Better FDA Act of 2025

This bill amends the Federal Food, Drug, and Cosmetic Act to require that food substances generally recognized as safe (GRAS) be reported to the Food and Drug Administration (FDA) and listed on a public registry, and it establishes a process for the FDA to reevaluate the safety of food additives, color additives, and GRAS substances after they are on the market.

Sec. 2, Mandatory reporting of substances generally recognized as safe: Two years after enactment, a GRAS substance will be considered unsafe unless it is on an FDA-maintained list or under review. Any person may file a notice with the FDA proposing inclusion of a GRAS substance on that list. For substances already in use as of enactment, the notice must be filed within two years; for new substances, at least 120 days before first use. The FDA must issue regulations for a public list within two years. Within 180 days of receiving a notice, the FDA must either add the substance to the list or make a preliminary determination to exclude it. If the FDA does not act in time, the substance is deemed added. If the FDA excludes or removes a substance, the user must submit a request for reconsideration, a food additive petition, or a phase-out plan. The FDA must make a final determination within 180 days of receiving sufficient information.

Sec. 3, Postmarket assessment of food additives, color additives, and food substances generally recognized as safe: If the FDA receives a citizen petition or state official notice about the safety of a food additive, color additive, or listed GRAS substance, or if the FDA initiates a review, the FDA may reevaluate it. The FDA may amend or revoke regulations for food or color additives, or determine a GRAS substance to be a food additive and remove it from the list via rulemaking. The FDA must prioritize petitions with clear and convincing scientific evidence, publish a request for safety information, and ensure that any final action is reviewed by career FDA scientists and subject to notice-and-comment rulemaking. The Secretary may not delegate this review to political appointees.