How Six Dyes Face an End-2026 FDA Request and Red No. 3 a January 15, 2027 Deadline

The Food and Drug Administration has asked food manufacturers to remove six petroleum-based synthetic dyes from the U.S. food supply by the end of 2026. The request comes from an April 2025 plan announced by the Department of Health and Human Services and the FDA and is part of the administration’s broader Make America Healthy Again initiative.

A separate track applies to Red No. 3, which the FDA has revoked by formal order. Food makers have until January 15, 2027 to reformulate products that contain it. The two tracks work differently, and the dates for each are set out below.

The April 2025 Plan and Its Six Dyes

On April 22, 2025, HHS and the FDA announced a plan to phase out petroleum-based synthetic dyes from the nation’s food supply. The plan named six color additives: FD&C Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1 and Blue No. 2. The FDA asked food manufacturers to remove all six by the end of 2026.

Two other additives were handled differently. The FDA said it would start the process to revoke authorization for Citrus Red No. 2 and Orange B within the coming months. Haynes Boone reports that food manufacturers no longer use either dye.

Red No. 3 was also part of the April 2025 plan, but as a separate item. The FDA said it wanted companies to remove that dye sooner than the 2027 and 2028 deadlines already in place. No new date was set for that earlier removal.

The plan’s scope is the food supply, and the six dyes are the ones the FDA asks manufacturers to remove. The announcement did not set a separate date for each dye, so the end-2026 date applies to all six together.

Red No. 3 Deadlines
The FDA gives January 15, 2027 as the deadline for food makers to reformulate products containing Red No. 3, and January 18, 2028 for ingested drugs.

A Voluntary Request, Not a Revocation

For the six dyes, the FDA does not currently plan to formally revoke authorization. Haynes Boone reports that the request is voluntary and that the FDA has no formal agreement with industry. Haynes Boone reports that the FDA is first leaning on industry to make changes.

Haynes Boone reports that Commissioner Makary has indicated that ‘there are a number of tools at our disposal’ if companies do not comply. Venable reports that Secretary Robert Kennedy described the arrangement with manufacturers as ‘an understanding.’

The end-2026 date is therefore a target set in the April 2025 plan, not a legal cutoff for the six dyes. That difference separates the six-dye effort from Red No. 3, which is governed by formal orders with stated compliance dates.

The FDA’s approach relies on companies choosing to reformulate.

Red No. 3 Runs on a Formal Revocation Track

Red No. 3 is governed by FDA orders. The FDA’s page on the dye says the agency revoked authorization for FD&C Red No. 3 in food and ingested drugs. The legal basis is the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, enacted in 1960 as part of the Color Additives Amendment and, per NatLaw Review, as Section 409(c)(1)(A). The clause bars authorizing a color additive found to cause cancer in humans or animals.

The FDA based its action on thyroid tumors in male rats, drawn from a 2022 color additive petition. According to the FDA, the effect in those rats was tied to a hormonal mechanism specific to male rats, and studies in other animals or humans did not show the same effect. The FDA also says there is no evidence that the dye causes cancer in humans.

NatLaw Review reports that the FDA said the clause left it no discretion to find the dye safe. The agency’s history with the dye runs back further. The FDA’s page says it denied a 1990 petition to permanently authorize the dye in cosmetics and topical drugs. In 1992 it announced plans to revoke the food and ingested-drug listings but did not act at that time.

The dates for the revocation orders differ across sources. The FDA page cites two orders, one dated January 16, 2025, and one dated August 5, 2026, and does not state their effective dates. NatLaw Review dates the revocation order to January 15, 2025 and gives February 18, 2025 as the deadline for objections and hearing requests. Haynes Boone cites a Federal Register notice dated January 16, 2025.

Both sources give the same compliance deadlines. Food manufacturers have until January 15, 2027 to reformulate, and makers of ingested drugs have until January 18, 2028. According to the FDA page, products manufactured before the effective date may still be on the market.

The end-2026 date is a target, while the Red No. 3 deadlines come from formal revocation orders.

Natural Colors Under Review

At the April 2025 announcement, the FDA said it planned to authorize four new natural color additives in the coming weeks and to accelerate review of others. Haynes Boone reports that the agency would fast-track review of calcium phosphate, Galdieria extract blue, gardenia blue and butterfly pea flower extract.

Venable reports that the FDA also planned guidance and regulatory flexibilities for manufacturers, but gives no timeline for either.

The FDA page says FDA scientists continue to review available information about the safety and toxicology of color additives.

What Has Not Been Announced

The April 2025 announcement set no specific date for revoking Citrus Red No. 2 or Orange B, saying only that the process would start within the coming months. Whether food makers have met the end-2026 target is not covered by that announcement.

The published dates for the Red No. 3 orders differ between the FDA page and NatLaw Review, as set out above. The January 15, 2027 food deadline and the January 18, 2028 drug deadline are the dates both sources give.