On November 6, 2025, U.S. Senator Roger Marshall (R-KS) introduced the Better Food Disclosure Act of 2025, or Better FDA Act of 2025, landmark legislation that would significantly overhaul the Generally Recognized as Safe (GRAS) provision of the Federal Food Drug and Cosmetic Act (FD&C Act). The bill is cosponsored by Katie Britt (R-AL) and Rick Scott (R-FL).
The FD&C Act currently allows companies to self-determine that a substance is GRAS under the conditions of its intended use. GRAS determinations are based either on common use in food or scientific procedures requiring the same quantity and quality of scientific evidence as would be required for food additive approvals. Notifications to the U.S. Food and Drug Administration (FDA) regarding self-GRAS determinations for food substances are voluntary under the current system.
The Better FDA Act of 2025 would command, for the first time, mandatory notification to FDA and public listing of food substances determined to be GRAS. The bill is aimed at increasing transparency and improving FDA oversight of ingredients in the food supply. The legislation also seeks to establish a “strong national standard of ingredient safety” and comes “in response to the great state-led efforts” in this space, according to Senator Marshall.
Implementation Date
Within two years of enactment of the bill, GRAS substances already in use must be reported and listed publicly by FDA. Thereafter, any GRAS substance not included on FDA’s list — or not under active review — would be deemed automatically unsafe and would render food adulterated under the FD&C Act.
New GRAS substances would need to be notified to FDA 120 days before their first use in food introduced into interstate commerce.
New FDA GRAS Review Process
The legislation would require FDA to respond to GRAS notifications within 180 days. If the Agency does not object within that timeframe, the ingredient would automatically be added to a public GRAS list. If FDA raises safety concerns, manufacturers may opt to do one of the following:
- Submit additional data for reconsideration;
- File a formal food additive petition; or
- Develop a plan to phase out the ingredient’s use.
The Better FDA Act of 2025 would obligate FDA within two years to establish procedures for maintaining and updating a public GRAS list.
Statutory Postmarket Review
The Better FDA Act also directs FDA to undertake a postmarket assessment of any food additive, color additive, or GRAS substance where “clear and convincing scientific evidence” supports such a review. FDA’s postmarket assessments could be triggered by:
- Citizen petitions;
- Notices from state officials; or
- FDA’s own initiative
if credible scientific evidence suggests a risk to public health arising from use of the additive or GRAS substance. Notice and comment rulemaking will govern all postmarket Agency actions. The legislation would also require that all postmarket safety reviews of food additives, color additives, or GRAS substances be conducted by career FDA officials with relevant scientific and regulatory expertise. Such reviews may not be carried out by, or delegated to, political appointees within FDA.
Initial Response
Proponents of the bill say it would modernize a decades-old system and ensure the FDA has full visibility into what substances are used in the food supply. Food industry groups are likely to prefer a national approach versus a patchwork of varying state laws. However, the bill lacks a preemption provision that would leave the issue solely up to FDA.