Lexology January 17, 2025
On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban responds to a 2022 color additive petition submitted by several interested parties and filed by FDA in 2023.
In support of the revocation, FDA is relying on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 379e(b)(5)(B)), which requires FDA to ban color additives that are found to cause or induce cancer in humans or animals. Specifically, FDA is invoking the Delaney clause as a result of data that shows FD&C Red No. 3 causes cancer in male...
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