Amazon Seller Compliance

Month: June 2025

Categories
FDA Food Safety News

FDA Updates Food Labeling Compliance Program

FDA food labeling compliance program update 2025

FDA food labeling compliance program update 2025

The FDA Food Labeling Compliance Program has just been updated to help food manufacturers and importers meet U.S. labeling requirements more effectively. On June 24, 2025, the U.S. Food and Drug Administration (FDA) announced a revised Compliance Program Manual (CPM) for general food labeling.

This update is part of the agency’s broader efforts to modernize food safety oversight and streamline inspections. If your business manufactures, processes, or imports packaged foods into the U.S., this change matters. Keep reading to learn what’s new and how to prepare.

What changed in the FDA labeling compliance manual?

The updated Compliance Program 7321.005 includes revised instructions for FDA investigators during routine inspections. While the foundational labeling regulations remain the same, the update improves how inspections are conducted.

It also introduces key content updates. For example, sesame is now recognized as the ninth major food allergen under the FASTER Act of 2021. Moreover, the program includes guidance on gluten-free claims and reflects the 2016 Nutrition Facts label updates, such as formatting and nutrient declaration changes. Together, these changes align compliance efforts with current laws and consumer needs.

According to the FDA’s official announcement, the revised manual aims to improve consistency across FDA field offices by streamlining inspection procedures and reinforcing how labeling regulations are interpreted and applied.

This update doesn’t add new rules. However, it indicates that inspections will become more structured and focused.

What does it mean for your business?

You might worry that a compliance program update means more paperwork or stricter rules. Fortunately, that’s not the case here. The core food labeling requirements under the Food, Drug, and Cosmetic Act (FDCA) and Fair Packaging and Labeling Act (FPLA) remain the same.

Still, your business should pay close attention. FDA investigators will now be guided by updated inspection procedures. This includes a focus on:

  • Proper display of net quantity of contents
  • Accurate ingredient and allergen declarations
  • Appropriate use of nutrient content claims and health claims

So, even though the regulations didn’t change, the way they’re enforced is evolving. That’s why it’s a good time to reassess your current food labels to ensure full compliance.

Do Canadian and international companies need to act?

Yes, especially if you export packaged food to the U.S. The FDA does not exempt foreign manufacturers from inspection or enforcement. Without proper labeling, your products may experience delays, detentions, or outright refusal at the border.

Fortunately, you can stay ahead of these changes with the right regulatory support.

How to stay compliant with evolving FDA labeling standards

Food labeling compliance can be complex, especially with different requirements across countries. That’s why working with experienced professionals is essential.

At Quality Smart Solutions, we help Canadian, U.S., and international businesses navigate FDA food labeling regulations with confidence. Our services include:

  • FDA-compliant label review and formatting
  • Nutrition facts table development (U.S. and bilingual formats)
  • Ingredient and allergen verification
  • Claims compliance for nutrient content and health statements

Need help reviewing your product labels? Contact our team to get started. You can also explore our FDA food compliance solutions and let our experts guide you every step of the way.

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 a dietary ingredient and a New Dietary Ingredient (NDI)? 

A dietary ingredient is a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of these ingredients.

Furthermore, 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. 

Who needs to submit a notification?

You must submit a premarket notification if you are:

  • A manufacturer who intends to market a new dietary ingredient.
  • A manufacturer who intends to market a dietary supplement that contains a new dietary ingredient.
  • A distributor who intends to market a new dietary ingredient.
  • A distributor who intends to market a dietary supplement that contains a new dietary ingredient.

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. 

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 happens after you submit a premarket notification?

FDA will not disclose the existence of, or the information contained in, your new dietary ingredient notification for 90 days after the filing date. After the 90th day, the information in your notification will be available through FDA’s Dockets Management Staff (Dockets) and at regulations.gov, except for any information that is trade secret or confidential commercial information.

