The US Food and Drug Administration (FDA) announced on Tuesday (February 10) that it is reviewing the use of Butylated Hydroxyanisole (BHA) in food and whether it is safe as a Food Contact Substance (FCS), which refers to materials that come into contact with food during the manufacturing, packaging, transportation, and storage processes.
This review is part of FDA’s broader effort to “examine chemical additives in the food supply.” In May last year, FDA initiated a mandatory program to evaluate chemical substances in the food supply, with BHA being listed as a major focus of the review.
According to data from the National Toxicology Program (NTP) in the United States, BHA is primarily used as an antioxidant and preservative in food (including butter, lard, various meats, grains, and baked goods), food packaging, animal feed, cosmetics, rubber, and petroleum products. In other words, it can be used to manufacture yoga mats as well as a food preservative in pasta production.
NTP indicates that based on animal studies, the additive “may be harmful to humans.”
US Secretary of Health and Human Services, Robert F. Kennedy Jr., mentioned the data from NTP on Tuesday.
Animal studies have shown a correlation between exposure to BHA and benign and malignant tumors in the forestomach, as well as liver cancer, although there is currently insufficient data to evaluate the relationship between human cancer and exposure to this compound.
In a statement, Secretary Kennedy Jr. said, “This reassessment marks the end of the era of ‘trust us’ in the field of food safety. If BHA cannot meet the highest standards of today’s science for its current uses, we will remove it from the food supply and continue to clean up chemical substances in food, starting with areas of greatest risk for children.”
FDA had classified BHA as generally recognized as safe in 1958 and approved it as a food additive in 1961.
On Tuesday, FDA noted that in several comments submitted in its agenda for public meetings, it had been “suggested to reevaluate BHA” as part of FDA’s systematic evaluation process for chemical substances in food. This evaluation was completed in January 2025.
In April last year, FDA announced a plan to gradually eliminate petroleum-based food dyes from food. Secretary Kennedy Jr. stated at the time that food companies were reaching a “truce” with the government to gradually phase out these dyes but did not disclose what punitive measures would be taken against companies that did not remove these dyes from their products.
FDA also stated last week that it will not yet enforce federal regulations regarding “false or misleading” information on food labels concerning artificial colors.
The International Agency for Research on Cancer (IARC), a subsidiary of the World Health Organization (WHO), classifies BHA as a Group 2B carcinogen (ranging from 1 to 4, with 1 being the strongest), meaning it is possibly carcinogenic to humans, the safety cannot be established, but it cannot be directly confirmed as a carcinogen.
(This article was referenced from a report by “The Hill.”)