WHAT HAPPENED: On August 11, 2026, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would convert the current voluntary Generally Recognized as Safe (GRAS) notification program into a mandatory one. Under the proposal, any company introducing a human or animal food substance into interstate commerce under the GRAS provisions of the Federal Food, Drug, and Cosmetic Act would be required to submit a GRAS notice to FDA explaining the basis for its safety conclusion — including substances that come into contact with food, such as conveyor belts, shipping containers, and packaging.
HISTORY: The current voluntary framework, finalized in 2016, has allowed but not required companies to share their supporting GRAS data with FDA. The new proposal stems from a March 2025 directive from HHS Secretary Robert F. Kennedy Jr. as part of the Administration’s Make America Healthy Again initiative, aimed at giving FDA greater visibility into substances entering the food supply.
WHAT ELSE IS IN IT: For substances already on the market, the rule would create a time-limited, streamlined submission option (open for one year after the final rule’s effective date) allowing companies to submit basic information about a substance and its conditions of use rather than a full GRAS notice. The proposal also outlines seven exceptions to the mandatory notification requirement, including substances covered by an existing FDA “No Questions” letter and food ingredients of natural biological origin that were commonly consumed in the U.S. without known adverse effects prior to January 1, 1958.
WHY IT MATTERS: If finalized, this rule would represent a significant shift in how food substances are brought to market, moving away from a system that has allowed companies to self-determine GRAS status without FDA review. Companies would need to assess their full ingredient and packaging portfolios — including materials that contact food during processing — to determine which substances require notification. Failure to notify would not automatically deem a product adulterated, but FDA has signaled it would factor a lack of notification into post-market review and enforcement priorities, including warning letters and seizures.
WHAT’S NEXT: Industry stakeholders should review the proposed rule and consider submitting comments before the December 9, 2026 deadline. NCC is reviewing the proposal’s implications for the chicken industry and will be preparing comments. A detailed legal analysis of the rule is available from Hogan Lovells Cadwalader by clicking here.
