Senators Propose Bill to Eliminate Self-Affirmed GRAS
Tuesday, November 28, 2023
  • On November 21, 2023, Senators Edward J Markey and Senator Cory Booker introduced the Ensuring Safe and Toxic-Free Foods Act, which would end the legal entitlement to market foods based on a self-determined generally recognized as safe (GRAS) position and would instead require notification to FDA and provision of supporting information. Currently, the GRAS Notification program is completely voluntary.
  • The bill would also:
    • Require that the notice and supporting information be available on FDA’s website and subject to public comment for 90 days.
    • Prohibit carcinogenic substance from receiving GRAS designation (this is already prohibited by the Federal Food, Drug, and Cosmetic Act).
    • Prohibit substances that show evidence of reproductive or developmental toxicity from receiving GRAS designations.
    • Prohibit people with conflicts of interest from serving as experts in reviewing and evaluating scientific data with regard to GRAS designations.
    • Create a new office within the FDA which would reassess whether existing food additives, food contact substances, color additives, and GRAS substances are safe, and establish a new committee to advise on standards, processes, and methods necessary for reassessment of substances.
  • The full text of the bill does yet appear to be available online, but virtually identical legislation under the same name was introduced in 2022. While the likelihood of passage is uncertain, we will continue to monitor and report on updates to this legislation.

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