FDA Food Dye Actions in 2026

Table of Contents

1. What the FDA Did in 2026: The Timeline
2. The “No Artificial Colors” Labeling Change
3. Beetroot Red: A New Color Made by Yeast Fermentation
4. Spirulina Extract: Wider Use and Lower Heavy-Metal Limits
5. Objections Put Both Approvals on Hold
6. Orange B: Authorization Revoked
7. Citrus Red No. 2: Revocation Proposed
8. New Color Petitions Filed in August
9. The Six Remaining Certified Dyes and the Industry Pledges
10. What These Actions Do Not Do
11. Legal Status as of 11 October 2026
12. How the 2026 Actions Fit Earlier FDA Actions
13. Primary Documents
14. Key Research Papers
15. Connections

1. What the FDA Did in 2026: The Timeline

1. 5 February 2026 — Press release “FDA Takes New Approach to ‘No Artificial Colors’ Claims” and a letter to the food industry announcing enforcement discretion for “no artificial colors” claims on foods that contain no certified colors. The same release announced the approval of beetroot red and the expanded use of spirulina extract.
2. 6 February 2026 — Two final orders published in the Federal Register: beetroot red (91 FR 5295, Docket FDA-2024-C-1085) and spirulina extract (91 FR 5291, Docket FDA-2024-C-3384), each set to take effect on 23 March 2026, with objections due by 9 March 2026.
3. 20 March 2026 — The effective dates of both orders were delayed indefinitely after timely objections were filed; the notices were published on 24 March 2026 (91 FR 13965 and 91 FR 13966).
4. 22–23 July 2026 — Press release “FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food,” followed by a final order revoking Orange B (91 FR 46276, Docket FDA-2025-C-3543) and a proposed order to revoke Citrus Red No. 2 (91 FR 46330, Docket FDA-2026-N-6304).
5. 19 August 2026 — Notices that the FDA had filed two new color additive petitions: expanded uses of gardenia (genipin) blue with a lower arsenic limit, and safflower extract as a new color.
6. 24 August 2026 — Deadline for objections to the Orange B order and for comments on the Citrus Red No. 2 proposal.
7. 8 September 2026 — Effective date of the Orange B revocation.

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2. The “No Artificial Colors” Labeling Change

Under the FDA’s labeling regulation (21 CFR 101.22(a)(4)), the term “artificial color” means any color additive, whatever its source. The 5 February press release explains the consequence: in the past, companies were “generally only able to make such claims when their products had no added color whatsoever — whether derived from natural sources or otherwise.”

The letter to the food industry, signed by the FDA Commissioner and the Deputy Commissioner for Human Foods and dated 5 February 2026, announces enforcement discretion — a statement that the agency does not intend to take enforcement action in a defined situation, without changing the underlying regulation. The FDA states it will not treat the following voluntary claims as misleading under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act when a food contains no color listed in 21 CFR Part 74 (the certified colors):

• “Made without artificial food colors/colorings”
• “No artificial color/colors/coloring”
• “No added artificial color/colors/coloring”

The letter is explicit that this “does not extend to foods that contain FD&C certified colors.” It also notes that colors derived from natural sources must still be pre-approved by the FDA through the color additive petition process, and that its existing flexibility on ingredient lists remains: a color exempt from certification can be declared by its common name (for example “colored with beet powder”) without the word “artificial.”

The FDA Commissioner was quoted in the release: “We acknowledge that calling colors derived from natural sources ‘artificial’ might be confusing for consumers and a hindrance for companies to explore alternative food coloring options.” The same release says the FDA is “reminding manufacturers of their responsibility to ensure color additive safety,” and that the letter highlights resources on maintaining safety and purity.

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3. Beetroot Red: A New Color Made by Yeast Fermentation

The final order of 6 February 2026 (91 FR 5295) adds a new section, 21 CFR 73.39, listing beetroot red as a color exempt from certification. The FDA acted on a color additive petition (CAP 4C0326) from a color manufacturer, which the agency had announced as filed on 12 March 2024.

Despite the name, the order explains that beetroot red is not pressed from beets. It is a reddish-purple liquid or powder made by controlled fermentation using a strain of baker’s yeast (Saccharomyces cerevisiae) genetically engineered to carry the genes red beets use to make betanin, the pigment that gives beets their color. Betanin belongs to the betalains, water-soluble pigments found mainly in red beets and related plants such as quinoa, spinach and amaranth. The order notes that the color’s pigment makeup is similar to that of dehydrated beets (beet powder), which the FDA has allowed as a color since 1967.

