U.S. Food and Drug Administration (FDA) Plan to Phase Out Petroleum-Based Food Dyes (2025)

Table of Contents

1. 1. What U.S. Department of Health and Human Services and the U.S. Food and Drug Administration Announced
2. 2. The Terms: Color Additives, Certified Dyes and Natural Sources
3. 3. The Reasons Officials Gave
4. 4. May 2025: Three Colors From Natural Sources Approved
5. 5. July 2025: Gardenia (Genipin) Blue and the Red No. 3 Letter
6. 6. Industry Commitments and the Two Target Dates
7. 7. September 2025: The Proposal to Remove Orange B
8. 8. What the 2025 Actions Do Not Do
9. 9. Dates and Legal Status (as of 11 October 2026)
10. 10. How the Plan Fits Earlier and Later Actions
11. 11. Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

1. What U.S. Department of Health and Human Services and the U.S. Food and Drug Administration Announced

The U.S. Food and Drug Administration news release dated 22 April 2025, “U.S. Department of Health and Human Services, U.S. Food and Drug Administration to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply,” states that the two agencies “today announced a series of new measures to phase out all petroleum-based synthetic dyes from the nation’s food supply.” It lists six steps the U.S. Food and Drug Administration said it was taking:

1. Establishing “a national standard and timeline” for the food industry to move from petrochemical-based dyes to natural alternatives.
2. Starting the process to revoke the authorization of two synthetic food colors, Citrus Red No. 2 and Orange B, “within the coming months.”
3. Working with industry to eliminate six remaining synthetic dyes — FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1 and FD&C Blue No. 2 — from the food supply “by the end of next year.”
4. Authorizing four new natural color additives “in the coming weeks,” while speeding the review of others.
5. Partnering with the National Institutes of Health (NIH) on research into how food additives affect children’s health and development.
6. Asking food companies to remove FD&C Red No. 3 sooner than the 2027–2028 deadlines set when its authorization was revoked in January 2025.

The release names the colors whose review the U.S. Food and Drug Administration was “fast-tracking”: calcium phosphate, Galdieria extract blue, gardenia blue and butterfly pea flower extract, “and other natural alternatives.” It adds that the agency was “taking steps to issue guidance and provide regulatory flexibilities to industries.” The U.S. National Institutes of Health work is described as a partnership with the U.S. National Institutes of Health Nutrition Regulatory Science and Research Program.

The announcement itself was a press release, not a Federal Register document: it did not change any regulation. The regulatory changes that followed in 2025 were the four color approvals and the Orange B proposal described in sections 4, 5 and 7.

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2. The Terms: Color Additives, Certified Dyes and Natural Sources

Color additive. Under the Federal Food, Drug, and Cosmetic Act, a color additive is any dye, pigment or other substance, whether made by synthesis or extracted from a vegetable, animal, mineral or other source, that can impart color to a food, drug, cosmetic or the human body. The U.S. Food and Drug Administration’s September 2025 Orange B document explains that color additives are “deemed unsafe and prohibited” unless the U.S. Food and Drug Administration approves their use through a regulation, and that the agency may list one only if it finds the additive “suitable and safe” for that use.

Certified (synthetic) dyes. Some listed colors must be batch certified: each batch is sent to the U.S. Food and Drug Administration, which tests a sample against the identity and purity specifications in the regulation before issuing a certificate. The Orange B document states that the U.S. Food and Drug Administration requires certification when a color’s composition needs to be controlled to protect public health, because some colors “in their uncertified forms, might contain impurities at levels that pose a health concern.” The petroleum-based dyes with “FD&C” names are certified colors; the U.S. Food and Drug Administration’s tracker uses “petroleum-based food dyes” and “certified color additives” for the same group.

Colors exempt from certification. Colors from natural sources, such as plant or algae extracts and minerals, are listed in a separate part of the regulations as “exempt from certification.” Each of the four 2025 approvals amended that list.

The safety standard. The May and July 2025 releases explain that the U.S. Food and Drug Administration decides whether a color is safe by comparing the projected dietary exposure with the additive’s toxicological data and other information, such as published literature. The calcium phosphate order states its finding as “reasonable certainty of no harm” from the intended uses. The releases add that once a color additive petition is approved, “any manufacturer can use the coloring for the approved uses.”

