On January 15, 2027, any food product containing FD&C Red No. 3 that enters the United States will be considered adulterated under federal law. FDA will detain and refuse it. The product cannot be sold, relabeled, or reconditioned. It must be exported or destroyed. This deadline is not a proposal. It is a final order with full statutory authority under the Delaney Clause. For food importers, the risk is uniquely high: your foreign suppliers in countries where Red No. 3 is still legal may be using it right now under its international name, erythrosine (E127), and you may not know it. The clock is at 9 months and counting. Here is exactly what you need to check, who needs to change, and what is coming after Red No. 3.
Key Takeaways
FD&C Red No. 3 is formally revoked for use in food effective January 15, 2027. For ingested drugs, the deadline is January 18, 2028.
After the deadline, any food product containing Red No. 3 is adulterated and subject to detention, refusal, and destruction at the border.
Red No. 3 is known internationally as erythrosine or E127. Many countries still allow its use. Your foreign suppliers may be using it without your knowledge.
Approximately 11.5% of U.S. packaged food products contain at least one synthetic dye. Products most commonly affected include candy, cakes, cookies, frozen desserts, frostings, and beverages.
Red No. 3 is only the beginning. FDA and HHS announced in April 2025 a plan to eliminate all 8 petroleum-based synthetic dyes from the U.S. food supply. Six additional dyes (Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3) are targeted for voluntary removal by the end of 2027.
Multiple states have passed laws banning synthetic dyes or requiring warning labels, creating a patchwork of compliance requirements beyond the federal deadline.
Major U.S. retailers and manufacturers (Walmart, Kraft Heinz, General Mills, Hershey's) have committed to removing all synthetic dyes by end of 2027, which will push reformulation pressure upstream to importers and their foreign suppliers.
What Is Red No. 3 and Why Is It Being Banned?
FD&C Red No. 3 is a synthetic food dye derived from petroleum that produces a bright cherry-red color. It has been used primarily in candy, cakes, cookies, frozen desserts, frostings, and some beverages.
The short answer is: Red No. 3 was banned under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act because studies showed it caused cancer in laboratory rats. The Delaney Clause has zero tolerance: if an additive causes cancer in any animal, FDA must revoke its authorization, regardless of the risk level in humans.
Key definition: Delaney Clause is a provision enacted in 1960 as part of the Color Additives Amendment to the FD&C Act. It prohibits FDA from authorizing any color additive found to induce cancer in humans or animals. There is no exception for low-risk exposure, practical certainty, or cost-benefit analysis. The clause is absolute.
FDA issued the revocation order on January 15, 2025. Manufacturers have until January 15, 2027, for food products and January 18, 2028, for ingested drugs to reformulate. FDA has requested that companies remove Red No. 3 sooner than these deadlines.
Why Is This an Importer Problem?
Many food importers assume their foreign suppliers are aware of and complying with U.S. regulatory changes. This assumption is dangerous for two reasons.
Red No. 3 is still legal in most other countries. It is known internationally as erythrosine or by its European color additive designation, E127. Countries across Asia, Latin America, the Middle East, and parts of Europe continue to permit its use. Your supplier in Mexico, Thailand, India, or Turkey may be producing products with erythrosine right now because it is perfectly legal in their market.
The importer is responsible for U.S. compliance, not the foreign manufacturer. Under U.S. law, the food offered for import must comply with U.S. requirements at the time of entry. If your product contains a revoked color additive, it is adulterated. FDA will detain it. There is no cure for adulteration with a banned ingredient. You cannot relabel your way out. The product must be exported or destroyed.
The short answer is: if your supplier is using erythrosine and you did not know, the product is still adulterated, and you still bear the cost.
Which Products Are Most Likely to Contain Red No. 3?
| Product Category | Common Uses of Red No. 3 | Import Risk Level |
|---|---|---|
| Candy and confectionery | Hard candy, gummies, lollipops, candy coatings | High: widely used in imported candy from Asia and Latin America |
| Baked goods | Cake decorations, frostings, cookie icings | Medium: often used in imported decorated baked goods |
| Frozen desserts | Ice cream, popsicles, frozen novelties | Medium: used for cherry, strawberry, and red coloring |
| Beverages | Fruit-flavored drinks, cocktail mixes | Medium: used in some imported beverage concentrates |
| Snack foods | Flavored chips, coated snacks | Low to medium: less common but present in some products |
| Dietary supplements | Capsule coatings, gummy vitamins | High: widely used for red coloring in supplement coatings |
| Maraschino cherries | The classic red cherry | High: Red No. 3 has been the traditional dye for maraschino cherries |
If you import any of these product categories, you should audit your supplier's formulations immediately.
