Robert F. Kennedy Jr. (RFK Jr.), recently confirmed Secretary of the U.S. Department of Health and Human Services (HHS), has directed the U.S. Food and Drug Administration (FDA) to explore rulemaking to eliminate the “Generally Recognized as Safe” (GRAS) process, which is widely 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.
According to a March 10 statement from HHS, at present, FDA strongly encourages manufacturers to submit GRAS notices through the agency’s GRAS Notification Program, but industry can self-affirm that the use of a substance is GRAS without notifying FDA. The agency has completed and published more than 1,000 GRAS notices and evaluates an average of 75 notices per year, record of which is maintained in a public inventory.