Senate Bill Questions FDA’s GRAS Process

June 3, 2022

Three Democrats propose overhauling the Generally Recognized as Safe process and the creation of a new FDA office to reassess existing food chemical safety.

A bill was introduced in the U.S. Senate calling for changes in the “Generally Recognized as Safe” process and the creation of a new FDA office to reassess existing food chemical safety.

Sen. Edward Markey (D-Mass.), who has tried before to change the FDA, introduced the “Ensuring Safe and Toxic-Free Foods Act of 2022.” Co-sponsors are Senators Elizabeth Warren (D-Mass.) and Richard Blumenthal (D-Conn.). It directs the agency to revise the Substances Generally Recognized as Safe (GRAS) Rule to include provisions that:

Prohibit manufacturers from independently designating substances as GRAS (or manufacturing or selling food containing said substances) without supplying proper notice and supporting information to the Secretary of Health and Human Services (HHS).
Require the GRAS notice and supporting information be publicly available on the FDA website and subject to a 90 day public review period.
Prohibit carcinogenic substances from receiving GRAS designation.
Prohibit substances that show evidence of reproductive or developmental toxicity from receiving GRAS designation.
Prohibit people with conflicts of interest from serving as experts in reviewing and evaluating scientific data with regard to GRAS designations.

It also directs HHS to create an Office of Food Chemical Safety Reassessment within the FDA’s Center for Food Safety and Applied Nutrition. “This office would be charged with reassessing whether existing food additives, food contact substances, color additives, and GRAS substances are safe,” said an announcement from Markey’s office.

“The Office would be required to reassess at least 10 such substances (or classes of substances) once every three years and identify any unsafe substances or, for substances deemed safe, identify their conditions of use.” The bill specifies the first 10 substances to be reassessed: