No More GRAS Self-Affirmations? FDA Proposes Mandatory GRAS Notifications

Key Takeaways

• What Happened: The U.S. Food and Drug Administration (FDA) proposed a rule that, for the first time, would require manufacturers to notify FDA of substances marketed for human or animal food use based on a conclusion that the substance is Generally Recognized as Safe (GRAS). The proposal, announced on August 10, 2026, would apply both to new and many existing uses, including food-contact substances.
• Who’s Impacted: Food and animal food manufacturers, ingredient suppliers, importers, and food-contact substance manufacturers and suppliers that rely on independent GRAS conclusions.
• What Should You Do: Inventory uses supported by independent GRAS conclusions, evaluate whether proposed exceptions or the transition pathway apply, preserve evidence of existing uses, and consider commenting on implementation issues and FDA’s statutory authority. Comments are due December 9, 2026.