Red No. 3 Ban From 15 January 2027: What Food and Supplement Exporters Must Change

If any product you send to the US is coloured with erythrosine, you have weeks, not years, to change it. On 16 January 2025 FDA published an order repealing the colour additive regulations that allowed FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. Objections paused the order, but on 5 August 2026 FDA rejected them, denied the requests for a hearing and lifted the stay. The effective dates are now confirmed: 15 January 2027 for food and 18 January 2028 for ingested drugs.

This guide is for UK and other overseas food and supplement businesses exporting to the US. It covers what has changed, why a product that is legal at home may still be caught, and what to fix before mid-January.

What Exactly Is Changing on 15 January 2027?

FDA's order removes the listing in 21 CFR 74.303 that permitted FD&C Red No. 3 in food, including dietary supplements. The listing for ingested drugs (21 CFR 74.1303) is removed from 18 January 2028. Red No. 3 has not been permitted in US cosmetics or externally applied drugs since 1990.

FDA acted under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. That clause bars FDA from authorising a colour additive found to induce cancer in humans or animals. FDA found that the petition data showed cancer in male laboratory rats exposed to high levels, through a hormonal mechanism specific to male rats. FDA also states that studies in other animals and in humans did not show the same effect. The ban is a legal consequence of the Delaney Clause, so it is not a finding that the colour is harmful to people.

After the effective date, Red No. 3 in food is no longer a listed colour additive, so it is unsafe under section 721(a) of the FD&C Act. A food that contains an unsafe colour additive is adulterated under section 402(c), and adulterated food can be refused admission at the US border under section 801(a).

Why Could a UK or EU Product Still Be Caught?

Erythrosine is still an authorised food colour on both sides of the Channel, but only for a very narrow use. Under Annex II of Regulation (EC) No 1333/2008, E127 may be used in canned or bottled fruit only in:

• ✓ Cocktail cherries and candied cherries, up to 200 mg/kg
• ✓ Bigarreaux cherries in syrup and in cocktails, up to 150 mg/kg

The same entries appear in the assimilated version of the regulation that applies in Great Britain, and the EU regulation itself continues to apply in Northern Ireland. So a glacé cherry, a cocktail cherry, or a bake or dessert containing one can be fully legal in the UK and EU and still be adulterated if it is offered for import into the US after 15 January 2027. The risk is greatest for cherry products and for finished goods that use them as an ingredient, such as fruit cakes, Bakewell-style bakes, trifles and confectionery.

Products made for other markets are another weak spot. If a line was formulated for a country that allows erythrosine more widely, check it before it is relabelled for the US.

What Should You Check in Your Ingredients and Suppliers?

• ✓ Search every US-bound specification for "FD&C Red No. 3", "Red 3", "erythrosine", "E127" and "CI 45430".
• ✓ Look inside compound ingredients. Candied fruit, sprinkles, icings, coatings and inclusions bought from others are where an unexpected colour most often sits.
• ✓ Get written declarations from colour suppliers confirming whether each colour blend contains erythrosine, with the product code and date.
• ✓ Get the same from ingredient suppliers for any red, pink or cherry component, and keep the declarations on file.
• ✓ Check supplement capsules and coatings, not only the fill. A colour in the shell or coating counts too.

US importers with a Foreign Supplier Verification Programme will want to see this evidence too, so share it with them before they ask.

What Needs to Change on the Label?

FDA requires certified colours such as Red No. 3 to be declared in the ingredient statement, as "FD&C Red No. 3", "FD&C Red 3" or "Red 3". When you reformulate, the label has to change with the recipe:

• ✓ Remove the Red No. 3 declaration and declare the replacement colour correctly under US rules.
• ✓ Do not simply relabel the old recipe. Taking "Red 3" off the label without removing it from the product makes the food misbranded as well as adulterated.
• ✓ Check any "no artificial colours" claim against the new colour, because some replacements are themselves certified colours.
• ✓ Keep the old and new label versions together with the date each version started.

For the wider rules, see our guide to FDA-compliant labelling for supplements and foods.

What About Stock Already on Its Way or in the US?

FDA's Red No. 3 page says consumers could still see it in food on the market after the effective date if the product was manufactured before that date. That is a statement about products already on sale. It is not a guarantee that every shipment made before 15 January 2027 will clear US entry afterwards.

• ✓ Plan your last Red No. 3 production run so it ships, enters and sells well before the date.
• ✓ Keep manufacturing date records for every lot, linked to the lot code on the pack.
• ✓ Talk to your US importer and distributors about stock levels, slow-moving lines and long shelf-life goods.
• ✓ Do not ship old-recipe stock after the effective date without specific advice on that shipment.

FAQ: The Red No. 3 Ban

Is the 15 January 2027 date final?
FDA lifted the administrative stay on 5 August 2026 and confirmed the effective dates of 15 January 2027 and 18 January 2028. Plan on those dates.

Our glacé cherries are legal in the UK. Can we still sell them in the US?
Not if they contain erythrosine and are offered for import after 15 January 2027. UK legality does not change the US position.

Does this affect dietary supplements?
Yes. FDA's order covers foods including dietary supplements, so the 15 January 2027 date applies to them. The later 2028 date is only for ingested drugs.

Does a new colour need FDA approval?
Colour additives in food must be listed for that use in FDA's regulations, and some must also be batch certified. Check that your replacement is listed for your product type before you switch.

How Global Import Agent Helps

• Ingredient and specification reviews to find Red No. 3, including inside compound ingredients
• Supplier and colour-supplier declaration templates and follow-up
• US label reviews for reformulated products, including the ingredient statement and colour claims
• FSVP support so your US importer has the evidence it needs on file

This article is for informational purposes only and does not constitute legal advice. Always re-check FDA's orders of 16 January 2025 (90 FR 4628) and 5 August 2026 (91 FR 50475), the current eCFR text of 21 CFR Part 74, sections 402, 721 and 801 of the Federal Food, Drug, and Cosmetic Act, and the current text of Regulation (EC) No 1333/2008 as it applies in the EU and Great Britain before acting. Global Import Agent LLC is a private compliance services company and is not affiliated with FDA, CBP, HMRC or the Food Standards Agency. For advice specific to your situation, consult a qualified regulatory attorney, customs broker or trade compliance specialist.