Categories
GRAS News

Senators Propose Bill To Eliminate Self-affirmed GRAS

New bill proposes changes to self-affirmed GRAS safety rule

A new bill introduced in the U.S. Senate could significantly alter how food ingredient safety is assessed, especially when it comes to self-affirmed GRAS determinations. The proposed changes aim to address long-standing concerns about transparency and potential risks associated with allowing companies to determine the safety of ingredients without regulatory oversight. 

On July 17, 2025, Senators Edward Markey and Cory Booker introduced the Ensuring Safe and Toxic-Free Foods Act, a legislative proposal targeting the FDA’s current Generally Recognized as Safe (GRAS) rule.  

If passed, this bill would eliminate self-affirmed GRAS decisions, closing what lawmakers call a major loophole that allows companies to bypass FDA review for certain food additives. Read on to learn what this means for food manufacturers and importers. 

What is self-affirmed GRAS? 

Under current FDA guidelines, ingredients can be deemed GRAS either through FDA review or by a company-led evaluation, commonly referred to as self-affirmed GRAS. This allows businesses to conduct their own safety assessments without submitting the ingredient for FDA approval, as long as the ingredient is considered safe by qualified experts and used under intended conditions. 

Critics argue this practice lacks transparency and can lead to conflicts of interest. According to Senator Markey, “Americans deserve to know the food on their kitchen tables is safe.” 

What would the new bill change? 

The proposed legislation would: 

  • Prohibit self-affirmed GRAS determinations 
  • Require all GRAS submissions to be reviewed and approved by the FDA 
  • Prevent ingredients linked to cancer or reproductive harm from being classified as GRAS 
  • Increase public access to ingredient safety data 

To understand how the FDA currently defines and handles self-affirmed GRAS, visit the FDA’s official GRAS guidance page. 

Why this matters to your business 

If you’re a food manufacturer, distributor, or importer relying on self-affirmed GRAS determinations, this bill may significantly impact your product development and time-to-market. Without the option for self-affirmation, all GRAS ingredients would require formal FDA review, increasing both regulatory burden and approval timelines. 

This shift also means more robust documentation, third-party safety assessments, and proactive compliance strategies will be necessary to avoid costly delays or enforcement. 

How to prepare for the potential changes 

While the bill has not yet passed, businesses can prepare by: 

  1. Reviewing current GRAS ingredient lists to assess which were self-affirmed. 
  2. Gathering robust safety data that aligns with FDA review standards. 
  3. Partnering with regulatory experts who can help navigate potential FDA submissions. 

At Quality Smart Solutions, we help companies stay ahead of regulatory shifts by providing strategic guidance and technical expertise in food compliance, GRAS evaluations, and ingredient approvals. 

FAQ: Self-affirmed GRAS rule changes

Will self-affirmed GRAS still be allowed in 2025?

Yes, for now. The bill has only been introduced and would need to pass both the Senate and the House before becoming law. Even then, the FDA would require time to develop and implement updated regulations. Until that process is complete, self-affirmed GRAS remains in effect. 

No, it is currently voluntary. However, the proposed changes would make FDA review compulsory. 

By proactively preparing a full GRAS dossier and submitting for FDA review. Partnering with compliance experts like Quality Smart Solutions can simplify the process and reduce risk. 

Final thoughts 

The future of self-affirmed GRAS may be changing. This proposed legislation represents a major shift in food ingredient safety regulation. If passed, companies will need to adapt quickly to maintain compliance and avoid setbacks in product approvals. 

Need help preparing? Contact us today or explore our GRAS compliance services to stay ahead of the curve. 

Categories
FDA News

FDA Approves Gardenia Blue as Red No. 3 Faces Phase-Out

FDA approval of gardenia (genipin) blue color additive and phase-out of FD&C Red No. 3

The U.S. Food and Drug Administration (FDA) has approved gardenia blue, a plant-derived color additive, for limited use in certain foods. At the same time, the agency is encouraging a faster transition away from synthetic FD&C Red No. 3 due to growing safety concerns. 

These developments reflect the FDA’s evolving approach to color additive safety. They may also affect ingredient choices and labelling practices across the food, dietary supplement, and confectionery industries.

So, if your products use synthetic dyes or color additives, this shift could impact your sourcing, formulation, and compliance strategies. Keep reading to learn what’s changing, and how your business can stay ahead. 

