FD&C Blue No. 1 (Brilliant Blue): FDA Phase-Out, State Bans & Compliance Guide

What Is FD&C Blue No. 1?

FD&C Blue No. 1 — known internationally as Brilliant Blue FCF and designated E133 in the European Union — is a synthetic triarylmethane dye derived from petroleum. Its CAS number is 3844-45-9 and its UNII code is H3R47K3TBD. The compound is principally the disodium salt of a sulfonated triphenylmethane structure, producing a vivid blue hue that is among the most widely used artificial colorings in the global food supply.

Blue 1 was permanently listed by the FDA for use in food and ingested drugs in 1969, making it one of the longest-standing certified color additives in the United States. It is batch-certified under 21 CFR Part 82, meaning every production lot must be submitted to FDA for chemical analysis and approval before it can enter the supply chain.

The dye appears across an extraordinarily broad range of product categories. In food, it colors candies, confections, beverages, ice cream, breakfast cereals, frosting, popsicles, and dairy products. In dietary supplements, it is used in coatings, capsule shells, and liquid formulations. In pharmaceuticals, it colors oral tablets, capsules, syrups, and solutions. In cosmetics, it is found in shampoos, soaps, mouthwashes, and decorative products. This cross-sector presence means that regulatory changes to Blue 1 simultaneously affect food manufacturers, supplement brands, pharmaceutical companies, and cosmetic formulators.

Blue 1 also has a noteworthy property that distinguishes it from other synthetic food dyes: it is a selective inhibitor of the Pannexin 1 (Panx1) ATP release channel, with an IC50 of 0.27 µM. This pharmacological activity has generated research interest in potential therapeutic applications for spinal cord injury, stroke, and inflammatory conditions — an unusual dual identity for a food colorant.

FDA Regulatory Status

Current Authorization

FD&C Blue No. 1 is currently authorized for use in the United States under three separate CFR sections:

• 21 CFR 74.101 — Use in food (including dietary supplements) generally, in amounts consistent with good manufacturing practice
• 21 CFR 74.1101 — Use in drugs generally
• 21 CFR 74.2101 — Use in cosmetics generally

The dye and its aluminum lake form are subject to batch certification under 21 CFR Part 82. There is no quantitative use limit; the standard is "amounts consistent with good manufacturing practice." Blue 1 may not be used in foods for which standards of identity have been established unless those standards explicitly authorize added color.

The April 22, 2025 Announcement

On April 22, 2025, HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary announced a sweeping initiative to phase out petroleum-based synthetic dyes from the American food supply. The announcement, part of the broader "Make America Healthy Again" agenda, targeted six certified color additives for voluntary industry phase-out by the end of 2027:

1. FD&C Red No. 40 (Allura Red)
2. FD&C Yellow No. 5 (Tartrazine)
3. FD&C Yellow No. 6 (Sunset Yellow)
4. FD&C Blue No. 1 (Brilliant Blue FCF)
5. FD&C Blue No. 2 (Indigotine)
6. FD&C Green No. 3 (Fast Green FCF)

Separately, the FDA initiated formal revocation proceedings against Citrus Red No. 2 and Orange B — two rarely used dyes that can be removed through straightforward rulemaking. Orange B has not been certified for use since 1978.

What "Voluntary" Means

The distinction between the voluntary phase-out and formal revocation is critical for compliance planning. For Blue 1:

• No proposed rule to revoke Blue 1's listing under 21 CFR 74.101 has been published as of March 2026.
• The Delaney Clause does not apply to Blue 1. Unlike Red No. 3, which was formally banned in January 2025 under the Delaney Clause based on evidence of carcinogenicity in animals, there is no comparable legal mechanism forcing Blue 1's removal.
• There is no legal requirement for companies to cease using Blue 1 by any specific date. The phase-out relies entirely on industry cooperation and public pressure.
• FDA is tracking industry pledges through a public portal — "Tracking Food Industry Pledges to Remove Petroleum-Based Food Dyes" — which catalogues voluntary commitments from manufacturers and trade associations.

The Consumer Brands Association has pledged that member companies will stop manufacturing with FD&C colors by December 31, 2027. The American Bakers Association has committed to eliminating synthetic dyes in K-12 school baked goods before the 2026-2027 school year. The International Dairy Foods Association has committed to removing synthetic dyes from ice cream by end of 2027, involving companies representing 90% of U.S. ice cream sales.

Pharmaceutical and Cosmetic Implications

The April 2025 announcement focused specifically on food. Blue 1's listings for drugs (21 CFR 74.1101) and cosmetics (21 CFR 74.2101) were not addressed. Pharmaceutical manufacturers face a distinct challenge: color changes to approved drug products require supplemental NDAs or ANDAs, which involve stability testing, bioequivalence assessments, and FDA review timelines measured in months to years.

