regulatory Updates

Health Canada electronic filing updates: Key changes in 2025

Health Canada electronic filing requirements for drug product submissions

 Health Canada electronic filing requirements for drug product submissions

If your team handles drug product submissions in Canada, there’s a recent update from Health Canada you might want to take a closer look at. As of April 1, 2025, new electronic filing rules are now in place for both eCTD and non-eCTD formats. 

These updates aim to make the submission process more streamlined and easier to manage on both sides. For many companies, it’s also a good opportunity to revisit internal systems, templates, and workflows. In this article, we’ll walk you through what’s changed, why it’s relevant, and how you can adapt with confidence. 

What changed in April 2025?

Health Canada released new guidance on how drug product submissions should be filed. This applies to both new submissions and those already in progress, especially if you’re using the non-eCTD format. Here’s a quick overview of the changes: 

  • Electronic-only submissions: All submissions must be sent electronically. Paper copies are no longer accepted. 
  • eCTD format now required for many product types: If you’re submitting to the Therapeutic Products Directorate (TPD) or Biologics and Genetic Therapies Directorate (BGTD), you need to use the eCTD format. Depending on the regulatory activity type, this may be either the mandatory or recommended format.
  • Non-eCTD is still allowed for certain products: This includes natural health products and some disinfectants, but they must now follow stricter file structure and naming rules. 
  • New validation rules:  Health Canada has updated its validation process for both eCTD and non-eCTD submissions. These rules are designed to ensure that sponsors submit properly structured and formatted transactions, reducing the chance of errors or the need for follow-up. Sponsors are encouraged to use a commercially available validation tool before filing. Once a submission is received, Health Canada performs a technical validation check. If issues are found, a validation report outlining the errors will be sent to the sponsor by email as a PDF attachment. 

You can read the full guidance on the Health Canada website. 

Why does this matter to you?

This isn’t just a technical update. If your tools, templates, or workflows aren’t ready for these changes, you could face: 

  • Delays in product approvals 
  • Extra costs for re-submissions 
  • Compliance issues 

If you’re still using paper-based processes or outdated file templates, now’s the time to make changes. Being proactive can help you avoid last-minute setbacks and keep your submissions moving forward. 

How to prepare for compliance

Here are five practical steps to help you adjust: 

  1. Review your current process 
    Look at how your team prepares and submits applications. Highlight areas that may need updates. 
  2. Update templates and file structures 
    Make sure your documents and folders match Health Canada’s new format and naming rules. 
  3. Use the right eCTD software 
    Choose a reliable tool that supports Health Canada’s updated validation checks. 
  4. Train your team 
    Everyone involved in submissions should be familiar with the new rules. Provide training if needed. 
  5. Ask for help if needed 
    If you’re unsure about anything, a regulatory partner can save you time and reduce risks. Contact us to see how we can support you. 

Final thoughts

Health Canada’s push for standardized electronic submissions is meant to improve review timelines and consistency. But to keep up, companies need to adjust how they prepare and submit documentation. 

Whether you’re working on an NDS, SNDS, or DIN application, it’s a good time to review your internal processes. Getting ahead of these changes helps reduce the chance of delays and compliance problems. 

Not sure how this update affects your next submission? Reach out to our regulatory experts or fill out the form below for personalized guidance. 

Categories
Blog FDA Health Canada Regulatory Compliance

Navigating FDA and Health Canada Rules for Eczema Products

FDA and Health Canada eczema compliance guide

FDA and Health Canada eczema compliance guide

The eczema product market continues to grow as consumer demand increases, but that doesn’t mean you can jump in without a plan. FDA and Health Canada rules for eczema products vary widely depending on the formulation and claims. Many companies risk product delays or enforcement action by misclassifying their product or using unapproved claims. 

If you’re marketing an eczema treatment in Canada or the United States, your first step is understanding whether your product is a drug, cosmetic, or natural health product (NHP). That classification affects your registration pathway, labelling requirements, and compliance obligations.  

Let’s break it down to help you choose the right path and avoid regulatory issues. Keep reading to make an informed decision. 

Product classification drives your compliance path

For both Canada and the U.S., the classification of eczema products hinges on their intended use and claims. If your product claims to treat, relieve, or prevent eczema symptoms, like inflammation, redness, or itching, it will likely be considered a drug. 

In Canada, some eczema treatments may qualify as NHPs if they contain ingredients such as colloidal oatmeal or calendula and follow approved monographs. If your product only moisturizes the skin without making therapeutic claims, it may be regulated as a cosmetic. 

Health Canada maintains a Natural Health Products Ingredients Database (NHPID) where you can verify whether your ingredients are permitted under the NHP framework: Visit the Health Canada NHPID to search ingredients and monographs. 

In the U.S., products that meet the conditions of an Over-the-Counter (OTC) Monograph, such as those containing hydrocortisone or colloidal oatmeal, may be marketed without pre-approval. If your product falls outside a monograph or makes new claims, you’ll need to file a New Drug Application (NDA). See the FDA’s OTC Drug Monograph Directory for reference. 

What you need to sell eczema products in Canada

If your eczema product is classified as an NHP, you must apply for a Natural Product Number (NPN) before selling it. This requires submitting detailed information about your product’s ingredients, claims, format, and recommended use. You’ll also need bilingual labelling and evidence of Good Manufacturing Practices (GMP). 

If your product is a cosmetic, you must submit a Cosmetic Notification Form (CNF) within 10 days of first sale in Canada. The formula must comply with the Cosmetic Ingredient Hotlist, and the label must list all ingredients in descending order of concentration. 

Some products fall into a grey area, especially if they include both moisturizing ingredients and therapeutic claims. We can help you determine the proper path to avoid compliance delays. 

What’s required in the U.S.

In the U.S., eczema treatments can be classified as OTC drugs or cosmetics, depending on claims and ingredients. For OTC drugs, you’ll need: 

  • An active ingredient listed in a final OTC monograph 
  • Drug Facts labeling format 
  • FDA establishment registration and product listing 
  • Manufacturing in a compliant facility 

If your product is a cosmetic only, it must follow the Modernization of Cosmetics Regulation Act (MoCRA), which includes registration and safety substantiation requirements. 

Trying to navigate these rules without proper guidance can lead to missteps and slow your time to market. 

Get it right the first time

Misclassifying your eczema product or making unapproved claims can result in: 

  • Refused submissions or delisting 
  • Warnings from regulators 
  • Product recalls or label changes 
  • Lost time and money 

That’s why it’s critical to classify your product correctly and align with all relevant compliance steps from the start. 

Support to streamline your compliance process

At Quality Smart Solutions, our team guides you through every stage of compliance. Whether you need help deciding if your product is an NHP or OTC drug, preparing an NPN application, or updating your Drug Facts label, we’re here to support you. 

We offer: 

  • Ingredient and product classification 
  • NPN application support 
  • Cosmetic notification filings 
  • OTC monograph compliance 
  • FDA and Health Canada label reviews 

And much more. 

Contact us or schedule a free consultation with one of our regulatory experts today to avoid costly mistakes and get your eczema product to market with confidence. 

Categories
Blog Cosmetics Regulatory Compliance

FDA vs Health Canada Cosmetic Compliance

Comparing FDA and Health Canada cosmetic compliance requirements

Comparing FDA and Health Canada cosmetic compliance requirements

How FDA and Health Canada Regulate Cosmetics Differently 

Thinking about launching your cosmetic line in North America? Whether you’re a seasoned brand or just getting started, understanding FDA cosmetic compliance vs Health Canada requirements is a must. Each country has its own set of rules, and missing even one detail can cause delays, product holds, or costly corrections. 

This guide is here to help you stay ahead. We’ll break down how the FDA’s Modernization of Cosmetics Regulation Act (MoCRA) stacks up against Health Canada’s Cosmetic Regulations.  

If you’re working with skincare, makeup, or personal care products, you’ll find out exactly what it takes to meet the requirements on both sides of the border, and how to do it with confidence. 

What qualifies as a cosmetic? 

Before diving into compliance rules, it’s important to define what’s considered a cosmetic in each jurisdiction. 

  • Health Canada defines a cosmetic as any substance used to cleanse, improve, or alter the skin, hair, or teeth without affecting the body’s structure or functions. This includes makeup, moisturizers, and shampoos. 
  • The FDA shares a similar definition but draws a sharper line between cosmetics and drugs. Any product claiming to treat or prevent a medical condition (like acne or eczema) could fall under drug regulations instead. 

If you’re unsure whether your product is a cosmetic or something else, consult Health Canada’s Cosmetic or Drug Decision Tree or work with a regulatory expert. 

Regulatory filing: Who needs to be notified? 

One of the most notable differences between FDA and Health Canada compliance lies in mandatory submissions. 

  • In Canada, all cosmetic products must be notified to Health Canada within 10 days of sale through a Cosmetic Notification Form (CNF). This includes a complete ingredient list and company details. 
  • Under MoCRA, cosmetic companies in the U.S. must register their manufacturing facilities and list their products with the FDA. This became mandatory in 2023, marking a significant shift from the previous voluntary model. The FDA’s official page on MoCRA outlines these new requirements in detail. 

Failure to complete these steps can result in enforcement actions, product holds at the border, and reputational damage. 

Ingredient restrictions and safety substantiation 

When comparing FDA cosmetic compliance vs Health Canada, ingredient requirements are another key area to watch. 

  • Health Canada maintains a Cosmetic Ingredient Hotlist, which outlines prohibited or restricted substances. Products must not contain any ingredients that pose health risks or violate this list. 
  • The FDA does not publish a similar hotlist, but MoCRA now requires companies to maintain safety substantiation. This means you must have evidence showing your cosmetic product is safe under its intended use. 

In both markets, you need to verify that ingredients comply with each jurisdiction’s requirements, including allergens, preservatives, and colourants. 

Labeling requirements: Canadian bilingual rules vs U.S. warnings 

Labeling is one of the most common compliance pitfalls. It’s also an area where Canada and the U.S. diverge quite a bit. 

  • Health Canada mandates bilingual labeling (English and French) on all cosmetic packaging, along with INCI ingredient names, product function, and net quantity. 
  • FDA labeling requirements under MoCRA include ingredient lists, product identity, and a responsible person’s contact information. You’ll also need to comply with new fragrance allergen disclosures, expected in future rulemaking. 

Make sure your artwork is reviewed by someone who understands these regional requirements, especially if you’re using the same packaging for both countries. 

Responsible party and accountability 

Under MoCRA, the U.S. now requires each cosmetic to identify a responsible person, typically the brand owner or manufacturer. This person must maintain safety records and submit product listings. 

Canada doesn’t currently have an equivalent rule, but you must still provide accurate contact information for the party responsible for the sale of the product in Canada. If you’re an international brand entering the Canadian market, this may require partnering with a Canadian Cosmetic Agent. 

Enforcement and penalties 

While enforcement has historically been more reactive than proactive in both countries, MoCRA has introduced more structured oversight. 

  • In the U.S., the FDA can now issue mandatory recalls, suspend facility registrations, and conduct inspections with more authority. 
  • In Canada, Health Canada can take enforcement action if a product is found to be non-compliant or if consumer complaints arise. This could include product seizures or public safety alerts. 

Staying proactive with your compliance can help you avoid penalties and product disruptions in both regions. 

How to enhance your compliance strategy 

Whether you’re launching a new cosmetic brand or expanding into the U.S. or Canadian market, understanding the key differences between FDA cosmetic compliance vs Health Canada is essential. 

At Quality Smart Solutions, our regulatory experts can support your team with: 

  • MoCRA facility registration and product listings 
  • Health Canada Cosmetic Notification Form submissions 
  • Ingredient and formula assessments 
  • Bilingual label reviews and compliance 
  • Ongoing regulatory monitoring and updates 

We simplify the regulatory process so you can focus on building your brand. Contact us today or fill out the form below for a free consultation. 

Categories
Health Canada News

April 2025 Updates to Medical Device Shortage Reporting

Medical devices added to Health Canada’s mandatory shortage reporting list April 2025

Medical devices added to Health Canada’s mandatory shortage reporting list April 2025

Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed. On April 17, 2025, Health Canada updated the List of Medical Devices – Notification of Shortages, adding new devices that now require mandatory reporting. 

If your business handles medical devices, understanding these updates is critical for maintaining compliance. Keep reading to learn more about the new requirements and how you can stay ahead. 

What changed in April 2025?

Health Canada has added control syringes with Luer lock tips to the list of medical devices that require mandatory shortage and discontinuation reporting. These syringes are critical in interventional and diagnostic procedures, and their absence can severely disrupt hospital workflows and patient treatments. This update strengthens Health Canada’s efforts to prevent critical device shortages that could impact patient care. 

The list of medical devices for shortage notification is incorporated by reference (IBR) into the Medical Devices Regulations. This means any updates to the list are automatically enforceable without further regulatory amendments. 

Who must report shortages?

Manufacturers of Class I to IV medical devices and importers of Class I devices must report shortages or discontinuations if their device is listed. Even components, accessories, or parts related to a medical device must be included in shortage reporting when applicable. 

Under sections 62.23 to 62.25 of the Medical Devices Regulations, failure to report a shortage could result in compliance actions. If you are a manufacturer or importer, it is your responsibility to monitor the list and submit reports when needed. 

You can find more information on the Health Canada medical device shortages web page. 

Why is medical device shortage reporting important?

Health Canada’s shortage reporting requirements aim to ensure timely interventions during device supply disruptions. By identifying shortages early, manufacturers and health authorities can coordinate responses to avoid compromising patient care. This reporting system also helps Health Canada assess market vulnerabilities and supply chain resilience.

What about voluntary shortage reporting?

In addition to mandatory reports, Health Canada encourages voluntary reporting for medical devices not listed but still facing potential shortages. You are encouraged to report shortages if: 

  • The shortage could create a safety issue for patients or users in Canada 
  • A substitute device, part, or component is not readily available 
  • The shortage is national in scope 

To submit a report, you can complete the electronic shortages reporting form or the discontinuation form if applicable. 

Tips to stay compliant with medical device shortage reporting

To meet Health Canada’s reporting requirements, it is important to: 

  • Regularly monitor the List of Medical Devices – Notification of Shortages 
  • Prepare internal procedures to identify potential shortages early 
  • Train regulatory and quality teams on how to complete shortage and discontinuation reports 
  • Keep detailed documentation of your shortage assessments 

Reports should be submitted as soon as a shortage is known or anticipated. The earlier the notification, the better Health Canada can assess and coordinate mitigation strategies. Delays in reporting could lead to enforcement actions or reputational risk.

Taking proactive steps ensures you avoid potential penalties and helps maintain trust with your clients and partners. 

How regulatory compliance experts can support you

Navigating medical device requirements can feel overwhelming, especially with frequent updates. Our team at Quality Smart Solutions is here to help you stay compliant. 

We offer a full range of regulatory support services for medical device companies, including compliance guidance, documentation support, and regulatory consulting tailored to your business needs.  

If you need assistance with your medical device regulatory obligations, contact us today to schedule a free consultation with one of our experts. We’re ready to help you protect your business and patients. 

For further guidance, you can also consult Health Canada’s Guide to reporting medical device shortages and discontinuations (GUI-0137). 

Categories
Blog Regulatory Compliance

How to Prepare a Food Additive Submission for Health Canada

Illustration of a food additive compliance checklist for Health Canada submission

Illustration of a food additive compliance checklist for Health Canada submission

Food additive submission may not be the flashiest part of launching a new food product in Canada, but it’s one of the most essential. If your ingredient isn’t listed under Health Canada’s approved food additives, you’ll need to submit it for evaluation before it can legally be used. 

Wondering what it really takes to get your food additive approved? Whether you’re introducing a new substance or updating how an existing one is used, the process can be detailed and technical.  

Keep reading to discover how to prepare a food additive submission that checks all the right boxes. We’ll walk you through what needs to be included, how to present it effectively, and how to avoid the most common pitfalls that lead to delays. 

What is considered a food additive under Canadian law? 

According to Health Canada, a food additive is any substance that becomes part of a food or alters its characteristics, directly or indirectly. This includes preservatives, colouring agents, and emulsifiers, but excludes nutrients like vitamins or minerals unless used in novel ways. 

Importantly, only additives included in the Lists of Permitted Food Additives are legal for use in Canada. If your ingredient isn’t on the list, or it is on the list but you intend to use it in a novel way, a submission to Health Canada is mandatory. 

When is a food additive submission required? 

A food additive submission is required when: 

  • The additive isn’t currently approved in Canada. 
  • The proposed use differs from the existing permitted use (e.g., new food category or higher levels). 
  • You’re introducing a new functional purpose for an approved additive. 

Health Canada uses this process to evaluate the safety, potential exposure, and benefits of the proposed additive. Without approval, using the additive could lead to compliance issues, import detentions, or even product recalls. 

Preparing your submission: key components 

To prepare a compliant submission, you’ll need to gather the following information: 

  • Identity and composition: Provide detailed information about the chemical makeup and purity of the additive. 
  • Function and benefits: Describe the technical purpose of the additive, such as preservation or thickening. 
  • Safety data: Include toxicological studies, allergenicity profiles, and any safety evaluations from other jurisdictions (like the FDA or EFSA). 
  • Exposure analysis: Estimate how much of the additive consumers are likely to ingest across different age groups and consumption patterns. 
  • Specifications and methods: Detail the manufacturing process and analytical methods used to ensure consistency and quality. 

For guidance on developing these documents, Health Canada outlines detailed requirements in their Guidelines for Food Additive Submissions, which provide a clear framework for assembling your technical dossier. 

Common mistakes and how to avoid them 

Incomplete or vague data is a leading cause of submission delays. Companies often submit documentation without clear scientific rationale or miss key elements. Here are three common pitfalls and how to sidestep them: 

  1. Missing safety data: Be proactive. Compile toxicological and dietary exposure studies upfront. 
  2. Unclear technical justification: Clarify exactly why the additive is needed and how it improves product quality or safety. 
  3. Poor formatting: Follow the structure and formatting outlined in Health Canada’s guidance to reduce review times. 

How long does approval take?

Timelines vary, but Health Canada generally completes evaluations within 12 to 18 months, depending on the complexity of the additive and the completeness of the submission. Complex submissions with international precedent may move faster, especially when supported by robust data from regulators like the FDA. 

Why expert guidance makes a difference 

Regulatory submissions are both a science and a strategy. For food innovators, startups, and global brands entering the Canadian market, partnering with an experienced regulatory team can speed up approval and reduce stress. 

At Quality Smart Solutions, we help you identify gaps early, assemble the right data, and communicate clearly with Health Canada. Our end-to-end support ensures your submission meets all regulatory expectations and avoids unnecessary revisions. 

Ready to move forward with your food additive submission?

If you’re planning a food additive submission and want to get it right the first time, we’re here to help. Our experts will guide you through every step, from dossier preparation to final approval.

Contact us today or fill out the form below to schedule a free consultation. Let’s bring your product to market with confidence and compliance.

Categories
Blog Cosmetics

How to Avoid Amazon Canada Cosmetic Delisting

Prevent Amazon Canada cosmetic delisting by staying Health Canada compliant

Prevent Amazon Canada cosmetic delisting by staying Health Canada compliantSelling cosmetics on Amazon Canada can open up a world of opportunity, but it comes with strict compliance expectations. Recently, many sellers have faced Amazon Canada cosmetic delisting due to missing or incomplete regulatory documentation. This issue not only disrupts sales but can damage your brand’s reputation and standing with Amazon. 

To prevent these setbacks, you need to align your product listings with Health Canada’s cosmetic regulations and Amazon’s documentation requirements. Keep reading to learn how to stay compliant, keep your listings live, and avoid unnecessary delistings. 

Understand Health Canada cosmetic requirements 

Before listing any cosmetic product in Canada, it’s critical to determine whether it meets the definition of a cosmetic under the Food and Drugs Act. Health Canada defines cosmetics as products applied to the body to clean, improve, or alter appearance, such as lotions, shampoos, makeup, and deodorants. 

Each cosmetic product must be supported by: 

  • A Cosmetic Notification Form (CNF) submitted to Health Canada within 10 days of first sale. 
  • A complete ingredient list using INCI names, placed on the label. 
  • Bilingual labelling that includes the product identity and net quantity. 

Failing to meet any of these criteria can make your listing non-compliant, prompting Amazon to delist it. 

You can review the official Health Canada cosmetic regulations for more guidance on ingredient safety, product classification, and compliance expectations. 

What triggers delisting on Amazon? 

Amazon requires proof that your cosmetic product is safe and authorized for sale in Canada. If Amazon’s compliance team requests documentation and you fail to provide it, your product may be suspended or removed. Common reasons for delisting include: 

  • Missing Cosmetic Notification Number (CNF confirmation) 
  • Incomplete or unverified ingredient list 
  • Labels that don’t meet bilingual or INCI requirements 
  • Products flagged as drugs or NHPs rather than cosmetics 

In some cases, sellers are unaware that their product is classified differently. Amazon may use AI or keyword-based detection to flag certain ingredients or claims, so even your marketing language can trigger a compliance review. 

What you can do to prevent delisting 

To avoid Amazon Canada cosmetic delisting, ensure that your product is registered and your documentation is organized before you list. Here are key steps to protect your listings: 

1. Submit your Cosmetic Notification Form (CNF)

You must submit a CNF to Health Canada and receive an acknowledgment email. Save this confirmation, as Amazon may ask for it at any time. For full details, refer to Health Canada’s official Guide to Notification of Cosmetics. 

2. Ensure your label meets Health Canada requirements

Make sure your label includes the INCI ingredient list, bilingual product name, and proper formatting. You can review Health Canada’s official Labelling of Cosmetics Guide to ensure your product meets all requirements. Avoid health claims that could reclassify your product as a drug or NHP. 

3. Respond quickly to Amazon’s compliance requests

If Amazon contacts you requesting documentation, act fast. Delays in responding can result in your listing being pulled. Prepare a compliance folder with your CNF, ingredient list, and label in advance. 

4. Get support from a regulatory expert

If you’re unsure whether your product meets cosmetic classification or label rules, working with a compliance partner can help. At Quality Smart Solutions, we guide businesses through Health Canada cosmetic notification, bilingual labelling, and Amazon compliance submissions. 

Stay compliant and keep your products listed 

You work hard to build your brand. Don’t let a preventable mistake interrupt your sales. By proactively meeting Health Canada’s cosmetic requirements and being ready to respond to Amazon’s requests, you can protect your listings and grow with confidence. 

Need help with your CNF submission or cosmetic classification? Visit our Amazon Canada Compliance page or explore our Cosmetics services page for more information. You can also contact us or fill out the form below to book a free consultation with one of our regulatory experts. 

Categories
FDA News

FDA announces ESG NextGen launch for industry submissions

Screenshot of FDA ESG NextGen Unified Submission Portal with real-time tracking

Screenshot of FDA ESG NextGen Unified Submission Portal with real-time tracking

FDA ESG NextGen is now officially live. If your company needs to submit regulatory documents to the FDA, you’ll now use this updated system instead of the retired WebTrader platform. 

The launch marks a major infrastructure upgrade. With improved file handling, automated submission tracking, and strengthened cybersecurity, ESG NextGen is designed to reduce submission errors, improve visibility, and support a more efficient regulatory process. 

Keep reading to find out how to register, what’s new, and how you can prepare your team. 

What is FDA ESG NextGen? 

FDA ESG NextGen is the modernized version of the Electronic Submission Gateway (ESG). Developed under the Prescription Drug User Fee Act (PDUFA) and Biosimilar User Fee Act (BsUFA) commitments, the platform was created to resolve performance issues with the older system and support high-volume, complex submissions across industry sectors. 

If your company regularly interacts with the FDA through structured electronic submissions, ESG NextGen is now your official point of access. 

Benefits of the new ESG NextGen system 

Here’s what makes this new platform easier and more efficient for you: 

  • User-friendly portal: The Unified Submission Portal (USP) has replaced WebTrader with a more intuitive design. 
  • Real-time tracking: You can check the status of your submission anytime. 
  • Stronger cybersecurity: With multi-factor authentication and better access control, your data stays protected. 
  • Automated workflows: The API feature allows your systems to connect directly and send updates automatically. 
  • Simplified requirements: You won’t need a signing certificate for USP submissions. 

How to register and get started 

To start using FDA ESG NextGen, visit the official FDA ESG NextGen registration page to log in or create your account. 

During your first submission, you’ll be prompted to download the File Catalyst Transfer Agent. This tool helps speed up your file transfers and ensures secure delivery. 

You can also review official training resources before getting started: 

Daily drop-in support sessions 

If you need help navigating the system, the FDA is offering live support. You can join daily drop-in sessions until April 25, 2025, at 1:00 PM ET via Microsoft Teams. Each session is open to the public but limited to 1,000 attendees, so be sure to join early to secure a spot. 

Common questions from businesses 

If you’re getting ready to switch to FDA ESG NextGen, you likely have a few questions. Here are some of the most common ones that companies are asking as they transition to the new system:  

Will WebTrader still work? 

No. WebTrader has been retired as of April 14, 2025. 

Do I need new software?

Yes. The system will prompt you to install the File Catalyst Transfer Agent when you begin. 

Can I still use AS2?

Yes. AS2 remains supported and still requires a signing certificate. 

Is a signing certificate needed for USP?

No. Signing certificates are no longer required for USP submissions. 

Make your transition smooth 

The launch of FDA ESG NextGen represents a shift in how companies manage regulatory communications with the FDA. Adapting quickly is essential to avoid submission delays and ensure continuity in product registration or compliance filings. 

Need help registering or planning your next submission? Contact us today or fill out the form below to get a free consultation with one of our experts. Talk to a Quality Smart Solutions expert today and ensure your FDA compliance process is ready to go. 

Categories
EFSA News Regulatory Updates

EFSA Opens 2025 Call for Novel Food Advice to SMEs

EFSA advisory support for novel food SME applications in 2025

EFSA advisory support for novel food SME applications in 2025

Are you a small or medium-sized business (SME) planning to launch a novel food in the European Union? If so, this is your chance to receive free EFSA novel food advice before submitting your application. The European Food Safety Authority (EFSA) has launched its second call for expressions of interest, specifically targeting SMEs preparing for novel food approvals. 

Whether you’re still in early development or putting the final touches on your application, EFSA is offering tailored support to help you get it right from the start. Keep reading to learn how this advisory service can simplify your regulatory path and how to apply before the June 12, 2025 deadline. 

What is EFSA’s SME advisory service?

EFSA’s initiative helps SMEs navigate the complex novel food application process in the EU. Through this call, eligible SMEs can access the General Pre-Submission Advice (GPSA) service in one of two formats: 

  • Early advice meetings for those still developing their novel food 
  • Pre-submission meetings for applicants close to finalizing their dossiers 

These virtual consultations are designed to address your specific questions about the rules, requirements, and documentation needed to move forward with confidence. 

Why apply for EFSA novel food advice?

For many SMEs, navigating EU regulations for novel food approval can be daunting, especially without prior experience. EFSA’s free advisory service offers several advantages: 

  • Clarifies regulatory expectations and content requirements Avoids
  • common mistakes that delay approvals 
  • Improves submission quality from the outset 
  • Saves time and resources during the intake phase 
  • Boosts your application’s success rate 

Last year, 47 SMEs benefitted from this service. Most participants found the sessions highly valuable, particularly those unfamiliar with EFSA procedures. 

Who’s eligible?

To qualify for EFSA’s 2025 advisory service, your business must meet the following criteria: 

  • Be an SME under the EU’s definition 
  • Intend to submit a novel food or traditional food application to the European Commission 
  • Have limited or no prior experience submitting novel food applications 
  • Submit questions that fall within the scope of EFSA’s GPSA services 

Even if you participated in the 2024 edition, you’re welcome to apply again-as long as your request concerns a different novel food. 

Application timeline and process

If you’re planning to take advantage of this opportunity, make sure you stay on top of the timeline. Here are some key dates to remember: 

  • Deadline to apply: June 12, 2025 at 13:00 CEST 
  • Meetings scheduled: April to July 2025 (rolling basis) 

To apply, you’ll need to fill out the Expression of Interest form through Microsoft Forms. Your submission should include a description of your novel food, intended market, timeline for submission, and your regulatory questions. 

EFSA will review each application as it’s received. If you meet the criteria, they’ll contact you to schedule your advice session. 

What to expect in your meeting 

In early advice meetings, EFSA will guide you on: 

  • Regulatory scope and EFSA’s role 
  • Key documents and how to use EFSA platforms 
  • Confidentiality protocols and study notification requirements 

In pre-submission meetings, you’ll receive insight into: 

  • Common dossier pitfalls 
  • Administrative and scientific expectations 
  • Documentation do’s and don’ts 

No informal assessments will be conducted. EFSA provides advice only within the limits of current guidance. 

Need help preparing your EOI?

At Quality Smart Solutions, we support SMEs in the food and ingredient sectors with regulatory strategy, document preparation, and application reviews. If you’re considering applying for EFSA novel food advice, our team can guide you through the eligibility requirements and help prepare a compelling submission. 

Contact us or fill out the form below to get a free consultation with one of our experts and explore how we can help you with your EU compliance journey. 

Categories
Blog Health Canada Natural Health Products (NHPs)

What’s the Difference Between Functional Foods and NHPs?

Functional food and natural health product examples like protein bars and mushroom capsules

Functional food and natural health product examples like protein bars and mushroom capsules

If you’re planning to launch a product like a protein bar, electrolyte drink, or mushroom supplement in Canada, it’s important to understand the difference between functional foods and NHPs (natural health products). If you don’t, you could run into problems like compliance issues, delays, or even product recalls. Figuring out which category your product falls into is one of the first steps toward getting it approved and ready for sale.

This article will break down the essential distinctions between Functional Foods and Natural Health Products. You’ll learn how to spot the differences and avoid costly mistakes. Keep reading to discover how to align your product with Health Canada’s classification framework and stay on track for a smooth market launch.

Understanding the difference 

Health Canada separates Functional Foods and Natural Health Products (NHPs) based on composition, intended use, format, and how consumers perceive them. For example, fortified beverages and protein powders might fit either category depending on their ingredients and marketing.

You can refer to Health Canada’s classification guidance for specific criteria. To make this comparison easier, here’s a visual breakdown:

Functional Foods vs. NHPs infographic

Key considerations for classification 

Before entering the market, you need to know how your product will be regulated. Health Canada uses several factors to determine the correct classification. Here’s how to start evaluating whether your product fits better as a Functional Food or a Natural Health Product:

  • Ingredients: Does your product include medicinal components like high-dose caffeine or isolated vitamins? If so, it’s likely an NHP.
  • Health claims: Statements like “boosts memory” or “relieves stress” typically require an NPN, placing the product in the NHP category.
  • Format: Capsules, tablets, or tinctures are usually NHPs. In contrast, snacks, beverages, and bars are generally considered foods – unless other criteria suggest otherwise.

Steps to ensure compliance 

Once you’ve identified whether your product leans more toward a Functional Food or a Natural Health Product, it’s time to make sure you’re following the right regulatory path.  

The steps below can help reduce compliance risks and prepare you for a smoother market entry. 

  1. Assess your product thoroughly: Consider your ingredients, claims, and format to determine classification. 
  2. Use Health Canada resources: Review classification guidelines and consult the Natural Health Products Ingredients Database. 
  3. Work with regulatory experts: Avoid mistakes and save time by partnering with professionals who understand the classification process. 
  4. Review your labels and marketing language: Ensure that product packaging and promotional materials align with your product’s classification to avoid non-compliance issues. 
  5. Plan for post-market obligations: If your product qualifies as a Natural Health Product, be prepared to follow GMP requirements, maintain safety records, and submit adverse event reports if necessary. 

Get expert support 

Classifying your product correctly in Canada can feel overwhelming. But you don’t have to do it alone. At Quality Smart Solutions, we guide companies through every step of compliance. From product classification to label reviews, we help make the process smoother.

We also offer full-service support for natural health products and food compliance in Canada. Whether you’re launching a protein bar, a supplement, or a new beverage, our regulatory experts can help you navigate your next steps. 

Contact us today or fill out the form below to get a free consultation with one of our experts. 

When your product is classified properly, it earns consumer trust, shortens approval times, and sets your business up for success.

Categories
Blog Health Canada Natural Health Products (NHPs)

What Is an NPN and Why It Matters in Canada?

Natural health product label showing its NPN issued by Health Canada

Natural health product label showing its NPN issued by Health Canada

If you plan to sell a natural health product in Canada, you’ve probably asked what an NPN is and why it’s important. A Natural Product Number (NPN) is an eight-digit identifier issued by Health Canada that confirms a product has been assessed and approved for safety, efficacy, and quality. The NPN is product-specific and must appear on the packaging of a product for sale.

Without an NPN, your product cannot be legally sold in Canada. Even if it’s available internationally, you still need Health Canada’s approval to enter the Canadian market. Without it, you risk enforcement actions, limited distribution opportunities, and a lack of trust from both retailers and consumers.

Keep reading to learn how the NPN process works and why it’s essential for compliance and consumer trust. Want a quick visual overview first? Check out our infographic below.

What is an NPN? Infographic

What is an NPN? 

An NPN is a licensing number assigned by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD). It ensures that your product meets strict quality standards and is safe for public use and consumption.

You’ll find the NPN printed on the product label or carton of every authorized natural health product sold in Canada. In this context, NPNs can appear in products like vitamins, minerals, herbs, and other natural health products.

Why do you need an NPN?

Canada has one of the most regulated markets for natural health products in the world. An NPN shows that your product has gone through a proper and extensive review process for safety and efficacy. This helps protect consumers and builds credibility with retailers and distributors. 

Selling without an NPN is highly risky and could have major implications. You could face enforcement actions, product recalls, or penalties. If you want to successfully enter the Canadian market, securing an NPN is a must. 

What products require the number?

If your product is marketed with health claims and contains naturally derived ingredients, you probably need an NPN. This includes: 

  • Multivitamins and minerals 
  • Probiotics and enzymes 
  • Herbals 
  • Amino acids and essential fatty acids 
  • Traditional medicines 

You can find full details on what qualifies as a natural health product on Health Canada’s official website.  

How to get an NPN in Canada

To receive an NPN, you must submit a product licence application to Health Canada. The application may include: 

  • Product formulation
  • Evidence supporting the safety and efficacy of the product 
  • Proposed health claims and recommended use 
  • Manufacturing and quality control processes 
  • Product label information

Depending on your product’s complexity, the review process can range from 60 days to several months. This makes planning ahead critical for a successful launch. 

Need help with your application?

Many companies struggle with delays and rejections because of incomplete applications or missing documentation. Working with a regulatory expert ensures your submission meets all of Health Canada’s requirements and moves through the system faster. 

At Quality Smart Solutions, we help businesses navigate every step of the NPN process. Whether you need full application support or advice on specific sections, we’ve got the expertise to guide you through. 

Explore our full NPN application services to see how we can support your compliance goals. Ready to move forward? Fill out the form below to book a free consultation with one of our experts, or contact us directly to get in touch. 

Categories
Blog Regulatory Compliance

Food and Supplement Labeling: Canada vs US Requirements

Canada vs US food and supplement labeling requirements

Canada vs US food and supplement labeling requirementsIf you’re trying to bring a food or supplement product to both the Canadian and US markets, you’ve probably already noticed how complicated labeling can get. Maybe you’ve had a label approved in one country but rejected in the other, or you’ve found yourself buried in pages of inconsistent regulations. You’re not the only one facing this. 

We get it. You’re just trying to do the right thing and get your product on shelves, without wasting time or money on rework. Labeling shouldn’t feel like navigating a maze.

That’s why we created this guide. It walks you through the key differences between Canadian and US labeling rules so you can move forward with clarity. Let’s break it down.

Different regulators, different frameworks 

In the United States, the Food and Drug Administration (FDA) regulates both food and dietary supplements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). You can learn more on the FDA’s Food Labeling and Nutrition page. Supplements follow additional rules under the Dietary Supplement Health and Education Act (DSHEA). 

Meanwhile, in Canada, Health Canada and the Canadian Food Inspection Agency (CFIA) regulate food under the Food and Drugs Act and the Food and Drug Regulations (FDR). You’ll find more information Health Canada’s Food Labelling page.  

Supplements, categorized as Natural Health Products (NHPs), are governed by the Natural and Non-prescription Health Products Directorate (NNHPD). You can explore their guidance on Health Canada’s NHP Regulations page. 

Food vs supplement labeling: Core differences 

Before diving into the specifics, it’s important to recognize that food and supplements are regulated very differently, even within the same country. These differences impact everything from your panel layout to what claims you’re allowed to make.  

Here’s a side-by-side comparison of the most significant distinctions between Canada and the US for both food and supplements:

Requirement Canada – Food Canada – Supplements (NHPs) US – Food US – Supplements 
Regulator CFIA / Health Canada NNHPD FDA FDA (DSHEA) 
Label Format Nutrition Facts Table (NFT) or Supplemented Food Facts TableProduct Facts TableNutrition Facts Supplement Facts 
Language Bilingual (English and French) Bilingual English only English only 
Ingredient Disclosure Mandatory, descending by weight Mandatory, must align with licence Mandatory, descending by weight Mandatory for active ingredients 
Health Claims Basic nutrient claims permitted with evidence Strictly controlled by monographs and licenced claims with evidencePermitted (must be truthful) Structure/function allowed with disclaimer 
Unique ID Not applicable NPN (Natural Product Number) Not applicable None 
Allergen Disclosure Mandatory Mandatory Mandatory (FALCPA) Mandatory (if applicable) 

Health claims and disclaimers 

In Canada, both food and supplement claims must comply with strict requirements: 

  • For food: Only certain nutrient content and function claims are allowed unless pre-approved. 
  • For NHPs: Claims must align with Health Canada’s published monographs or be supported by clinical evidence. 

In contrast, the US allows structure/function claims on supplements, as long as you include the following disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” 

However, disease reduction claims for both categories must receive FDA authorization based on significant scientific agreement.

Common compliance pitfalls and how to avoid them 

Trying to reuse the same label across markets is a common, and often costly, mistake. For instance, missing bilingual requirements in Canada, using unapproved claims, or confusing Nutrition Facts with Supplement Facts can all trigger compliance issues. 

The good news? These challenges are manageable with the right support. With expert support, you can get ahead of these challenges and launch with confidence. At Quality Smart Solutions, we offer practical services to help you avoid these setbacks: 

  • Label audits for both food and supplements 
  • Product classification assistance (is it a food or a supplement?) 
  • NHP product license applications 
  • Supplement Facts and Nutrition Facts compliance reviews 
  • Ingredient and claim assessments 

With expert guidance, you can move confidently into new markets knowing every label meets local requirements before your product hits the shelf. 

Final thoughts 

Food and supplement labeling requirements differ substantially between Canada and the US. What passes in one country may be flagged in another, even for the same product. By understanding the nuances of each regulatory system, you’ll save time, reduce risk, and protect your brand. 

Need expert help? Contact us or fill out the form below to streamline your compliance process and launch with confidence. 

Categories
FDA News

FDA Releases Cosmetic Facility & Product Registration Summary

FDA summary data - cosmetic facility and product registration

FDA summary data - cosmetic facility and product registrationOn March 13, 2025, the U.S. Food and Drug Administration (FDA) released its first public summary data on the mandatory registration of cosmetic product facilities and the listing of cosmetic products, as required under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). 

If you’re a manufacturer, processor, or brand owner distributing cosmetics in the U.S., this release marks a key moment. It signals the FDA’s increased oversight and commitment to transparency. Keep reading to learn how these updates may impact your regulatory obligations and what you need to do to stay compliant. 

Overview of MoCRA Requirements

Under MoCRA, all facilities that manufacture or process cosmetic products for distribution in the United States must register with the FDA and renew this registration every two years. Additionally, a “responsible person” must list each marketed cosmetic product with the FDA, including product ingredients, and provide annual updates. 

Exemptions apply to certain small businesses and to specific products and facilities already regulated as drugs or medical devices. 

Key Highlights from the FDA’s Summary Data 

The FDA’s new public data provides a snapshot of: 

  • The number of cosmetic facilities that have registered to date 
  • Volume and categories of product listings 
  • Common ingredients reported in listings 

The FDA’s Registration and Listing of Cosmetic Product Facilities and Products page provides access to this data. This release helps both regulators and industry stakeholders better understand the current landscape and prepare for future compliance initiatives. 

What This Means for Cosmetic Companies 

If you manufacture, process, or market cosmetic products in the U.S., it is your responsibility to ensure your facility is registered and your products are properly listed. The release of summary data signals increased monitoring and expectations for compliance. 

To stay compliant, ensure you: 

  • Register your facility with the FDA and renew every two years 
  • List each marketed cosmetic product and its ingredients 
  • Submit updates annually or when changes occur 

Companies unsure of their obligations or seeking regulatory support are encouraged to consult with regulatory specialists. Quality Smart Solutions offers full-service assistance with FDA cosmetic registration and listing. 

Accessing FDA Guidance and Support 

If you’re unsure how these requirements apply to your business or want help completing your FDA cosmetic registration, Quality Smart Solutions can guide you through every step. Fill out the form below for a free consultation or contact us directly to speak with a regulatory expert.  

For more detailed information, consult the following FDA resources: 

Categories
Food Safety News

FDA to Extend Food Traceability Rule: What You Need to Know

FDA announcement on plans to extend Food Traceability Rule compliance date

FDA announcement on plans to extend Food Traceability Rule compliance dateThe FDA Food Traceability Rule compliance date could soon be pushed back. The U.S. Food and Drug Administration (FDA) is planning to give businesses an extra 30 months to fully comply with the final rule’s requirements. 

Why is this happening now, and what does it really mean for your business? While the extension isn’t official yet, the FDA is expected to move forward with a formal proposal. Could this give your organization the breathing room it needs, or is this a sign to speed up your compliance efforts? Let’s explore what’s behind this move and what comes next. 

Why is the FDA extending the timeline?

After receiving significant industry feedback, the FDA recognized that businesses need more time to coordinate with supply chain partners and implement the final rule effectively. The rule, part of the FDA’s Food Safety Modernization Act (FSMA) rollout, requires a higher level of traceability and collaboration across sectors than ever before. 

Even companies that were on track to comply by January 2026 voiced concerns about depending on supply chain partners who may not be ready. To ensure the rule’s full public health benefits, the FDA intends to allow the entire industry additional time to prepare. 

What Is the FDA Food Traceability Rule?

The FDA Food Traceability Rule, part of FSMA, introduces additional recordkeeping requirements for companies that manufacture, process, pack, or hold foods listed on the FDA’s Food Traceability List.

In particular, this applies to high-risk foods such as leafy greens, fresh-cut fruits, seafood, and cheeses. Specifically, the rule aims to improve how these foods are tracked throughout the supply chain, so potentially contaminated products can be identified and removed much faster.

