FDA Proposes Mandatory GRAS Notifications for Ingredients Introduced to U.S. Food Supply
The U.S. Food and Drug Administration (FDA) has proposed a rule that would require companies to notify the agency when they conclude that a substance used in human or animal food is Generally Recognized as Safe (GRAS), which would end the existing voluntary notification system for most GRAS substances.
The proposed rule would amend 21 CFR parts 170 and 570 to require any person introducing a substance into interstate commerce under the GRAS provision of the Federal Food, Drug, and Cosmetic Act to notify FDA of the basis for their GRAS conclusion, unless an exception applies. The requirement would cover both ingredients added directly to food and substances added indirectly, such as substances migrating from food packaging.
Importantly, the proposal would not establish a premarket review and approval process for GRAS substances. Companies could still independently conclude that a substance is GRAS and market it before submitting a notice to FDA, or while FDA evaluates the notice. Rather, mandatory notification would give FDA information needed for post-market oversight and to determine whether a purported GRAS use is actually a food additive use requiring premarket authorization.
FDA is accepting comments on the proposed rule for 120 days following its August 11 publication in the Federal Register. If finalized as proposed, the rule would take effect 60 days after publication of the final rule, with compliance with the mandatory GRAS notification requirements required 18 months after the effective date.
Closing the GRAS ‘Loophole’
Under the present system, companies can independently conclude that an ingredient is GRAS without notifying FDA or proactively providing the agency with the supporting safety evidence used to make the GRAS self-determination. Critics have described this aspect of the GRAS framework as a “loophole” that allows new, potentially unsafe ingredients and additives to enter the food supply without formal FDA review.
The GRAS pathway was originally intended to allow widely used food ingredients, commonly understood to be safe for consumption, to remain on the market without extensive review. However, in the present day, companies have used GRAS to market substances without subjecting them to formal review.
Proposed Rule Requirements, Exemptions, and Submission Pathways
Under the proposed rule, FDA would generally require a GRAS notice for substances already in the food supply, as well as substances being introduced for food use for the first time. However, several exceptions would apply, including when FDA has already issued a “no questions” letter covering the substance and its intended conditions of use; when the substance and use are already listed or affirmed as GRAS in FDA regulations; or when FDA has considered the intended use through certain established processes.
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For substances already marketed based on independent GRAS conclusions before the effective date of a future final rule, FDA has proposed a time-limited, streamlined submission pathway. Companies could provide basic information about the substance and its conditions of use instead of initially submitting a full GRAS notice. The submission would have to identify the substance, as well as its intended uses and use levels, and provide evidence that it was already in interstate commerce. FDA would publish the information, but inclusion on the public list would not mean that FDA had reviewed or agreed with the GRAS conclusion. The agency could subsequently require a full GRAS notice or food additive petition.
The proposed rule would also establish a 45-day timeframe for FDA to determine whether to file a GRAS submission as a notice. Once filed, FDA would generally have 180 days to respond, although the proposal would allow up to two additional 90-day extensions when necessary.
If a notifier asked FDA to cease evaluating a GRAS notice, the notification requirement would no longer be considered satisfied. Conversely, an FDA response finding an insufficient basis for the GRAS conclusion would not mean the company failed to satisfy the notification requirement, although FDA said such a finding could inform post-market action.
FDA Cites Longstanding Transparency and Oversight Concerns
In its proposed rule, FDA said nearly 30 years of experience with voluntary GRAS notification had demonstrated that the existing pathway causes significant information and oversight gaps. As of March 2025, FDA's Human Foods Program had filed more than 1,200 GRAS notices, but the agency does not know the total number of substances being marketed based on independent GRAS conclusions. FDA cited a 2011 estimate suggesting that approximately 1,000 human food substances were being used based on such independent conclusions.
FDA also pointed to cases involving caffeinated alcoholic beverages, Delta-8 tetrahydrocannabinol (THC), stevia leaves and crude extracts, ashwagandha, and Areca catechu palm-leaf dinnerware as examples of situations in which the agency identified safety or regulatory concerns involving GRAS substances already being marketed.
A mandatory notification system, FDA said, would allow the agency and public to better understand which substances are entering the food supply under GRAS conclusions, provide earlier opportunities to identify inadequately supported conclusions, and help ensure that supporting scientific documentation exists.
Consumer Groups Say GRAS Rule Does Not Go Far Enough
Although upheld as a win for the "Make America Healthy Again" (MAHA) movement by Secretary Kennedy, consumer protection groups voiced their opinion that the proposed rule will not bring meaningful change.
For example, Brian Ronholm, Director of Food Policy at Consumer Reports, said, “Given the lack of any real enforcement under the proposed rule for failing to submit a GRAS notice, combined with the fact that it would not apply to chemicals already in our foods, it risks maintaining the status quo that allows secret ingredients and chemicals to remain on the market without FDA review." He added, “This should not preclude states from passing laws that protect consumers more quickly.”
Food & Water Watch Food Policy Director, Rebecca Wolf, shared a similar opinion. "While today’s proposed rule is a baby step towards safer food, it falls short of the true reform needed to keep dangerous chemicals out of the food supply," she said. "For decades, corporations have exploited the GRAS loophole to self-police which chemicals make it into the food we eat. We need stronger regulation to close the loophole once and for all, and we need to invest in the agencies charged with ensuring food safety."
Meanwhile, Secretary Kennedy said the move "brings greater transparency to what is in our food and stronger science to federal nutrition policy."
Acting FDA Commissioner Kyle Diamantas, J.D., added, “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply."
