Is the FDA Ending Self-Affirmed GRAS? What You Need to Know

Generally Recognized As Safe (GRAS) is a regulatory designation for food ingredients that are considered safe by expert consensus under intended use. The U.S. Food and Drug Administration (FDA) currently allows two pathways to GRAS status: self-affirmation and FDA notification. However, recent developments indicate the FDA may eliminate the self-affirmation option in favor of stricter oversight. 

This report compares self-affirmed vs. FDA-notified GRAS, explains why the FDA is moving to end self-affirmed GRAS, and outlines what this means for food and beverage companies. It also highlights BeyondMushrooms – a line of mushroom extracts with FDA-notified GRAS status – as a smart solution for brands needing compliant, high-quality ingredients.

GRAS 101: Self-Affirmed vs. FDA-Notified

Under the law, if an ingredient’s safety is “generally recognized” by qualified experts and published science, it is exempt from FDA pre-approval​. The key difference between GRAS pathways is who reviews and knows about the safety determination:

• Self-Affirmed GRAS: The company convenes its own expert panel and concludes an ingredient is safe, without any requirement to notify or consult the FDA​. As long as the GRAS criteria are met (consensus of expert opinion and publicly available safety data), the company can use the ingredient. This process is entirely internal – the FDA and public may not even know the ingredient is in the food supply.
• FDA-Notified GRAS: The company prepares a GRAS notice and submits it to the FDA for review. This notice includes a detailed description of the ingredient, its intended use, and the scientific evidence of safety. The FDA evaluates the submission and, if satisfied, issues a “no questions” response letter (essentially an FDA affirmation that it has no objections to the GRAS determination). The FDA then lists the notice on a public inventory along with the supporting data and agency’s decision. This path is currently voluntary (not legally required), but it provides an extra layer of scrutiny and transparency.

In summary, a self-affirmed GRAS determination stays within the company’s files, whereas an FDA-notified GRAS determination is shared with regulators and the public. Both pathways are legal, but they carry very different levels of oversight and transparency. Table 1 below highlights the key differences:

Table 1: Comparing Self-Affirmed vs. FDA-Notified GRAS

FDA's Move to Eliminate Self-Affirmed GRAS: Rationale and Context

The FDA is now poised to close the “self-affirmation” loophole. On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. directed the FDA to explore rulemaking that eliminates the self-affirmed GRAS pathway​. The reason is simple: safety and transparency.

“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” said Secretary Kennedy.

“Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”

In other words, regulators are concerned that under self-affirmation, ingredients can enter foods without any FDA knowledge or review. FDA currently “strongly encourages” companies to use the notification program, and has reviewed 1,000+ GRAS notices (about 75 per year), which are all catalogued in a public inventory. But because notification is optional, many substances may have been self-certified as safe behind closed doors. A 2010 Government Accountability Office (GAO) report flagged this issue, and a decade later experts noted that the FDA “has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers.”. Even when the FDA finalized updates to the GRAS rule in 2016, it did not require companies to submit self-GRAS substances or create a master list of all GRAS ingredients in use. This gap means FDA cannot fully ensure the safety of the food supply if it doesn’t even know what additives are being used. 

The push to eliminate self-affirmation is a response to these longstanding concerns. By mandating FDA notification, every new GRAS ingredient would face some level of FDA oversight and public disclosure before use. Kennedy emphasized that this step will help “ensure that ingredients being introduced into foods are safe” and bolster consumer confidence. HHS and FDA are even considering working with Congress on legislation to “completely close the GRAS loophole”, indicating a strong commitment to reform.

Impact on Companies Currently Using Self-Affirmed GRAS Ingredients

Companies currently formulating with self-affirmed GRAS ingredients face a critical decision point. If your product relies on an ingredient that only you (or your supplier) have deemed GRAS without FDA input, you should begin strategizing now:

• Regulatory Risk: Once the self-affirmation route is closed, continuing to use an ingredient that hasn’t been FDA-notified could pose regulatory risks. FDA could determine that any ingredient not on its GRAS inventory (or without prior approval) is an unapproved food additive. This could lead to warning letters, import detentions, or product reformulation mandates. To avoid disruption, companies should identify which ingredients in their portfolio are self-affirmed GRAS and plan to bring them into compliance.
• GRAS Notification for Legacy Ingredients: If you wish to keep using a self-affirmed ingredient, you (or your ingredient supplier) may need to submit a GRAS notice for it. Preparing a successful GRAS notice involves assembling comprehensive safety evidence – including published toxicology studies, usage estimates, and expert analyses – to demonstrate general recognition of safety. This process can take months and often benefits from consulting experts. Starting early is key. Some suppliers might already be planning GRAS notices for their ingredients in light of FDA’s stance; partnering with such proactive suppliers is wise.
• Switching to FDA-Reviewed Alternatives: In many cases, the faster solution will be to switch to an alternative ingredient that already has FDA-notified GRAS status. By sourcing ingredients that have an official FDA “no objection” letter, companies can immediately reduce uncertainty. Many ingredient categories have at least one supplier with an FDA-reviewed GRAS. Choosing those ensures you’re ahead of the regulatory curve and can reassure stakeholders (regulators, consumers, investors) of your commitment to safety and compliance.

