Yellow No. 6 (Sunset Yellow): FDA Phase-Out, State Bans & Contaminant Concerns

What Is Yellow No. 6?

FD&C Yellow No. 6, known chemically as Sunset Yellow FCF (CAS 2783-94-0, UNII: GR3583FMH3), is a synthetic monoazo dye that produces an orange-yellow color in food, drugs, and cosmetics. It is principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid and has been one of the most widely used certified color additives in the United States for decades. It is currently authorized under 21 CFR 74.706 (food use), 21 CFR 74.1706 (drug use), and 21 CFR 74.2706 (cosmetic use).

Yellow No. 6 is distinct from FD&C Yellow No. 5 (tartrazine), a different azo dye with separate regulatory treatment. The two are frequently used in combination and appear together in many reformulation discussions. In the EU, Yellow No. 6 is designated E110 and is one of the "Southampton Six" — a group of six synthetic dyes subject to mandatory behavioral warning labels since 2010.

Yellow No. 6 appears across an enormous range of consumer products: candy, baked goods, snack foods, cereals, beverages, sauces, dietary supplements, OTC medications, and cosmetics. It is the second most commonly used food dye in the U.S. by volume, behind Red No. 40.

FDA Regulatory Status

Yellow No. 6 is currently authorized but targeted for voluntary phase-out. Unlike Red No. 3 — which the FDA formally banned via revocation of its color additive listing in January 2025 — Yellow No. 6 has not been the subject of formal revocation proceedings. Instead, it is part of a broader voluntary industry initiative announced on April 22, 2025, when HHS Secretary Robert F. Kennedy Jr. and the FDA announced plans to phase out all six remaining petroleum-based synthetic food dyes from the U.S. food supply.

The distinction matters: Yellow No. 6 remains a legally authorized color additive under 21 CFR 74.706. There is no rulemaking pending to revoke its listing. The FDA's approach relies on voluntary industry compliance rather than the Delaney Clause mechanism used against Red No. 3.

The April 2025 Announcement

On April 22, 2025, HHS and the FDA announced a plan to eliminate eight petroleum-based synthetic dyes from the food supply. The initiative covers:

• Six dyes for voluntary phase-out: FD&C Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3
• Two dyes for formal revocation: Orange B and Citrus Red No. 2 (rarely used)

The original target was elimination by end of 2026. As of early 2026, the FDA's public communications reference end of 2027 as the working timeline — a one-year slip that reflects the complexity of reformulating thousands of SKUs across the food supply chain. The FDA maintains a public Industry Pledge Tracker at fda.gov to monitor corporate commitments.

Voluntary vs. Mandatory

This is not a ban. HHS Secretary Kennedy stated that "the industry has voluntarily agreed" to the phase-out, but there is no binding legal requirement. CSPI has characterized the arrangement as an "industry understanding" rather than enforceable regulation. To formally prohibit Yellow No. 6, the FDA would need to initiate rulemaking to revoke the color additive authorization — a process that has not begun and would require notice-and-comment rulemaking under the FD&C Act.

The regulatory uncertainty is the key compliance challenge: companies must decide whether to invest in reformulation based on a voluntary framework that could accelerate into formal action — or stall if political priorities shift.

MAHA Initiative and Political Context

The food dye phase-out is a centerpiece of the Make America Healthy Again (MAHA) movement led by HHS Secretary Kennedy. The initiative has driven both federal and state action at an unprecedented pace.

At the federal level, the FDA approved three new natural color additive petitions on May 9, 2025 — galdieria extract blue (algae-derived), butterfly pea flower extract, and calcium phosphate — to provide industry with alternatives. The agency also issued new enforcement discretion guidance in February 2026 allowing companies to use "no artificial colors" labeling claims during the transition period, even before full reformulation is complete.

At the state level, MAHA-aligned legislation surged in 2025. Over 140 food additive bills were introduced across 38 states, with school food dye restrictions enacted in at least eight states. The movement has found bipartisan support, particularly on school food safety — an area where the political calculus favors action.

State-Level Legislation

California — AB 2316 (California School Food Safety Act)

Signed by Governor Newsom on September 28, 2024, AB 2316 prohibits public schools in California from serving or selling food containing six synthetic dyes: Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3. The ban takes effect December 31, 2027. Children may still bring food containing these dyes from home, and fundraiser food is exempt.

AB 2316 was prompted by a California Environmental Protection Agency report concluding that synthetic food dyes are linked to hyperactivity and neurobehavioral effects in children, and that current FDA Acceptable Daily Intake levels are outdated and not protective of children.

