What Is FD&C Blue 1 and is it Bad for You?

You may be hearing about artificial colors floating around social media and the internet these days, and might be wondering, “What is Blue 1?” As a scientist, I’m going to explain what Blue 1 is, its side effects, and whether it’s potentially bad for your health.

Blue 1, also known as Brilliant Blue FCF, FD&C Blue No. 1, or E133, is a synthetic food dye widely used to impart a vibrant blue hue to a variety of foods, beverages, pharmaceuticals, and cosmetics.

Like other artificial colorants such as Red 40 and Yellow 5, Blue 1 is popular among manufacturers because it is stable, cost-effective, and produces consistent, eye-catching color.

While Blue 1 helps make products more visually appealing, ongoing research and consumer advocacy have raised questions about its safety and potential health effects.

Some studies and public health groups have highlighted possible links to allergic reactions, behavioral changes in children, and other health concerns, prompting regulatory scrutiny and a growing demand for natural alternatives.

I’ve always had a serious sweet tooth, and Sour Punch Bites used to be one of my favorite treats while I worked at the laboratory.

Their tangy, chewy goodness is hard to resist! But after learning that they contain artificial food dyes like Blue 1, I’ve started to think twice before grabbing a handful.

While I still crave that nostalgic burst of flavor, I now find myself trying to avoid candies with synthetic colorants like Blue 1 as I become more mindful about what I’m putting into my body.

Ingredients list highlighting Blue 1, Yellow 5 (Tartrazine), and Red 40

Where Is Blue 1 Used?

Blue 1 is found in a wide range of products, including:

Beverages: Sports drinks, sodas, powdered drink mixes, and flavored waters
Candies: Gummies, hard candies, chewing gum, and popsicles
Baked Goods: Frostings, cakes, cookies, and pastries
Cereals: Brightly colored breakfast cereals
Dairy Products: Flavored yogurts, ice cream, and pudding
Processed Foods: Canned peas, applesauce, salad dressings, and enteral nutrition formulas
Medications and Supplements: Tablets, capsules, syrups, and vitamins
Personal Care: Toothpaste, mouthwash, shampoo, soaps, and cosmetics

Health Concerns and Potential Risks of Blue 1

Despite its widespread use and regulatory approval, Blue 1 has been the subject of ongoing health debates. Here are some of the main concerns:

Health Concern	Evidence/Notes
Allergic Reactions	Can cause skin rashes, hives, nasal congestion, and rarely blue discoloration of skin/urine ^(1🍃)
Hyperactivity/Behavioral Issues	Some studies suggest a link to hyperactivity and behavioral issues in children ^(2🍃)
Organ Damage	Animal studies hint at possible liver and organ effects with high, long-term exposure ^(3🍃)
Genotoxicity/Cancer Risk	Not found to be genotoxic in most studies, but some chromosomal aberrations observed ^(1🍃)
Neurotoxicity	Preliminary studies raised concerns about nerve cell effects; more research needed ^(1🍃)
Digestive Discomfort	Most of the dye is not absorbed and is excreted in feces; minor digestive symptoms possible ^(4🍃)

Allergic Reactions and Sensitivities

Blue 1 can cause hypersensitivity reactions in some individuals, including skin rashes, hives, and nasal congestion. Severe reactions are rare but possible, especially in those with existing allergies or sensitivities. ^(1🍃)

Behavioral and Neurological Effects:
Some studies and case reports suggest a possible link between artificial food dyes like Blue 1 and hyperactivity or behavioral changes in children, particularly those with ADHD or behavioral sensitivities. ^(3🍃) However, this connection is still debated and not universally accepted.

Carcinogenicity and Genotoxicity:
Most animal studies have not found Blue 1 to be carcinogenic or genotoxic, though some preliminary studies observed chromosomal changes and an unpublished study suggested a possible link to kidney tumors in mice.

Regulatory agencies consider current evidence insufficient to classify Blue 1 as a human carcinogen, but some advocacy groups urge further research and caution. ^(3🍃)

Organ and Other Effects:
Animal studies have hinted at potential organ effects from long-term, high-dose exposure, but these findings are not consistent or robust enough to prompt regulatory bans. ^(1🍃) Most of the dye is not absorbed by the body and is excreted unchanged in the stool. ^(4🍃)

Year/Period	Regulation/Action	Details
1929–1939	Early Approvals	FD&C Blue No. 1 provisionally approved for food, drugs, and cosmetics. ^(5🍃)
1969	Permanent Listing	Permanently listed for use in foods, drugs, and cosmetics; certification required. ^(8🍃)
Ongoing	Certification Requirement	Each batch must be certified by FDA before use in regulated products. ^(8🍃)
Ongoing	Usage Restrictions	Allowed in foods generally, ingested and externally applied drugs (including eye area), and cosmetics. ^(8🍃)
Ongoing	Acceptable Daily Intake (ADI)	U.S./EU: 1–12 mg/kg body weight/day; JECFA: 0–6 mg/kg/day. ^(3🍃)
2024	State-Level Bans	Law passed to prohibit Blue 1 (and others) in foods sold in-state. ^(9🍃)
2025	National Phase-Out Announced	FDA to phase out all petroleum-based synthetic dyes, including Blue 1, by end of 2026. ^(9🍃)

United States and International Regulations

FDA Approval: Blue 1 has been FDA-approved for use in foods, drugs, and cosmetics since 1969, with a recommended Acceptable Daily Intake (ADI) of 12 mg/kg body weight per day. ^(5🍃)
International Standards: The European Union and JECFA have similar ADIs (up to 12.5 mg/kg and 6 mg/kg, respectively). ^(3🍃)
Labeling: Products containing Blue 1 must declare it on ingredient labels in the US and Europe. ^(4🍃)
Recent Trends: Some US states, like California, are moving to restrict or ban Blue 1 in school foods, and there is growing momentum to phase out synthetic dyes in favor of natural alternatives. ^(3🍃)

How Is Blue 1 Made?

Blue 1 is a synthetic dye produced from petroleum-derived aromatic hydrocarbons, such as benzene or naphthalene.

The manufacturing process involves chemical reactions (such as diazotization and coupling with H-acid), followed by purification and conversion to a water-soluble salt form. ^(6🍃)

This process is similar to that used for other synthetic food dyes, such as Yellow 5 and Red 40.

Natural Alternatives to Blue 1

With increasing consumer demand for cleaner labels and fewer artificial additives, many companies are exploring natural blue colorants, including:

Butterfly Pea Flower: Produces a vibrant blue pigment, now popular in beverages and desserts. ^(7🍃)
Red Cabbage: Can yield blue hues when pH is adjusted, though stability is a challenge. ^(7🍃)
Spirulina: A blue-green algae that offers both color and nutritional benefits. ^(7🍃)
Anthocyanins: Plant pigments found in berries and some vegetables, though often less stable than synthetic dyes. ^(7🍃)

Final Thoughts on Blue 1

Blue 1 is a widely used synthetic dye that helps make foods and other products visually appealing.

Regulatory agencies currently consider it safe when consumed within established limits, but ongoing research and advocacy highlight potential risks, especially for sensitive individuals and children.

As public awareness grows and regulations evolve, the food industry is increasingly turning to natural alternatives, signaling a shift away from petroleum-based synthetic dyes in the years ahead.