Moreover, businesses are required to maintain Key Data Elements (KDEs) for Critical Tracking Events (CTEs) such as growing, receiving, transforming, creating, and shipping. In doing so, these records help regulators trace contaminated products more quickly, ultimately preventing foodborne illnesses and protecting public health.

What does this mean for your business?

An extended compliance date means your business will have more time to: 

  • Collaborate with supply chain partners to ensure seamless data sharing. 
  • Integrate or upgrade traceability software and systems. 
  • Train your team on new recordkeeping and data management protocols. 
  • Work directly with regulatory experts to identify and address compliance gaps. 

However, it’s critical to treat this extra time as a strategic advantage, not a reason to delay. While the compliance date extension offers temporary relief, the requirements of the final rule remain unchanged.  

Ready to Get Compliant?

At Quality Smart Solutions, we’re here to help your organization navigate complex FDA regulations like the Food Traceability Rule. From conducting gap assessments to implementing best-in-class traceability solutions, we ensure you stay compliant and ahead of regulatory deadlines.  

Let’s discuss how we can support your compliance journey. Contact us today to learn more or fill out the form below for a free consultation with one of our regulatory experts. For the FDA’s official statement, view the full update here. 

Categories
Cannabis Health Canada News

Health Canada Announces Amendments to Cannabis Regulations

cannabis plant in a licensed cultivation facility

cannabis plant in a licensed cultivation facilityAs of March 12, 2025 Health Canada has implemented changes to the Cannabis Act and its Regulations. These changes may impact licensed operations as well as current applicants.

While some of these changes apply immediately, others have transition periods to give businesses time to adjust. Understanding these updates now can help you stay compliant, cut unnecessary costs, and take advantage of new opportunities. 

Keep reading to find out how these updates affect your business and what you need to do next. 

Key Cannabis Regulation Changes and Their Impact 

1. Expanded Micro Licensing Production Allowances

One of the most significant updates is the expansion of micro licensing production allowances. These changes are expected to have a substantial impact on smaller operators:

  • Micro cultivators will now be able to have a growing space of 800 square meters (up from 200 square meters)

  • Micro processors will now be able to process up to 2,400 kg of cannabis annually (up from 600 kg)

These changes will allow smaller operations to expand and operate without the significant financial burden of standard license fees. For standard businesses operating within these new thresholds, there may be opportunities to reduce annual costs by applying to change from a standard to a micro licence.

2. Administrative & Reporting Relief for Licence Holders

Health Canada has also introduced measures to ease the administrative burden and improve operational flexibility:

  • Changes to import and export requirements

  • Reduction in physical security requirements

  • Adjustments to monthly and annual reporting obligations

These updates are designed to streamline processes and reduce operating costs for cannabis businesses of all sizes.

3. Lower Compliance Costs & Simplified Licensing

Health Canada has streamlined cannabis licensing and reporting obligations, reducing administrative workload for licensed producers and processors.

  • Less frequent reporting requirements for cannabis license holders

  • Reduced documentation burden for compliance submissions

  • Significant cost savings on operational compliance efforts

4. Cannabis Tracking System Overhaul

The Cannabis Tracking System Order has been revised to exclude cultivation waste (e.g., leaves, branches, and shoots) from mandatory tracking requirements.

  • Cannabis cultivators can focus on core business operations instead of excessive reporting

  • Reduces unnecessary tracking of non-consumable plant materials

5. Expanded Industrial Hemp Market Opportunities

The definition of industrial hemp now includes derivatives from certain plant parts, provided they do not contain isolated or concentrated phytocannabinoids.

  • New opportunities for hemp-based product innovation

  • Easier regulatory approval for hemp-derived extracts

  • Greater flexibility for companies in the hemp industry

6. Packaging and Labelling Modernization

Health Canada has made several important revisions to packaging and labelling requirements, expected to benefit consumers, retail staff, and producers alike. Processors will have one year to comply with these updates.

  • Allowing the cap and container to be different colours

  • Allowing cut-out windows for dried cannabis, fresh cannabis, and cannabis seeds

  • Allowing transparent packaging for dried cannabis and fresh cannabis

  • Allowing images and information on wrappers if required by another act or regulation (e.g., the universal recycling symbol)

  • Permitting co-packing for dried cannabis, fresh cannabis, cannabis extracts, cannabis topicals and edible cannabis (all items must be identical; THC limits still apply)

  • Removing the requirement to include a packaging date on the outermost co-pack label

  • Permitting the use of an additional barcode (e.g., a QR code)

  • Allowing accordion and peel-back labels

  • Allowing informational inserts or leaflets

  • Removing the requirement to include an equivalency statement

  • Removing the requirement to state “No expiry date has been determined”

  • Requiring only total THC and total CBD on potency labels

  • Allowing potency information font to match the size of the health warning message

  • Permitting a 7-day variance in the packaging date shown on the label

7. Changes to Consumer Information Documents

Previously, cannabis processing license holders were required to distribute a Consumer Information Document with every shipment. As of March 12, 2025, this is no longer mandatory. Instead, a revised document will be released on April 10, 2025, exclusively for:

  • Medical cannabis sales license holders

  • Hospital administrators

  • Simplified product distribution for cannabis manufacturers

  • Fewer documentation requirements for cannabis shipments

For more details, see the official Health Canada announcement.

For more details, see the official Health Canada announcement. 

Compliance and Transition Periods 

While the amendments are in effect, certain provisions allow a transition period for businesses to adapt to new regulations. 

Ensuring compliance with Health Canada’s cannabis regulations is critical to avoid penalties or business disruptions. To stay compliant, you can: 

  • Review the full regulatory
  • Assess how the changes impact your licensing and compliance processes. 
  • Consult with regulatory experts to ensure smooth implementation. 

How Compliance Experts Can Help 

Navigating regulatory updates can be complex. Quality Smart Solutions specializes in compliance consulting for the cannabis industry. Our experts can help you: 

  • Understand how the new regulations impact your business. 
  • Ensure your licensing and compliance requirements are met. 
  • Provide ongoing support to keep your business aligned with Health Canada’s regulations. 

Have questions? Contact us for expert guidance. Fill out our contact form or email us at info@qualitysmartsolutions.com. 

Final Thoughts 

These regulatory amendments mark a positive shift toward reducing compliance burdens for cannabis businesses while ensuring public health and safety. Companies in the cannabis and hemp sector should take proactive steps to adapt to these changes and maintain compliance. 

For the latest updates, refer to official Health Canada sources: 

Categories
Dietary Supplements & OTC Drugs News

Health Canada Proposes Changes to Caffeine as a Supplemental Ingredient

Health Canada’s proposed changes to caffeine as a supplemental ingredient.

Health Canada’s proposed changes to caffeine as a supplemental ingredient.Changes are on the horizon for caffeine as a supplemental ingredient, and they could directly impact your business. Whether you manufacture energy drinks, snack bars, or functional beverages, these updates will determine how you formulate and market your products moving forward. 

At the same time, Health Canada is tightening regulations to ensure consumers stay informed and protected, which means businesses must adapt. In this article, we’ll break down exactly what’s changing, why it matters, and what you need to do to stay compliant.  

So, keep reading to make sure your business is ready for these regulatory shifts. 

What are the proposed changes? 

Health Canada is updating the List of Permitted Supplemental Ingredients to include new requirements for caffeine use in certain supplemented foods. One of the key changes is the introduction of a mandatory cautionary statement: “Do not [eat/drink] on the same day as any other source of caffeine” for solid supplemented foods containing more than 56 mg of caffeine per serving.  

Specifically, this applies to products such as chocolate confectioneries, protein-isolate- and cereal-based bars, chewing gums, and the newly proposed category of gummies. 

Moreover, new labelling requirements will take effect, giving businesses until January 1, 2028 to comply. The goal is to enhance consumer awareness and reduce excessive caffeine consumption. 

In addition, Health Canada is revising the conditions under which caffeine as a supplemental ingredient can be added to foods. These changes focus on: 

1. Permitted food categories

Firstly, limiting caffeine supplementation to specific food and beverage types. 

2. Maximum allowable levels

Secondly, adjusting the amount of caffeine permitted per serving to align with safety assessments. 

3. Labelling requirements

Finally, strengthening disclosure to ensure consumers understand caffeine content and potential health impacts. These changes aim to mitigate risks associated with excessive caffeine consumption, particularly among vulnerable populations such as children and pregnant individuals. 

Who will be affected? 

Manufacturers and distributors of supplemented foods, including energy drinks, snack bars, and functional beverages, must assess their product formulations to ensure compliance. Otherwise, non-compliance could result in reformulation needs, relabelling efforts, or even product removal from the market. 

In particular, if your product includes caffeine as an additive, now is the time to review your ingredients and packaging in alignment with the new guidelines. 

List of Permitted Supplemental Ingredients 

Health Canada maintains a List of Permitted Supplemental Ingredients, detailing ingredients approved for use in supplemented foods, along with their specific conditions. Specifically, if your product contains caffeine, it’s essential to check this list to ensure compliance with the latest regulations.  

By doing so, you can help prevent reformulation delays and ensure your products remain on the market. 

How to stay compliant 

To prepare for the proposed regulatory changes, businesses should take a proactive and strategic approach. Here’s how you can get started:

  1. First, review product formulations: Assess caffeine levels and ensure they align with the new permitted thresholds. This will help you avoid costly reformulations later.
  2. Next, update labelling: Ensure packaging includes required caffeine disclosures and safety warnings. Businesses have until January 1, 2028, to comply with new labelling requirements. Taking early action can smooth your transition. 
  3. Monitor regulatory updates: Stakeholders can stay informed by signing up for Health Canada’s Consultation and Stakeholder Information Management System (CSIMS). That way, you won’t miss critical updates.
  4. Also, submit feedback: Industry stakeholders can provide input on the proposed modifications until May 21, 2025, by emailing food.ibr-ipr.aliments@hc-sc.gc.ca with “caffeine (P-SIS-25-01)” in the subject line. Your input may help shape the final regulations.
  5. Finally, consult compliance experts: Work with regulatory specialists to navigate changes efficiently. They can help you stay ahead and avoid unnecessary risk.

Why this matters for your business 

Regulatory changes can impact product development timelines, marketing strategies, and overall brand reputation. Therefore, staying ahead of compliance updates helps prevent costly disruptions and ensures consumer trust in your products. 

At Quality Smart Solutions, we specialize in helping businesses navigate evolving regulations. If you need assistance ensuring compliance, contact us today or fill out the form below.

Categories
FDA FDA GRAS News

Self-Affirmed GRAS May End – What It Means for You

FDA self-affirmed GRAS

FDA self-affirmed GRASThe self-affirmed GRAS pathway may soon be eliminated. On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the FDA to explore rulemaking to remove the option for companies to self-affirm that food ingredients are safe. If implemented, this shift will require all GRAS determinations to undergo FDA review, significantly altering the regulatory landscape for food manufacturers. 

This decision follows concerns that self-affirmed GRAS has allowed food ingredients into the market without FDA oversight, raising questions about transparency and safety. If this change moves forward, it could bring significant shifts for businesses like yours. Understanding what this means now can help you stay ahead of the curve and ensure compliance. Keep reading to find out what steps you should take next. 

Why Is FDA Reviewing the Self-Affirmed GRAS Pathway? 

The self-affirmed GRAS process enables companies to determine ingredient safety based on publicly available scientific data without requiring FDA review. While voluntary GRAS notifications exist, they are not mandatory, meaning some ingredients enter the market without FDA awareness. 

HHS has cited concerns that this “loophole” undermines consumer confidence and creates risks due to insufficient transparency. Under the proposed rule change, companies would need to formally notify the FDA of GRAS determinations and await review before marketing their ingredients. 

Potential Delays Due to FDA Staffing Cuts 

One major concern surrounding this change is the FDA’s ability to manage the increased workload. Recent federal employee cuts have significantly reduced staffing at the FDA, which could lead to prolonged review times for GRAS determinations. 

For businesses relying on timely approvals for new food ingredients, these delays could disrupt product launches and supply chains. Planning ahead and seeking expert regulatory guidance will be essential to mitigate potential slowdowns. 

How to Prepare for the GRAS Rule Change 

1. Stay updated on FDA announcements

Regulatory changes can move quickly. Regularly check the FDA website and industry sources for updates. 

2. Proactively submit GRAS notifications

If your company relies on self-affirmed GRAS, consider voluntarily submitting GRAS notices now to avoid potential compliance challenges later. 

3. Strengthen safety documentation

Ensure that all safety data, toxicology studies, and scientific evidence for your ingredients are well-documented and ready for FDA review. 

4. Work with regulatory experts

Navigating GRAS compliance can be complex. Partnering with regulatory consultants, like Quality Smart Solutions, can help streamline the process and avoid costly delays.  

Final Thoughts 

The FDA’s potential elimination of the self-affirmed GRAS pathway marks a major shift in food ingredient regulation. While aimed at increasing transparency, this change may also result in longer review times due to reduced FDA staffing. Businesses must act now by staying informed, proactively submitting GRAS notices, and strengthening compliance strategies. 

For expert support in navigating these regulatory changes, reach out to Quality Smart Solutions: fill out the form below or contact us today to ensure compliance. Our team is here to help you stay ahead in a rapidly evolving regulatory landscape. 

Categories
Medical Devices News

FDA’s New AI Rules for Medical Devices: What’s Changing?

Medical device integrated with AI technology

Medical device integrated with AI technologyArtificial intelligence (AI) is reshaping the medical device industry, making diagnostics, treatment planning, and patient monitoring more efficient than ever. But with innovation comes regulation. The FDA’s new AI rules for medical devices introduce critical updates that manufacturers must understand to stay compliant and competitive.

These guidances are part of a broader effort led by the FDA’s Digital Health Center of Excellence (DHCoE), which supports the development and oversight of digital health technologies, including AI-enabled medical devices.  

So, what’s changing? And how do these new guidelines affect your business? Let’s break it down. 

Two New Guidances Released in 2025

In January 2025, the FDA released two significant guidance documents addressing the regulation of AI-enabled medical devices. One is finalized and enforceable, and the other is still in draft with potential changes ahead:

  1. Marketing Submission Recommendations for Predetermined Change Control Plans (PCCPs) – finalized in December 2024 and now enforceable
  2. AI-Enabled Device Software Functions: Life Cycle Management and Marketing Submission Recommendations

Together, these guidances outline how manufacturers can manage changes to AI-based medical software while staying compliant. They support both innovation and patient safety through clear regulatory expectations.

Understanding PCCPs

The PCCP guidance allows manufacturers to propose pre-approved modifications to AI software during the initial marketing submission. This flexibility reduces the need for future submissions, making AI updates faster and more efficient.

Key Changes in the PCCP Guidance

  1. Emphasis on PCCPs:
    Manufacturers are encouraged to submit a Predetermined Change Control Plan to support future AI software changes without new regulatory hurdles.
  2. Clear documentation requirements:
    Plans should include detailed descriptions of proposed modifications, how they will be developed, validated, and their expected impact on safety and performance.
  3. Greater focus on risk assessment: The guidance highlights the importance of identifying and mitigating risks related to evolving AI behavior.

Understanding the AI-Enabled Software Functions Guidance

The second January 2025 draft guidance provides a broader regulatory framework for AI-enabled device software functions (AI-DSFs). The guidance applies to software functions that include AI models designed to achieve a medical purpose. Here are its key areas:

  1. Total product lifecycle (TPLC) approach:
    FDA recommends ongoing oversight from development through postmarket use. This includes documentation, validation, deployment planning, and updates. 
  1. Marketing submissions: 
    The guidance outlines what’s needed to demonstrate substantial equivalence or safety and effectiveness, and encourages early FDA engagement for novel technologies. 
  1. Focus areas: 
    Emphasizes risk management, data management, performance validation, and continuous monitoring. It also addresses transparency and bias mitigation, calling for design considerations that support fairness and explainability. 
  1. Use of standards 
    The FDA promotes recognized consensus standards and includes examples in appendices, such as a) Model cards that explain the purpose, training data, performance, and limitations of AI models and b) 510(k) summaries with model cards to demonstrate equivalence and support transparency. 

How This Impacts Medical Device Manufacturers

If you’re developing AI-powered medical devices, these new rules mean: 

  • Faster regulatory approval for AI updates with an approved PCCP. 
  • Increased accountability for performance, bias, and safety. 
  • More robust data and risk management expectations across the product lifecycle. 

Understanding and implementing both guidances is now essential to staying competitive and compliant. 

Staying Ahead with Regulatory Experts

Navigating the FDA’s new AI rules for medical devices can be complex, but you don’t have to do it alone. At Quality Smart Solutions, we support risk management, data management, and innovation planning to help keep your AI systems compliant and effective. 

With AI rapidly evolving, staying on top of regulations is essential. These new FDA rules aim to balance innovation and safety, and understanding them now can save time and prevent delays down the road. 

Need help navigating these changes? Contact us and fill out the form below for a free consultation. We help you ensure your AI-enabled medical devices meet FDA standards while staying ahead of the competition. 

Categories
Natural Health Products (NHPs) News

NHP Labelling: Ministerial Exemption Order Announced

Natural Health Products labelling compliance update from Health Canada

Natural Health Products labelling compliance update from Health Canada

The regulatory landscape for NHP labelling is evolving, with businesses facing increasing pressure to comply with Health Canada’s updated regulations. Initially published on June 21, 2022, the Regulations Amending the Natural Health Products Regulations introduced stricter labelling requirements, set to take effect on June 21, 2025.

Many industry stakeholders have shared their concerns about the challenges of implementing these new regulations. Health Canada is listening and actively working with businesses, consumer groups, and health professionals to find solutions that work for everyone. Keep reading to learn how these changes might impact your business and what steps you can take to stay ahead. 

Ministerial Exemption Order: What It Means for Your Business 

Recognizing these challenges, Health Canada has announced a Ministerial Exemption Order, delaying the mandatory compliance date for newly licensed NHPs. Published on February 25, 2025, this exemption extends the deadline for newly licensed NHPs to June 21, 2028, aligning with the transition period granted to products licensed before June 21, 2025. 

NHPs licensed and labelled in Canada prior to June 21, 2025, already have a transition period of three years starting on June 21, 2025, during which they can continue to be sold with their current labels. This means that all NHPs now have the same date, June 22, 2028, to comply with the new labelling requirements.

This move aims to provide businesses with additional time to adapt to the changes while maintaining compliance with existing safety and quality standards. 

How Health Canada Is Supporting the Industry 

To help businesses navigate these changes smoothly, Health Canada is introducing several support measures. These efforts aim to simplify compliance, address stakeholder concerns, and ensure that companies have the necessary resources to meet regulatory requirements. Here’s what you can expect: 

  • Updated NHP monographs: Providing clearer guidance on ingredient labelling and safety information. 
  • Revised labelling guidance documents: Improving clarity and reducing ambiguity in compliance requirements. 
  • Ongoing stakeholder engagement: Ensuring businesses have the necessary resources and support to meet regulatory expectations. 

Next Steps: What Businesses Should Do Now 

This exemption gives businesses extra time, but don’t wait until the last minute! Now is the perfect time to proactively prepare for compliance by: 

  1. Reviewing the updated labelling requirements: Ensure that your team is aware of the latest regulations. 
  2. Developing a compliance strategy: Begin planning for packaging updates and regulatory alignment. 
  3. Engaging with regulatory experts: Seek professional guidance to navigate compliance challenges efficiently. 

At Quality Smart Solutions, our regulatory experts are here to help you stay ahead of the evolving NHP labelling landscape.  

Contact us today to ensure your products remain compliant or fill out the form below to get started. For official details, visit the Health Canada website. 

Categories
Cosmetics News

Is Your Cosmetic Ready for Canada’s New Allergen Rules?

Cosmetic product label displaying fragrance allergen information

Cosmetic product label displaying fragrance allergen informationHealth Canada’s 2026 Fragrance Allergen Rules: What You Need to Know 

Health Canada recently reminded the cosmetics industry that all products must comply with fragrance allergen rules requirements by April 12, 2026. This regulation aims to support consumers in making informed choices about products containing fragrance ingredients they may be allergic or sensitive to.  

If you manufacture, import, or distribute cosmetic products in Canada, it is crucial to understand these labelling changes and take proactive steps toward compliance. How will these new fragrance allergen rules impact your products? Keep reading to find out what you need to do to stay compliant! 

What Does the Allergen Rules Rule Mean? 

The updated regulation mandates that cosmetic products must clearly disclose fragrance allergens on their labels. The goal is to enhance transparency, ensuring consumers can easily identify and avoid ingredients that may trigger allergic reactions. This aligns with international standards and strengthens consumer protection measures. 

Why Compliance Matters 

Failure to comply with the new fragrance allergen rules requirements could result in regulatory action, including product recalls, fines, or restrictions on product sales. Ensuring your labels meet Health Canada’s standards not only helps you avoid penalties but also builds consumer trust and enhances product credibility. 

Key Steps to Ensure Compliance 

1. Review your ingredient list

Identify whether your products contain any of the recognized fragrance allergens specified in the new regulations. These must be clearly listed on the product packaging. 

2. Update your product labels

Modify your cosmetic product labels to include fragrance allergen information. Labels should be clear, accurate, and easy to read to help consumers make informed decisions. 

3. Ensure regulatory notification

If your product formulation changes due to these requirements, you may need to update your Cosmetic Notification Form (CNF) with Health Canada. 

4. Educate your team

Your compliance, marketing, and product development teams should be aware of these changes to avoid delays and ensure smooth implementation before the deadline. 

Stay Ahead of Compliance Deadlines 

Navigating regulatory changes can be complex, but you don’t have to do it alone. Our team of regulatory experts at Quality Smart Solutions can assist with cosmetic labelling compliance, product notifications, and regulatory strategy to ensure you meet Health Canada’s fragrance allergen rules requirements. 

For further details, refer to the official Health Canada announcement. 

With the April 12, 2026 deadline approaching, now is the time to act. Get ready to ensure your cosmetic products comply with Health Canada’s updated fragrance allergen rules regulations. Fill out the form below or contact us. Our experts are here to help! 

Categories
Health Canada News

Health Canada’s New Front-of-Package Label Rules Explained

Example of a front-of-package nutrition label as per Health Canada's 2026 regulations.

Example of a front-of-package nutrition label as per Health Canada's 2026 regulations.Introduction 

Health Canada’s new front-of-package label rules are set to take effect on January 1, 2026, marking a significant shift in how food products must be labelled. These regulations are designed to help consumers make informed choices by clearly identifying products high in saturated fat, sugars, or sodium. If you’re a food manufacturer, retailer, or importer, it’s crucial to understand how these new rules will impact your business. 

Failure to comply could lead to costly product recalls, penalties, or even damage to your brand’s reputation. In this guide, we break down what you need to know about Health Canada’s new label rules and how to ensure your business stays compliant. 

What Are Health Canada’s New Label Rules? 

Starting January 1, 2026, Health Canada will require prepackaged food products that meet or exceed certain thresholds of saturated fat, sugars, or sodium to display a standardized front-of-package (FOP) nutrition symbol. This symbol must appear on the front of the package to provide a quick visual cue for consumers. These regulations apply to: 

  • Food manufacturers selling prepackaged products in Canada. 
  • Importers bringing food products into Canada. 
  • Retailers that sell store-brand or private-label products. 

Certain foods are exempt from these regulations, including: 

  • Whole, unprocessed foods such as fresh vegetables, fruits, and meats. 
  • Foods with minimal nutritional impact, like coffee and tea. 
  • Specific dairy products due to naturally occurring nutrients. 

What the Front-of-Package Nutrition Symbol Looks Like  

The new front-of-package (FOP) nutrition symbol is designed to provide consumers with a clear and immediate understanding of the nutritional content of prepackaged foods. This black and white symbol features a magnifying glass icon, emphasizing the presence of specific nutrients that are high in the product.  

Depending on the product’s content, the symbol will highlight “saturated fat,” “sugars,” “sodium,” or any combination of these. At the bottom of the symbol, the words “Health Canada / Santé Canada” are displayed, signifying its official endorsement. Below is an example of the front-of-package nutrition symbol: 

How to Stay Compliant 

1. Review Your Product Portfolio

Conduct a thorough audit of your product labels to identify items that may require the new FOP nutrition symbol. Use Health Canada’s guidelines to determine whether your product meets or exceeds the saturated fat, sugars, or sodium limits. 

2. Adjust Product Formulations (If Needed)

If your products exceed the thresholds, consider reformulating recipes to reduce saturated fat, sugars, or sodium content. Reformulation not only helps in compliance but can also enhance your brand’s appeal to health-conscious consumers. 

3. Update Packaging & Labels

Ensure your packaging design includes the required FOP nutrition symbol in a visible and compliant format. The symbol must: 

  • Be black and white 
  • Include the wording “High in [Saturated Fat/Sugars/Sodium]” 
  • Appear in the upper 50% of the package 

4. Train Your Team & Supply Chain Partners

Your regulatory and packaging teams, along with your suppliers and distributors, must be fully aware of these new labelling requirements. Hold training sessions to ensure alignment. 

5. Stay Updated with Health Canada

Health Canada may release further guidance documents or compliance updates leading up to the 2026 deadline. Regularly check their official website for any updates. 

Why Compliance Matters 

Ignoring Health Canada’s new front-of-package label rules can lead to: 

  • Fines & penalties for non-compliant products. 
  • Product recalls, resulting in financial loss. 
  • Reputation damage, affecting consumer trust and sales. 

On the other hand, compliance presents an opportunity to build consumer trust by demonstrating transparency and a commitment to public health. 

Need Help Navigating Compliance? 

At Quality Smart Solutions, we specialize in regulatory compliance for food labelling and can guide your business through the FOP (front-of-package) nutrition labelling process. Our experts can assist with label audits, product reformulation, and regulatory strategy to ensure you meet the January 1, 2026, deadline without hassle. 

Contact us today to ensure your labels meet Health Canada’s requirements and visit our services page to learn more about our FOP solutions. By following these steps, businesses can avoid penalties while building a stronger, health-conscious brand. Start preparing now to ensure a seamless transition to compliance before January 1, 2026. 

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Health Canada News

How to Make ‘Made in Canada’ Claims Amid Trade Tensions

A Canadian-made food product label highlighting compliance requirements.

A Canadian-made food product label highlighting compliance requirements.Understanding ‘Made in Canada’ Claims 

With trade tensions rising and new tariffs affecting cross-border business, Canadian brands must ensure they accurately label their products. Claiming a product is “Made in Canada” can boost consumer trust and appeal, but businesses must follow strict regulations to avoid misleading advertising. 

Recent changes and increased scrutiny from the Competition Bureau make it more critical than ever to meet compliance standards. If you’re running a food, beverage, or consumer goods business, you need to understand how to legally make a ‘Made in Canada’ claim. Ensuring your product meets the right criteria will help you protect your brand, maintain customer trust, and avoid costly penalties. 

Let’s dig into the specific considerations that will help you navigate this process smoothly. Whether you’re unsure about cost breakdowns, final processing rules, or labelling requirements, we’ve got you covered. Keep reading to ensure your business stays compliant and competitive. 

The Legal Criteria for ‘Made in Canada’ Claims 

According to Gowling WLG, to use a ‘Made in Canada’ claim, your product must meet the following conditions: 

  • At least 51% of total direct costs (manufacturing, production, labour, and materials) must be incurred in Canada. 
  • Final transformation of the product must occur in Canada. 
  • If foreign ingredients are included, the claim must include a qualifying statement (e.g., “Made in Canada from imported ingredients”). 

Failing to comply with these requirements can result in fines or consumer backlash for misleading claims. 

Common Mistakes to Avoid 

Many businesses unintentionally misrepresent their products due to misunderstandings about compliance. Some common errors include: 

  • Not meeting the 51% rule: If a product is mostly made with imported materials, it may not qualify. 
  • Vague or misleading claims: Phrases like “Proudly Canadian” may imply full Canadian production when only packaging happens in Canada. 
  • Incorrect qualifying statements: If ingredients come from outside Canada, companies must state this explicitly. 

To avoid these pitfalls, you should conduct a thorough cost analysis and review your supply chain before making any claims. 

Why Compliance Matters More Than Ever 

With the new tariffs on Canadian goods creating market uncertainty, businesses must strengthen their Made in Canada messaging to retain customer loyalty. 

Consumers are actively seeking domestic products, especially in the food and beverage industry. However, misleading claims can lead to legal repercussions and damage your brand’s reputation. To safeguard your business, ensure that your labelling meets all Canadian regulatory standards. 

Steps to Ensure Compliance 

Ensuring compliance with Made in Canada claims requires careful attention to regulations and proper documentation. By following these steps, you can confidently market your products while avoiding legal issues and consumer mistrust. Here’s what to do: 

  1. Audit your supply chain: Ensure at least 51% of costs are incurred in Canada. 
  2. Verify final processing: Confirm that your product undergoes significant manufacturing in Canada. 
  3. Use correct labelling: If using foreign ingredients, include “Made in Canada from imported ingredients.” 
  4. Document compliance: Keep records of sourcing, manufacturing, and cost structures for regulatory checks. 
  5. Consult a compliance expert: Stay updated on advertising and trade regulations to avoid penalties. 

How Quality Smart Solutions Can Help 

Navigating trade regulations can be complex, but Quality Smart Solutions can provide expert guidance on compliance and labelling. Our team ensures your Made in Canada claims are accurate, legally sound, and optimized for consumer trust. 

If you’re unsure whether your product meets Made in Canada requirements, our experts are here to help. Contact us today to ensure your claims align with Canadian regulations and market expectations. 

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Blog Regulatory Compliance

How to Get TGA Approval for New Substances in Listed Medicines

TGA approval process for new substances in listed medicines

TGA approval process for new substances in listed medicinesBringing a new substance into Australia’s listed medicines market can be challenging. The TGA approval for new substances process involves strict regulatory oversight to ensure public safety and product efficacy. If you’re developing a product with a new ingredient, understanding the Therapeutic Goods Administration (TGA) process is critical for a smooth application. 

With the right preparation and expert guidance, you can avoid delays and compliance issues. This guide walks you through the key steps to obtaining approval, from assessing eligibility to ensuring post-approval compliance. 

Understanding the TGA Approval Process 

TGA approval is necessary for any new ingredient that isn’t currently listed under the current version of the Permissible Ingredients Determination. The process involves a comprehensive assessment of the substance’s safety, quality, and intended use.

Steps to Obtain TGA Approval for New Substances 

1. Assess Ingredient Eligibility

Before initiating an application, confirm whether your ingredient requires TGA assessment. If the substance isn’t in the current version of the Permissible Ingredients Determination, you’ll need to submit a TGA new substance application for use in Listed medicines or Listed assessed medicines.

2. Gather Essential Documentation

The approval process involves submitting a dossier with: 

  • Safety and toxicological data 
  • Clinical and non-clinical studies 
  • Quality and manufacturing information 
  • Justification for the ingredient’s therapeutic use 

3. Work with Regulatory Experts

Regulatory consultants, such as Quality Smart Solutions, can help streamline the submission process and reduce the likelihood of application rejection. 

4. Submit the Application and Respond to TGA Queries

Once submitted, the TGA may request additional information or clarifications. A well-prepared response can prevent unnecessary delays. 

5. Ensure Post-Approval Compliance

Even after approval, ongoing compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), as well as reporting obligations, is required to maintain regulatory standing. 

Avoiding Common Application Challenges 

  • Incomplete or Inaccurate Submissions: Ensure all documentation meets TGA’s stringent requirements. 
  • Lack of Scientific Justification: Supporting data must be robust and align with TGA standards. 
  • Non-Compliance Post-Approval: To ensure long-term business partnerships with brands, setting your systems up for effective communication with brand partners is essential to help them meet their ongoing regulatory obligations.

Get Expert Guidance for Your TGA Submission 

Successfully obtaining TGA approval for new substances requires meticulous planning, documentation, and compliance. Partnering with regulatory experts ensures a smoother process and minimizes potential roadblocks. 

If you need support with your application, contact us today to get expert regulatory assistance. 

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Blog Dietary Supplements FDA

5 Steps to Navigate FDA Compliance for Shilajit

FDA approval process for shilajit

FDA approval process for shilajitNavigating the FDA compliance process for shilajit can be challenging, especially if you’re new to the regulatory landscape. As shilajit gains popularity in the U.S. for its health benefits, it’s crucial to ensure your product meets FDA requirements before introducing it to the market. Understanding these steps from the beginning can help you streamline the process and avoid delays. 

In this blog, we’ll walk you through the key steps you need to follow to successfully navigate the FDA compliance process for shilajit. From labelling to shipping regulations, we’ll cover everything you need to know to ensure your product is compliant. Keep reading to learn how to bring your shilajit supplement to the U.S. market with confidence. 

1. FDA Compliant Dietary Supplement Labeling

The first step in the FDA compliance process for shilajit is ensuring that your dietary supplement label complies with FDA guidelines. This means using structure-function claims, which are statements that describe the role of a nutrient or ingredient intended to affect the structure or function of the body. The label must include only these types of claims. Health claims or claims suggesting a therapeutic benefit are not allowed unless they have FDA approval. 

2. Submit a 30-Day Pre-Market Notification

If your dietary supplement contains at least one structure-function claim, you must submit a 30-day pre-market notification to the FDA. This notification informs the agency of your intent to market the product and provides necessary details about the supplement’s composition and claims. This step is essential for ensuring that the product meets regulatory standards before it enters the U.S. market. 

3. Ensure FDA Registration for Foreign Manufacturers

If your shilajit supplement is manufactured overseas, your foreign manufacturer must be FDA registered. Additionally, the manufacturer must have a U.S. agent who can act as the liaison with the FDA. This step ensures that the FDA can reach the manufacturer if necessary and verifies that the product complies with U.S. regulations. 

4. Work with an FSVP Agent Who is PCQI Certified

An FSVP (Foreign Supplier Verification Program) agent is required for all dietary supplements that are imported into the U.S. The FSVP agent must be PCQI (Preventive Controls Qualified Individual) certified. This certification ensures that the foreign supplier is in compliance with the FDA’s food safety standards and that the shilajit supplement will be safe for consumption. 

5. No License Required, but Shipping Time Must Be Considered

One of the key benefits of selling shilajit in the U.S. is that you do not need a license for distribution. However, it’s important to factor in transit shipping time from the overseas manufacturer to the U.S. The entire process can take anywhere from 1-2 months on average, depending on shipping logistics. While this is a relatively quick timeline for international trade, it’s important to plan accordingly to avoid delays. 

Ready to Navigate the FDA Process for Shilajit?

Navigating the compliance process for shilajit can seem overwhelming, but by following these five key steps, you can ensure that your product complies with FDA regulations and reaches the U.S. market smoothly. From labeling compliance to shipping logistics, each step plays a critical role in ensuring your shilajit supplement is safe and legal for consumers. 

To learn more about how Quality Smart Solutions can help you navigate FDA regulations and other compliance processes, contact us today. For more detailed guidance on dietary supplement labeling, visit the official FDA page on dietary supplements. 

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News

Understanding Health Canada’s Approval on Grape Seed Extract in Foods

Grape Seed Extract Allowed in Foods by Health Canada

Grape Seed Extract Allowed in Foods by Health CanadaHealth Canada has made an important decision regarding grape seed extract, now approved for use as a supplemental ingredient in foods. This modification marks a major development for businesses operating in the health and nutrition sector. Keep reading to learn how this change can affect your products and compliance strategies. 

Health Canada’s Decision on Grape Seed Extract 

Health Canada’s Food and Nutrition Directorate has completed a safety assessment of grape seed extract (oligomeric proanthocyanidins) for use in foods, concluding that it is safe for consumption. As of January 16, 2025, this ingredient is now officially listed as a permitted supplemental ingredient under the Supplemented Foods regulatory framework. 

What Does This Mean for Your Business? 

Does your company manufacture or market supplemented food products containing grape seed extract? If so, it’s important to be aware of the recent regulatory changes. This decision allows you to include the ingredient in your formulations, but compliance with the updated regulations is still required.

Steps for Ensuring Compliance 

As the industry adapts to this new regulation, staying compliant will be crucial. We recommend reviewing Health Canada’s guidelines on supplemented foods and consulting with experts to ensure your products meet all safety standards. You can find further information in the Notice of Modification. 

The Importance of Ongoing Safety Assessments 

Health Canada’s process involved a thorough safety assessment and a public consultation, ensuring that the ingredient’s use in food is safe for consumers. As a result, they determined the ingredient is safe for inclusion in supplemented food products. Therefore, you must follow future updates regarding similar ingredients and stay informed about the regulatory landscape.

New Opportunities Ahead 

The approval of the ingredient for use in foods is a significant move by Health Canada that can open new opportunities for the health and nutrition industry. By staying informed and adhering to the new regulations, your business can continue to innovate while ensuring consumer safety. 

For more information and guidance on compliance, contact us at Quality Smart Solutions. 

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News

Why Are FDA Food Contact Notifications No Longer Effective?

FDA Food Contact Notifications are no longer effective

Have you heard about the recent updates to FDA Food Contact Notifications (FCN)? The FDA has determined that several FCN are no longer effective due to changes in manufacturing and regulatory standards. These updates directly affect businesses that rely on food contact substances (FCS). Furthermore, they include strict compliance deadlines that organizations must meet.

Understanding these changes is essential to stay ahead of compliance requirements and avoid disruptions. In this article, we will explore what these updates mean, highlight the FCN that are affected, and explain how your business can adapt effectively.

What Are Food Contact Notifications (FCN)? 

Food Contact Notifications (FCN) are approvals issued by the FDA for specific substances used in food contact materials. Specifically, the FDA assesses these substances for safety and ensures they comply with regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Each FCN has the following characteristics:

  • Manufacturer-specific: Valid only for the listed manufacturer or supplier. 
  • Purpose-specific: Tied to a particular use case or food contact material. 
  • Safety-driven: Assessed for human and environmental safety. 

When the FDA declares an FCN ineffective, businesses must stop using the associated substance unless it receives re-approval.

Why Are Some FCN No Longer Effective? 

The FDA declared specific FCN ineffective for two main reasons: 

  1. Abandonment by Manufacturers: Manufacturers voluntarily informed the FDA that they have ceased producing, supplying, or using specific substances. Commitment letters submitted by these manufacturers confirmed that these substances would no longer be used in food contact applications. 
  1. Regulatory Updates: Recent changes to FDA regulations now allow the agency to declare an FCN ineffective for reasons beyond safety, such as the cessation of production. This aligns with updates to Section 170.105, enabling the FDA to streamline approvals and ensure public safety. The FDA’s ability to declare FCNs ineffective under Section 170.105 reflects a shift toward streamlining approvals and ensuring outdated substances are removed from circulation. While safety is not always a factor, businesses should anticipate future reviews that may impact additional substances.

Highlighted Affected Substances  

Some of the affected food contact substances include: 

  • Glycine, N,N-bis[2-hydroxy-3-(2-propenyloxy)propyl]-, monosodium salt: Used in coatings for food packaging (FCN No. 59). 
  • Fluorinated polyurethane anionic resin: Commonly applied in grease-proofing food paper products (FCN No. 187). 
  • Diphosphoric acid polymers with ethoxylated perfluoroether: Found in grease-proof paper coatings (FCN No. 195). 

These are just a few examples. The FDA has provided a compliance deadline of June 30, 2025, for certain FCN to give businesses time to transition. For the complete list of affected substances, visit the FDA’s No Longer Effective FCN Inventory. 

What Does This Mean for Your Business? 

If your company uses any of the affected FCS, you must act swiftly to remain compliant: 

  1. Audit your inventory: Identify materials containing ineffective FCS. 
  2. Transition to alternatives: Replace discontinued substances with FDA-approved options. 
  3. Monitor deadlines: Ensure that products under the compliance deadline are phased out before June 30, 2025. 

These changes primarily affect industries relying on food packaging, grease-proof coatings, and polymer-based food contact materials. Businesses in these sectors may face reformulation challenges, increased costs, or supply chain disruptions as they transition to FDA-compliant alternatives.

Failing to meet compliance requirements could result in operational disruptions and legal consequences. The FDA’s updates to Food Contact Notifications reflect the evolving nature of food safety regulations.  

By understanding these changes and adapting your processes, you can ensure compliance and maintain operational continuity. For expert guidance on navigating FDA regulations, contact Quality Smart Solutions today! 

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Blog

What Are FDA Medical Device Classes?

FDA medical device classification system: Class I, II, and III medical devices.

Understanding the FDA classification system for medical devices is key to getting your product to market safely and efficiently. Knowing how the FDA medical devices are categorized can help you avoid setbacks and ensure compliance, whether you’re dealing with a simple tool or a life-saving implant.

But how exactly does the FDA determine a device’s class, and what does it mean for you? Keep reading to uncover the answers and learn how you can navigate the process with confidence.

Why Does the FDA Classify Medical Devices?

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes: Class I, II, and III. Each class reflects the device’s risk level and the regulatory controls required to ensure safety and effectiveness.

  • Class I: Low-risk devices with minimal regulatory requirements.
  • Class II: Moderate-risk devices needing unique controls.
  • Class III: High-risk devices requiring premarket approval.

These classifications determine the level of scrutiny your product will face during the FDA approval process. Misunderstanding these classifications can lead to setbacks like penalties, recalls, or approval delays. By the end of this guide, you’ll know exactly where your product fits in the FDA medical devices system.

Class I Medical Devices: Simple and Low Risk

Class I medical devices pose the least risk to patients and are typically simple tools used in daily medical practice. They are common, affordable, and essential in healthcare settings. Class I devices account for nearly half of all FDA medical devices, making them the most common category.

These low-risk tools still require proper compliance to ensure safety for end-users. Some examples of Class I devices include:

  • Bandages and gauze
  • Examination gloves
  • Surgical sponges
  • Hand-held surgical instruments like forceps
  • Basic thermometers (non-electronic)

While most Class I devices are exempt from Premarket Notification (510(k)), they must meet General Controls, such as proper labelling, record-keeping, and adherence to quality system regulations.

Class II Medical Devices: Moderate Risk and Special Controls

Class II medical devices present a moderate risk to patients and healthcare providers. They require more oversight than Class I devices to ensure consistent safety and performance.

This classification makes up about 43% of all FDA medical devices, playing a critical role in diagnostics, treatment, and patient care while maintaining manageable risk levels. Examples include:

  • Blood pressure monitors
  • Syringes (non-automated)
  • Infusion pumps
  • Catheters
  • Ultrasound imaging tools
  • Powered wheelchairs

To achieve compliance, most Class II devices require Premarket Notification (510(k)) to demonstrate equivalence to an already-approved product. Additional Special Controls may apply, such as performance testing, labelling requirements, and post-market monitoring.

Class III Medical Devices: High Risk and Highly Regulated

Class III medical devices are critical for sustaining life, preventing serious health issues, or addressing significant risks if they malfunction. Due to their life-critical nature, these devices undergo the most rigorous testing and regulatory scrutiny.

