The U.S. Food and Drug Administration plans to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food.
The action comes after BVO landed on a list of ingredients recently banned by California. The FDA 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.
Brominated vegetable oil is found in as many as 70 sports drinks and sodas, as well as other foods. The substance is said to help liquids mix. It keeps citrus flavorings from coming apart and rising to the top of the beverage.
BVO is a vegetable oil that is modified with bromine. It’s been permitted in small amounts by the FDA. 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 U.S. contain BVO.
“The evidence is clear that brominated vegetable oil in sodas and other beverages poses an unacceptable risk to our health,” said Brian Ronholm, food policy director at Consumer Reports. “Toxic additives like BVO that have been shown to pose toxic risks to the thyroid and other chronic health problems should not be allowed in our food. We’re encouraged that the FDA has re-examined recent studies documenting the health risks posed by BVO and is taking action to prohibit its use.”
Consumer Reports supported the passage of the California ingredient ban.
Consumer Reports says peer-reviewed studies conducted on rodents have linked BVO to neurological problems, thyroid, heart, and liver problems, and behavioral, developmental, and reproductive issues. The European Union also bans the use of BVO in food.
California’s new law bans BVO, Red Dye 3, potassium bromate, and propylparaben from food sold in the state beginning in 2027.
The FDA says it prioritizes its review of chemicals in food based on risk, science, and regulatory authority. FDA further says its research in collaboration with the NIH has now given us “conclusive scientific evidence” to support our proposal to remove the FDA’s food additive authorization for BVO.
“We recognize that California recently took steps to ban the use of four food ingredients, including BVO, in that state,” the FDA said in the announcement. “The agency is continuously reviewing and reassessing the safety of various 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. 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.”
The color additive decision from the FDA is “forthcoming.”
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