One public comment asked the FDA not to use the word “beetroot” because the color is not derived from beetroot. The agency kept the name, reasoning that the color is produced from red-beet genes and contains other pigments and constituents besides betanin.

The safety section of the order reports that:

• the FDA estimated betanin intake from the new uses at 27 mg per person per day on average and 53 mg at the 90th percentile for people aged 2 and older (19 mg and 37 mg for children aged 2 to 5);
• genetic-toxicity tests (bacterial, cell and animal assays) did not show the color to be mutagenic or genotoxic under the test conditions;
• in a 90-day rat study, no adverse effect was seen at the highest dose tested (about 3,581 mg/kg body weight per day in males and 4,055 mg/kg in females);
• a comparison of the proteins introduced into the yeast with known allergens found no significant match, which the FDA says it verified independently.

The listing sets impurity limits of 0.15 mg/kg lead, 0.05 mg/kg arsenic, 0.01 mg/kg mercury and 0.05 mg/kg cadmium. It allows beetroot red in human foods generally at levels consistent with good manufacturing practice, except in meat, poultry and egg products regulated by the U.S. Department of Agriculture, in infant formula, and in foods with a federal standard of identity (a legal recipe for foods such as certain cheeses or jams) unless that standard allows added color.

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4. Spirulina Extract: Wider Use and Lower Heavy-Metal Limits

Spirulina extract is a blue color already permitted under 21 CFR 73.530. Before 2026 its use was limited to a list of foods that included candy and chewing gum, frostings, ice cream, yogurt, puddings, beverages, breakfast cereals (excluding extruded ones), salad dressings and coatings on dietary supplement tablets. The final order of 6 February 2026 (91 FR 5291), granting a color manufacturer’s petition (CAP 4C0334), widens it to human foods generally, with the same exclusions as beetroot red: USDA-regulated meat, poultry and egg products, infant formula, and standardized foods unless the standard allows added color.

The order describes the color as a blue powder or liquid made by water extraction and filtration of the dried biomass of Arthrospira platensis (also called Spirulina platensis), an edible blue-green cyanobacterium. Its main coloring component is c-phycocyanin, a pigment-protein.

During its review, the FDA noted that the heavy-metal limits in the regulation could be lowered based on the petitioner’s batch analyses and that a cadmium limit could be added, which the order says aligns with the agency’s work to reduce dietary exposure to contaminants. The amended specifications are:

• lead, not more than 0.2 mg/kg;
• arsenic, not more than 0.3 mg/kg;
• mercury, not more than 0.1 mg/kg;
• cadmium, not more than 0.3 mg/kg (a new limit);
• negative for microcystin toxin.

The FDA confirmed the petitioner’s intake estimate of 6.3 g of spirulina extract per person per day on average among people who eat the colored foods (14.1 g at the 90th percentile; 5.1 g and 10.7 g for children aged 2 to 5). The order also explains a point that recurs in color regulation: there is no GRAS (“generally recognized as safe”) route for colors. Several spirulina ingredients have been the subject of GRAS notices, but if a substance imparts color to a food it can still need approval as a color additive.

The press release states that with these two petitions, the number of new food color options approved under the current administration reached six.

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5. Objections Put Both Approvals on Hold

A color additive order can be challenged: anyone who would be adversely affected may file objections by the deadline and may ask for a public hearing. Both February orders were to take effect on 23 March 2026, with objections due by 9 March 2026.

On 24 March 2026 the FDA published two notices (91 FR 13965 for beetroot red and 91 FR 13966 for spirulina extract) stating that, as of 20 March 2026, the effective date of each order “is delayed indefinitely.” The beetroot red order drew timely objections; the spirulina extract order drew timely objections and a request for a hearing. The notices say the delay “is required by law” once timely objections are filed.

Both notices add that the delay “does not reflect a change in our determination that there is a reasonable certainty of no harm” from the color under its intended conditions of use, and that it is not a determination that every issue raised is a valid objection or that a hearing is justified. The FDA says it will publish a further Federal Register document announcing a new effective date or other action. A check of the Federal Register on 11 October 2026 found no such document for either color.

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6. Orange B: Authorization Revoked

Orange B was a certified color permitted for one use only: coloring the casings or surfaces of frankfurters and sausages (21 CFR 74.250). The FDA proposed revoking it on 17 September 2025 (90 FR 44786) and finalized the revocation in an order published on 23 July 2026 (91 FR 46276, Docket FDA-2025-C-3543), effective 8 September 2026.

