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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 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 Australian Register of Therapeutic Goods (ARTG). 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 ARTG’s permitted list, you’ll need to submit a TGA new substance application. 

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 Practice (GMP) and 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: Failing to meet post-approval obligations can result in product recall or penalties. 

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. 

Categories
Blog Food Safety

How Bill 96 Impacts Bilingual Labelling in Canada

Bill 96 bilingual labelling requirements in QuebecThe introduction of Bill 96 in Quebec brings new challenges for businesses across Canada. As a result, this legislation emphasizes the importance of the French language and enforces stricter rules for bilingual labelling.

If your products reach the Quebec market, you must understand these regulations to maintain compliance and avoid penalties. Keep reading to learn how Bill 96 affects your business and what steps you can take to stay compliant.

What Is Bill 96? 

Bill 96, formally known as “An Act respecting French, the official and common language of Québec,” strengthens Quebec’s Charter of the French Language. In other words, the law aims to protect and promote French as the predominant language in the province. More specifically, one of its key areas of impact is on bilingual product labelling, which is now subject to stricter enforcement and additional requirements.

Key Changes to Bilingual Labelling 

1. Mandatory French Language Dominance

Under Bill 96, French must not be given lesser prominence than other languages on product labels and packaging. This means: 

  • French text must be displayed before any other language.
  • Font size for French text must be equal to or larger than the font size of other languages.

2. Changes to Trademarks

Bill 96 restricts the use of non-French trademarks on product packaging. Previously, businesses could use any recognized trademark in English or another language without a French translation. Now, only registered trademarks (or those with pending applications) can remain in English. If a trademark is unregistered, it must be translated into French. 

Additionally, if a registered trademark contains generic or descriptive terms, those words must appear in French somewhere on the packaging. 

3. Expanded Scope of Products

In addition to retail packaging, the regulation extends to include instruction manuals, warranty cards, and promotional inserts.

4. New Compliance Deadlines

Businesses must comply with the new regulations by June 1, 2025. Non-compliant products manufactured before this date have a two-year phase-out period, allowing them to remain on the market until June 1, 2027. Companies should ensure all labelling updates are completed on time to avoid non-compliance penalties.

Who Is Affected by Bill 96?

As a consequence of these changes, several groups must adhere to the new rules:

  • Businesses operating in Quebec: Companies distributing products in Quebec must adhere to the new rules, regardless of whether they are based inside or outside the province.
  • International manufacturers: Similarly, businesses exporting goods to Quebec must comply with these bilingual labelling regulations to sell products in the market.
  • Retailers: Any retailer distributing non-compliant products may face fines or be required to pull products off shelves. 

What Are the Risks of Non-Compliance?

Failing to comply with Bill 96 can result in serious consequences. For example:

  • Fines and penalties: Businesses can face significant financial consequences for violations.
  • Product recalls: Non-compliant items may need to be removed from Quebec markets, disrupting supply chains.
  • Reputational damage: Failure to adhere to regulations may harm your brand’s credibility in a sensitive consumer market. 

How to Ensure Compliance with Bill 96

To stay compliant, consider these proactive steps:

  1. Audit Your Labels: Review all product packaging to ensure French text is prominently displayed and meets font size requirements. 
  2. Update Marketing Materials: Likewise, ensure that any promotional materials, including digital content and brochures, comply with the new rules. 
  3. Engage with Compliance Experts: For a smoother process, partnering with regulatory professionals, like Quality Smart Solutions, can streamline the compliance process. Our team helps businesses navigate complex regulations and implement practical solutions. 
  4. Educate Your Team: Train your staff on the implications of Bill 96 to ensure company-wide adherence to the regulations. 

Why Partner with Quality Smart Solutions? 

Navigating the regulatory landscape can be overwhelming. That’s why at Quality Smart Solutions, we specialize in guiding businesses like yours through compliance challenges. Whether it’s bilingual labelling or broader regulatory strategies, we’re here to help. 

