FDA Revokes Red No. 3 in Food and Ingested Drugs (2025)

Table of Contents

1. 1. What the FDA Did
2. 2. What the Order Changes, and When
3. 3. The Legal Basis: the Delaney Clause
4. 4. The Science the Order Describes
5. 5. What Red No. 3 Is and Where It Was Used
6. 6. Public Comments and the FDA’s Responses
7. 7. What the Order Does Not Do
8. 8. The 2025 Objection and the Automatic Stay
9. 9. August 2026: Objection Denied, Stay Lifted
10. 10. Dates and Legal Status (as of 11 October 2026)
11. 11. How the Order Fits Earlier Actions
12. 12. Primary Documents
13. Key Research Papers
14. Connections

1. What the FDA Did

The document is a final order (in the Federal Register’s words, “Final amendment; order”) that amends the FDA’s list of approved color additives in Title 21 of the Code of Federal Regulations, part 74. It was dated 10 January 2025, announced by an FDA constituent update on 15 January 2025, and published on 16 January 2025 at 90 FR 4628–4634.

• What it grants. The order grants a color additive petition filed in 2022 (petition number CAP 3C0323) by a coalition of advocacy and consumer organizations and several scientists. The FDA had announced that it was considering the petition on 17 February 2023 (88 FR 10245) and took public comments until 18 May 2023.
• What it repeals. Two regulations: 21 CFR 74.303, which allowed Red No. 3 in foods including dietary supplements, and 21 CFR 74.1303, which allowed it in ingested drugs.
• Why. The order’s summary states that the petitioners “provided data demonstrating that this additive induces cancer in male rats,” and that under the law this makes the dye unsafe for ingested uses.
• Docket. FDA-2023-N-0437. A Federal Register docket is the public file for a rulemaking on regulations.gov, where the petition, comments, objections and supporting memoranda are posted.

The order also states that it partially responds to a separate 2008 citizen petition on the dye (Docket FDA-2008-P-0349).

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2. What the Order Changes, and When

• Foods and dietary supplements: the listing in 21 CFR 74.303 is removed effective 15 January 2027.
• Ingested drugs: the listing in 21 CFR 74.1303 is removed effective 18 January 2028. Because the food section is removed first, the order temporarily copies the dye’s chemical identity and purity specifications into the drug section so that section still works on its own until 2028.
• Certification ends. Red No. 3 is a certified color: every batch must be tested and certified by the FDA before it can be sold under that name. The order states that once the listings are removed, the FDA will no longer certify the dye, existing certificates stop being valid for food on the 2027 date and for ingested drugs on the 2028 date, and food or drugs made with the dye after that point would be considered “adulterated” (unlawful) under federal law.
• Products already made. The order states that food or drugs colored with the dye while its certificate was still valid are not adulterated because of it. The FDA’s program page says consumers could see Red No. 3 on the ingredient list of a product sold after the deadline if the product was made before it.
• Imports. The constituent update notes that other countries still allow some uses of the dye (under the name erythrosine), but that foods imported into the United States must meet U.S. requirements.

The FDA described the gap between publication and the deadlines as time for manufacturers “to reformulate their products.”

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3. The Legal Basis: the Delaney Clause

The Federal Food, Drug, and Cosmetic Act (FD&C Act) treats every color additive as unsafe unless the FDA has approved the specific use. Normally the FDA approves a use only if there is “a reasonable certainty of no harm” — the so-called general safety clause, under which the agency weighs how much people are likely to eat, cumulative exposure and appropriate safety factors from animal data.

The Delaney Clause (section 721(b)(5)(B) of the FD&C Act, enacted in 1960 as part of the Color Additives Amendment) is an exception to that weighing. For a color additive that is eaten or swallowed, it states that the additive “shall be deemed unsafe” if it is found “to induce cancer when ingested by man or animal.” The order explains that:

• Federal appeals courts have read the clause as a complete ban. The order quotes a 1987 D.C. Circuit decision describing the clause as “extraordinarily rigid” and rejecting an argument that a color additive with only a minimal (“de minimis”) cancer risk could still be approved.
• The clause leaves the FDA no room to consider how large the risk is, how relevant the animal study is to people, or whether the dye causes cancer through a non-genetic route. The order repeats the FDA’s 2018 wording that the clause applies “regardless of the probability, or risk, of cancer associated with exposure to the additive.”
• Because the clause applies, the agency states that it “does not have discretion to consider alternatives to revoking the color additive listing.”