West Virginia — HB 2354

Signed on March 24, 2025, HB 2354 is the most aggressive state-level food dye ban enacted to date. It operates on a split timeline:

• August 1, 2025: School meals ban — prohibits schools from serving food containing Red No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1, Blue No. 2, and Green No. 3
• January 1, 2028: Broader retail ban — prohibits sale of food and drugs containing the same seven dyes plus BHA and propylparaben

However, in December 2025, U.S. District Judge Irene Berger issued a preliminary injunction blocking enforcement of the 2028 retail provisions, ruling that HB 2354 lacks sufficient standards to prevent arbitrary enforcement. The school meals provisions remain in effect. The case was brought by the International Association of Color Manufacturers (ICAM).

Other State Activity

State	Bill	Scope	Status
Virginia	S 1289 / H 1910	Bans Yellow No. 6 and six other dyes in school food	Effective July 1, 2027
Utah	HB 402	Bans Yellow No. 6 and other dyes/additives in school food	Enacted May 7, 2025; compliance 2026-27 school year
Arizona	HB 2164	Bans synthetic dyes in school food	Effective 2026-2027 school year
Delaware, Louisiana, Tennessee, Texas	Various	School food dye restrictions	Enacted 2025
Illinois, New York, Pennsylvania	Various	Broader consumer food additive bans pending	Introduced 2025

As of early 2026, eleven school food dye restriction bills have been enacted across eight states, and the legislative trajectory suggests additional states will follow in the 2026 session.

EU and International Status

European Union — E110

Yellow No. 6 is authorized in the EU as E110 but has been subject to heightened scrutiny since 2008. Following the 2007 Southampton study, the European Parliament mandated that any food containing E110 (or the other five "Southampton" colors) must carry the warning: "may have an adverse effect on activity and attention in children."

This mandatory warning label, effective since July 2010 under EU Regulation (EC) No 1333/2008, has driven significant voluntary reformulation across European food manufacturers. Many major brands reformulated for the EU market years ago to avoid the warning label — experience that U.S. companies can now leverage.

EFSA ADI history: EFSA initially set a temporary ADI of 1 mg/kg bw/day in 2009, based on liver toxicity findings. After reviewing additional data — including JECFA's 2011 reassessment — EFSA established a permanent ADI of 4 mg/kg bw/day in 2014, concluding that consumer exposure is well below this level for all age groups.

Other International Assessments

• JECFA (WHO/FAO): ADI of 4 mg/kg bw/day (2011). JECFA has evaluated Sunset Yellow multiple times and considers it acceptable at current use levels.
• United Kingdom: Follows EU warning label requirements post-Brexit. The UK Food Standards Agency cited the Southampton study as the basis for recommending voluntary industry reformulation as early as 2008.
• Australia/New Zealand: Permitted. Food Standards Australia New Zealand (FSANZ) has reviewed Sunset Yellow and considers it safe at approved levels.
• Norway: Previously banned; ban lifted upon joining the EEA. Now follows EU regulations including mandatory warning labels.

Behavioral Effects Research

The Southampton Study (2007)

The foundational research driving regulatory action worldwide is the McCann et al. study published in The Lancet in September 2007. This randomized, double-blinded, placebo-controlled trial tested whether mixtures of artificial food colors and sodium benzoate affected hyperactivity in 153 three-year-olds and 144 eight/nine-year-olds from the general population — not children pre-selected for ADHD.

The study used two active drink mixes and one placebo. Mix A contained Sunset Yellow (Yellow No. 6), tartrazine, carmoisine, and ponceau 4R plus sodium benzoate. Mix B contained Sunset Yellow, carmoisine, quinoline yellow, and allura red AC plus sodium benzoate. Yellow No. 6 was present in both active mixes.

Key findings:

• Mix A produced a statistically significant increase in hyperactivity in 3-year-olds (effect size 0.20, p=0.044)
• Both mixes produced significant effects in 8/9-year-olds when analysis was restricted to children consuming at least 85% of test drinks
• Effects were observed in the general population, not just children with pre-existing behavioral conditions

EFSA's evaluation acknowledged the study provided "limited evidence" of a small effect on activity and attention but noted inconsistencies between age groups and mixtures. The study could not isolate which specific dye or combination drove the effect — a limitation that has allowed the FDA to maintain authorization while the EU opted for warning labels.

California EPA Report (2021)

The California Office of Environmental Health Hazard Assessment (OEHHA) published a comprehensive review concluding that synthetic food dyes cause or exacerbate hyperactivity and other neurobehavioral problems in some children. The report found that current FDA ADIs are based on outdated toxicological endpoints and do not account for neurobehavioral effects. This report directly informed California's AB 2316 legislation.