What did the FDA approve and why does it matter? 

The FDA recently approved gardenia blue, derived from genipin extracted from Gardenia jasminoides, for use as a color additive in certain foods. The approval comes after a color additive petition submitted by a global ingredient manufacturer. This petition included safety data, identity specifications, and manufacturing information.

Therefore, the green light for gardenia blue provides manufacturers with a new plant-based alternative at a time when public concern over synthetic dyes continues to grow. Additionally, the FDA has also reiterated its intention to accelerate the phase-out of FD&C Red No. 3 due to potential health concerns. 

What is gardenia blue (genipin) and how is it used? 

Gardenia blue is produced through the reaction of genipin, a naturally occurring compound found in gardenia fruit, with amino acids. As a result, it forms a blue pigment that is stable under heat and light, making it suitable for various applications such as: 

  • Candies and chewing gum 
  • Bakery decorations and coatings 
  • Ice cream and frozen desserts 

That said, manufacturers must ensure that gardenia blue meets all identity and purity specifications as outlined by the FDA before using it in food products. 

Why is FD&C Red No. 3 being phased out? 

FD&C Red No. 3, also known as erythrosine, has long been a subject of safety reviews. In 1990, the FDA banned its use in cosmetics and externally applied drugs, citing evidence of thyroid tumors in animal studies. However, it remained approved for use in foods and oral medications. 

Now, with mounting pressure from advocacy groups and evolving consumer preferences for natural ingredients, the FDA is encouraging manufacturers to move away from Red No. 3 in food and supplement products. While the agency has not yet banned it outright, the signal is clear: its use will likely become more limited in the near future. 

How does this impact food and supplement companies? 

This dual announcement by the FDA represents both a challenge and an opportunity: 

  • Ingredient reformulation: If your product currently includes Red No. 3, you may need to begin sourcing and testing alternative colorants such as gardenia blue or other FDA-approved natural options. 
  • Labelling updates: Switching to new color additives may require updates to ingredient labels, technical documentation, and marketing materials. 
  • Regulatory documentation: You’ll need to ensure your formulations and labels remain compliant with current FDA regulations. 

Consequently, companies in the natural health product space should also review any dietary supplements that use synthetic dyes. The demand for clean-label alternatives continues to rise, and staying ahead of these changes can give your brand a competitive edge. 

What should you do now? 

To stay compliant and minimize disruption, we recommend that you: 

  1. Audit your product formulations for the presence of Red No. 3. 
  2. Evaluate alternative ingredients, such as gardenia blue, and assess compatibility with your product matrices. 
  3. Update your regulatory documentation and labelling in line with new FDA approvals. 

You can read the full FDA announcement here. 

FAQs About Gardenia Blue and Red No. 3 Compliance

Is FD&C Red No. 3 now banned in foods

No. While the FDA encourages a faster phase-out, it has not officially banned Red No. 3 in food products at this time. However, manufacturers should begin exploring alternatives now to stay ahead.

Not yet. Currently, gardenia blue is approved only for limited use in specific foods like candy and baked coatings. Therefore, you must follow FDA guidelines for permitted uses.

Yes. Since gardenia blue is derived from plant sources, it is considered a naturally sourced color additive. As a result, it aligns well with clean-label trends.

To make the transition easier, our regulatory experts at Quality Smart Solutions can help you evaluate your current formulations and ensure your compliance documentation is up to date.

Stay compliant with FDA color additive regulations 

As FDA regulations continue to evolve, having a proactive strategy is more important than ever. That’s why, whether you’re reformulating due to Red No. 3 or exploring gardenia blue, our team can support your compliance, documentation, and labelling needs.

Contact us today or explore our food compliance solutions and ingredient compliance services to get tailored support for your product portfolio. 

Categories
FDA News

How the SAFE Sunscreen Act Could Change FDA Compliance

FDA compliance for OTC sunscreen ingredients under SAFE Sunscreen Standards Act

Sunscreen compliance in the U.S. may be on the edge of its most significant update in over two decades. On June 3, 2025, lawmakers introduced the SAFE Sunscreen Standards Act (H.R.3686), a bipartisan bill that aims to modernize how the FDA reviews and approves sunscreen active ingredients. 

