FDA Bans Brominated Vegetable Oil in Food Products

The U.S. Food and Drug Administration is revoking the regulation authorizing the use of brominated vegetable oil in food. Brominated vegetable oil 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 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.

The FDA is taking this action as part of our 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 our food safety mission.

The rule is effective on Aug. 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.

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