Petition, final order, docket. A color additive petition is a formal request, usually from a manufacturer or industry group, to list a new color or new use. The U.S. Food and Drug Administration answers with an order published in the Federal Register, the U.S. government’s daily journal of rules and notices. Each action has a public docket number (for example FDA-2025-C-3543), the file where documents and public comments are kept. Each 2025 final order gave the public 30 days after publication to file objections.

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3. The Reasons Officials Gave

The April 2025 release gives the reasons as statements by two officials, not as findings of a Federal Register document.

• The U.S. Department of Health and Human Services Secretary is quoted as saying that “some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent,” and that “these poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development.”
• The U.S. Food and Drug Administration Commissioner is quoted as saying that the U.S. Food and Drug Administration was “asking food companies to substitute petrochemical dyes with natural ingredients for American children as they already do in Europe and Canada,” and that “we have a new epidemic of childhood diabetes, obesity, depression, and attention-deficit/hyperactivity disorder (ADHD),” pointing to “the growing concerns of doctors and parents about the potential role of petroleum-based food dyes.”

These are the officials’ words, reported as they were said. The release does not cite studies, and none of the 2025 Federal Register documents for this plan makes a finding that Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2 or Green No. 3 is unsafe. The published research on synthetic food colors and children’s behavior is listed under Key Research Papers below.

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4. May 2025: Three Colors From Natural Sources Approved

On 9 May 2025 the U.S. Food and Drug Administration announced that it had granted three color additive petitions. The three final orders were published in the Federal Register on 12 May 2025, each effective 26 June 2025; the U.S. Food and Drug Administration published confirmations of that effective date on 21 August 2025.

• Galdieria extract blue (90 FR 20104, Docket FDA-2021-C-0925). A blue color extracted with water from the dried biomass of the red microalga Galdieria sulphuraria; its principal coloring component is C-phycocyanin, the same pigment found in spirulina extract. Approved for nonalcoholic beverages and beverage bases, fruit drinks, smoothies and juices, dairy drinks and flavored milks, yogurt drinks, meal-replacement beverages, breakfast cereal coatings, hard and soft candy and chewing gum, frostings, ice cream and frozen desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, creamers and whipped toppings. The order states that the 90th-percentile estimated exposure for people aged 2 and older (630 mg per person per day) does not exceed the no-observed-adverse-effect level of 4,000 mg per kg of body weight per day, and concludes the color is safe for the petitioned uses.
• Butterfly pea flower extract, expanded use (90 FR 20101, Docket FDA-2024-C-0971). A blue color made by water extraction of the dried petals of the butterfly pea plant, which the release says can give bright blues, intense purple and natural greens. It was already approved in drinks, candy, gums, ice cream, yogurt and other foods; the order adds ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked) and plain corn, tortilla and multigrain chips. The order repeats the U.S. Food and Drug Administration’s earlier finding that, because the extract must be ultrafiltered, it presents “an insignificant allergy risk.”
• Calcium phosphate (90 FR 20097, Docket FDA-2023-C-0544). A white color for ready-to-eat chicken products, white candy melts, doughnut sugar and sugar for coated candies, with use limits by weight of the finished food. The order states that the 90th-percentile cumulative exposure to calcium and to phosphorus from all dietary sources, supplements included, stays below the Institute of Medicine upper limits of 2,000 mg and 3,000 mg per person per day.

The release quotes the U.S. Food and Drug Administration Commissioner: “On April 22, I said the U.S. Food and Drug Administration would soon approve several new color additives and would accelerate our review of others.” Each petition was filed by a private firm; the site does not name petitioners.

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5. July 2025: Gardenia (Genipin) Blue and the Red No. 3 Letter

On 14 July 2025 the U.S. Food and Drug Administration announced its approval of gardenia (genipin) blue, which it described as “the fourth color derived from natural sources approved by the U.S. Food and Drug Administration for use in foods in the last two months.” The final order was published on 15 July 2025 (90 FR 31586, Docket FDA-2021-C-0522) and took effect on 29 August 2025, a date the U.S. Food and Drug Administration confirmed on 1 October 2025 (90 FR 47229).

