Is Red Dye 3 really banned?

Yes, but not removed for a few more years

On January 15, 2025, the FDA announced that FD&C Red No. 3 (Red Dye 3) would no longer be allowed to be used in food or ingested drugs, stating that “the petitioners provided data demonstrating that this additive induces cancer in male rats.”

Oh my, FDA. Where have you been?

The Textile Industry

The history of dyes in our food originated 175 years ago with the cotton industry. By the 1850s, ships loaded with bales of cotton from India and Egypt arrived in England, where an extensive network of mills stretching across its northern cities turned the raw material into textiles for export. Between 1851 and 1857, textile exports became nearly 50 percent of the British economy.

The first fabric dye was discovered accidentally by William Perkin, an eighteen-year-old student who boiled nitric acid and benzene together. The resulting precipitate was violet in color and was named aniline mauve. It could dye cotton fabric without bleeding and could not be bleached out. Around the same time, German textile manufacturers sought to capture a share of the burgeoning American market. However, this market was already saturated by British producers, so German cloth makers shifted their focus to the development of dyes. They collaborated with chemists to break into the clothing market by producing brighter, stronger, and cheaper chemical dyes, including bromides, alkaloids, amides, and phenols—substances never previously encountered in nature. By the 1870s, synthetic chemists had created more molecules than they knew what to do with. This rapidly growing industry expanded its applications to include chemicals as weapons of war, chemotherapeutics, and medical applications, and they were placed into food.

Food and Cosmetics

The placement of color-imparting chemicals in food was among the first public initiatives undertaken by the U.S. Department of Agriculture's (USDA) Bureau of Chemistry. In 1881, the bureau began researching using colorants to improve food appearance. The federal government authorized the use of artificial coloring in butter and cheese.

By 1900, many foods, drugs, and cosmetics available in the U.S. were artificially colored. However, not all coloring agents were harmless; in fact, many were found to be outright poisonous, containing lead, arsenic, and mercury. In many cases, the toxicities were irritants, sensitizers, or carcinogens.

By 1931, a handful of straight colors, additives that had not been mixed with any other substance, were approved for use in food. Six of the seven are still in use today: Blue No. 1 (Brilliant Blue FCF), Blue No. 2 (Indigotine), Green No. 3 (Fast Green FCF), Red No. 3 (Erythrosine), Yellow No. 5 (Tartrazine), and Yellow No. 6 (Sunset Yellow). The FDA website has a short history of Color Additives for more details. Individually, these ingredients show little toxicity. However, cumulative exposure from daily consumption of food colorants, additives, and dyes over a lifetime can increase the risk of developing diseases, especially for vulnerable populations like children, who are more likely to consume products containing artificial dyes.

Red Dye 3, also known as erythrosine, is a petroleum-based synthetic food dye that gives foods and drinks a bright, cherry-red color. It was developed in 1876 by German chemist Johann Peter Friedrich as a fluorescent dye for the textile industry. The name "erythrosine" originates from the Greek word "erythros," which means red, which reflects its characteristic color. One of the distinctive features of erythrosine is that it contains four iodine atoms in its molecular structure, making it an iodinated dye that fluoresces under UV light. The dye produces a bright, vivid color, especially in applications requiring a bold red or pink hue.

Red No. 3 was first listed in 1907 under the provisions of the 1906 Food and Drugs Act. In 1938, the revised Federal Food, Drug, and Cosmetic Act (FD&C) was enacted, establishing new regulations for food additives in the United States. Erythrosine was among the first synthetic dyes to receive official approval for use in food. In 1969, Red Dye No. 3 was permanently listed for use in food and ingested drugs.

At that time, the dye was seen as a safe and effective way to enhance the appearance of food products. It was used in various products, including candies, baked goods, beverages, frozen desserts, icings, many processed foods, cough syrups, and gummies. Additionally, it was used in cosmetics such as powdered blush and lipsticks that required a bright red color.

Research studies conducted in the 1970s and 1980s raised significant concerns about the potential cancer-causing effects of Red Dye 3. Specifically, studies involving rats and mice demonstrated that high doses of erythrosine had carcinogenic potential, particularly for thyroid tumors. Additionally, it exhibited endocrine-disrupting effects when applied topically through cosmetics, lotions, lipstick, and other topical products. In 1983, the National Toxicology Program (NTP) conducted additional studies supporting the earlier findings. The risk was deemed significant enough to warrant a ban on the use of Red Dye 3 in cosmetics and topical drugs, but it was allowed to be used in food.