This matters because no new sunscreen ingredients have been approved by the FDA since 1999. If you manufacture, import, or label sunscreen products, this could shift how quickly and effectively your products enter the U.S. market. Keep reading to find out what this means for your business and how you can prepare. 

What is the SAFE Sunscreen Standards Act? 

The SAFE Sunscreen Standards Act, short for Supporting Accessible, Flexible, and Effective Sunscreen Standards, was introduced in the House of Representatives by Representatives Dr. John Joyce, Debbie Dingell, Dave Joyce, and Deborah Ross. The bill proposes amendments to the Federal Food, Drug, and Cosmetic Act to improve how sunscreen active ingredients are reviewed and approved. 

This legislation was introduced in response to mounting concerns that current FDA regulations are outdated and restrictive. Because sunscreens are classified as over-the-counter (OTC) drugs in the U.S., any new UV filter must undergo a lengthy New Drug Application (NDA) process, which often takes years. Consequently, this has prevented innovative and globally recognized ingredients from entering the market. 

As a result, many promising ingredients remain stuck in regulatory limbo, while some ingredients currently in use have not been fully assessed for safety. The bill aims to fix this by creating a faster, more transparent review process that still prioritizes public health and safety. 

Key provisions of the SAFE Sunscreen Standards Act 

The U.S. currently allows only 16 active sunscreen ingredients, while regions like the EU permit more than 30. Many globally accepted ingredients remain stuck in FDA limbo, leaving companies with limited options and longer timelines. So, here’s what the bill proposes: 

  • A streamlined pathway for reviewing and approving sunscreen active ingredients. 
  • An emphasis on non-animal testing methods, supporting alternative evidence models. 
  • A requirement for the FDA to deliver a formal report to Congress on its progress implementing new testing standards. 

If passed, this legislation would remove long-standing regulatory bottlenecks and improve sunscreen ingredient compliance in the U.S. market. 

Why this matters for sunscreen compliance 

For businesses looking to enter or expand in the U.S. OTC market, sunscreen compliance is a critical barrier. Products containing active ingredients not currently approved by the FDA are classified as unapproved new drugs, making them subject to warning letters, import refusals, or recalls. 

With that in mind, the new bill could bring several important changes. It may lead to faster ingredient approvals, particularly for companies using internationally recognized sunscreen actives.  

Additionally, if the FDA begins accepting more alternative testing methods, businesses could benefit from reduced costs and quicker product registration timelines.  

The requirement for a formal Congressional report may also encourage greater transparency and predictability in the approval process, supporting more confident planning for product launches. 

What sunscreen brands and manufacturers should do next 

Although the SAFE Sunscreen Standards Act is not yet law, it’s a strong signal that regulatory change is on the horizon. Therefore, companies operating in the OTC space should start evaluating how these changes could impact their portfolio. Some actions you can take now include: 

  • Reviewing your current ingredients and formulations for FDA alignment. 
  • Assessing your product claims and labels to ensure full FDA and OTC drug monograph compliance. 
  • Consulting regulatory experts to help you navigate pre-market pathways if your ingredients are not currently monograph-listed. Our team at QSS can guide you through these steps and keep you updated as the legislation progresses. 

FAQ: SAFE Sunscreen Standards Act

Is the SAFE Sunscreen Standards Act in effect now?

No. As of July 2025, the bill has only been introduced and is not yet law. 

Not immediately. However, if passed, it may affect how new ingredients are added or approved moving forward.

Yes. If enacted, it could allow for more flexibility and faster approvals for products that already meet standards in other regions.

No immediate action is required, but it’s smart to start evaluating your product pipeline and testing strategies now, especially if you plan to introduce non-monograph ingredients in the near future.

Stay compliant and ahead of regulatory change 

At Quality Smart Solutions, we specialize in helping OTC and cosmetic companies navigate FDA compliance, labelling regulations, and ingredient approvals. Whether you’re planning to launch a new sunscreen product or reformulate to meet new standards, our regulatory experts can help. 

Visit our Contact Us page to schedule a free consultation and learn how we can support your compliance journey.  

You can also explore our OTC Drug Compliance services to learn more about how we help businesses like yours meet FDA requirements and streamline your regulatory process. 