Although Class III devices represent a smaller percentage of FDA medical devices, their impact is substantial. Examples of Class III devices include:

  • Pacemakers
  • Implantable defibrillators
  • Heart valves
  • Cochlear implants
  • Artificial joints like hip or knee replacements
  • Stents for heart or vascular conditions

Approval for Class III devices requires Premarket Approval (PMA), which involves extensive clinical testing to prove safety and efficacy. After approval, ongoing post-market monitoring is necessary to identify any long-term risks or complications.

Wellness Products in the Medical Device Category

Some general wellness products fall under the medical device category but are not regulated by the FDA, offering a faster pathway to market. These products are intended for general health and wellness, such as improving fitness or promoting relaxation, rather than diagnosing or treating medical conditions. Examples include: 

  • Fitness trackers 
  • Non-invasive heart rate monitors 
  • Apps promoting healthy habits 
  • Sleep monitors 

For more details on general wellness products that are exempt from FDA regulation, refer to the FDA’s guidance on general wellness products. 

What Happens When You Cannot Properly Classify Your Device?

Misclassifying a medical device can lead to significant setbacks, including regulatory fines, product recalls, or delayed market entry. When uncertainty arises, companies can submit a 513(g) request to the FDA for guidance, which provides:

  • Clarity on classification: The FDA evaluates your product and determines the appropriate device classification.
  • Regulatory pathway guidance: Information on what is required for approval or clearance.

While submitting a 513(g) request involves additional time and cost, it can prevent costly errors in the long term by ensuring your product is on the right regulatory path from the start. For companies unsure of their device’s classification, this is a critical step toward achieving compliance. Learn more about 513(g) requests in the FDA guidance document.

How to Identify Your Medical Device’s Class

Knowing where your product fits will save time, reduce errors, and ensure you complete the right approval process. It starts with understanding the FDA’s system and comparing your product to similar devices that have already been approved.

  1. Define the intended uses and indications for use: What does your device do, and who will use it?
  2. Assess the risk level: Consider the potential harm if the device malfunctions.
  3. Check FDA databases: Look up similar devices in the FDA medical devices Product Classification Database.
  4. Prepare the right submission: Based on the class, complete a 510(k) notification or PMA application.

When in doubt, consulting regulatory experts can save you time and ensure your device meets all FDA medical devices requirements.

Simplify Your Compliance Journey

Navigating the FDA classification system for medical devices doesn’t have to be overwhelming. By understanding the differences between Class I, II, and III medical devices, you can take the right steps to bring your product to market faster and safer.

Need help identifying your device’s classification and managing submissions? Reach out to our team for expert support and guidance in complying with FDA medical devices standards.

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Blog News

Health Canada Fees 2025 Guide

Canadian flag symbolizing Health Canada Fees 2025 and regulatory compliance.

Canadian flag symbolizing Health Canada Fees 2025 and regulatory compliance.Are you ready for the upcoming changes to Health Canada Fees in 2025? These fees, effective from April 2025, impact businesses dealing with drugs, medical devices, and cannabis. With updates spanning licensing, submissions, and compliance requirements, staying informed is key to avoiding disruptions.

Health Canada is introducing a phased fee structure that ensures businesses contribute to maintaining high standards for product safety and efficacy. From updated pre-market evaluation fees for drugs and medical devices to regulatory costs for cannabis producers, these changes could affect your budget and planning.

Want to know how these updates might impact your operations? Keep reading to explore the details and learn how to navigate these fees effectively with expert tips from Quality Smart Solutions.

Medical Devices

If you’re in the medical device sector, you will encounter fees tied to your initial Medical Device License (MDL) Application. These fees vary based on the classification of your medical device. The following are the fees for an MDL application as of April 1, 2025:

  • Class 2 Devices: $632
  • Class 3 Devices: $13,926
  • Class 3 Devices (Near Patient): $29,664
  • Class 4 Devices: $30,199

Applicable MDL amendments are also subject to additional application fees.

If you wish to apply for a Medical Device Establishment License (MDEL), you will need to pay both the initial application fee and the annual license renewal fee each year. The following are MDEL fees as of April 1, 2025.

  • Application for a new MDEL and annual review of license: $5426

Annual fees for right to sell licensed devices also apply. The fee as of April 1, 2025 is $452. These fees support ongoing regulatory oversight, ensuring that devices meet safety and compliance standards.

Drugs (Drug Identification Number Registration)

For drugs for human use requiring a Drug Identification Number (DIN), Health Canada has detailed fees based on the type of submission:

  • New Active Substance: $606,286
  • Clinical and Non-Clinical Data with Chemistry: $313,944
  • Comparative Studies Only: $70,750
  • Administrative Submissions: $1,002
  • Labelling only: $6,328
  • Disinfectant – Full review: $13,186
  • Drug identification number application – Labelling standards: $1,912

These fees cover the rigorous evaluation process, ensuring products meet Health Canada’s stringent standards.

Additionally, companies engaged in various activities must hold a Drug Establishment License (DEL) which requires annual renewal. Fees are determined by the scope of activities and the types of products handled. The DEL fees for 2025 are:

  • Fabrication – Sterile dosage form: $49,558
  • Importation: $38,265
  • Fabrication – Non-sterile dosage form: $36,740
  • Distribution: $19,531
  • Wholesaling: $11,398
  • Packaging/labelling: $7,164
  • Testing: $5,913
  • Building outside Canada (each): $1,088

DEL fees ensure that establishments meet Good Manufacturing Practices (GMP) standards, supporting the safety and quality of pharmaceutical products in Canada.

For drugs already holding a Drug Identification Number (DIN), companies are required to pay an annual “Right to Sell” fee. The fee are as follows:

  • Human drugs – Disinfectant: $1,730
  • Human drugs – Non-prescription: $3,334
  • Human drugs – Prescription: $5,531

These fees enable ongoing compliance monitoring and market authorization renewal.

Cannabis

For businesses operating in Canada’s cannabis industry, Health Canada Fees cover several areas, including application screening, security clearance, and regulatory oversight. As of now, Health Canada has not published updated cannabis-related fees for the fiscal year 2025-2026. The most recent fee adjustments, effective April 1, 2024, are as follows:

  • Application Screening Fee: $3,933 for a standard-level license or sale for medical purposes and $1,969 for a micro-level license.
  • Security Clearance Fee: $1,987 per individual requiring clearance.
  • Annual Regulatory Fee:
    • Micro Cultivator: If the cannabis revenue is $1 million or less, the greater of 1% of the cannabis revenue, and $2,500 OR if the cannabis revenue is greater than $1 million, the maximum amount plus 2.3% of the amount by which the cannabis revenue exceeds $1 million.
    • Standard Cultivator: The greater of 2.3% of gross revenue or a minimum of $23,000.

Navigating these fees is critical for maintaining compliance and ensuring uninterrupted operations.

Why It Matters

Missing deadlines or miscalculating Health Canada fees can lead to costly delays or penalties. By planning ahead and leveraging expert guidance, you can focus on what matters most: growing your business.

Regulatory compliance doesn’t have to be daunting. At Quality Smart Solutions, we provide expert guidance to help you stay informed and save money. Explore more about our services to see how we can support your regulatory journey.

For a complete overview of all fees, visit Health Canada’s Funding and Fees page$1,002$36,740$3,334

Categories
Blog News

Health Canada’s New Nicotine Rules: What’s Changing in 2024

Nicotine pouches

Nicotine pouches in a round container on a wooden surface.

If you’re in the business of nicotine products like pouches, gums, patches, sprays, or lozenges (collectively known as nicotine replacement therapies, or NRTs), you need to know about Health Canada’s new nicotine rules. Major regulatory changes are now in place to ensure NRT products are marketed responsibly, labeled clearly, and sold in ways that prioritize consumer safety.

These new regulations introduce tighter advertising restrictions, comprehensive labeling requirements, and significant limits on where and how nicotine pouches can be sold. So, what do these changes mean for your business?

Whether you’re a manufacturer, supplier, or marketer, they could impact your products, packaging, and promotions. Keep reading to learn what’s changing, how it affects your operations, and how you can stay ahead. 

What’s Changing and Why It Matters

Health Canada’s new regulations are reshaping the nicotine industry, particularly for products like NRTs. These changes intend to tackle growing concerns about youth access and ensure consumers have accurate, transparent information. Here’s a closer look at the updates and their impact on your business:

Clearer Labeling Standards 

All nicotine products must now display nicotine content in milligrams. This gives consumers a clear understanding of product strength, helping them make better choices. Labels also require bold health warnings about addiction risks to ensure safety information is easy to spot. 

For businesses, this is an opportunity to strengthen customer trust. Transparent labelling shows accountability and can help your product stand out in a competitive market. 

Stricter Advertising Guidelines 

Marketing campaigns must focus on adult smokers looking for smoking cessation tools. Claims like “helps reduce cravings” now require solid evidence to back them up. Additionally, anything that could appeal to youth or non-smokers, like colourful imagery or playful language, is strictly prohibited. 

As you may already know, this shift is about responsible promotion. Therefore, aligning your campaigns with these rules keeps your business compliant while ensuring your message resonates with the right audience. 

New Sales and Distribution Rules

The sale of nicotine products, especially pouches, is now only available in pharmacies and must stay behind the counter. Convenience stores and other general retailers can no longer stock them, ensuring tighter control over access.

This change might seem limiting, but it also provides businesses with a sales channel that prioritizes specific goals and follows strict rules. Partnering with pharmacies can streamline distribution and help you reach your target audience more effectively.

How These Changes Impact Your Business

Adapting to Health Canada’s new rules requires strategic adjustments across various aspects of your business:

  • Manufacturers: Labels and packaging need to be updated to meet the new standards. Additionally, products may need reformulation to comply with flavor restrictions, as only mint and menthol are permitted.
  • Suppliers: Distribution channels must shift to focus on pharmacy sales. This may involve building new partnerships and streamlining supply chains.
  • Marketers: Advertising strategies must be reviewed and refined. Focus on clear, evidence-based messaging that targets adult smokers and highlights approved therapeutic benefits.

While these adjustments may seem challenging at first, they also create opportunities to demonstrate your commitment to safety, compliance, and customer trust.

How to Stay Ahead

Navigating these changes doesn’t have to be overwhelming. Here are actionable steps to ensure compliance:

  1. Understand the rules: Start by reviewing Health Canada’s full guidelines on advertising nicotine replacement therapies.
  2. Update your products: Ensure your labels and packaging clearly display the required nicotine content and health warnings in a way that meets the standards. If necessary, you’ll need to adjust product formulations to meet flavor restrictions.
  3. Revise your marketing: Focus on approved claims, like smoking cessation benefits, and target adult smokers. Avoid any messaging that could appeal to youth or non-smokers.
  4. Optimize your sales strategy: Shift your focus to pharmacy sales and strengthen partnerships with regulated distributors.
  5. Get expert support: Compliance can be complex, but it doesn’t have to be. At Quality Smart Solutions, we specialize in helping businesses meet regulatory requirements quickly and effectively.

The Bottom Line

As you’ve learned, Health Canada’s new nicotine rules are all about creating a safer, more transparent market for consumers. By adapting to these changes, you protect your business, build trust with your audience, and position yourself as a leader in the industry.

Need help with the new rules? Quality Smart Solutions can help you meet NRT compliance. Contact us today and let us guide you through the process!

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FDA 510(k) Pre-Submission: Steps for Medical Device Approval

Medical diagnostic device with a control panel and digital screen displaying test results, used for optical measurements.Are you trying to make sense of the FDA’s 510(k) pre-submission process? You’re not alone. Many companies, especially those new to the regulatory landscape, find themselves wondering where to start, what’s required, and how to get FDA approval for their medical devices. Without a clear plan, it’s easy to waste time and money on unnecessary steps, or worse, miss critical requirements that delay approval by years. 

That’s where the pre-submission process helps by clarifying what’s needed early on. Connecting with the FDA at this stage can prevent costly mistakes, keep your submission on track, and give you a roadmap for moving forward with confidence.  

By engaging with the FDA early, you’ll gain insights that can help avoid unexpected requirements or delays, setting you up for a smoother journey to approval. Keep reading to learn more about how the pre-submission process works and what steps to follow. 

What is the FDA 510(k) Pre-Submission Process? 

The FDA 510(k) pre-submission process is a chance to open a conversation with the FDA before committing to a full application. It begins by creating a structured document package that explains your device’s technology, intended use, and operation.  

This preparation demonstrates to the FDA that you’ve thoroughly researched your regulatory needs and are ready to proceed with compliance.

The pre-submission process actually helps you build your regulatory strategy by connecting with the FDA early. You’re allowed to ask questions on specific topics, like intended use, regulatory strategy, or software validation, to get clear, actionable feedback that helps you avoid missteps.

And here’s something you might not know: this process is part of the FDA’s Q-Submission Program, which supports several regulatory pathways, including 510(k). Curious to learn more? You can find more details in the FDA’s official guidance on the Q-Submission Program. 

Key Steps in the FDA 510(k) Pre-Submission Process

Following these steps in the pre-submission process can help you avoid roadblocks and streamline your path to FDA approval. Here are the essential steps to follow in the FDA 510(k) pre-submission process: 

  1. Build your document package 
    To begin, start by putting together a comprehensive package that details your device’s technology, intended use, and comparisons with similar products. This package should reflect your due diligence regarding regulatory requirements and competitive products. 
  2. Ask targeted questions 
    Once your package is ready, you can submit questions on specific topics, such as intended use, regulatory strategy, or validation methods. While you have flexibility, focus on well-chosen questions for the most practical feedback. Clients pay us to ensure their document package is clear and to choose the right questions. FDA responses typically arrive within 60 days, depending on their workload. 
  3. Review FDA responses and follow-up 
    After receiving responses, review the FDA’s feedback carefully. If anything is unclear, schedule a follow-up meeting with FDA specialists to discuss your technology and clarify any points. These one or two-hour meetings are ideal for getting additional insights into questions that may need further discussion.
  4. Reuse pre-submission documents 
    Did you know? One of the biggest advantages is that much of the work done in pre-submission can be reused in your official submission. Documentation developed during pre-submission serves as a foundation for your final 510(k) application, saving time and effort. 

Why the FDA 510(k) Pre-Submission Process Matters

Many companies feel the pressure to get their devices to market as fast as possible, but skipping or rushing through pre-submission can often lead to setbacks. For complex devices, approval timelines can vary widely, sometimes stretching from two years to five years or even longer if unexpected issues arise. Who wants to face delays like that? 

That’s why the pre-submission process is so valuable: it gives you a clear preview of what the FDA expects, helping you avoid surprises and keep your device on a faster, more reliable path to approval.  

The work we do at Quality Smart Solutions in pre-submission isn’t just about getting FDA feedback, it’s also about creating a foundation for a successful, streamlined approval process. By investing in pre-submission, clients set themselves up for a smoother journey through FDA approval, avoiding costly and time-consuming mistakes.

Common Questions in FDA 510(k) Pre-Submission

Here are a few examples of questions that can guide your device approval process: 

  • Is clinical testing required for this device? 
  • What specific performance standards should we meet? 
  • Can we use a particular testing approach, or are alternatives preferred? 

These questions help focus your efforts and make sure you’re on the right path from the start. 

How Quality Smart Solutions Can Help

Navigating the FDA pre-submission process for medical devices doesn’t have to be overwhelming. At Quality Smart Solutions, our consulting team is here to guide each step, from creating your regulatory strategy to building a well-prepared submission package. 

  • Regulatory strategy: We help you find the best path to FDA approval. 
  • Submission package: Our team prepares a clear, complete package that meets FDA standards. 
  • Targeted FDA questions: We guide you in asking the right questions to avoid roadblocks. 
  • Follow-up support: We’re here to guide you through each step with the FDA. 
  • Efficient 510(k) submission: We make sure all your pre-submission work flows right into your final application, saving you time. 

Let us help you bring your device to market with confidence and clarity, every step of the way. 

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How to Ensure Compliance with Canada’s Infant Formula Registration

Canada infant formula rules
Baby Formula

Canada Infant Formula Registration Process

Are you looking to bring your infant formula to the Canadian market? Successfully navigating Canada infant formula registration is essential to ensure compliance with Health Canada’s strict regulations.

Canada enforces some of the world’s strictest regulations to ensure that infant formulas meet the highest standards for safety, quality, and nutrition. Successfully navigating this process requires a thorough understanding of Health Canada’s guidelines.

In this guide, we’ll break down the essential steps you need to follow to ensure compliance and streamline your registration. Keep reading to gain insights into the regulatory requirements and best practices for a successful market entry.

Step-by-Step: Canada Infant Formula Registration Process

1. Understand Health Canada’s Regulatory Framework

Before applying, familiarize yourself with Canada’s Food and Drugs Act and Food and Drug Regulations (FDR), which set strict safety and nutrition standards. Key regulatory areas include: 

  • Nutritional composition: Infant formulas must meet strict dietary thresholds for proteins, fats, carbohydrates, vitamins, and minerals. 
  • Labeling requirements: Labels must comply with Health Canada’s detailed guidelines on nutritional claims, ingredient lists, and preparation instructions. 
  • Pre-market notification (PMN): Companies must submit a PMN detailing the formula’s composition, manufacturing process, and safety before selling in Canada. 

2. Submit a Comprehensive Pre-Market Notification (PMN)

A well-prepared PMN is critical for approval. Ensure you include: 

  • Nutritional analysis: Provide detailed nutrient data that meets Health Canada’s guidelines. 
  • Safety and efficacy data: Submit clinical trial data or other safety reports verifying compliance. 
  • Manufacturing process overview: Detail ingredient sourcing, production quality controls, and contamination prevention measures. 

3. Conduct Clinical Studies (If Required)

For novel or significantly altered formulas, Health Canada may require clinical studies. These studies must follow Good Clinical Practices (GCP) and confirm the formula’s safety and ability to support infant growth and development. 

4. Comply with Labeling Regulations

Labeling plays a crucial role in compliance. Your infant formula’s label must clearly present: 

  • Complete Nutritional Information: A detailed breakdown of essential nutrients. 
  • Approved Health Claims: Only permitted claims regarding nutritional adequacy can be included. 
  • Preparation Instructions: Clear guidelines for safe preparation and feeding. 

5. Submit Your Application to Health Canada

Once your documentation is ready, submit your PMN via the Electronic Regulatory Submissions (ERS) Gateway. Accuracy is crucial to avoid delays. 

  • Typical Review Time: 90-180 days. Missing information can result in further delays, so ensure all details are correct. 

6. Maintain Ongoing Compliance Monitoring

Compliance does not end after registration. Companies must continue to meet Health Canada’s evolving standards by: 

  • Adverse Event Reporting: Promptly report any safety concerns. 
  • Product Recalls: Implement immediate recall procedures if necessary. 
  • Label Updates: Adjust labeling to reflect any regulatory changes. 

Common Questions About Infant Formula Registration 

How long does the approval process take? 

The approval process for infant formula registration in Canada typically takes between 90 and 180 days. The timeline depends on the completeness of the submission and whether additional information is required by Health Canada. 

Do all formulas require clinical studies? 

Not all infant formulas require clinical studies. However, if a formula is new or significantly modified, Health Canada may mandate clinical trials to confirm its safety and effectiveness. 

Can I make health claims on my infant formula label? 

Yes, but only those that have been approved by Health Canada. Ensuring compliance with these regulations is essential to avoid delays and potential penalties. 

Why Compliance Matters: Avoiding Costly Mistakes 

Failing to meet Health Canada’s requirements can lead to: 

  • Delays in market entry due to missing or incorrect documentation. 
  • Increased costs from additional clinical trials and resubmissions. 
  • Regulatory penalties for non-compliant labeling or safety violations. 

How Quality Smart Solutions Can Help 

Navigating Canada’s infant formula registration process can be complex. Quality Smart Solutions offers expert guidance to streamline your application and ensure compliance. Our regulatory specialists will help you prepare accurate submissions, reducing the risk of costly delays or rejections. 

Need assistance with your infant formula registration? Fill out the form below or contact us to ask us any questions you have.   

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Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input

Batch 4B

FDA Warning Letter

Health Canada Opens 75-Day Consultation on Batch 4b – Share Your Input

The Natural and Non-Prescription Health Products Directorate (NNHPD) invites industry stakeholders to provide feedback on Batch 4b, with consultation open for 75 days. We encourage you to support any suggestions for monograph revisions with published evidence or clear rationale.

What’s Included in Batch 4b?

  • Updated Monographs for Topical Ingredients
    • 16 single-ingredient monographs for traditional plants now represent ingredient quantities as percentages. Your input confirms whether these concentrations are reasonable and align with industry standards.
  • New Topical Analgesics/Antipruritic Monograph
    • This addition, featuring natural health product ingredients, is based on the Nonprescription Drug Topical Anaesthetic/Analgesic/Antipruritic Labelling Standard.

Access all documents in Batch 4b, including new monographs, directly here.

Step-by-Step Instructions to Submit Comments

Follow these steps to access and comment on the documents:

  1. Choose Your Language
    • Double-click the language-specific folder.
  2. Download the Monograph
    • Double-click the monograph you wish to view and click “Download” in the top right corner.
  3. Enable Editing
    • Open the document on your computer and click “Enable Editing” if prompted by a Protected View banner.
  4. Add Comments
    • Go to the “Review” tab in Word and use “New Comment” to add your input.
  5. Send Back Your Edited Document
    • Save your version with comments and email it to: nnhpd.consultation-dpsnso@hc-sc.gc.ca

Prefer Text-Based Comments?
You can also email your comments directly, clearly linking each comment to the corresponding monograph.

Deadline for Submission: January 14, 2025

We appreciate your insights and participation in shaping health product standards. Feedback must be submitted by January 14, 2025.

How Quality Smart Solutions Can Assist

Quality Smart Solutions specializes in guiding businesses through regulatory challenges like this consultation. Our experts clarify the comment submission process, ensuring your insights are aligned with regulatory expectations—partner with us to make your voice heard in compliance consultations like Batch 4b. Reach out to us by filling out the form below.

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How to Master FDA Audits for Your Dietary Supplement Facility: A Complete Preparation Guide

Introduction 

Preparing for an FDA audit can be challenging, especially for dietary supplement manufacturers who must meet stringent Good Manufacturing Practices (GMP) requirements. The FDA regularly inspects dietary supplement facilities to ensure manufacturing, labeling, and safety regulations compliance. But how can you ensure you’re ready? Failing to meet FDA standards can lead to severe consequences, including costly recalls and facility shutdowns. This guide will outline practical strategies to help you confidently and efficiently navigate the FDA audit process. 

What is an FDA Audit and Why is it Essential? 

An FDA audit is a thorough review of your manufacturing facility, focusing on processes, practices, and documentation to verify compliance with the FDA’s Current Good Manufacturing Practices (cGMP). The FDA’s primary concerns during an audit include: 

  • Ensuring safe manufacturing practices. 
  • Validating that product labeling is accurate and non-misleading. 
  • Confirming adherence to testing standards. 

Why Does It Matter? 

Failing an FDA audit could damage your brand’s reputation, disrupt your supply chain, and, in extreme cases, halt operations entirely. Ensuring your facility is always ready for inspection can minimize risk, safeguard your business, and build consumer trust. 

How to Prepare for an FDA Audit: Step-by-Step Guidelines 

1. Review and Update Your SOPs Regularly 

Ensure your Standard Operating Procedures (SOPs) are thorough, up-to-date, and reflect daily operations accurately. SOPs are crucial for: 

a. Detailing manufacturing processes. 

b. Outlining quality control protocols. 

c. Documenting employee training and qualifications. 

d. Ensuring traceability of raw materials. 

Action: Appoint a dedicated team to review SOPs regularly and ensure employees understand these protocols inside and out. 

2. Conduct Routine Internal Audits 

Internal audits allow you to identify issues before an official inspection. Prioritize areas such as: 

a. Documentation accuracy. 

b. Maintenance logs for equipment. 

c. Sanitation and cleanliness. 

d. Traceability of ingredients and products. 

Action: Schedule quarterly internal audits to address any potential gaps in compliance. Use these audits as practice to refine your processes for the real audit. 

3. Invest in Comprehensive Employee Training 

The FDA assesses employee training quality, as untrained staff can contribute to errors in manufacturing, packaging, and documentation. 

Action: Develop a training program that includes onboarding and ongoing education for all staff. Keep detailed training records to demonstrate competency and compliance readiness. 

4. Ensure Accurate, Detailed Record-Keeping 

Record-keeping is crucial for FDA audits, covering areas like: 

a. Batch production records. 

b. Results of quality control tests. 

c. Supplier qualification documents. 

d. Product labeling approvals. 

Action: Implement a structured system to ensure all records are up-to-date, complete, and readily accessible. Automating this process reduces the risk of errors and ensures records are audit-ready. 

5. Enhance Product Testing and Quality Control 

Dietary supplements require rigorous quality control to guarantee product safety including: 

a. Testing raw materials and finished products for contaminants. 

b. Keeping records of all testing for each batch. 

c. Ensuring validated testing methods. 

Action: Partner with a reliable third-party lab to conduct product testing and ensure your protocols meet FDA standards. Organize testing records for easy access during inspections. 

6. Verify Your Product Labeling and Claims 

The FDA scrutinizes dietary supplement labels to verify compliance with regulatory guidelines. Misleading or exaggerated claims can lead to penalties. 

Action: Review all product labels to ensure they align with FDA regulations. Avoid claims suggesting your product treats, cures, or prevents diseases, as these could reclassify the supplement as a drug. 

7. Schedule Mock Audits for Stress-Free Preparation 

Mock audits simulate the inspection process, allowing you to identify weaknesses and make improvements. 

Action: Hire a third-party consultant to conduct a mock FDA audit. This external perspective provides invaluable insights and allows you to fine-tune operations before the actual audit. 

Frequently Asked Questions (FAQs) 

  1. How frequently does the FDA audit dietary supplement facilities?

Typically, the FDA audits facilities every 2-3 years, but high-risk or more extensive facilities may see more frequent inspections. 

  1. What if my facility fails an FDA audit?

A failed audit can result in warning letters, product recalls, or even legal action. Fortunately, manufacturers often have an opportunity to address deficiencies before facing penalties. 

  1. How long does an FDA audit usually last?

Audits can last from a few days to several weeks, depending on the facility’s complexity and size. 

Conclusion 

Preparing for an FDA audit doesn’t have to be stressful. You can ensure your facility is always audit-ready by following these steps—regular SOP reviews, internal audits, staff training, accurate record-keeping, thorough testing, compliant labeling, and mock audits. Staying proactive and addressing any issues early will strengthen your compliance and help you confidently face FDA inspections. 

How Quality Smart Solutions Can Help 

At Quality Smart Solutions, we specialize in comprehensive FDA audit preparation for dietary supplement manufacturers. Our expert team offers services ranging from SOP development and employee training to mock audits, helping you achieve compliance with ease. Trust us to guide you through every step of the audit process so you’re fully prepared to meet FDA standards and build lasting consumer confidence. 

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Health Canada’s NDS, SNDS, and ANDS Pathways: Which One Is Right for You?

Health Canada drug submission pathways explained: NDS, SNDS, ANDS

If you’re thinking about bringing a pharmaceutical product to the Canadian market, getting familiar with drug submission pathways is a crucial first step. These regulatory routes can seem a bit confusing at first, but understanding them will save you time, money, and potential setbacks. Whether you’re introducing a new drug, modifying an existing one, or entering the generic market, Health Canada requires that you follow a specific regulatory route.

Each submission type (NDS, SNDS, or ANDS) has its own criteria, data requirements, review timelines, and costs. Choosing the wrong one can slow your approval process, increase expenses, or even result in rejection. But don’t worry, this blog will walk you through each pathway clearly and simply.

Keep reading to learn which submission pathway best fits your product, and how to avoid common regulatory missteps.

What is an NDS?

A New Drug Submission (NDS) is required for drugs with new active ingredients, formulations, or therapeutic uses that haven’t yet been authorized in Canada. This is the most comprehensive submission type and applies to innovative therapies entering the market for the first time.

When to use NDS

  • Introducing a new active ingredient
  • Launching a drug with a new indication
  • Creating a new dosage form or formulation

Key requirements

  • Extensive clinical and preclinical data
  • Health Canada average review timeline: 300 to 600 calendar days
  • CAD 590,346 submission fee (2024-2025)

Example: You’ve developed a new treatment for a chronic condition. Since it has never been marketed in Canada, you’ll need an NDS to apply.

What is an SNDS?

The Supplemental New Drug Submission (SNDS) is used for significant changes to the safety, efficacy, or quality of an already approved drug. If those updates could affect the product’s safety, effectiveness, or quality, you must submit supporting documentation for Health Canada’s review.

When to use SNDS

  • Changing dosage or formulation
  • Adding a new therapeutic use
  • Modifying manufacturing or labelling details

Key requirements

  • Supporting clinical data (as needed)
  • Review timeline of 180 to 300 days
  • CAD 305,690 submission fee (2024-2025)

Example: You want to add a secondary indication for your approved blood pressure medication. This requires an SNDS.

What is an ANDS?

The Abbreviated New Drug Submission (ANDS) is for generic drugs and falls under Division 8. It allows manufacturers to show that their product is bioequivalent to an approved reference drug, without having to conduct new clinical trials.

When to use ANDS

  • Launching a generic version of a brand-name drug
  • Demonstrating equivalence in absorption and delivery

Key requirements

  • Bioequivalence studies (except for certain routes of administration, e.g., intramuscular)
  • Review timeline of 180 to 300 days
  • CAD 305,690 submission fee (2024-2025)

Example: You’re creating a generic cholesterol-lowering drug. You’ll file an ANDS to show it matches the reference product.

Comparing NDS, SNDS, and ANDS pathways

Now that we’ve gone through each submission pathway, let’s look at them side by side in the comparison chart below. The visual summary below helps clarify how the three options differ in scope, requirements, and timelines. Whether you’re launching a new drug, modifying an approved one, or developing a generic, the chart makes it easier to spot the best fit for your product.

How to navigate Health Canada's drug submission pathways: comparison chartFrequently asked questions

Still unsure which path is right for your product? You’re not alone. Here are some common questions we hear from businesses trying to figure out Health Canada’s drug submission process. We’ve expanded the answers to help you understand what to expect and make informed decisions.

  1. I’m reformulating a drug. Which pathway do I use?
    If the changes affect the product’s safety, quality, or intended use, you’ll need to go through the SNDS process. This includes updates to dosage forms, manufacturing methods, new therapeutic indications, or significant labelling changes.
  2. How long does the ANDS process take?
    It usually takes between 180 and 300 days. That said, a complete and accurate submission can prevent delays. Make sure your bioequivalence studies and supporting documents are in order.
  3. Can I use the NDS pathway for a generic?
    No. Generics must follow the ANDS route. You’ll need to demonstrate that your product is bioequivalent to an approved reference drug, without having to submit new clinical trial data.
  4. Do I need clinical trial data for an SNDS?
    It depends on the nature of the change. If you’re changing the dosage or therapeutic indication, you may need to include new clinical data. For more minor changes, such as manufacturing site updates, this might not be required.
  5. What if my product falls between two categories?
    If your submission doesn’t clearly meet the requirements for one pathway, it’s best to consult Health Canada or work with a regulatory expert. Submitting under the wrong pathway can lead to unnecessary delays or rejections.

How regulatory experts can help

Navigating drug submission pathways doesn’t have to be stressful. Our regulatory team at Quality Smart Solutions can help you evaluate your product, prepare the necessary documentation, and ensure your submission meets Health Canada’s expectations.

Whether you’re preparing an NDS, SNDS, or ANDS, we’ll guide you from strategy through to approval. You can visit our Contact page or simply fill out the form below to schedule a free consultation with one of our regulatory experts.

References

Health Canada. (2024). Fees for the Examination of Drug Submissions and Applications. Government of Canada. Retrieved from https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submission-applications/fees.html 

Canada Gazette, Part 1, Volume 158, Number 13. (2024). Notice amending Health Canada’s National Dosimetry Services Products, Services, and Fees Schedule. Government of Canada. Retrieved from https://gazette.gc.ca/rp-pr/p1/2024/2024-03-28/html/notice-avis-eng.html

Health Canada. (2023). Drug Submission Application Review Fees. Government of Canada. Retrieved from https://www.canada.ca/en/health-canada/services/submission-applications/review-fees.html

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Health Canada’s Drug vs Product Monograph: Key Differences

Health Canada Drug Monograph vs Product Monograph

If you’re bringing a drug or health product to the Canadian market, you’ll need to understand Health Canada’s regulations. Two important terms you’ll come across are Drug Monographs and Product Monographs. While they sound similar, they serve different purposes. Knowing the difference can help you navigate approvals smoothly and avoid delays.

In this article, we break down the key differences between a Health Canada Drug Monograph and a Product Monograph, emphasizing why knowing these distinctions can be the difference between quick market access and costly delays. Let’s dive in!  

What is a Health Canada Drug Monograph?  

A Health Canada Drug Monograph serves as a regulatory framework set by Health Canada that outlines the pre-approved conditions for selling specific classes of drugs, typically non-prescription, without needing clinical trials. This guide is handy for companies dealing with non-prescription or over-the-counter products, as it provides a standardized way to bring these items to market with reduced time and financial investment.

Common categories include pain relievers, antihistamines, and cough suppressants. The approval process is far more straightforward for products that meet monograph standards. Some critical characteristics of Health Canada drug monographs include:

  1. Predefined Standards: Health Canada Drug Monographs include predefined dosages, indications, and labelling standards that manufacturers must follow. These monographs enable manufacturers to market products in specified categories without a full clinical trial. 
  2. Simplified Approval Process: Products that fit within these predefined standards can bypass the clinical trial requirement, making it a cost-effective and time-efficient path to the market.  

Why Are Drug Monographs Important?

Drug monographs streamline product approval by providing a clear pathway with pre-approved guidelines. They allow manufacturers to move forward quickly while ensuring products remain safe and compliant under Health Canada’s established regulations.  

What is a Product Monograph?  

Unlike the Drug Monograph, a Product Monograph is a comprehensive, specific document that companies must submit to Health Canada to market a new prescription or over-the-counter drug requiring unique clinical data. This document details how a particular drug is used and prescribed, serving as a crucial reference for healthcare professionals.

Product Monographs are exclusive to the specific drug they cover, unlike Drug Monographs that apply to a whole class of drugs.  They are critical in ensuring that healthcare providers have comprehensive knowledge of a drug’s safety, risks, and prescribing guidelines. Therefore, this document is essential for achieving regulatory approval from Health Canada for prescription drugs. Important features of a product monograph include:

  1. Detailed Clinical Data Required: Unlike a Drug Monograph, a Product Monograph demands extensive clinical data, including safety, efficacy, and dosage. This information is essential for Health Canada to evaluate the risks and benefits of a specific drug.
  2. Three-Part Structure: A Product Monograph is divided into the following parts:
    • Part I: Health Professional Information – Prescribing details for professionals;
    • Part II: Scientific Information – Clinical trial results, safety, and pharmacodynamic
    • Part III: Consumer Information – User-friendly instructions on safe drug use for consumers.  

Differences Between Drug and Product Monographs

To simplify, here are the four main distinctions between a drug monograph and a product monograph:

Purpose 

  • Health Canada Drug Monograph: Offers a pre-approved, standardized approach for classes of drugs.
  • Product Monograph: Details all aspects of a unique drug’s safety, efficacy, and instructions. 

Scope of Coverage

  • Drug Monograph: Applies to broad classes (e.g., pain relievers).
  • Product Monograph: Applies to a specific drug only. 

Clinical Data Requirement 

  • Drug Monograph: No new clinical data required.
  • Product Monograph: Extensive data and clinical trial results needed. 

Approval Time to Market 

  • Drug Monograph: Faster approval, lower regulatory burden.
  • Product Monograph: Longer review process due to the need for comprehensive data. 

Frequently Asked Questions

  1. Why are Health Canada Drug Monographs Faster to Approve? Because they don’t require new clinical trials, these monographs offer a quicker path to market for products that fit pre-approved categories.  
  2. Does Every Drug Need a Product Monograph?  No, only drugs that are prescription-based or require unique clinical evidence need a Product Monograph.  
  3. Can a Product Have Both Types of Monographs? Typically, no. A drug falls into a class requiring a Drug Monograph or a detailed, unique Product Monograph.   

How Quality Smart Solutions Can Help

Quality Smart Solutions specializes in helping businesses navigate Canada’s complex regulatory landscape. With expertise in Health Canada Drug Monographs and Product Monographs, their team ensures every submission is complete and compliant and fast-tracks your product to market. Reach out to us today by filling out the form below or contact us by clicking here. 

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FDA Fees Summary for 2025

FDA User Fees for Fiscal Year 2025 (FY2025) 

The FDA’s user fees for FY2025, which runs from October 1, 2024, to September 30, 2025, apply to various industries, including pharmaceuticals, medical devices, biologics, and animal drugs. These fees help support the FDA’s regulatory and review processes, promoting efficient approval and compliance. 

1. Prescription Drug User Fee Act (PDUFA) Fees 

For human prescription drugs and biologics, PDUFA fees expedite the drug approval process: 

  • New Drug Application (NDA) with clinical data: $4,310,002 
  • NDA without clinical data: $2,155,001 
  • Program Fees (for approved drugs): $403,889 per product 

2. Medical Device User Fee Amendments (MDUFA) Fees 

MDUFA fees apply to medical devices to support review and regulation: 

  • 510(k) Premarket Notification Submission: $24,335 
  • Premarket Approval (PMA) Application: $540,783 
  • De Novo Classification Request: $162,235 
  • Annual Establishment Registration Fee: $9,280 

3. Generic Drug User Fee Amendments (GDUFA) Fees 

GDUFA applies to generic drug manufacturers to enhance the generic application review process: 

  • Abbreviated New Drug Application (ANDA) Fee: $252,453 
  • Program Fees: 
    • Large companies (20+ approved ANDAs): $1,891,664 
    • Medium companies (6-19 ANDAs): $756,666 
    • Small companies (1-5 ANDAs): $189,166 

4. Biosimilar User Fee Act (BsUFA) Fees 

BsUFA fees are for biosimilar biological products to aid in regulatory review: 

  • Application Fee (with clinical data): $1,471,118 
  • Application Fee (without clinical data): $735,559 
  • Biosimilar Program Fee: $256,168 

5. Animal Drug User Fee Act (ADUFA) Fees 

ADUFA fees apply to veterinary drug manufacturers: 

  • Animal Drug Application (NADA): $581,735 
  • Supplement requiring safety or efficacy data: $290,867 
  • Annual Product Fee: $10,705 
  • Annual Establishment Fee: $157,702 

6. Animal Generic Drug User Fee Act (AGDUFA) Fees 

AGDUFA supports generic animal drug manufacturers: 

  • Abbreviated New Animal Drug Application (ANADA): $161,907 
  • Annual Product Fee: $116,139 
  • Annual Establishment Fee: $157,702 

7. Over-The-Counter (OTC) Monograph Drug User Fee 

Fees for non-prescription drugs marketed under OTC monographs: 

  • OTC Monograph Order Request (Tier 1): $559,777 
  • OTC Monograph Order Request (Tier 2): $111,955 
  • Annual OTC Monograph Drug Facility Fees: 
    • Monograph Drug Facility (MDF): $34,166 
    • Contract Manufacturing Organization (CMO) MDF: $22,777 

Key Notes 

  • Establishment Fees: Annual registration fees apply to industries like medical devices, prescription drugs, and animal drugs. 
  • Small Business Reductions: Some fees may be reduced for small businesses in medical devices and pharmaceuticals that meet eligibility criteria. 
  • Annual Adjustments: The FDA reviews and adjusts these fees annually based on inflation and regulatory demands to improve review efficiency and post-market safety. 

How Quality Smart Solutions Can Help 

Keeping up with regulatory fees and submission requirements is crucial for your business’s success in FDA-regulated industries. Quality Smart Solutions is here to simplify the registration and compliance process for your company, whether you’re working with the FDA, Health Canada, or the European Food Safety Authority (EFSA). Contact Quality Smart Solutions today to ensure smooth, cost-effective compliance that aligns with the latest regulatory standards. 

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New Modification to Buffer Zone Affects Food Manufacturers and Suppliers

Simplified Explanation of Changes to Labeling Rules 

Starting July 2022, food manufacturers and suppliers have been required to display special labeling symbols on certain food products. These include a front-of-package (FOP) nutrition symbol for products high in saturated fat, sugar, or sodium, and a supplemented food caution identifier (SFCI) for supplemented foods with specific health or safety concerns (e.g. added caffeine). Some products may require both symbols on the front of the package, which has caused concerns about space on labels and packaging design. 

Why Was a Change Needed? 

Manufacturers and suppliers raised concerns that placing both symbols on the packaging would take up too much space, leaving less room for other important information. To address this concern, Health Canada modified the rules to allow these symbols to be placed directly next to each other without a gap between them. This is especially helpful for products that need more than one FOP nutrition symbol or both the FOP symbol and the SFCI. 

What Has Changed? 

Before this change, there was a required empty space, or “buffer zone,” around each symbol. Now, if the FOP nutrition symbol and the SFCI are next to each other, there doesn’t need to be a gap where they touch. This also applies to products needing multiple FOP symbols. However, any remaining sides of the symbols not touching another symbol must still have the required space around them. 

How This Affects Food Manufacturers 

This modification gives manufacturers and suppliers more flexibility in how they design their labels. They can now place these symbols side-by-side without worrying about taking up too much space, while still meeting legal requirements. This helps reduce the impact on available label space, making it easier for manufacturers and suppliers to comply with the rules, while still maintaining their brand integrity and marketing design. 

Next Steps 

The change was finalized after Health Canada received feedback from industry representatives and other stakeholders. This adjustment should make it easier for manufacturers to follow labeling guidelines while maintaining the integrity of the symbols for consumers. This update allows more efficient use of space on food packaging while keeping important health information visible and clear. 

Quality Smart Solutions Can Help

Navigating the latest labeling requirements can be challenging, but Quality Smart Solutions is here to simplify the process. With recent changes to Canada’s labeling rules, Quality Smart Solutions offers expert guidance to ensure your labels meet these updated requirements efficiently and effectively. Let us help you create compliant, clear, and consumer-friendly labels that uphold the integrity of your brand. Reach out to Quality Smart Solutions to streamline your labeling process and stay ahead in the industry. Fill out the form below to get started.

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Quality Smart Solutions Launches GRAS Experts to Protect Against Food Safety Risks

GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and avoiding recalls

In light of McDonald’s recent recall of Quarter Pounders due to E. coli contamination, the need for stringent oversight on food ingredients has never been more critical. Quality Smart Solutions has launched GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and avoiding recalls.

“Everyone’s talking about food safety right now, and for good reason,” said Andrew Parshad, President & Founder of Quality Smart Solutions. “The McDonald’s recall is a stark reminder of what can happen when ingredient or food safety isn’t airtight. GRAS Experts was created to help businesses avoid these exact scenarios by ensuring their ingredients are proven safe and fully compliant with evolving regulations.”

