U.S. Senate Bill Would Prohibit Independent GRAS Designations

U.S. Senate bill S. 3387, “Ensuring Safe and Toxic-Free Foods Act of 2023,” would prohibit independent Generally Recognized as Safe (GRAS) designations and create an Office of Food Chemical Safety, Dietary Supplements, and Innovation. The bill was introduced by Senators Edward J. Markey (D-MA), Cory Booker (D-NJ), Richard Blumenthal (D-CT), and Elizabeth Warren (D-MA) on December 4, 2023.

More specifically, the bill would require the U.S. Food and Drug Administration (FDA) to revise its GRAS regulations (see 81 Fed. Reg. 54960) to prohibit manufacturers from designating a substance as GRAS unless the Secretary of Health and Human Services, after receiving supporting information, has made a final determination in writing that the substance is GRAS under it intended conditions of use. In addition, safety information relevant to the determination would need to be available on FDA’s website and subject to a 90-day review period.

The bill would also prohibit individuals with a conflict of interest from serving as experts in evaluating scientific data to determine GRAS designations. FDA would also be required to establish a procedure to reassess substances previously designated as GRAS. These reassessments would be the responsibility of the Office of Food Chemical Safety, Dietary Supplements, and Innovation. This Office would also be responsible for re-evaluating and reassessing the safety of food additives, food-contact substances, color additives, and prior-sanctioned substances.

The bill was referred to the Senate Committee on Health, Education, Labor, and Pensions on December 4, the day it was introduced.