RFK Jr. targets food ingredient 'loophole,' aims for increased FDA oversight

Health and Human Services Secretary Robert Kennedy has begun his campaign to improve Americans’ health by increasing the U.S. Food and Drug Administration’s oversight of the food industry. His first step was directing the FDA to explore eliminating the "self-affirmed GRAS" pathway for food ingredients. 

GRAS stands for “Generally Recognized As Safe.” The directive signals a potential shift in how new food additives are introduced into the American marketplace.

The current GRAS rule allows manufacturers to determine the safety of new ingredients without notifying the FDA. While the agency encourages voluntary submissions through its GRAS Notification Program, many companies utilize the self-affirmation route, effectively bypassing formal FDA review.

Kennedy has long criticized this practice, labeling it a "loophole" that has allowed ingredients with potentially "unknown safety data" to enter the food supply undetected. He has cataloged a number of additives in American food that are not allowed in other countries.

"Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately make America healthy again," Kennedy said in a statement.

FDA is on board

Kennedy said the FDA, under the leadership of Acting Commissioner Sara Brenner, has pledged to cooperate with the directive. Brenner said the agency is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food. 

If implemented, the proposed rule change would eliminate the voluntary provisions and mandate that companies seeking to introduce new food ingredients submit notifications, along with supporting safety data, to the FDA for review. The FDA said that would significantly increase the agency's oversight and provide public access to information about new food additives.

Currently, the FDA maintains a public inventory of GRAS notices submitted through its voluntary program, showcasing the agency's reviews and supporting data. However, the self-affirmed GRAS pathway remains outside this formal process.

HHS has also indicated its intention to collaborate with Congress to explore legislative options that would completely close the “GRAS loophole.” 

Even before Kennedy was sworn in, some food companies announced they were open to change. In January, burger chain Shake Shack announced it would no longer use seed oil to cook its fries, but would switch to "100% beef tallow," as advocated by Kennedy.