The FDA recently announced it will start a full safety review of butylated hydroxyanisole (BHA), a chemical preservative commonly used in cereals, frozen meals, snack foods, and other foods with fats and oils.
The agency’s decision to review this chemical, which was first approved for food use in the 1950s and 1960s, shows a tougher approach to ingredients that have been considered safe for a long time. The review follows the National Toxicology Program’s classification of BHA as “reasonably anticipated to be a human carcinogen” based on animal studies.
What’s driving the review?
This is the FDA’s first major post-market review under its updated chemical review program, which started in May 2025. The agency chose BHA as a priority after considering public comments and recommendations from health advocates who have raised safety concerns for years.
Although BHA use has gone down in recent years, according to label data, the agency notes that it’s still found in many products, especially those sold to children.
What’s next?
The FDA said this is only the start. Officials also named two other substances that will be reviewed soon: butylated hydroxytoluene (BHT), another synthetic preservative, and azodicarbonamide, a dough conditioner that is also used in making foam.
What should food manufacturers do now?
The FDA has asked for information about how BHA is currently used and its safety profile. Companies that use BHA or the other chemicals listed should:
Audit product formulations to identify which SKUs contain BHA, BHT, or azodicarbonamide
Review available alternative preservatives and their relative costs
Monitor the FDA’s dedicated webpage tracking chemicals under review
Prepare contingency reformulation plans in case restrictions are imposed
Consider whether proactive reformulation offers marketing advantages
The agency’s announcement describes a new regulatory era focused on “gold-standard science” for food chemicals. Manufacturers using preservatives approved many years ago should expect more scrutiny and prepare for possible changes.
According to the FDA, no specific timeline has been given for the completion of the BHA assessment.
