The US Food and Drug Administration has 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 studies conducted in collaboration with the National Institutes of Health (NIH) found the potential for adverse health effects in humans.
According to a release issued by FDA, 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 US contain BVO.
The FDA says it prioritizes its review of chemicals in food based on risk, science, and regulatory authority. 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 studies 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.
FDA said the proposed action is an example of how the agency monitors emerging evidence and, as needed, conducts scientific research to investigate safety related questions, and takes regulatory action when the science does not support the continued safe use of additives in foods.
“We recognize that California recently took steps to ban the use of four food ingredients, including BVO, in that state. The agency is continuously reviewing and reassessing the safety of a variety of chemicals in food to ensure the science and the law support their safe use in food, including all four ingredients that are part of the recent California law. In fact, 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,” FDA said.
“While these reviews take time, one of the key reasons for the proposed Human Foods Program (HFP) transformation currently underway is to enhance our review of food chemical safety. The proposed HFP would include the creation of the Office of Food Chemical Safety, Dietary Supplements and Innovation where we intend to develop a faster and more nimble process for evaluating chemicals in the food supply,” FDA said..
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.