The Department of Health and Human Services announced Sunday that it plans to eliminate a controversial rule that currently permits food manufacturers to introduce new ingredients without formal FDA approval. Under the existing Generally Recognized As Safe (GRAS) protocol, companies can independently determine the safety of food additives without regulatory oversight.
HHS Secretary Robert F. Kennedy Jr. has instructed the acting FDA commissioner to investigate options for removing this “self-affirmed GRAS pathway,” aiming to enhance regulatory supervision and provide greater transparency for consumers regarding food ingredients.
The current system allows manufacturers to voluntarily submit notices through the FDA’s GRAS notification program, with the agency reviewing approximately 75 such submissions annually. The proposed change would mandate that companies publicly notify the FDA before incorporating new ingredients into food products, including comprehensive safety data and intended usage information.
Research from the Environmental Working Group in 2022 revealed that since 2000, nearly 99% of new food chemicals were approved through the GRAS system without FDA review. Of 766 new chemical additions to the food supply during this period, only 10 cases involved companies seeking direct FDA approval, with nine of these occurring before 2010.
“The food industry has long exploited a loophole allowing new ingredients and chemicals to enter the U.S. food supply without proper notification or public disclosure,” Kennedy stated. “By closing this gap, we can ensure ingredient safety, increase consumer awareness, and advance our goal to Make America Healthy Again.”
The EWG’s analysis highlighted concerning examples of GRAS-listed additives, including butylated hydroxyanisole (BHA), a meat
preservative identified as a potential carcinogen by the National Toxicology Program. Another notable example is the green tea extract EGCG, which researchers suggest may increase cancer risk despite its GRAS classification.
Dr. Mona Calvo, an adjunct professor at the Icahn School of Medicine at Mount Sinai, noted that many common food additives received GRAS status between 1970 and 1975, when dietary habits were significantly different from today’s prevalence of ultra-processed foods. Dr. Jaime Uribarri, a nephrology specialist at the same institution, pointed out that the FDA currently lacks systematic safety monitoring for approved additives once they enter the market.
This regulatory initiative aligns with President Donald Trump’s recent establishment of the Make America Healthy Again Commission, which includes examining how certain food ingredients and chemicals might impact children’s health.
Kennedy shared on social media platform X that he had engaged in productive discussions with executives from major food companies including Kraft Heinz, General Mills, Tyson Foods, Kellogg’s, and Pepsi regarding food safety improvements and transparency measures. “We will strengthen consumer trust by getting toxins out of our food,” Kennedy declared in his post.
The proposed elimination of the self-affirmed GRAS pathway represents a significant shift in food safety regulation, potentially affecting how thousands of ingredients enter the American food supply. This change would mark a new era of oversight in the food industry, requiring manufacturers to demonstrate ingredient safety before market introduction rather than relying on self-determination.