• What it is. The order describes a dark blue or purple liquid or powder made by reacting genipin, refined from the fruit of Gardenia jasminoides, with soy protein hydrolysate and polymerizing the product.
• Approved uses. Sports drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy and soft candy.
• Safety finding. From a 24-month rat study the U.S. Food and Drug Administration set an acceptable daily intake (ADI) of 21.75 mg per kg of body weight per day and found the 90th-percentile estimated exposure, 1.27 mg per kg per day, below it.
• Soy allergen labeling. Because soy protein hydrolysate is used to make the color, the order states that it requires soy allergen labeling under the food allergen law unless an exemption is granted; an exemption petition filed in September 2022 was, in the order’s words, “currently under review.”

The same release reported that the U.S. Food and Drug Administration had sent a letter to manufacturers encouraging them to stop using FD&C Red No. 3 in foods, including dietary supplements, before the required date of 15 January 2027. The letter is quoted as saying that “accelerating the phase out of the use of FD&C Red No. 3 in foods will help further the goal of Making America Healthy Again.” The Red No. 3 order itself is described on the site’s U.S. Food and Drug Administration Revokes Red No. 3 in Food and Ingested Drugs (2025) page.

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6. Industry Commitments and the Two Target Dates

The removal of the six main certified dyes depends on companies agreeing to reformulate. The documents give the following account, each part dated to its source:

• 22 April 2025 — the U.S. Department of Health and Human Services/U.S. Food and Drug Administration release says the U.S. Food and Drug Administration would work with industry to eliminate the six dyes “by the end of next year,” which, read from the release’s date, is the end of 2026.
• 9 May 2025 — the U.S. Food and Drug Administration release says that since the April announcement “more U.S. food manufacturers have committed to removing them within the U.S. Food and Drug Administration’s set time frame of the end of next year.”
• 14 July 2025 — the U.S. Food and Drug Administration release says “about 40 percent of the food industry has committed to a voluntary phase-out of such dyes.” It also reports that on 11 July a national trade association for makers of packaged consumer goods announced a voluntary commitment to encourage its members to remove certified colors from products served in schools by the start of the 2026–2027 school year.
• U.S. Food and Drug Administration tracker, current as of 15 September 2026 — the U.S. Food and Drug Administration page “Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes” says the U.S. Food and Drug Administration is working with manufacturers, retailers and trade associations to eliminate the same six certified colors “by the end of 2027.”

The two dates come from different documents and are reported here side by side; the tracker does not say when or why the target moved. The tracker lists individual companies’ pledges, each marked “Complete” or “In progress,” with deadlines that range from 2025 to December 2028; many cover school foods first and full retail product lines later. The site does not reproduce the company names.

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7. September 2025: The Proposal to Remove Orange B

On 17 September 2025 the U.S. Food and Drug Administration published a proposed order to remove the color additive listing for Orange B (90 FR 44786, Docket FDA-2025-C-3543), with comments accepted until 17 October 2025. It was the first of the two revocations promised in April to reach the Federal Register.

• What Orange B was allowed for. Since a regulation of 4 January 1966, only for coloring the casings or surfaces of frankfurters and sausages, at no more than 150 parts per million of the finished food, with every batch certified.
• The ground given. U.S. Food and Drug Administration records show Orange B was last batch certified in 1978 and that no request to certify it has been received since. The U.S. Food and Drug Administration “tentatively” concluded that the authorized use “has been abandoned” and that the listing is “outdated and unnecessary.”
• The policy basis. The document ties the proposal to the executive order on reducing unnecessary regulation (Executive Order 14192, February 2025), a U.S. Department of Health and Human Services deregulation request for information of May 2025, and the long-standing order requiring periodic review of existing rules (Executive Order 13563). It also describes the step as a partial response to a 2008 citizen petition (Docket FDA-2008-P-0349) that asked, in part, for Orange B’s approval to be revoked.
• What finalizing would do. Certificates for any remaining batches would stop being valid for food on the effective date, and food containing Orange B after that date would be adulterated under the law.

The proposal makes no new safety finding about Orange B; its stated reason is that the color is no longer used. The order was finalized in 2026 (section 9).

