What foods have Red Dye 3? Reasons and products explored as FDA bans additive from multiple items 

The FDA has announced the revocation of authorization for Red Dye 3 (FD&C Red No. 3) in food and ingested drugs, a decision driven by the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This synthetic dye has been commonly used in products such as candies, baked goods, gelatins, frostings, and certain medications.

This regulation prohibits the use of additives found to cause cancer in humans or animals. This move follows a 2022 color additive petition that cited studies showing that male rats exposed to high levels of FD&C Red No. 3 developed cancer due to a rat-specific hormonal mechanism.

While these findings do not directly apply to humans — because the mechanism is not observed in human biology — the FDA was compelled to act under the Delaney Clause.

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What is Red Dye 3?

Many candies use Red Dye 3 to get the bright red color (Image via Pexels)

FD&C Red No. 3, also known as erythrosine, is a synthetic dye used to produce a bright cherry-red color in various food and drug products. Its application has spanned candies, cakes, cookies, frostings, and some ingested drugs. However, the FDA estimates its usage is less widespread compared to other certified colors.

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Key details of the FDA's decision to ban Red Dye 3

Food And Drug Administration Headquarters In Maryland - Source: Getty

Why the ban?

The FDA's decision follows decades of research and growing consumer concern. Although studies in animals and humans have not conclusively demonstrated harm at typical human exposure levels, the Delaney Clause mandates action when any additive is shown to cause cancer in animals, regardless of the dose.

Historical context

This is not the first time the FDA has invoked the Delaney Clause. In 2018, the agency revoked the authorization for certain synthetic flavors after a similar finding.

Impact on manufacturers

As per the FDA, Food and drug manufacturers using FD&C Red No. 3 must reformulate their products for food by January 15, 2027, and for ingested drugs by January 18, 2028. Products imported into the U.S. must also comply with these updated standards.

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Foods and products affected by the Red Dye 3 ban

FD&C Red No. 3 is also found in cupcakes and frostings (Image via Pexels)

Despite its relatively limited use compared to other dyes, FD&C Red No. 3 has been found in several popular products, including:

• Candies: Used in gummies, hard candies, and lollipops.
• Baked Goods: Cakes, cupcakes, cookies, and frostings.
• Gelatins and puddings: Used to enhance the vibrant colors of certain gelatin desserts.
• Frozen treats: Frequently added to popsicles and flavored ice.
• Ingested Drugs: Medications for ADHD treatments such as Vyvanse.

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International regulations

The European Union allows Red Dye 3 to be used in cocktail cherries (Image via Pexels)

Globally, FD&C Red No. 3 is regulated differently. For instance:

• European Union: Red Dye 3's use is limited to certain applications, such as cocktail cherries.
• South Korea: Synthetic dyes, including erythrosine, are banned from being used in products targeting children.

While the FDA's decision represents a stricter stance, many countries still allow limited use of the dye in specific products.

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The path forward

The FDA continues to emphasize that the cancer risk associated with FD&C Red No. 3 is negligible for humans at typical exposure levels. However, this Red Dye 3 ban aligns with the growing movement toward transparency and safer alternatives in food production.

Natural substitutes, like beet juice, purple sweet potato extract, and red cabbage pigments, are expected to replace synthetic dyes, ensuring compliance with U.S. standards.

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While the science does not suggest significant harm to humans, the FDA's decision to revoke the authorization of Red Dye 3 reflects a precautionary approach in line with evolving consumer expectations for cleaner and more natural ingredients. As manufacturers transition to reformulated products, the shift away from synthetic dyes marks a step toward a safer and more transparent food system.