As more companies face scrutiny over what goes into their products, the GRAS (Generally Recognized as Safe) process has become a critical standard for ingredient approval. GRAS Experts simplifies this complicated process, providing businesses with expert guidance to secure GRAS status for their ingredients, navigate Health Canada approvals, and meet EFSA Novel Food regulations.

Additionally, the Toxic Free Food Act just introduced, complicates the compliance process. The issue being the self affirmed GRAS pathway (not filing with FDA) gives any novel ingredient supplier the ability to put together a dossier or evidence without a government agency vetting it. The Act proposes to end that and require that novel ingredients mandatorily be filed with FDA. GRAS Experts was designed to successfully navigate this process.

With a dedicated team of regulatory specialists, GRAS Experts takes the stress out of compliance, helping food manufacturers and ingredient suppliers prevent costly recalls and protect their reputation.

In a time when consumers are more concerned than ever about what’s in their food, Quality Smart Solutions is stepping up to ensure businesses can deliver products that meet the highest safety standards. GRAS Experts is not just about compliance—it’s about trust.

Read the News Release on GlobalNewsWire

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Government of Canada Launches Consultation on Plant-Based Egg Alternative Labelling: What Businesses Need to Know

The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg products, a critical development for businesses involved in Novel Food Products and ingredients. As the plant-based food market skyrockets, this new consultation presents both an opportunity and a challenge for companies to ensure their products meet compliance standards. Businesses must now navigate the complex landscape of food labelling, and the right strategy can make all the difference. If you’re in the plant-based or novel food space, this consultation is something you can’t afford to ignore.

The Growing Importance of Clear Food Labelling

With plant-based foods booming, clarity in labelling is essential for legal compliance and consumer trust. The Government of Canada’s proposed guidelines seek to ensure that plant-based alternatives to egg products are labelled truthfully and are not misleading to consumers. These guidelines are vital as more people turn to plant-based diets and expect transparency in the products they purchase. But how can businesses keep up with the ever-evolving regulations in the food industry?

If you’re a company that deals with Novel Food Products or innovative plant-based alternatives, now is the time to act. Ensuring compliance with new labelling standards will protect your brand from legal challenges and boost your reputation for honesty and transparency. Are you prepared for this shift?

Why This Matters for Businesses in the Novel Food Space

The plant-based food sector is no longer niche—it’s mainstream, and the competition is fierce. The CFIA’s consultation focuses on creating clear distinctions between plant-based alternatives and traditional egg products. Businesses need to get ahead by revisiting their product labels to ensure they meet the proposed guidelines while standing out in a crowded marketplace.

So, what does this mean for you?

If your company deals in plant-based or novel food products, you are entering a complex compliance maze. The terms, images, and packaging design must be clear and non-misleading. Simple errors could lead to consumer confusion, a damaged brand image, or even costly legal ramifications.

Here’s where it gets more complicated: the CFIA is not just asking for feedback from businesses but also asking for input from consumers. Consumer perception of your product is under the microscope, and businesses must consider how their labels resonate with the end-user.

Now, more than ever, it’s essential to ask: Is your product being perceived in the right way?

The Stakes Are High—Don’t Let Your Brand Get Left Behind

According to the CFIA, this consultation aims to “help the industry comply with the legislation and support consistency in how these foods are promoted.” For companies, this means adopting clear and honest labels that don’t mislead consumers. While the proposed guidance provides tools like the Industry Labelling Tool to help businesses, it’s not just about following the rules—it’s about staying ahead of them.

This consultation ends on October 28, 2024, giving businesses a narrow window to evaluate their labelling practices and prepare for potential changes.

Is your company prepared to handle the upcoming changes in labelling regulations?

How Quality Smart Solutions Can Help You Navigate This Complex Process

Having a trusted partner like Quality Smart Solutions can make all the difference when dealing with regulatory changes, especially those involving novel and plant-based foods. Navigating the maze of CFIA compliance and staying updated on evolving standards can be daunting. That’s why businesses need expert guidance to ensure their products are compliant and competitive. Quality Smart Solutions specializes in helping companies meet GRAS (Generally Recognized as Safe), Health Canada, and CFIA standards, ensuring your product stays on the shelf and in consumers’ good graces.

Final Thoughts: You Must Ensure Compliance and Consumer Trust

The CFIA’s new consultation on plant-based egg alternatives is critical for businesses involved in Novel Food Products and plant-based alternatives. It’s an opportunity to strengthen your brand’s reputation by showing consumers you’re serious about transparency and safety. But the window for action is short, and the stakes are high.

How Quality Smart Solutions Can Help

With a deep understanding of food regulations, Quality Smart Solutions offers expert guidance in navigating compliance for plant-based alternatives and Novel Food Products. Whether you aim to meet CFIA standards or require help with Health Canada approvals, they provide tailor-made solutions to ensure your product is compliant and market-ready. Reach out to QSS today by filling out the form below.

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New Hydration Product Monographs Launched

The NNHPD Opens Consultation on Batch 4 

Through new guidelines, stakeholders are invited to shape the future of homeopathic and topical health products. 

The Natural and Non-Prescription Health Products Directorate (NNHPD) has made a significant announcement, opening a crucial consultation period for Batch 4 of their latest product monographs, including several that will impact the growing market for hydration-related health products. This new development is not just about regulatory changes—it represents an opportunity for stakeholders to influence the standards governing these products directly, ensuring they are both safe and effective for consumers. For companies and professionals in the natural health sector, this consultation is a chance to align their products with the latest health regulations, cement their place in a rapidly evolving market, and contribute to the overall advancement of health product innovation. 

Why These New Hydration Monographs Matter 

The release of the new monographs has implications beyond simple regulatory compliance. With health-conscious consumers seeking more natural solutions for hydration, the products covered in Batch 4a, particularly those related to homeopathic remedies and topical treatments, offer companies an opportunity to meet growing demand confidently. Hydration products are now a central part of self-care routines, and the NNHPD’s focus on these products demonstrates their significance in the modern health landscape. 

According to experts at Quality Smart Solutions, leading consultants in regulatory affairs, these monographs play a critical role in setting product safety, efficacy, and consumer trust standards. Companies that integrate these regulations into their hydration product development can expect to meet compliance requirements and strengthen their credibility in a competitive market. 

A Closer Look at New Homeopathic Hydration Monographs 

Batch 4a introduces six homeopathic-like monographs, particularly relevant to hydration products aimed at maintaining and restoring fluid balance in the body. Homeopathy, a system of alternative medicine, is gaining momentum in wellness circles, and hydration-focused homeopathic products are poised to address a variety of consumer needs—from electrolyte balance to skin hydration. 

These monographs are a crucial development for manufacturers looking to introduce innovative, natural hydration solutions. By adhering to the guidelines set out by the NNHPD, companies can ensure their products are both compliant and positioned to capitalize on the growing trend toward natural, non-prescription health products. 

In this consultation, stakeholders are encouraged to provide suggestions for revisions supported by published evidence or rationales. This collaborative process ensures that the final monographs are scientifically sound, practical for manufacturers, and beneficial for consumers. 

Batch 4b: Spotlight on Topical and Buccal Hydration Products 

While the homeopathic monographs in Batch 4a focus on internal hydration and fluid balance, Batch 4b, slated for release on November 1, will center around topical and buccal (oral mucosal) hydration products. With 17 single-ingredient topical/buccal monographs under review, this consultation will explore traditional plant-based ingredients used for hydration, from aloe vera to hyaluronic acid. 

Topical hydration products, such as moisturizers, serums, and gels, are essential for maintaining skin health, particularly in harsh climates and dry conditions. The new monographs will provide clear guidelines on the traditional quantity crude equivalent amount of these ingredients, ensuring that products using these ingredients are both practical and safe for consumer use. 

Buccal hydration products are equally important, particularly for individuals with specific hydration needs related to oral health. These products, often in sprays or lozenges, provide targeted hydration and relief, and the upcoming consultation will establish concentration guidelines that ensure their efficacy. 

A direct link to all the monographs in batch 4a and to the new monographs can be found here.   

Or copy and paste the link below: 

https://drive.google.com/drive/folders/1zOpHiShCS6VOWgJgW2fOCjw9pw4wkEyE?usp=sharing 

 

Your Chance to Shape the Future 

One of the most critical aspects of this consultation is its collaborative nature. The NNHPD is actively seeking input from industry professionals, manufacturers, and other stakeholders to ensure that the new hydration monographs are both scientifically accurate and practically applicable. This open consultation is a unique opportunity to influence the regulatory landscape for hydration products. 

The NNHPD encourages stakeholders to carefully review the monographs and provide comments by October 2, 2024, for Batch 4a and by January 14, 2025, for Batch 4b. These deadlines provide ample time for carefully considering the monographs, ensuring that feedback is comprehensive and informed. 

When submitting feedback, stakeholders can use the “Comments” function in the restricted Word documents provided by the NNHPD. Detailed instructions are available, ensuring that the process is straightforward and accessible. Alternatively, comments can be submitted via email with explicit references to the associated monographs. 

How to Participate in the Consultation 

Participating in the consultation process is simple. To review the documents and provide input, stakeholders are encouraged to follow these steps: 

  1. Access the Monographs: Visit the NNHPD’s official website, where links to Batch 4a monographs are available. 
  2. Download the Documents: Double-click the folder in your preferred language, download the monographs you would like to view and open them on your computer. 
  3. Enable Editing: The documents are in “Protected View,” so you will need to click “Enable Editing” to add comments. Click the Review tab in Word. 
  4. Submit Comments: Use the “New Comment” function in Word to provide feedback. Once complete, save the file and email it to the NNHPD at mailto:mnnhpd.consultation-dpsnso@hc-sc.gc.ca. 
  5. Alternatively, You can submit feedback via email, ensuring that each comment references the appropriate monograph. 

Building a Better Future for Hydration Products 

This consultation period is a defining moment for the future of natural hydration products. Participating allows stakeholders to shape regulations that will ultimately improve product quality, safety, and consumer trust. Whether you’re a product developer, a regulatory affairs expert, or a consumer advocate, your input could have a lasting impact on the health and wellness industry. 

Quality Smart Solutions emphasizes regulatory compliance is not just about meeting minimum standards; it’s about leading the market by offering products that consumers can trust. It’s important to underscore these consultations for companies looking to innovate in the natural health product space. Navigating these regulatory waters with expertise and precision is undoubtedly essential for success. 

Don’t Miss This Opportunity 

For stakeholders in the hydration product industry, the NNHPD’s Batch 4 consultation is a critical opportunity to help shape the future of homeopathic and topical hydration products. With the rising consumer demand for natural health products, this is your chance to ensure that your products meet the highest safety, efficacy, and quality standards. 

Submit your comments by October 2, 2024, for Batch 4a, and be part of this collaborative effort to improve the hydration product landscape. Your insights could make all the difference in helping consumers access the best natural health products. 

If you need help making your contribution, reach out to Quality Smart Solutions at 1(800)396-5144, and we will help you navigate this exciting new opportunity. 

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7 Must-Know EFSA Novel Food Regulation Changes for 2025: You Need To Be Ready

Are your novel food products ready for the new European Food Safety Authority (EFSA) regulations? If you’re planning to enter the European market in 2025, significant updates to the EFSA novel food regulatory framework are on the horizon, effective from February 1, 2025. These changes will affect everything from risk assessments to labelling, sustainability, and more. Staying ahead of these updates could be the difference between success and costly delays.

This guide breaks down the fundamental regulatory changes and how your business can prepare for them. Plus, we’ll reveal how the common industry practice of partnering with experts can help you navigate these complex updates smoothly and avoid potential roadblocks.

What are these new EFSA Regulations?

1. Stricter Risk Assessments for Novel Foods

The EFSA is sharpening its focus on safety, particularly for foods created using cutting-edge technology like nanomaterials or synthetic biology.

Fundamental Change: Comprehensive assessments of potential toxicological, allergenic, and nutritional impacts.

What This Means: You should conduct long-term safety studies, especially for foods with novel production processes or bioactive components.

FAQ: Do I need new safety studies for already approved products? Answer: If your novel food includes new technology or production processes, you will need updated safety data that aligns with EFSA’s enhanced criteria.

2. Simplified Process for Traditional Foods from Non-EU Countries

Good news for those introducing traditional foods from outside the EU! EFSA is streamlining the process for these products if you can prove a safe consumption history.

Fundamental Change: Foods with at least 25 years of safe consumption in non-EU markets will benefit from a fast-tracked approval process.

What This Means: Less time-consuming reviews and easier entry into the European market.

FAQ: How do I prove my food has been consumed safely for 25 years? Answer: You must provide documented evidence like historical records, studies, or testimonials from recognized institutions.

3. Transparency in the Application Process

EFSA is taking steps to increase transparency, making more information about novel food applications accessible to the public.

Fundamental Change: A public database will feature safety evaluations and risk assessments.

What This Means: Consumers, researchers, and competitors can see the details of novel food approvals, increasing industry accountability.

4. Stricter Labeling and Health Claims Regulations

Misleading labels and exaggerated health claims will no longer be tolerated under EFSA’s new rules.

Fundamental Change: Labels must include clear information about the food’s novel nature, allergens, and proper preparation or consumption instructions.

What This Means: Ensure health claims are backed by scientific evidence to avoid non-approval or removal from the market.

FAQ: What happens if my product label is misleading? Answer: EFSA could reject or remove your product from the market, costing you time and money. Avoid exaggerated claims by relying on robust scientific evidence.

5. Protection of Proprietary Data

While EFSA is enhancing transparency, it’s also offering more protection for proprietary data submitted during novel food applications.

Fundamental Change: A five-year protection period for proprietary data ensures competitors can’t use your research for similar product approvals.

What This Means: You maintain a competitive advantage while benefiting from data exclusivity.

6. Sustainability Takes Center Stage

Sustainability is more important than ever, and EFSA’s updates reflect this by incorporating environmental factors into its review process.

Fundamental Change: Foods produced through sustainable practices—like alternative proteins and insect-based products—will receive added support in the approval process.

What This Means: Highlighting your food’s sustainability metrics (like carbon footprint) can boost your chances of approval.

FAQ: Can sustainability give my product an edge? Answer: Absolutely! Emphasizing low environmental impact practices aligns your product with EFSA’s sustainability goals and may lead to a priority review.

7. Increased Scrutiny of Supplements

If you’re producing supplements with novel ingredients, expect stricter rules.

Fundamental Change: New upper safety limits on bioactive compounds and mandatory consumer warnings.

What This Means: Supplements must now include clear usage instructions to prevent overconsumption.

How GRAS Experts Can Help

Navigating the intricate EFSA updates can be daunting, but GRAS Experts, a division of Quality Smart Solutions, can help your business comply with the new regulations. From assisting with long-term safety studies to advising on sustainability metrics, GRAS Experts ensure you meet all the latest requirements and successfully launch your novel food in the European market.

Don’t Wait Until it is too Late, Contact GRAS Experts Today

Ready to comply with EFSA’s 2025 regulations? With these updates around the corner, now is the time to ensure your novel food products meet all requirements. Whether providing long-term safety data, fast-tracking traditional foods, or crafting compliant labels, understanding the changes is critical to your success. With EFSA’s emphasis on sustainability, transparency, and public health, companies must stay proactive to stay competitive.

Don’t let complex regulations hold your product back—prepare now and position your business for success in 2025 and beyond.

References: 

https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.8966 

https://www.efsa.europa.eu/en/news/navigating-novel-foods-what-efsas-updated-guidance-means-safety-assessments 

https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.8961 

https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2024.8946 

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Breaking News: Health Canada’s New GMP Guide for Natural Health Products – Are You Ready?

NPN license

Health Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental shift in how businesses will manufacture, package, label, and store their products. This guide introduces sweeping changes, the first since 2015, to ensure NHPs sold in Canada meet modern safety and quality standards. With updates that will affect every aspect of your production process, if your business does not fully understand or is not clear on these updates, the penalties for non-compliance could be serious. 

If you’re an NHP business or manufacturer, this draft GMP guide isn’t just another regulatory hurdle—it’s a roadmap to protecting your brand, safeguarding your consumers, and avoiding potentially severe consequences of non-compliance. So, what’s new, and how can you prepare? 

What’s Inside the Draft GMP Guide for NHPs? 

1. Major Focus on Quality Management Systems (QMS) 

In an era of growing consumer demand for transparency and safety, Health Canada’s new draft emphasizes the need for robust Quality Management Systems (QMS). For the first time, NHP manufacturers must align their practices with industries like pharmaceuticals and medical devices, where QMS is already essential. 

What does this mean for you? 

You’ll need to develop detailed procedures for everything—from sourcing raw materials to final product testing. Failing to implement a strong QMS can open the door to product recalls, tarnished reputation, and heavy fines. This updated system will ensure consistency, safety, and quality in your production process, protecting both your brand and your customers.

2. Enhanced Record-Keeping and Traceability 

With the new draft, record-keeping takes center stage. Detailed records will need to track each part of your production process, including where ingredients are sourced, batch numbers, production methods, and quality control tests. 

Why is this crucial? 

In the event of an audit or product recall, your business must show a clear trail of accountability—from raw materials to finished product. Enhanced traceability safeguards consumers and protects your business from regulatory non-compliance. Are your records ready for scrutiny? 

3. Rigorous Testing and Stability Requirements 

The draft introduces stricter testing and stability requirements to ensure that NHPs remain safe and effective throughout their shelf life. This means more frequent testing and precise documentation. 

What’s new? 

Expect Health Canada to ask for real-time stability tests, justification for rotational testing, and robust finished product testing practices. These measures guarantee your products deliver on their promises, ensuring long-term consumer trust. 

4. International Standards Now in Play 

The inclusion of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a game-changer. This allows greater international flexibility for companies sourcing products or ingredients from abroad. 

 

How does this help your business? 

By adopting these internationally recognized standards, Canada aims to modernize and smooth out inspections and ensure NHPs made or sourced globally meet Canadian safety and quality requirements. This opens up opportunities for businesses that rely on international suppliers while raising the bar substantially for compliance. 

5. Supplier and Ingredient Verification Now Critical 

Supplier verification is no longer optional—it’s mandatory. Health Canada expects NHP businesses to conduct thorough audits of suppliers, particularly those outside of Canada. This is where an NHP business can’t afford to miss anything and should use a partner fully versed in Health Canada regulatory compliance to help navigate this potentially risky juncture.  

What’s at stake? 

Businesses must maintain ongoing verification processes to ensure their ingredients meet Canadian standards. Those importing foreign-manufactured NHPs must pay particular attention to the new expectations for supplier audits. As a result of audits now being mandatory, demand for them has skyrocketed and wait times are getting longer. Don’t wait until it’s too late—get your supplier audits in order now. 

6. Push for Internal Audits and Continuous Improvement 

Additionally, Health Canada now requires NHP manufacturers to conduct regular internal audits, identifying compliance gaps before they become costly problems. 

For Health Canada, it is a way to make your business better 

By adopting a proactive approach to continuous improvement, you’ll not only comply with regulations but also enhance your production processes, ensuring consistent product quality and fewer regulatory issues. 

Why These Changes Matter to Your Business 

Canada’s natural health product industry is booming, and these new GMP guidelines aim to align with international standards and modern consumer expectations. Here’s why these updates are so important, and why any non-compliance is taken very seriously: 

  • Consumer Protection: Stricter controls ensure that products are safe, effective, and traceable from source to shelf. 
  • Global Harmonization: By incorporating international standards like PIC/S, Canadian businesses can more easily navigate cross-border trade. 
  • Enhanced Compliance: With internal audits, record-keeping, and stricter supplier verification, businesses can avoid compliance risks and focus on growth. 

But navigating these changes is no small task, and failure to comply could result in product recalls, loss of consumer trust, and even hefty penalties that could cripple your business or worse, bring lawsuits. So how can you prepare? 

How to Ensure Compliance with Health Canada’s New GMP Guide 

  1. Review Your Quality Management Systems (QMS):

Make sure your QMS covers the entire production process, from raw material sourcing to final product testing, and incorporates a culture of continuous improvement. 

  1. Conduct Thorough Supplier Audits:

Ensure your suppliers meet the new verification standards. For importers, this is especially critical to prevent non-compliance from international suppliers. 

  1. Strengthen Your Record-Keeping Systems:

Keep detailed, accessible records that track your entire production cycle, from ingredients to final products. 

  1. Prepare for More Rigorous Testing:

Update your product testing protocols to meet the new stability and testing requirements. This will ensure that your NHPs remain safe throughout their shelf life. 

  1. Engage with Health Canada:

Take advantage of the consultation period to review and comment on the draft guide. The consultation runs from October 15 to December 16, 2024—use this time to ask questions and prepare your business for what’s to come. 

Preparation in the key 

Health Canada’s draft GMP guide for natural health products is a major regulatory update designed to ensure transparency, safety, and quality across the NHP industry. With the global market for natural health products rapidly expanding, this new guide aims to protect consumers and align Canadian businesses with international best practices. 

By preparing for these changes now, you can stay ahead of the curve and ensure your products meet the highest standards, protecting your brand and your bottom line. 

How Quality Smart Solutions Can Help 

Quality Smart Solutions specializes in helping NHP businesses navigate the complexities of regulatory compliance. From implementing robust QMS to conducting supplier audits and ensuring proper documentation, our experts can guide your company through Health Canada’s new GMP guidelines and position you for long-term success. Don’t wait for these updates to take your business by surprise. Reach out to QSS now and position yourself for success. Fill out the form below to get started. 

 

Reference 

Health Canada. (2024). Consultation: Draft Good Manufacturing Practices Guide for Natural Health Products. Government of Canada. Retrieved from https://www.canada.ca/en/health-canada/programs/consultation-draft-good-manufacturing-practices-guide-natural-health-products/overview-about-nhp-quality-systems.html 

 

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Understanding the Key Changes to Natural Health Product (NHP) Labeling in Canada

Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic medicines. As these products play a vital role in promoting health and wellness, clear and accurate labeling is essential to ensure consumers can make informed decisions about the products they use.

To strengthen consumer safety and product transparency, Health Canada has introduced new labeling regulations for NHPs that align closely with non-prescription drug labeling standards. These changes are aimed at improving readability, consistency, and access to important product information. Below is a comprehensive breakdown of the most significant changes to NHP labeling and what they mean for manufacturers, retailers, and consumers.

Why Health Canada Updated NHP Labeling Requirements

The updated regulations reflect a growing concern for consumer safety, particularly as the market for natural health products continues to expand. With so many products available, it is essential that consumers have access to clear and concise information regarding ingredients, usage, risks, and allergens. The goal of these updates is to provide standardized and user-friendly labels that enhance transparency and facilitate better decision-making.

In addition, these changes address challenges identified through consumer feedback, industry consultations, and research on product labeling practices. By ensuring that NHP labels follow stringent standards, Health Canada is also working to increase confidence in the products available on the market.

Key NHP Labeling Changes: An Overview

The new NHP labeling rules include several critical changes designed to improve clarity, transparency, and accessibility. Below are the most important elements of these changes:

1. Product Facts Table

One of the most significant changes to NHP labeling is the introduction of a standardized Product Facts Table. This table is similar to the Drug Facts Table found on non- prescription drugs and serves as a quick reference for consumers to find essential product information.

  •  Required Information: The Product Facts Table must include key details such as active ingredients, dosage instructions, uses, warnings, and potential allergens.
  • Format: The table must follow a consistent format, making it easier for consumers to compare products and access relevant information quickly.
  • Importance: This change ensures that important safety information is highlighted and easily accessible, especially for consumers with specific health concerns or allergies.

2. Minimum Font Size

The updated regulations set strict requirements for minimum font sizes to improve the legibility of NHP labels.

  • Why It Matters: Previously, some NHP labels were difficult to read due to small fonts, especially for older consumers or those with vision impairments.
  • New Standards: The new rules specify that key information, such as the product name, dosage, and warnings, must be printed in a minimum font size to enhance readability. This requirement applies to both the Product Facts Table and other parts of the label.

3. Use of Plain Language

Another critical update is the requirement for labels to use plain language. This change is aimed at ensuring that the health claims, warnings, and instructions provided on NHP labels are written in simple, easy-to-understand terms.

  • Health Claims: Label must list at least one recommended purpose and must use the exact wording on your terms of market authorization.
  • Warnings and Risk Information: Warnings about potential risks, side effects, or interactions with other products must be communicated as they are on your terms of market authorization and must be in specific order under the new regulations.

4. Allergen Disclosure

Allergen labeling is a critical aspect of food and natural health product regulations, and the new NHP rules enhance allergen disclosure to align with food labeling requirements.

  • Required Information: NHP labels must clearly identify potential allergens such as

peanuts, tree nuts, gluten, and other common allergens that may be present in the product.

  • Why It’s Important: This change helps protect consumers with allergies and ensures they can make safe choices when selecting products. Clear allergen disclosure also prevents accidental exposure, which could lead to serious health consequences.

5. Expiry Date and Lot Number

Consumers rely on product labels to determine the shelf life and safety of natural health products. The updated regulations require that expiry dates and lot numbers be displayed more prominently on NHP labels.

  • Visibility: Expiry dates must be easy to locate and read, ensuring consumers are aware of when the product may lose its efficacy or safety by expressing in a specific format.
  • Lot Numbers: Lot numbers are essential for tracking purposes, especially in the case of product recalls. This ensures that manufacturers, retailers, and consumers can identify specific batches of products quickly and efficiently.

6. Standardized Risk Information

In addition to clear instructions on product use, labels must now include standardized risk information that outlines any potential side effects, interactions, or precautions associated with the NHP.

  • Risk Information: Cautionary statements must be clearly stated as they are written on the terms of market authorization. Subsections such as Allergens, Flammability warning, Choking Warning, and Keep out of reach of children may be included on the Product Facts Table.

7. Contact Information

The updated labeling regulations also require NHP labels to include contact information for the license holder.

  • Why This Matters: Including a phone number or email address or website ensures that consumers can quickly reach out to the company if they have questions about the product or wish to report any adverse reactions. This promotes greater accountability and transparency in the NHP industry.

8. Transitional Period for Compliance

License holders are given a transitional period of up to 3 years from the effective date of the new label regulations to comply with the new labeling requirements, allowing time to adjust packaging and update label designs.

  • Products with NPNs issued before June 21, 2025: They will have until June 21, 2028 to comply with the new label regulations.
  • Products licensed on or after June 21, 2025: Labels must comply with the new label regulations immediately. No grace period

What the Changes Mean for Consumers

These new labeling requirements have been implemented with the consumer in mind. By standardizing how information is presented on NHP labels, Health Canada aims to

improve the consumer experience and ensure that all individuals have access to accurate, easy-to-understand product information.

1. Enhanced Clarity and Transparency

Consumers will benefit from clearer labels that provide straightforward, easy-to-find information about product usage, risk information and ingredients. The new Product Facts Table makes it simpler to compare products and understand essential details about their use and safety.

2. Improved Safety for Vulnerable Populations

With better allergen disclosures, clearer warnings, and standardized expiry date formats, consumers can make safer, more informed choices when selecting natural health products. This is particularly important for individuals with allergies, chronic health conditions, or those taking other medications.

3. Easier Access to Product Information

The inclusion of plain language, readable fonts, and contact information ensures that all consumers, regardless of literacy level or health knowledge, can access the information they need to use NHPs safely and effectively.

Implications for Manufacturers and Retailers

The updated labeling regulations present both challenges and opportunities for manufacturers and retailers in the NHP industry. While the changes require adjustments to packaging and label design, they also offer several long-term benefits.

1. Increased Consumer Trust

By adhering to the new labeling standards, manufacturers can enhance the trust consumers place in their products. Clear, transparent labeling signals that the company is committed to safety and regulatory compliance, boosting brand reputation.

2. Streamlined Compliance

While the new regulations may require an initial investment in redesigning labels, they provide a standardized framework for compliance, reducing ambiguity and ensuring that all manufacturers are held to the same standards.

3. Competitive Advantage

Companies that implement these labeling changes promptly and effectively may gain a competitive advantage by being seen as early adopters of best practices in the NHP industry. Consumers are more likely to trust and purchase products that prioritize safety and transparency.

4. Need for Regulatory Guidance

To ensure compliance, manufacturers and license holders may need to seek guidance from regulatory experts who are familiar with the updated labeling requirements. This can help streamline the process and avoid costly mistakes that could lead to product recalls or regulatory penalties.

Why NHP License Holders should start Updating Labels Now

Though current NHP license holders have until 2028 to update their labels to meet the new label requirements the reason to start the changes now is consumer clarity. Having two types of label formats under the same brand will inevitably create confusion in the short term. Major retailers will likely require current NPN holder brands to comply with the new label regulations much sooner than the 2028 deadline. Managing packaging inventory and product turns will be key to developing a roll out strategy for new NHP label implementation.

Also, NHPs with product license/s issued on or after June 21 2025, must meet the new labeling requirements.

A Positive Step for Consumer Safety and Transparency

The new NHP labeling requirements represent a significant step forward in improving consumer safety, transparency, and product consistency in Canada. By introducing standardized labeling practices, Health Canada is ensuring that natural health products are labeled in a way that is clear, concise, and accessible to all consumers.

For manufacturers and retailers, these changes may require an investment of time and resources to ensure compliance, but the long-term benefits—both in terms of consumer trust and regulatory alignment—are substantial. As the natural health product market continues to grow, the importance of clear and transparent labeling will only increase, making these updates a vital component of public health and consumer protection.

How Quality Smart Solutions Can Help

With thousands of natural health product registrations and NHP label reviews we can ensure your packaging complies with the new NHP label regulations. We can help strategize the optimal time to begin this process if your products are licensed before the effective date so you minimize packaging liability. Reach out to us today by completing the form below.

Reference: https://www.canada.ca/en/health-canada/services/drugs-health- products/natural-non-prescription/legislation-guidelines/guidance- documents/labelling.html

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FDA Considerations Selling Foods in USA

 
Regulatory Considerations when Selling Foods and Beverages in the United States 

Selling food products in the United States requires compliance with various regulations to ensure consumer safety and public health. The regulatory framework is complex, involving multiple federal agencies, state laws, and industry standards. Here’s an overview of the key regulatory requirements: 

Federal Agencies: 
  1. Food and Drug Administration (FDA): Responsible for ensuring the safety and labeling of most food products, including dietary supplements.
  2. United States Department of Agriculture (USDA): Oversees meat, poultry, and egg products, as well as organic and bioengineered foods. 
  3. Federal Trade Commission (FTC): Regulates advertising and marketing claims. 
Three Regulatory Requirements: 
  1. FDA Compliant label – A Canadian Nutrition Facts table (NFT) differs from a Nutrition Facts Panel (NFP). Some noticeable differences include “calories from fat” required on an NFP. Rounding rules differ which could result in different numbers and impact nutrient claim qualifier statements. There are many other differences.  Bottom line is that you must prepare a new nutrition facts panel and have a FDA compliant label when launching in the United States.
  2. FSVP Agent – Under the Food Safety Modernization Act (FSMA) that came into effect in 2016, similar to the Safe Foods for Canadians Regulations (SFCR), this preventive plan was to protect US consumers from foodborne illness and ensure food safety measures and practices are adhered to by all food businesses. A FSVP Agent is a designated representative responsible for ensuring that foreign food suppliers meet the US food safety standards under the Foreign Supplier Verification Program (FSVP). The FSVP Agent verifies that foreign suppliers have adequate procedures in place to prevent or significantly minimize hazards in the food they produce 
  3. Food Facility Registration and US Agent (if applicable): Manufacturers, processors, packers, and holders of food products must register with the FDA. In addition, for foreign sites (ie. outside the United States) a US Agent must be linked to the registered food facility. Site renewal occurs every 2 years on the even numbered year.  
Penalties for Non-Compliance: 

Failure to comply with regulatory requirements can result in: 

  1. Warning letters and fines 
  2. Product recalls and seizures 
  3. Detainment at US border entry point
  4. Legal action and criminal penalties 
  5. Damage to reputation and consumer trust 
Conclusion: 

Selling food products in the United States requires a thorough understanding of the regulatory landscape. Compliance with federal agencies, industry standards, and, in some cases, state laws is crucial to ensure consumer safety and avoid legal consequences. Food businesses must stay up-to-date on changing regulations and industry developments to maintain a competitive edge and build trust with consumers. 

How Quality Smart Solutions Can Help with FDA Compliance
We offer solutions to meet the 3 requirements to sell your food in the United States. We will review your food label, register your manufacturing site and act as your US Agent, if applicable, and act as your FSVP agent.  With a former FDA inspector acting as your FSVP agent you have the assurance, trust and reliability to enter the US market. 

 

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Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT)

Health Canada 2024 Changes for Nicotine Replacement Therapies (NRT) 

On August 22, 2024, the Honourable Mark Holland, Minister of Health, announced new measures aimed at preventing youth from being harmed by nicotine replacement therapies (NRTs). The following outlines the recent updates from Health Canada concerning NRTs. 

There is increasing concern that NRTs, particularly newer formats like nicotine pouches, are being used recreationally by youth under 18. To address these concerns, Health Canada has introduced new regulatory measures. Businesses involved with NRTs must comply with these updated requirements. 

What Are the New Measures? 

The Ministerial Order introduces the following changes: 

  • Prohibition on Advertising: Any advertising or promotion that could appeal to youth is now prohibited. 
  • Pharmacist Supervision: New and emerging NRTs can only be sold by pharmacists or under their supervision. 
  • Flavor Restrictions: Flavors other than mint or menthol are prohibited for new and emerging NRTs. 
  • Mandatory Warnings: Clear nicotine addiction warnings and indications of intended use as a smoking cessation aid are required. 
  • Label and Packaging Review: Manufacturers must submit label and package mock-ups for Health Canada’s review.  
Implications for Your Business 

Adults trying to quit smoking will continue to have access to smoking cessation aids like nicotine gums, lozenges, sprays, and inhalers at various retail locations in approved flavors. However, if you are a manufacturer or retailer of NRTs, it is essential to comply with these new measures to avoid appealing to youth and ensure adherence to Health Canada’s regulations. Non-compliance can result in your product/s becoming illegal to sell in Canada. 

Legal Sale of NRTs in Canada 

To legally sell NRTs in Canada, a natural health product (NHP) must have a Natural Product Number (NPN) license and bilingual labeling. If the NHP is manufactured outside of Canada, it requires a Health Canada licensed importer of record. The licensing timeline for NRTs, classified as Class 3 NHPs, typically takes approximately 210 days, although this is non-binding. 

How We Can Help 

At Quality Smart Solutions, we have prepared over 9,000 NPNs and possess the expertise needed to ensure compliance with Health Canada’s regulations. Navigating the complexities of NRT product licensing and preparing a comprehensive safety and efficacy report can be challenging. Our experienced and highly qualified team is here to help you achieve the best outcome for your product registration and market access strategy. Contact us today to discuss how we can support your business! 

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How to Create Health Canada Compliant Food Labels

How to Create Health Canada Compliant Food Labels 

When entering the Canadian market, designing your food labels correctly is not just important—it’s critical. The Canadian food labelling landscape is complex and unforgiving, with stringent requirements that can make or break your product’s success. Quality Smart Solutions (QSS) can get your labels compliant so you can successfully start selling in Canada effortlessly. 

4 Things You Need To Know  

Before you start designing your packaging, there are four key Canadian food labelling requirements that you need to understand: bilingual labelling, nutrition and health claims, location and legibility requirements, and the new front-of-pack nutrition symbol. Ignoring or misunderstanding these can lead to costly redesigns and delays in bringing your product to market.

1. Canadian Bilingual Requirements

In Canada, all mandatory information on a food label must be presented in both official languages—French and English. This is not a mere formality; it’s a legal requirement that applies across the country. If you plan to sell your product in Quebec or through Canada’s national retailers, every piece of information on your packaging must be in French, with French given equal prominence to English. 

For many U.S. brands, this requirement can come as a shock, often necessitating a significant increase in label text. Without careful planning and design, this can clutter your packaging and disrupt your brand’s communication hierarchy, potentially harming your product’s appeal. 

2. Nutrition and Health Claims

Canada’s health and nutrition claims are subject to meticulous and aggressive standards set by Health Canada and the Canadian Food Inspection Agency (CFIA). Claims about your product’s origin, content, quality, and the absence of allergens must be carefully vetted against Canadian regulations. 

Common claims like “Source of Protein” or “No Sugar Added” that are widely used in the U.S. may not be permitted on Canadian food labels. Failing to comply with these standards can lead to your product being pulled from shelves or, worse, legal action.

3. Location and Legibility

Canadian regulations prescribe exactly where information must appear on your packaging and how legible it must be. This includes specific minimum type sizes for mandatory information such as net weight, ingredients, common name, dealer name and address, and any claims. 

These requirements are not merely suggestions—they are enforced rigorously. Getting this wrong could lead to costly reprints or delays in your product launch.

4. New Canadian Front-of-Pack (FOP) Nutrition Labelling

Starting January 1, 2026, Canada will require a new front-of-pack nutrition symbol on products containing 15% DV or more of saturated fat, sugar, or sodium. This is a significant new requirement that could impact your product’s shelf appeal and consumer perception. 

Understanding and correctly applying this new symbol will be crucial for any brand looking to enter or expand in the Canadian market. 

QSS is Your Essential Partner in Canadian Food Labelling Compliance 

Canadian food labelling laws can feel like a non-tariff barrier for many U.S. companies, particularly small and medium-sized businesses. However, when executed correctly, these regulations can become a competitive advantage, showcasing your brand’s commitment to transparency and consumer trust. 

QSS brings decades of experience in helping brands navigate these complexities. We ensure that your packaging not only meets Canadian regulatory requirements but also resonates with Canadian consumers. Our expertise in both compliance and design means that your product will stand out for all the right reasons. 

If you have questions about Canadian food labelling, package design, or navigating the Canadian market, QSS is here to help. 

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News

New Update on FDA Sodium Reduction Efforts

The FDA has taken a significant step forward in its ongoing sodium reduction initiative by issuing new, voluntary sodium reduction targets in a draft guidance, marking the launch of Phase II in their efforts. This follows Phase I, aimed at decreasing diet-related diseases associated with high sodium intake, where final voluntary sodium reduction goals were established in 2021. 

The Journey Towards a Healthier Food Environment  

Excessive sodium consumption is a major public health concern in Canada and worldwide. The average Canadian consumes over 3,400 milligrams of sodium per day, exceeding the recommended daily limit of 2,300 milligrams. High sodium intake can lead to high blood pressure, heart disease, stroke, and kidney disease, resulting in significant healthcare costs and early mortality. 

FDA’s Sodium Reduction Initiative 

In 2021, the FDA set voluntary sodium reduction targets for food manufacturers, aiming to reduce sodium levels in processed and restaurant foods. The agency established two-year and four-year targets, encouraging industry-wide sodium reduction. The next phase of this initiative involves: 

  1. Revised targets: The FDA has revised its sodium reduction targets, setting more stringent goals for certain food categories. 
  2. Expanded scope: The initiative now includes additional food products, such as canned vegetables, soups, and sauces. 
  3. Monitoring progress: The FDA will track industry progress towards meeting the targets, providing guidance and support where needed. 

The industry has been working towards meeting the Phase I targets by April 2024. The newly proposed Phase II targets set the next milestone for industry to achieve within three years after the finalization of this guidance. These targets are designed to address the excessive sodium intake in the U.S., which currently averages nearly 50% above the recommended limits. 

Impact on Public Health and Benefits of Sodium Reduction  

Reducing sodium in food products can have numerous benefits, including: 

  • Improved public health: Lower sodium intake can lead to reduced blood pressure, cardiovascular disease risk, and stroke incidence. 
  • Increased consumer choice: As manufacturers reformulate products, consumers will have access to a wider range of lower-sodium options. 
  • Economic benefits: Reducing sodium can help alleviate healthcare costs associated with diet-related diseases. 

Excess sodium intake is a major contributor to high blood pressure, which is a leading risk factor for heart disease and stroke—conditions that disproportionately affect racial and ethnic minority groups in the United States. The FDA’s efforts are grounded in strong scientific evidence that reducing sodium intake can significantly lower the risk of these health issues, potentially preventing hundreds of thousands of premature deaths and illnesses in the coming years. 

Impact on Businesses 

The new sodium reduction targets set by the FDA could have significant implications for various businesses, particularly those involved in the food manufacturing and food service industries. Companies may need to reformulate their products to meet the new sodium reduction goals, which could involve altering recipes, sourcing new ingredients, or adjusting production processes. This may lead to increased costs and require changes in marketing strategies to communicate these adjustments to consumers. 

Small and medium-sized enterprises (SMEs) might face additional challenges due to limited resources for research and development. However, staying compliant with the FDA’s voluntary targets is crucial not only to avoid potential scrutiny but also to align with consumer demand for healthier food options. 

Challenges and Opportunities 

While the FDA’s initiative is a crucial step towards reducing sodium in food products, challenges remain: 

  • Industry compliance: Encouraging industry-wide adoption of sodium reduction targets may require ongoing support and monitoring. 
  • Consumer education: Raising consumer awareness about the importance of sodium reduction and providing guidance on healthier choices is essential. 
  • Innovation and reformulation: Manufacturers must innovate and reformulate products to meet sodium reduction targets while maintaining taste and quality. 

Andrew Parshad, CEO of Quality Smart Solutions, commented on the FDA’s new draft guidance: 

“The FDA’s continued efforts to reduce sodium levels in the U.S. food supply reflect an important public health initiative that we fully support. However, we recognize that these new targets present significant challenges for businesses, especially smaller companies with limited resources. At Quality Smart Solutions, we are committed to helping our clients navigate these changes efficiently and effectively, ensuring that their products remain compliant while also meeting consumer expectations for healthier options.” 

Progress and Future Assessments 

Preliminary data from 2022 indicates that about 40% of food categories have already reached or are close to the Phase I targets. The FDA plans to continue assessing progress on sodium reduction every three years, with more comprehensive data expected in the future to evaluate the full impact of Phase I. 

How to Get Involved 

The FDA is welcoming comments on the draft guidance through November 14, 2024. Stakeholders can submit their feedback electronically via regulations.gov.  

If you have any feedback or concerns regarding the new sodium reduction targets, connect with us today to ensure your voice is heard in this important regulatory process. Quality Smart Solutions is here to assist you in this process. We can help consolidate your responses and submit a comprehensive, industry-relevant submission to the FDA on your behalf. 

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Health Canada plans to share document about health products containing CBD this fall

This fall, Health Canada is anticipating sharing a policy consultation document about health products containing (CBD). This proposal has been in the works since 2019.

In 2022, Health Canada  released  a report on health products containing cannabis.

Released earlier this year, The Forward Regulatory Plan for 2024 to 2026 details regulatory initiatives that Health Canada will be proposing or finalizing in the next 2 years.

New regulatory initiatives underway

According to the Food and Drugs Act of this plan, Health Canada plans to amend the Food and Drug Regulations, Natural Health Products Regulations and Pest Control Products Regulations ensuring a consistent and flexible approach to the regulation of biocides (surface disinfectants and surface sanitizers).

