BVO No Longer Authorized for Food Use by FDA

Effective August 2, 2024, the U.S. Food and Drug Administration (FDA) has revoked its authorization of the use of brominated vegetable oil (BVO) in food due to studies showing the potential for adverse health effects to humans. The compliance date is one year after the effective date, by which point companies must reformulate, relabel, and deplete their inventories of BVO-containing products.

Conducted in collaboration with the U.S. National Institutes of Health (NIH), the study that prompted FDA to revoke its authorization of BVO in food showed damaging effects on the thyroid. Specifically, scientists conducted a 90-day dietary exposure study in Sprague Dawley rats and analyzed tissue distribution of the main metabolites. Male and female rats aged six weeks were fed diets containing varying amounts of BVO by weight. Statistically significant increases were observed in the serum bromide in the high-dose group of both sexes; as well as in the incidence of thyroid follicular cell hypertrophy in the two highest dose groups of males and in the high-dose group of females. An increase in thyroid stimulating hormone (TSH) serum was observed in the high-dose group for both sexes, as well as a decrease in serum T4 in the high-dose males. A clear dose-response was observed in di- and tetra-bromostearic acid levels in the heart, liver, and inguinal fat.

The findings of the NIH study expand upon previous observations in rats and pigs that oral exposure to BVO is associated with increased tissue levels of inorganic and organic bromine, and that the thyroid is a potential target organ of toxicity.

FDA has regulated BVO as a food additive since the agency removed it from the list of Generally Recognized As Safe (GRAS) substances in 1970. As authorized, it was used in small amounts to keep the citrus flavoring from floating to the top in some beverages, and manufacturers were required to list BVO, or the specific type of BVO such as brominated soybean oil, in the ingredients list if it was used. In the present day, few beverages in the U.S. contain BVO.

FDA’s revocation of its regulation authorizing BVO for use in food is the result of its efforts to strengthen systematic post-market chemical reassessment, following a recent uptick in state legislative action to regulate food additives. BVO is one of the food additives banned by the 2023 California Food Safety Act, and is the target of similar pieces of legislation pending in other states.