Why did the FDA ban Red Dye No. 3? Reasons explained

The U.S. Food and Drug Administration (FDA) has revoked the authorization of Red Dye No. 3, also known as erythrosine, from food, beverages, and ingested drugs.

This decision comes after evidence linking the synthetic dye to cancer in animals was found. It has sparked conversations about food safety and regulatory policies. Red Dye No. 3 has been a popular additive in various candies, frostings, and even some medicines for decades as it has a bright cherry-red hue.

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The ban follows decades of advocacy from consumer health organizations. The FDA’s action represents a shift in the way food additives are scrutinized under U.S. law, particularly the Delaney Clause. It highlights a broader concern about synthetic food dyes and their long-term health impacts.

Below is how the FDA represents the Delaney Clause:

"The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals."

It also adds,

"This is not the first time the agency revoked an authorization based on the Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition."

What is the Red Dye No. 3?

Red Dye No. 3, also known as erythrosine, is a synthetic food coloring widely used to give foods, beverages, and some medications a bright cherry-red hue. It is also known as erythrosine. It is derived from petroleum.

Below is how the FDA describes it:

"FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright, cherry-red color. The FDA estimates that FD&C Red No. 3 is not as widely used in food and drugs when compared to other certified colors based on information available in third-party food product labeling databases, food manufacturers’ websites and other public information, and the FDA’s certification data."

The FDA's authority to ban Red Dye No. 3 comes from the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. This clause prohibits the FDA from authorizing any additive found to cause cancer in humans or animals.

Studies conducted in the 1990s linked Red Dye No. 3 to thyroid tumors in male rats. Although the dye has not shown similar effects in humans, the law mandates its removal based on animal studies.

In November 2022, a petition led by the Center for Science in the Public Interest (CSPI) and other advocacy groups urged the FDA to act on this evidence.

Where Is Red Dye No. 3 Found?

This has been a key ingredient in many food and beverage products due to its eye-catching red color. Common items containing the dye include:

Candy: Treats like candy corn and dyed marshmallows.
Baked Goods: Cakes, cupcakes, frostings, and some other items.
Frozen Desserts: Ice pops and strawberry-flavored ice creams.
Other Products: Maraschino cherries, fruit cocktails, and colored beverages like strawberry milk.

Apart from food, the dye is also used in some oral medicines, including pain relievers, antidepressants, and cough syrups.

Manufacturers have been given a grace period to reformulate their products. For food products, it is till January 15, 2027, and for ingested medicines, the period runs till January 18, 2028.