FDA Proposes Mandatory GRAS Notification Rule for Animal Food, Ending Voluntary Self-Determination Era

On August 11, 2026, the U.S. Food and Drug Administration published a proposed rule (Docket No. FDA-2025-N-3262) that would replace the decades-old voluntary GRAS (Generally Recognized as Safe) notification program with a mandatory filing obligation for substances added to animal food. The 120-day comment period ends December 9, 2026.

Under the current system, manufacturers have been permitted to independently determine that certain substances are GRAS under their intended conditions of use without notifying FDA. The proposed rule would require any person introducing a GRAS substance into interstate commerce to file a notification with the agency — a change that applies not only to new ingredients but also to substances already in the food supply.

Key provisions include a narrow exception for ingredients listed in Chapter 6 of the 2024 AAFCO Official Publication, though post-2024 ingredients and those subject to an FDA public statement of concern would not qualify. The proposed streamlined pathway offers a one-year window for existing substances to submit identifying information without full safety data. If finalized, compliance would be required 18 months after the rule’s effective date, with implementation expected in 2029-2030.

The FDA estimates the rule will cost the industry approximately $10.5 million annually. Acting FDA Commissioner Kyle Diamantas stated the proposal is intended to close critical information gaps and give the agency greater visibility into substances entering the food supply.

For pet food manufacturers, the rule represents the most significant regulatory overhaul since the 1958 Food Additives Amendment. Companies with large legacy ingredient portfolios may face the largest compliance burden, while the narrow AAFCO exception creates uncertainty for ingredients approved through the SRIS pathway after 2024.