The FDA’s constituent update summarizes this as revoking the authorization “as a matter of law.”

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4. The Science the Order Describes

The order rests on two chronic feeding studies in rats, reported together in a 1987 publication (listed under Key Research Papers below). Its own description of the evidence:

• The finding that triggered the law. At high exposure, Red No. 3 induced thyroid tumors in male rats. The highest dose in those studies was 4 percent of the diet; the FDA states this did not shorten the animals’ lives or cause other toxic effects, so it met the agency’s definition of a maximum tolerated dose.
• The proposed route. The tumors appear to follow a disturbance of the hormone loop between the brain and the thyroid: higher levels of thyroid-stimulating hormone (TSH) cause the thyroid’s follicle cells to multiply, which can progress to tumors. The FDA calls the TSH rise a “key event” because the exact mechanism has not been determined.
• Not genotoxic. The FDA states the dye is “likely not genotoxic” — it does not appear to damage DNA directly.
• Other species. Cancer was not seen in female rats, or in mice, gerbils or dogs of either sex.
• Relevance to people. The FDA states that rodents are far more sensitive to TSH disturbances than humans, that there is no conclusive clinical evidence that raised TSH causes thyroid cancer in humans, and that human studies have not shown consistent changes in thyroid hormones from the dye. Its program page states that “there is no evidence showing FD&C Red No. 3 causes cancer in humans.”
• Exposure margin. The FDA estimated the highest U.S. exposure from all approved uses at 0.25 mg per kg of body weight per day. Against the no-observed-adverse-effect level for the thyroid effects in male rats (35.8 mg/kg/day), that is a 210-fold margin. The order notes this is also below the acceptable daily intake of 6 mg/kg/day set in 2018 by the joint FAO/WHO Expert Committee on Food Additives (JECFA).
• Other regulators. The order states that JECFA, the European Food Safety Authority and Food Standards Australia New Zealand have also concluded that the rat thyroid tumors are of limited relevance to humans.

The order is explicit that these points do not change the outcome: “as a matter of law … we must revoke the regulations authorizing the uses of FD&C Red No. 3 because it has been shown to induce cancer in male rats.” In the constituent update the agency also wrote that “claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.”

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5. What Red No. 3 Is and Where It Was Used

• Chemistry. The regulation describes the dye as principally the disodium salt of a tetra-iodinated fluorescein (four iodine atoms on a fluorescein backbone). Other names include erythrosine, C.I. Acid Red 51, C.I. No. 45430 and C.I. Food Red 14.
• Color. The FDA describes it as a synthetic food dye giving foods and drinks a “bright, cherry-red color.”
• Uses named by the FDA. Candy, cakes and cupcakes, cookies, frozen desserts, frostings and icings, and certain ingested drugs.
• How widely. Based on label databases, manufacturer websites and its own certification data, the FDA estimated Red No. 3 is “not as widely used” as other certified colors.
• Labels. Under FDA labeling rules a certified color must appear in the ingredient list, as “FD&C Red No. 3,” “FD&C Red 3” or “Red 3.”

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6. Public Comments and the FDA’s Responses

The order states that most comments simply supported revocation. It summarizes and answers nine comments, including these:

• “The science has moved on.” Some comments argued the FDA could use scientific judgment because newer research shows limited human relevance. The FDA agreed the tumors are of limited relevance to humans but said the literature still supports the male-rat finding, and the clause removes discretion.
• “It is not genotoxic.” The FDA agreed the dye is non-genotoxic but said the clause does not distinguish between genotoxic and non-genotoxic carcinogens.
• “The doses were too high.” The FDA answered that the two studies were appropriately designed and did not exceed the maximum tolerated dose under its current toxicology guidance (the “Redbook 2000”).
• “Convene an advisory committee.” The FDA declined, stating there was no genuine scientific debate that the dye induced cancer in male rats, so no exercise of scientific judgment was needed.
• “Exposure is below safe limits.” The FDA agreed that exposure is below the JECFA acceptable daily intake and that the dye meets the general “reasonable certainty of no harm” standard, but said the Delaney Clause still requires revocation.
• “Consider alternatives.” The FDA said that once the clause applies, it has no discretion to weigh alternatives.

