FDA to re-examine controversial BHA preservative, a move advocates say is overdue

Butylated hydroxyanisole (BHA), a chemical preservative used in food, is facing increased scrutiny from the Food and Drug Administration, which announced Tuesday it launched a “comprehensive re-assessment” to determine its safety for use in food and as a contact substance. FDA issued a request for information on BHA’s use and safety. Comments are due April 13. Meanwhile, organizations pushing to ban the chemical have criticized the FDA’s delay in reviewing BHA. Comments from Health and Human Services Secretary Robert F Kennedy, Jr suggested the preservative’s days could be numbered. “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,” Kennedy said in the press release. “This reassessment marks the end of the ‘trust us’ era in food safety.” Kennedy added that BHA must achieve “today’s gold-standard science for its current uses,” or FDA will ban it from the food supply. “We are taking decisive action to ensure that chemicals in our food supply are not causing harm,” according to FDA Commissioner Marty Makary, who added that the BHA review is just the beginning of the review of additives. ”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 FDA determined BHA to be Generally Recognized as Safe (GRAS) in 1958 and approved it as a food additive in 1961. It is used as an antioxidant to preserve oils and fats in products such as frozen meals, ice cream, cereals, cookies, candy and meat products. BHA’s use is less common these days, but it is still found in many products, including those marketed to children, according to the FDA. Scrutiny of the additive is nothing new, according to the FDA, which noted that health advocates have raised health concerns for decades. The National Institute of Health’s National Toxicology Program noted in its 15th Report on Carcinogens , released in 2021, that BHA is “ reasonably anticipated to be a human carcinogen .” “Dietary exposure to BHA caused benign and malignant tumors of the forestomach (papilloma and squamous-cell carcinoma) in rats of both sexes and in male mice and hamsters,” the report noted. “Since BHA was listed in the Sixth Annual Report on Carcinogens, an additional study in experimental animals has been identified. Dietary administration of BHA to fish (hermaphroditic Rivulus marmoratus) as larvae caused liver cancer (hepatocellular carcinoma) in the adult fish.” FDA said on Tuesday that BHA was recommended for re-assessment in comments submitted to the docket for Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food that closed in January 2025. The Report on Carcinogens also explained that workers in the food industry also face high levels of exposure to BHA. “Workers potentially are exposed to BHA in certain industries, including food producers, animal feed producers, livestock producers, cosmetic manufacturers, some petroleum workers and rubber producers and those who handle the end products, such as tires,” the report noted. “Fast food service personnel who normally cook and serve fried and oily foods potentially are exposed to BHA at high levels.” The Environmental Working Group criticized the announcement, arguing that advocates have been pushing to ban BHA for three decades. Melanie Benesh, vice president for government affairs at the Environmental Working Group, released a statement Tuesday, calling the announcement an example of “FDA planning to plan instead of taking decisive action.” “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,” Benesh said. West Virginia already has banned BHA and retailers like Kroger, Hy-Vee and Aldi prohibit the chemical’s use in their private-label brands, according to Benesh. “This raises the obvious question of what, exactly, the FDA is hoping to learn now. Instead, the FDA could simply grant the pending petition and get BHA off the shelves everywhere much more quickly,” she said. “A request for information that follows decades of inaction is not leadership; it’s a paper exercise. Americans deserve timely, decisive food safety regulation, not another slow-walked process that treats urgency as optional.” BHA and other controversial additives and preservatives could face ongoing scrutiny under the Food Chemical Reassessment Act of 2025 , which was introduced last year and still awaits a hearing in the House Energy and Commerce Committee. Under that proposal, BHA and a host of other chemicals would undergo a review every three years. Those chemicals found in food and food packaging include: Tert-butylhydroquinone (TBHQ), titanium dioxide, red dye 40, yellow dye 5, blue dyes 1 and 2, green dye 3, perchlorate, butylated hydroxytoluene (BHT), trichloroethylene, methylene chloride, benzene, ethylene chloride, propyl gallate, sodium nitrate and sodium benzoate. Meanwhile, states are pursuing their own review of BHA and other chemicals. The Pennsylvania Show Us Your Science Act includes HB 1133 , which requires warning labels on products containing BHA.

FDA to re-examine controversial BHA preservative, a move advocates say is overdue

The long-awaited re-evaluation of butylated hydroxyanisole could preview the agency’s future approach to food additives flagged under federal and state chemical safety proposals

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