The short answer
From January 15, 2027, FD&C Red No. 3 (erythrosine) can no longer be used in any food or dietary supplement sold in the United States — and that includes imported products. FDA is also pushing the industry away from other petroleum-based dyes, but that part is still voluntary. Here is what is law, what is not, and what exporters should do now.
| Color | Status | Date | Mandatory? |
|---|---|---|---|
| Red No. 3 — foods & supplements | Authorization revoked (21 CFR 74.303 removed) | January 15, 2027 | Yes |
| Red No. 3 — ingested drugs | Authorization revoked (21 CFR 74.1303 removed) | January 18, 2028 | Yes |
| Orange B | Authorization revoked by final order | Announced July 22, 2026 | Yes |
| Citrus Red No. 2 | Revocation proposed; comments closed | Comments closed August 24, 2026 | Pending |
| Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3 | Still FDA-listed; industry asked to remove them | No compliance date | No — voluntary |
What FDA decided about Red No. 3
On January 15, 2025, FDA issued a final order revoking the color additive listings for FD&C Red No. 3 in food and in ingested drugs. It was published in the Federal Register on January 16, 2025 (FR Doc. 2025-00830, 90 FR 4629).
The legal reason is the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, which bars FDA from authorizing a color additive found to cause cancer in humans or animals. Studies showed thyroid tumors in male rats. FDA itself said the mechanism is of limited relevance to people — but the Delaney Clause leaves no room for a risk-based exception, so the listing had to go.
On the compliance dates, FDA color certificates for Red No. 3 batches stop being valid for those uses. In July 2025, FDA wrote to manufacturers urging them to reformulate as soon as practicable, ahead of the 2027 deadline.
Are the other synthetic dyes banned by the end of 2026?
No — not as a matter of law. This is the most common misunderstanding we see.
In April 2025, HHS and FDA announced a plan to work with industry to eliminate six petroleum-based dyes from the food supply by the end of 2026: FD&C Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2 and Green No. 3. These remain FDA-listed color additives. FDA has not published a rule or a compliance date removing them; it tracks progress through voluntary company pledges.
What it means for imported food
Under section 402(c) of the FD&C Act, a food that contains a color additive that is not authorized for that use is adulterated. Adulterated food can be refused entry when it is offered for import, and products already on the US market can be subject to recall.
FDA's order does not set a separate sell-through period for imported products. Plan for every shipment arriving at a US port — and every unit on US shelves — to be Red No. 3–free from January 15, 2027. Long shelf-life products with slow sell-through (confectionery, cake decorations, supplements) need the most attention.
Where Red No. 3 hides
Check finished-product labels and ingredient specifications. Red No. 3 may appear as:
- FD&C Red No. 3 or Red 3
- Erythrosine or erythrosine B
- E127 — the EU/Codex numbering often used by suppliers outside the US
Typical products include candied and cocktail cherries, hard candy and gummies, sprinkles and cake decorations, frostings, some baked goods, flavored drink mixes and coated supplement tablets. It can also arrive inside a sub-ingredient — a colored sugar topping or a pre-mixed inclusion bought from another supplier.
Example: a confectionery exporter selling to several markets
A sweets maker in the UK, Italy or Mexico often sells one recipe in several countries. A color that is permitted at home can still make the same product adulterated in the US. Keep a US-specific specification for every SKU you ship here, and confirm the color system with your color supplier in writing.
Checklist for exporters and importers
- 1Audit every US SKU.Look for Red No. 3 in the product and in sub-ingredients, coatings and toppings.
- 2Get written supplier confirmation.Ask color and ingredient suppliers to confirm their materials are Red No. 3–free. FSVP importers should keep this in their supplier verification records.
- 3Reformulate with a permitted color.“Natural” does not mean “allowed” — every color additive, synthetic or natural, must be FDA-listed for that specific food use.
- 4Update the label.Remove Red No. 3 from the ingredient list and declare the replacement color correctly.
- 5Plan stock rotation.Make sure no Red No. 3 product is shipped to, or sitting in, US distribution from January 15, 2027.
- 6Ask your buyer about the other six dyes.Many US customers want Red 40, Yellow 5/6 and Blue 1/2 removed too, even though FDA does not yet require it.
Natural colors and “No Artificial Colors” claims
FDA has been approving more colors from natural sources. On February 5, 2026 it approved beetroot red and expanded the permitted uses of spirulina extract — which FDA said brought the number of new food color options approved under the current administration to six.
The same day, FDA announced it will use enforcement discretion for “no artificial colors” claims on products that contain no petroleum-based colors. Before, the claim generally required no added color at all. If you reformulate with natural colors, this can be a marketing opportunity — but the rest of the label still has to comply.
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Frequently asked questions
Is Red No. 3 still allowed in cosmetics?
FDA's 2025 order covers food and ingested drugs. Red No. 3 had already lost its authorization for cosmetics and externally applied drugs in 1990.
Are Red 40 and Yellow 5 banned in the US?
No. They remain FDA-listed color additives. FDA has asked industry to phase them out voluntarily, but there is no rule or compliance date.
Can I sell Red No. 3 stock that is already in the US after January 15, 2027?
Do not plan on it. FDA's order does not provide a sell-through period. Clear Red No. 3 products from US distribution before the deadline, and get advice for any specific stock you are unsure about.
Do dietary supplements count as food for this rule?
Yes. The January 15, 2027 date applies to foods including dietary supplements. Ingested drugs have until January 18, 2028.
Sources
Dates and regulation numbers checked against FDA and Federal Register sources on November 3, 2026.
- Federal Register, final order revoking FD&C Red No. 3 for food and ingested drugs, FR Doc. 2025-00830, 90 FR 4629 (January 16, 2025) — federalregister.gov
- FDA, FDA encourages food manufacturers to accelerate phasing out Red No. 3 ahead of the 2027 deadline (July 14, 2025) — fda.gov
- HHS, plan to phase out petroleum-based synthetic dyes (April 22, 2025) — hhs.gov
- FDA, further steps to remove outdated color additive authorizations — Orange B and Citrus Red No. 2 (July 22, 2026) — fda.gov
- FDA, new approach to “no artificial colors” claims and new natural colors (February 5, 2026) — fda.gov
- FDA guidance, Colored Sea Salt (adulteration under FD&C Act section 402(c)) — fda.gov