FDA to Revoke Brominated Vegetable Oil Food Additive Authorizatio

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FDA to Revoke Authorization for Brominated Vegetable Oil in Food

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Tuesday, July 2, 2024

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FDA will publish a rule revoking the existing food additive authorization for brominated vegetable oil (BVO) on July 3, 2024. BVO is a mixture of vegetable oils (generally corn, cottonseed, olive, and soybean) that has been modified with bromine. It has been used as a flavoring oil stabilizer and emulsifier since the 1920s and is primarily used in citrus-flavored soft drinks. We previously blogged about the proposed rule, which was published November 2, 2023.
In 1970, FDA removed BVO from the codified list of generally recognized as safe (GRAS) substances and established an interim food additive regulation, later codified at 21 CFR 180.30. The initial authorization was for a 3-year basis and then expanded indefinitely to allow completion of subsequent safety studies. In 2014, FDA determined the existing data on BVO did not provide evidence of a health threat but that there were deficiencies in the existing studies and many studies did not clearly establish safe levels of chronic use. In 2022, the National Center for Toxicological Research published new rodent safety studies that confirmed dietary exposure to BVO results in 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.
FDA received more than 40 comments to the proposed rule, all of which supported revoking the authorization for BVO, with some urging the Agency to take action against other potentially harmful substances. The rule will become effective 30 days after it is published in the Federal Register. To allow sufficient time for companies to reformulate, relabel, and deplete the inventory of BVO-containing products, the compliance date will be 1 year after the effective date.
This rule follows California’s AB 418, which was passed in October 2023 to prohibit BVO and other chemicals in food. However, the BVO revocation has been on FDA’s regulatory agenda since the spring of 2023.