In collaboration with the National Institutes of Health (NIH), FDA found “conclusive scientific evidence to support our proposal to remove the FDA’s food additive authorization for BVO,” the agency wrote in a Nov. 2 statement.
In 1970, FDA removed BVO from the Generally Recognized as Safe (GRAS) list and instead authorized it as a food additive which allowed companies to use it in minute amounts to prevent separation in citrus flavored beverages.
Since its GRAS removal, beverage manufacturers reformulated its products with alternative ingredients.
In a statement, FDA wrote that 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. 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.”
The agency cited California’s recent ban of four additives, including BVO, affirming that it 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.”
FDA is also reviewing the use of FD&C Red No. 3 in drugs and food, including dietary supplements under the Delaney Clause of the Federal Food, Drug and Cosmetic Act, which “prohibits the FDA from approving a color additive that is ingested if it causes cancer in animals or humans when ingested.
Under the proposed Human Foods Program (HFP) which includes the formation of the Office of Food Chemical Safety, Dietary Supplements and Innovation, FDA intends to “develop a faster and more nimble process for evaluating chemicals in the food supply.”