Categories
Blog Natural Health Products (NHPs)

Are you meeting Health Canada’s site license renewal requirements?

Health Canada bulletin on NHP site license renewal

Over the past few weeks, many natural health product (NHP) companies have been caught off guard by an increase in site license suspensions or renewal refusals. Health Canada is reinforcing its compliance expectations and taking action where gaps are found. If your site license renewal is coming up, this is the time to double-check your processes. 

A single oversight, such as missing documentation or insufficient GMP evidence, can trigger delays or a full suspension. To avoid costly disruptions, it is imperative that you take a proactive approach to meeting Health Canada’s expectations. Keep reading to learn what you need to know, and how to stay ahead. 

What is Health Canada expecting during your NHP site license renewal 

Health Canada is paying closer attention to how you handle compliance. This includes how thoroughly you investigate non-conformances, whether your QAP has documented GMP experience, how you manage deviations before releasing products, and how effective your CAPA (Corrective and Preventive Action) process is, and whether you have a functioning recall program in place. 

A weak or incomplete CAPA, such as one missing a retrospective review of affected batches, can lead to refusal or suspension. Health Canada now expects companies to proactively identify root causes, implement targeted solutions, and document each step taken to prevent future recurrence. They’ve outlined these expectations in a bulletin on how to develop a CAPA, which every company should review. 

Common reasons for license refusal or suspension 

If your site license was refused or suspended, here are some likely reasons: 

  • CAPAs submitted were incomplete or didn’t include adequate root cause analysis 
  • No documented GMP training or experience for your QAP 
  • Inadequate investigation into deviations or product release failures 
  • Failure to update procedures in line with the most recent Health Canada guidance 

These are some common red flags that your site may not meet GMP standards. 

How to prepare for your next renewal 

Start by reviewing the latest Health Canada bulletins. Next, make sure your QAP’s GMP experience is clearly documented. Finally, conduct a thorough internal audit and revise your SOPs accordingly so they align with the most recent guidance and expectations. 

If you’re unsure about your readiness or need help interpreting regulatory requirements, it’s time to seek professional support. 

Frequently asked questions

Can my license be suspended even if I’ve submitted a renewal?

Yes. A submitted renewal doesn’t mean your license is safe. If Health Canada finds gaps in documentation, GMP practices, or unresolved inspection issues, they can suspend or refuse your license. 

Mistakes happen, but Health Canada expects you to act fast and responsibly. If a product was released out of specification, you are expected to conduct a full retrospective analysis and implement appropriate CAPAs. Ignoring the issue or submitting incomplete documentation increases your risk of non-renewal. 

The good news is that transparent, proactive responses with expert guidance can improve your chances of a successful renewal. 

Absolutely. One of the most common reasons for license refusal is appointing a QAP without documented GMP experience. Your QAP must be able to demonstrate relevant knowledge and training that align with Health Canada’s expectations. 

If your Corrective and Preventive Action plan doesn’t fully address the issue. For example, if you miss a retrospective review, Health Canada may consider your response inadequate. Depending on the severity of the issue, your renewal will experience either delays, or even a complete rejection and suspension, leading to a loss of market access and sales.

SOPs should be reviewed and updated regularly to reflect the latest regulatory requirements. A best practice is to review them annually or immediately following any major inspection findings, regulatory updates, or operational changes. 

Yes, but it takes time and effort. You’ll need to submit a strong remediation plan, demonstrate corrective actions, and possibly undergo re-inspection. Working with an expert can significantly improve your chances of regaining your license. 

Why work with a compliance expert 

A regulatory consultant can guide you through every stage of the renewal process. From reviewing documentation and identifying compliance gaps to training your QAP on GMP expectations, the right support makes all the difference. 

At Quality Smart Solutions, we’ve supported hundreds of successful NHP site license renewals. Our team can help you navigate the process and avoid costly mistakes. 

Don’t wait until it’s too late 

The increase in Health Canada enforcement actions shows how critical proper site license renewal preparation is. Whether your renewal is due soon or you’ve recently faced challenges, it’s time to act. 

Contact us today to speak with our regulatory experts. We’ll help you stay compliant, protect your business, and ensure your NHP operations run smoothly. 

Looking for more guidance? Visit our NHP site license page to learn how we can help. 