Don’t wait until it’s too late. Let us support your business in staying ahead of the curve. Contact us today for a consultation.

Categories
Blog Dietary Supplements FDA

5 Steps to Navigate FDA Compliance 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

What’s New in the EFSA QPS Update for Food Safety?

EFSA 2025 QPS Update - New Microorganisms for Food SafetyThe EFSA QPS update is here, and it brings important changes for businesses involved in food and feed safety. As the European Food Safety Authority (EFSA) continuously evaluates microorganisms intentionally added to food and feed, this new update reflects the most recent findings and safety considerations.  

Whether you’re a producer, importer, or distributor in the food and feed industries, staying informed about the QPS list changes is crucial for ensuring compliance and maintaining safety standards. Let’s dive into what this update means for your business and how it might affect your operations. 

What Is the Qualified Presumption of Safety (QPS)? 

The Qualified Presumption of Safety (QPS) is a process developed by EFSA to evaluate microorganisms intentionally added to food and feed. By identifying taxonomic units (TUs) that are generally considered safe, EFSA helps businesses streamline safety assessments, reducing the need for exhaustive individual evaluations. This list is updated regularly based on new research. 

Key Changes in the EFSA 2025 QPS Update 

The 2025 update introduces several important changes that could impact your business: 

  1. New Microorganisms Assessed for QPS Status

In the latest update, Lacticaseibacillus huelsenbergensis has been granted QPS status, owing to its close relation to other safe Lacticaseibacillus species. This is good news for businesses using Lacticaseibacillus strains in their products. 

  1. Exclusions and Safety Concerns

EFSA also identified microorganisms that pose safety risks. For example, Bacillus thuringiensis was excluded from the QPS list due to its potential to produce harmful toxins. Businesses working with Bacillus species should ensure that their products meet safety standards. 

  1. Verification of Previously Approved Microorganisms

The update also verifies the safety of microorganisms already on the QPS list. Most previously approved taxonomic units remain on the list, offering stability for businesses using these microorganisms. 

How This Affects Your Business 

Compliance and Safety Assurance 

For businesses in the food and feed sectors, the EFSA QPS update provides a clear framework for ensuring that your products are safe for consumers. By using microorganisms approved for QPS status, you meet regulatory requirements and ensure safety. 

Product Development 

If you’re involved in product development, the QPS list can guide ingredient selection. With Lacticaseibacillus huelsenbergensis now on the list, you may consider it for use in your products. 

Risk Management 

The update also helps you manage risks. For instance, the exclusion of Bacillus thuringiensis due to safety concerns means you need to avoid using strains that could compromise product safety. 

Next Steps for Your Business 

To stay compliant with EFSA’s regulations: 

  1. Review the QPS List: Check whether the microorganisms used in your products are on the latest QPS list. 
  2. Collaborate with Suppliers: Ensure your suppliers are aware of the new updates and use compliant ingredients. 
  3. Consult Experts: If you need clarification on the QPS status of specific microorganisms, reach out to regulatory experts for guidance. 

The EFSA 2025 QPS update is a vital development for ensuring food and feed safety across Europe. By staying informed about the changes and aligning your processes with the updated list, you can maintain compliance, mitigate risks, and foster innovation in your business. If you need to get expert advice, contact us at Quality Smart Solutions. For more information on the latest updates, read EFSA’s article. 

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News

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

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

FDA to Revoke Use of Red No. 3: What You Need to Know

FDA to revoke Red No. 3 authorizationThe FDA has just announced a significant decision: Red No. 3, a widely used synthetic dye in foods and ingested drugs, is being banned. This move has sparked attention across industries due to its potential impact on production and compliance requirements. If you’re wondering how this decision affects you and what steps you need to take, you’re in the right place. Let’s explore the details together so you can stay informed and prepared. 

In this article, we’ll break down the FDA’s ruling, explain what it means for businesses and consumers, and provide actionable guidance to ensure you remain compliant. 

