US regulator begins comprehensive scientific review of widely used antioxidant preservative, signalling tougher scrutiny of legacy additives and potential future removals from food supply.
The US Food and Drug Administration (FDA) has launched a comprehensive re-assessment of butylated hydroxyanisole (BHA), a widely used food preservative, to determine whether it remains safe under current conditions of use.
The review will evaluate BHA in food and food contact materials using the latest scientific evidence, while inviting additional data through a formal Request for Information.
The action forms part of the FDA’s strengthened programme to re-evaluate chemicals already present in the food supply, launched in May 2025, with BHA identified as a top priority. The agency said the post-market review is one of several ongoing assessments under a more systematic approach to scrutinising food chemicals and protecting public health.
Health and Human Services Secretary Robert F. Kennedy, Jr said:
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.
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.”
Widespread use and long-standing safety debate
BHA has been used for decades to prevent spoilage in fats and oils and is commonly found in products such as frozen meals, breakfast cereals, biscuits, confectionery, ice cream and processed meat. Although packaged food label data suggest its use has declined in recent years, the preservative remains present in many products, including some marketed to children.
The FDA first classified BHA as Generally Recognised as Safe (GRAS) in 1958 and approved it as a food additive in 1961.
However, safety concerns have persisted among health advocates, and the National Institutes of Health’s National Toxicology Program continues to list the substance as “reasonably anticipated to be a human carcinogen” based on animal evidence. Stakeholders also submitted calls for re-assessment during consultations on the FDA’s enhanced chemical review framework, which closed in January 2025.
FDA Commissioner Marty Makary explained:
We are taking decisive action to ensure that chemicals in our food supply are not causing harm.
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 - a chemical used in yoga mats and also used as a dough conditioner.”
The reassessment aligns with broader federal priorities to strengthen oversight of chemical additives, including recommendations from the Make America Healthy Again Commission to prioritise post-market reviews across additives, food contact substances and colourings. The FDA has also advanced draft rulemaking to reform its GRAS framework, aiming to improve transparency and tighten oversight of industry-led safety determinations.
Kyle Diamantas, Deputy Commissioner for Human Foods added:
The FDA is committed to ensuring the safety of chemicals in our food supply through rigorous, science-based evaluation.
This comprehensive post-market assessment of BHA reflects our proactive approach to food safety and our dedication to protecting public health by continuously reviewing the latest scientific evidence."
For more information on the Request for Information on BHA, visit the FDA’s list of select chemicals in the food supply under review.
