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.