For once, Europe is the looser regulator on this one.
On January 15, 2025, the FDA revoked authorization for FD&C Red No. 3 — the pink-red dye behind decades of candy, maraschino cherries, and cough syrup — in every food and ingested drug sold in the United States. The European Union still allows it, in three narrow product categories, under a safety finding its food authority reaffirmed as recently as 2011.
On January 16, 2025, the FDA published a final rule in the Federal Register (90 FR 4628) revoking the color additive listings that had authorized FD&C Red No. 3 for food and dietary supplements (21 CFR 74.303) and for ingested drugs (21 CFR 74.1303). The action followed a 2022 petition from the Center for Science in the Public Interest and a coalition of scientists and state attorneys general, but the legal trigger behind it is much older than the petition: the Delaney Clause, a provision of the Federal Food, Drug, and Cosmetic Act stating that a color additive "shall be deemed unsafe" for ingested use if it is "found ... to induce cancer in man or animal" — a bright-line rule, with no weighing of dose or real-world exposure once that finding exists.
That legal mechanism matters, because the FDA's own rule says something closer to the opposite of what a ban usually implies. In the same notice, the agency wrote that "FD&C Red No. 3-induced thyroid tumors in male rats are of limited relevance to humans" and that the chance of thyroid tumors in people at typical dietary exposure is "unlikely." The FDA revoked the dye not because it concluded people were at meaningful risk, but because the Delaney Clause left it no discretion once the rat data existed — the statute required action "regardless of the probability, or risk, of cancer."
Manufacturers have until January 15, 2027 to remove Red No. 3 from food and dietary supplements; ingested drugs get until January 18, 2028, when the drug-specific listing is struck from the federal code entirely. The FDA isn't waiting quietly for those dates to arrive. On April 22, 2025, HHS announced a broader push to eliminate petroleum-based synthetic dyes from the food supply, and in a July 14, 2025 letter to manufacturers, the FDA said it "encourages food manufacturers to, as soon as is practicably possible, reformulate to stop using FD&C Red No. 3 in foods."
None of this rests on a new discovery. In 1990, the FDA denied permanent approval of Red No. 3 for cosmetics and externally applied drugs — lipstick, for instance — citing the same rat thyroid-tumor data. Two years later, in 1992, the agency said publicly that it intended to revoke the food and ingested-drug uses too, for consistency with the cosmetics decision. Then it didn't, for thirty-three years. The underlying study dates to the late 1980s. The 2025 rule is less a response to new science than the FDA finally finishing an action it announced and shelved before most of today's shoppers were born.
The reflex assumption is that Europe moves first and harder on food chemicals. Red No. 3 runs the other way. The EU's food safety authority, EFSA, re-evaluated erythrosine (E 127) in 2011 and found no reason to revise its acceptable daily intake of 0.1 mg per kilogram of body weight, concluding that average adult exposure — about 0.003 mg/kg bw per day — sat roughly thirty-fold below that threshold. On the strength of that margin, the EU has kept erythrosine authorized under Regulation (EC) No 1333/2008, though only for a narrow list: cocktail cherries, candied cherries, and bigarreaux cherries in syrup. It does not appear in EU candy, baked goods, or medication.
Neither regulator is wrong on its own terms. The FDA's Delaney Clause is a categorical rule: any animal carcinogenicity finding, in any species, ends ingested use, independent of the dose math. EFSA's framework is exposure-based: it asks whether the amount people actually consume clears a safety margin, and for erythrosine's remaining, narrow uses, it decided that it does. That structural divergence — one regulator working from a hazard trigger, the other from a measured-exposure model — is the same split that runs in the opposite direction on other additives, where the EU restricts something the U.S. still permits. Here, the U.S. is the stricter regulator, and the reason is worth sitting with: not new evidence of harm, but a different legal standard for what counts as acceptable risk once any cancer signal exists at all, in any amount.
Until January 2027, Red No. 3 can still legally appear on a U.S. label — look for "FD&C Red No. 3" or "Red 3" on the ingredient list, most commonly in candy, maraschino cherries, some cough syrups and children's medications, and cake-decorating products. After the compliance deadline, newly manufactured food has to be free of it, though product already on shelves before the deadline doesn't have to be pulled retroactively. A "no artificial colors" claim made today shouldn't include it going forward — but that claim is a manufacturer statement, not an independently verified government inspection stamp.
This is exactly the kind of record that's easy to get backwards from headlines alone — assuming the U.S. is trailing Europe when here it's the reverse, or assuming a 2025 ban means 2025 science. PurityIQ puts the actual regulatory timeline in front of you at the shelf: what's authorized, where, since when, and under whose legal standard — cited to the Federal Register notice or the EU regulation behind it, with no score and no verdict attached. You see the record. You decide.
Sources
FDA Final Rule, 90 Fed. Reg. 4628 (Jan. 16, 2025) — https://www.federalregister.gov/documents/2025/01/16/2025-00830/color-additive-petition-from-center-for-science-in-the-public-interest-et-al-request-to-revoke-color
FDA, "FD&C Red No. 3" industry page — https://www.fda.gov/industry/color-additives/fdc-red-no-3
FDA, letter encouraging accelerated phase-out ahead of 2027 deadline — https://www.fda.gov/food/food-ingredients-packaging/fda-encourages-food-manufacturers-accelerate-phasing-out-use-fdc-red-no-3-foods-2027-deadline
EFSA Scientific Opinion, Re-evaluation of Erythrosine (E 127) as a food additive (2011) — https://www.efsa.europa.eu/en/efsajournal/pub/1854
EU Regulation (EC) No 1333/2008 on food additives (consolidated text) — https://www.legislation.gov.uk/eur/2008/1333/annexes/2017-08-18
As of July 27, 2026.