Brominated vegetable oil (BVO) is a vegetable oil that has bromine added to it. It is used in small amounts to keep the citrus flavoring from floating to the top in some beverages. When used, BVO must be listed as an ingredient on the label. BVO may be listed as “brominated vegetable oil” or as the specific oil that has been brominated, such as “brominated soybean oil.”
The FDA evaluates the safe use of any food ingredient using the best available science and has continued to evaluate information about BVO as it becomes available. In our evaluation, we identified areas where additional information about possible health effects was needed. To help address these data gaps, we collaborated on several studies with the National Institute of Environmental Health Sciences’ (NIEHS) Division of the National Toxicology Program (DNTP).
Over the years, many beverage makers have reformulated their products to replace BVO with an alternative ingredient. Today, few beverages in the U.S. contain BVO.
Regulatory Approach for BVO in Food
BVO is added to a food for a specific purpose and is regulated by the FDA as a direct food additive. BVO is allowed for use in a small amount, not to exceed 15 parts per million, in the U.S. as a stabilizer for fruit flavoring used in beverages.
The FDA is working on a proposed rule to amend our regulations to remove the authorization of the use of BVO as a food ingredient. For more information, see the unified agenda.
Previous Research on Possible Health Effects of BVO
On July 28, 1970, the FDA limited the use of BVO as a food additive on an interim basis due to concerns raised in rodent studies conducted in the late 1960s. These studies were done on test animals that were fed BVO at levels that far exceeded estimates of most human consumption but raised concerns about possible effects on the heart. These concerns were resolved by later studies in the 1970s.
The FDA has continued to evaluate new information about BVO as it becomes available. In addition, the FDA has developed improved methods to better measure the amount of BVO in commercial soft drinks on the market and to measure small amounts of fats in vegetable oil. These enabled the development and validation of the method used in our later animal studies to detect the level of brominated fats in tissues of animals fed BVO. Later studies and reports suggested other possible health effects, but they had limitations.
The FDA’s Continued Evaluation of BVO
We have identified areas where additional information about possible health effects is needed and are working to obtain this information, including through ongoing FDA-NIEHS research. This will help inform our next steps on regulating the use of BVO in food.
Building on our earlier studies, the FDA conducted animal studies funded by an interagency agreement with NIEHS to assess potential effects and identify the level of BVO in the body after consumption. The FDA recently published the results from one of these studies.
On May 16, 2022, the FDA published in the journal Food and Chemical Toxicology a study that evaluated potential health effects related to BVO consumption in rodents. We measured the amounts of BVO present in the animal food and brominated fats in tissues from test animals. We also fed test animals amounts of BVO that were near our estimated BVO consumption for people who consume BVO at high levels to better simulate real-life exposure. The data from the study suggest that 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. An additional study to identify the level of BVO in the body after consumption of BVO is being finalized.
The FDA takes seriously the potential safety concerns raised by the recently published study and is evaluating this study and other available information in determining next steps. We will inform the public if new information or recommendations about BVO become available.