Are biocides affected?

At present, biocides are regulated under separate regimes. This causes heavy difficulties for many industry regulators as they continue to work with biocides. This became clear throughout the COVID-19 pandemic.

The proposed amendments will:

  • form 1 comprehensive framework for regulating biocides
  • allow regulatory oversight based on risk and evolving evidence
  • present a use of foreign decisions pathway

Note: The Biocides Regulations were formerly termed Regulations Amending the Food and Drug Regulations, Part C (Biocides, use of foreign decisions for disinfectants and surface sanitizers).

All of these initiatives form part of a larger spectrum of work on contemporary regulations all related to Health and Biosciences Sector Regulatory Review Roadmap.

What is Health Canada’s goal?

The intention of Health Canada is to fashion regulatory pathway for health products containing cannabidiol that would not require practitioner oversight.

How do you proceed? Get assisted by Quality Smart Solutions 

For detailed insights into these regulatory changes and ongoing consultations, reach out to our team of former Health Canada experts at Quality Smart Solutions. We help ensure compliance with modernized regulations governing natural health products (NHPs) and non-prescription drugs, enhancing safety and quality standards across Canada while facilitating business growth and innovation.  Fill in the form below and let’s get started!

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Understanding MoCRA and Safety Substantiation Requirements for Cosmetics

The Modernization of Cosmetics Regulation Act (MoCRA) brings significant changes for everyone in the cosmetics industry, from manufacturers to distributors. Its main goal is to make sure that cosmetic products are safe and comply with regulations before they reach consumers.
The main objective of MoCRA was to improve the safety and transparency of cosmetic products. It sets stricter rules for businesses, requiring them to prove their products are safe before they can be sold.
If you’re in the cosmetics business, it’s crucial to understand and follow these new regulations to stay in the market and keep consumers’ trust. Click here if you want to comply with the updated MoCRA cosmetic regulations by FDA. Let’s break down the key parts of MoCRA and the guidelines for proving product safety, so you can easily meet these new requirements.
What is MoCRA?
MoCRA, or the Modernization of Cosmetics Regulation Act, is designed to update and improve the regulatory framework for cosmetics in the U.S. It mandates that cosmetic manufacturers ensure their products are safe for use, substantiated through rigorous testing and documentation. This act aligns the U.S. more closely with international standards, aiming to protect consumers and ensure product safety.
Benefits of MoCRA for businesses
  • Future-Proofs Your Business: MoCRA sets the new standard for cosmetic safety. By complying now, you avoid scrambling to catch up later and ensure your products can stay on shelves.
  • Builds Brand Trust & Loyalty: Consumers are increasingly concerned about safety.
    • MoCRA compliance demonstrates your commitment to safe ingredients and high-quality products, fostering trust and loyalty from customers.
  • Reduces Risk & Saves Money: Recalls, lawsuits and bad publicity due to safety concerns can be financially devastating.
    • MoCRA compliance minimizes these risks, saving you money and protecting your brand reputation.
  • Competitive Advantage: As consumers become more aware of MOCRA, businesses that can clearly communicate their compliance will gain a competitive edge.
Key requirements of MoCRA
  1. Product Registration: As a cosmetic manufacturer, you must register your facilities and products with the FDA under MoCRA . This registration includes detailed information about the ingredients and formulations used in each product. Click to learn about the registration and listing of cosmetic product facilities and products.
  2. Adverse Event Reporting: If your products cause any serious health issues or reactions, you need to report these events to the FDA. This proactive approach helps the FDA monitor product safety and take necessary actions, showing consumers that their well-being is their priority.
  3. Labeling Requirements: MoCRA enforces strict labeling requirements, ensuring that all cosmetic products have accurate and clear ingredient lists. This helps consumers make informed decisions and avoids misleading claims, fostering trust and transparency. Learn here what is MoCRA label compliance.
  4. Good Manufacturing Practices (GMP): According to the act, you must adhere to Good Manufacturing Practices. This means making cosmetics in a clean, controlled, and consistent environment.
    • By sticking to these practices, you reduce the chance of contamination, making your products safer for customers.
    • Consistent manufacturing ensures that every product meets high standards, showing your commitment to quality.
    • Following GMP shows that you care about providing safe and reliable products, and building trust and loyalty with your customers.
Safety Substantiation Guidelines
Safety substantiation is a crucial aspect of MOCRA, requiring you to provide evidence that your products are safe for use. Here are the key steps, explained simply:
1. Assess Ingredient Safety:
  • Scientific Literature Review: Search for published studies on individual ingredients and their safety profiles. Look for reputable sources like peer-reviewed journals and safety data sheets (SDS) provided by suppliers.
  • Testing Options: Consider various testing methods beyond traditional animal testing, which MoCRA doesn’t mandate. Explore alternative methods like:
    • In Vitro (cell-based) testing: Evaluate ingredient effects on cultured cells.
    • Human Volunteer Patch Testing: Assess potential skin irritation or allergic reactions on a small group of volunteers under controlled conditions.
    • Computer Modeling: Utilize computer simulations to predict ingredient behavior and potential risks.
  • Concentration Matters: Evaluate safety based on the specific concentration of each ingredient in the final product. Lower concentrations may pose less risk.
2. Test the Product:
  • Stability Testing: Conduct studies to ensure the product maintains its physical and chemical properties over its shelf life. This includes factors like:
    • Separation
    • Color changes
    • Potential degradation of ingredients.
  • Microbial Testing: Test for potential contamination by bacteria, fungi, or other microorganisms. Implement good manufacturing practices (GMPs) to minimize contamination risk.
  • Clinical Testing: While not always mandatory, consider human volunteer studies to assess the product’s safety and potential for irritation or allergic reactions. Patch tests are a common option for this.
3. Document Everything:
  • Maintain Detailed Records: Create a comprehensive safety substantiation dossier for each cosmetic product. This should include:
    • Ingredient lists with CAS numbers (unique identifiers) and sources.
    • Scientific literature review summaries.
    • Testing protocols and results for all conducted tests.
    • Risk assessments and mitigation strategies.
  • Accessibility for Review: Ensure all documentation is readily available for inspection by the FDA upon request. This demonstrates your commitment to transparent safety practices.
4. Perform Risk Assessments:
  • Hazard Identification: Identify all potential hazards associated with the product, including:
    • Individual ingredient risks.
    • Potential for allergic reactions or skin irritation.
    • Microbiological contamination risks.
    • Improper use or misuse of the product.
  • Evaluate Likelihood and Severity: Assess the probability of each hazard occurring and the potential severity of any adverse effects.
  • Risk Mitigation Strategies: Implement measures to minimize identified risks. This may involve adjusting ingredient concentrations, adding preservatives, or including clear warnings and usage instructions on the label.
Additional Tips:
  • Stay Updated: Keep abreast of evolving scientific data and regulations regarding cosmetic safety.
  • Seek Expert Advice: Consider consulting with cosmetic scientists or regulatory specialists to ensure your safety substantiation practices are robust and compliant.
  • Transparency is Key: Clearly communicate safety information to consumers through product labels and readily accessible safety data sheets.
By following these detailed guidelines, businesses can ensure they meet MoCRA requirements and demonstrate their commitment to providing safe and effective cosmetic products.
Bottom Line
Complying with MoCRA not only ensures regulatory adherence but also enhances consumer trust and product credibility. By demonstrating a commitment to safety and transparency, you can build a loyal customer base and minimize the risk of legal and reputational issues.
Are MoCRA and Safety Substantiation Requirements complex for your cosmetic business? Do not worry !
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Health Canada’s Regulatory Plan 2024-26: Proposed Amendments to NHP and Non-Prescription Drugs

Health Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and the Food and Drug Regulations under the Food and Drugs Act.  

These amendments are designed to align the regulatory approach for self-care products, ensuring a streamlined and risk-based framework that reflects contemporary standards. 

To better understand the proposed amendment, it’s essential to first understand Natural Health Products (NHPs) and Non-Prescription Drugs. 

What is NHP? 

Natural Health Products (NHPs) are a category of health products regulated by Health Canada. These products include a variety of items that support health and wellness through natural means. The category of health products include: 

  • Essential nutrients that support overall health and wellness. 
  • Herbal remedies or plant-based products used for their medicinal properties. 
  • Products based on homeopathy, a system of alternative medicine. 
  • Medicines used traditionally, such as those from traditional Chinese medicine or Ayurvedic medicine. 

Click to learn how you can get an NHP Licence for Nicotine Pouches in Canada? 

What is non-prescription drug? 

Non-Prescription Drugs are medications that can be purchased without a prescription from a healthcare professional. These drugs are also known as Over-the-Counter Drugs or OTC drugs. These drugs are made to treat common, self-diagnosed conditions and symptoms such as pain, fever, coughs, colds, and allergies.  

Examples of OTC drugs are Pain Relievers and Fever Reducers, Cough and Cold Remedies, Allergy Medications and Antacids and Acid Reducers.  

Click this link to learn more about non-prescription drugs, how you can sell it in Canada, and more facts about it.  

Now, let’s explore Health Canada’s Forward Regulatory Plan 2024-26 and outline significant amendments to the Natural Health Products Regulations and the Food and Drug Regulations under the Food and Drugs Act.    

Health Canada forward regulatory plan: key changes proposed 
  1. Simplified Pathways and Alignment:

Health Canada proposes a new system to fast-track approval for lower-risk non-prescription drugs. This system will align these OTC drugs with natural health products that have similar uses. The goal is to streamline the process while still ensuring that safety standards remain high. 

  1. Modernization of Natural Health Products Regulations:

The amendments also target the Natural Health Products Regulations, introducing a structured risk-based categorization system and enhanced quality oversight measures. 

Key proposals include: 
  • Annual Notification Requirement: Businesses will be required to annually notify Health Canada of marketed natural health products, enhancing transparency and regulatory oversight. 
  • Good Manufacturing Practices (GMP): Strengthening requirements for GMP will ensure that natural health products meet high standards of quality throughout the manufacturing process. 
  • Risk-Based Site Licensing: Introducing a risk-based site licensing program will enhance oversight of production facilities, further safeguarding product quality and consistency. 

These amendments are in response to recommendations from the Commissioner of the Environment and Sustainable Development’s 2021 audit, underscoring Health Canada’s commitment to addressing regulatory gaps and enhancing consumer confidence in natural health products. 

International alignment and impact 

While these changes aren’t part of a formal international cooperation plan, they will bring Canada’s regulations closer to those of the U.S., EU, and Australia. This alignment should make it easier for Canadian businesses to compete globally and ensure imported products meet Canadian standards. 

What it means for businesses and consumers 

The proposed amendments are expected to impact businesses involved in the sale and manufacture of natural health products and non-prescription drugs in Canada.  

  • For natural health products, the amendments promise strengthened oversight and improved assurance of product quality, aligning with global best practices.  
  • Meanwhile, amendments to the Food and Drug Regulations aim to maintain robust regulatory oversight while reducing administrative burdens and enhancing operational efficiencies for businesses. 
Consultations and stakeholder engagement 

Health Canada has engaged stakeholders extensively since 2016 and will continue to do so throughout 2024. The recent publication of regulatory amendments in the Canada Gazette, Part II on July 6, 2022, marked a significant milestone in this ongoing consultation process. These consultations are crucial for gathering feedback from industry stakeholders, healthcare professionals, and the public to ensure that the regulatory framework remains responsive and effective. 

Get assisted by Quality Smart Solutions 

For detailed insights into these regulatory changes and ongoing consultations, reach out to our team of former Health Canada experts at Quality Smart Solutions. We help ensure compliance with modernized regulations governing natural health products (NHPs) and non-prescription drugs, enhancing safety and quality standards across Canada while facilitating business growth and innovation.   

  

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Health Canada 2024 Drug Establishment Licensing (DEL) Update

Health Canada Drug Licensing Update

Health Canada is introducing a new plan to modernize the Drug Establishment Licensing (DEL) framework over the coming years.

This plan, divided into two phases, focuses on strengthening regulatory oversight, aligning with international standards, and easing administrative burdens. 

Before going into details of the update, let’s throw light on what DEL is and who needs it. 

What is Drug Establishment Licensing (DEL)?  

Health Canada’s Drug Establishment Licensing (DEL) is a regulatory framework that governs the licensing of establishments involved in the drug manufacturing and distribution process in Canada. The DEL program is designed to ensure that drugs and related products meet high standards of quality, safety, and efficacy before they are available on the Canadian market. 

The DEL framework governs the licensing of businesses that manufacture, package, label, import, distribute, and wholesale drugs in Canada. This framework ensures that drugs available to Canadians are safe, effective, and of high quality. 

Who Needs DEL?  

  • Manufacturers: Facilities that produce, package, or label drugs must obtain a DEL to ensure compliance with Good Manufacturing Practices (GMP). 
  • Distributors: Establishments involved in the import, export, and distribution of drugs also require a DEL. 
  • Importers/Exporters: Entities involved in importing or exporting drugs must hold a DEL to ensure adherence to regulatory requirements. 

Want to know why Drug Establishment Registration (DEL) is important for you? Read this blog.  

2024 DEL Updates

Here’s a breakdown of what DEL updates in 2024 by Health Canada mean and how they will impact your businesses and consultants involved in drug establishment licensing in Canada. 

Phase 1: Enhancing Drug Recall and Testing Regulations

The first phase of Health Canada’s plan includes several important updates: 

  1. New Drug Recall Framework: A structured regulatory framework will be established for recalls ordered by the Minister of Health. This will streamline the recall process, ensuring faster and more efficient action to protect public health. 
  1. Clear Reporting for Voluntary Recalls: Businesses will have clear guidelines on their obligations for reporting voluntary recalls, aligning with current policies to improve transparency and accountability. 
  1. Updated Mutual Recognition Agreements (MRAs): Outdated references to regulatory authorities in mutual recognition agreements will be replaced with a dynamic list accessible on the Government of Canada website. This makes it easier for businesses to stay up-to-date with recognized authorities. 
  1. Testing Exemptions for Advanced Therapies: Conditional exemptions will be introduced for certain biologics (like gene and cell therapies) and radiopharmaceuticals from some finished product testing requirements. This will apply where alternative safety controls are in place, supporting the development and accessibility of these advanced treatments. 
  1. Direct Shipment Provisions: Clarification that certain biologics and radiopharmaceuticals can be directly shipped to healthcare practitioners or facilities. This helps ensure timely access to critical treatments. 

Phase 2: Streamlining Licensing and Compliance 

The second phase will focus on reducing the regulatory burden and modernizing compliance measures: 

  1. Simplified Annual Licence Review: The annual review process for establishment licences will be simplified, reducing the administrative workload for businesses and Health Canada. 
  1. Modern Compliance Tools: Provisions related to compliance and enforcement will be updated, including the use of terms and conditions and suspensions. This will provide a more flexible and effective regulatory framework. 
  1. Flexible Oversight: Less prescriptive regulations will be introduced, maintaining appropriate oversight while allowing more flexibility in regulated activities. This approach aligns with a risk-based regulatory philosophy, focusing resources where they are most needed. 

Benefits for Businesses and Consultants

Enhanced Efficiency: The updated recall framework and clear reporting obligations will help businesses manage recalls more efficiently, minimizing disruptions and protecting their reputations. 

Simplified Compliance: By updating MRAs and introducing conditional exemptions, Health Canada is making it easier for businesses to navigate regulatory requirements, particularly for advanced therapies. You should also know that MRAs are formal agreements between countries or regions to accept each other’s regulatory evaluations and certifications for certain products, services, or processes. 

Reduced Administrative Burden: The streamlined annual licence review and modern compliance tools will significantly reduce the time and effort businesses need to spend on regulatory processes. 

International Alignment: Aligning Canada’s regulations with those of major international partners like the U.S., EU, UK, Australia, and Switzerland will facilitate smoother trade and regulatory processes, benefiting Canadian businesses operating globally. 

What’s Next?

Health Canada has been actively engaging with stakeholders throughout this process: 

  • Initial Consultations: Between April and June 2019, Health Canada consulted with DEL and Medical Device Establishment Licensing (MDEL) holders. 
  • Notice of Intent: In December 2021, a notice of intent was published in the Canada Gazette, Part I, followed by a 60-day comment period. 
  • Public Comments: Proposed changes for Phase 1 were pre-published in the Canada Gazette, Part I on April 15, 2023. During the 75-day comment period, Health Canada received feedback from 46 respondents, including individuals, businesses, and associations. 

Publication Timeline

The final regulations for Phase 1 are expected to be published in the Canada Gazette, Part II in spring 2024. Proposed amendments for Phase 2 will be pre-published in the Canada Gazette, Part I in winter/spring 2025, followed by another 75-day comment period. 

By modernizing the DEL framework, Health Canada aims to enhance drug safety, streamline regulatory processes, and support the growth of the pharmaceutical industry in Canada.  

Businesses and consultants should prepare for these changes, which promise to bring greater clarity, efficiency, and international alignment to the regulatory landscape. 

How Quality Smart Solutions can help you 

At Quality Smart Solutions, we’re dedicated to helping you stay ahead of regulatory changes. Our team of experts is ready to guide you through the new DEL framework, ensuring your drug establishment practices meet the latest standards. Contact us today to learn how we can support your regulatory needs! 

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How to get an NHP Licence for Nicotine Pouches in Canada?

NHP license for nicotine pouchesRemember the days of gumming patches, sucking lozenges, and hiding bulky vaporizers? Nicotine pouches, those discreet little packets promising rapid release and sleek satisfaction, are rewriting the playbook. But for NHP manufacturers, the thrill of this pocket-sized revolution comes with a hefty stack of regulatory paperwork.

Before you get lost in the regulatory labyrinth, let’s take a deep breath and unpack the stats. The global nicotine pouch market is expected to surge past $3 billion by 2027, propelled by a 21% annual growth rate. In Canada alone, nearly 2 million adults have embraced the pouch, proving they’re more than just a passing fad.

This booming market, however, is met with a regulatory hurdles, with Health Canada’s NHP regulations and the FDA’s premarket pathways posing a significant challenge for NHP manufacturers.

Navigating the Compliance Maze

  • Understanding the Landscape:
    • Health Canada’s NHP regs dictate labeling, ingredients, and safety claims.
    • The FDA requires premarket clearance or submission of Tobacco Product Applications (TPAs).
  • Common Pitfalls:
    • Misidentifying ingredients as NHP-compliant.
    • Making unsubstantiated health claims.
    • Omitting mandatory labeling elements.
  • The Perils of Non-Compliance:
    • Product seizure and market withdrawal.
    • Hefty fines and legal repercussions.
    • Damage to brand reputation and consumer trust.

Building Your Compliance Compass

  • Partnering with NHP Compliance Specialists:
    • Leverage their expertise in navigating regulations.
    • Ensure accurate ingredient verification and labeling.
    • Streamline the premarket approval process.
  • Investing in the Right Tools:
    • Utilize compliance software for ingredient databases and labeling templates.
    • Stay updated on regulatory changes and industry best practices.
    • Seek guidance from reputable sources like the Canadian NHP Network.

Compliance is Your Key to Business Success

Complying with regulations isn’t just about avoiding penalties; it’s your passport to success:

  • Market Access and Trust: Compliant products secure distribution channels and consumer confidence.
  • Sustainable Growth: Compliance safeguards your business from costly setbacks and builds a solid foundation for future expansion.
  • Building a Responsible Industry: Responsible compliance paves the way for a thriving and ethical nicotine pouch market.

Charting Your Journey

The path to nicotine pouch NHP success is paved with knowledge, preparation, and collaboration. With the right tools and partners, you can confidently navigate the compliance landscape and unlock the full potential of this dynamic market.

For inquiries about NHP Nicotine Pouch regulations or assistance with compliance and business growth, book a free consultation with our NHP experts at Quality Smart Solutions by filling out the form below.

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FDA Updates Yogurt Standard: Key Changes for Manufacturers

FDA Updates Yogurt Standard

Attention all yogurt makers, big and small! The U.S. Food and Drug Administration (FDA) has finalized changes to the standard of identity for yogurt, effective January 1, 2024. These updates aim to modernize regulations while maintaining the core characteristics of this beloved food.

Here’s the scoop:

  • Yogurt’s getting a modern makeover. The FDA is updating its definition of yogurt to reflect newer ingredients and production methods, while still keeping it, well, yogurt-y. This means saying goodbye to separate standards for “lowfat” and “nonfat” yogurt.
  • Small businesses, listen up! The FDA knows complying with new rules can be tricky, especially for smaller yogurt producers. That’s why they released a Small Entity Compliance Guide (SECG). Think of it as a roadmap to understand the changes and how to adapt your labels and products.
  • What does this mean for me? If you’re a small yogurt maker, check out the SECG! It explains what you need to do to comply with the new rule by the January 1, 2024 deadline. It also has handy resources and answers to common questions.

So, what exactly are the changes?

  • Modernized Definition: Gone are separate categories for “low-fat” and “non-fat” yogurt. The new definition focuses on core elements: live and active cultures, smooth texture, and a characteristic tangy flavor. This allows for diverse milk bases, sweeteners, and thickeners. Almond milk yogurt with agave nectar? Plant-based yogurt packed with protein? All fall under the revised definition.
  • Ingredient Expansion: The permissible ingredient list grows, opening doors for exciting possibilities. Lactose-free yogurt with berries? Greek yogurt fortified with essential vitamins? Manufacturers can cater to various dietary needs and preferences, offering guilt-free indulgences and nutrient-rich options.
  • Transparency Tweak: While “low-fat” and “non-fat” labels disappear from the main label, fat content remains easily accessible. Manufacturers can voluntarily declare fat content alongside nutritional information, ensuring transparency for health-conscious consumers.

Implications for Manufacturers:

  • New Product Potential: The revised definition empowers developing novel yogurt creations, pushing the boundaries of flavor and functionality. Imagine unique offerings like plant-based yogurt with matcha or Greek yogurt infused with exotic spices.
  • Ingredient Sourcing: Collaboration with new suppliers of alternative milks, natural sweeteners, and plant-based thickeners becomes crucial. Diversifying ingredient palettes unlocks endless possibilities and caters to evolving consumer demands.
  • Labeling Revamp: Adapt labeling strategies to comply with new regulations. This involves revising ingredient lists, clarifying nutritional information, and exploring creative ways to highlight new ingredients and formulations.
  • Regulatory Navigation: Partnering with FDA compliance experts can smooth the transition and minimize potential risks. Navigating the updated standard can be complex, and expert guidance ensures a seamless adaptation process.

Adapting to the Change:

  • Review the FDA Final Rule and Small Entity Compliance Guide for detailed specifics and implementation timelines.
  • Assess existing products and identify opportunities for reformulation or new development under the revised definition.
  • Embrace innovation and experiment with new ingredients and formulations, pushing the boundaries of what yogurt can be.
  • Delight your customers with unique and exciting yogurt creations that cater to modern preferences.

The 2023 FDA Yogurt Standard Update marks a significant shift in the industry, paving the way for a more diverse and dynamic yogurt landscape. Manufacturers who stay informed, embrace change, and adapt to the new requirements stand to thrive and continue offering delicious and nutritious options for all to enjoy.

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Navigating GRAS Panels: A Guide to Best Practices

When it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The GRAS (Generally Recognized as Safe) designation plays a critical role in this process. The U.S. Food and Drug Administration (FDA) provides guidance on how to convene a GRAS panel effectively and responsibly, ensuring that the substances used are indeed safe for human and animal consumption. In this summary blog, we’ll explore the key takeaways from the FDA’s guidance on “Best Practices for Convening a GRAS Panel.

Understanding the GRAS Provision

GRAS, or “Generally Recognized as Safe,” is a designation that signifies that a substance is deemed safe for its intended use in food. However, obtaining this status is no small feat. The FDA offers valuable insights into this process, specifically when a GRAS panel’s input may be needed.

When Is a GRAS Panel Necessary?

In many cases, a proponent, the entity seeking GRAS status for a substance, may not require a GRAS panel to determine the safety of a new ingredient. The proponent can evaluate existing data and information independently. However, there are instances where the proponent might opt to consult a GRAS panel. This decision depends on the complexity of the substance or the potential need for expert opinions.

The Role of a GRAS Panel

A GRAS panel serves as a valuable resource, offering an expert assessment of the safety and suitability of a substance for its intended use. Importantly, the panel’s conclusion does not inherently establish general recognition of the substance’s safety. Instead, it serves as evidence that there is general acceptance within relevant scientific communities based on generally available information.

Choosing the Right GRAS Panel

The FDA emphasizes the importance of assembling a qualified and balanced panel. Members should possess subject matter expertise relevant to the scientific considerations associated with the intended conditions of use of the food substance. Only when a panel adequately represents a larger scientific community can its conclusions be considered “generally accepted.”

The Need for Expertise

A “GRAS panel” opinion carries weight only if its members have the expertise appropriate to address the safety questions specific to the substance in question. A panel consisting of scientists without the requisite expertise cannot establish “generally accepted” conclusions.

When a GRAS Panel May Not Be Necessary

In most cases, a robust GRAS conclusion can be reached without the input of a GRAS panel. Therefore, proponents should carefully assess whether the resources and efforts required to convene such a panel are warranted for their specific case.

FDA’s Guidance Recommendations

The FDA’s guidance offers recommendations for those considering GRAS panels:

  1. Identifying Panel Members: Ensure that GRAS panel members have appropriate expertise in the relevant field.
  2. Mitigating Bias: Take steps to reduce any potential bias or conflicts of interest among panel members to maintain the credibility of the panel’s output.
  3. Limiting Data and Information: Only provide GRAS panels with public information, avoiding trade secret data.

Conclusion

In summary, the FDA’s guidance on convening GRAS panels provides essential insights into the complex process of establishing the safety of food substances. The right choice between seeking a GRAS panel’s input or relying on independent evaluation depends on the circumstances. Ensuring that the panel is composed of qualified experts and that potential biases are minimized is crucial. Ultimately, the GRAS process plays a pivotal role in protecting the safety of consumers and maintaining the quality of the food supply.

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Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices

Navigating the Regulatory Landscape: Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices

 

Navigating the Regulatory Landscape: Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices

The process of bringing medical devices to market in the United States involves stringent regulations imposed by the Food and Drug Administration (FDA). Understanding the distinction between FDA FURLS (FDA Unified Registration and Listing System), FDA Approved, and FDA Registered is crucial for manufacturers and distributors seeking to comply with these regulations.

This article explores the differences between these designations and provides insights into how to obtain the necessary licenses for medical devices. Keep reading to learn more and stay compliant.

Device Registration and Listing Requirements

Since October 1, 2012, specific medical device listing requirements have been in effect. It is imperative for all stakeholders to adhere to these regulations:

  • All proprietary names under which a device is marketed must be reported during initial listing and in the annual update of registration and listing information.
  • Combination products, which include devices and biological products or drugs, must be clearly identified, specifying the type of combination product, such as convenience kit or prefilled drug delivery device, through the FDA Unified Registration and Listing System (FURLS).
  • Regardless of commercial distribution, all contract manufacturers and sterilizers of finished devices are obligated to register and list their products.
  • Initial importers must identify the manufacturers of the devices they import.
  • Foreign establishments exporting devices to the United States must identify all known U.S. importers of their devices.
  • Devices must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or re-packer/re-labeler before a foreign exporter, contract manufacturer, or contract sterilizer can list them.
  • Establishments handling complaints, previously registered as manufacturers or specification developers, should update their establishment type to “Complaint File Establishment.”

FDA Approved: Ensuring Safety and Efficacy

FDA approval refers to the process by which a new medical device undergoes rigorous evaluation to ensure its safety and efficacy before it can be marketed in the United States. The approval process involves the submission of a premarket approval (PMA) application or a 510(k) premarket notification, depending on the device’s classification.

PMA applications are required for Class III devices, which are high-risk devices such as implantable pacemakers and certain diagnostic imaging devices. 510(k) premarket notifications are for devices that are equivalent to a legally marketed device (predicate device) and are typically lower risk.

FDA Registered: Establishment Compliance

FDA registration is a mandatory requirement for all medical device establishments. It involves providing detailed information about the facility, its operations, and the devices it manufactures, processes, packs, or holds. FDA-registered establishments are subject to inspections to ensure compliance with FDA regulations, including good manufacturing practices (GMP).

Registration is a prerequisite for selling medical devices in the U.S. market, and failure to register can lead to serious consequences, including legal actions and fines.

How to Obtain Licenses? Step-by-Step Guide

  1. Identify the correct classification of your medical device according to the FDA’s classification system (Class I, II, or III).
  2. Prepare the required documentation, such as a 510(k) premarket notification or a PMA application. Work closely with regulatory experts and consultants to ensure the accuracy and completeness of the submission.
  3. Submit the application to the FDA along with the required fees. The FDA will review the submission and provide feedback or request additional information if necessary.
  4. Ensure that your establishment is registered in the FDA FURLS database. Update registration information annually to maintain compliance.
  5. Quality System Requirements: Implement a quality management system compliant with FDA regulations, including GMP. Prepare for FDA inspections to demonstrate compliance with quality system requirements.
  6. Establish a post-market surveillance system to monitor the performance and safety of your device after it enters the market. Report adverse events and product issues promptly to the FDA.

Conclusion

Navigating the intricate regulatory landscape of medical device approval and registration demands a deep understanding of FDA FURLS, FDA Approved, and FDA Registered designations. By aligning with expert consultants and regulatory professionals, manufacturers and distributors can successfully obtain the necessary licenses, providing safe and effective medical devices to enhance healthcare outcomes for patients across the United States.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification. Fill out the form below to book a free consultation with our experts or contact us for more information.

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What Are Critical Control Points (CCPs) in HACCP?

Critical Control Points (CCPs) in HACCP

Introduction 

Ensuring food safety is crucial for businesses in the food industry. That’s where Hazard Analysis and Critical Control Points (HACCP) comes in, a structured approach that helps prevent contamination and maintain high safety standards. At the center of this system are Critical Control Points (CCPs), key stages in food production where risks must be controlled to avoid hazardous outcomes. 

But why do CCPs matter, and how can you implement them effectively? This guide will walk you through everything you need to know, from defining CCPs to meeting regulatory requirements. Keep reading to learn how to protect consumers, maintain compliance, and strengthen your food safety practices. 

Defining Critical Control Points (CCPs) 

A Critical Control Point (CCP) in HACCP is a specific step in the food production process where control must be applied to mitigate biological, chemical, or physical hazards. Without effective CCP management, the risk of contamination increases, potentially leading to foodborne illnesses or non-compliance penalties. 

Importance of CCPs in HACCP 

Properly managing CCPs not only ensures product integrity but also helps businesses avoid risks associated with contamination. Here’s why CCPs are so important: 

  • Risk reduction: Identifying and managing CCPs minimizes the likelihood of hazardous contamination, reducing the risk of foodborne illnesses. 
  • Quality assurance: CCPs help maintain consistency in food quality by enforcing strict control measures throughout the production process. 
  • Regulatory compliance: Many regulatory bodies mandate HACCP-based food safety systems. Implementing CCPs ensures compliance with international food safety regulations, preventing legal and financial issues. 

Regulatory Standards Governing CCPs 

Food safety regulations vary across countries, but most follow similar principles based on HACCP guidelines. These regulations help ensure that food businesses implement proper controls to minimize risks and protect consumers. Below are key regulatory bodies and frameworks that govern CCPs worldwide: 

United States: FDA Food Safety Modernization Act (FSMA) 

In the U.S., The Food Safety Modernization Act (FSMA) enforces preventive food safety measures, including HACCP principles and CCP identification. 

Canada: Safe Food for Canadians Regulations (SFCR) 

Canada enforces HACCP principles through the Safe Food for Canadians Regulations (SFCR), which guarantees that food businesses maintain high safety standards. 

European Union: European Food Safety Authority (EFSA) 

The EFSA establishes guidelines for CCPs across the European Union, securing stringent food safety compliance. 

Global Standards: Codex Alimentarius Commission 

This international organization sets food safety benchmarks that many countries adopt, making HACCP and CCPs a globally recognized standard. 

How to Implement CCPs in HACCP 

Successfully implementing critical control points (CCPs) in HACCP requires a structured approach. Each step is designed to identify potential risks, establish control measures, and ensure ongoing compliance. Below is a streamlined process to help businesses effectively implement CCPs: 

  1. Conduct a hazard analysis: Identify biological, chemical, and physical hazards that may compromise food safety. 
  2. Determine critical control points: Pinpoint stages in the production process where risks must be controlled to prevent contamination. 
  3. Establish critical limits: Define measurable thresholds for factors like temperature, time, and microbial counts to maintain safety. 
  4. Implement monitoring procedures: Regularly track CCPs through inspections, testing, and data collection to ensure compliance. 
  5. Develop corrective actions: Create protocols to address deviations from critical limits and quickly restore safety measures. 
  6. Conduct verification and record-keeping: Maintain detailed records of monitoring, corrective actions, and verification activities to demonstrate compliance.  

At Quality Smart Solutions (QSS), we can guidance you on HACCP compliance and CCP implementation. Our services include formula review, product labeling, and nutrition facts (Canada & USA); supplemented foods registration (TMALs) & compliance; safe foods for Canadian regulations (HACCP, PCP, import licensing, GRAS notifications); facility registration, FSVP agent, and U.S. Agent services.  

Contact us today to ensure your food safety compliance. 

Read more 

Want to dive deeper into HACCP, CCP, and food safety? Here are some helpful resources to expand your knowledge: 

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GRAS Notice vs. Self-Affirmed GRAS: Which Is Best?

GRAS Notice vs Self-Affirmed GRAS

GRAS Notice vs Self-Affirmed GRAS

If you’re introducing a new ingredient or additive into food products, understanding the GRAS Notice vs. Self-Affirmed GRAS pathways is essential. In the U.S., substances that are Generally Recognized as Safe (GRAS) can be used in food without requiring a formal FDA approval.

But how do you determine which GRAS pathway is right for you?  

Keep reading to explore the key differences, regulatory requirements, and best practices for ensuring compliance. 

What is GRAS? 

GRAS, or generally recognized as safe, means a substance is deemed safe for its intended use based on expert consensus and scientific evaluation. The GRAS status of a substance is determined through two primary pathways, GRAS Notice (FDA-reviewed) and Self-affirmed GRAS (internally determined by the company). 

Both pathways have regulatory and business implications, so selecting the right one depends on your compliance needs, transparency preferences, and available resources. 

GRAS Notice: The FDA-reviewed pathway 

The GRAS Notice pathway involves submitting a formal notification to the U.S. Food and Drug Administration (FDA) for review. This process provides a higher level of regulatory validation. 

Key steps in the GRAS Notice process 

  1. Scientific evidence compilation: You must provide toxicology studies, clinical trials, and historical data demonstrating the substance’s safety. 
  2. Independent panel review: A third-party panel of experts evaluates the safety data before submission. 
  3. FDA review and response: The FDA assesses the submission and issues either a “no questions” letter, confirming the GRAS determination, or a request for more data if they need further clarification. 

Benefits of the GRAS Notice pathway 

  • The FDA reviews this process, enhancing regulatory credibility and reducing compliance risks. 
  • The process is transparent, as submissions are publicly available and referenced by regulators, industry professionals, and consumers. 
  • It assures consumers, investors, and partners, strengthening trust in the product’s safety and compliance. 

Self-affirmed GRAS: The internal pathway 

Self-affirmed GRAS allows a company to determine a substance’s safety without FDA review. Instead, the company conducts an internal scientific evaluation and expert review. 

Key steps in the Self-Affirmed GRAS process 

  1. Internal scientific review: The company compiles safety data similar to a GRAS Notice. 
  2. Expert consensus: A qualified panel (internal or external) confirms safety. 
  3. Documentation and record-keeping: The company maintains detailed records but does not submit to the FDA. 

Benefits of the Self-Affirmed GRAS pathway 

  • The process moves faster and reduces costs, making it an efficient option. 
  • Companies maintain confidentiality over business decisions and regulatory strategies. 
  • Organizations can voluntarily share the GRAS determination with customers or regulatory agencies if needed.
  • Once Self-Affirmed GRAS is obtained, it increases the probability of getting FDA GRAS Notice if submitted.  

GRAS Notice vs. Self-Affirmed GRAS: Key differences 

Feature 

GRAS Notice 

Self-Affirmed GRAS 

FDA involvement 

Yes, FDA reviews submission 

 Independent expert panel determines status

Independent panel 

Recommended but not mandatory

 Required

Transparency 

Publicly available 

Can be kept confidential 

Legal considerations 

Stronger FDA endorsement 

Higher liability if challenged 

Which pathway should you choose? 

If you want formal FDA recognition and transparency, the GRAS Notice pathway is best. However, if speed, cost savings, and confidentiality are priorities, Self-Affirmed GRAS may be the better option. Regardless of the pathway, ensuring food safety and compliance is critical. One can always go for FDA GRAS once self-affirmed GRAS is obtained.

Need help navigating GRAS compliance? 

Choosing the right GRAS pathway requires careful consideration of regulatory, financial, and business factors. Our experts at Quality Smart Solutions can help you navigate GRAS Notification, Self-Affirmation, and FDA compliance. 

Contact us today or fill out the form below to ensure your food additives and ingredients meet industry standards! 

 

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What Are GRAS Substances? A Complete Guide

GRAS substances used in food, pharmaceuticals, and cosmetics

GRAS substances

GRAS substances, or “Generally Recognized as Safe” substances, are essential to product development in the food, pharmaceutical, and cosmetic industries. If you’re in any of these fields, it’s important to understand how GRAS substances work so your products stay compliant, safe, and ready for market. 

Maybe you’re working on a new formulation or reviewing an ingredient label. Either way, knowing the role and regulations of GRAS substances can make your life easier. In this guide, you’ll get a clear overview of what they are, how they’re used, and how to navigate the compliance process with confidence.  

Stick with us. This might just be the piece you need to move forward with clarity and confidence. 

What Does GRAS Mean? 

GRAS substances are ingredients that experts widely agree are safe under the conditions of their intended use. The U.S. Food and Drug Administration (FDA) oversees GRAS determinations and maintains a GRAS database, although companies can also self-affirm GRAS status with the proper documentation. There are two main pathways to GRAS status: 

  • FDA GRAS Notification: A voluntary submission to the FDA for review. 
  • Self-Affirmed GRAS: An internal scientific review by qualified experts, without FDA involvement. 

Regardless of the route, your documentation must support the ingredient’s safety, based on scientific data and public availability of information. 

Types of GRAS Substances 

GRAS substances fall into three main categories: 

1. Food additives

These include preservatives, flavor enhancers, emulsifiers, and colorants that improve shelf life, taste, and appearance. For example, ascorbic acid (Vitamin C) is a common GRAS additive in juice to prevent spoilage. 

2. Pharmaceutical excipients

GRAS substances also play a role in drug formulation. These “inactive” ingredients help with drug stability, absorption, and delivery. Think fillers, binders, and disintegrants. 

3. Cosmetic ingredients

In the cosmetics industry, GRAS substances are found in moisturizers, surfactants, and preservatives. Their safety must be demonstrated for topical use, ensuring they don’t harm the skin or body.

4. Food Ingredients

GRAS substances can also be used as food ingredients with nutritional value. This includes items like pea protein powder or microorganisms used as probiotics, both of which contribute to the overall nutritional profile of a food product.

Where GRAS Substances Are Used 

GRAS substances are everywhere. Here’s how different industries depend on them: 

  • Food industry: Extend shelf life, enhance flavour, and prevent spoilage. 
  • Pharmaceutical industry: Ensure drug consistency and performance. 
  • Cosmetics industry: Create safer, effective products that meet regulatory standards. 

Understanding the right category and application is crucial for compliance and consumer safety. 

Is Your GRAS Substance Compliant? 

GRAS substances may be recognized, but they still require scientific support and regulatory strategy. To ensure your GRAS substance complies with FDA requirements, consider: 

Staying compliant means documenting safety, evaluating exposure levels, and regularly reviewing ingredient data. 

Why GRAS Certification Matters 

Achieving GRAS status isn’t just a regulatory milestone. It builds trust with consumers, streamlines market entry, and protects your brand. 

Whether you’re launching a new dietary ingredient or expanding your food product line, a clear GRAS strategy reduces risk and gives you a competitive edge. If your team needs help preparing a GRAS dossier or navigating the notification process, our team at Quality Smart Solutions is here to help. 

Learn More About GRAS 

Want to dive deeper? Explore these helpful resources: 

Still have questions? Reach out to us about GRAS notifications, self-affirmation, or dossier preparation. Contact us today or fill out the form below for a free consultation with one of our regulatory experts. 

 
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Everything businesses should know about the Supplemented Foods Facts Table (SFFT)

Supplemented Foods Facts Table

Supplemented Foods Facts TableIntroducing the Supplemented Foods Facts Table (SFFT), your go-to guide for navigating the ever-changing world of supplemented foods. With consumer demand skyrocketing for these products, grasping the SFFT is vital for businesses looking to excel in this booming market.

In this article, we’ll unravel everything you need to know about the SFFT, from its purpose to its must-follow rules. We’ll also explore how it can empower your business to effectively convey your supplemented food products’ benefits and nutritional value to consumers. Whether you’re a fresh-faced startup or a seasoned brand, consider this article your trusty companion for mastering the Supplemented Foods Facts Table.

Whether you’re a small startup or an established brand, this article is your go-to resource for understanding and complying with the SFFT. Stay ahead of the competition and enhance consumer trust by mastering the ins and outs of the Supplemented Foods Facts Table.

Why is the SFFT important for businesses?

The Supplemented Foods Facts Table (SFFT) is an essential tool for businesses operating in the supplemented foods industry. This table gives businesses a standardized format to communicate important product information to consumers. By including the SFFT on product labels, companies can ensure that consumers can access accurate and transparent information about their supplemented food products’ nutritional content and benefits.

The SFFT is crucial in building consumer trust and confidence in supplemented foods. With the increasing interest in health and wellness, consumers are becoming more conscious about the nutritional value of their products. By providing clear and comprehensive information through the SFFT, businesses can meet this demand and differentiate themselves in the market.

Furthermore, the SFFT helps businesses comply with regulatory requirements. Many countries have specific regulations that mandate the use of SFFT on product labels. By adhering to these regulations, companies can avoid potential legal issues and ensure that their products comply with industry standards.

In summary, the SFFT is essential for businesses because it allows them to communicate vital information to consumers, build trust, comply with regulations, and differentiate themselves in the competitive supplemented foods market.

What are the components of the Supplemented Foods Facts Table SFFT?