Key Deadlines

Date	Event	Type
April 22, 2025	FDA/HHS announces voluntary phase-out of 6 petroleum-based dyes including Blue 1	Federal (voluntary)
May 9, 2025	FDA approves butterfly pea flower extract, galdieria extract blue, and calcium phosphate as natural color alternatives	Federal
May 27, 2025	Texas SB 314 signed — school meal ban including Blue 1	State (enacted)
June 27, 2025	Louisiana SB 14 signed — school meal ban including Blue 1	State (enacted)
August 1, 2025	West Virginia school meal ban takes effect (HB 2354 Phase 1)	State (mandatory)
August 2026	Arizona HB 2164 and Texas SB 314 school bans take effect (2026-2027 school year)	State (mandatory)
July 1, 2027	Virginia HB 1910 / SB 1289 school ban takes effect	State (mandatory)
December 31, 2027	California AB 2316 school food ban takes effect; FDA voluntary phase-out target	State/Federal
January 1, 2028	West Virginia retail and drug ban scheduled (HB 2354 Phase 2 — currently enjoined)	State (enjoined)
August 2028	Louisiana SB 14 school meal ban takes effect (2028-2029 school year)	State (mandatory)

State-Level Bans

State legislatures have moved aggressively on synthetic food dyes, with Blue 1 included in every major bill. As of early 2026, food additive legislation has been introduced in over 38 states, with 11 bills enacted across eight states.

West Virginia — HB 2354 (Most Aggressive)

West Virginia's HB 2354, signed March 24, 2025, is the most comprehensive state food dye law in the country. It operates in two phases:

• Phase 1 (effective August 1, 2025): Prohibits Red 3, Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3 from any meal served in a school nutrition program. This provision is active and enforceable.
• Phase 2 (scheduled January 1, 2028): Bans the sale of food and drugs containing the same seven dyes plus butylated hydroxyanisole (BHA) and propylparaben throughout the state — a true retail ban, not limited to schools.

On December 23, 2025, Judge Irene Berger of the U.S. District Court for the Southern District of West Virginia issued a preliminary injunction blocking enforcement of the Phase 2 retail provisions. The International Association of Color Manufacturers (IACM) successfully argued that HB 2354 is unconstitutionally vague. The injunction does not affect the Phase 1 school meal provisions, which remain in force.

California — AB 2316

The California School Food Safety Act, signed by Governor Newsom on September 28, 2024, bans Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, and Green 3 from foods sold or offered at public schools. The ban takes effect December 31, 2027. As the first state to pass such legislation, California set the template that subsequent states have followed.

Utah — HB 402

Signed in March 2025, Utah's law prohibits public schools from selling or serving food containing Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5, Yellow 6, potassium bromate, and propylparaben. Effective May 7, 2025, it was one of the fastest state-level food dye restrictions to take effect.

Arizona — HB 2164

Arizona's law prohibits schools from providing food containing Blue 1, Blue 2, Green 3, Red 3, Red 40, Yellow 5, Yellow 6, potassium bromate, propylparaben, titanium dioxide, and brominated vegetable oil. Takes effect at the beginning of the 2026-2027 school year. The law allows parents to provide their own children with food containing these ingredients.

Virginia — HB 1910 / SB 1289

Governor Glenn Youngkin signed identical House and Senate bills prohibiting public elementary and secondary schools from serving lunches containing seven synthetic color additives including Blue 1. Effective July 1, 2027.

Texas — SB 314

Signed May 27, 2025, Texas's law prohibits school districts and open-enrollment charter schools from providing free or reduced-price meals containing Blue 1 and 16 other specified ingredients. Effective for the 2026-2027 school year.

Louisiana — SB 14

Signed June 27, 2025, Louisiana's ban prohibits public and state-funded private schools from serving meals containing Blue 1 and 14 other ingredients. Effective for the 2028-2029 school year — the latest effective date among enacted state laws.

Federal Preemption Risk

The WV injunction raises a significant question for all state dye bans: can states ban FDA-approved color additives? If the case proceeds to a merits ruling favorable to industry, it could undermine the enforcement mechanism for retail-level bans in other states. School meal bans, which operate under state education authority rather than food safety law, may be more legally durable.

International Status

European Union — E133

Brilliant Blue FCF is authorized as E133 under EU Regulation (EC) No 1333/2008. The EFSA re-evaluated E133 in 2010 and established an ADI of 6 mg/kg body weight per day, based on a NOAEL of 631 mg/kg bw/day from chronic toxicity studies in rats with a 100x safety factor applied.

A critical distinction from other synthetic dyes: Blue 1 is NOT one of the "Southampton Six." The 2007 McCann et al. study at the University of Southampton, which linked food dye mixtures to hyperactivity in children, tested two specific mixtures containing Tartrazine (E102), Quinoline Yellow (E104), Sunset Yellow (E110), Carmoisine (E122), Ponceau 4R (E124), and Allura Red (E129). Blue 1 was not included in either test mixture. Consequently, Blue 1 does not trigger the mandatory EU warning label — "may have an adverse effect on activity and attention in children" — that is required for the six dyes tested in the Southampton study.

This gives Blue 1 a somewhat more favorable regulatory position in the EU compared to dyes like Red 40 (E129) and Yellow 5 (E102), which do carry the warning label.

United Kingdom

The UK retained the EU warning label requirements for the Southampton Six colors after Brexit. Blue 1 (E133) remains approved and, as in the EU, does not require the hyperactivity warning label.