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8. What the 2025 Actions Do Not Do

• No ban on the six main dyes. No rule revokes Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2 or Green No. 3. They remain listed color additives; their removal rests on voluntary industry commitments, as the April 2025 release (“working with industry”) and the U.S. Food and Drug Administration tracker both describe.
• No 2025 action on Citrus Red No. 2. Although the April release said the revocation process would start “within the coming months,” the Citrus Red No. 2 proposal was not published until 23 July 2026.
• No requirement to switch. The four natural-color orders permit new uses; they require no manufacturer to use them or to stop using a certified dye.
• No published national standard in the Federal Register in 2025. The April release announced “a national standard and timeline”; none of the 2025 Federal Register documents listed in section 11 sets one.
• No change to Red No. 3’s legal deadlines. The July 2025 letter encouraged earlier removal; the legal dates of 15 January 2027 (food) and 18 January 2028 (ingested drugs) come from the January 2025 order.
• No change to drugs or cosmetics. The 2025 phase-out plan and orders concern colors in food.

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

• Status: MIXED. The four color approvals are FINAL and in effect. The Orange B revocation proposed in 2025 became FINAL in 2026. Citrus Red No. 2 is PROPOSED for revocation. The phase-out of the six main certified dyes is VOLUNTARY, with no rule. The 2026 steps are covered on the site’s U.S. Food and Drug Administration Food Dye Actions in 2026 page.
• 22 April 2025 — U.S. Department of Health and Human Services/U.S. Food and Drug Administration announcement of the phase-out measures.
• 9 May 2025 — U.S. Food and Drug Administration announces three color approvals; orders published 12 May 2025 (90 FR 20097, 20101, 20104).
• 26 June 2025 — Galdieria extract blue, butterfly pea flower extract (expanded use) and calcium phosphate orders take effect; confirmed 21 August 2025 (90 FR 40703–40704).
• 14 July 2025 — gardenia (genipin) blue approval announced and Red No. 3 letter to manufacturers; order published 15 July 2025 (90 FR 31586).
• 29 August 2025 — gardenia (genipin) blue order takes effect; confirmed 1 October 2025 (90 FR 47229).
• 17 September 2025 — Orange B removal proposed (90 FR 44786); comments closed 17 October 2025.
• February 2026 — beetroot red approved as a further color from a natural source; on 24 March 2026 its effective date was delayed indefinitely after objections were filed (FR Doc. 2026-05732; see the 2026 page).
• 23 July 2026 — Orange B revocation finalized (91 FR 46276, effective 8 September 2026); Citrus Red No. 2 proposed for revocation (91 FR 46330, Docket FDA-2026-N-6304).
• End of 2026 — target for the six certified dyes as stated in the 22 April 2025 release (“by the end of next year”).
• 15 January 2027 — legal deadline for Red No. 3 in food, from the January 2025 order.
• End of 2027 — target for the six certified dyes as stated on the U.S. Food and Drug Administration tracker current as of 15 September 2026.

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10. How the Plan Fits Earlier and Later Actions

• 15 January 2025 — before the plan, the U.S. Food and Drug Administration revoked the authorization for FD&C Red No. 3 in food and ingested drugs (see the Red No. 3 page). The April plan asked companies to move faster than that order’s deadlines, and the July letter repeated the request.
• 22 April 2025 — the plan widened the focus from one dye to every petroleum-based dye, pairing revocations of two little-used dyes with voluntary removal of the six common ones and faster approval of substitutes.
• May–July 2025 — the four approvals named in April were completed within about three months of the announcement, as the July release notes (“in the last two months”).
• September 2025 — the Orange B proposal followed, grounded in abandonment of use and in the deregulation orders rather than in a safety finding.
• 2026 — the U.S. Food and Drug Administration approved beetroot red, updated its labeling policy to give companies, in the tracker’s words, “greater flexibility in making ‘no artificial colors’ claims when using naturally derived colors”, finalized the Orange B revocation and proposed revoking Citrus Red No. 2; the tracker moved its stated target for the six dyes to the end of 2027. These are described on U.S. Food and Drug Administration Food Dye Actions in 2026.

Other 2025 food-chemical steps, including the U.S. Food and Drug Administration’s review of chemicals already on the market and of the generally recognized as safe (GRAS) (“generally recognized as safe”) pathway, are on the site’s Food Chemical Oversight page.

