FDA Finally Revokes Authorization of Red No. 3 in Food and Drugs Over Cancer Concerns

Robert F. Kennedy Jr., President-elect Donald Trump's choice to lead HHS has called for Red No. 3's removal 

Red Dye No. 3, also known as FD&C Red No. 3 or erythrosine, is a synthetic food coloring derived from petroleum. It has been used in the United States since its approval in 1907 to give foods and drinks a vivid red hue. Common applications include candies, frostings, frozen desserts and snack cakes.

WASHINGTON DC – The U.S. Food and Drug Administration (FDA) has announced its decision to revoke the authorization of Red No. 3 for use in food products and ingested pharmaceuticals, citing potential health risks associated with the synthetic dye.

The ruling, revealed on Monday, follows years of scientific scrutiny and advocacy calling for its removal, including Robert F. Kennedy Jr., President-elect Donald Trump’s choice to lead the Department of Health and Human Services.

Red No. 3, also known as erythrosine, is a synthetic colorant long used to give a bright pink or red hue to candies, cereals, and some medications. Despite restrictions on its use in cosmetics and topical drugs since 1990, the dye has remained present in edible products for decades.

The FDA’s decision is based on a comprehensive evaluation of studies suggesting potential carcinogenic effects of the dye when consumed in significant quantities over extended periods. The move comes after a 2022 petition spearheaded by the Center for Science in the Public Interest (CSPI) and supported by 23 other organizations and scientists, urging the agency to ban all remaining uses of Red No. 3.

“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick but perfectly legal to feed to children in the form of candy,” said CSPI President Dr. Peter G. Lurie.

“The primary purpose of food dyes is aesthetic. When the function is purely decorative, why accept any cancer risk?”

Products Containin Red Dye 3

Candies
■ Pez Candy Assorted Fruit
■ Dubble Bubble Original Twist Bubble Gum
■ Brach’s Candy Corn
■ Jelly Belly candies
■ Trolli Sour Crunchy Crawlers

Baked Goods and Snacks
■ Entenmann’s Little Bites Party Cake Mini Muffins
■ Betty Crocker Fruit by the Foot
■ Toaster pastries
■ Cookies with red icing or decorations

Dairy and Frozen Desserts
■ Strawberry-flavored milk
■ Certain ice cream flavors and frozen yogurt
■ Ice pops and frozen fruit bars
■ Fruit Products
■ Maraschino cherries
■ Some fruit cocktails

Beverages
■ Yoo-hoo Strawberry Drink
■ Certain sodas and fruit-flavored drinks
■ Medications and Supplements
■ Some cough syrups
■ Gummy vitamins
■ PediaSure Grow & Gain Kids’ Ready-to-Drink Strawberry Shake

A Long-Delayed Decision

Critics have pointed to what they describe as a decades-long failure by the FDA to uphold its mandate to ban cancer-causing additives. The CSPI noted that Red No. 3 has remained legal for consumption for more than 34 years after the FDA initially acknowledged its potential risks.

The new regulation will give manufacturers a grace period to reformulate their products. Companies must remove Red No. 3 from food products by January 15, 2027, and from oral pharmaceuticals by January 18, 2028.

Transitioning to Safer Alternatives

As the FDA works with companies to ensure compliance, manufacturers must identify alternative colorants that meet safety standards while maintaining consumer appeal. The agency has pledged to guide during the transition period.

Consumers are encouraged to check product labels for Red No. 3, which may also appear as E127 or erythrosine. The FDA warns that it may take time for all affected products to disappear from store shelves.

The move is part of a broader FDA effort to reevaluate food additives and ensure their safety. Advocacy groups hope this decision will pave the way for stronger oversight of other potentially harmful substances in the food supply.

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