Categories
Food and nutrition compliance News

Health Canada issues interim report on sodium targets for processed food

Health Canada’s interim report on sodium targets for processed food

Did you know? Sodium reduction in processed foods is no longer optional. It is a critical step for industry players to safeguard consumer health and meet Health Canada’s 2025 targets. Too much sodium raises blood pressure and increases the risk of heart disease and stroke, which are among the leading causes of death in Canada. 

In December 2020, Health Canada introduced voluntary sales-weighted average (SWA) sodium targets for nine processed food categories and continues to measure progress through interim assessments. The latest report sampled 1,283 products between October 2023 and July 2024, revealing that while some categories have made headway, overall progress remains modest. 

Keep reading to learn more about how your business can align with Health Canada’s targets and improve compliance outcomes. 

Why sodium reduction matters 

High sodium intake contributes to hypertension, affecting roughly one in four Canadian adults and elevating the risk of cardiovascular disease and stroke. Because over 75% of dietary sodium comes from processed and prepared foods, reformulation is key to lowering population-level intake and reducing healthcare costs. By meeting SWA targets, you not only support public health but also demonstrate leadership in responsible manufacturing. 

Interim results at a glance 

The interim assessment shows varied progress across categories. Hearth breads led the way, reaching about 40% of the reduction needed to meet the 2025 SWA target. In contrast, pizza crusts and tomato sauces recorded increases in sodium levels since the 2017 baseline. Below is a summary of progress by category: 

Food category 

Progress toward 2025 target (%) 

Hearth bread 

40.3 

White bread 

18.5 

Bread with savoury additions 

15.3 

Processed cheese products 

15.3 

Ready-to-serve soups 

6.2 

Whole wheat and mixed grain bread 

-7.6 

Ready-to-eat cereals 

-19.2 

Tomato sauce 

-26.4 

Pizza crust 

-57.6 

Common challenges for the industry 

Manufacturers often face multiple hurdles when reducing sodium. Salt contributes to flavour, texture, and shelf life, and reducing it by more than 15 to 20% at once can affect product quality and consumer acceptance. Lower sodium levels also require adjustments in processing to maintain microbial safety, leading some businesses to delay or slow reformulation efforts. 

Practical steps to meet targets 

If your product portfolio still exceeds the SWA or maximum level targets, consider these actions: 

  1. Audit your sodium levels. Compare each SKU’s sodium content per 100 g against the 2025 SWA and maximum level targets. 
  2. Prioritize high-volume SKUs. Focus reformulation efforts on best-selling items to maximize impact on overall averages. 
  3. Implement gradual reductions. Aim for incremental decreases of 5 to 10% at a time to maintain taste and safety while allowing consumers to adapt. 
  4. Communicate transparently. Highlight sodium reductions on packaging and in marketing materials and explain the health benefits to consumers. 
  5. Leverage expert support. Partner with regulatory compliance specialists who can guide formulation changes, testing protocols, and labelling requirements. 

By following these steps, you position your products to meet Health Canada’s endpoints and gain a competitive edge. 

Frequently asked questions

What if my products still exceed the 2025 targets?

Failing to meet voluntary targets will not trigger immediate penalties. However, slow progress may invite increased scrutiny under the Healthy Eating Strategy and erode consumer trust. Acting now minimizes risk if targets become mandatory in the future. 

No, current targets remain voluntary. Yet Health Canada’s ongoing monitoring signals a potential move toward enforcement. Companies that adapt early will face fewer surprises. 

You can review the complete interim assessment, including detailed tables and methodology, by visiting the Health Canada’s website. 

Conclusion 

Although the industry has made some strides in sodium reduction, the interim results show much work remains to meet the 2025 SWA targets. By auditing your products, prioritizing popular SKUs, and adopting gradual reformulation, you can achieve compliance and strengthen your brand’s reputation for health-focused innovation. 

Contact us to connect with Quality Smart Solutions’ regulatory compliance experts and design a sodium reduction roadmap that aligns with Health Canada’s guidelines. 

Categories
Food Safety News

Why is CFIA Updating its Feed Regulations?

CFIA feed regulatory modernization updates for Canadian businesses

The Canadian Food Inspection Agency (CFIA) is in the process of modernizing its feed regulations to better protect animal health, food safety, and the environment. If you’re a feed manufacturer, importer, or distributor, the CFIA feed regulatory modernization will impact your operations and compliance requirements directly. 