Bottom line: Brands using self-affirmed GRAS ingredients should act now. Conduct an audit of your ingredient GRAS statuses, engage with suppliers about their GRAS plans, and consider reformulating with FDA-notified GRAS ingredients where possible. This will future-proof your products in anticipation of the new rule.

Transitioning to FDA-Notified GRAS Ingredients: Why Choose BeyondMushrooms

For companies formulating with functional mushroom ingredients (a popular category for wellness beverages, supplements, and foods), BeyondMushrooms offers a timely solution. BeyondMushrooms is a line of mushroom extract ingredients that have already gone through the FDA’s GRAS Notification process – in fact, they are the world’s only FDA-notified GRAS mushroom extracts available today​. This unique status means that their safety has been thoroughly vetted and acknowledged by the FDA at the highest level​, eliminating the uncertainties associated with self-affirmed ingredients. In a landscape where self-affirmed GRAS is on the way out, using BeyondMushrooms allows brands to seamlessly comply with upcoming rules and confidently innovate with mushrooms.

Beyond just regulatory peace of mind, BeyondMushrooms brings significant formulation advantages that make it an attractive choice for product developers:

• Proven Safety & Compliance: Each BeyondMushrooms extract has been reviewed under the FDA’s GRAS program, so you have an official record of safety. You won’t need to scramble for GRAS documentation or worry about regulatory crackdowns – it’s already done. As the “only mushroom extract on the planet with FDA-notified GRAS status”, BeyondMushrooms gives you a clear compliance edge. This is especially crucial as regulators and retailers may start insisting on FDA-reviewed ingredients.
• High Potency, Low Dose: BeyondMushrooms concentrates the active compounds to an industry-leading potency. Its beta-glucan content of ≥70% sets it apart from typical mushroom powders that might contain <10% of these beneficial polysaccharides. This high potency means efficacy can be achieved at a low inclusion rate – the extracts deliver clinically validated benefits at just 200 mg per serving. For formulators, that translates to cost savings and simpler formulation (you need only a small dose to get functional effects). 
• Clinical Research Backing: Unlike many wellness ingredients, BeyondMushrooms isn’t supported by reference literature alone – it’s built on 14+ human clinical studies demonstrating real-world efficacy. This scientific backing not only helped secure GRAS status (by evidencing safety and expected use levels) but also gives your marketing teams credible health claim support. You can formulate with confidence that the ingredient does what it says, and point to published research when educating consumers. 
• Superior Taste Profile: Mushrooms are nutritious, but they can taste earthy or bitter – a challenge for formulating appealing foods and drinks. BeyondMushrooms flips the script with a naturally mild, almost sweet taste. Due to a proprietary extraction that removes bitterness-causing compounds (e.g. proteins, which are <1% in the powder), the extract has no lingering “shroomy” aftertaste or off-notes. Its light beige color is a telltale sign of this purity (ultra-low impurities) and means it won’t turn your product dark or off colored​. Brands can incorporate these mushroom extracts without heavy flavor-masking or sweeteners – whether you’re crafting a berry-flavored beverage or a latte, the mushroom ingredient won’t overpower your intended flavor profile.
• Effortless Solubility: BeyondMushrooms extracts are designed for easy use in all kinds of formulations. They dissolve readily into water and other liquids with no clumping or grittiness. This high solubility is ideal for ready-to-drink beverages, drink mixes, and even dairy or baking applications – you can simply stir it in and it integrates seamlessly. Formulators save time (no special processing needed) and consumers enjoy a pleasant mouthfeel, free of the grainy sediment that some powders can leave behind.
  
• Stability and Clean-Label: BeyondMushrooms supports clean-label goals and exceptional stability. Each mushroom extract is heat-stable up to 503°F and pH-stable (1–11), ideal for pasteurized products, gummies, and baked goods. USDA Organic, U.S.-grown, and free from additives, it enables simple labeling ("organic lions mane extract"), streamlining regulatory reviews and appealing to label-conscious consumers.

By leveraging BeyondMushrooms, companies not only align with the anticipated FDA rules but also gain a superior ingredient that can make their products better. It’s a rare win-win for compliance and innovation: you avoid regulatory headaches and simultaneously improve product performance.

Key Takeaways for Brands and Formulators

The FDA’s expected elimination of the self-affirmed GRAS pathway marks a new era of transparency and oversight in food ingredient safety. Brands should begin adapting now by prioritizing ingredients that come with FDA-notified GRAS status or equivalent regulatory review. In practical terms, this means working closely with suppliers, reformulating where necessary, and choosing proven ingredients like BeyondMushrooms that have already met the highest safety standards. Not only will this proactive approach keep you ahead of regulations, but it will also strengthen the trust consumers place in your products.

As the industry transitions, staying informed is crucial. Keep an eye on FDA’s rulemaking progress and be ready to pivot as guidelines evolve. By understanding the difference between self-affirmed and FDA-reviewed GRAS and acting accordingly, food and beverage companies can ensure both regulatory compliance and consumer confidence in every ingredient they use. The bottom line: safety and transparency are becoming non-negotiable – and embracing them now will set your brand up for lasting success.