Todd Harrison and Thomas Smith examine the FDA’s proposed shift from voluntary to mandatory GRAS notifications and the legal and practical implications for the food industry in their Food Safety Magazine article, “FDA's Proposed Mandatory GRAS Rule: What Food Safety Professionals Need to Know.” An excerpt is below.
Need to Know
- FDA’s newly proposed rule would replace voluntary GRAS notifications with mandatory filings for substances introduced into the U.S. food supply under the GRAS provision
- The proposal raises unresolved legal questions about FDA’s statutory authority to mandate GRAS notifications
- Mandatory notification would provide FDA greater marketplace visibility, but filing would not constitute premarket approval, confer GRAS status, or provide companies with regulatory certainty
- Ambiguities about who must file, whether notices cover downstream users, and what constitutes a “significantly different” substance could create compliance challenges and duplicative filings across supply chains
- Companies should use the comment period, which closes December 9, to document compliance costs and reliance interests, address operational concerns, and preserve evidence needed for the proposed streamlined pathway.
On August 11, 2026, the U.S. Food and Drug Administration (FDA) proposed “Docket FDA-2025-N-3262” in the Federal Register, replacing the voluntary GRAS notification program with a mandatory filing obligation, and representing the most significant structural change to the GRAS framework since the 1958 Food Additives Amendment. Initiated under U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy's Make America Healthy Again (MAHA) agenda, the proposal covers human and animal food, direct ingredients, and indirect additives. Comments close December 9, 2026.
For companies managing ingredient compliance, the proposal raises questions about statutory authority, agency capacity, and whether its design matches its stated objectives.
For the full article, click here.