Another piece of legislation targeting the U.S. Food and Drug Administration’s (FDA’s) “Generally Recognized as Safe” (GRAS) rule has been introduced to Congress. The Ensuring Safe and Toxic-Free Foods Act of 2025 would set stricter requirements for the classification of a substance as GRAS. It also sets an annual quota of GRAS notices for FDA to review, and lays the groundwork for a systematic chemical reassessment process.

The Ensuring Safe and Toxic-Free Foods Act of 2025 was introduced by Senator Edward J. Markey (D-MA), a member of the Health, Education, Labor, and Pensions (HELP) Committee and the Environment and Public Works Committee, and Senator Cory Booker (D-NJ). Senators Richard Blumenthal (D-CT) and Elizabeth Warren (D-MA) are cosponsors of the legislation.

GRAS is considered by critics to be a “loophole” that allows food companies to introduce ingredients to the food supply without oversight or a formal safety review. The rule was established by FDA in 1972 with the original intent of making it possible for widely used food ingredients, commonly understood to be safe for consumption through a history of safe use (e.g., vinegar), to remain on the market without extensive review. GRAS allows manufacturers to determine for themselves whether a food ingredient is “safe.” Manufacturer notification to FDA of the use of a GRAS substance is voluntary. In the present day, companies have used GRAS as a way to use novel additives and ingredients without subjecting them to a safety review.

Aiming to set stricter requirements for GRAS determinations, the Ensuring Safe and Toxic-Free Foods Act of 2025 would mandate:

• That GRAS determinations are submitted to FDA along with extensive scientific evidence, including toxicological data, exposure analysis, and proof the substance is not carcinogenic or harmful to the reproductive system or childhood development
• FDA to publicly post GRAS notices and allow for a 60-day public comment period
• That FDA can object to GRAS claims if documentation is incomplete, the experts involved have conflicts of interest, or the evidence does not support safety
• That substances can be reassessed and GRAS status withdrawn at any time
• Exclusion of certain toxic or untested substances—including those not marketed prior to the bill’s enactment—from GRAS eligibility.

Additionally, the legislation would require FDA to review at least 50 GRAS notices per year until a full backlog is addressed. FDA would have to make all GRAS determinations public, including the associated scientific evidence. The bill would also mandate FDA to update its guidance on how GRAS expert panels are convened, emphasizing the need for independence and transparency to prevent biased safety evaluations.

Beyond GRAS substances, the Ensuring Safe and Toxic-Free Foods Act of 2025 also addresses the need for a systematic process for food chemical safety reassessment. If enacted, it would require FDA to reassess the safety of at least 10 food substances or substance classes every three years, with priority given to substances that are subject to petitions, regulatory concern, or citizen complaints. Manufacturers would be obligated to provide data for safety reassessments upon request. The same stringent standards for scientific evidence that the bill outlines for GRAS determinations would also apply to chemical safety assessments.

The Ensuring Safe and Toxic-Free Foods Act of 2025 is not the first piece of legislation seeking to address the GRAS “loophole.” Most recently, on July 1, U.S. Representatives Jan Schakowsky (D-IL-09) and Rosa DeLauro (D-CT-03) introduced the Food Chemical Reassessment Act of 2025, which would require FDA to reevaluate the safety of GRAS substances on a regular basis, beginning with ten priority chemicals.

These bills follow a memo from U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. directing FDA to explore rulemaking to eliminate the GRAS process—although he did not prescribe the manner in which this objective should be achieved.

Senators Markey and Booker hope the Ensuring Safe and Toxic-Free Foods Act of 2025 will guarantee FDA has the authority it needs to ensure food chemical safety, even amid Trump Administration cuts to the agency’s workforce and funding. Food industry and consumer protection stakeholders have expressed skepticism that FDA will be able to achieve Secretary Kennedy’s lofty “Make America Healthy Again” (MAHA) goals, including stricter food chemical oversight, without sustained resources.

The Ensuring Safe and Toxic-Free Foods Act of 2025 is endorsed by the Environmental Working Group, the Center for Science in the Public Interest, and the Environmental Defense Fund.