The US Food and Drug Administration (FDA) has begun a wide-ranging re-evaluation of the food preservative butylated hydroxyanisole (BHA) and issued a Request for Information to support the review.
The agency said it will assess whether BHA remains safe under its existing conditions of use in food and as a food contact substance, taking into account the most recent scientific evidence.
The initiative is part of the FDA’s broader push to reassess chemical additives used across the food supply.
In May 2025, the regulator introduced a strengthened framework for reviewing chemicals already present in food and named BHA as a priority for scrutiny.
The current post-market assessment forms one of several reviews being carried out under the agency’s enhanced and more systematic oversight process for food-related substances.
BHA was designated as generally recognised as safe (GRAS) in 1958 and subsequently approved as a food additive in 1961.
It is commonly used to delay the deterioration of fats and oils and appears in a range of products, including frozen meals, breakfast cereals, biscuits, confectionery, ice cream and processed meat items.
While data from packaged food labels suggest that the use of BHA has decreased in recent years, the preservative is still found in numerous products, including those aimed at children.
Health and Human Services Secretary Robert F Kennedy, Jr. said: “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.”
According to the press statement, health advocates have long questioned the safety profile of BHA.
The National Institutes of Health’s National Toxicology Program classifies the substance as “reasonably anticipated to be a human carcinogen” based on animal research findings.
BHA was also highlighted for re-examination in submissions to the public meeting docket for the development of an enhanced systematic process for FDA’s post-market assessment of chemicals in food, which closed in January 2025.
In addition, the Make America Healthy Again (MAHA) Commission’s Strategy Report identified post-market reviews of food additives, food contact substances, GRAS substances and colour additives as a central priority.
The FDA said it also plans to propose a regulation aimed at closing the GRAS loophole.