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7. What the Order Does Not Do

• It does not find that Red No. 3 causes cancer in people. The FDA states the opposite: the rat mechanism does not occur in humans and there is no evidence of cancer in humans. The order exists because the Delaney Clause leaves no discretion once cancer is found in an animal.
• It does not cover cosmetics or externally applied drugs. Those uses had already ended in 1990 (see section 11). The 2025 order concerns food, dietary supplements and ingested drugs only.
• It does not take effect immediately. Food uses end on 15 January 2027 and ingested-drug uses on 18 January 2028.
• It does not order a recall. Products colored while the dye’s certificate was valid are not adulterated by that fact and may remain on shelves after the deadline.
• It is not a separate “ban” law. Many 2025 headlines called it a ban; legally it is the revocation of a color additive listing by order under existing law.
• It does not address other dyes. The wider plan to phase out petroleum-based dyes came later, on 22 April 2025, from HHS and the FDA (see the Synthetic Dye Phase-Out Plan page).

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8. The 2025 Objection and the Automatic Stay

Under the FD&C Act, anyone adversely affected by a color additive order may file objections and request a public hearing within 30 days; the order set the deadline at 18 February 2025. Filing proper objections automatically pauses (an “administrative stay”) the order’s effectiveness until the FDA takes final action on them.

The FDA received one submission, from counsel for a manufacturer of color-coded tracers — small colored particles added to medicated animal feed so that the presence of a specific medicated premix can be confirmed. The 2026 FDA response records the order as administratively stayed as of 18 February 2025. The submission raised three objections and asked for a hearing on each:

1. Statistics. That the FDA erred in combining benign adenomas with carcinomas and in its analysis of the rat data, supported by a Bayesian reanalysis.
2. Animal-feed tracers. That the FDA failed to consider the dye’s use in tracers for medicated animal feed and other legal uses.
3. An exemption. That the FDA should have exempted tracer use, or allowed it under a provision of the law dealing with additives in animal feed.

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9. August 2026: Objection Denied, Stay Lifted

On 5 August 2026 the FDA published its “response to objections and denial of public hearing requests; removal of administrative stay” at 91 FR 50475 (FR Doc. 2026-15920), in the same docket, FDA-2023-N-0437.

• The FDA concluded that the objections did not raise genuine and substantial issues of fact that a hearing could resolve, overruled them and denied the hearing requests.
• On the statistics, it stated that its conclusion on the rat feeding study “has not changed.”
• On tracers, it concluded that the dye used in color-coded tracers in medicated feed is regulated as a color additive, and that the animal-feed provision cannot exempt that use unless a proponent shows the required conditions are met.
• It lifted the administrative stay as of 5 August 2026 and confirmed the effective dates of 15 January 2027 (food) and 18 January 2028 (ingested drugs).
• The FDA described the decision as consistent with the United States’ long-standing “Appropriate Level of Protection” regarding carcinogenic additives in food.

The FDA stated that this document is its final action on the objections to the January 2025 order. The 2026 dye steps are covered on the site’s FDA Food Dye Actions in 2026 page.

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10. Dates and Legal Status (as of 11 October 2026)

• Status: FINAL. The order is in force on its stated dates; the 2025 administrative stay was lifted on 5 August 2026.
• 17 February 2023 — notice that the FDA filed the 2022 petition (88 FR 10245); comments open until 18 May 2023 after an extension.
• 10 January 2025 — order signed.
• 15 January 2025 — FDA constituent update announcing the revocation.
• 16 January 2025 — order published, 90 FR 4628.
• 18 February 2025 — deadline for objections; one submission filed; order administratively stayed.
• 14 July 2025 — letter from the FDA Commissioner and the Deputy Commissioner for Human Foods to food manufacturers.
• 5 August 2026 — objections overruled, hearing denied, stay lifted, dates confirmed (91 FR 50475).
• 15 January 2027 — Red No. 3 no longer permitted in food, including dietary supplements.
• 18 January 2028 — Red No. 3 no longer permitted in ingested drugs.

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11. How the Order Fits Earlier Actions

• 1907. The dye, as erythrosine, was first listed under the Food and Drugs Act of 1906.
• 1960. Provisionally listed as Red No. 3 for food, drug and cosmetic use; the same year the Color Additives Amendment added the Delaney Clause to the FD&C Act.
• 1969. Permanently listed for food and ingested drugs (34 FR 7446) — the two listings the 2025 order removes.
• 1990. The FDA did not extend the provisional listing for cosmetics and externally applied drugs (55 FR 3516), because of thyroid tumors in rat studies. That ended those uses but left the food and ingested-drug listings in place.
• 1992. The FDA announced an intention to revoke the food and ingested-drug listings (57 FR 16702). Its program page states the agency “decided not to take action at that time, given the resources required.”
• 2018. The FDA used the similarly worded Delaney Clause for food additives to revoke the authorization of certain synthetic flavors (83 FR 50490); the 2025 order cites it as precedent.
• 22 April 2025. HHS announced measures to phase out petroleum-based synthetic dyes from the food supply, and HHS and the FDA asked food companies to remove Red No. 3 sooner than the 2027 deadline.
• 14 July 2025. The FDA Commissioner and the Deputy Commissioner for Human Foods wrote to manufacturers encouraging them to reformulate “as soon as is practicably possible,” with the goal of completing the phase-out before 15 January 2027. The letter notes that any replacement color, including plant-derived ones, must itself meet the “reasonable certainty of no harm” standard through a color additive petition.

