On November 2, 2023 the FDA proposed to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. The FDA conducted studies that clearly show adverse health effects in animals in levels more closely approximating real-world exposure. Therefore, the FDA can no longer conclude that this use of BVO in food is safe.
The studies were conducted in collaboration with the National Institute of Environmental Health Sciences’(NIEHS) Division of Translational Toxicology (formerly the Division of the National Toxicology Program), to assess unresolved toxicological questions. Results from these studies demonstrate bioaccumulation of bromine and toxic effects on the thyroid – a gland that produces hormones that play a key role in regulating blood pressure, body temperature, heart rate, metabolism and the reaction of the body to other hormones.
BVO is a vegetable oil that is modified with bromine. As authorized, it is used in small amounts, not to exceed 15 parts per million, as a stabilizer for fruit flavoring in beverages to keep the citrus flavoring from floating to the top. When used, BVO is required to be listed as an ingredient on the label as “brominated vegetable oil” or as the specific oil that has been brominated, such as “brominated soybean oil”.
Over time, many beverage makers have reformulated their products to replace BVO with an alternative ingredient. Today, few beverages in the U.S. contain BVO.
The FDA identifies chemicals in food for which the science suggests there may be benefit from further research.
This assessment is part of FDA’s continuing evaluation of the safety of chemicals in food. The agency uses its currently available scientific and regulatory tools for these assessments while continually evolving to incorporate new approaches to evaluating the safety of food chemicals. To do this, FDA scientists:
- Stay abreast of advances in food composition including added chemical substances, chemical contaminants, food consumption and the development of new chemicals for use in or with food and methods to evaluate chemical safety.
- Apply our existing authority flexibly and effectively to support rapidly evolving areas of technological innovation, while maintaining our rigorous safety standard.
- Invest resources into building our capacity to collect, analyze and integrate scientific data to assess the safety of chemicals to meet our regulatory responsibilities.
History and Timeline
BVO had been used as a food ingredient since the 1920s.
In 1958, the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act gave the FDA specific authority to regulate food ingredients.
In the late 1950s and early 1960s, the FDA considered the use of BVO to be generally recognized as safe (GRAS) and placed BVO on its original “GRAS list,” in the Code of Federal Regulations (CFR).
In the late 1960s, the FDA became aware of questions about the safe use of BVO and removed it from the “GRAS list”. However, there was not enough data to restrict its use overall. Instead, the agency limited the use of BVO as a flavoring oil stabilizer in fruit-flavored beverages at a reduced use level and began regulating it as a food additive. The FDA also determined that there would be an adequate margin of safety from the use of BVO in beverages at the reduced use level of 15 parts per million on an interim basis while additional, longer-term safety studies with BVO were conducted.
On January 27, 1970, the FDA concluded that the use of BVO in food was not GRAS because of toxicity concerns under the conditions of use at the time. Studies performed by other regulatory agencies and research institutions on test animals that were fed BVO at levels that far exceeded estimates of most human consumption raised concerns about possible effects on the heart. The available safety data did not indicate an immediate health threat from the limited use of BVO in beverages but did not establish a level at which BVO could be safely used in food over a person’s lifetime.
On July 28, 1970, the FDA began regulating BVO as a food additive while additional safety studies were conducted. These additional safety studies resolved the safety concerns related to the heart.
The FDA continued to evaluate new information about the possible health effects of BVO as it became available. In 2014, FDA scientists reassessed available information on the safety of BVO and identified areas where additional information on possible health effects was needed and worked to obtain this information. 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.
Between 2016 and 2020, the FDA published improved methods to more accurately measure the amount of BVO in commercial soft drinks on the market and to measure small amounts of fats in vegetable oil. These research efforts 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.
On May 16, 2022, the FDA published a study in the journal Food and Chemical Toxicology that evaluated potential health effects related to BVO consumption in rodents. The FDA 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 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. The agency also conducted a study to identify the level of BVO in the body after consumption of BVO.
On November 2, 2023, the FDA issued a proposed rule that, if finalized, would revoke the regulation allowing the use of BVO in food. Animal and human data, including new information from recent FDA-led studies on BVO, no longer provide a basis to conclude the use of BVO in food is safe.
For More Information
- Constituent Update: FDA Proposes Rule to No Longer Allow the Use of Brominated Vegetable Oil (BVO) in Food