FDA Revokes Regulation Allowing Use of Brominated Vegetable Oil in Food

The U.S. Food and Drug Administration (FDA) revoked the regulation authorizing the use of brominated vegetable oil (BVO) in food. Brominated vegetable oil (BVO) is a vegetable oil that is modified with bromine. The agency concluded that the intended use of BVO in food is no longer considered safe after the results of studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans.

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. 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 brominated vegetable oil such as brominated soybean oil, in the ingredients list if it was used. Few beverages in the U.S. contain BVO, according to the FDA.

The FDA is taking this action as part of its regulatory authority over ingredients added to food, which includes reassessing previously evaluated food ingredients and addressing safety concerns. Reassessing the safety of food ingredients as new, relevant data become available is a priority for the FDA and a key part of its food safety mission, the agency said.

The rule is effective on August 2. The compliance date for this rule is one year after the effective date to provide the opportunity for companies to reformulate, relabel and deplete the inventory of BVO-containing products before the FDA begins enforcing the final rule.