The stated ground is abandonment. Because every batch of a certified color must be certified by the FDA before use, the agency’s certification records show whether a color is still being made. According to the order, Orange B was last batch certified in 1978 and the FDA has received no request to certify it since. The order calls the regulation “outdated and unnecessary.”

The FDA received 16 comments on the proposal; all but one supported revocation, and none claimed Orange B was still in use. Responding to comments, the agency said:

• color additives, including Orange B, cannot be GRAS, because the law has no GRAS provision for color additives;
• by the late 1970s there had been evaluations, by the dye’s sole manufacturer and others, of potential health implications of Orange B, which led to the end of its production;
• the safety of synthetic food colors in general was outside the scope of this action.

The order places the revocation within executive-branch deregulation directives, including Executive Order 14192 (“Unleashing Prosperity Through Deregulation”) and Executive Order 13563, which asks agencies to review existing regulations for ones that are outmoded.

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7. Citrus Red No. 2: Revocation Proposed

Citrus Red No. 2 is a certified color permitted only on the skins of mature oranges that are not intended for processing (21 CFR 74.302), at no more than 2.0 parts per million calculated on the weight of the whole fruit. The FDA first listed it temporarily on 17 April 1959 and issued the regulation on 22 May 1963.

On 23 July 2026 the FDA published a proposed order to revoke that listing (91 FR 46330, Docket FDA-2026-N-6304). The proposal says certification records show Citrus Red No. 2 was last batch certified in 2020, with no request since, and the agency “tentatively” concludes that its use has been abandoned.

The proposal describes what a final order would do:

• take effect 90 days after publication;
• end the validity of certificates for any existing batches on that date, so any remaining lots would count as uncertified;
• give a further one-year compliance period, during which the FDA would not enforce the order against foods already made, to allow any remaining certified stock to be used up — the agency asked for comments on whether to provide this period and on its appropriate duration.

Comments closed on 24 August 2026. The July press release states that after reviewing them, the FDA “will determine whether to finalize the proposed revocation.”

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8. New Color Petitions Filed in August

On 19 August 2026 the FDA published notices (both at 91 FR 53545) that it had filed two more color additive petitions. Filing means the agency has accepted a petition for review; it is not an approval.

• Gardenia (genipin) blue (CAP 6C0343, Docket FDA-2026-C-8831, filed 4 August 2026): a petition from an industry group proposes expanding this already-listed blue color (21 CFR 73.168) to 20 food categories, including carbonated and powdered drinks, breakfast cereals, chewing gum, ice cream, yogurt and flavored milk, snack foods and chewable tablets, and lowering its arsenic limit from 2 mg/kg to 1 mg/kg.
• Safflower extract (CAP 5C0338, Docket FDA-2026-C-8086, filed 20 July 2026): a color manufacturer’s petition proposes listing an extract of safflower (Carthamus tinctorius) as a new color exempt from certification in 17 food categories, including beverages, extruded breakfast cereals, pickles, frostings, hard and soft candy, frozen dairy desserts and broth.

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9. The Six Remaining Certified Dyes and the Industry Pledges

The FDA’s web page “Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes” (content current as of 15 September 2026) describes the program behind these actions. It traces it to 22 April 2025, when the Department of Health and Human Services and the FDA announced a national initiative to phase out petroleum-based (certified) food dyes. The page states that the HHS Secretary and the Acting FDA Commissioner said these dyes “offer no nutritional benefit and may pose health risks, particularly to children,” citing concerns about childhood obesity, diabetes, depression and ADHD.

On the six certified colors still most used in food — FD&C Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1 and Blue No. 2 — the tracker states that the FDA is “working closely with food manufacturers, retailers, and trade associations to eliminate” them “by the end of 2027.”

The tracker lists voluntary commitments by food manufacturers, retailers, school food-service providers and trade associations, each with its planned change and a status of “In progress” or “Complete.” The commitments vary in scope — some cover school foods only, some a single product line, some an entire U.S. portfolio — and target dates range from 2025 to December 2028 (one trade association’s baked-goods commitment). It also lists the new colors from natural sources the FDA has approved: calcium phosphate, Galdieria extract blue, gardenia blue, butterfly pea flower extract and beetroot red.