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 regulatory compliance consultants 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
Health Canada Natural Health Products (NHPs)

Class II NHP submissions: What Health Canada’s new workload rules mean for you

Health Canada Class II NHP workload management criteria and submission rules

Health Canada Class II NHP workload management criteria and submission rules

Starting June 9, 2025, Class II NHP submissions will no longer be reviewed just based on the date you filed them. Health Canada is updating how it handles licensing applications by applying a new workload management approach, prioritizing submissions based on intent to sell or manufacture in Canada.

If your product doesn’t meet these criteria, or you forget to submit the right form, your application might be delayed. In this blog, we explain what the new approach means, how it affects your licensing strategy, and what steps you need to take to stay on track.

What are Class II NHPs?

Class II natural health products (NHPs) fall in the middle of Health Canada’s risk-based classification system. These products usually include ingredients with strong evidence of safety and efficacy but require more documentation than Class I products.

Unlike Class I submissions, which rely only on pre-cleared information, Class II submissions may combine monograph and non-monograph ingredients. This means applicants need to provide additional data to support their claims, though review times are typically faster than for Class III submissions.

Why Health Canada is changing how it handles Class II NHPs

Until now, Class II NHP submissions were managed on a first-come, first-served basis. But with growing submission volumes and limited resources, Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) is shifting its review strategy.

From June 9 onward, only applications that show a clear intent to sell or manufacture in Canada within six months will be prioritized for review. This aligns with how Class III submissions are already being handled. For you, this means extra steps, but also more predictability if you follow them correctly.

What you need to do to stay compliant

To benefit from prioritized review, you’ll need to follow a few extra steps under Health Canada’s updated system. It’s no longer just about submitting your application and waiting your turn. Now, Health Canada is prioritizing submissions that show a clear plan to enter the Canadian market soon.

If you plan to sell or manufacture your product within six months of licensing, and you submit the correct form on time, you’ll move ahead in the queue. If not, your submission could be delayed. Here’s what you’ll need to do to stay on track:

  • Confirm that your product will be sold or manufactured in Canada within six months of licensing
  • Submit a Workload Management Form within seven days of receiving your acknowledgment letter from NNHPD
  • Provide accurate information, including your submission number, brand name, and authorized signing official

The form you choose will depend on whether the product is being sold or only manufactured in Canada. And yes, Health Canada will deprioritize your file if you skip this step or fill it out incorrectly.

Supporting your Class II NHP submissions

Navigating licensing is already a time-consuming process. With these new changes, staying compliant is about more than just submitting the right paperwork, it’s about knowing when and how to act.

At Quality Smart Solutions, we help guide you through every stage of the NHP licensing process. We prepare your product licence application, assist with your Workload Management Form, and make sure your submission is complete, accurate, and aligned with the new criteria.

We act as your regulatory partner, so you don’t have to worry about missed deadlines or deprioritized submissions.

Key tips for staying on track with Health Canada’s new process

Here’s what to keep in mind when submitting your Class II NHP application:

  1. Choose the right form:
    1. Form 1: Products Sold in Canada – For products intended for sale (and possibly manufacturing) or
    2. Form 2: Manufactured in Canada – For products only being manufactured, not sold
  2. Submit within 7 days: Once you receive your acknowledgment letter and submission number, you have 7 calendar days to submit your form
  3. Verify your info: Double-check your company name, brand name, file/submission number, and signing official
  4. Monitor your submission status: If your form isn’t submitted or is filled out incorrectly, your submission will be reviewed later, when resources allow
  5. Include accurate site info: You must comply with section 22 of the NHPR by providing valid site details before your product goes to market

For additional information, you can check the full bulletin directly from Health Canada.

Frequently asked questions

Will my Class II submission be delayed if I don’t submit the form?

Yes. Without the Workload Management Form, your application will be deprioritized and only reviewed when capacity allows.

It’s better to wait. You can withdraw and resubmit when your product is closer to entering the market.

Good news, applications submitted before this date don’t need a Workload Management Form and will be processed under the previous system.

You can use the ‘Products Sold in Canada’ form and include both sets of information in your submission.

Ready to get licensed? Let us help

Health Canada’s updated process for Class II NHP submissions puts more pressure on applicants to meet the right requirements within a narrow timeframe. But you don’t have to manage this alone.

