GRAS Act

The Grocery Reform And Safety Act (GRAS Act) would overhaul how “generally recognized as safe” (GRAS) substances are treated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It would remove the current GRAS exemption from the food-additive definition and require formal FDA oversight of GRAS determinations. Specifically, manufacturers and others who use GRAS substances would have to notify the FDA about any new use or GRAS determination, providing comprehensive safety data. The bill also mandates periodic reassessments of safety for certain categories of substances (every three years, starting within three years of enactment), and creates a framework for how reassessments and GRAS notices would be handled, including public posting, opportunities for comment, and potential FDA objections or revocations. It would fund these activities through new and updated user fees and would authorize appropriations. Overall, the bill aims to increase transparency, data requirements, and FDA oversight of GRAS substances, with potential safety benefits but higher regulatory and cost burdens for industry.