Credit: Photo by Allison Bailey/NurPhoto via AP
Health and Human Services secretary Robert F. Kennedy Jr. has ordered the Food and Drug Administration to close a loophole that allows industry to self-declare food ingredients as generally recognized as safe.
Robert F. Kennedy Jr., secretary of the US Department of Health and Human Services, is pushing the Food and Drug Administration to close a loophole that allows food companies to decide for themselves whether an ingredient is generally recognized as safe (GRAS). On March 10, Kennedy ordered the FDA to explore eliminating that self-determination pathway to ensure that companies notify the agency and provide safety evidence before they market new food ingredients that fall under the GRAS category.
“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” Kennedy said in a statement. “Eliminating this loophole will provide transparency to consumers” and ensure that ingredients introduced into foods are safe, he said.
Kennedy is the mastermind behind the Make America Healthy Again (MAHA) movement, which aims to identify the root causes of chronic illnesses like type 2 diabetes, allergies, asthma, and depression—particularly in children. He is targeting ultraprocessed foods that contain added sugars, refined grains, and seed oils, as well as chemical additives like food dyes and preservatives, as potential culprits.
Kennedy’s order to close the GRAS loophole comes before the FDA has a commissioner in place. President Donald Trump nominated Johns Hopkins Hospital surgeon Marty Makary for the position, but the Senate has yet to confirm him. Acting FDAcommissioner Sara Brennersays in a statement that the FDA is committed to ensuring that GRAS ingredients are reviewed for safety by the agency before manufacturers add them to food.
Consumer and public health advocacy groups welcome Kennedy’s order but say it is a small step toward fixing a broken food safety system.
“Simply pledging to ‘take steps to explore’ changing a system that has been broken for more than 60 years is not the change consumers rightly expect,” Scott Faber, senior vice president for government affairs at the Environmental Working Group, says in a statement. Kennedy’s order “is best seen as a 'plan to plan,' not real progress toward ensuring our food is safe,” he says.
Faber is less concerned about new food ingredients than the thousands of chemicals that are already allowed in food “without ever having been reviewed by the FDA, or without having been reviewed by the FDA for many decades,” he says.
Since 2000, nearly all new food ingredients in the US have gone through the GRAS process, says Michael Hansen, a senior scientist in the advocacy division of Consumer Reports. The number of food ingredients going through the FDA’s more rigorous food additive process, which requires premarket approval of ingredients, has dropped to almost nothing, he says. The FDA does not know how many GRAS ingredients have entered the market because industry does not have to notify the agency, Hansen says. “The number has been estimated in the thousands,” he says.
FDA has limited resources to address food safety, but last year “the public interest community managed to get FDA to finally set up the Human Foods Program and even got them $50 million so they could hire experts to do the proper risk assessments,” Hansen says. The agency laid off several of those people earlier this year, but many of them have been rehired, he notes.
The Consumer Brands Association, which represents makers of consumer packaged goods, including food and beverages, claims that the GRAS process enables food companies to develop innovative ingredients to meet consumer demand. “As the administration looks to revise GRAS, we stand ready to work with agency experts on continued analysis of safe ingredients and increased consumer transparency,” Sarah Gallo, senior vice president of product policy and federal affairs at the trade group, says in a statement. says in a statement.
The FDA did not immediately respond to a request for comment on specific steps that it will take to review the GRAS pathway.
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