Why Is the FDA Banning Red No. 3? 

Red No. 3 has been a common ingredient in many colorful foods and pharmaceutical products. However, scientific studies have linked the dye to potential carcinogenic risks in laboratory animals. Public health advocates have long campaigned for its removal, emphasizing the need for safer alternatives. 

The FDA’s decision to ban Red No. 3 highlights its commitment to consumer safety and aligns with international regulatory trends to eliminate harmful additives from products. 

What Does This Mean for Manufacturers? 

The FDA’s ban on Red No. 3 prohibits its use in food products, including candies, baked goods, and beverages, as well as ingested drugs, such as over-the-counter medications. To comply, manufacturers must: 

  1. Reformulate products using FDA-approved color additives. 
  2. Update product labels to reflect the absence of Red No. 3. 
  3. Revise compliance strategies to avoid regulatory issues. 

Steps to Ensure Compliance 

Here are some actionable steps businesses can take: 

  1. Audit product lines:

Identify all products containing Red No. 3 and prioritize reformulation for high-volume or fast-moving items. 

  1. Partner with suppliers:

Collaborate with ingredient suppliers to secure safe, FDA-approved alternatives. Maintain quality assurance protocols throughout the supply chain. 

  1. Update labels and packaging:

Ensure product labels comply with updated FDA regulations by removing Red No. 3 from ingredient lists. Highlight new formulations where applicable. 

  1. Monitor regulatory updates:

Stay informed on FDA guidelines and industry trends. Join relevant associations or subscribe to compliance-focused resources for real-time updates. 

Consumer Impact and Industry Trends 

Consumers are increasingly demanding transparency and safety in food and drug products. The FDA’s ban on Red No. 3 may accelerate the shift toward natural, plant-based colorants. Businesses that adapt quickly can position themselves as leaders in offering clean and safe products, earning trust and loyalty from health-conscious consumers. 

Need Support with FDA Compliance? 

Quality Smart Solutions offers expertise in navigating complex regulatory requirements. From product audits to reformulation strategies, our team ensures your operations meet FDA standards. 

Contact us today for tailored solutions to keep your business compliant and competitive. 

Staying informed and proactive is essential as the FDA enforces the ban on Red No. 3. Businesses that prioritize compliance and consumer safety can turn this regulatory change into a valuable opportunity. 

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News

What’s Behind the FDA’s New Front-of-Package Labeling Proposal?

FDA front-of-package nutrition labeling proposed rule.The FDA’s proposed front-of-package (FOP) nutrition labeling rule introduces significant changes to how nutritional information is displayed. It aims to make critical data like calories, added sugars, saturated fat, and sodium more visible and accessible, helping consumers make informed choices. 

For your business, this new nutrition labeling proposal is an opportunity to enhance transparency, build consumer trust, and showcase a commitment to public health. At the same time, it presents challenges that require preparation and strategic planning. 

Curious about how these changes might impact your operations or how they compare to Canada’s regulations? Read on to uncover the key takeaways and strategies for staying ahead. 

Key Takeaways from the FDA’s Proposed FOP Regulations 

The FDA’s nutrition labeling proposal marks a significant step toward improving transparency in food labeling and empowering consumers with better information. Here’s what you need to know: 

  • Uniform labeling standards: A consistent design will be required to improve readability and comparability across products. 
  • Nutritional focus: The rule prioritizes calories, added sugars, saturated fat, and sodium as key data points on packaging. 
  • Broad application: The changes will affect nearly all packaged foods and beverages sold in the U.S., with few exceptions. 

These measures align with the goals of the nutrition labeling proposal to address health concerns like obesity and chronic diseases by promoting informed dietary choices. 

How Does This Compare to Canada’s FOP Regulations? 

