FDA GRAS Rule 2026: Key Changes, compliance & Industry Impact
FDA’s 2026 GRAS Proposal: A New Era of Food Ingredient Transparency By 2026, the U.S. Food and Drug Administration (FDA) is expected to publish a proposed regulation that would require all Generally Recognized as Safe (GRAS) determinations to be formally notified to the agency. If implemented, this rule would mark a major shift in food safety oversight—effectively ending the long-standing practice of self-affirmed GRAS determinations and ushering in a new era defined by transparency, accountability, and regulatory visibility. Understanding GRAS and Its Regulatory Role The GRAS (Generally Recognized as Safe) framework has been a foundational element of U.S. food ingredient regulation under the Federal Food, Drug, and Cosmetic Act. It allows substances to be used in food if they are generally recognized as safe by qualified experts, based on publicly available scientific evidence. Historically, companies have had two pathways: Submit a GRAS notification to the FDA ...