U.S. Senate Bill Would Eliminate Self-GRAS Pathway to Market Food Substances

On July 17, Senators Markey (D-MA), Booker (D-NJ), Warren (D-MA), and Blumenthal (D-CT) introduced the Ensuring Safe and Toxic-Free Foods Act of 2025, which would significantly curtail the Generally Recognized as Safe (GRAS) pre-market exemption for food substances, including food ingredients, food packaging, and other food-contact substances. The law, if passed, would deem any substance that qualifies as a food additive under the Federal Food, Drug, and Cosmetic Act (FDCA) as unsafe, unless the substance is already the subject of an FDA approval (e.g., listed in a food additive regulation or under an effective Food Contact Notification) or (1) the substance is the subject of a GRAS Notification that is pending or that has received a “no questions” letter from FDA prior to enactment; or (2) is the subject of a GRAS Notification that was submitted to FDA between enactment and the effective date of the legislation (two years later). In effect, within two years after enactment, food substances, including food-contact substances, that are on the market based on self-GRAS determinations would render food adulterated and unsafe within the meaning of Section 402(a) of the FDCA, unless a manufacturer has submitted a GRAS Notification for them.

The law would also restrict the types of substances that could qualify for GRAS Notification, excluding substances that have been found to induce cancer in man or animals when ingested; show evidence of reproductive or developmental toxicity, including through an endocrine mode of action; or are otherwise identified as toxic by the National Toxicology Program, the Environmental Protection Agency (EPA), the Agency for Toxic Substances and Disease Registry (ATSDR), or California’s Office of Environmental Health Hazard Assessment (OEHHA).

In addition, the legislation introduces several elements of future GRAS assessments that are not currently part of FDA’s voluntary GRAS Notification Program:

• FDA must publicly post submitted GRAS notices and allow for a 60-day public comment period;
• Upon review of a GRAS Notification, the Secretary of Health and Human Services must either (1) issue a written, affirmative statement that it is not objecting to a notifier’s determination that a substance is GRAS under its intended conditions of use; or (2) object to the Notification, if any of the following apply:
  • the documentation providing the basis for the GRAS determination is incomplete;
  • data supporting the determination are provided by experts that have a conflict of interest; or
  • the available evidence does not adequately support a determination that a substance is GRAS under its intended conditions of use.

The bill also directs FDA to issue new guidance within 180 days of enactment to strengthen the recommendations in an existing December 2022 Agency Guidance on “Best Practices for Convening a GRAS Panel.”

Food Chemical Reassessment Program

The Ensuring Safe and Toxic-Free Foods Act of 2025 also addresses FDA’s Food Chemical Reassessment Program by requiring the Agency to reassess the safety of at least 10 food substances or substance classes every three years. Furthermore, manufacturers would be required to provide data to facilitate the reassessments when requested. Priority for reassessment would be given to substances or classes of substances that are subject to petitions, regulatory concern, or citizen complaints.

Previously, Senator Markey introduced the Ensuring Safe and Toxic-Free Foods Act of 2023 (see the Packaginglaw.com article, U.S. Senate Bill Would Prohibit Independent GRAS Designations), which failed to pass out of Committee, although the new legislation substantially modifies the prior version of the Bill.