Canada’s front-of-package labeling regulations, introduced in 2022, offer a useful benchmark for understanding the FDA’s approach. Key comparisons include: 

  • Symbols vs. text: Canadian labels employ visual symbols to denote high nutrient levels, while the FDA’s proposal focuses on text-based presentation. 
  • Compliance timelines: Canadian businesses were given a set timeline for compliance, whereas the FDA’s timeline remains under consideration. 
  • Nutrient emphasis: Both systems target calories, sugars, fats, and sodium, but Canada’s rules place additional focus on the health implications of these nutrients. 

These distinctions are critical for businesses operating in both markets, as they may require tailored strategies to ensure compliance. 

Why This Matters for Your Business 

Adapting to these updates is essential for maintaining compliance and building trust with your consumers. Here’s why it’s important: 

  1. Consumer trust: Transparent labels increase consumer confidence and can boost brand loyalty. 
  2. Regulatory compliance: Meeting FDA requirements avoids the risks of fines, recalls, or other penalties. 
  3. Market leadership: Proactive adoption of FOP labels can set your brand apart as a forward-thinking industry leader. 

Steps to Prepare for FDA’s FOP Regulations 

Taking a proactive approach to the nutrition labeling proposal ensures your business remains compliant, competitive, and aligned with evolving consumer expectations. Consider these steps: 

  1. Evaluate existing labels: Conduct a thorough review of your current packaging to identify areas needing updates. 
  2. Engage with experts: Work with regulatory compliance specialists like Quality Smart Solutions for guidance and support. 
  3. Stay informed: Monitor FDA announcements for updates on implementation timelines and final rules. 
  4. Train your teams: Educate your internal teams to ensure alignment with the new requirements. 

Partner with Quality Smart Solutions 

At Quality Smart Solutions, we specialize in helping businesses navigate complex regulatory landscapes. Whether it’s label audits, compliance strategies, or market insights, we’re here to ensure your products meet the latest standards. Let us guide you through the FDA’s proposed front-of-package nutrition labeling updates. Contact us. 

Final Thoughts 

The FDA’s proposed front-of-package nutrition labeling rule is a significant step toward empowering consumers and enhancing transparency in food labeling. Comparing it to Canada’s established regulations highlights the growing global emphasis on informed choices.  

Preparing your business now ensures compliance, fosters consumer trust, and positions your brand as a leader in the evolving food industry landscape. Take action today to prepare for these changes and keep your business ahead of the curve! 

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Events Past

Arab Health 2025

Arab Health 2025 is one of the largest healthcare exhibitions globally, bringing together key players in the industry to showcase innovation, foster collaboration, and discuss advancements in healthcare.  

Quality Smart Solutions will be attending this year, offering expertise in regulatory compliance for a variety of industries. If you’d like to schedule a one-on-one meeting with our experts during the event, you can select a time that works best for you: 

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Events Past

VitaFoods India 2025

Vitafoods India 2025 is a premier event for the food, beverage, and dietary supplement industries, bringing together professionals, innovators, and experts to explore the latest trends, solutions, and opportunities in the market. 

GRAS Experts, a division of Quality Smart Solutions, will be attending, offering guidance on regulatory compliance for ingredients and finished products in key markets like Europe, the UK, and North America. 

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Blog

What Are Health Canada’s Rules for Probiotic Health Claims?

Navigating Health Canada’s rules for probiotic health claims can feel overwhelming, especially with the growing demand for these products. Businesses in the food and health product industries often struggle to understand the complexities of these regulations. However, ensuring compliance is essential for protecting your business and gaining consumer trust. 

Probiotics are widely marketed as solutions for digestive health, immune support, and overall wellness. While the demand for these products continues to grow, making unsubstantiated health claims can result in serious regulatory consequences. Health Canada has established clear guidelines to ensure all claims are backed by science. 

This article breaks down Health Canada’s rules for probiotic health claims, covering the key requirements and actionable tips to help your business stay compliant. Read on to learn how to navigate these regulations effectively. 

What Does Health Canada Require for Probiotic Health Claims? 

Health Canada has strict requirements for making health claims about probiotics or any microorganism. These claims must be based on robust scientific evidence demonstrating a clear and measurable benefit to human health. 