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10. What These Actions Do Not Do

• No ban on the six most-used dyes. None of the 2026 documents revokes or restricts Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2 or Green No. 3. Their removal rests on voluntary industry pledges that the FDA tracks.
• No new safety finding on synthetic dyes. The Orange B and Citrus Red No. 2 actions rest on abandonment — no batches certified for decades or years — not on a new safety determination; the Orange B order says the safety of synthetic food colors generally is beyond its scope.
• Beetroot red and the wider spirulina use are not in effect. Both orders were stayed indefinitely by objections in March 2026 and remained so as of 11 October 2026.
• Citrus Red No. 2 is not yet revoked. Only a proposed order exists; no final order had appeared in the Federal Register as of 11 October 2026.
• The labeling change does not change the regulation. The definition of “artificial color” in 21 CFR 101.22 is unchanged; the FDA has said only that it does not intend to take enforcement action against the listed claims on foods free of certified colors.
• The August petitions are not approvals. Filing begins the FDA’s review of gardenia blue’s expansion and of safflower extract.

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11. Legal Status as of 11 October 2026

1. “No artificial colors” enforcement discretion — in place since 5 February 2026 (a policy letter, not a regulation).
2. Beetroot red (new listing, 21 CFR 73.39) — final order issued; effective date stayed indefinitely since 20 March 2026 following objections.
3. Spirulina extract (expanded use, 21 CFR 73.530) — final order issued; effective date stayed indefinitely since 20 March 2026 following objections and a hearing request. While the stay lasts, the amended listing has not taken effect.
4. Orange B revocation — final; effective 8 September 2026. A check of the Federal Register on 11 October 2026 found no notice delaying or staying it.
5. Citrus Red No. 2 revocation — proposed; comment period closed 24 August 2026; no final order as of 11 October 2026.
6. Red No. 3 in food — revoked 15 January 2025, with a food deadline of 15 January 2027, according to the FDA tracker.
7. Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2 — still authorized; voluntary phase-out targeted by the FDA for the end of 2027.
8. Gardenia (genipin) blue expansion and safflower extract — petitions filed; under review.

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12. How the 2026 Actions Fit Earlier FDA Actions

The documents place the 2026 actions in a sequence that began before the year:

• 15 January 2025 — the FDA revoked the authorization for FD&C Red No. 3 in food, with a 15 January 2027 deadline for foods; the tracker says the FDA has encouraged industry to remove it ahead of that date.
• 22 April 2025 — HHS and the FDA announced measures to work with industry to phase out petroleum-based synthetic colors from the food supply, the program the February letter and both 2026 press releases cite.
• 17 September 2025 — the FDA proposed revoking Orange B (90 FR 44786), the proposal finalized in July 2026.
• 2025–2026 approvals — the FDA approved several colors from natural sources (the tracker names calcium phosphate, Galdieria extract blue, gardenia blue and butterfly pea flower extract, then beetroot red); the February 2026 press release counts six new color options under the current administration.

The July 2026 press release describes the Orange B and Citrus Red No. 2 actions as part of “reviewing and updating color additive regulations that are no longer relevant to current industry practices,” and the Federal Register orders tie them to the executive orders on reducing unnecessary regulation. The February actions, by contrast, aim at the substitutes: easier labeling for foods colored without certified dyes and more approved colors from natural sources. The Deputy Commissioner for Human Foods was quoted in February: “We are working diligently to facilitate industry’s phase out of petroleum-based colors and speed up authorizations for colors that are derived from alternative sources.”

Other 2026 FDA food-chemical actions — the proposal to make GRAS notices mandatory and the reassessments of the preservatives BHA and BHT and the dough conditioner azodicarbonamide — are described on their own pages linked under Connections.

