FDA Launches Comprehensive Safety Review of Food Preservative BHA Over Cancer Concerns

The FDA announced a full reassessment of butylated hydroxyanisole (BHA), a chemical preservative used in packaged foods, to determine if it remains safe based on current science. The review follows decades of concerns about BHA being listed as "reasonably anticipated to be a human carcinogen."

The U.S. Food and Drug Administration announced on February 10, 2026, that it has launched a full review to decide whether butylated hydroxyanisole, or BHA, is still safe to use in food and food packaging based on the latest science. The reassessment will consider whether BHA is safe under its current conditions of use in food and as a food contact substance based on current scientific data.

As part of that process, the FDA is asking the public to submit new information about how BHA is used and its safety. The agency issued a request for information on the current uses of BHA in human food and as a food contact substance as well as any related safety data. Comments on the request for information are due April 13, 2026.

"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," U.S. Department of 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."

The National Institutes of Health's National Toxicology Program lists BHA as "reasonably anticipated to be a human carcinogen" based on animal studies. Health advocates have raised concerns about BHA for years. In 1990, FDA received a Food Additive Petition calling for the prohibition of BHA in certain uses, which has remained open.

BHA was first listed as "generally recognized as safe" (GRAS) in 1958 and approved as a food additive in 1961. It is mainly used to prevent fats and oils from spoiling and can be found in foods such as frozen meals, breakfast cereals, cookies, candy, ice cream and some meat products. BHA acts as an antioxidant and is used to prevent the spoilage of oils and fats in these products.

Currently, BHA is authorized for use in food and as a food contact substance through multiple different pathways, including GRAS for use as an antioxidant in food generally with limitations, prior-sanctioned use as a food contact substance with limitations, direct food additive use as an antioxidant alone or with butylated hydroxytoluene (BHT) in certain foods, flavoring substances, and chewing gum with specified limitations, indirect or secondary direct food additive use as an antioxidant in food contact surfaces including defoaming agents, adhesives, semirigid and rigid acrylic and modified acrylic plastics, closures with sealing gaskets for food containers, ethylene-vinyl acetate copolymers, machinery lubricants with incidental food contact, and polyethylene film, and ingredient use in the FDA and USDA standard of identity for margarine and the USDA specification for butteroil.

While its use has declined in recent years, BHA is still present in many foods, including products marketed to children.

FDA Commissioner Dr. Marty Makary said, "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 move is part of a larger effort by the FDA to more closely review chemicals already in the food supply. In May 2025, the agency launched a new program to reassess food additives, and BHA was named one of its top priorities. This review is part of FDA's broader effort to review chemical additives in the food supply on a proactive basis as a part of the agency's Post-Market Chemical Assessment Program, which was referenced in the Make America Healthy Again Commission's Strategy Report.

In August 2024, FDA released for public comment a discussion paper outlining its plan for an enhanced systematic process for post-market assessment of chemicals in food. Food chemical safety was listed as the top priority in FDA's list of 2026 Priority Deliverables, which specifically noted FDA would be assessing the safety of phthalates, propylparaben, BHA, and BHT in 2026.

The FDA's request for information is focused on uses, use levels, dietary exposure, and safety data on BHA currently used in food and as a food contact substance, including the general food categories in which BHA is used, typical and maximum levels of BHA in each food category, data on the migration of BHA from food contact materials into food in current uses, subpopulations with high dietary exposure to BHA or other relevant safety concerns, other dietary sources of BHA, market share of foods and food contact substances using BHA, biomonitoring data for BHA or its metabolites, market disappearance or poundage data, information on chemically or pharmacologically related substances, safety data on the use of BHA, documentation of GRAS conclusions or prior sanctioned uses for BHA, and information supporting the conclusion BHA is no longer used for one or more of its authorized or intended uses.

The FDA said the new review is part of its push for stronger oversight and more transparency in the food supply. The agency is also working to reform how GRAS decisions are made, which could bring more chemicals under review.

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References

  1. FDA Reviews Safety of Food Preservative BHA Over Cancer Concerns · www.dermatologyadvisor.com
  2. FDA Requests Information on BHA to Support Safety Assessment | Hogan Lovells - JDSupra · www.jdsupra.com
  3. FDA Reviews Safety of Food Preservative BHA Over Cancer Concerns · www.drugs.com