FDA to reassess safety of food preservative BHA
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.
USA – The U.S. Food and Drug Administration (FDA) has launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a widely used synthetic antioxidant preservative in snacks, cereals, and meats, amid long-standing cancer concerns flagged by animal studies.
The review seeks public input on BHA’s current uses and safety in food and packaging, based on the latest scientific information.
As part of this reassessment, the agency issued a Request for Information on the use and safety of BHA.
BHA prevents rancidity in fats and oils, and is found in potato chips, chewing gum, baked goods, and frozen dinners at levels up to 0.02% of the fat content.
Classified as “reasonably anticipated to be a human carcinogen” by the National Toxicology Program based on animal studies, it prompted scrutiny after forestomach tumors in rats, though humans lack that organ.
This is part of the FDA’s broader efforts to review chemical additives in the food supply proactively. In May 2025, the FDA launched a strengthened program to review chemicals currently in the food supply.
The FDA 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.
Health Secretary Robert F. Kennedy Jr. declared the review ends the “trust us” era, vowing a ban if BHA fails modern safety standards.
This action follows state bans, Texas from 2026/27 school lunches, Louisiana in 2027/28, and advocacy from groups decrying FDA delays.
FDA Commissioner Marty Makary called it the start of broader scrutiny of additives under the Trump administration.
Past evaluations, such as EFSA’s 2011 ADI of 1 mg/kg body weight, deemed low exposures safe, but critics demand updates on genotoxicity and endocrine data.
For the food industry, reformulation looms if banned, spurring natural alternatives like tocopherols or rosemary extract amid clean-label demands.
Bakery and snack makers, key BHA users, face supply chain shifts, potentially hiking costs but boosting consumer trust.
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 Generally Recognized as Safe (GRAS) framework in an effort 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.
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