November 2, 2023
Today, the U.S. Food and Drug Administration (FDA) proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. This action is part of our regulatory authority over ingredients added to food, which includes reassessing previously evaluated food ingredients and addressing safety concerns. Brominated vegetable oil (BVO) is a vegetable oil that is modified with bromine. As authorized, it is used in small amounts to keep the citrus flavoring from floating to the top in some beverages.
The FDA is issuing a 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. Results from these studies show bioaccumulation of bromine and toxic effects on the thyroid – a gland that produces hormones that play a key role in regulating blood pressure, body temperature, heart rate, metabolism and the reaction of the body to other hormones.
The studies were conducted in collaboration with the National Institute of Environmental Health Sciences’ Division of Translational Toxicology (formerly the Division of the National Toxicology Program), to assess unresolved toxicological questions.
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.
Over the years, many beverage makers have reformulated their products to replace BVO with an alternative ingredient. Today, few beverages in the U.S. contain BVO. Consumers who wish to avoid products that contain brominated vegetable oil may do so by looking for it by name in the ingredients list.
Reassessing the safety of food ingredients as new, relevant data become available, is a priority for the FDA and a key part of our food safety mission.
Submit Comments
Comments about the proposed rule should be submitted by January 17, 2024. Submit comments electronically on Regulations.gov to docket number FDA-2023-N-0937.
Additional Information
- Federal Register Notice: Revocation of Uses of Brominated Vegetable Oil in Foods
- Brominated Vegetable Oil (BVO)