Our experts at Quality Smart Solutions are here to guide you through it all, from forms to filings and final approvals. Get in touch with us today or learn more about our Natural Health Product licensing and consulting services. Let’s make your path to compliance easier.

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 FDA Compliance

FY 2025 OMUFA Fees Due June 2: What You Need to Know

FDA OMUFA FY 2025 fee deadline for OTC manufacturers

FDA OMUFA FY 2025 fee deadline for OTC manufacturers

The FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a manufacturer or contract manufacturer of over-the-counter (OTC) monograph drug products at any time in 2024, you’ll need to pay this annual fee.

The Over-the-Counter Monograph Drug User Fee Program (OMUFA) is modeled after the Prescription Drug User Fee Act (PDUFA). Under OMUFA, fees paid by industry help fund the FDA’s oversight of OTC monograph drugs. In return, the FDA commits to performance goals that include timelines for reviewing and updating OTC monograph activities.

OTC monograph drug facility fees for FY 2025 are due on Monday, June 2, 2025. If you miss the fee deadline, your facility could be placed on a public arrears list, and any OTC monograph drugs made there could be classified as misbranded.

Who this applies to and what’s required

The Over-the-Counter Monograph Drug User Fee Program (OMUFA) applies to manufacturers and contract manufacturers of OTC monograph drug products.

Under OMUFA, the FDA collects two types of user fees: facility fees and OTC Monograph Order Request (OMOR) fees. Facility fees are due annually, while OMOR fees are due at the time of submission. For FY 2025, the facility fee must be paid by Monday, June 2, 2025.

From fiscal years 2021 through 2025, facility fees are due on the later of either the first business day of June each year or the first business day after Congress passes an appropriations act allowing the FDA to collect OMUFA fees.

If your company qualifies, you have 20 calendar days from the official announcement (June 2, 2025) to pay. That puts your final deadline at June 22, 2025.

Missing this deadline means your company could appear on the FDA’s arrears list, your products could be labeled as misbranded, and your business may face regulatory or distribution delays.

How much is the FY 2025 FDA user fee?

The FDA has released the official FY 2025 OMUFA user fees: 

  • Monograph Drug Facility (MDF) Fee: $37,556 USD 
  • Contract Manufacturing Organization (CMO) Fee: $25,037 USD 

You can review the complete list, including OMOR Tier 1 and Tier 2 fees, on the FDA’s OMUFA user fee page. 

What to do before June 2

To avoid penalties and stay in good standing with the FDA, make sure to: 

  • Check your registration status: Was your facility registered with the FDA as an OTC drug manufacturer or contract manufacturer in 2024? 
  • Confirm your classification: Determine whether you’re subject to the MDF or CMO fee based on your facility’s role. 
  • Prepare and submit payment: Ensure the correct fee is paid before the June 22, 2025 deadline. 

Taking action now helps prevent misbranding issues, delays in product distribution, and placement on the FDA’s arrears list. 

Frequently asked questions

I received a fee notice, but I don’t think my facility should be charged an OMUFA facility fee for FY 2025. What should I do?

If you believe your facility is not an OTC monograph drug facility as described in this notice and should not be assessed an OMUFA FY 2025 facility fee, please contact CDERCollections@fda.hhs.gov.

No. All companies pay the same applicable fee (i.e., facility and/or OMOR), regardless of size.

No. It’s your responsibility to track your registration status and meet the payment deadline.

Your facility may be listed publicly in arrears, and your OTC products could be misbranded. This can delay sales and trigger compliance actions.

We can help you assess your situation. Reach out and we’ll review your registration and business model to confirm.

Don’t risk being out of compliance 

The OMUFA FY 2025 fee deadline is right around the corner. If you’re registered as a facility that makes or supports OTC monograph drugs, make sure to submit your payment by June 2, 2025. 

Need support? Connect with our regulatory experts today and let us help you stay compliant. 

Get Updates And Stay Connected -Subscribe To Our Newsletter
Subscribe Now
About us

Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

Know More
Twitter Facebook-f Youtube Linkedin Instagram
Compliance Solutions
Quick Links
Contact Us

Subscribe to global regulatory updates

We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.