Contaminant Concerns

Beyond behavioral effects, Yellow No. 6 raises safety questions due to manufacturing contaminants.

4-Aminobiphenyl

Yellow No. 6 may contain 4-aminobiphenyl at levels ranging from 5 to 275 ppb. 4-Aminobiphenyl is classified as a known human carcinogen by the National Toxicology Program (NTP), based on sufficient evidence linking occupational exposure to urinary bladder cancer. The FDA's specifications at 21 CFR 74.706 set purity standards but do not explicitly set a limit for 4-aminobiphenyl — the dye is controlled through overall subsidiary color limits and batch certification.

Sudan I

Sudan I, classified by IARC as a Category 3 carcinogen, has been identified as a contaminant in FD&C Yellow No. 6. While Sudan I is banned as a food additive globally, its presence as a trace contaminant in Yellow No. 6 arises from the azo dye manufacturing process. Gastrointestinal metabolism of Sudan dyes generates carcinogenic and teratogenic metabolites.

Benzidine

Yellow No. 6 may also contain trace levels of benzidine, another known human carcinogen. The FDA requires that certified batches of Yellow No. 6 meet purity specifications, including limits on uncombined intermediates, but advocacy groups have argued that any detectable level of a known carcinogen in a food additive warrants removal.

Affected Product Categories

Yellow No. 6 is one of the most broadly used food dyes. Companies should audit any product line with orange, yellow, or warm-toned coloring.

Food Products

• Candy and confections — Orange and yellow candies, gummy products, candy corn, fruit-flavored hard candy, chocolate-coated confections
• Snack foods — Cheese-flavored snacks (Doritos, Cheetos), flavored crackers, flavored popcorn
• Baked goods — Orange and yellow frostings, cake mixes, snack cakes, cookie decorations
• Beverages — Orange sodas, sports drinks, flavored waters, citrus-flavored drinks
• Cereals — Fruity and sweetened cereals with orange/yellow coloring
• Sauces and condiments — Cheese sauces, certain salad dressings, flavored syrups
• Dairy products — Flavored yogurts, puddings, ice cream
• Frozen desserts — Sherbet, popsicles, flavored ice cream

Dietary Supplements

• Coated tablets and capsules with orange/yellow coloring
• Gummy vitamins (children's and adult formulations)
• Flavored liquid supplements

Drugs

• OTC medications with orange/yellow coatings
• Liquid medications (cough syrups, oral suspensions)
• Chewable tablets

What Companies Should Do

Assess Your Exposure

1. Audit every SKU listing FD&C Yellow No. 6, Sunset Yellow FCF, CI 15985, or E110. Include contract-manufactured and private-label products.
2. Map your state risk. If you sell into school food channels in California, Utah, Arizona, Virginia, or West Virginia, compliance deadlines range from 2025 to 2027. West Virginia's retail ban is enjoined but could be reinstated.
3. Monitor the FDA Pledge Tracker. If your competitors have committed to removal timelines, customer and retailer expectations will follow.

Plan Reformulation

Natural alternatives for Yellow No. 6 include beta-carotene, turmeric extract (curcumin), annatto, paprika oleoresin, and saffron. Each has different stability profiles — beta-carotene is pH-sensitive, turmeric fades under light, and annatto can shift color in acidic formulations. Start stability testing now; color reformulation typically requires 6-12 months of lead time.

The FDA's approval of new natural color additives (galdieria extract blue, butterfly pea flower extract) in May 2025 expands the available palette for reformulation, particularly for companies needing to replace multiple synthetic dyes simultaneously.

Watch for Rulemaking

The voluntary phase-out could convert to mandatory action. If industry compliance falls short of FDA expectations, or if political momentum from MAHA continues to build, the agency could initiate formal rulemaking to revoke 21 CFR 74.706. Companies that have not begun reformulation by that point will face compressed timelines and supply chain pressure for natural alternatives.

Major food companies including General Mills, Nestle USA, Conagra, Kraft Heinz, Hershey, Kellanova, WK Kellogg Co., Campbell's, Grupo Bimbo, JM Smucker, and Tyson have all announced commitments to remove synthetic dyes. General Mills targets summer 2026 for cereals and school food; Nestle USA targets mid-2026 for full U.S. elimination. Companies that lag behind these timelines face not only regulatory risk but competitive and reputational disadvantage in an environment where "no artificial colors" has become a market differentiator.