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FDA Proposes to Ban Food Additive (brominated vegetable oil), Continues Assessments of Additional Chemicals

November 2, 2023 from the FDA:

Today, the U.S. Food and Drug Administration proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. The agency concluded that the intended use of BVO in food is no longer considered safe after the results of studiesExternal Link Disclaimer conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans.

BVO is a vegetable oil that is modified with bromine. It is authorized by the FDA for use in small amounts to keep the citrus flavoring from separating and floating to the top of some beverages. In 1970, the FDA determined BVO was no longer “Generally Recognized as Safe” (GRAS) and began overseeing its use under our food additive regulations. Over the years many beverage makers reformulated their products to replace BVO with an alternative ingredient, and today, few beverages in the U.S. contain BVO.

Although BVO has a long history of use in foods and was at one time considered GRAS, we have continued to study it to understand any potential health impacts. Recent toxicology studiesExternal Link Disclaimer conducted in collaboration with the NIH have now given us conclusive scientific evidence to support our proposal to remove the FDA’s food additive authorization for BVO.

The FDA is currently reviewing the color additive regulations authorizing the use of FD&C Red No. 3 in ingested drugs and foods (including dietary supplements) under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which, in relevant part, prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested. A decision from the FDA is forthcoming.