https://foodadditiveindex.com/additives/fd-and-c-red-no-3/changesFD&C Red No. 3 — regulatory changes — Food Additive Index2026-10-19T00:00:00ZFood Additive Indexhttps://foodadditiveindex.comtag:foodadditiveindex.com,2027-01-15:event/US/fd-and-c-red-no-3/prohibitedScheduled: FD&C Red No. 3 no longer permitted in food in the United States2026-10-19T00:00:00ZUnited States, 2027-01-15. The repeal of 21 CFR 74.303 takes effect, ending the use of FD&C Red No. 3 in food, including dietary supplements. The date was set by the order at 90 FR 4628 and confirmed at 91 FR 50475 when the stay was lifted. Its use in ingested drugs continues until 18 January 2028.tag:foodadditiveindex.com,2026-08-05:event/US/fd-and-c-red-no-3/phase_out_announcedFDA rejects objections, lifts the stay and confirms the FD&C Red No. 3 deadlines2026-08-05T00:00:00ZUnited States, 2026-08-05. At 91 FR 50475, FDA concluded that the objections did not raise issues of material fact justifying a hearing, and lifted the administrative stay as of 5 August 2026. The objections argued, among other things, that FDA should not have counted benign adenomas alongside carcinomas when finding that the dye induces cancer in male rats. The effective dates of 15 January 2027 for food and 18 January 2028 for ingested drugs are confirmed.tag:foodadditiveindex.com,2025-02-18:event/US/fd-and-c-red-no-3/stayedFD&C Red No. 3 revocation stayed after objections were filed2025-02-18T00:00:00ZUnited States, 2025-02-18. Objections and requests for a public hearing, filed on behalf of Micro-Tracers, Inc., administratively stayed the January 2025 order as of 18 February 2025, the deadline for objections. The stay held the effective dates open while FDA considered the objections. FDA records the stay in its later response at 91 FR 50475; no separate notice of the stay appears in the Federal Register.tag:foodadditiveindex.com,2025-01-16:event/US/fd-and-c-red-no-3/phase_out_announcedFDA orders FD&C Red No. 3 removed from food, effective 15 January 20272025-01-16T00:00:00ZUnited States, 2025-01-16. The order at 90 FR 4628 granted a colour additive petition from the Center for Science in the Public Interest and others, repealing 21 CFR 74.303, which permits FD&C Red No. 3 in food including dietary supplements, from 15 January 2027. Its listing for ingested drugs, 21 CFR 74.1303, is removed from 18 January 2028. The basis is the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, under which a colour additive found to induce cancer in humans or animals is deemed unsafe as a matter of law. FDA found that FD&C Red No. 3 can induce cancer in male rats, through a rat-specific hormonal mechanism.