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13. Primary Documents

1. U.S. Food and Drug Administration (2026). FDA Takes New Approach to “No Artificial Colors” Claims. FDA News Release, 5 February 2026 — fda.gov press announcement
2. U.S. Food and Drug Administration (2026). Letter to the Food Industry on “No Artificial Colors” Labeling Claims, 5 February 2026 — fda.gov letter
3. Food and Drug Administration, HHS (2026). Listing of Color Additives Exempt From Certification; Beetroot Red. Final order. Federal Register 91:5295–5299, 6 February 2026. Docket No. FDA-2024-C-1085 — FR Doc. 2026-02313
4. Food and Drug Administration, HHS (2026). Listing of Color Additives Exempt From Certification; Spirulina Extract. Final order. Federal Register 91:5291–5295, 6 February 2026. Docket No. FDA-2024-C-3384 — FR Doc. 2026-02314
5. Food and Drug Administration, HHS (2026). Listing of Color Additive Exempt From Certification; Beetroot Red; Delay of Effective Date. Federal Register 91:13965–13966, 24 March 2026. Docket No. FDA-2024-C-1085 — FR Doc. 2026-05732
6. Food and Drug Administration, HHS (2026). Listing of Color Additive Exempt From Certification; Spirulina Extract; Delay of Effective Date. Federal Register 91:13966–13967, 24 March 2026. Docket No. FDA-2024-C-3384 — FR Doc. 2026-05733
7. U.S. Food and Drug Administration (2026). FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food. FDA News Release, 22 July 2026 — fda.gov press announcement
8. Food and Drug Administration, HHS (2026). Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages. Final order. Federal Register 91:46276–46279, 23 July 2026. Docket No. FDA-2025-C-3543 — FR Doc. 2026-14910
9. Food and Drug Administration, HHS (2026). Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges. Proposed order. Federal Register 91:46330–46332, 23 July 2026. Docket No. FDA-2026-N-6304 — FR Doc. 2026-14909
10. Food and Drug Administration, HHS (2026). Filing of Color Additive Petition (gardenia (genipin) blue, expanded uses and lower arsenic specification). Federal Register 91:53545, 19 August 2026. Docket No. FDA-2026-C-8831 — FR Doc. 2026-16944
11. Food and Drug Administration, HHS (2026). Filing of Color Additive Petition (safflower extract). Federal Register 91:53545, 19 August 2026. Docket No. FDA-2026-C-8086 — FR Doc. 2026-16939
12. U.S. Food and Drug Administration. Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes (content current as of 15 September 2026) — fda.gov tracker

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Key Research Papers

1. Bateman B, Warner JO, Hutchinson E, Dean T, Rowlandson P, Gant C, Grundy J, Fitzgerald C, Stevenson J (2004). The effects of a double blind, placebo controlled, artificial food colourings and benzoate preservative challenge on hyperactivity in a general population sample of preschool children. Archives of Disease in Childhood 89(6):506-511 — PubMed PMID: 15155391
2. McCann D, Barrett A, Cooper A, Crumpler D, Dalen L, Grimshaw K, Kitchin E, Lok K, Porteous L, Prince E, Sonuga-Barke E, Warner JO, Stevenson J (2007). Food additives and hyperactive behaviour in 3-year-old and 8/9-year-old children in the community: a randomised, double-blinded, placebo-controlled trial. Lancet 370(9598):1560-1567 — PubMed PMID: 17825405
3. Nigg JT, Lewis K, Edinger T, Falk M (2012). Meta-analysis of attention-deficit/hyperactivity disorder or attention-deficit/hyperactivity disorder symptoms, restriction diet, and synthetic food color additives. Journal of the American Academy of Child and Adolescent Psychiatry 51(1):86-97.e8 — PubMed PMID: 22176942
4. Miller MD, Steinmaus C, Golub MS, Castorina R, Thilakartne R, Bradman A, Marty MA (2022). Potential impacts of synthetic food dyes on activity and attention in children: a review of the human and animal evidence. Environmental Health 21(1):45 — PubMed PMID: 35484553
5. Oplatowska-Stachowiak M, Elliott CT (2017). Food colors: Existing and emerging food safety concerns. Critical Reviews in Food Science and Nutrition 57(3):524-548 — PubMed PMID: 25849411
6. Khan MI (2016). Plant Betalains: Safety, Antioxidant Activity, Clinical Efficacy, and Bioavailability. Comprehensive Reviews in Food Science and Food Safety 15(2):316-330 — PubMed PMID: 33371594
7. Ma J, Hu J, Sha X, Meng D, Yang R (2024). Phycobiliproteins, the pigment-protein complex form of natural food colorants and bioactive ingredients. Critical Reviews in Food Science and Nutrition 64(10):2999-3017 — PubMed PMID: 36193900

The first four papers are the human and review evidence most often cited on synthetic food colors and children’s attention and activity; the last two review betalains (the beetroot red pigment family) and phycobiliproteins (the spirulina extract pigment family).

PubMed Topic Searches

1. PubMed: synthetic food dyes and children’s behavior
2. PubMed: betanin as a food colorant
3. PubMed: phycocyanin and spirulina as a food colorant
4. PubMed: Citrus Red No. 2

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Connections

• FDA and Regulation
• FDA Proposal to Make GRAS Notices Mandatory (2026)
• FDA Safety Reassessments of BHA, BHT and ADA (2026)
• Artificial Food Dyes
• Food Dyes Banned in Other Countries
• Red 40 (Allura Red)
• Red 3 (Erythrosine)
• Yellow 5 (Tartrazine)
• Spirulina
• Beets
• Oranges
• ADHD
• News: FDA Phases Out Synthetic Food Dyes
• News: American Food and Health Policy Reset

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