The new framework focuses on risk-based oversight, clarity, and adaptability. But navigating these changes can feel overwhelming without clear guidance. In this post, you’ll learn what’s changing, why it matters to your business, and how you can stay ahead of compliance issues.  

Keep reading to prepare your team and avoid costly delays or enforcement actions. 

Why is CFIA updating its feed regulations? 

Canada’s feed regulations haven’t seen a major overhaul since 1983. As the global feed industry evolves and new risks emerge, the outdated regulations are no longer aligned with current science, trade needs, and safety standards. 

The CFIA feed regulatory modernization aims to: 

  • Strengthen food safety and animal health 
  • Reduce regulatory burden through clearer requirements 
  • Support innovation and international trade 

This update is also part of CFIA’s broader initiative to modernize all its regulatory frameworks under the Safe Food for Canadians Act. 

Key changes under CFIA feed regulatory modernization 

Understanding what’s changing is essential for staying compliant. Here are some of the most significant updates: 

1. Licensing requirements 

Licensing will now be mandatory for all commercial feed businesses involved in manufacturing, exporting, importing, and distributing feed products. This applies even if you’re only dealing with a single feed ingredient. 

2. Hazard identification and preventive controls 

Businesses must implement written Preventive Control Plans (PCPs) that outline how they identify and mitigate hazards during feed production and handling. These plans should be risk-based and tailored to your operation. 

3. Product labelling and composition 

The new regulations clarify labelling requirements for both single-ingredient feeds and mixed feeds. Clear, consistent labels ensure that end-users understand what’s in the feed, reducing safety risks and improving traceability. 

4. Ingredient authorization process 

The list of approved feed ingredients is being restructured. Each ingredient must meet a specific standard before it can be included in the Feeds Ingredient Table. Businesses submitting new ingredients must provide data to support safety and efficacy. 

Learn more about the modernization initiative on the CFIA’s official page. 

What does this mean for your business? 

If you’re not proactive, these changes could disrupt your feed supply chain. Without the required licence or a compliant PCP, you may face shipment holds, import rejections, or penalties. 

But the good news is: you still have time to adapt. By starting now, you can streamline your compliance process and avoid last-minute stress when the new regulations come into effect. 

What if my feed business is small or low-risk? 

Smaller operations often think the rules don’t apply. Unfortunately, this isn’t the case. Whether you’re a niche importer or a regional mill, the CFIA feed regulatory modernization applies across the board. 

However, the framework is designed to be scalable. If your operation poses lower risk, your preventive controls may be simpler. But you still need documented processes, traceability, and proper labelling. 

How to prepare for the new CFIA feed regulations 

Here are a few steps you can take now to get ready: 

  • Assess your current practices: Review your hazard control, documentation, and labelling practices. 
  • Develop or update your Preventive Control Plan: Make sure it aligns with CFIA’s expectations. 
  • Gather documentation for licensing: Have records ready to show how you meet safety standards. 

Frequently asked questions

Is the CFIA feed regulatory modernization already in effect?

Not entirely. While some requirements are already in place, others are being phased in over time. The CFIA is continuing to consult with stakeholders, and updates will be rolled out in stages. It’s important to start preparing now.

Yes. Importers and exporters are also required to meet the new licensing, labelling, and preventive control requirements. The modernization affects all players in the commercial feed chain.

Operating without a compliant PCP could result in enforcement actions, including shipment delays, import holds, or financial penalties. Even small businesses must have a plan in place that aligns with their level of risk.

No. Feed ingredients must now meet updated standards and go through the revised authorization process. You may need to provide additional safety and efficacy data depending on the ingredient.

You can bookmark and regularly check the CFIA feed modernization page. Or work with a compliance expert like Quality Smart Solutions to get proactive guidance.

Why work with Quality Smart Solutions 

Need help interpreting these requirements or building a compliant plan? At Quality Smart Solutions, we guide businesses through every step of feed regulatory compliance.

From licensing and ingredient submissions to preventive control plans and product labels, our team ensures you meet CFIA’s updated requirements with confidence. 

Don’t wait until it’s too late. Contact us for tailored support. You can also explore our Animal Feed Compliance Services to see how we can help your business stay compliant. 

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