Key Points to Know: 

  1. Scientific evidence is mandatory: Any health claims, such as “supports digestion” or “boosts immunity,” must be backed by peer-reviewed research or equivalent data. This ensures that consumers are not misled about the product’s benefits. 
  2. Proper use of the term “probiotic”: Simply labeling a product as “probiotic” suggests it offers health benefits. According to Health Canada, this term should only be used when the specific strain’s health benefits are supported by scientific evidence. 
  3. Clear labelling standards: Probiotic products must provide precise details on the label, including the strain’s name (e.g., Lactobacillus rhamnosus) and the quantity present in the product. This transparency helps consumers make informed decisions. 

How to Ensure Your Probiotic Product Is Compliant 

Navigating Health Canada’s requirements can be complex, but following these steps can streamline the process: 

  1. Invest in scientific research: Conduct or reference studies that validate your product’s health benefits. Collaborating with accredited research institutions can ensure your data meets regulatory standards. 
  2. Label products transparently: Use precise language to describe the strain, quantity, and specific health benefits of the probiotic. Avoid vague claims that could mislead consumers. 
  3. Consult regulatory experts: Partnering with regulatory compliance professionals can help you navigate Health Canada’s guidelines effectively and avoid costly mistakes. 
  4. Stay updated on regulations: Regulatory standards evolve. Regularly check Health Canada’s website or subscribe to updates to remain informed about changes that could affect your products. 
  5. Licence your product: Probiotic products are generally classified as Natural Health Products (NHPs) in Canada. This means you’ll need to licence your product and obtain a Natural Product Number (NPN) before selling.

Why Compliance Matters 

Non-compliance with Health Canada’s rules for probiotic health claims can lead to serious consequences, including product recalls, fines, and damage to your brand’s reputation. By adhering to these guidelines, you not only avoid penalties but also build consumer trust and maintain your competitive edge. 

For a detailed overview of permitted health claims and how they apply, visit Health Canada’s table of live microorganism health claims. 

Need Help Navigating Probiotic Health Claims? 

At Quality Smart Solutions, we specialize in helping businesses achieve compliance with regulatory requirements. Whether you’re launching a new product or updating your labeling, our experts are here to guide you every step of the way. 

Contact us today to ensure your probiotic health claims align with Health Canada’s standards. 

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News

Canada Simplifies Pet Food Imports from the US

Simplified pet food import process for 2025Starting January 21, 2025, importing pet food products from the United States to Canada will become easier. Health Canada has announced significant updates to the documentation requirements for shipments of pet food, treats, and supplements. These changes aim to streamline processes and make compliance simpler for businesses. 

Here, we’ll break down everything you need to know about these new rules, including deadlines, required documents, and actionable steps to stay compliant. 

Key Changes to Pet Food Import Documentation 

The updated regulations eliminate the need for the Importer’s Statement of Compliance. Instead, each shipment must now include: 

A commercial invoice: This document should list all products and quantities in the shipment and must clearly reference the USDA zoosanitary export certificate number. 

A zoosanitary export certificate: Issued by the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Services (APHIS), this certificate verifies compliance with health and safety standards. 

These documents ensure transparency and facilitate smooth customs inspections. 

Transition Period: Key Dates to Remember 

Health Canada has implemented a three-month transition period from January 21 to April 21, 2025, to help businesses adjust to the new rules. During this period: 

Shipments can still include the Importer’s Statement of Compliance. 

By April 21, 2025, all commercial invoices must reference the USDA zoosanitary export certificate number. 

After the transition period, failure to comply may result in shipment delays or penalties. Act now to ensure a seamless transition. 

Why These Changes Are Important 

The removal of the Importer’s Statement of Compliance is designed to: 

Simplify documentation: Reduce administrative tasks and streamline shipping processes. 

Improve traceability: Enhance the ability to track pet food products across borders. 

