The U.S. Food and Drug Administration announced on Tuesday its intention to undergo a renewed safety evaluation of butylated hydroxyanisole (BHA), a chemical preservative extensively utilized in foods such as potato chips, cereals, frozen meals, and meat products. This initiative involves the issuance of a fresh request for information specific to BHA, underlining the agency's commitment to reassessing whether its use in food products and food-contact materials complies with current safety standards.
According to an official FDA statement, the forthcoming review will carefully examine BHA's safety "under its current conditions of use in food and as a food contact substance." This action is embedded within a broader FDA effort aimed at scrutinizing the range of chemical additives incorporated into the U.S. food system. BHA was previously identified as a priority for such a review as early as May, illustrating its significance within regulatory safety considerations.
FDA Commissioner Marty Makary emphasized this decisive move by stating, "We are taking decisive action to ensure that chemicals in our food supply are not causing harm." BHA's regulatory history dates back over six decades, with the FDA first designating it as "generally recognized as safe" (GRAS) in 1958 and subsequently approving it as a food additive in 1961.
Despite its longstanding approval, BHA has been classified as "reasonably anticipated to be a human carcinogen" since 1991 by the National Toxicology Program, reflecting ongoing concerns regarding its long-term safety. In addition, health advocacy organizations such as the Center for Science in the Public Interest have consistently advised consumers to avoid products containing BHA, citing animal studies that demonstrated carcinogenic effects in rats, mice, and hamsters.
Further compounding concerns, BHA has been officially listed as a known carcinogen under California’s Proposition 65 regulations since 1990, highlighting its recognized potential risk at the state level.
The FDA's latest assessment also noted that although use of BHA has declined in recent years based on package labeling data, it remains present in many food products, including some marketed toward children. This ongoing presence raises questions about exposure risks across various demographics, particularly among vulnerable consumers.
This regulatory reassessment fits within the FDA’s comprehensive approach to continuously vetting the safety and approval status of chemical additives in foods, ensuring alignment with contemporary scientific evidence and public health considerations.