The Grocery Reform And Safety Act (GRAS Act) significantly amends the Federal Food, Drug, and Cosmetic Act by explicitly including substances "generally recognized as safe" (GRAS) within the definition of a food additive. This change requires manufacturers to submit a notice to the Food and Drug Administration (FDA) for any new use of a GRAS substance or for substances not previously marketed in the U.S. before they can be used in food. The bill aims to enhance food safety oversight by ensuring that these substances undergo a more rigorous review process.

The required notice must include comprehensive scientific data demonstrating the substance's identity, manufacturing process, intended effect, and safety, including analysis of cumulative effects, hazard, dose response, and absence of carcinogenicity or reproductive toxicity. A substance can only be used if the FDA issues a written statement not to object to the GRAS determination, a decision the agency must make within 180 days, with public availability of notices and a comment period. The FDA is mandated to object if the notice is incomplete, experts have conflicts of interest, or the data is insufficient.

Furthermore, the bill establishes a program for the FDA to systematically reassess the safety of at least 10 food substances or classes every three years, including existing GRAS substances. During these reassessments, the FDA can require updated safety evaluations from manufacturers and may revoke prior "statements not to object" if safety concerns arise. To support these new regulatory activities, the Act introduces fees for persons submitting GRAS notices and those subject to reassessments, ensuring resources are available for the FDA's expanded oversight responsibilities.