On the heels of a new California law banning the use of brominated vegetable oil (BVO), potassium bromate, propyl paraben and Red Dye No. 3 as food additives, the FDA has announced its proposal to revoke the regulation authorizing the use of BVO in food. Food companies are currently allowed to use BVO, a vegetable oil that is modified with bromine, in small amounts to keep the citrus flavoring from floating to the top in some beverages.
The FDA announced that it is issuing the proposed rule now because the agency has recent data from studies it conducted that demonstrate adverse health effects in animals at levels more closely approximating real-world human exposure. “Based on these data and remaining unresolved safety questions, the FDA can no longer conclude that the use of BVO in food is safe,” the agency stated in its announcement. The studies, which were conducted in collaboration with the National Institute of Environmental Health Sciences’ Division of Translational Toxicology, showed bioaccumulation of bromine and toxic effects on the thyroid gland.
The FDA has regulated BVO as a food additive since the agency removed it from the codified list of Generally Recognized As Safe or “GRAS” substances in 1970. “We recognize that California recently took steps to ban the use of four food ingredients, including BVO, in that state,” the FDA wrote. “The agency is continuously reviewing and reassessing the safety of a variety of chemicals in food to ensure the science and the law support their safe use in food, including all four ingredients that are part of the recent California law. In fact, the FDA is currently reviewing the color additive regulations authorizing the use of FD&C Red No. 3 in ingested drugs and foods (including dietary supplements) under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which, in relevant part, prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested. A decision from the FDA is forthcoming.”
The agency also noted that one of the key reasons for the proposed Human Foods Program (HFP) transformation currently underway is to enhance FDA’s review of food chemical safety. The proposed HFP would include the creation of the Office of Food Chemical Safety, Dietary Supplements and Innovation with the goal of developing a faster and more nimble process for evaluating chemicals in the food supply.
Comments about the proposed BVO rule should be submitted by January 17, 2024, using docket number FDA-2023-N-0937.