,On January 15, 2025, the U.S. Food and Drug Administration (FDA) announced its decision to revoke the authorization for the use of FD&C Red No. 3 in food and ingested drugs. This action responds to a 2022 color additive petition and is based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which prohibits the approval of additives found to induce cancer in humans or animals. Studies cited in the petition indicated that high levels of FD&C Red No. 3 caused cancer in male rats through a mechanism not applicable to humans. Despite the FDA's assessment that typical human exposure levels are much lower and do not pose a risk, the agency is proceeding with the revocation as mandated by law. Manufacturers have until January 15, 2027, to reformulate food products and until January 18, 2028, for ingested drugs to comply with this change.
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