To effectively create a compliant SFFT for your products, it is essential to understand the critical components of the table. The SFFT consists of several sections, each providing specific information about the supplemented food product. Let’s take a closer look at these components:

1. Serving Size: This section indicates the recommended serving size of the product. Determining an appropriate serving size that accurately reflects how consumers typically consume the product is vital.
2. Calories: The product’s calorie content is displayed in this section. It provides consumers with an understanding of the energy value of the product.
3. Total Fat: This section includes information about the total fat content of the product, including the amount of saturated and trans fats. It is essential to disclose this information as it helps consumers make informed choices about their dietary intake.
4. Cholesterol: The cholesterol content of the product is displayed in this section. High cholesterol levels can have adverse health effects, so providing this information to consumers is essential.
5. Sodium: This section indicates the sodium content of the product. High sodium intake can harm health, so disclosing this information allows consumers to manage their sodium intake effectively.
6. Total Carbohydrates: This section provides information about the total carbohydrate content of the product, including dietary fiber and sugars. It helps consumers understand the carbohydrate composition of the product, which is particularly important for individuals following specific diets.
7. Protein: The product’s protein content is displayed in this section. Protein is an essential nutrient, and disclosing this information helps consumers decide based on their dietary needs.
8. Vitamins and Minerals: This section lists the vitamins and minerals present in the product and their respective quantities. It is crucial to provide this information as it allows consumers to assess the product’s nutritional value.

By understanding these components, businesses can create a comprehensive and accurate SFFT for their supplemented food products.

How do you create a compliant SFFT for your products?

Creating a compliant SFFT for your products involves following specific guidelines and regulations. Here are the steps to ensure your SFFT meets the requirements:

1. Research Regulatory Requirements: Research the specific regulatory requirements for SFFT in your target market. Different countries may have varying guidelines and regulations, so it is crucial to understand and comply with the relevant standards.
2. Gather Accurate Nutritional Data: Collect accurate and up-to-date nutritional data for your supplemented food products. This includes information on serving sizes, calories, fats, cholesterol, sodium, carbohydrates, protein, vitamins, and minerals. Ensure that a reputable source or laboratory verifies the data.
3. Organize the SFFT: Use a standardized format to organize the SFFT. The table should be clear, readable, and prominently displayed on the product label. Use bold headings, appropriate font size, and spacing to enhance readability.
4. Calculate Percent Daily Values: The percent daily values (%DV) for each nutrient listed in the SFFT. %DV indicates the proportion of a specific nutrient in the product relative to the recommended daily intake. This information helps consumers understand the nutritional significance of the product.
5. Review for Accuracy and Compliance: Double-check the SFFT for accuracy and compliance with regulatory requirements. Ensure that all information is correctly displayed and that there are no misleading or false claims. It is advisable to consult with experts or regulatory bodies to verify the compliance of your SFFT.

By following these steps, businesses can create a compliant SFFT that provides accurate and transparent information to consumers.

Tips for optimizing your SFFT for consumer understanding

Creating a compliant SFFT is essential, but optimizing the table for consumer understanding is equally important. Here are some tips to help you achieve this:

1. Use Simple Language: Avoid technical jargon and use simple language that is easy for consumers to understand. Break down complex terms and provide explanations where necessary.
2. Provide Context: Supplement the SFFT with additional information or context to help consumers make informed decisions. For example, you can briefly describe the product’s benefits or usage instructions.
3. Consider Visual Aids: Incorporate visual aids, such as icons or symbols, to enhance the readability of the SFFT. These visual cues can help consumers quickly identify essential information, such as allergen warnings or nutritional highlights.
4. Highlight Key Nutrients: Use formatting techniques, such as bold or colored text, to highlight critical nutrients or beneficial ingredients. This can draw consumers’ attention to the nutritional value of the product.
5. Include Additional Information: Consider including additional information, such as allergen statements, dietary claims, or certifications, to further enhance consumer understanding and trust.
By optimizing the SFFT for consumer understanding, businesses can effectively communicate their supplemented food products’ benefits and nutritional value.

What are the common mistakes to avoid when creating an SFFT?

While creating an SFFT, businesses should be aware of common mistakes that can compromise the accuracy and compliance of the table. Here are some errors to avoid:

1. Inaccurate Nutritional Data: Ensure that the nutritional data used in the SFFT is accurate and current. Refrain from relying on outdated or incorrect information to mislead consumers and result in non-compliance with regulations.
2. Misleading Serving Sizes: Provide serving sizes that accurately reflect how consumers consume the product. Misleading serving sizes can misrepresent the product’s nutritional content and confuse consumers.
3. Omitting Key Nutrients: Include all relevant nutrients in the SFFT. Omitting vital nutrients can mislead consumers and result in non-compliance with regulations.
4. False or Misleading Claims: Avoid making false or misleading claims in the SFFT. All information should be accurate, transparent, and supported by scientific evidence.
5. Non-compliance with Regulations: Stay updated with the latest regulations and guidelines for SFFT. Non-compliance can lead to legal issues and damage the reputation of your business.

By avoiding these common mistakes, businesses can ensure the accuracy, compliance, and effectiveness of their SFFT.

What is the role of the SFFT in product labeling and marketing?

The Supplemented Foods Facts Table (SFFT) is vital in product labeling and marketing. Here’s how the SFFT contributes to these aspects:

1. Transparency and Consumer Trust: By including the SFFT on product labels, businesses demonstrate transparency and provide consumers with accurate and comprehensive information about their supplemented food products’ nutritional content and benefits. This builds trust and confidence in the brand.
2. Differentiation and Competitive Advantage: The SFFT allows businesses to differentiate by highlighting their products’ nutritional value and benefits. Companies can attract health-conscious consumers and gain a competitive advantage by effectively communicating this information.
3. Educating Consumers: The SFFT is an educational tool that helps consumers make informed choices about their dietary intake. By providing clear and understandable information, businesses empower consumers to make healthier and more conscious decisions.
4. Compliance with Regulations: The SFFT ensures compliance with regulations set by governing bodies. By adhering to these regulations, businesses avoid legal issues and maintain the integrity of their product labeling.

The SFFT is crucial in product labeling and marketing by promoting transparency, differentiation, consumer education, and regulation compliance.

What are the regulatory considerations for the SFFT?

When creating an SFFT, businesses must consider the specific regulatory requirements in their target market. Here are some regulatory considerations to keep in mind:

1. Country-specific Guidelines: Different countries may have specific guidelines and regulations for SFFT. Research and understand the requirements of your target market to ensure compliance.
2. Language Requirements: Some countries may have language requirements for the SFFT. Ensure that the table is presented in the appropriate language(s) for your target market.
3. Formatting and Placement: Regulatory bodies may have specific requirements for the formatting and placement of the SFFT on product labels. Familiarize yourself with these guidelines to ensure compliance.
4. Health Claims and Disclaimers: Some countries have strict regulations regarding health claims and disclaimers on product labels. Ensure that any claims made in the SFFT are supported by scientific evidence and comply with these regulations.
5. Updates and Changes: Stay updated with any changes or updates to the regulatory requirements for SFFT in your target market. Regularly review and revise your SFFT to ensure continued compliance.
By considering these regulatory aspects, businesses can create an SFFT that meets the specific requirements of their target market.

Resources for businesses to learn more about the SFFT

As businesses navigate the world of supplemented foods and the requirements of the Supplemented Foods Facts Table (SFFT), it is essential to have access to reliable resources. Here are some valuable resources to learn more about the SFFT:

1. Regulatory Bodies: Consult the websites and publications of regulatory bodies in your target market. These organizations often provide detailed guidelines and resources related to SFFT.
2. Industry Associations: Join industry associations or organizations specializing in the supplemented foods sector. These associations often provide resources, webinars, and workshops to help businesses understand and comply with SFFT requirements.
3. Professional Consultants like Quality Smart Solutions: Seek guidance from professional consultants who specialize in food labeling and compliance. These experts can provide personalized advice and assistance tailored to your business needs.
4. Online Research: Conduct online research to access articles, studies, and publications related to the SFFT. Many reputable sources provide free information and resources to help businesses better understand the topic.

Remember to verify the credibility and relevance of the resources you consult to ensure accurate and up-to-date information.

Conclusion: The future of the SFFT in the food industry.

The Supplemented Foods Facts Table (SFFT) is an essential tool for businesses operating in the supplemented foods industry. As consumer demand for transparent and nutritious products continues to rise, the SFFT plays a crucial role in providing accurate and comprehensive information to consumers. By understanding the components of the SFFT, following regulatory guidelines, and optimizing the table for consumer understanding, businesses can effectively communicate the benefits and nutritional value of their supplemented food products. Compliance with regulations ensures transparency, builds consumer trust, and enhances the competitiveness of businesses in the market.

As the food industry evolves, the SFFT will likely play a significant role in product labeling and marketing. By staying updated with regulatory changes and industry trends, businesses can adapt and thrive in the dynamic landscape of supplemented foods. Remember, the Supplemented Foods Facts Table is not just a regulatory requirement but an opportunity for businesses to showcase their commitment to transparency, health, and consumer satisfaction. Mastering the ins and outs of the SFFT will position your business for success in the ever-growing market of supplemented foods.

Click here to learn about the Supplemented Facts Table Regulations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

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Medical Device Compliance in Canada: A Guide for Manufacturers

Batch 4B


So, you’re a medical device manufacturer eyeing the Canadian market? Great choice! But before you dive in, let’s talk about the regulatory hoops you’ll need to jump through. Selling medical devices in Canada comes with its own set of rules, and trust me, you want to be on the right side of these regulations. This article will discuss the key steps and considerations for ensuring your medical devices meet Canadian compliance standards.

1. Who’s the regulatory boss in Canada?

First, Health Canada is the big cheese, specifically the Medical Devices Directorate (MDD). They’re the folks overseeing all things medical devices. Their rulebook is called the Canadian Medical Devices Regulations (CMDR) and is your go-to guide.

2. Know your device

Before anything else, you must determine where your device fits into Canada’s risk-based classification system. There are four classes (Class I to IV), each with its own rules. Knowing where your device falls is like the North Star guiding you through the compliance maze.

3. Get yourself a partner in Canada

You’ll need a friend there if you’re not based in Canada. Specifically, a Canadian Medical Device License (MDL) holder or agent. This person or entity will be your point person for Canadian regulations and keep you in the loop with Health Canada.

4. Register your Facility

Your manufacturing facilities must be registered with Health Canada through the Establishment Licensing and Medical Device Establishment Registration (MDEL) system. Expect questions about your facility, its activities, and other nitty-gritty details.

5. Quality is Key

Implement a Quality Management System (QMS) that follows the ISO 13485 standard. It’s the international gold standard for medical devices. Your QMS should cover everything from the design phase to distribution.

6. License to Thrill

You’ll need a Medical Device License (MDL) from Health Canada for most medical devices. Think of it as your golden ticket to sell legally in Canada. Your application should be detailed and backed up with proof of CMDR compliance.

7. Labeling Love

Make sure your device’s labeling and packaging are up to snuff with Canadian requirements. It’s bilingual, baby! English and French, please. You must include device details, manufacturing info, and usage instructions.

8. Watch and Learn

Please set up a system for keeping tabs on your devices after they hit the market. If anything goes south, you need to be ready to report it to Health Canada. Safety first, always!

9. Money Talks

Remember fees. There are application fees for licensing and annual fees for keeping that MDL shining. Approval times vary, so budget and plan accordingly.

10. Stay in the Know

Canadian regulations can change, just like anywhere else. Keep your ear to the ground for updates because compliance is a journey, not a destination.

Medical device manufacturers relying on Regulatory Experts

Making your mark in the Canadian medical device market can be daunting. The labyrinth of regulations, registrations, and quality standards can leave even the savviest manufacturers scratching their heads. That’s where regulatory consultants come to the rescue. 

The case of swift Registration

Imagine this: You’re a medical device manufacturer based outside Canada and eager to tap into the lucrative Canadian market. You’ve done your homework, but the paperwork for registering your manufacturing facility with Health Canada is overwhelming. Enter the regulatory consultant. They help you understand the complex requirements and streamline the process. With their guidance, your facility gets registered swiftly, giving you the green light to start the licensing process.

The license to sell

Once your manufacturing facility is cleared, the next hurdle is obtaining a Medical Device License (MDL). Here’s where another manufacturer’s story comes into play. They had tried navigating the application process independently. Still, they were met with delays and confusion. Frustrated, they turned to a regulatory consultant with in-depth knowledge of the Canadian system. With their expert guidance, the application was error-free and supported by a robust quality management system (QMS), significantly expediting the license approval.

Acing the labelling game

Picture this: You’ve secured your MDL and are all set to launch your medical device in Canada. But wait, have you got the bilingual labelling right? This is where another manufacturer found itself in a bind. Their labelling didn’t meet Canadian requirements, risking their entire launch. Thankfully, their regulatory consultant was quick to spot the issue. They helped redesign the labeling and ensure it complied with Canadian regulations, saving the day and their product launch.

4. The long-term partnership

These success stories aren’t just about one-off solutions. They highlight the lasting partnerships manufacturers develop with regulatory consultants. These experts assist with immediate compliance needs and keep a watchful eye on regulatory updates. This vigilance ensures that manufacturers stay ahead of the curve, making necessary adjustments to their processes and products to remain compliant.

Why do Medical Device Manufacturers trust experts like Quality Smart Solutions?

So, why do medical device manufacturers rely so heavily on regulatory consultants? It’s simple: expertise and peace of mind. Professionals like ours bring years of experience and an in-depth understanding of the ever-evolving medical device regulations. We’ve seen it all and know how to navigate the complexities.

Our consultants are proactive. They anticipate changes in regulations, helping manufacturers adapt before issues arise. This forward-thinking approach saves time and resources in the long run. Having an expert by your side is a strategic advantage in medical device compliance, where the stakes are high. It’s not just about meeting regulations; it’s about ensuring your products are safe, effective, and ready to serve the Canadian market without hiccups. Manufacturers trust experts like ours to forge partnerships that lead to success stories and smooth market entry.

In Conclusion

Getting your medical devices into the Canadian market is brilliant but challenging. Registering your facilities, securing the correct licenses, and maintaining quality standards are all part of the game. Consider teaming up with a regulatory consultant who knows the Canadian ropes—they’ll be your best friend through this process. With a bit of patience and diligence, you can conquer the world of medical device compliance in Canada and offer your products to a whole new audience, all while ensuring they’re safe and effective.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice in Canada and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification. 

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Selling Food in Canada: Navigating the Requirements for Conventional and Supplemented Products

This article will explore what it takes to sell food in Canada, from staple products to those with added supplements.

This article will explore what it takes to sell food in Canada, from staple products to those with added supplements.Canada is known for its diverse culinary landscape. If you’re considering selling food products in this country, you’re in for a rewarding venture. However, it’s essential to understand the specific requirements and regulations governing the sale of conventional and supplemented food items. This article will explore what it takes to sell food in Canada, from staple products to those with added supplements.

1. Regulatory Framework: Understanding the Basics

First, let’s delve into the regulatory framework shaping the Canadian food industry. The Canadian Food Inspection Agency (CFIA) and Health Canada jointly oversee food regulations, with the CFIA primarily responsible for enforcing these rules. This agency ensures that food products meet safety and labeling standards, regardless of type.

2. Conventional Food Products: Compliance Essentials

Selling conventional food items in Canada comes with specific requirements. Here are some key aspects to consider:

  • Labeling and Packaging: Food labels must display essential information such as the product name, ingredient list, nutrition facts, allergen declarations, and the manufacturer’s contact details. Ensuring accuracy and compliance with labeling regulations is paramount.
  • Safety Standards: Conventional foods must meet safety standards to prevent contamination and ensure they are fit for consumption. This includes adherence to good manufacturing practices (GMPs) and maintaining sanitary conditions throughout production.
  • Product Classification: Different categories of food may be subject to distinct regulations. Understanding how your product is classified is crucial in ensuring compliance.

3. Supplemented Food Products: Extra Considerations

When it comes to selling supplemented food products in Canada, additional requirements come into play:

  • Health Claims: If your product makes health claims related to supplements or functional ingredients, you must ensure these claims are substantiated by scientific evidence and approved by Health Canada. Unverified claims can lead to regulatory issues.
  • Natural Health Products: If your supplemented food product falls into the category of natural health products, it may be subject to separate regulations. Compliance with the Natural Health Products Regulations is necessary in such cases.
  • Ingredient Approval: Ingredients added to supplemented foods must be approved in Canada. Health Canada maintains a list of permitted food additives and supplements; any new ingredients must undergo a rigorous assessment.

4. Licensing and Registration: The Basics

Whether you’re selling conventional or supplemented food products, certain businesses may need to register or obtain a license with the CFIA. Factors such as the type of product and its intended use can impact whether these requirements apply to your operation.

5. Import and Export Considerations

If you’re importing food into Canada or exporting Canadian food products abroad, additional regulations and documentation may come into play. This includes compliance with international standards and trade agreements.

6. Staying Informed and Compliant

The regulatory landscape for selling food in Canada is dynamic, and it’s crucial to stay informed about updates and changes. Engaging with regulatory experts, conducting thorough research, and seeking guidance from the CFIA and Health Canada can help you navigate the requirements successfully.

In conclusion, selling food in Canada involves adherence to specific regulations and standards, whether conventional or supplemented. Understanding and complying with these requirements ensures your products are safe, accurately labeled, and ready to delight Canadian consumers and meet their dietary needs.

Check out our 10 tips for preparing for the SFCR License Application process.

Our Experts at Quality Smart Solutions offer support with understanding the Safe Foods for Canadians Regulations and applying for the SFCR License.

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FDA 510(k) Clearance: Unveiling the Medical Device Regulations.

This article will break down the regulatory complexities of FDA 510(k) clearance, including submission requirements, classification, and more.

This article will break down the regulatory complexities of FDA 510(k) clearance, including submission requirements, classification, and more.

Navigating the intricate world of medical devices can be daunting, especially when it comes to ensuring their safety and effectiveness. In the United States, the FDA 510(k) clearance process is the critical checkpoint manufacturers must pass before introducing medical devices. This article will break down the regulatory complexities of FDA 510(k) clearance, including submission requirements, classification, and more.

1. Decoding the FDA 510(k) Clearance: What Does It Mean?

At its core, FDA 510(k) clearance is the pathway through which manufacturers gain approval to sell their medical devices in the U.S. This regulatory process is named after Section 510(k) of the Food, Drug, and Cosmetic Act, which outlines the requirements that must be met to obtain this clearance. Essentially, it’s the FDA’s way of ensuring that new or modified medical devices are safe and effective.

2. What’s Needed for Submission?

Manufacturers must embark on a detailed journey when submitting a 510(k) premarket notification to the FDA. This submission is a comprehensive dossier that provides evidence that the device is substantially similar to an already legally marketed device, known as a “predicate device.” The submission includes information about the device, labeling, and any proposed changes.

3. Understanding Device Classification: How Risk Plays a Role

One of the first crucial steps in this process is determining the classification of the medical device. The FDA classifies devices into three categories—Class I, II, and III—based on their complexity and level of risk. This classification dictates the level of regulatory scrutiny and the type of evidence required for clearance.

4. Substantial Equivalence: The Heart of the Matter

Substantial equivalence is the linchpin of the 510(k) clearance process. Manufacturers must present compelling evidence showcasing how their device is akin to the predicate device, including aspects like safety, performance, and technological distinctions.

5. Quality Matters: Embracing Quality System Regulations (QSR)

Ensuring the quality of medical devices is paramount. The FDA’s Quality System Regulations (QSR), outlined in 21 CFR Part 820, dictate manufacturers’ standards. These standards encompass everything from design and manufacturing practices to labeling and post-market surveillance.

6. Clinical Data and Testing: Ensuring Safety and Effectiveness

Clinical data may be required depending on the device’s classification and any variances from the predicate device. This data includes bench testing, animal studies, or clinical trials. It’s the bedrock upon which safety and effectiveness claims are built.

7. The FDA Review Journey: A Dialogue with Experts

After the submission, the FDA performs a thorough review, examining the device’s scientific, technical, and clinical aspects. This is also when manufacturers discuss with the FDA to address any questions or concerns.

8. Beyond Clearance: Your Health in Focus

When the FDA issues a 510(k) clearance letter, it signifies the device’s green light for the U.S. market. However, the story doesn’t end there. Manufacturers uphold post-market surveillance and reporting requirements to ensure your safety and the device’s ongoing effectiveness. Manufacturers should know the steps or partner with a regulatory consultant to provide medical devices that have a real and positive impact on their target consumers.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification. 

To learn when and how to file your 510k submissions click here:

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Drug Registration and NDC Number in the U.S.: A Complete Guide

Flowchart of U.S. drug registration process from preclinical testing to FDA approval

drug registration and NDC number

Drug registration and NDC number might sound technical, but they play a big role in how medications make it to the U.S. market. If you’re in the pharmaceutical space, understanding how these systems work is key to getting your products approved, listed, and safely into the hands of patients. 

In this guide, we break it all down in a simple, accessible way. You’ll learn what’s involved in registering a drug, how the National Drug Code (NDC) number works, and why both matter for compliance, billing, and patient safety. So, if you’re looking for clarity, keep reading, and we’ll help you move forward with confidence.

What is the drug registration process? 

Before a medication can be sold in the U.S., it must go through a thorough registration process. This step is essential because it ensures the drug is safe, effective, and meets the U.S. Food and Drug Administration (FDA) standards. To give you a clearer picture, here’s a simplified overview of the main steps involved for a new drug product:

1. Preclinical Testing

At the start, the drug is tested in labs and on animals to evaluate safety and potential effectiveness. This foundational research helps determine if it’s ready for further testing on humans.

2. IND Application

Next, if the preclinical data is promising, the manufacturer submits an Investigational New Drug (IND) application to the FDA. This includes details about the drug’s composition, how it’s made, and how it will be tested in people.

3. Clinical Trials

Then come the clinical trials, which take place in three main phases:

  • Phase I: Small group to test safety and dosage. 
  • Phase II: Larger group to test how well it works and any side effects. 
  • Phase III: Even bigger group to confirm effectiveness and monitor long-term side effects. 

4. NDA or BLA Submission

After successful clinical trials, the next step is submitting a New Drug Application (NDA) for new small molecules or Biologics License Application (BLA) for new large molecules. This submission includes all the collected data from previous steps, including the results of non-clinical studies, clinical studies, and the Chemistry, Manufacturing, and Controls (CMC) section.

5. FDA Review and Approval

From there, the FDA conducts a comprehensive review. If the drug meets all requirements, it’s approved for sale in the U.S., often with specific labeling and safety conditions.

6. Post-Market Monitoring

Finally, even after approval, the drug continues to be closely monitored for safety. As new side effects are identified, updates to the labeling may follow. Ongoing post-market monitoring also helps evaluate the drug’s long-term safety and effectiveness.

What is the National Drug Code (NDC) and why the NDC number matters 

Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which is a universal product identifier for human drugs.

The National Drug Code (NDC) works like a barcode for medications in the U.S., making it easier to identify, track, and manage drug products throughout their life cycle. As a result, it plays a central role in helping manufacturers, healthcare providers, and regulatory bodies maintain accuracy and transparency. 

Specifically, the NDC is made up of three parts: 1. the labeler code, assigned by the FDA to identify the manufacturer or distributor; 2. the product code, which defines the specific drug, its strength, and dosage form; and 3. the package code, which reflects the packaging type and size. For example, a full NDC might look like this: 12345-678-09 or 12345-0678-9, depending on the firm’s configuration

Together, these segments ensure that the right drug is listed, billed, dispensed, and monitored correctly across the healthcare system. In turn, this structure helps reduce errors, streamline inventory, and improve patient safety.

Breaking down the NDC segments 

The National Drug Code is made up of three main segments: the labeler code, product code, and package code. Together, they provide a full picture of a drug product’s origin, formulation, and packaging. To make it easier to understand, here’s a quick summary of each component in table format for easier reference: 

Segment 

Assigned by 

What it identifies 

Labeler code 

FDA 

Identifies the manufacturer or distributor. Also used in FDA listings and billing. 

Product code 

Firm

Indicates the drug’s strength, dosage form and formulations. Appears on labels and listings. 

Package code 

Firm

Details of package type and size.

As a result, this structured format not only helps with accurate product identification but also improves compliance and traceability throughout the entire pharmaceutical supply chain.

Key tips for drug manufacturers 

If you’re a manufacturer, here’s what else you should know: 

  • Know your NDC format: The standard NDC format is limited to 10 digits. Therefore, when a firm is assigned a 5-digit labeler code, it must choose between using a 3-digit product code with a 2-digit package code, or a 4-digit product code with a 1-digit package code. 
  • Use unique NDCs: Different strengths or forms (like a tablet vs. syrup) need separate NDCs, even if it’s the same drug. 
  • Private labeling: If you sell to private labels, those versions also need their own NDCs. 
  • Repackaging needs a new NDC: If you change the packaging, assign a new NDC to reflect that. 
  • Keep your info updated: Always notify the FDA if your codes change or a product is discontinued. 
  • Stay compliant with other countries: The NDC is U.S.-specific. If you’re exporting, be aware of global regulations too. 

Final thoughts 

Drug registration and the NDC number are more than just paperwork. In fact, they are essential tools for maintaining safety, transparency, and regulatory compliance in the pharmaceutical industry. By staying informed and keeping documentation current, you set your products up for long-term success.

At Quality Smart Solutions, we specialize in helping companies register their drug products with Health Canada. From DIN applications to Drug Establishment License (DEL) support, our team of experts is here to guide you every step of the way. 

Ready to get started? Contact us or fill out the form below for a free consultation. We’re here to make the process smoother and help you meet your regulatory goals with confidence. Explore our FDA OTC drug compliance solutions to learn more about how we can support your U.S. drug compliance strategy.

Visit the FDA’s official NDC Directory to look up or verify drug listings. Learn about Canadian drug registration on the Health Canada website. 

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Navigating the Regulatory Seas: How Experts Ensure Your Medical Devices Set Sail Smoothly

medical device regulation requirements

medical device regulation requirements

Introduction 

In the ever-changing world of medical device manufacturing, ensuring your product complies with regulations is akin to navigating stormy seas. The safety of patients, the assurance of quality, and the complexities of compliance weigh heavily on manufacturers. This article sheds light on the challenges faced and how expert navigators—regulatory consultants—play a pivotal role in ensuring your medical device not only sails through but sets a course for success.

Here are the key points regarding medical device regulations in Canada:

  1. Medical Device Licensing: Health Canada requires all medical devices to be licensed before they can be sold in the country. There are different classes of medical devices, and the requirements for licensing vary depending on the class. Class I devices, which pose the lowest risk, generally require a Medical Device Establishment License (MDEL), while Class II, III, and IV devices require a device license.

  2. Device Classification: Medical devices are classified into four classes (Class I, II, III, and IV) based on their potential risk. Class I devices have the lowest risk, while Class IV devices pose the highest risk. The classification of a device determines the level of scrutiny and requirements for licensing.

  3. Quality Management Systems: Manufacturers are often required to have a certified Quality Management System (QMS) in place, such as ISO 13485, which demonstrates their ability to produce medical devices consistently and meet regulatory requirements.

  4. Labeling and Language Requirements: Medical device labeling must be in both English and French, as Canada is a bilingual country. Labels must include essential information about the device, including its intended use, precautions, and directions for use.

  5. Post-Market Surveillance: Manufacturers are obligated to monitor the performance of their devices once they are on the market. This includes reporting adverse events, conducting recalls if necessary, and addressing safety concerns.

  6. Unique Device Identification (UDI): Health Canada introduced a UDI system to enhance the traceability of medical devices. Manufacturers are required to label their devices with a unique identifier, allowing for easier tracking and recall if safety issues arise.

Understanding the Regulatory Maze

Medical device requirements are like a vast, intricate map; understanding them is no small feat. Some standards and guidelines can make even the most seasoned manufacturer feel lost at sea from the design phase to production.

The challenges of medical device requirements and compliance

  1. Ever-Changing Tides: Regulatory requirements are not stagnant; they are constantly shifting and evolving. Keeping up with these changes and understanding how they apply to your specific device is a daunting challenge.
  2. Diverse Global Standards: To market your device internationally, you must navigate diverse regulations. Each country has its requirements, making compliance a multifaceted challenge.
  3. Complex Documentation: The paperwork required for regulatory submissions is not for the faint of heart. Ensuring every document is accurate, complete, and submitted on time adds another layer of complexity.

What role will our medical device regulatory consultants fill?

  1. Seasoned Seafarers: Regulatory consultants are like seasoned captains who have sailed these waters before. Their experience and expertise help manufacturers make sense of the maze of regulations, providing practical and invaluable guidance.
  2. Customized Navigation: Every medical device and its challenges regarding compliance are unique. Consultants tailor their strategies, ensuring your compliance journey is specifically designed for your product and preventing common pitfalls.
  3. Mitigating Compliance Challenges: Consultants don’t just help you navigate; they help you anticipate challenges. By identifying potential issues early on, they assist in making necessary course corrections, preventing refusals, and ensuring a smoother voyage.

How our Regulatory Consultants help us to prevent refusals

  1. Early Warning Systems: Consultants act as early warning systems, identifying compliance challenges in the initial stages of development. This proactive approach allows manufacturers to make necessary adjustments, preventing refusals before they become possible.
  2. Comprehensive Risk Assessment: Consultants conduct thorough risk assessments, mapping potential obstacles. By understanding these risks, manufacturers can take preventive measures, significantly reducing the chances of refusals.

Conclusion 

In the unpredictable seas of medical device regulations, having a seasoned navigator by your side can make all the difference. Regulatory consultants provide the expertise to navigate the challenges, ensuring your product sails smoothly through approval. By investing in their knowledge, manufacturers can meet compliance requirements and innovate confidently, ultimately bringing safe, high-quality medical devices to the market. Safe travels!

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification. 

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510k Submission Guidance: Unpacking the 510k Requirements

510(k) Submission Process

510k Submissions

Introduction

In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a critical step for manufacturers seeking clearance from the U.S. Food and Drug Administration (FDA) to market their devices. This process can be complex, but it plays a pivotal role in bringing innovative medical devices to market. In this article, we’ll unpack the 510(k) submission requirements, helping manufacturers navigate the regulatory landscape with confidence.

Understanding the 510(k) Submission

The 510(k) submission is named after Section 510(k) of the Federal Food, Drug, and Cosmetic Act, which requires device manufacturers to notify the FDA at least 90 days in advance before introducing a new medical device into commercial distribution. The purpose of this notification is to demonstrate that the device is “substantially equivalent” to a legally marketed device (often referred to as a predicate device) in terms of safety and effectiveness.

Here’s a step-by-step guide to help manufacturers understand and meet the 510(k) submission requirements:

  1. Identify the Appropriate Predicate Device: The first and most crucial step is identifying a suitable predicate device. This is a device already on the market that is similar to the one you want to submit for clearance. The FDA uses the predicate device as a benchmark to assess the substantial equivalence of your device.

  2. Determine Substantial Equivalence: Your device must be substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance data. Any differences must be justified and explained thoroughly in the submission.

  3. Compile a Comprehensive 510(k) Submission: Prepare a thorough submission that includes:

    • A cover letter: This summarizes the submission and states its purpose.
    • Device description: Provide detailed information about your device, including its intended use, design, materials, and manufacturing processes.
    • Comparison to the predicate device: Highlight the similarities and differences between your device and the predicate device.
    • Performance data: Include test results, clinical data, and any other relevant information demonstrating the safety and effectiveness of your device.
    • Proposed labeling: Submit labeling, including user manuals and package inserts.
    • Biocompatibility data: Detail how your device interacts with the human body and any biocompatibility testing results.
    • Risk analysis: Identify potential risks associated with your device and how you plan to mitigate them.

  4. Compile Quality System Information: Include documentation of your Quality System Regulation (QSR) compliance. This should cover your manufacturing processes, quality control procedures, and any relevant certifications.

  5. Prepare an FDA Application: Register your establishment with the FDA and submit your 510(k) application online through the FDA’s electronic submission gateway.

  6. Wait for FDA Feedback: Once submitted, the FDA will review your 510(k) submission. They may provide feedback or request additional information. Respond promptly and thoroughly to any requests to expedite the review process.

  7. FDA Clearance: If your submission is successful, the FDA will issue a clearance letter. This means you can market your device in the United States.

Conclusion

Navigating the 510(k) submission process can be challenging, but it’s a crucial step in bringing your medical device to market. Properly understanding and meeting the 510(k) requirements, from identifying a suitable predicate device to compiling a comprehensive submission, is essential for success. Collaboration with regulatory experts and consultants who are well-versed in the FDA’s processes can be invaluable during this journey. By following these guidelines and investing in due diligence, you can increase your chances of obtaining FDA clearance and contributing to the advancement of medical technology while ensuring patient safety.

To learn when and how to file your 510k submissions click here:

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification. 

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Navigating French Language Labeling Requirements in Canada: A Guide for Food Manufacturers

Navigating French Language Labeling Requirements in Canada: A Guide for Food Manufacturers

Navigating French Language Labeling Requirements in Canada: A Guide for Food ManufacturersIntroduction:

As a food manufacturer in Canada, ensuring that your product labels comply with Health Canada’s regulations is crucial for successful market entry and consumer safety. For businesses looking to distribute food products in Canada, one essential aspect is adherence to bilingual labeling requirements, notably including French alongside English on product labels. In this blog, we’ll explore common questions about French label requirements in Canada and how food manufacturers can ensure compliance with Health Canada’s regulations.

Food Labeling Regulations and Food Label French Translation in Canada

  • Mandatory Bilingual Content:

In Canada, food labeling must be bilingual, meaning it should be in French and English to cater to the bilingual population. This includes provinces where French is the official language, such as Quebec and certain parts of New Brunswick.

  • Essential Information:

Labels must include essential information such as the product name, ingredient list, nutrition facts, allergens, and mandatory statements, where applicable. All this information must be available in both official languages.

Common food labeling mistakes to avoid in Canada

  • Incorrect Translation:

One of the most common mistakes is the incorrect translation of labeling information. It’s crucial to ensure that translations into French are accurate and compliant with Canadian standards.

  • Inadequate Font Size:

The font size used for French information must be large enough to be legible. Errors occur when the font size is too small to meet readability requirements.

  • Omission of Allergens:

It is a severe error to mention common allergens in French. Consumers must be clearly and comprehensibly informed about allergens in products.

  • Failure to Comply with Standards:

Non-compliance with French labeling regulations can lead to penalties, product recalls, and financial losses. Staying informed about constantly evolving regulatory requirements is essential.

FAQs on French Labeling Requirements in Canada

 

1. Do I need to provide French labeling for my food products in Canada?

  • Yes, if you’re a food manufacturer selling products in Canada, it’s mandatory to have bilingual labels. French labeling is required alongside English to cater to the country’s bilingual population.

2. What information should be included in the French portion of the label?

  • The French portion of the label should contain all the necessary information, such as product names, ingredient lists, nutrition facts, allergen information, and any mandatory statements, all presented accurately in French.

3. Can I use a bilingual label with English and French side by side?

  • Yes, bilingual labels with both English and French text are acceptable. However, ensuring that all required information is present in both languages and meets legibility requirements is essential.

Product Name and Ingredient List

1. Do I need to translate the product name into French?

  • Absolutely. If your product name is in English, it should be accurately translated into French. This translation should reflect the product’s nature.

2. Should I provide the ingredient list in French as well?

  • Yes, the ingredient list must be provided in French, including accurate translations of ingredient names to ensure clarity for French-speaking consumers.

Nutrition Facts and Allergen Information

1. How do I present nutrition facts in French?

  • Nutrition facts should be presented in English and French, with the French text close to English and designed for easy readability.

2. What about allergen information in French?

  • Any allergen information, including “Contains” statements, must be presented in French if it appears in English on the label. Ensure that these translations are accurate and prominently displayed.

Font Size and Legibility

1. Are there specific font size and legibility requirements for the French text?

  • Yes, Health Canada mandates that the French text be easily readable. Font size requirements vary based on the size of your packaging. Additionally, ensure that the text contrasts sufficiently with the background for clear visibility.

Conclusion

Compliance with French label requirements in Canada is a regulatory necessity and an essential step in building consumer trust. Non-compliance can lead to consequences such as product recalls and legal issues. To ensure your food labels align with Health Canada’s regulations, consult their guidance and consider seeking legal advice when needed. By adhering to these bilingual labeling requirements, you can confidently introduce your food products to the Canadian market and cater to its diverse, bilingual population.

At Quality Smart Solutions, we have a team of experts who are skilled in both Canadian and USA food labelling compliance. We offer several solutions to meet your needs and understand the importance of french translation food labelling. 

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Why is it crucial to avoid FDA Warning Letters for dietary supplements and health products?

The Implications of FDA Warning Letters

The Implications of FDA Warning Letters

 

As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory landscape. Ensuring that your products meet the stringent requirements set forth by the U.S. Food and Drug Administration (FDA) is not merely a matter of legal obligation; it’s imperative for your brand’s success and consumer safety. This article will explore the importance of steering clear of FDA Warning Letters and what they signify for your business.

The FDA’s Role in Ensuring Product Safety

The FDA plays a pivotal role in safeguarding public health by overseeing the safety and efficacy of various products, including dietary supplements and health products. These regulatory guidelines are designed to protect consumers from potential health hazards and misleading claims. For business owners, compliance with these guidelines is a legal requirement and a responsibility towards their customers.

FDA Warning Letters: A Red Flag

Receiving an FDA Warning Letter indicates that your business needs to comply with federal regulations. It serves as an official communication from the FDA to notify you of significant violations that require immediate attention. Warning Letters are issued when the FDA finds misbranded products, unapproved health claims, adulteration, or non-compliance with Current Good Manufacturing Practices (cGMPs).

The Implications of FDA Warning Letters

  1. Reputation Damage: Perhaps the most immediate and damaging consequence of receiving a Warning Letter is the negative impact on your brand’s reputation. Consumers often view these letters as red flags, leading to decreased trust in your products and company.
  2. Market Access Challenges: Non-compliance can limit your product’s market access or lead to development recalls, resulting in significant financial losses.
  3. Legal Consequences: Ignoring or inadequately addressing Warning Letters can escalate the situation, potentially leading to legal actions, including product seizures, injunctions, and fines.
  4. Resource Drain: Rectifying compliance issues can be time-consuming and costly, diverting resources from business growth and development.
  5. SEO: Resources and FDA pages always appear on the first page of Google due to their high domain authority. Therefore, if you are given a warning letter whenever someone Google your company’s name, they’ll see you failed to be compliant at some time and hurt your image.

The Path to Compliance

To avoid the pitfalls associated with FDA Warning Letters, proactive measures are paramount:

  1. Stay Informed: Regularly monitor FDA guidance and regulations related to your products. The FDA frequently updates guidelines, and staying informed is critical.
  2. Invest in Quality Control: Adhering to cGMPs is essential for ensuring the quality and safety of your products. Implement robust quality control measures to maintain compliance.
  3. Labeling and Marketing Claims: Ensure your product labels and marketing materials adhere to FDA guidelines. Avoid making unapproved health claims or using misleading language.
  4. Documentation: Maintain meticulous records of your products’ formulation, testing, and distribution to demonstrate compliance in case of an audit.
  5. Seek Expert Guidance: Engage regulatory experts or consultants specializing in FDA compliance. Their expertise can help you navigate the complexities of regulatory requirements effectively.

Conclusion

Maintaining FDA compliance in the competitive landscape of dietary supplements and health products is not just about legal obligations; it’s a strategic imperative. Avoiding FDA Warning Letters is vital for preserving your brand’s reputation, ensuring consumer safety, and securing your market presence. By prioritizing compliance, you protect your business and contribute to enhancing public health through safe and effective products.

Our Regulatory experts can help you ensure compliance with your medical devices, food/beverage, dietary supplements, cosmetics with MoCRA Regulations, and drug products including all FDA Facility Registration. 

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Everything businesses should know about submitting a 30-Day Pre-Market Notification and Structure-Function Claims

Title: Everything Businesses Should Know About Submitting a 30-Day Pre-Market Notification and Structure-Function Claim for Dietary Supplements

Title: Everything Businesses Should Know About Submitting a 30-Day Pre-Market Notification and Structure-Function Claim for Dietary SupplementsIn dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting a 30-day Pre-Market Notification and Structure-Function Claim to the U.S. Food and Drug Administration (FDA) is a pivotal regulatory requirement. This notification must be submitted at least 30 days before introducing your dietary supplement to the market. This article delves into this process’s essential facets, including steps awaiting FDA confirmation and regulatory solutions for label review, facility registration, and compliance with the Foreign Supplier Verification Program (FSVP) Import Agent requirement.

Understanding the 30-Day Pre-Market Notification

The 30-Day Pre-Market Notification is a regulatory mandate meticulously enforced by the FDA for all novel dietary supplement products entering the market. This notification serves as a conduit for the FDA to scrutinize and assess the product’s safety and adherence to labeling requirements. The primary objective is to guarantee the security of these products for consumers, coupled with the veracity of the labeling regarding ingredients and intended use.

Steps for Submitting a 30-Day Pre-Market Notification

  1. Determining Product Eligibility: Not all dietary supplements necessitate a 30-day pre-market notification. In specific cases, exemptions are available for products containing ingredients marketed in the United States before October 15, 1994, or products meeting particular criteria. Engaging regulatory experts for definitive clarification concerning your product’s eligibility is imperative.
  2. Compilation of Essential Information: Before initiation, assemble all requisite data, encompassing a comprehensive ingredient list, dosage instructions, intended use, and any structure-function claims you intend to assert.
  3. Preparation of the Notification: Utilize the FDA’s Dietary Supplement Registration and Notification System (DSN) to prepare and submit your notification. This online platform streamlines the process, ensuring the provision of all necessary details.
  4. Payment of Applicable Fees: The FDA typically charges a notification submission fee. Scrutinize the current fee schedule and proceed with the requisite amount.
  5. Submission of the Notification: Submit your notification via the DSN portal after the preparation. Expect an acknowledgment from the FDA confirming receipt of your request.

Waiting for FDA Confirmation

Upon submitting your 30-day pre-market notification, the FDA will engage in an extensive review process to ascertain compliance with safety and labeling requirements. This procedure may extend to 75 days, encompassing the obligatory 30-day waiting period. During this interval, the FDA might request supplementary information or clarifications regarding your product. It is imperative to exercise patience while awaiting the FDA’s confirmation before embarking on marketing and distribution endeavors for your dietary supplement. A premature product launch can culminate in regulatory complications and potentially tarnish the reputation of your business.

Regulatory Solutions for Label Review, Facility Registration, and FSVP Import Agent

  1. Label Review: Ensuring strict adherence to FDA labeling regulations for dietary supplements is imperative. Consider engaging regulatory experts or consultants with specialized knowledge of dietary supplements to review your labels for compliance. This prudent step serves as a bulwark against costly label-related issues in the future.
  2. Facility Registration: Manufacturers and distributors of dietary supplements must meticulously register their facilities with the FDA. Ensure comprehensive facility registration to obviate regulatory hurdles. Continuously update your registration information to maintain compliance.
  3. FSVP Import Agent: If you’re involved in importing dietary supplements into the U.S., securing a proficient Foreign Supplier Verification Program (FSVP) Import Agent is paramount. The designated agent is tasked with ensuring foreign suppliers align with FDA requirements. Selecting a knowledgeable FSVP Import Agent is pivotal to complying with this crucial regulation.