Related 2025 steps are on the Synthetic Dye Phase-Out Plan and Food Chemical Oversight pages; the overview of how other countries handle dyes is on Food Dyes Banned in Other Countries.

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12. Primary Documents

1. Food and Drug Administration, HHS (2025). Color Additive Petition; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs. Final amendment; order. Federal Register 90:4628–4634, 16 January 2025. Docket No. FDA-2023-N-0437 — FR Doc. 2025-00830 (official PDF, govinfo.gov)
2. U.S. Food and Drug Administration (2025). FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs. Human Foods Program Constituent Update, 15 January 2025 — fda.gov constituent update
3. U.S. Food and Drug Administration. FD&C Red No. 3 (program page, content current as of 5 October 2026) — fda.gov FD&C Red No. 3
4. U.S. Food and Drug Administration (2025). FDA Encourages Food Manufacturers to Accelerate Phasing Out the Use of FD&C Red No. 3 in Foods Before 2027 Deadline. Letter to manufacturers, 14 July 2025 — fda.gov letter
5. Food and Drug Administration, HHS (2026). Response to Objections and Requests for a Public Hearing; denial of public hearing requests; removal of administrative stay. Federal Register 91:50475–50482, 5 August 2026. Docket No. FDA-2023-N-0437 — FR Doc. 2026-15920 (official PDF, govinfo.gov)
6. Public docket FDA-2023-N-0437 — regulations.gov FDA-2023-N-0437

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Key Research Papers

1. Borzelleca JF, Capen CC, Hallagan JB (1987). Lifetime toxicity/carcinogenicity study of FD & C Red No. 3 (erythrosine) in rats. Food and Chemical Toxicology 25(10):723-733 — PubMed PMID: 2824305
2. Borzelleca JF, Hallagan JB (1990). Multigeneration study of FD & C Red No. 3 (erythrosine) in Sprague-Dawley rats. Food and Chemical Toxicology 28(12):813-819 — PubMed PMID: 2177442
3. Jennings AS, Schwartz SL, Balter NJ, Gardner D, Witorsch RJ (1990). Effects of oral erythrosine (2′,4′,5′,7′-tetraiodofluorescein) on the pituitary-thyroid axis in rats. Toxicology and Applied Pharmacology 103(3):549-556 — PubMed PMID: 2160137
4. Gardner DF, Utiger RD, Schwartz SL, Witorsch P, Meyers B, Braverman LE, Witorsch RJ (1987). Effects of oral erythrosine (2′,4′,5′,7′-tetraiodofluorescein) on thyroid function in normal men. Toxicology and Applied Pharmacology 91(3):299-304 — PubMed PMID: 2447681
5. Lin GH, Brusick DJ (1986). Mutagenicity studies on FD&C red No.3. Mutagenesis 1(4):253-259 — PubMed PMID: 2457780
6. Poulsen E (1993). Case study: erythrosine. Food Additives and Contaminants 10(3):315-323 — PubMed PMID: 8395413

The first paper is the 1987 report of the two chronic rat feeding studies that the FDA order names as the basis for its Delaney Clause finding.

PubMed Topic Searches

1. PubMed: erythrosine and the thyroid
2. PubMed: erythrosine carcinogenicity
3. PubMed: erythrosine genotoxicity
4. PubMed: synthetic food dyes and children

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Connections

• FDA Actions of 2025
• FDA and Regulation
• FDA Food Dye Actions in 2026
• Synthetic Dye Phase-Out Plan (2025)
• Food Chemical Oversight: GRAS and Post-Market Review (2025)
• Red 3 (Erythrosine)
• Food Dyes
• Food Dyes Banned in Other Countries
• Red 40 (Allura Red)
• FDA Phases Out Synthetic Food Dyes (News)
• Thyroid Disorders

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