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Colors/Dyes

Two Food Dyes Just Lost FDA Approval — and Safety Had Nothing to Do With It

Published August 14, 2026

Facts verified as of August 14, 2026

The FDA revoked two food dye authorizations this summer. Neither action happened because the dyes turned out to be dangerous.

On July 23, 2026, the agency finalized the end of Orange B, a color additive once used to redden hot dog casings, and separately proposed doing the same to Citrus Red No. 2, the narrow-use dye that made blemished orange skins look orange at the grocery store. Both moves landed in the same FDA press release, under the same "outdated authorizations" banner as the broader synthetic-dye phase-out that took down Red No. 3 last year. But read the actual Federal Register notices, and the reasoning splits from that earlier story in a way worth being precise about.

Orange B's ending is final. The FDA's order, published at 91 Fed. Reg. 46276 on July 23, 2026, revokes the color additive listing at 21 CFR 74.250, effective September 8, 2026, under Docket FDA-2025-C-3543. After that date, any Orange B on the market is legally "uncertified," and food containing it would be considered adulterated.

Citrus Red No. 2 is not final. The same day, the FDA published a proposed rule at 91 Fed. Reg. 46330 to revoke the listing at 21 CFR 74.302, under Docket FDA-2026-N-6304, with a public comment period running through August 24, 2026. Nothing has changed yet for Citrus Red No. 2 — it remains a lawful color additive on paper until the FDA finalizes the rule, which could still be amended or dropped depending on the comments it receives.

That distinction matters: one dye's authorization is gone, the other's is only proposed to end. Acting FDA Commissioner Kyle Diamantas framed both actions as regulatory modernization, saying the agency is "committed to maintaining a science-based, modern regulatory framework that reflects current manufacturing practices and marketplace realities." HHS Secretary Robert F. Kennedy Jr. tied the actions to the administration's broader dye-elimination push, saying the FDA is "modernizing our food safety regulations" by removing "outdated authorizations for petroleum-based color additives that are no longer used."

Both dyes trace back to a narrower moment in food regulation than most additive stories. Orange B was authorized on January 4, 1966 (31 Fed. Reg. 8) for one purpose only: coloring the casings or surfaces of frankfurters and sausages, capped at 150 parts per million by weight of the finished product. It was never a general-purpose food color. FDA's own July 2026 order states that the last batch of Orange B was certified in 1978, and the agency has not received a single certification request since — essentially half a century of an authorization nobody used. The order also notes that by the late 1970s there were "some evaluations…of potential health implications associated with Orange B," which the agency says contributed to manufacturers discontinuing production at the time — though FDA is explicit that non-use, not a current safety finding, is what's driving the 2026 revocation.

Citrus Red No. 2 has a similarly narrow history, plus a wrinkle worth sitting with. It was authorized in 1959 for exactly one use: coloring the skins — never the flesh — of mature oranges that ripen with a green-tinged rind even though the fruit inside is ready to eat, capped at no more than 2 parts per million on the whole fruit's weight, and restricted to oranges meeting state maturity standards rather than fruit destined for processing. That listing, codified at 21 CFR 74.302, has not been used to certify a batch since 2020, according to FDA's proposed rule. Here's the wrinkle: the International Agency for Research on Cancer classified Citrus Red No. 2 as a Group 2B substance — possibly carcinogenic to humans — in 1987 (IARC Monograph Volume 8, Supplement 7), based on animal studies in which oral dosing produced bladder tumors and injection produced lung and lymphatic tumors in mice; IARC noted no human data existed to evaluate. That classification is nearly forty years old, and it is not what the FDA cites in its 2026 proposal. The stated basis is the same as Orange B's: nobody has certified a batch in years, so the authorization is being retired as regulatory housekeeping under deregulatory executive orders, not as a response to the cancer classification.

Neither dye tells the "banned in Europe" story that Red No. 3 does, because neither one made it onto the EU's list in the first place. When the EU harmonized its food-color rules under Directive 94/36/EC — the framework later folded into Regulation (EC) No 1333/2008 — Citrus Red No. 2 (E121) did not appear among the roughly forty colors the EU authorized for food use. It's absent from that list, not removed from it later; the EU never cleared it for food to begin with. Orange B never even got that far: it carries no E-number and was never submitted for or granted EU authorization. Both were, from the outset, narrow American allowances tied to a specific commodity — dyed orange peels and hot dog casings — that other regulators never had occasion to approve or reject.

Practically, this is not a "check your pantry" story. Orange B hasn't been certified for sale since 1978; Citrus Red No. 2 hasn't been certified since 2020. If either name ever showed up on an ingredient list you've bought recently, that would be unusual — most shoppers have gone years, in Orange B's case decades, without encountering either dye regardless of what the regulation on the books said. What this cleanup does is close the gap between "authorized" and "actually used." The 2B classification is decades old. It is not why the FDA acted in 2026 — the absence of any certification request is.

This is exactly the kind of action that's easy to misread from a headline alone — "FDA revokes two more dyes" sounds like the Red No. 3 story, and it isn't. PurityIQ's job is to put the actual government record in front of you when you're scanning a product: what's authorized, what's only proposed, what's final, and why the agency says it acted, cited to the notice itself. No score, no verdict — just the record, so you can tell a safety revocation from a housekeeping one yourself.

Sources

FDA Final Order, Revocation of Orange B, 91 Fed. Reg. 46276 (Jul. 23, 2026) — https://www.federalregister.gov/documents/2026/07/23/2026-14910/revocation-of-the-color-additive-listing-for-use-of-orange-b-on-casings-or-surfaces-of-frankfurters

FDA Proposed Rule, Citrus Red No. 2, 91 Fed. Reg. 46330 (Jul. 23, 2026) — https://www.federalregister.gov/public-inspection/2026-14909/proposal-to-revoke-the-color-additive-listing-for-use-of-citrus-red-no-2-on-the-skins-of-mature

FDA press release, "FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food" (Jul. 22, 2026) — https://www.fda.gov/news-events/press-announcements/fda-takes-further-steps-remove-outdated-authorizations-color-additives-food

eCFR, 21 CFR 74.250 (Orange B) — https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74/subpart-A/section-74.250

eCFR, 21 CFR 74.302 (Citrus Red No. 2) — https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-74/subpart-A/section-74.302

FDA original Orange B authorization, 31 Fed. Reg. 8 (Jan. 4, 1966), cited in FDA's 2025 proposal — https://www.federalregister.gov/documents/2025/09/17/2025-18023/proposal-to-remove-the-color-additive-listing-for-use-of-orange-b-on-casings-or-surfaces-of

IARC Monographs, List of Classifications — Citrus Red No. 2, Group 2B (Vol. 8, Suppl. 7, 1987) — https://monographs.iarc.who.int/wp-content/uploads/2018/09/List_of_Classifications.pdf

EU Directive 94/36/EC on colours for use in foodstuffs (permitted-colours framework, later folded into Regulation (EC) No 1333/2008) — https://faolex.fao.org/docs/pdf/eur18711.pdf

As of July 30, 2026.

Sources

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