FDA's GRAS Notification: Regulatory Requirements and Implications for Food-Contact Substances

On August 11, 2026, the U.S. Food and Drug Administration (FDA) published a proposed rule, Substances Generally Recognized as Safe, 91 Fed. Reg. 51834 (Docket No. FDA-2025-N-3262; RIN 0910-AJ02), that would fundamentally restructure the Generally Recognized as Safe (GRAS) framework under 21 CFR Parts 170 and 570. For the first time since the GRAS concept was created by the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act), companies that market a substance in reliance on a self-determined (“self-affirmed”) GRAS conclusion would be required to notify FDA of that conclusion and its basis, unless a specified exception applies.

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