FDA proposes mandatory notification for 'generally recognized as safe' food ingredients

The U.S. Food and Drug Administration has unveiled a proposal to mandate that food manufacturers notify the agency about ingredients they deem 'generally recognized as safe' (GRAS). This move seeks to close a long-standing regulatory loophole that has allowed companies to self-affirm the safety of chemicals used in food products without prior FDA oversight.

Under the current system, companies are not required to inform the FDA when they use GRAS ingredients, leading to concerns about the unknown safety of numerous substances in the American food supply. A recent study indicated that at least 111 substances of unknown safety have been added to foods, drinks, and supplements without FDA notification. The proposed rule would transform the GRAS standard from a voluntary process to a mandatory one, requiring manufacturers to submit safety data to the agency.

Health and Human Services Secretary Robert F. Kennedy Jr., a proponent of the 'Make America Healthy Again' movement, lauded the proposal as a significant step in combating ultraprocessed foods and promoting healthier diets. He criticized the existing system, stating that the food industry had exploited the loophole. Acting FDA Commissioner Kyle Diamantas described the plan as a blueprint for effective oversight involving the FDA, industry, and consumer safety advocates.

The proposal is expected to undergo a period of public and industry comment. Separately, a definition of ultraprocessed foods, also part of the MAHA agenda, is still under review by multiple federal agencies, with some concerns raised about its potential breadth.