FDA revoked Red No. 3 authorization after a 2022 petition because the Delaney Clause applies to color additives shown to induce cancer in animals. FDA also said the male-rat mechanism does not occur in humans and available information does not support human-risk claims.
The FDA is revoking the authorization for the use of FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA revoked Red No. 3 authorization after a 2022 petition because the Delaney Clause applies to color additives shown to induce cancer in animals. FDA also said the male-rat mechanism does not occur in humans and available information does not support human-risk claims. Binding revocation, not a finding of demonstrated human carcinogenicity. Compliance dates are January 15, 2027 for food and January 18, 2028 for ingested drugs; these deadlines remained in the current record checked October 2026.