FDA Lifts Stay on FD&C Red No. 3 Repeal, Confirming 2027–2028 Removal Deadlines

Background and the January 2025 Order

The FDA's move to eliminate FD&C Red No. 3 from the U.S. food supply traces to a color additive petition (CAP 3C0323) jointly filed by the Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, and others, which the agency announced it had filed in the Federal Register of February 17, 2023 (88 FR 10245). The petitioners proposed repealing the color additive regulations at 21 CFR 74.303 and 21 CFR 74.1303, which respectively authorize the safe use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The petition cited the Delaney Clause — section 721(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act — which deems a color additive unsafe for any use that will or may result in its ingestion if the additive is found to induce cancer when ingested by man or animal, or found after appropriate tests to induce cancer in man or animal.

Acting on the petition, the FDA issued an order published in the Federal Register of January 16, 2025 (90 FR 4628) amending 21 CFR 74.303 and 74.1303 to no longer provide for the safe use of FD&C Red No. 3 in food, effective January 15, 2027, and in ingested drugs, effective January 18, 2028. The agency determined that information in the petition and other publicly available relevant data demonstrated that FD&C Red No. 3 has been shown to cause cancer in male rats, rendering its use as a color additive unsafe under the Delaney Clause as a matter of law.

Objections, Administrative Stay, and Denial of a Hearing

Under sections 701(e)(2) and 721(d) of the FD&C Act, any person adversely affected by such an order may, within 30 days of publication, file objections and request a public hearing. Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc., filed a submission on February 18, 2025 — the last day of the 30-day window — raising three specific objections to the order and requesting hearings on each. Under section 701(e)(2), the filing of those objections automatically placed an administrative stay on the order's effective dates, with the stay taking effect as of February 18, 2025.

The FDA reviewed the submission under its regulations at 21 CFR 12.24(b)(1), which permit the agency to deny a hearing request if the objections do not raise genuine and substantial issues of fact that can be resolved at a hearing. After that review, the agency concluded that the objections do not raise issues of material fact that justify a hearing. The agency also noted that the submission included a copy of Micro-Tracers' comments on the petition filing notice, dated November 13, 2023 — but because those comments were submitted after the comment period closed on May 18, 2023, they were not included in the docket and were not considered part of the objection record.

Stay Lifted; Compliance Deadlines Confirmed

With the hearing request denied, FDA published its response in the Federal Register on August 5, 2026, simultaneously lifting the administrative stay as of that date. The agency confirmed that the two compliance deadlines from the January 2025 order remain in force: January 15, 2027, for the repeal of food-use authorizations under 21 CFR 74.303, and January 18, 2028, for the repeal of ingested-drug authorizations under 21 CFR 74.1303. Both dates correspond to amendatory instruction 4 of the original order (90 FR 4628).

What to Watch

• January 15, 2027 — Effective date for the repeal of FD&C Red No. 3 authorization in food and dietary supplements (21 CFR 74.303).
• January 18, 2028 — Effective date for the repeal of FD&C Red No. 3 authorization in ingested drugs (21 CFR 74.1303).

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