This was a strange compromise: It banned the use of Red Dye 3 in lipstick and shampoo but allowed children to continue consuming it in candy and colas.

Ban on use in Food

In February 2023, a petition submitted by the Center for Science in the Public Interest and several other groups demonstrated (again) that this additive induces cancer in male rats. The FDA has finally revoked the use of Red No. 3 as a food color additive, but it is going to be a slow victory. The FDA's order will go into effect on January 15, 2027, with an exception for amendatory instruction 4, which became effective on January 18, 2028.

What is instruction 4? The FDA does not define this provision in its announcement or in the Federal Register. When reviewing other FDA regulatory orders, instruction 4 could involve:

• Labeling Requirements: Manufacturers may be given additional time to revise labels to remove references to Red Dye 3 and update ingredient lists.

• Product Reformulation: Instruction 4 could provide additional time for manufacturers to find suitable alternatives.

• Regulatory Compliance: This could be related to specific compliance deadlines to prove that they have complied with the ban through inspections or audits.

• Grace Period for Existing Stock: Some regulations include grace periods that allow existing stock to be legally sold before being pulled from shelves.

SIDEBAR:

• The petition was submitted jointly to the FDA by the following groups. The research asserting Red Dye 3 causes cancer has been known for FIFTY years. It took all of these groups together to finally get the FDA’s attention:

  • Center for Science in the Public Interest,

  • Breast Cancer Prevention Partners,

  • Center for Environmental Health,

  • Center for Food Safety,

  • Chef Ann Foundation,

  • Children's Advocacy Institute,

  • Consumer Federation of America,

  • Consumer Reports,

  • Defend Our Health,

  • Environmental Defense Fund,

  • Environmental Working Group,

  • Feingold Association of the United States,

  • Food & Water Watch,

  • Healthy Babies Bright Futures,

  • LifeTime Foundation,

  • MomsRising,

  • Prevention Institute,

  • Public Citizen,

  • Public Health Institute,

  • Public Interest Research Group, and

  • Real Food for Kids

Red Dye 3 vs. Red Dye 40

Red Dye 3 (erythrosine) and Red Dye 40 (allura red AC) are both synthetic food colorants, but they differ significantly in their chemical composition, common uses, safety profiles, and regulatory status. As mentioned previously, Red Dye 3 is a xanthene dye containing iodine, giving it unique fluorescent properties. On the other hand, Red Dye 40 is an azo dye that lacks iodine and is not fluorescent, making it more commonly used in products where fluorescence is not needed. Both dyes provide a bright red color.

Red Dye 40 remains one of the most widely used food colorants globally. It has been approved by the FDA and other international regulatory bodies and is found in food and cosmetics. However, Red Dye 40 has not been without controversy, as some studies have suggested a link to hyperactivity in children. Despite this, most countries still allow it in food and cosmetics without a warning label. Due to consumer demands, Red Dye 40 is being replaced with natural alternatives such as beet juice and hibiscus extract, and manufacturers are exploring safer, plant-based alternatives.

Why are Color Additives in Our Food?

Color additives are used in foods for many reasons, including to:

• offset color loss due to exposure to light, air, temperature extremes, moisture, and storage conditions

• correct natural variations in color

• enhance colors that occur naturally, and

• provide color to colorless "fun" foods.

The FDA’s regulations require evidence that a color additive is safe before it may be added to foods. When the FDA approves the use of a color additive in food, regulations specify:

• the types of foods in which it can be used

• any maximum amounts allowed to be used

• how the color additive is to be listed on the food label.

As you can see, the FDA has long been rubber-stamping the use of food colorings. The list of chemicals “allowed” or “approved” for use in food is long. The Make America Healthy Again (MAHA) movement certainly needs to take on cleaning up our food and removing all this unnecessary stuff.

However, I hope that the focus of the Healthy Food Movement will not distract MAHA away from the actual detriment to our health, vaccines, starting with the childhood vaccine schedule, which now recommends 32 vaccines by two years of age.

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