FDA proposes mandatory GRAS notification rule for animal food

On Aug. 10, the U.S. Department of Health and Human Services (HHS) announced a proposed rule that would require manufacturers to notify the U.S. Food and Drug Administration (FDA) when they conclude that a substance added to human or animal food is generally recognized as safe (GRAS).

The proposed rule is scheduled for Federal Register publication on Aug. 11, 2026, as Docket No. FDA-2025-N-3262 (RIN 0910-AJ02). 

Acting FDA Commissioner Kyle Diamantas said the proposal is intended to give the agency more insight into ingredients entering the food supply.

"By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply," Diamantas said.

The proposed rule would apply to substances used in both human and animal food. Since Congress established the GRAS exemption in 1958, manufacturers have been permitted to determine independently that certain substances are generally recognized as safe under their intended conditions of use. The FDA has operated voluntary notification programs, but companies have not been required to report these determinations to the agency.

GRAS notifications would become mandatory

Under the proposal, GRAS notifications would become mandatory, and the FDA would expand its public inventory of submitted notices.

For substances already on the market based on manufacturers' independent GRAS conclusions, the proposal would create a time-limited, streamlined submission pathway allowing companies to provide the FDA with information about existing uses. The agency said this would allow it to prioritize post-market safety evaluations while limiting additional regulatory burden.

10 things to know

Venable LLP, an American law firm headquartered in Washington, D.C., outlined the following takeaways to know about the proposed rule:

1. Voluntary becomes mandatory. Anyone introducing a substance into interstate commerce under the GRAS provision of Section 201(s) of the Federal Food, Drug and Cosmetic Act would be required to notify the FDA of the basis for their GRAS conclusion. This would apply to substances already in the food supply and to new introductions.
2. This is not premarket approval. The FDA states that companies may continue marketing GRAS substances before submitting a notice, after submission and during FDA review, provided the use satisfies the statutory GRAS criteria. Venable characterized the proposal as a post-market information-gathering tool.
3. The consequence of non-notification is soft but real. The FDA would treat a failure to notify as a factor in prioritizing substances for post-market review. Non-notification alone would not constitute a per se adulteration finding or an FDA determination that a use is not GRAS.
4. Seven exceptions apply to human food. Proposed exceptions include uses covered by an existing "no questions" letter, substances listed or affirmed as GRAS in FDA regulations, certain historical-use substances, uses reviewed through established FDA consultation processes such as biotechnology or cultured animal cells, threshold-of-regulation exemptions, and uses covered by an effective food-contact notification.
5. A streamlined pathway would apply to substances already on the market. For substances in interstate commerce before the final rule's effective date based on independent GRAS conclusions, the FDA proposes a time-limited streamlined submission requiring identifying information only, not underlying safety data. The window would remain open for one year after the effective date. Venable noted this is a conditional deferral, not a permanent exemption, and that the FDA retains discretion to later require a full GRAS notice or food additive petition.
6. "No questions" letters may carry less certainty than companies assume. The FDA proposes authority to revisit, update or rescind prior "no questions" letters if new information calls a GRAS conclusion into question. Venable advised companies that have treated these letters as de facto regulatory clearance to reassess that position.
7. Confidentiality protections would be use-it-or-lose-it. Under the proposal, any data not specifically identified as exempt from Freedom of Information Act disclosure at the time of submission may be treated as nonexempt or subject to a waiver of confidentiality. Venable said failure to designate exempt information at filing could result in irreversible public disclosure.
8. The comment period would run 120 days. Comments would be due approximately Dec. 9, 2026, 120 days from the Aug. 11 publication date. The FDA is also inviting comments through the Paperwork Reduction Act process on burden estimates.
9. The compliance timeline is measured in years. If finalized, the mandatory notification provisions would carry a compliance date 18 months after the rule's effective date, which itself would be 60 days after publication of the final rule. The streamlined submission window would close one year after the effective date.
10. The rulemaking carries significant political backing. Venable noted the rulemaking was initiated at the direction of HHS Secretary Robert F. Kennedy Jr. as part of the "Make America Healthy Again" initiative, which Venable said suggests institutional momentum toward finalization.

Read more tips from Venable here.