FDA revoked authorization for FD&C Red No. 3 in food and ingested drugs on January 15, 2025. Foods (and dietary supplements) that use it have until January 15, 2027 to reformulate; ingested drugs have until January 18, 2028. The basis is the Delaney Clause, a 1960 provision that requires FDA to revoke a color additive once it’s shown to cause cancer in humans or animals, regardless of dose or human relevance (Federal Register, FDA).
Why this happened
The revocation followed a color additive petition from the Center for Science in the Public Interest and others, citing studies showing FD&C Red No. 3 caused cancer in male laboratory rats. FDA has been explicit that the mechanism involved (a hormonal pathway specific to rats) isn’t understood to occur the same way in humans, and that the agency isn’t aware of evidence the dye causes cancer in people at the levels used in food. That distinction doesn’t change the legal outcome: the Delaney Clause doesn’t ask whether a finding is relevant to humans, only whether the additive has been shown to induce cancer in humans or animals at all. Once that finding was made, revocation was required by statute rather than a discretionary risk call (FDA).
Who this affects, and by when
Any product using FD&C Red No. 3 as a color additive needs to be reformulated before its compliance date. FDA has flagged candy, baked goods, and some sauces and glazes as common categories, and encourages manufacturers to switch “as soon as is practicably possible” rather than waiting until the 2027 deadline (FDA). The two-year compliance window (versus immediate revocation) exists specifically so manufacturers have time to reformulate and repackage rather than pull products overnight.
What makers should actually check
If you make candy, baked goods, or sauces, this is mostly an ingredient-statement and supplier-documentation problem, not a legal one:
- Read your own ingredient statement. The additive appears on labels as “FD&C Red No. 3” or by its chemical/common name, erythrosine. Both refer to the same substance, so check for both spellings when scanning a label or recipe.
- Check supplier spec sheets, not just your own formula. If you buy a pre-made glaze, sprinkle mix, maraschino cherry, or colored coating from a supplier, the dye may be in an ingredient you didn’t formulate yourself. Ask suppliers directly whether a product contains FD&C Red No. 3 / erythrosine and get a current spec sheet; don’t rely on an old one.
- Watch for reformulated products that quietly changed color. A supplier switching away from Red No. 3 sometimes shifts a product’s shade slightly (common substitutes include Red No. 40 or natural colorants like beet juice or carmine); a new spec sheet should reflect the new ingredient, not just a note that “the formula changed.”
- Update your ingredient statement when you reformulate. Removing or swapping a color additive changes what belongs in the ingredient list under 21 CFR 101.9, so this is a labeling update, not just a recipe change.
None of this requires a compliance guarantee from us. It’s a documentation check you can run against your own recipe and your suppliers’ paperwork well before the January 2027 deadline for foods.
A related but separate rule: Front-of-Package nutrition labeling
FDA proposed a separate rule in January 2025 that would require a front-of-package nutrition information box, covering saturated fat, sodium, and added sugars, on most packaged foods. As of September 2026, this rule remains proposed, not final. The comment period closed in mid-2025, and FDA’s own 2026 priorities describe the agency as still reviewing public comments and preparing options for a final regulation, with no published final rule or new compliance date yet (FDA). If you’re planning label artwork now, it’s worth knowing this is coming but not yet in effect. Nothing in the current Nutrition Facts requirements changes until (and unless) FDA finalizes it.
If you’re updating an ingredient statement after a Red No. 3 reformulation, or building a compliant label from scratch, our builder generates print-ready files in every FDA format your product qualifies for and keeps your ingredient statement and allergen declaration in sync with your recipe.
Updating your ingredient statement well before January 2027 means your next print run already matches your reformulated recipe. Enter your recipe, then see your label: free with no card required, you see your calories, the claims you qualify for, your allergen line and the nutrient to watch, and every other value and %DV stays hidden until you unlock it. $29 unlocks every other nutrient value and %DV, every FDA format your product qualifies for, the ingredient statement and allergen declaration, ready to print. Start your label, or browse more labeling rules.
Last checked: September 15, 2026
Sources
- 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
- https://www.fda.gov/industry/color-additives/fdc-red-no-3
- https://www.fda.gov/food/hfp-constituent-updates/fda-revoke-authorization-use-red-no-3-food-and-ingested-drugs
- https://www.fda.gov/food/food-ingredients-packaging/fda-encourages-food-manufacturers-accelerate-phasing-out-use-fdc-red-no-3-foods-2027-deadline
- https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/front-package-nutrition-labeling