FDA Opens Safety Review of Synthetic Food Preservative BHA (1)

Officials at the US Food and Drug Administration on Tuesday launched a safety review of a decades-old preservative used in a variety of packaged foods including frozen meals and meat products.

The agency is seeking public input on how food manufacturers use a chemical known as butylated hydroxyanisole, or BHA, and whether the latest science says it’s still safe to use, according to a notice scheduled to publish Wednesday in the Federal Register.

Although public health advocates have for decades raised questions about the substance’s safety and the National Toxicology Program has identified BHA as a likely human carcinogen, the FDA has found it to be “generally recognized as safe” since 1958 and approved its use as a food additive in 1961. Health and Human Services Secretary Robert F. Kennedy Jr. called the post-market safety review part of advancing policy goals to review chemicals in food outlined in a report produced by the Make America Healthy Again Commission.

“This reassessment marks the end of the ‘trust us’ era in food safety,” Kennedy said in a Tuesday statement. “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.”

Officials at the FDA said food manufacturers have used BHA as a food additive less in recent years, citing food label data, but said the chemical remains present in a range of food products, including those marketed to children.

“We appreciate FDA’s proactivity in reviewing butylated hydroxyanisole (BHA) in the food supply as the industry continues to advocate for national ingredient safety uniformity to give Americans everywhere confidence in the safety of food and beverage products,” said Sarah Gallo, the senior vice president of the Consumer Brands Association, which represents major food makers including Kraft Heinz Co., General Mills Inc., and PepsiCo Inc.

The Environmental Working Group, which has advocated for BHA’s removal from food products, estimated in 2024 that more than 4,600 foods contained the substance.

“This is yet another instance of the FDA planning to plan instead of taking decisive action,” EWG’s Vice President of Government Affairs Melanie Benesh said in a comment emailed Tuesday. “And this time the FDA’s plan is more than three decades late. A petition to ban BHA has been pending for over 30 years, during which time evidence of risk has accumulated, consumers have voiced concern and states and retailers have stepped in where federal regulators would not.”

Separately, the agency is working to bolster oversight of which food additives fall under the “generally recognized as safe,” or GRAS, category. Officials at the FDA in 2025 proposed a rule mandating that manufacturers notify the agency when they introduce a new substance to the food supply, a notification that is currently voluntary and largely self-determined by companies.

The White House’s Office of Management and Budget started reviewing the rule in December. OMB approval is the final step before an agency publishes a final rule.