How to Audit Your Supply Chain for Red No. 3
Step 1: Identify Every Product With Red, Pink, or Cherry Coloring
Pull your product catalog and flag every SKU that has any shade of red, pink, cherry, strawberry, or similar coloring. Do not rely on the product name alone. Some products use Red No. 3 in combination with other dyes to achieve colors that do not appear red, including orange and purple shades.
Step 2: Request Current Certificates of Analysis and Ingredient Lists
For every flagged product, request from your supplier a current certificate of analysis (COA) and a complete ingredient list that uses both U.S. naming conventions and international naming conventions. Search specifically for FD&C Red No. 3, Red 3, erythrosine, E127, and CI 45430 (the Color Index name). If any of these appear, the product must be reformulated before the deadline.
Step 3: Verify With Laboratory Testing
Do not rely solely on supplier declarations. Supplier ingredient lists may be outdated, may not account for subcomponent ingredients, or may use generic terms like "permitted colors" or "artificial colors" that obscure the specific dyes used. For high-risk products, commission independent laboratory testing to confirm the presence or absence of erythrosine.
Step 4: Communicate the Deadline to Every Foreign Supplier
Send a written notice to every foreign food supplier informing them that FD&C Red No. 3 (erythrosine/E127) is banned in U.S. food products effective January 15, 2027, that any product containing this ingredient will be refused at the U.S. border after that date, and that you require written confirmation that their formulations for U.S.-destined products do not contain and will not contain Red No. 3.
Step 5: Update Your FSVP Hazard Analysis
If you identify products that currently contain Red No. 3, update the hazard analysis in your Foreign Supplier Verification Program to reflect the unauthorized additive hazard. Document the corrective action (supplier reformulation) and the verification activity (COA review, laboratory testing) that confirms the reformulated product is compliant. See our FSVP guide for the complete framework.
What Comes After Red No. 3? The Broader Synthetic Dye Phase-Out
Red No. 3 is the only synthetic dye subject to a legally enforceable federal ban with a hard compliance deadline. But it is the leading edge of a much larger shift.
The 6 Remaining Targeted Dyes
In April 2025, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary announced a plan to work with industry to eliminate six additional petroleum-based synthetic dyes from the U.S. food supply by the end of 2027.
| Dye | Common Uses | Federal Status | State-Level Action |
|---|---|---|---|
| FD&C Red No. 40 | Beverages, candy, cereals, snacks | Voluntary removal target: end of 2027 | Banned in WV by 2028; warning label required in TX by 2027 |
| FD&C Yellow No. 5 | Beverages, cereals, snacks, baked goods | Voluntary removal target: end of 2027 | Banned in WV by 2028; warning label required in TX by 2027 |
| FD&C Yellow No. 6 | Beverages, cereals, candy, baked goods | Voluntary removal target: end of 2027 | Banned in WV by 2028; warning label required in TX by 2027 |
| FD&C Blue No. 1 | Beverages, candy, ice cream, cereals | Voluntary removal target: end of 2027 | Banned in WV by 2028 |
| FD&C Blue No. 2 | Candy, pet food, beverages | Voluntary removal target: end of 2027 | Banned in WV by 2028 |
| FD&C Green No. 3 | Beverages, candy | Voluntary removal target: end of 2027 | Banned in WV by 2028 |
Additionally, FDA is pursuing formal revocation of Orange B and Citrus Red No. 2, two rarely used synthetic dyes.
Why "Voluntary" Still Means "Mandatory" for Importers
The phase-out of the remaining six dyes is technically voluntary at the federal level. FDA has not issued formal revocation orders. However, three forces make compliance effectively mandatory.
Retail requirements. Walmart is removing synthetic dyes from its private label brands by January 2027. Kraft Heinz, General Mills, and Hershey's have committed to elimination by end of 2027. If you supply products to these retailers or their private label programs, your products must be reformulated to meet their requirements, regardless of federal enforcement.
State-level bans. West Virginia has banned all seven synthetic dyes effective January 1, 2028, with a ban in school meals starting in 2026. California has banned Red No. 3 in all foods starting in 2027. Texas and Louisiana require warning labels on products containing synthetic dyes starting in 2027. Other states are advancing similar legislation. Selling non-compliant products in these states creates legal exposure.
Consumer and litigation pressure. Class-action lawsuits targeting food companies for marketing products as "healthy" or "natural" while containing synthetic dyes are increasing. The Texas Attorney General has opened investigations into companies making health claims on products containing artificial dyes. This legal risk exists independent of federal enforcement.
