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If you have an existing approved formula that has changed or will change to remove BVO or FD&C Red No. 3, you must apply for a new TTB formula approval prior to the compliance dates listed below.
Source: Alcohol and Tobacco Tax and Trade Bureau
Photo: Courtesy
As a reminder, the U.S. Food and Drug Administration (FDA) has amended its regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food (which includes alcohol beverages) and FD&C Red No. 3 in food and ingested drugs. If you have an existing approved formula that has changed or will change to remove BVO or FD&C Red No. 3, you must apply for a new TTB formula approval prior to the compliance dates listed below.
Brominated Vegetable Oil
AGENCY: Food and Drug Administration, HHS
ACTION: Final Rule
SUMMARY: The FDA issued a final rule to revoke the authorization for the use of BVO in food. This action was taken because there is no longer a reasonable certainty of no harm from the continued use of BVO in food. Specifically, the final rule revokes the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. There are no authorizations for other uses of BVO in food.
DATES: The rule took effect on August 2, 2024. The compliance date for this rule is August 2, 2025 (one year after the effective date of the final rule), to provide the opportunity for companies to reformulate, relabel, and deplete the inventory of BVO-containing products before the FDA begins enforcing the final rule.
For more information on BVO, please refer to FDA’s website: Brominated Vegetable Oil (BVO) | FDA.
FD&C Red No. 3
AGENCY: Food and Drug Administration, HHS
ACTION: Final Amendment; order
SUMMARY: The FDA is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing color additive regulations that permit the use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA issued an order revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations.
DATES: This order is effective January 15, 2027, for food, and January 18, 2028, for ingested drugs. If any provisions are delayed or stayed by the filing of proper objections, FDA will publish such notification in the Federal Register.
For more information on FD&C Red No. 3, please refer to FDA’s website: FD&C Red No. 3 | FDA.