Align with international standards: Support consistent regulatory practices for cross-border trade. 

These updates save time and improve efficiency for businesses importing pet food products into Canada. 

Steps to Ensure Compliance 

Follow these steps to meet the updated requirements: 

Update your processes: Ensure your commercial invoices include product details and the USDA certificate number. 

Work with your suppliers: Verify that your US-based suppliers can provide the required zoosanitary export certificate. 

Educate your team: Train staff on the new requirements to avoid errors and delays. 

Stay informed: For questions or clarifications, contact Health Canada’s import team for animal products and by-products at APABPImport@inspection.gc.ca. 

FAQs About the New Requirements 

What happens if I don’t comply with the new documentation rules? 
Non-compliance may lead to shipment delays, fines, or rejection at the border. Ensure you have the required documents for all shipments. 

Can I still use the Importer’s Statement of Compliance during the transition period?Yes, but only until April 21, 2025. After this date, it will no longer be accepted. 

How do I obtain a USDA zoosanitary export certificate? 
Coordinate with your suppliers in the United States. They can secure this certificate from USDA APHIS. 

How Quality Smart Solutions Can Help 

Navigating regulatory updates can be challenging, but Quality Smart Solutions is here to assist. Our team of experts specializes in compliance and import regulations, ensuring your shipments meet all Canadian requirements. 

Contact us today to learn how we can simplify your pet food import process and keep your business running smoothly. Stay compliant and confident as you adapt to these changes. Make 2025 your most efficient year yet for pet food imports. 

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News

Understanding the FDA’s Updated “Healthy” Nutrient Content Claim

FDA Healthy Label Updates and ComplianceThe FDA has finalized its updated definition for the “Healthy” nutrient content claim, aiming to promote better transparency in food labeling and encourage healthier eating habits. This move is part of a broader initiative to improve public health by helping consumers make informed decisions. 

If you’re a food manufacturer, distributor, or compliance expert, you need to stay ahead of these changes. Keep reading to understand what’s new and how it might affect your labeling practices. 

Why the FDA’s Definition Matters 

The FDA’s updated “Healthy” claim sets stricter criteria for food products that want to use this label. These criteria align with current nutritional science and dietary guidelines. Foods must now contain a meaningful amount of at least one of the food groups recommended by the Dietary Guidelines, such as fruits, vegetables, or whole grains. At the same time, limits on saturated fat, sodium, and added sugars must be met. 

This update impacts manufacturers aiming to market their products as “healthy.” Non-compliance could lead to penalties or even product recalls, making it crucial to adapt your labeling strategy now. 

Key Changes to the “Healthy” Label Requirements 

Here are the primary changes you need to know: 

  • Nutritional Standards: Products must meet specific criteria for beneficial nutrients and limits on unhealthy components. 
  • Food Categories: The claim applies only to certain categories like fruits, vegetables, whole grains, and lean proteins. Processed foods face stricter scrutiny. 
  • Added Sugars: A significant focus is on reducing added sugar levels in products labeled as “healthy.” 

These updates not only redefine what qualifies as “healthy” but also challenge brands to innovate healthier recipes that meet these stricter guidelines. 

How the New Definition Affects Your Compliance Strategy 

For businesses, these updates mean reevaluating your product line to ensure compliance. Here’s how to get started: 

1. Review Your Product Portfolio 

Audit your products to identify those that currently use or plan to use the “Healthy” claim. Analyze their nutrient composition against the FDA’s updated standards. 

2. Reformulate Recipes 

If necessary, consider reformulating products to meet the criteria. This could involve reducing sodium, saturated fats, or added sugars and adding more whole grains or other beneficial nutrients. 

3. Update Labeling Processes 

Work closely with your compliance team to ensure your labeling practices align with the FDA’s new requirements. Incorrect labeling can lead to significant financial and reputational risks. 

4. Educate Your Team 

Ensure your marketing and regulatory teams understand the changes to avoid inadvertent non-compliance. Providing training on the new standards can mitigate future risks. 

