Regulatory Watch
FDA to Reassess Use of BHA in Food
The U.S. Food and Drug Administration has launched a re-assessment of butylated hydroxyanisole (BHA), a chemical preservative used in food.
The review will consider whether BHA is safe under its current conditions of use in food and as a food contact substance, based on the latest scientific information. As part of this re-assessment, the agency issued a request for information on the use and safety of BHA.
The FDA says this is part of its broader efforts to review chemical additives in the food supply. The agency has identified BHA as a top priority for review. The FDA’s post-market assessment of BHA used in food is one of several ongoing post-market assessments under the agency's enhanced systematic process for scrutinizing chemicals in our food supply.
“BHA has remained in the food supply for decades despite being identified by the National Toxicology Program as ‘reasonably anticipated to be a human carcinogen’ based on animal studies,” says Health and Human Services Secretary Robert F. Kennedy, Jr. “This reassessment marks the end of the ‘trust us’ era in food safety. If BHA cannot meet today’s gold-standard science for its current uses, we will remove it from the food supply and continue cleaning up food chemicals — starting where children face the greatest exposure.”
The FDA listed BHA as Generally Recognized as Safe (GRAS) in 1958 and approved it as a food additive in 1961. It is used to prevent spoilage of fats and oils and can be found in various food products including frozen meals, breakfast cereals, cookies, candy, ice cream and meat products.
"We are taking decisive action to ensure that chemicals in our food supply are not causing harm," says FDA Commissioner Marty Makary. "The scientific community has raised significant concerns about some chemicals currently in the food supply. Once we complete our assessment of BHA, we expect to conduct similar assessments for butylated hydroxytoluene, a synthetic preservative known as BHT, and azodicarbonamide.”
The National Institute of Health’s National Toxicology Program lists BHA as “reasonably anticipated to be a human carcinogen” based on animal studies. BHA was recommended for re-assessment in several comments submitted to the public meeting docket for the Development of an Enhanced Systematic Process for the FDA's Post-Market Assessment of Chemicals in Food that closed in January 2025.
The Make America Healthy Again Commission’s Strategy Report identified as a key priority the post-market review of chemical additives in food, including food additives, food contact substances, GRAS substances and color additives. The FDA has advanced draft rulemaking to reform its GRAS framework to drive greater transparency into the food supply by addressing independent GRAS conclusions and bringing greater oversight into the review of chemicals added to food.
Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!
