WASHINGTON – The US Food and Drug Administration on July 3 said it no longer approves the use of brominated vegetable oil (BVO) in foods and beverages. The FDA concluded the intended use of BVO is no longer safe after studies that it conducted in collaboration with the National Institutes of Health found potential for adverse health effects in humans.

Previously, the FDA allowed BVO for use in small amounts (not to exceed 15 parts per million) to keep citrus flavoring from floating to the top in some beverages. The ingredient often is prepared from soybean oil and declared on labels as “brominated soybean oil” according to the FDA. Few beverages in the United States contain BVO, according to the agency.

The rule becomes effective Aug. 2. Companies need to be compliant a year later (Aug. 2, 2025), which will give them the opportunity to reformulate, relabel and deplete inventories of products containing BVO, according to the FDA.

“Revoking the regulation that authorized the use of brominated vegetable oil in food is an example of FDA using its risk and science-based post-market authority,” said Sarah Gallo, vice president, product policy for the Consumer Brands Association “This process shows that FDA's system on reviewing food additives is active and working. Food safety is the No. 1 priority for the makers of America's trusted household brands, and we will continue to actively participate in the regulatory process to ensure a safe and wholesome food supply.”

The FDA on May 16, 2022, published a study in Food and Chemical Toxicology that evaluated potential health effects related to BVO consumption in rats. The data from the study suggested oral exposure to BVO is associated with increased tissue levels of bromine and that at high levels of exposure the thyroid is a target organ of potential negative health effects in rodents. The FDA on Nov. 2, 2023, issued a proposed rule to revoke the regulation allowing the use of BVO in food and beverages.