JECFA (WHO/FAO)

The Joint FAO/WHO Expert Committee on Food Additives evaluated Brilliant Blue FCF at its 84th meeting in 2017 and confirmed an ADI of 0–6 mg/kg body weight, aligning with EFSA's assessment.

Canada

Health Canada lists Brilliant Blue FCF as a permitted food color, allowed at Good Manufacturing Practice (GMP) levels across various food categories. No additional restrictions or warning labels are required.

Affected Product Categories

Blue 1's cross-sector authorization means that regulatory changes affect a wide range of industries simultaneously.

Food (21 CFR 74.101)

Blue 1 is one of the most versatile food colorants, appearing in:

• Confectionery and candy — hard candies, gummies, chocolate coatings, fondant
• Beverages — sports drinks, flavored waters, sodas, cocktail mixers
• Frozen desserts — ice cream, popsicles, frozen yogurt, sorbet
• Breakfast cereals — colored cereal pieces, marshmallow inclusions
• Baked goods — frosting, icing, cake decorations, sprinkles
• Dairy products — flavored yogurt, pudding, cheese products
• Savory products — salad dressings, condiments, processed meats (often combined with Yellow 5 to create green)

Blue 1 is frequently used in combination with other dyes: mixed with Yellow 5 (Tartrazine) it produces green, and combined with Red 40 it produces purple. Reformulating away from Blue 1 therefore requires rethinking multi-dye color systems, not just substituting a single ingredient.

Dietary Supplements (21 CFR 74.101)

Blue 1 is used in supplement capsule shells (both hard gelatin and HPMC), tablet coatings, gummy supplements, and liquid formulations.

Pharmaceuticals (21 CFR 74.1101)

Blue 1 appears in numerous FDA-approved drug products as an inactive ingredient. Color changes in approved drugs require regulatory submissions — supplemental NDAs or ANDAs — with associated stability testing and review timelines. The FDA's April 2025 announcement did not directly address pharmaceutical uses.

Cosmetics (21 CFR 74.2101)

Blue 1 is used in shampoos, soaps, mouthwashes, toothpastes, and decorative cosmetics. The cosmetic use is not subject to the voluntary food phase-out.

What Companies Should Do

Immediate Actions

1. Audit your product portfolio. Identify every SKU that contains FD&C Blue No. 1, including products where Blue 1 is part of a color blend (e.g., combined with Yellow 5 for green). Map each product to the jurisdictions where it is sold.

2. Assess state-level exposure. If you sell into school food programs in West Virginia, Utah, Arizona, Texas, Louisiana, Virginia, or California, determine which products are affected and when each deadline hits. Utah and West Virginia Phase 1 are already active. Texas and Arizona take effect for the 2026-2027 school year.

3. Monitor the WV litigation. The preliminary injunction blocking West Virginia's retail ban has implications beyond that state. If the court ultimately rules that states cannot ban FDA-approved color additives, it constrains the retail-ban pathway. If the state prevails, expect other legislatures to pursue retail-level restrictions.

4. Track industry pledge deadlines. If your company is a member of the Consumer Brands Association, American Bakers Association, or International Dairy Foods Association, you may be subject to voluntary pledge timelines with end-of-2027 deadlines.

Natural Alternatives

The FDA has been actively clearing natural blue color alternatives to facilitate the transition:

• Spirulina extract (phycocyanin) — Already approved, the most established natural blue alternative. Limitations include heat sensitivity and pH instability in acidic applications.
• Butterfly pea flower extract — Approved May 9, 2025. pH-responsive (blue in neutral/alkaline, purple in acidic conditions), making it versatile for beverages and baked goods. Heat stable.
• Galdieria extract blue — Approved May 9, 2025. Derived from a red microalga, this provides a blue hue suitable for a range of food applications.
• Gardenia blue — Approved in 2025 through a separate petition. Derived from gardenia fruit, used extensively in Asian markets.

Reformulation challenges for Blue 1 specifically include matching the vivid, stable blue hue that synthetic Blue 1 provides; achieving color consistency in multi-dye blends (particularly green formulations using Blue 1 + Yellow 5); maintaining shelf stability across temperature and pH ranges; and managing the higher cost of natural alternatives.

Supply Chain Considerations

• Dual-SKU strategy. Companies selling nationally may need to maintain both reformulated and original formulations during the transition, particularly for products sold into school food programs in ban states while still serving retail channels elsewhere.
• Supplier qualification. Natural color suppliers should be qualified and validated well ahead of reformulation deadlines. Butterfly pea flower and galdieria blue are newly approved — supply chains for these ingredients are still maturing.

Pharmaceutical Considerations

Drug manufacturers face the longest runway. No regulatory action against Blue 1 in drugs has been proposed. However, companies planning long-term reformulations should consider filing color change supplements proactively to avoid a rush if regulatory pressure eventually extends to pharmaceuticals.

Regulatory Intelligence

Policy Canary currently tracks 17 regulatory items linked to FD&C Blue No. 1, including recalls, warning letters, and enforcement actions. Subscribe to receive alerts when new regulatory actions affect this substance.