FDA Proposes Brominated Vegetable Oil Ban

November 6, 2023

On Nov. 2, 2023, the Food and Drug Administration proposed revoking the regulation that authorizes the use of brominated vegetable oil (BVO) in food. BVO is a vegetable oil with added bromine that prevents the separation of ingredients to ensure emulsification in certain drinks, such as fruit-flavored sports drinks and sodas.

After recent studies revealed that BVO may have adverse health effects in humans, with studies indicating toxic effects on the thyroid as a result of bioaccumulation, the FDA no longer considers it safe.

The FDA considered revoking the BVO rule for some time, but may have been spurred to act after the California Food Safety Act (CFSA) was signed into law on Oct. 7, 2023 (effective Jan. 1, 2027) and New York proposed a ban through Senate Bill S6055A, which is working its way through the state legislature. If signed into law, the New York ban would be effective in 2025.

However, with the FDA’s move to revoke approval for BVO as an additive, the effect on the California and New York legislation is unclear, as the effective date of the FDA’s revocation is unknown. The FDA recognizes that the food industry needs sufficient time to reformulate products, so the compliance date would be one year after the effective date of the final rule, if issued, which likely means a compliance date in 2025.

The FDA is seeking comments on the proposed rule, which should be submitted by Jan. 17, 2024. The FDA will review the public comments and determine if further action is needed or, more likely, issue a final rule.

The FDA continues to review the status of other ingredients banned in the CFSA, such as Red No. 3. The FDA is considering reviewing titanium dioxide, which was not included in the CFSA but is included in New York’s proposed ban.

For more information on how this proposed guidance may apply to you or for assistance drafting a comment, contact the authors of this article.