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11. Primary Documents

1. U.S. Food and Drug Administration (2025). U.S. Department of Health and Human Services, U.S. Food and Drug Administration to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply. U.S. Food and Drug Administration News Release, 22 April 2025 — fda.gov press announcement
2. U.S. Food and Drug Administration (2025). U.S. Food and Drug Administration Approves Three Food Colors from Natural Sources. U.S. Food and Drug Administration News Release, 9 May 2025 — fda.gov press announcement
3. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Listing of Color Additives Exempt From Certification; Galdieria Extract Blue. Final order. Federal Register 90:20104, 12 May 2025, effective 26 June 2025. Docket No. FDA-2021-C-0925 — FR Doc. 2025-08250
4. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract. Final order. Federal Register 90:20101, 12 May 2025, effective 26 June 2025. Docket No. FDA-2024-C-0971 — FR Doc. 2025-08248
5. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Listing of Color Additives Exempt From Certification; Calcium Phosphate. Final order. Federal Register 90:20097, 12 May 2025, effective 26 June 2025. Docket No. FDA-2023-C-0544 — FR Doc. 2025-08249
6. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Confirmations of effective date for the galdieria extract blue, butterfly pea flower extract and calcium phosphate orders. Federal Register 90:40703–40704, 21 August 2025 — FR Doc. 2025-16046 (with FR Docs. 2025-16045 and 2025-16047)
7. U.S. Food and Drug Administration (2025). U.S. Food and Drug Administration Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3. U.S. Food and Drug Administration News Release, 14 July 2025 — fda.gov press announcement
8. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue. Final order. Federal Register 90:31586, 15 July 2025, effective 29 August 2025. Docket No. FDA-2021-C-0522 — FR Doc. 2025-13175; confirmation of effective date, 90:47229, 1 October 2025 — FR Doc. 2025-19166
9. Food and Drug Administration, U.S. Department of Health and Human Services (2025). Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages. Proposed order. Federal Register 90:44786–44788, 17 September 2025. Docket No. FDA-2025-C-3543 — FR Doc. 2025-18023
10. Food and Drug Administration, U.S. Department of Health and Human Services (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, 23 July 2026, effective 8 September 2026. Docket No. FDA-2025-C-3543 — FR Doc. 2026-14910
11. Food and Drug Administration, U.S. Department of Health and Human Services (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, 23 July 2026. Docket No. FDA-2026-N-6304 — FR Doc. 2026-14909
12. U.S. Food and Drug Administration. Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes. Program page, content current as of 15 September 2026 — fda.gov tracker

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Key Research Papers

1. Schab DW, Trinh NH (2004). Do artificial food colors promote hyperactivity in children with hyperactive syndromes? A meta-analysis of double-blind placebo-controlled trials. Journal of Developmental and Behavioral Pediatrics 25(6):423-434 — PubMed PMID: 15613992
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. Stevens LJ, Burgess JR, Stochelski MA, Kuczek T (2014). Amounts of artificial food colors in commonly consumed beverages and potential behavioral implications for consumption in children. Clinical Pediatrics 53(2):133-140 — PubMed PMID: 24037921
5. Trasande L, Shaffer RM, Sathyanarayana S; Council on Environmental Health (2018). Food Additives and Child Health. Pediatrics 142(2) — PubMed PMID: 30037972
6. 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

The 2025 U.S. Department of Health and Human Services and U.S. Food and Drug Administration documents cite none of these papers; they are peer-reviewed trials and reviews on synthetic food colors and children’s behavior, listed for readers who want the research behind the debate.

PubMed Topic Searches

1. PubMed: synthetic food dyes and children’s behavior
2. PubMed: artificial food colors and ADHD meta-analyses
3. PubMed: natural food colorants (phycocyanin, genipin) safety

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Connections

• U.S. Food and Drug Administration Actions in 2025
• U.S. Food and Drug Administration and Regulation
• U.S. Food and Drug Administration Food Dye Actions in 2026
• U.S. Food and Drug Administration Revokes Red No. 3 (2025)
• Food Chemical Oversight: Generally Recognized as Safe and Post-Market Review (2025)
• Front-of-Package Nutrition Label Proposal (2025)
• Artificial Food Dyes
• Red 40 (Allura Red)
• Yellow 5 (Tartrazine)
• Red 3 (Erythrosine)
• Food Dyes Banned in Other Countries
• Butterfly Pea
• Butterfly Pea: Anthocyanins and the Colour Change
• Attention-Deficit/Hyperactivity Disorder
• News: U.S. Food and Drug Administration Phases Out Synthetic Food Dyes

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