Benefits of Adapting to the New Guidelines 

While the updates may pose initial challenges, they also present significant opportunities: 

  • Building Consumer Trust: Accurate and transparent labeling strengthens your brand’s reputation. 
  • Gaining a Competitive Edge: Products meeting these new standards could stand out as healthier choices, attracting more health-conscious consumers. 
  • Contributing to Public Health: Aligning with the FDA’s goals helps promote better eating habits nationwide. 

Supporting Your Compliance Efforts 

Staying informed and proactive is essential. The FDA provides detailed resources and updates to guide businesses through these changes. Read the FDA’s official announcement here. For tailored compliance support, contact us at Quality Smart Solutions and book a free consultation today. Our team of experts can help you navigate these updates with ease. 

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News

FDA Sets 2028 Compliance Date for Food Labels

FDA food labeling compliance 2028

The U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes January 1, 2028, as the deadline for compliance with all final labeling rules published between January 1, 2025, and December 31, 2026. 

By providing a consistent timeline, the FDA aims to reduce the economic and operational burden on food manufacturers and distributors, allowing them to adapt to changes in a more orderly fashion. 

This decision highlights the FDA’s ongoing commitment to fostering transparency and consistency in the food labeling process. Understanding how this compliance date impacts your business is essential for staying ahead in an evolving regulatory landscape. 

In this article, we will look at the FDA’s recent update and give you and your business clear steps to prepare effectively. Keep reading to learn more.

What Is the Uniform Compliance Date? 

The FDA’s uniform compliance date ensures that all new food labeling regulations published within a specific timeframe adhere to a single implementation deadline. By setting January 1, 2028, as the compliance date, the FDA allows food manufacturers and distributors to: 

  • Plan labeling updates systematically 
  • Minimize economic disruptions from staggered regulatory deadlines 
  • Optimize existing label inventories before transitioning to new requirements 

The FDA also encourages businesses to adopt new labeling standards as early as possible to maintain compliance and consumer trust. 

Why Does This Matter? 

Uniform compliance dates provide significant benefits to the food industry, including: 

1. Simplified planning 

Rather than juggling multiple compliance deadlines, your team can focus on preparing for a single date. This simplifies project timelines, reduces stress, and ensures smoother transitions. 

2. Cost savings

Updating labels is a costly endeavor. By consolidating compliance dates, you can maximize your use of existing label stock, reduce waste, and manage costs effectively. 

3. Regulatory clarity 

Having a uniform deadline avoids confusion and ensures everyone in the industry operates on the same timeline. This promotes consistency and fairness across the board. 

Key Details of the FDA’s Update 

  • Timeframe: The compliance date applies to labeling regulations published between January 1, 2025, and December 31, 2026. 
  • Exceptions: Some regulations may have specific compliance dates if justified by unique circumstances. Always check final rule publications for details. 
  • Implementation: All food products introduced into interstate commerce on or after January 1, 2028, must comply with the applicable labeling regulations. 

For more information, visit the FDA’s official update. 

How to Prepare for the 2028 Compliance Date 

Evaluate current labels: Conduct an audit of your existing labels to identify areas that may require updates to align with forthcoming regulations. 

Stay informed: Subscribe to regulatory updates from the FDA and consult trusted partners, like Quality Smart Solutions, for expert guidance. 

Plan ahead: Begin developing a strategy to update your labels well before the 2028 deadline. This gives you ample time to address design, production, and inventory challenges. 

Partner with experts: Navigating compliance can be complex. At Quality Smart Solutions, we provide tailored advice and support to help you meet FDA requirements with ease. Contact us today to learn more. 

The FDA’s uniform compliance date for food labeling regulations offers a streamlined approach to regulatory adherence. By understanding the requirements and preparing early, you can avoid disruptions and stay ahead in the industry. Need help navigating FDA compliance? Reach out to Quality Smart Solutions for expert advice. 

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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. 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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