In conclusion, submitting a 30-day pre-market notification and adhering to dietary supplement regulations are essential undertakings for businesses in this area. By comprehending the intricacies of the process, patiently awaiting FDA confirmation, and proactively addressing labeling, facility registration, and FSVP Import Agent prerequisites, businesses can navigate the regulatory terrain adeptly, thereby facilitating the introduction of safe and compliant products into the market. Compliance ensures consumer safety and contributes to dietary supplement enterprises’ enduring success and esteem.

Learn about the impact of the pre-market notification and structure-function claims on the 510k medical device process.

We can help you create the best structure-function claims to propel your business to new heights. Learn about the pre-market notification and structure-function claim process for food and dietary supplements.

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Health Canada’s Notice Enables the Use of L-alpha Glycerylphosphorylcholine in Supplemented Food

Discover Health Canada's latest approval of L-alpha-glycerylphosphorylcholine in supplemented foods. Learn about regulatory changes, safety assessments, and conditions for use.

Health Canada Approves Alpha GPC in Foods

Discover Health Canada's latest approval of L-alpha-glycerylphosphorylcholine in supplemented foods. Learn about regulatory changes, safety assessments, and conditions for use.On September 20, 2023, Health Canada approved the use of L-alpha-glycerylphosphorylcholine (alpha GPC) as a supplement in foods. This decision followed a thorough safety review by Health Canada’s Food Directorate.

How Health Canada Administers Foods and Food Supplements

Health Canada ensures food and drug safety is maintained in Canada. They set the rules for food safety under the Food and Drugs Act. In July 2022, they introduced regulations specifically for foods with supplements. These regulations outline the requirements for adding supplements to foods.

Alpha GPC Safety Assessment

Health Canada conducted a detailed safety review of alpha GPC, looking at its chemistry, nutrition, and potential health risks. The review confirmed that alpha GPC is safe to use as a choline supplement in foods as long as it meets labeling and maximum usage guidelines.

Public Feedback

Health Canada opened a public comment period from April 17 to July 1, 2023, on its proposal to allow alpha GPC in foods. No new scientific information or objections were submitted, so the original safety conclusions remained unchanged.

Enforcement and Implementation

The change allowing alpha GPC in foods took effect on September 20, 2023. The Canadian Food Inspection Agency will enforce these new regulations to ensure compliance.

Access to Supplemental Ingredient Information

Health Canada provides a list of all approved supplemental ingredients, including alpha GPC, on their website. This list outlines which foods can contain these ingredients, the maximum allowed amounts, and any required safety labels.

Guidance for Food Manufacturers

Health Canada has also published a guidance document for food manufacturers. This document explains how to comply with the regulations, including labeling and safety standards for supplemented foods.

Background on the Health Canada Regulatory Authority

Under the Food and Drugs Act, Health Canada is authorized to establish requirements and conditions for foods available in the Canadian market. To facilitate this, the “Supplemented Foods Regulations,” which amended the Food and Drug Regulations and the Cannabis Regulations, were introduced on July 21, 2022. These regulations define the specific regulatory requirements applicable to supplemented foods, outlined within the Food and Drug Regulations (Part B, Division 29, and other relevant provisions). Additionally, Subsection 102(2) of the Cannabis Regulations plays a role in overseeing these regulations.

The permitted categories of supplemented foods and the supplemental ingredients, along with their conditions of use, are detailed in the “List of Permitted Supplemented Food Categories” and the “List of Permitted Supplemental Ingredients,” respectively. These lists are incorporated by reference into the Food and Drug Regulations and are regularly updated on the Canada.ca website.

Safety Assessment of L-alpha Glycerylphosphorylcholine

The decision to enable the use of L-alpha-glycerylphosphorylcholine in supplemented foods was grounded in a rigorous safety assessment conducted by Health Canada’s Food Directorate. This assessment encompassed various aspects, including chemistry, nutrition, microbiology, toxicology, and allergenicity. The evaluation concluded that the available information unequivocally supports the safe use of L-alpha-glycerylphosphorylcholine as a source of supplemental choline in supplemented foods, provided that its usage levels do not exceed the previously established maximum levels for choline and that all labeling requirements are met.

Notification: Summary of Comments and Health Canada’s Responses

As mentioned earlier, Health Canada received no comments or objections regarding the proposal. This lack of feedback reaffirms the department’s confidence in the safety assessment of L-alpha-glycerylphosphorylcholine.

Implementation and Enforcement

As of September 20, 2023, the modification allowing the use of L-alpha-glycerylphosphorylcholine in supplemented foods came into effect. This change was published in the “List of Permitted Supplemental Ingredients.” It is crucial to note that the Canadian Food Inspection Agency is responsible for enforcing the Food and Drugs Act and its associated regulations, particularly concerning foods.

Health Canada’s decision to use L-alpha-glycerylphosphorylcholine in supplemented foods underscores the department’s commitment to ensuring the safety and quality of food products available to Canadians.

This regulatory change aligns with Health Canada’s ongoing efforts to provide consumers access to safe and beneficial dietary supplements while maintaining stringent safety standards. As this modification takes effect, consumers and food manufacturers can expect to see L-alpha-glycerylphosphorylcholine as an approved source of supplemental choline in a range of supplemented food products across Canada.

Accessing the list of Supplemental Ingredients and their conditions

This document is a valuable resource for those interested in exploring the List of Permitted Supplemental Ingredients and understanding their use conditions. It provides detailed information about the supplemental ingredients authorized for addition to supplemented foods. It outlines the specific requirements governing their usage. These conditions encompass:

  1. Food Category: This indicates the type of food to which the supplemental ingredient may be added.
  2. Maximum Amount and Units per Serving: Specifies the highest quantity of the supplemental ingredient that can be included in a serving of food, along with the units of measurement applicable to the stated serving size.
  3. Cautionary Statements: Identifies any mandatory cautionary statements that must be included on the product label for each supplemental ingredient and establishes the threshold level at which these statements become obligatory.
  4. Additional Conditions of Use and Labeling Requirements: Outlines any other conditions or labeling requirements on using the supplemental ingredient.

It is essential to note that certain ingredients are strictly prohibited from being added to supplemented foods at any level. Furthermore, additional restrictions may apply to including specific supplemental ingredients in food products.

Guidance Document for Supplemented Foods Regulations

For those seeking comprehensive guidance on supplemented foods regulations, including detailed information on permitted supplemental ingredients and their conditions of use, Health Canada has provided a dedicated resource known as the “Guidance Document for Supplemented Foods Regulations.”

This guidance document offers a wealth of information, encompassing:

  1. Supplemental Ingredient Details: Comprehensive information on all permitted supplemental ingredients, their respective conditions of use, and other essential details.
  2. Regulatory Compliance: Guidance on ensuring compliance with the regulations governing supplemented foods, including labeling requirements and safety standards.
  3. Amendment Process: An explanation of the procedures and requirements for proposing and adding new supplemental ingredients to the List of Permitted Supplemental Ingredients.

Accessing the list of Supplemental Ingredients and their conditions

Discover Health Canada's latest approval of L-alpha-glycerylphosphorylcholine in supplemented foods. Learn about regulatory changes, safety assessments, and conditions for use.This document is valuable for those interested in exploring the List of Permitted Supplemental Ingredients and understanding their use conditions. It provides detailed information about the supplemental ingredients authorized for addition to supplemented foods. It outlines the specific requirements governing their usage. These conditions encompass:

  1. Food Category: This indicates the type of food to which the supplemental ingredient may be added.
  2. Maximum Amount and Units per Serving: Specifies the highest quantity of the supplemental ingredient that can be included in a serving of food, along with the units of measurement applicable to the stated serving size.
  3. Cautionary Statements: Identifies any mandatory cautionary statements that must be included on the product label for each supplemental ingredient and establishes the threshold level at which these statements become obligatory.
  4. Additional Conditions of Use and Labeling Requirements: Outlines any other conditions or labeling requirements on using the supplemental ingredient.

It is essential to note that certain ingredients are strictly prohibited from being added to supplemented foods at any level. Furthermore, additional restrictions may apply to including specific supplemental ingredients in food products.

Guidance Document for Supplemented Foods Regulations

For those seeking comprehensive guidance on supplemented foods regulations, including detailed information on permitted supplemental ingredients and their conditions of use, Health Canada has provided a dedicated resource known as the “Guidance Document for Supplemented Foods Regulations.”

This guidance document offers a wealth of information, encompassing

  1. Supplemental Ingredient Details: Comprehensive information on all permitted supplemental ingredients, their respective conditions of use, and other essential details
  2. Regulatory Compliance: Guidance on ensuring compliance with the regulations governing supplemented foods, including labeling requirements and safety standards
  3. Amendment Process: An explanation of the procedures and requirements for proposing and adding new supplemental ingredients to the List of Permitted Supplemental Ingredients

By consulting this guidance document, stakeholders, including food manufacturers, can better understand the regulatory landscape for supplemented foods in Canada. It serves as a valuable reference for newcomers and experienced industry professionals, facilitating compliance with Health Canada’s stringent standards and ensuring the safety and quality of supplemented food products in the Canadian market.

Health Canada’s commitment to transparency and safety in supplemented foods is underscored by the availability of these resources. Accessing the List of Permitted Supplemental Ingredients and the Guidance Document for Supplemented Foods Regulations empowers industry players and consumers with the knowledge and tools to navigate the regulatory landscape effectively and make informed decisions regarding supplemented food products.

Click here to learn about the Supplemented Facts Table Regulations.

How We Can Help 

At Quality Smart Solutions, we have the expertise needed to ensure your foods or food supplements comply with Health Canada. Navigating the complexities of this process can be challenging so our experienced and highly qualified team is here to help you achieve the best outcome for your success. Contact us today to discuss how we can support your business!

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Navigating Cosmetic Product Regulations through FDA Recent MoCRA Update

Navigating Cosmetic Product Regulations through FDA Recent MoCRA Update

Navigating Cosmetic Product Regulations through FDA Recent MoCRA UpdateIntroduction:

In response to the FDA’s recent draft guidance on the Registration and Listing of Cosmetic Product Facilities and Products, we’ve got some updates and insights that might interest you, especially if you’re in the cosmetic business.

First, nearly 50 public comments were submitted to the FDA regarding this draft guidance by the September 5, 2023 deadline. These comments covered various aspects, from concerns about the burden estimates to suggestions for making the whole process smoother and more transparent.

Let’s break down some of the key takeaways:

1. Burden Estimates: The FDA noted the public’s feedback and increased its burden estimates for certain reporting activities related to product listings. However, they didn’t tweak the estimates for tasks such as updating product labels or reporting severe adverse events. So, some things remain unchanged.

2. Confidentiality: If you were concerned about the confidentiality of the data you’d be submitting, the FDA referred to existing regulations. They pointed out that privacy and protection of trade secrets and commercially confidential information are covered by the Privacy Act of 1974 and FDA regulations (21 CFR part 20).

3. Deadlines: Unfortunately, if you were hoping for an extension of the December 29, 2023, deadlines for product listing and facility registration, there won’t be one. The FDA emphasized that these deadlines are mandated by law, so they’re set in stone.

Here’s a new term for FEI: Facility Establishment Identifier. This nifty little number is generated by the FDA and is used to identify your firm. You’ll need it when you’re submitting product listings and facility registrations.

If you’re wondering whether your company already has an FEI, here’s how to find out:

  • Request access to the FEI portal [link].
  • You’ll get an email with a password for the portal.
  • Log in and search for your company using its name and address.
  • If you need help finding an FEI for your company, you can request one by emailing feiportal@fda.hhs.gov. Just make sure you provide all the required information listed in the article.

Getting an FEI ensures your cosmetic business complies with the FDA’s regulations. So, if you still need one, we suggest getting on that pronto.

We hope this update helps you navigate the regulatory landscape more smoothly. If you have any more questions or need assistance, please reach out. Your compliance is essential, and we’re here to support your cosmetic business every step of the way.

Need help ensuring your cosmetic ingredients are safe for use? Get assistance with your U.S.A cosmetic product compliance from our consultants. 

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Selling Your Food Products in the USA: A Guide for Food Business Owners

Selling Your Food Products in the USA: A Guide for Food Business Owners

Selling Your Food Products in the USA: A Guide for Food Business OwnersIf you’re selling food products in the United States, understanding and complying with FDA regulations is non-negotiable. The Food and Drug Administration (FDA) has established rigorous requirements to ensure the safety and transparency of food products available to consumers. Here’s a practical guide tailored to food business owners on ensuring your food products meet the requirements for successful sales in the U.S.

1. Complying with FDA Food Label Requirements

Your food product’s label is more than just branding; it’s the first point of contact with your consumers. To ensure compliance with FDA food label requirements, here are some key considerations:

  • Nutrition Facts Panel: Your product label must feature a Nutrition Facts Panel prominently. This panel provides crucial information about the nutritional content of your product, empowering consumers to make informed choices.
  • Allergen Declaration: Clearly state any significant food allergens present in your product. This is essential for consumers with food allergies; non-compliance can have serious consequences.
  • Ingredient List: Provide a comprehensive ingredient list, arranging ingredients in descending order of predominance. Transparency here is vital for consumers with dietary restrictions or preferences.
  • Net Quantity Declaration: Accurately state the net quantity of your product. This helps consumers understand the amount they’re purchasing.

2. FDA Facility Registration and U.S. Agent

FDA facility registration is obligatory if your operations involve manufacturing, processing, packing, or storing food products. Here’s what you need to know:

  • Registration Requirement: Your food facility must be registered with the FDA. This legal requirement applies to domestic and foreign facilities involved in food-related activities.
  • U.S. Agent: For foreign facilities, designating a U.S. Agent is essential. Your U.S. Agent is a vital communication link between your facility and the FDA. They’ll receive FDA communications, inspection notices, and other official correspondence on your behalf.

3. Navigating the FSVP Import Agent Requirement Compliance

The Foreign Supplier Verification Program (FSVP) is a critical component if your business involves importing food into the United States. Here’s how to ensure your compliance:

  • Mandatory Program: FSVP is not optional; it’s compulsory for importers of food products. Its primary goal is to ensure that your foreign suppliers adhere to U.S. food safety standards.
  • Qualified FSVP Import Agent: Appoint a qualified FSVP Import Agent. This individual or entity is responsible for developing and implementing your FSVP plan. They’ll make sure the food you import aligns with FDA regulations.
  • Documentation and Verification: Keep meticulous records of your verification activities. This includes supplier assessments, food testing results, and audit reports. These records serve as tangible proof of your compliance with FSVP requirements.

Conclusion

Navigating the labyrinth of requirements for selling food products in the United States is a complex but essential task for food business owners. From meticulous food labeling to facility registration and FSVP compliance, your attention to detail ensures both the safety of consumers and the success of your business. Remember, consumers trust that the food they buy is safe and accurately labeled, making compliance with these regulations a cornerstone of your business’s reputation and prosperity.

We can provide FDA food label compliance, Nutrition Facts Panel creation and act as your FSVP Import Agent. We can also guide you through the entire FDA Facility Registration or FDA Facility Renewal process for domestic and foreign Food facilities.

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How to Obtain an NPN License for Your Natural Health Product in Canada

NPN license

NPN license

When it comes to selling natural health products (NHPs) in Canada, securing an NPN license is your ticket to success. Issued by Health Canada, this license confirms that your product is safe, effective, and manufactured to meet high-quality standards. It is not just about compliance; it is about building trust with your customers and standing out in a competitive market. Without it, your product cannot legally be sold in Canada.

If the process sounds complicated, do not worry. From understanding Health Canada’s requirements to preparing the right documents, this guide will break down everything you need to know about obtaining an NPN license. Whether you are launching a new product or expanding your business, these steps will help you navigate the process and get your product ready for the Canadian market. Let’s dive in!

What Is an NPN License?

A Natural Product Number (NPN) is a unique code assigned to natural health products approved by Health Canada. This number must appear on your product label, signaling that the product has undergone thorough evaluation and meets federal standards for safety, efficacy, and quality.

Without an NPN, you cannot legally sell your NHP in Canada. Whether you’re selling dietary supplements, herbal remedies, or vitamins, securing an NPN ensures your product is compliant and provides confidence to consumers and retailers alike.

Step 1: Understand Health Canada’s Requirements

Health Canada evaluates natural health products based on three key criteria:

  1. Safety – Does the product contain safe and approved ingredients?
  2. Efficacy – Are the product’s health claims supported by reliable evidence?
  3. Quality – Does the product meet Good Manufacturing Practices (GMP) standards?

Understanding these requirements will help you prepare a strong application and minimize the risk of delays.

Step 2: Prepare the Necessary Documents

A complete application is crucial for approval. You’ll need to provide:

  • A Product License Application Form (PLA) submitted through the Natural Health Products Online Solution (NHP Online) portal
  • Evidence supporting your product’s health claims (e.g., clinical studies or scientific literature)
  • A detailed ingredient list, including source, potency, and dosage

Make sure every document is accurate and comprehensive. Errors or missing details can lead to rejections or lengthy processing times.

Step 3: Submit Your Application

Submit your application using the NHP Online portal. Health Canada has three application classes:

  • Class I: Simple claims backed by pre-cleared information.
  • Class II: Moderate claims requiring additional evidence.
  • Class III: Complex claims needing detailed scientific evidence.

Choose the appropriate class based on the complexity of your product’s claims. Applications in Class I are processed faster (usually within 30 days), while Class III can take up to 210 days.

Step 4: Respond to Health Canada’s Requests

Health Canada may request additional information after your submission. This could include clarifications about your product’s health claims, manufacturing process, or ingredients. Prompt responses will help avoid delays and ensure the approval process moves smoothly.

Step 5: Receive Your NPN and Start Selling

Once approved, you’ll receive your unique NPN, which must be displayed on your product’s label. This number reassures consumers and retailers that your product is safe, effective, and compliant with Canadian regulations.

Common Challenges and How to Overcome Them

The NPN application process can be tricky. Here are some common challenges and tips to address them:

  • Insufficient Evidence: Ensure your health claims are backed by strong scientific data.
  • Ingredient Issues: Only use ingredients permitted by Health Canada.
  • Incomplete Applications: Review all documents thoroughly before submission.

Avoiding these mistakes can save you time and resources during the approval process.

Why Work with an NHP Expert?

Navigating the regulatory landscape can be daunting, but you don’t have to do it alone. Regulatory experts like NHP License Experts specialize in simplifying the process. From preparing your application to submitting it correctly, they can help you get your Natural Product Number faster and with fewer complications.

Learn more about how NHP License Experts can assist you in bringing your product to market.

Securing an NPN license is a critical step in selling natural health products in Canada. By following the steps above, you can streamline the process and avoid common pitfalls. Let Quality Smart Solutions or NHP License Experts help simplify the journey so you can focus on growing your business.

Contact us to get started today.

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How to prepare and submit an eStar 510k Submission as of October 1st

How to prepare and submit an eStar 510k Submission as of October 1st

Navigating FDA Registration and the 510(k) Process: Your Guide to Getting Your Medical Device to Market

Introduction: 

Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023, the FDA introduced the electronic Submission Template and Resource (eSTAR) for Pre-Submissions, revolutionizing the process for medical device applicants. Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted electronically using the eSTAR template. Given this impact on the medical device industry, we’ll answer all your questions about eSTAR in this blog. This article is simply a high-level analysis of the guidance document simplified to give you the most important information broken down but is not a substitute for the full FDA guidance document. 

What Is the eSTAR Template? 

The eSTAR template is your go-to tool for preparing electronic submissions of medical devices, simplifying the process significantly. It’s an interactive PDF form designed to guide applicants through creating a comprehensive submission. With automation features, alignment with FDA review templates, integration of resources, guided section construction, and automatic verification, the eSTAR template streamlines the submission process.

Why Choose eSTAR? 

Aside from it being a requirement eSTAR is available for voluntary use by all medical device applicants, whether you’re submitting 510(k)s, De Novo requests, or Pre-Submissions to the Center for Devices and Radiological Health (CDRH). It’s also applicable for those offering 510(k)s to the Center for Biologics Evaluation and Research (CBER) and combination products.

What Are the Benefits? 

The eSTAR template aims to enhance submission quality by facilitating comprehensive data submission in a standardized format. This ensures completeness, helping the FDA conduct premarket reviews more efficiently. The best part? It reduces the likelihood of your submission undergoing a refuse-to-accept (RTA) process.

How to Get Started with eSTAR:

  • Download the eSTAR PDF template following simple steps.
  • Familiarize yourself with the template’s instructions.
  • Use the template to construct your submission.

Important Tips:

  • Be cautious of file sizes to ensure smooth submission.
  • Combine similar attachments for better organization.
  • You don’t need to include additional forms if you’re using eSTAR.

eSTAR Application Review Process:

  • The FDA conducts a virus scanning and technical screening process for eSTAR submissions.
  • Incomplete eSTAR submissions will be held until completed.
  • Subsequent review processes follow FDA guidelines for substantial equivalence and De Novo classification requests.

How to Submit your eSTAR 510k application: 

Choose from various submission methods, including online through the Electronic Submission Gateway, the CDRH portal, or by mail. Stay updated and make your medical device submissions more efficient with the eSTAR template – your gateway to smoother FDA interactions.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification. 

Frequently Asked Questions about eSTAR

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Blog Dietary Supplements FDA

10 Steps to Sell Dietary Supplements in the U.S.

dietary supplements in the U.S.

dietary supplements in the U.S.

The dietary supplement industry in the U.S. is growing fast. More people are looking for vitamins, minerals, and other supplements to support their health. If you’re planning to sell supplements, you need to follow strict regulations to make sure your products are safe and legal.

Unlike regular foods or prescription drugs, dietary supplements have their own set of rules. The Food and Drug Administration (FDA) oversees these products, ensuring they meet safety, labeling, and manufacturing standards. If businesses don’t follow these guidelines, they risk fines, product recalls, or being removed from the market.

To help you get started, this guide covers the 10 essential steps for legally selling dietary supplements in the U.S. You’ll learn about FDA requirements, labeling rules, ingredient safety, and best practices to keep your business on the right track.

What Are Dietary Supplements?

Before diving into the requirements, let’s define dietary supplements. According to the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements are products intended to supplement the diet. They can include:

  • Vitamins & minerals

  • Herbs & botanicals
    Amino acids

  • Enzymes & probiotics

  • Other nutritional substances

Understanding this definition is crucial because dietary supplements are regulated differently from conventional foods and prescription drugs.

Key Requirements for Selling Dietary Supplements in the U.S.

To legally market dietary supplements in the U.S., you must comply with FDA regulations and industry best practices. Here are the 10 essential steps you need to follow:

1. Compliance with DSHEA

The DSHEA serves as the foundational regulatory framework for dietary supplements in the U.S. It sets forth essential requirements that manufacturers and distributors must adhere to:

  • Product Labeling: Dietary supplements must have accurate labeling, including a Supplement Facts panel that provides information about the product’s ingredients and serving size.

  • Ingredient Safety: Manufacturers are responsible for ensuring the safety of ingredients used in their products. They should not include ingredients that are unsafe or unapproved.

  • Claims and Statements: Claims made on dietary supplement labels must be truthful and not misleading. They cannot claim to treat or cure specific diseases.

2. Follow FDA Good Manufacturing Practices (GMPs)

The FDA’s Good Manufacturing Practices (GMPs) ensure dietary supplements are produced consistently and meet quality standards. These guidelines cover:

  • Facility cleanliness & sanitation

  • Proper ingredient sourcing

  • Equipment maintenance

  • Employee training & compliance

Failure to meet GMP requirements can result in product recalls or penalties.

3. Submit a New Dietary Ingredient Notification (NDIN)

If your dietary supplement contains a new ingredient not previously used in the U.S. before October 15, 1994, you must submit a New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before market launch.

4. Notify the FDA About Your Product

While dietary supplements do not require pre-market FDA approval, manufacturers must notify the FDA within 30 days of launching a product that contains structure/function claims (e.g., “supports immune health”).

5. Ensure Proper Labeling Compliance

Your dietary supplement label must include:

  • Product name & form (capsule, tablet, powder, etc.)

  • Net quantity of contents

  • Supplement Facts panel with ingredient details

  • Serving size & daily values

  • Manufacturer’s name & contact information for adverse reaction reporting

  • Allergen warnings (if applicable)

Labels must be clear and truthful and should not suggest that the product is a drug or a cure for medical conditions.

6. Avoid Disease Claims

Supplements cannot claim to:

  • Diagnose medical conditions
  • Cure or treat diseases
  • Prevent illnesses

Instead, businesses can use approved structure and function claims, such as:

  • “Supports immune health” instead of “Prevents infections”
  • “Promotes joint flexibility” instead of “Treats arthritis”

7. Implement Quality Control and Testing

To ensure product safety and effectiveness, manufacturers must:

  • Verify ingredient identity and potency
  • Test for contaminants such as heavy metals and pesticides
  • Maintain accurate ingredient concentrations

Regular third-party testing can improve credibility and consumer trust.

8. Report Serious Adverse Events to the FDA

If consumers experience serious side effects from a supplement, manufacturers must report these cases to the FDA. This helps protect public safety and ensures transparency in the industry.

9. Check for Additional State Regulations

Some states have stricter rules for dietary supplements than the federal government. Businesses should check local regulations before distributing products nationwide.

10. Stay Updated on Regulatory Changes

The dietary supplement industry is always evolving. To stay compliant, businesses should:

  • Subscribe to FDA and Federal Trade Commission (FTC) updates
  • Join industry organizations like the Council for Responsible Nutrition (CRN)
  • Consult regulatory experts when launching new products

Final Thoughts on Selling Supplements in the U.S.

Selling dietary supplements in the U.S. is an exciting opportunity, but it comes with strict legal responsibilities. By following FDA regulations, ensuring proper labeling, and maintaining high-quality standards, businesses can build trust with consumers and avoid legal issues.

Understanding these compliance steps will help you confidently enter the market and offer safe, high-quality supplements. For expert guidance on dietary supplement regulations, contact our team today.

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A Comprehensive Guide to FSVP Rules and Records for Importers

A Comprehensive Guide to FSVP Rules and Records for Importers Introduction:

 

A Comprehensive Guide to FSVP Rules and Records for Importers Introduction:

For importers in the global food trade, ensuring the safety and compliance of imported products is a top priority. The Foreign Supplier Verification Program (FSVP) is vital to this effort, requiring importers to adhere to specific rules and meticulously maintain accurate records.

In this article, we’ll delve into everything importers need to know about FSVP rules and the crucial role of journals in demonstrating compliance and safeguarding consumer health. Keep reading to learn more about the FSVP Importer Requirements.

Understanding FSVP Rules

  1. Hazard Analysis: Importers are required to perform a thorough hazard analysis for each imported food product. This involves identifying potential hazards, assessing their likelihood and severity, and determining appropriate preventive measures.
  2. Verification Activities: FSVP rules mandate that importers conduct verification activities to ensure the safety of imported products. These activities include on-site audits, testing, supplier questionnaires, and reviewing supplier records.
  3. Supplier Verification: Importers must verify that their foreign suppliers meet the same safety standards required for domestic food producers. This involves assessing the supplier’s compliance history, safety practices, and product testing.
  4. Documentation and Records: Comprehensive documentation is essential for FSVP compliance. Importers must maintain records that demonstrate their adherence to FSVP rules. This includes hazard analysis documentation, verification results, communication with suppliers, and corrective action plans.

The Crucial Role of FSVP Records

  1. Record-Keeping Requirements: FSVP regulations require importers to maintain records for a specific duration, typically two years. These records must be readily accessible for inspection by regulatory authorities, allowing them to verify compliance.
  2. Transparency and Accountability: Accurate and well-organized records clarify your compliance efforts. In the event of an audit or inspection, thorough records demonstrate your commitment to safety and help build trust with regulatory authorities.
  3. Evidence of Compliance: Records indicate that you have conducted hazard analyses, performed verification activities, and taken necessary corrective actions. This evidence showcases your dedication to product safety.
  4. Corrective Actions: Records of disciplinary actions taken in response to identified hazards or non-compliance demonstrate your commitment to addressing issues promptly and effectively.

Maintaining Effective FSVP Records

  1. Organized Documentation: Create a systematic approach to record-keeping. Maintain digital or physical folders for each imported product, including hazard analyses, verification reports, and supplier communication.
  2. Timely Updates: Ensure records are updated in real-time as you conduct verification activities and identify hazards. Timely updates provide an accurate representation of your compliance efforts.
  3. Regular Reviews: Periodically review your records to identify any gaps or areas for improvement. This proactive approach ensures that your documentation remains comprehensive and accurate.

For importers, FSVP rules and records form the backbone of product safety and regulatory compliance. By understanding FSVP rules, diligently maintaining accurate records, and embracing transparency, importers contribute to a safer global food supply chain. Effective record-keeping demonstrates compliance, builds trust with regulatory authorities, and prioritizes consumer health.

As importers continue to navigate the intricate landscape of FSVP regulations, comprehensive records are a powerful tool in upholding the highest standards in importing food products.

How Quality Smart Solutions can help

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA). Secondly, we can also help with registering supplemented foods or reviewing when the new Supplemented Food rules. Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). Help with facility registration, FSVP agent, and US Agent.  Unlock your FSVP Certification with these 7 steps.

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Inside Scoop: Draft Guidance for MLMD Application Submissions

MLMD Application Submissions

MLMD Application Submissions

*This summary of Health Canada’s guidance document provides compliance details for manufacturers submitting a new or amended application. Under the regulations, this applies to Class II, III, and IV for MLMD. It does not cover the non-ML information required in a medical device license application.*

Artificial intelligence (AI) encompasses algorithms and models that perform tasks like learning and decision-making. Machine learning (ML) is a subset of AI, where algorithms learn from data to create models. When ML is applied to medical devices, they are called machine learning-enabled medical devices (MLMD), subject to regulations.

“Transparency” means clear information about a device’s impact on risks and patient outcomes, which is crucial for safety and informed decisions.

A predetermined change control plan (PCCP) allows Health Canada to manage planned changes to ML systems addressing known risks. Terms and conditions (T&Cs) may be added to medical device licenses to enhance safety.

Health Canada follows the International Medical Device Regulators Forum (IMDRF) terms. An “ML training algorithm” establishes model parameters from data, the “ML model” makes predictions, and the “ML system” is a medical device with ML capabilities, all regulated by Section 1 of the regulations.

Relevant guidance relating to medical devices, including the following:

Policy Objective:

The policy objective of this guidance is to provide manufacturers with a framework for demonstrating the safety and effectiveness of Machine Learning-Enabled Medical Devices (MLMDs) in various contexts. This guidance applies when manufacturers seek Class II, III, or IV medical device licenses or amend such permits throughout the device lifecycle.

Policy Statements:

  1. MLMD Definition: An MLMD can be standalone software meeting the medical device definition or a medical device incorporating software meeting the definition.
  2. In Vitro Diagnostic Devices (IVDDs): MLMDs can be either IVDDs or non-IVDDs, with risk classifications ranging from Class I to Class IV.
  3. Cover Letter Statements: Manufacturers must explicitly state in their cover letters for Class II, III, and IV MLMD applications that the device employs ML. For MLMDs with a Predetermined Change Control Plan (PCCP), manufacturers must mention the presence of a PCCP in the cover letter to prevent application delays.
  4. Classification Justification: Manufacturers should justify the proposed medical device classification of the MLMD, referring to the classification rules in Schedule 1 of the regulations.
  5. Regulatory Requirements: MLMDs must meet the applicable requirements outlined in sections 10 to 20 of the regulations. Manufacturers must ensure the availability of objective evidence supporting the device’s intended use, safety, effectiveness, and associated claims.
  6. Safety and Effectiveness Assurance: Applications must demonstrate that the MLMD, including the PCCP, if applicable, adheres to safety and effectiveness requirements and maintains a favorable risk-benefit profile for patients.
  7. Application Information: Class II, III, and IV applications must include the information in section 32 of the regulations. Health Canada may request additional information during the review process.
  8. Evidence Consideration: Health Canada recognizes the diversity of information, methodologies, and evidence manufacturers use to establish MLMD safety and effectiveness. The guidance offers considerations rather than fixed requirements to accommodate different scenarios.
  9. Representative Data: Data used by manufacturers should adequately represent the Canadian population and clinical practices, including factors like skin pigmentation, sex differences, and other identity-related variables.
  10. Predetermined Change Control Plan (PCCP): Changes made under an authorized PCCP do not require a separate medical device license amendment application. Such changes remain subject to post-market regulatory oversight.
  11. Amendments Outside PCCP: For modifications outside an authorized PCCP, manufacturers should consult the regulations and relevant guidance to determine if the change constitutes a significant change requiring a license amendment application.
  12. PCCP Submission: Manufacturers may submit a PCCP with applications for new medical device licenses or amendments.
  13. Policy Evolution: This guidance represents Health Canada’s current approach, subject to revision as technology advances and regulatory oversight matures. Health Canada remains adaptable to optimize regulatory practices.

Health Canada MLMD Product Lifecycle Components

Health Canada emphasizes the significance of product lifecycle information in establishing the safety and effectiveness of Machine Learning-Enabled Medical Devices (MLMDs). The MLMD lifecycle comprises several key components, including:

  1. Design: The initial design phase is where the MLMD’s architecture, features, and functionalities are conceptualized and developed.
  2. Risk Management: The assessment and management of risks associated with the MLMD throughout its lifecycle, ensuring patient safety.
  3. Data Selection and Management: The careful selection and effective management of data used in MLMD development and operation is vital for accuracy and reliability.
  4. Development and Training: The process of training ML algorithms, establishing parameters, and refining the ML model to enhance performance.
  5. Testing and Evaluation: Rigorous testing and evaluation to verify the MLMD’s functionality, accuracy, and safety under various conditions.
  6. Clinical Validation: Validation through clinical studies and real-world use to confirm that the MLMD meets its intended medical purpose.
  7. Transparency: Ensuring clear and comprehensive information about the MLMD is available, contributing to informed decision-making.
  8. Post-Market Performance Monitoring: Ongoing monitoring of the MLMD’s performance and safety once it is in the market, including detecting any adverse events or issues.

According to Health Canada’s perspective, these components collectively form the MLMD product lifecycle, which is critical in demonstrating its safety and effectiveness.

Good Machine Learning Practice (GMLP) for MLMDs

Implementing Good Machine Learning Practice (GMLP) is crucial in all Machine Learning-Enabled Medical Device (MLMD) development and maintenance phases. GMLP ensures the creation of safe, effective, and high-quality medical devices.

When applying for an MLMD license, manufacturers should provide evidence of adopting GMLP practices throughout their organization and the product’s lifecycle. This evidence should also include details about quality practices to support changes outlined in a Predetermined Change Control Plan (PCCP).

Predetermined Change Control Plan (PCCP): Concept

A PCCP is a documentation that characterizes the MLMD, its boundaries, intended ML system changes, change management protocols, and impacts. It is an integral part of the device’s design.

PCCPs should be risk-focused, evidence-supported, and provide transparency. They should consider the entire product lifecycle.

Changes listed in a PCCP must ensure the device remains within its intended use. Changes to medical conditions, purposes, or benefits require a separate medical device license amendment application before implementation.

Appropriate changes for inclusion in a PCCP require pre-authorization to address known risks while preserving patient benefits. For instance, changes may aim to maintain or enhance performance, countering the threat of ML performance decline due to environmental alterations or input data variations.

PCCPs facilitate proactive risk management while maintaining rigorous regulatory standards to ensure the safety and effectiveness of the device.

MLMD Risk Management Guidance

Manufacturers are crucial in managing Machine Learning-Enabled Medical Devices (MLMDs) risks. This involves providing descriptions of:

  1. Identified Risks and Controls: Manufacturers should detail the risks linked to the MLMD and the measures to mitigate or eliminate these risks.
  2. Risk Assessment Technique: The method employed for initial and ongoing risk assessments and the system for categorizing and evaluating risk levels.
  3. Risk Assessment Outcomes: The results of the risk assessment process.

The risk analysis should also consider the following factors, where applicable:

  • Erroneous Outputs include instances of false positives, false negatives, or incorrect information used for diagnosis or treatment.
  • Bias: While SGBA Plus analysis may address some intolerance, manufacturers should consider and manage unwanted bias in MLMDs.
  • Overfitting: This issue occurs when a model is overly tailored to specific training examples, making it less applicable to broader problems.
  • Underfitting: When a model doesn’t capture all relevant properties of the training population, resulting in limited applicability.
  • Performance Degradation: ML system performance can decline due to various factors like demographic shifts, changes in clinical practice, or alterations in input data.
  • Automation Bias occurs when users overly rely on device outputs, potentially disregarding contradictory data or human decisions.
  • Alarm Fatigue: Users become desensitized to alarms due to excessive exposure, which can lead to missed alarms.
  • PCCP-Related Risks: Consider risks associated with Predetermined Change Control Plans (PCCPs) and their impacts on risk management.

For comprehensive risk management in MLMDs, manufacturers should refer to ISO 14971, which guides applying risk management to medical devices.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification. 

For more information, click here to read the full guidance document:

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FSMA Assurance: Safeguarding Food Safety at Every Step

FSMA Assurance

FSMA Assurance

The Food Safety Modernization Act (FSMA) Made Simple

Imagine a world where preventing food-related illnesses is more important than dealing with them after they happen. That’s precisely what the FSMA, introduced in 2011, aims to achieve. The FSMA focuses on stopping contamination and illnesses before they occur, covering various stages of the food supply chain, like production, transportation, and imports. Its main goal is to find and eliminate risks before they become dangerous.

Key Parts of FSMA Safety

  1. Preventive Controls for Human Food (PCHF): This is the heart of FSMA. It says that companies must create plans to keep food safe. These plans include finding possible problems, putting in actions to prevent issues, keeping a close watch, fixing problems, and checking to ensure the method works.
  2. Preventive Controls for Animal Food: This part is like PCHF for animal food. It ensures the same safety principles, including finding hazards, putting controls in place, and watching suppliers.
  3. Foreign Supplier Verification Program (FSVP): Since our food comes from all over the world, this ensures that the food brought into the US is safe. Importers must ensure that foreign suppliers follow the same safety rules as the US.

Meeting FSMA Rules

In a world where following rules keeps us safe, understanding and sticking to FSMA rules is super important. Follow these rules to avoid big problems like fines, recalling products, and hurting your reputation. Here’s how to make sure you’re doing the right thing:

  1. Know What Applies to You: Figure out which FSMA rules matter for what you do. FSMA covers food-related issues, so knowing your role in the food chain is vital.
  2. Plan for Safe Food: A solid plan to keep food safe is necessary. This plan involves looking at possible problems, using smart controls to avoid them, keeping a close eye on things, and ensuring the method works.
  3. Trust Your Suppliers: If you work with suppliers, make sure they’re reliable. Checking them thoroughly helps ensure that what they give you is safe to use.
  4. Teach Your Team: Your team is crucial to keeping food safe. Training them well in safety rules, cleanliness, and their roles in keeping things safe is a must.

How FSMA Consulting Helps

Experts can guide you through the FSMA maze. FSMA consulting services can help you make sense of the rules and give you tailored plans for food safety. They’re great at finding possible problems, making safety plans, and offering ongoing help for following the rules.

To Sum up,

FSMA is all about keeping us healthy. By preventing problems rather than dealing with them later, it makes sure our food is safe. Following FSMA rules isn’t just a formality; it’s about protecting public health and our food supply. Businesses that understand this and work with FSMA experts are leading the way in providing safe, top-quality food to all of us.

Learn more about FSVP Importer requirements and why certification is important in the global supply chain here.

How Quality Smart Solutions can help

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods or reviewing when the new Supplemented Food rules.

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent.  Unlock your FSVP Certification with these 7 steps.

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FSVP Planning: Everything you should know before choosing an FSVP Agent for Import/Export

Everything you should know before choosing an FSVP Agent for Import/Export

Everything you should know before choosing an FSVP Agent for Import/Export

Introduction: 

In the intricate world of global trade, ensuring the safety and compliance of imported and exported food products is a shared responsibility. The Foreign Supplier Verification Program (FSVP) stands as a cornerstone in this effort, safeguarding the well-being of consumers and the integrity of the food supply chain. When navigating the FSVP landscape, choosing the right FSVP agent is a pivotal decision for both importers and exporters. In this article, we’ll delve into the benefits of partnering with an FSVP agent and provide a list of essential FAQs to ask before making this significant choice. Click here to learn more about the FSVP Importer Requirements.

Benefits of Choosing an FSVP Agent:

  1. Expertise and Compliance: An experienced FSVP agent possesses in-depth knowledge of FSVP regulations. By partnering with an agent, importers and exporters ensure full compliance with the requirements.
  2. Tailored Solutions: Each business has unique operations and needs. An FSVP agent crafts personalized solutions that align with the specific nature of your imports or exports, streamlining the compliance process.
  3. Navigating Complexities: FSVP regulations can be complex and subject to updates. An FSVP agent constantly monitors changes, keeping you informed and helping you adapt to evolving compliance standards.
  4. Audit Readiness: Regular audits are part of FSVP compliance. A seasoned FSVP agent prepares your business for audits, ensuring all documentation and processes are audit-ready.
  5. Risk Assessment: Identifying potential hazards and risks is vital. An FSVP agent conducts thorough risk assessments, guiding you in prioritizing mitigation efforts and enhancing product safety.

FAQs to Ask Before Choosing an FSVP Agent:

  1. What is Your Experience with FSVP Compliance? Please inquire about the agent’s background and expertise in FSVP regulations to ensure a strong track record.
  2. How Will You Tailor Compliance Strategies to My Business? Understanding how the agent customizes solutions to your unique needs ensures effective compliance.
  3. What Tools and Resources Do You Provide for Record-Keeping? Comprehensive record-keeping is crucial. Ask about the tools and support they offer to maintain accurate records.
  4. How Do You Stay Updated with Regulatory Changes? To keep your business compliant, an agent should have a straightforward process for staying informed about FSVP regulation updates.
  5. Can You Provide References or Case Studies? Request references or case studies to gauge their success in assisting businesses like yours.
  6. What Support Do You Offer During Audits? Ensuring the agent assists during audits provides a smoother experience when regulatory authorities review your operations.
  7. What is Your Approach to Risk Assessment? Understanding their risk assessment process highlights their dedication to product safety.

Ten steps to creating an FSVP plan

Step 1: Understand FSVP Requirements: Before diving into implementation, familiarize yourself with the FSVP requirements outlined by the U.S. Food and Drug Administration (FDA). Gain a clear understanding of your responsibilities, including conducting hazard analyses, supplier verification, record-keeping, and corrective actions.

