On November 2, 2023, the U.S. Food and Drug Administration (FDA) released a proposed rule to revoke the regulation that authorized the use of brominated vegetable oil (BVO) in food. Any comments can be submitted online by January 17, 2024.
BVO is a vegetable oil modified with bromine. Since its removal from the Generally Recognized As Safe (GRAS) substances in 1970, the FDA regulates BVO as a food additive. According to 21 CFR 180.30, food additive BVO may be safely used in beverages as a stabilizer for fruit flavoring, with a maximum permissible limit of 15 parts per million. Its purpose is to prevent the citrus flavoring from floating to the top. Besides, when used, BVO must be accurately disclosed as an ingredient on the product label, either by identifying the "brominated vegetable oil" or specifying the particular oil that has been brominated, such as "brominated soybean oil."
On May 16, 2022, the FDA published a study in the journal Food and Chemical Toxicology, which assessed the potential health effects of consuming BVO in rodents. The study data indicated that oral exposure to BVO led to increased levels of bromine in the tissues. Besides, at high levels of exposure, the thyroid appeared to be a target organ for potential adverse health effects in rodents. As thyroid is a gland responsible for producing hormones, it plays a vital role in regulating various bodily functions, including blood pressure, body temperature, heart rate, metabolism, and the body's response to other hormones. Hereafter, due to adverse health effects in animals at levels more closely approximating real-world exposure, the FDA no longer concludes that BVO in food is safe.
Over the years, many beverage manufacturers have reformulated their products by substituting BVO with alternative ingredients, such as sucrose acetate isobutyrate (SAIB, E444) and glycerol ester of wood rosin (ester gum, E445). As a result, now there are only a few beverages in the United States that still contain BVO.
On the same day, FDA also announced that they would continue to evaluate additional chemicals (or additives). Currently, the FDA is reviewing the authorization of FD&C Red No. 3 in ingested drugs and foods (including dietary supplements). The specific review process includes the assessment of its potential carcinogenic effects in animals and humans, in accordance with the Delaney Clause, which prohibits the approval of color additives that may cause cancer when ingested. A decision from the FDA can be expected soon.