The Importer's Timeline
| Deadline | What Happens |
|---|---|
| Now through June 2026 | Audit product catalog and supplier formulations for Red No. 3 and all synthetic dyes |
| July through September 2026 | Receive reformulated products, verify through COA and/or lab testing, update labels |
October through December 2026
Clear remaining pre-reformulation inventory. Do not import any product containing Red No. 3 that will arrive after January 15, 2027
January 15, 2027
Red No. 3 ban takes effect. Products containing Red No. 3 are adulterated and subject to detention and refusal
Throughout 2027
Continue monitoring voluntary synthetic dye phase-out. Audit suppliers for remaining 6 dyes. Prepare for state-level compliance deadlines
January 1, 2028
West Virginia ban on all 7 synthetic dyes takes effect
Frequently Asked Questions
When does the Red No. 3 ban take effect?
January 15, 2027, for food products. January 18, 2028, for ingested drug products. After these dates, products containing Red No. 3 are considered adulterated under federal law.
What happens to imported food containing Red No. 3 after the deadline?
FDA will detain and refuse the shipment. Products containing a revoked color additive cannot be reconditioned or relabeled to achieve compliance. They must be exported or destroyed at the importer's expense.
Is Red No. 3 banned in other countries?
No. Red No. 3 (known as erythrosine or E127 internationally) is still permitted in many countries. Some countries restrict its use to certain applications, but it is not universally banned. Your foreign suppliers may still be using it.
How do I check if my products contain Red No. 3?
Review ingredient lists and certificates of analysis for the terms FD&C Red No. 3, Red 3, erythrosine, E127, and CI 45430. For high-risk products, commission independent laboratory testing.
Are all synthetic food dyes being banned?
Red No. 3 is the only synthetic dye subject to a legally enforceable federal ban with a hard deadline. The six remaining dyes (Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3) are targeted for voluntary industry removal by the end of 2027. State-level bans (West Virginia, California) and warning label requirements (Texas, Louisiana) create additional compliance obligations.
Who is responsible for compliance, the importer or the foreign manufacturer?
The importer. Under U.S. law, the party offering food for import must ensure it complies with all U.S. requirements. If a foreign manufacturer uses a banned ingredient, the importer bears the consequences at the border.
What natural alternatives are available to replace Red No. 3?
FDA-approved natural color alternatives for red shades include beet juice, carmine (cochineal extract), paprika oleoresin, and lycopene. FDA has also recently approved new natural color additives including Galdieria Extract Blue and Butterfly Pea Flower Extract. Reformulation requires testing for stability, shelf life, and sensory performance in each specific product application.
Does this affect my FSVP?
Yes. If any of your imported products currently contain Red No. 3, your FSVP hazard analysis must be updated to identify the unauthorized additive hazard. Your verification activities should include confirmation that the reformulated product does not contain Red No. 3 (through COA review and/or laboratory testing). See our FSVP guide.
Will FDA enforce the deadline on imported products specifically?
Yes. Products containing revoked color additives are adulterated under 21 U.S.C. § 342. FDA's PREDICT screening system can flag products for examination based on product type, origin, and manufacturer history. Import alerts may be issued for product categories with known Red No. 3 usage after the deadline.
What about products manufactured before January 15, 2027, that arrive after?
Products manufactured before the effective date may still be sold and consumed after the date. However, products offered for import after the deadline must comply. If your products are manufactured before January 15 but arrive at a U.S. port after January 15, FDA's position will depend on when the product was manufactured and whether it was intended for the U.S. market. To avoid ambiguity, do not import any product containing Red No. 3 that will arrive on or after January 15, 2027.
How will this affect my customers and retail partners?
Major retailers are moving faster than the federal deadline. Walmart, Costco, and others are removing synthetic dyes from private label products by early 2027. If your products contain any synthetic dye and you sell to these retailers, expect reformulation requests before the federal deadline. Noncompliance with retailer requirements could cost you shelf space regardless of FDA enforcement.
This guide reflects FDA revocation of FD&C Red No. 3, the broader synthetic dye phase-out initiative, and state-level legislation as of April 3, 2026. Compliance deadlines, voluntary industry commitments, and state laws are evolving. Food importers should verify current requirements through FDA.gov and monitor state legislation in their distribution markets. For related topics, see our guides on FSVP compliance, FDA import compliance, prior notice filing, FDA holds on perishable food, food labeling for imports, and choosing a customs broker for food imports.
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