Step 2: Identify Applicable Foreign Suppliers: Compile a list of foreign suppliers who provide food products to your business. Prioritize suppliers based on the risk level associated with their products and ensure you have access to their necessary information.

Step 3: Conduct a Hazard Analysis: Evaluate potential hazards associated with each imported food product. Consider biological, chemical, and physical risks during production, transportation, and handling.

Step 4: Determine Verification Activities: Based on the hazard analysis, identify appropriate verification activities to ensure the safety of imported products. These activities may include on-site audits, sampling and testing, supplier questionnaires, and documentation reviews.

Step 5: Develop a Supplier Verification Program: Craft a comprehensive supplier verification program outlining each supplier’s specific verification activities. This program should detail the frequency of verifications, criteria for approval, and any corrective actions required.

Step 6: Establish Record-Keeping Procedures: Maintain meticulous records of your FSVP activities: document hazard analyses, verification results, corrective actions, and communication with suppliers. Ensure records are organized, easily accessible, and retained for the required timeframe.

Step 7: Implement Corrective Actions: In cases where hazards are identified, or verification activities uncover non-compliance, take prompt corrective actions. These actions should address the root cause of the issue and prevent its recurrence.

Step 8: Provide Supplier Training: Educate your foreign suppliers about FSVP requirements and the importance of compliance. Offer guidance on meeting safety standards and providing necessary documentation.

Step 9: Review and Update Your FSVP Plan: Regularly review and update your FSVP plan to ensure it remains effective and aligned with changing regulations. Conduct internal audits to assess the plan’s implementation and identify improvement areas.

Step 10: Seek Expert Assistance: Navigating the complexities of FSVP implementation can be daunting. Consider partnering with regulatory consultants who specialize in FSVP compliance. These experts provide invaluable guidance, ensuring your plan is comprehensive and compliant.

Conclusion: 

Selecting the right FSVP agent is a pivotal choice for importers and exporters, impacting compliance, safety, and the success of their businesses. With the benefits of expertise, tailored solutions, and audit readiness, an FSVP agent becomes a trusted partner in navigating the regulatory landscape. By posing crucial questions about compliance strategies, resources, and support, businesses can make an informed decision, confident that their chosen FSVP agent will guide them toward maintaining the highest standards in the global food trade.

How Quality Smart Solutions can help

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods or reviewing when the new Supplemented Food rules.

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent.  Unlock your FSVP Certification with these 7 steps.

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Staying Ahead of the Game: Key Insights on the Latest Requirements for New Drug Submissions

New Drug Submissions

New Drug Submissions

 

From FDA guidelines to global regulatory standards, understanding the nuances of each requirement is essential to ensure a timely and successful drug submission. Our experts have analyzed the latest updates and compiled a comprehensive guide to help you stay ahead of the curve.

In the dynamic and highly regulated world of pharmaceuticals, staying ahead of the game is not just a competitive advantage; it’s a necessity. Understanding the latest requirements for new drug submissions is essential for pharmaceutical companies seeking to bring new drugs to market. This article delves into the key insights that can keep your drug development process on track and compliant with evolving regulations while highlighting the substantial benefits of investing in new drug submissions. Check out our dedicated page for ANDS and NDS submissions for more information.

The Evolving Landscape of New Drug Submissions

The landscape of new drug submissions is continuously evolving. Regulatory authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others worldwide regularly update their guidelines and requirements. Staying informed about these changes is paramount, allowing pharmaceutical companies to adapt swiftly and ensure their submissions meet the latest standards.

Navigating the Regulatory Maze: A Worthwhile Investment

One of the first steps in preparing a new drug submission is identifying your product’s specific regulatory pathway. Different types of drugs (e.g., small molecules, biologics, generics) often follow distinct regulatory routes. Understanding which path your prescription falls under is crucial to meeting the correct submission requirements.

Investing in a well-versed regulatory affairs team or partnering with experts in the field can streamline this process. Pharmaceutical companies can confidently avoid costly delays and navigate the regulatory maze by doing so.

Quality Data Is King: Ensuring Successful Approvals

The quality of the data submitted is a cornerstone of a successful new drug submission. Rigorous testing and documentation of the drug’s safety, efficacy, and manufacturing processes are paramount. The FDA and other regulatory bodies emphasize the importance of comprehensive and well-organized data to support a submission.

Investing in robust data collection, analysis, and documentation processes is not just a regulatory requirement; it’s a strategic investment in the success of your drug. A well-prepared submission can increase the likelihood of timely approvals and market access.

Benefit-Risk Assessment: A Strategic Advantage

Assessing the benefit-risk profile of your drug is a central focus for regulatory authorities. It would be best to thoroughly analyze the drug’s benefits compared to its potential risks. A well-structured benefit-risk assessment can make a difference in the approval of your submission.

Investing in comprehensive benefit-risk assessments during drug development can enhance your product’s competitive edge. By proactively addressing potential risks and demonstrating superior benefits, your drug stands a better chance of receiving regulatory approval.

Patient-Centricity and Real-World Data: Gaining Market Advantage

Regulatory agencies increasingly value patient-centric approaches and real-world data in assessing drug submissions. Demonstrating how your drug meets patients’ needs and leveraging real-world evidence can strengthen your proposal.

Investing in patient engagement and real-world data collection aligns with regulatory expectations. It resonates with healthcare providers, payers, and patients. It can differentiate your product in the market and accelerate its adoption.

New Drug Submissions

Global Harmonization: Expanding Market Reach

Global harmonization initiatives aim to align regulatory requirements across different regions. Understanding and navigating these harmonization efforts can simplify the submission process for drugs intended for multiple markets.

Investing in a global regulatory strategy can maximize market reach and profitability. By aligning submissions with international standards, pharmaceutical companies can reduce duplication of efforts and capitalize on larger patient populations.

Digital Submissions and eCTD: Efficiency and Compliance

The move toward electronic Common Technical Document (eCTD) submissions is becoming more prevalent. Familiarizing yourself with eCTD formats and requirements is crucial for a smooth submission process.

Investing in digital submission capabilities enhances efficiency and compliance. It streamlines document management, accelerates review processes, and reduces the risk of errors.

Post-Submission Interaction: Collaboration Yields Success

The interaction between the pharmaceutical company and regulatory authorities continues after submission. Engaging in a collaborative dialogue and promptly addressing questions and concerns raised during the review process can significantly impact the outcome.

Investing in effective communication and a responsive regulatory affairs team can lead to faster approvals and a more favorable regulatory relationship.

Conclusion: A Sound Investment in Patient Health and Market Success

In conclusion, new drug submissions are not just a regulatory requirement; they represent a sound investment in patient health and market success. By staying informed, prepared, and flexible, pharmaceutical companies can successfully navigate the complex world of drug submissions. The benefits include expedited market access, enhanced competitiveness, and, most importantly, the opportunity to bring life-changing therapies to needy patients. As the pharmaceutical landscape evolves, those who invest wisely in new drug submissions stand to reap the rewards of innovation and impact.

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Demystifying GHP and GMP Regulatory Food Safety Audits: Why They Matter

Food Safety Audits

In the realm of food production and processing, safety is paramount. Ensuring our food is free from contaminants and meets stringent quality standards is a shared responsibility. This is where Good Hygiene Practices (GHP) and Good Manufacturing Practices (GMP) come into play. This comprehensive guide will explore the significance of GHP and GMP regulatory food safety audits. We’ll uncover why these audits are crucial and how they contribute to safeguarding the integrity of our food supply. We’ll help you unpack everything to do with food regulations.

Food Safety Audits

Understanding GHP and GMP: The Foundation of Food Safety

GHP (Good Hygiene Practices): GHP focuses on the cleanliness and hygiene of facilities and personnel involved in food handling and production. It encompasses a wide range of practices, including proper handwashing, sanitation of equipment, safe food storage, and maintaining hygienic working conditions. GHP lays the foundation for safe food handling from farm to fork.

GHP includes practices such as:

  1. Personal Hygiene: Ensuring that food handlers maintain cleanliness through proper handwashing, wearing suitable protective clothing, and minimizing the risk of contamination.
  2. Sanitization: Regular cleaning and sanitizing of equipment, utensils, and food preparation surfaces to prevent the growth of harmful bacteria.
  3. Safe Food Storage: Proper storage conditions to prevent spoilage and contamination of food products.
  4. Waste Management: Proper disposal of food waste and other materials to prevent pests and cross-contamination.

Good Hygiene Practice, or GHP, is a critical element in managing food chain hygiene along the entire food supply chain and ensuring that the food is secure and fit for consumption. It deals with many facets of the food industry, such as physical and chemical pollution control, worker hygiene, sanitary facilities, and the food supply chain. It is frequently required for other food safety management programs, including HACCP, ISO 2200, GAP, etc.

The essential hygienic and sanitary procedures are covered by GHP compliance. It draws attention to problem areas and possible roadblocks to raising your standards for food safety. Your workplaces, equipment, and facilities will be examined throughout the audit to identify potential hazards and areas that need improvement. It will assess and ensure that the food being processed is suitable for human consumption and is the bare minimum required to comply with regulations in the industry for hotels and restaurants. Food contamination and disease should not be taken lightly; GHP compliance will aid in that consideration.

What is the purpose of GHP in Food Safety?

The purpose of GHP is to:

  1. Minimize Health Risks: GHP practices reduce the risk of foodborne illnesses by preventing contamination at every stage of food production and handling.
  2. Maintain Product Quality: By adhering to GHP, businesses ensure that their products meet quality standards and are safe for consumption.
  3. Compliance: GHP helps businesses comply with food safety regulations and standards, avoiding legal issues and penalties.

GMP (Good Manufacturing Practices): GMP deals with the specific processes and procedures used to manufacture and process food products. It ensures that products are consistently produced and controlled to meet quality standards. GMP covers aspects like ingredient sourcing, equipment maintenance, and product testing.

What Are the Good Manufacturing Practices (GMP) in the Food Industry?

GMP in the food industry includes:

  1. Quality Control: Implementing measures to maintain product quality throughout the production process.
  2. Documentation: Keeping detailed records of production processes, ingredient sources, and quality control measures.
  3. Employee Training: Ensuring that staff is adequately trained in GMP procedures.

What Are the 10 Principles of GMP?

Nevertheless, the GMP guidelines can change based on the area of the food processing industry.

They consist of ten fundamental GMP guidelines that all food producers must adhere to:

  1. Standard Operating Procedures (SOPs) should be written in step-by-step format.
  2. Apply the SOPs and procedures.
  3. For the aim of traceability, promptly and precisely document processes and procedures.
  4. Verify the efficiency of your SOPs and the efficacy of your procedures.
  5. Integrate quality and safety into the equipment and facilities.
  6. Regularly maintain the building, its systems, and its equipment, and keep records of it.
  7. Internally establish job competency.
  8. Encourage cleanliness by performing regular sanitization.
  9. Implement a methodical quality control for both the components and the processes.
  10. To maintain legal compliance and GMP efficacy, conduct routine audits.

Conclusion: 

GHP and GMP regulatory food safety audits are not just routine procedures; they are the backbone of a safe and reliable food supply chain. By adhering to these practices and undergoing audits, businesses ensure that their food is of the highest quality and, most importantly, safe for consumers. The importance of these audits cannot be overstated, as they are instrumental in protecting public health and maintaining the integrity of the food industry.

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

Check out this blog on why Food Certifications are so important.

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Navigating the FDA Registration 510K Process: Your guide to getting your Medical Device to market

Navigating FDA Registration and the 510(k) Process: Your Guide to Getting Your Medical Device to Market

Navigating FDA Registration and the 510(k) Process: Your Guide to Getting Your Medical Device to Market

Introduction: 

So you’ve got a game-changing medical device that could reshape healthcare as we know it. Amazing! But before making that impact, you must navigate the labyrinth of FDA regulations and registrations, specifically the 510(k) pathway. In this guide, we’ll break down the process in a relatable way, covering everything from FDA regulations to the nitty-gritty of 510(k) clearance. Let’s roll up our sleeves and dive into the world of FDA registration for your medical devices.

Understanding FDA Registration and the 510(k) Process: 

Before your medical device hits the market, it needs an FDA seal of approval. Think of the FDA as the safety net, ensuring your medical device is effective and safe for users. FDA registration is your golden ticket to entering the healthcare market. The 510(k) process, named after the corresponding section of the law, is your roadmap to getting there.

Why Opt for 510(k) Clearance? 

The 510(k) clearance isn’t just a bureaucratic hurdle; it’s your express pass to the market. Compared to the often-length premarket approval (PMA) process, the 510(k) pathway offers a quicker route. If your device resembles existing ones, this pathway could be your best bet to bring your innovation to those needing it swiftly.

Breaking Down the 510(k) Journey:

  1. Getting Acquainted with Device Classification: Consider device classification, like assigning clothing categories. Your device falls into Class I, II, or III, each with its requirements. Knowing your class is the first step in the journey.
  2. Meet the “Predicate Device”: Imagine this as finding your device’s kindred spirit. A predicate device is a similar device that has already received FDA clearance. Proving substantial equivalence to this device is a cornerstone of the 510(k) process.
  3. Creating Your Device’s Showcase – 510(k) Submission: This is your device’s time to shine. Your submission package is like a comprehensive portfolio, including specs, performance data, comparisons to the predicate device, safety data, and what sets your device apart.
  4. Lights, Camera, Action – FDA Review: Think of the FDA review process like a grand movie premiere. FDA experts meticulously review your submission, ensuring your device meets safety and effectiveness standards. They might request more info or give you a thumbs-up.
  5. The Victory Lap – 510(k) Clearance: If your submission meets FDA expectations, you’ll receive a letter granting 510(k) clearance. It’s like your device’s graduation day, marking the moment it’s officially ready to hit the market.

Navigating Challenges with a Smile: 

The journey can be challenging. Challenges like selecting the predicate device or collecting solid data can crop up. These hurdles are opportunities to fine-tune your submission and demonstrate your device’s value.

Deciphering the Jedi-Level – FDA 510(k) Regulations: 

The FDA’s 510(k) regulations are like the rules of engagement for medical device clearance. They outline everything from what data you need to submit to how to address potential risks. It’s your playbook for a successful submission.

Consultants as Your Co-Pilots: 

FDA-speak can feel like a foreign language, and that’s where consultants come in. These experts have navigated the FDA terrain numerous times. They’ll guide you through the process, translate the jargon, and ensure your submission is thorough and compliant.

Conclusion: 

Securing FDA clearance through the 510(k) process isn’t just a milestone; it’s a testament to your commitment to healthcare innovation. Armed with knowledge and supported by experts, you’re well-equipped to bring your medical device to market. The journey might be filled with twists and turns, but each step brings you closer to impacting lives and improving healthcare outcomes.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification. 

To learn when and how to file your 510k submissions click here:

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Navigating HACCP Regulations: A Comprehensive Guide for Industry Compliance

HACCP Regulations: A Experts Guide for Industry Compliance

HACCP Regulations: A Experts Guide for Industry ComplianceIn today’s fast-paced and diverse industries, pursuing safety and quality isn’t just a goal; it’s a non-negotiable commitment. This is where HACCP – Hazard Analysis and Critical Control Points – takes center stage. It’s not just a buzzword; it’s a systematic approach that safeguards products and instills consumer trust. Let’s delve into the depths of HACCP regulations, understanding their significance, implementation, and how they empower industries across the board.

Understanding HACCP Regulations: Laying the Foundation

Deciphering HACCP Regulations HACCP regulations are the compass that guides businesses toward producing safe and consistent products. By identifying potential hazards and critical control points, industries can create robust protocols to mitigate risks. These regulations form the backbone of product integrity and consumer confidence.

The Weight of HACCP Compliance HACCP compliance isn’t a mere checkbox; it’s a commitment to delivering products that won’t compromise consumer safety. Whether in the food, pharmaceutical, cosmetic, or any other industry, adherence to HACCP guidelines is a testament to your dedication to quality assurance.

Unraveling the HACCP Guidelines: Step by Step

1. Assessment of Hazards begins with identifying hazards that could lurk within your production process. These hazards can range from microbiological contaminants to physical hazards. This step equips you with the knowledge needed to address potential risks.

2. Determining Critical Control Points (CCPs) CCPs are pivotal stages in your process where risks can be controlled or eliminated. For instance, CCPs could include cooking, chilling, or packaging in the food industry. By pinpointing these points, you’re proactively taking charge of product safety.

3. Setting Critical Limits Critical limits are the boundaries that ensure hazards are managed effectively. Whether it’s temperature, time, pH levels, or any other factor, staying within these limits guarantees that your products remain safe and consistent.

4. Implementing Monitoring Procedures Once you’ve set your critical limits, it’s time for vigilant monitoring. Regular checks and inspections ensure that CCPs are operating as intended. Monitoring is your safety net, preventing potential issues from escalating.

5. Corrective Actions and Verification: Even with meticulous planning, deviations can occur. Robust corrective actions are your toolkit for addressing these deviations promptly. Verification steps ensure that your HACCP plan is effective and reliable.

6. Documentation and Record-Keeping Documenting each phase of your HACCP plan isn’t just a formality; it’s a testament to your commitment. These records prove your due diligence and can be invaluable during audits.

Mastering HACCP Certification: The ultimate stamp of excellence

Embarking on the HACCP Certification Journey HACCP certification isn’t just a recognition; it’s a validation of your dedication to safety and quality. Achieving certification involves a thorough evaluation of your HACCP plan by authorized bodies. It’s a badge that signifies your commitment to meeting the highest standards.

The Ripple of Benefits HACCP certification ripples across your operations. It’s not just about compliance; it’s about operational efficiency, enhanced reputation, and access to new markets. Consumers, stakeholders, and regulators recognize and value the seal of HACCP certification.

Conclusion: Elevating Industries Through HACCP

HACCP regulations are more than just rules; they’re a mindset. They foster a culture where safety, quality, and excellence are non-negotiables. From assessing hazards to achieving certification, the journey is a testament to your commitment to consumer well-being. By embracing HACCP, you’re not just complying with regulations but pioneering a new standard of excellence across industries.

Learn about the cost of HACCP certification here or contact our team through the form below:

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

Resources:

HACCP Process and CCP

The evolution of food safety standards

Why are HACCP consultants important?

7 principles of HACCP and how they impact food safety

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AAFCO Membership Approves New Pet Food Regulations for Enhanced Transparency and Consistency

Pet Food Regulations

VHP Notification Program, VHP Notification, VHP, VHP ConsultingIntroduction

In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul of pet food and specialty pet food regulations. This decision is set to transform the way pet owners perceive and choose pet food products, marking a significant shift after more than four decades. With an emphasis on clarity and transparency, these changes aim to offer consumers standardized nutritional information, unequivocal ingredient details, and clear storage instructions.

The revisions come as a result of collaborative efforts between feed regulatory professionals, industry experts, and engaged pet owners from across the United States and Canada. The goal was to create a unified set of guidelines that would guide pet food manufacturers and distributors, ensuring that packaging and labels provide a comprehensive understanding of the product in question.

Austin Therrell, the executive director of AAFCO, emphasized the importance of feedback received during the collaborative process. “We sought public comment to learn more about how pet food label changes would enhance transparency and provide clearer information in a consumer-friendly format. New packaging and labels will be well-defined and easy to understand. And that’s good news for all of us, from pet owners and manufacturers to pets themselves,” said Therrell.

The AAFCO has recommended a period of enforcement discretion for states to adopt and enforce the revised Model Regulations for Pet Food and Specialty Pet Food. This approach encourages uniform adoption across states, ensuring consistency in the implementation of the new regulations.

Key highlights of the label changes include:

  1. Nutrition Facts Box: Resembling human-food labeling more closely for easier comprehension.
  2. Intended Use Statement: Relocated to the lower third of the front display panel to assist consumers in quickly understanding the purpose of the pet food.
  3. Ingredient Statement: Clarified with consistent terminology usage and the inclusion of parentheticals and common names for vitamins.
  4. Handling and Storage Instructions (Optional): Standardized and updated, including the incorporation of optional icons for enhanced consistency.

AAFCO’s Pet Food Committee will evaluate the enforcement discretion recommendation annually, addressing potential challenges that may arise during the transition. The ultimate goal is to ensure a seamless and uniform adoption process that benefits consumers, manufacturers, and pets.

The revisions are a result of the Pet Food Label Modernization (PFLM) initiative that began in 2015. The AAFCO collaborated with stakeholders and conducted multiple rounds of consumer research to create a set of regulations that better communicate essential information. This process highlights the power of collaboration between industry professionals and consumers, ultimately leading to improved pet food labels that empower pet owners to make informed decisions. For more information about PFLM, visit AAFCO’s official page.

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IOR Compliance USA: Navigating Regulations and Tax Responsibilities

USA IOR compliance

USA IOR complianceIntroduction: Navigating international trade regulations and the intricacies of Importer of Record (IOR) compliance and taxes can be complex. This comprehensive guide breaks down IOR compliance and its connection to tax obligations in the USA, offering a clear understanding for businesses engaged in global trade.

IOR Compliance USA: Connecting Regulations and Tax Responsibilities

What is IOR Compliance?

At the heart of successful international trade lies IOR compliance – the adherence to rules when bringing goods into the US. This guide demystifies IOR compliance and explains its crucial role in maintaining smooth import processes.

IOR Compliance and Taxes: A Balanced Approach

  1. Import Duties and Taxes: Learn how IOR compliance extends beyond import duties to include accurate tax calculations and payments.

  2. Customs Valuation and Tax Calculation: Discover how proper customs valuation impacts tax calculations and ensures accuracy in financial planning.

  3. Harmonized System Codes and Tax Alignment: Find out how aligning Harmonized System codes with tax categories prevents confusion and ensures correct tax application.

Handling Tax Obligations in IOR Compliance

  1. Understanding Tax Rates: Get insights into determining tax rates for various goods, ensuring accurate tax payments.

  2. Effective Tax Documentation: Learn about the importance of thorough documentation for transparent transactions and easy audits.

  3. Meeting Tax Deadlines: Explore the significance of timely tax payments to avoid penalties and disruptions in supply chains.

Strategic IOR Compliance and Tax Management

  1. Strategic Tax Planning: Understand how strategic tax planning within IOR compliance can positively impact your business’s financial outcomes.

  2. Managing Risks: Discover how adhering to tax obligations in IOR compliance reduces financial and legal risks, safeguarding your business’s reputation.

IOR Compliance for Different Business Models: Considering Taxes

  1. IOR Compliance for eCommerce: Find out how eCommerce businesses can ensure IOR compliance aligns with tax considerations for seamless cross-border transactions.

  2. IOR Compliance for International Shipping: Learn how IOR compliance simplifies tax challenges for businesses engaged in international shipping.

Conclusion: Navigating IOR Compliance and Tax Responsibilities

IOR compliance and tax obligations are essential aspects of thriving in international trade. This guide equips businesses with the knowledge to confidently handle IOR compliance, manage taxes, and operate seamlessly in the global marketplace.

Stay Tuned: In the ever-evolving world of regulations and taxes, staying informed and seeking professional advice ensures a positive business journey, navigating the complexities with confidence.

Need an Importer of Record? Then you should check out these blogs; 5 Benefits of Using an Importer of Record and How to Maximize Your Import Process with an Importer of Record.

Related Reading:

IOR Compliance and customs clearance

Medical Device Importer Benefits

FSVP Importer Food Importing

NHP Third-Party Importer Benefits

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Decoding Food Labeling Regulations: Unveiling Requirements on Food Labels

Food Labelling Food Regulations

Understanding Food Labels: A Simple Guide

Food Labelling Food Regulations Food labels are more than just ingredient stickers on packaging; they are a key tool that helps consumers make informed choices about what they eat. This guide simplifies the complex world of food labeling regulations, focusing on the rules set by Health Canada, the U.S. Food and Drug Administration (FDA), and the European Union (EU). From required elements to health claims and country-of-origin labeling, this article breaks down the essential information you need to know about food labels and their purpose.

Why Food Labels Are Important

Food labels serve several important functions:

  1. Informing Consumers: Labels show what’s in the food, including ingredients, nutritional information, and allergens. This helps people choose foods that fit their diet.
  2. Ensuring Safety: Labels warn about allergens or other health hazards, helping people avoid foods that might cause health problems.
  3. Promoting Healthy Eating: Nutritional information on labels encourages better food choices and supports dietary goals.
  4. Catering to Preferences: People with specific dietary needs or preferences can use labels to make informed choices.
  5. Building Trust: Accurate labels follow the rules set by regulatory authorities, promoting consumer confidence.
  6. Preventing Misleading Claims: Labels help prevent false advertising, ensuring consumers get what they expect.
  7. Making Recalls Easier: In the event of a recall, clear labeling makes it easier to identify and remove unsafe products from stores.
  8. Encouraging Comparisons: Uniform standards make it easier for consumers to compare products.
  9. Supporting Public Health: Accurate food labels are a key part of public health campaigns, helping reduce health risks like obesity and foodborne illnesses.

Key Elements of a Food Label

While food labeling rules vary by region, there are several basic elements that are usually required on labels:

  1. Product Name: A clear, accurate name that identifies what the product is.
  2. Ingredient List: All ingredients must be listed in order of weight, with allergens clearly marked.
  3. Nutrition Facts: This section includes serving size, calories, and information on key nutrients like fat, protein, vitamins, and minerals.
  4. Allergen Information: Labels must clearly state if the product contains common allergens, such as nuts, dairy, or gluten.
  5. Net Quantity: The total amount of food in the package, either by weight or volume.
  6. Dates: Labels often include a "best before" or "use by" date to ensure consumers know when the product is fresh.
  7. Country of Origin: This indicates where the food was grown, harvested, or produced.
  8. Usage Instructions: Guidelines for how to prepare or use the product properly.
  9. Storage Instructions: Tips on how to store the product to maintain its freshness and safety.
  10. Manufacturer Information: Contact details for the company that made, packed, or distributed the product.
  11. Food Additives: If any additives are used, they must be listed on the label.
  12. Health Claims: Some labels include claims about the health benefits of the food, but these must follow strict rules to prevent misinformation.

Health Claims on Labels

Health claims on food labels can be confusing, but they are divided into three main categories:

  1. Nutrient Content Claims: These claims describe the level of a nutrient in the food, like "low-fat," "high-fiber," or "good source of calcium." They must meet specific criteria set by regulatory authorities to ensure they are accurate.
  2. Structure-Function Claims: These claims talk about how a nutrient supports normal body functions, such as "calcium supports strong bones." These claims do not promise to cure or prevent any disease and usually include a disclaimer.
  3. Specific Health Claims: These claims link a particular food or ingredient to a specific health outcome, like "oats may reduce the risk of heart disease." These claims require scientific evidence and approval from regulatory authorities.

The Consequences of Misleading Health Claims

If a company makes false or unauthorized health claims, it can face serious consequences, including fines and legal action. That's why it's crucial for manufacturers to follow the rules and consult experts to ensure their claims are backed by science and comply with regulations.

What Isn’t Required on Food Labels?

Not everything that appears on a food label is legally required. Some things are optional and are added to enhance the consumer experience. These optional elements can include:

  1. Brand Names: While many products have fancy names, they are not required. The key is that the product name accurately reflects what it is.
  2. Marketing Language: Words like "delicious" or "tasty" are common on labels but not required.
  3. Recipes or Serving Suggestions: Some products offer ideas on how to use the food, but this is not a legal requirement.
  4. Retail Price: Prices usually vary by store and are not part of the label.
  5. Pictures or Graphics: Images can make a product more attractive but are not required by law.
  6. Contact Information for Consumers: While some companies provide a phone number or website for consumer questions, this is not always mandatory.
  7. Manufacturer’s Signature: Although a signature may appear on some products, it’s not a legal necessity.
  8. QR Codes or Smart Labels: QR codes that offer more information, such as sourcing or sustainability details, are optional.
  9. Cultural or Ethical Labels: Labels like "vegan" or "kosher" may be helpful for certain consumers, but they are not required unless the product is making a specific claim.
  10. Environmental Labels: Claims about sustainability or eco-friendly practices are often voluntary.
  11. Non-GMO Labeling: This is not always required by law, but many companies include it to inform consumers that their products do not contain genetically modified organisms.

Country-of-Origin Labeling

The rules for country-of-origin labeling differ depending on where you are. In the U.S., certain products like meat and fresh produce must display the country of origin. In the EU, origin labeling is required for fresh meat, fruits, and vegetables. Canada has similar rules, with certain foods like fish, seafood, and fresh produce requiring origin labels.

Food labels are essential for making informed choices and maintaining trust between consumers and manufacturers. Although complex, food label regulations are critical and full compliance is mandatory. Understanding the basic principles of food labeling can help both producers and consumers navigate this complex but crucial part of the food industry.

QSS is Your Essential Partner in Canadian Food Labelling Compliance

Food labelling laws can feel intimidating for many small and medium-sized businesses. However, when executed correctly, these regulations can become a competitive advantage, showcasing your brand’s commitment to transparency and consumer trust.

QSS brings decades of experience in helping brands navigate these complexities. We ensure that your packaging not only meets regulatory requirements across the U.S., Canada and Europe, but also resonates with today’s consumers. Our expertise in both compliance and design means that your product will stand out for all the right reasons.

If you have questions about food labelling, package design, or navigating the food-labelling market, QSS is here to help, contact us today.

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Del Health Canada: Roles & responsibilities in protecting Canadians

In this guide, we'll explore the responsibilities and functions of Del Health Canada in more detail.

In this guide, we'll explore the responsibilities and functions of Del Health Canada in more detail.Del Health Canada is a crucial regulatory body responsible for ensuring the safety and effectiveness of drugs and medical devices in Canada. This organization plays a vital role in protecting the health and well-being of Canadians by setting standards, conducting research, and enforcing regulations. In this guide, we’ll explore the responsibilities and functions of Del Health Canada in more detail.

What is Del Health Canada?

Del Health Canada is a federal agency that operates under the umbrella of Health Canada. Its primary role is to regulate drugs and medical devices in Canada, ensuring they are safe, effective, and high-quality. Del Health Canada is responsible for reviewing and approving new drugs and medical devices before they can be sold in Canada and monitoring their safety and effectiveness once they are on the market. The agency also works to prevent and address potential risks associated with drugs and medical devices and takes action when necessary to protect the health and safety of Canadians.

What are DEL Health Canada’s responsibilities?

DEL Health Canada regulates drugs and medical devices in Canada, ensuring they are safe, effective, and high-quality. This includes reviewing and approving new drugs and medical devices before they can be sold in Canada and monitoring their safety and effectiveness once they are on the market. The agency also works to prevent and address potential risks associated with drugs and medical devices and takes action when necessary to protect the health and safety of Canadians. Also, DEL Health Canada is responsible for enforcing compliance with regulations and standards related to drugs and medical devices and providing information and guidance to healthcare professionals and the public.

How does the DEL ensure the safety and efficacy of drugs and medical devices?

DEL Health Canada uses a rigorous review process to ensure the safety and efficacy of drugs and medical devices. This process includes evaluating clinical trial data, assessing the benefits and risks of the product, and reviewing the manufacturing process to ensure quality and consistency. The agency also monitors the safety and effectiveness of drugs and medical devices once on the market and takes action if any safety concerns arise. Additionally, DEL Health Canada works closely with international regulatory agencies to share information and collaborate on regulatory issues.

What is the drug approval process in Canada?

The drug approval process in Canada is a rigorous and multi-step process overseen by DEL Health Canada. It involves several stages, including pre-clinical testing, clinical trials, and a review of the data by DEL Health Canada. The agency evaluates the safety and efficacy of the drug and its manufacturing process before approving it. Once a drug is approved, DEL Health Canada continues to monitor its safety and effectiveness through post-market surveillance. This process ensures that Canadians have access to safe and effective medicines.

How can Canadian consumers access information about approved drugs and medical devices?

Canadian consumers can access approved drug and medical device information through the DEL Health Canada website. The website provides a searchable database of approved drugs and medical devices and information on drug recalls and safety alerts. Consumers can also report adverse reactions to medications or medical devices through the website. Additionally, healthcare professionals can access information on drug interactions, dosing, and prescribing through the website. Overall, the DEL Health Canada website is a valuable resource for Canadians seeking information on the safety and efficacy of drugs and medical devices.

We can help you with your USA compliance for Medical Devices, and Drug facilities or Canadian medical device and drug compliance.

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Everything you should know about Health Canada Controlled Substances

Health Canada Controlled Substances

Health Canada Controlled Substances

Health Canada, the Canadian federal health department, oversees the regulation of controlled substances in Canada. Controlled substances are regulated due to their potential for abuse, dependence, and public health and safety harm. They include drugs and substances that are categorized into different schedules based on their level of risk and potential for misuse.

In Canada, controlled substances are classified under the Controlled Drugs and Substances Act (CDSA). The CDSA categorizes controlled substances into various schedules, each with its regulations and restrictions that we’ll discuss in this blog.

What is a controlled substance in Canada?

Schedule I: Substances listed in Schedule I are considered the most tightly regulated and have a high potential for abuse. They are often prohibited for general use and may only be used for specific medical or scientific purposes. Examples of substances in Schedule I include heroin, cocaine, and LSD.

Schedule II: Substances listed in Schedule II have a high potential for abuse but may also have recognized medical uses. They are subject to strict controls, and their production, distribution, and service are tightly regulated. Examples of substances in Schedule II include cannabis, methamphetamine, and certain opioids.

Schedule III: Substances listed in Schedule III have a lower potential for abuse and may have recognized medical uses. They are subject to fewer restrictions compared to Schedule I and II substances. Examples of substances in Schedule III include certain anabolic steroids and some prescription drugs.

Schedule IV: Substances listed in Schedule IV have a lower potential for abuse than those in previous schedules and are often prescription medications. They are subject to less stringent controls. Examples of substances in Schedule IV include benzodiazepines and certain sedatives.

Schedule V: Substances listed in Schedule V have the lowest potential for abuse and are generally available over the counter or with a prescription. They are subject to minimal controls. Examples of substances in Schedule V include certain cough preparations containing small amounts of codeine.

It’s important to understand that the classification of substances into these schedules can change based on new research, evidence, and evolving public health concerns. Health Canada oversees the regulation and enforcement of controlled substances in Canada to ensure they are used safely and appropriately.

Suppose you have questions about a particular substance, its classification, legal status, or related regulations. In that case, I recommend referring to Health Canada’s official resources or consulting with our regulatory experts knowledgeable about Canadian drug regulations.

Health Canada Controlled Substances

How does Health Canada regulate controlled substances?

Health Canada regulates controlled substances in Canada through the Controlled Drugs and Substances Act (CDSA) and its associated regulations. The CDSA is the primary legislation that governs the legal framework for controlling and regulating drugs and substances with the potential for abuse, dependence, and harm to public health and safety. 

Here’s an overview of how controlled Health Canada regulates substances:

1. Classification and Scheduling: Health Canada categorizes controlled substances into different schedules (I to V) based on their potential for abuse, medical use, and overall risk. The schedules determine the level of control, restrictions, and regulations that apply to each substance. Substances with a higher potential for abuse and harm are placed in higher schedules with stricter rules.

2. Licensing and Permits: Manufacturers, distributors, healthcare professionals, researchers, and other entities involved with controlled substances must obtain appropriate licenses, permits, or authorizations from Health Canada to handle, produce, distribute, prescribe, or research these substances. These licenses outline the specific permitted activities and the conditions that must be met.

3. Production and Distribution: Health Canada regulates controlled substances’ production, distribution, and import/export. Manufacturers and distributors of controlled substances must adhere to strict quality standards, record-keeping, and reporting requirements. They must also follow Good Manufacturing Practices (GMP) to produce controlled substances.

4. Prescription and Dispensing: Certain controlled substances are available only by prescription from authorized healthcare professionals. Prescribing, dispensing, and administering controlled substances must comply with specific regulations and guidelines to ensure patient safety and prevent misuse.

5. Monitoring and Reporting: Health Canada oversees the monitoring of controlled substances through various mechanisms, including collecting data on production, distribution, prescriptions, and adverse reactions. Manufacturers, distributors, healthcare professionals, and researchers must report certain activities and events related to controlled substances.

6. Inspections and Enforcement: Health Canada conducts inspections of facilities involved with controlled substances to ensure compliance with regulations, including Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Non-compliance can result in enforcement actions, such as license suspension, revocation, or legal penalties.

7. Research and Clinical Trials: Researchers conducting studies involving controlled substances must obtain specific authorizations from Health Canada. These authorizations ensure the research is conducted ethically, safely, and in compliance with regulations.

8. Education and Public Awareness: Health Canada provides educational resources and information to healthcare professionals, patients, and the public about the risks, safe use, and regulations related to controlled substances. Public awareness campaigns help promote responsible use and prevent misuse.

It’s important to note that controlled substance regulations are subject to change. Health Canada may update or amend the rules based on new research, emerging trends, and public health considerations.

Individuals and organizations involved with controlled substances should stay informed about the latest regulations and guidelines provided by Health Canada to ensure compliance and the safe handling of these substances. Health Canada also forewarns about their roles and duties, responses to non-compliance, enforcement actions, and guiding principles. 

Other Frequently Asked Questions about Controlled Substances in Canada

1. What are controlled substances in Canada?

  • Controlled substances are drugs and substances regulated under the Controlled Drugs and Substances Act (CDSA). They include narcotics, controlled drugs, and precursor chemicals used to produce controlled substances.

2. Who regulates controlled substances in Canada?

  • The regulation of controlled substances in Canada falls under the jurisdiction of Health Canada and the Controlled Drugs and Substances Act (CDSA).

3. What is the purpose of regulating controlled substances in Canada?

  • The primary purpose is to ensure public safety and health by controlling the production, distribution, and use of substances with potential abuse and harm.

4. How are controlled substances classified in Canada?

  • Controlled substances are classified into schedules (Schedules I to IV) based on their potential for abuse, medical use, and safety. Schedule I substances are considered the most dangerous. In contrast, Schedule IV substances have the lowest potential for abuse.

5. What licenses or permits are required to handle controlled substances in Canada?

  • Depending on the activities involving controlled substances, individuals and organizations may require licenses, permits, or exemptions from Health Canada. These include charges for production, distribution, importation, and research.

6. How can I apply for a license to handle controlled substances in Canada?

  • The application process for controlled substance licenses involves submitting a detailed application to Health Canada, demonstrating compliance with regulatory requirements, security measures, and record-keeping protocols.

7. What security measures are required for handling controlled substances in Canada?

  • Security measures include physical security (e.g., secure storage), personnel security (background checks), and operational security (protocols to prevent theft or diversion).

8. Are there specific record-keeping requirements for controlled substances in Canada?

  • Individuals and organizations handling controlled substances must maintain detailed records of activities, including acquisitions, disposals, and inventories, as Health Canada outlines.

9. Can healthcare professionals prescribe controlled substances in Canada?

  • Healthcare professionals, such as physicians and dentists, can prescribe controlled substances in Canada. Still, they must follow strict guidelines and maintain accurate records.

10. What are the penalties for unauthorized possession or trafficking of controlled substances in Canada? 

  • Penalties for unauthorized possession or trafficking of controlled substances can be severe, including fines, imprisonment, and criminal charges.

11. Can controlled substances be imported or exported in Canada

  • Controlled substances can be imported or exported for legitimate purposes. Still, individuals or organizations must have the appropriate licenses and permits from Health Canada.

12. Where can I find comprehensive guidance on regulatory compliance for controlled substances in Canada?

  • Health Canada provides comprehensive guidance documents and resources on regulating controlled substances in Canada. Additionally, legal and regulatory experts can offer guidance and support for compliance.
Categories
News

New CFIA regulatory responsibilities regarding caffeinated energy drinks

In response to an increasing number of consumer inquiries, the Canadian Food Inspection Agency (CFIA) would like to inform Canadians about regulatory responsibilities with respect to caffeinated alcoholic beverages.

In response to an increasing number of consumer inquiries, the Canadian Food Inspection Agency (CFIA) would like to inform Canadians about regulatory responsibilities with respect to caffeinated alcoholic beverages.The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety of Canadians. This includes ensuring products are packaged, labeled, and advertised by government regulations and guidelines that set standards to protect the health and safety of consumers.

In response to an increasing number of consumer inquiries, the Canadian Food Inspection Agency (CFIA) would like to inform Canadians about regulatory responsibilities concerning caffeinated alcoholic beverages. in this news article, we’ll review the CFIA recall warnings, the impact of this news on vulnerable populations, CFIA inspection activities, and how our Supplemented Foods service can help you.

CFIA recall warnings:

Several brands of caffeinated energy drinks have received recall alerts from the Canadian Food Inspection Agency (CFIA). We know that many importers, merchants, and internet vendors are offering customers caffeinated energy drinks (CEDs) that must comply. This serves as a reminder that it is your responsibility to ensure that the CEDs you produce, import, or distribute comply with Canadian regulations, including the need that they do not contain more than 180 mg of caffeine per single-serving container, and display the necessary warnings required for Supplemented Foods.. Supplemented Foods (SFs) are prepackaged foods with 1 or more supplemental ingredients. Supplemental ingredients include things such as vitamins, minerals, amino acids, or caffeine.

Impact on vulnerable populations:

Drinking CED products may negatively impact vulnerable groups, including children, women who are breastfeeding or pregnant, and adults who are caffeine sensitive. Negative health impacts are also anticipated if other people consume these goods excessively. These groups rely on and have faith in the industry not to offer them goods that do not adhere to Canadian food safety regulations. If you market a product that falls short of these requirements, it may be ingested by a vulnerable consumer and cause harm to them.

CFIA inspection activities to locate non-compliance:

The CFIA is conducting inspections to determine who needs to comply. The CFIA may take legal action when non-compliance is discovered, including product seizure and detention, license suspension, administrative fines, or criminal prosecution.

License holders under the Safe Food for Canadians Regulations will still be obligated to inform the CFIA if their food threatens human health.

If you import CEDs:

  • Ensure you meet the requirements set out in your Temporary Marketing Authorization Letter (TMAL) from Health Canada or under the newly implemented Supplemented Foods Regulations
  • Ensure your products meet the needs of the regulations at the time of import If you distribute CEDs :
  • Ensure your product meets the requirements before distributing further.

How can our Supplemented Foods Service help you?

Quality Smart Solutions can help ensure your Supplemented Food products, including CEDs, comply with the newly implemented Supplemented Food Regulations. We will review your product formulation to check that caffeine levels are below the 180 mg limit (if applicable) and that the rest of the formulation complies with Health Canada’s list of permitted supplemented food categories as well as the list of permitted supplemental ingredients. After tailoring your formulation to meet the regulations, we can help bring your product label into compliance by making sure all the required labeling elements are present, including the supplemented food caution identifier and high caffeine content declaration. Quality Smart Solutions has recently helped several brands bring their energy drinks into compliance! Reach out to us today.

Helpful Information

To assist the industry in the interpretation of the SFs requirements and to ensure their SFs are compliant, the following resources are available:

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Importer of Record Licensing, NDIN/GRAS Ingredients and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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