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FDA
News
February 6, 2025

FDA ban of Red No. 3 dye to take effect in 2027

By TRISHA GEDON OSU AG. EXT. 

Brightly colored candies, cookies and cupcakes have long been sweet treats, but the U.S. Food and Drug Administration is removing a specific color due to health concerns.

Brightly colored candies, cookies and cupcakes have long been sweet treats, but the U.S. Food and Drug Administration is removing a specific color due to health concerns.

Red No. 3 dye, also known as E127 or erythrosine, gives some beverages, candies, cupcakes and icings their bright red appearance. It was approved for use in food, cosmetics and pharmaceuticals in 1969, but some studies show it may cause health risks.

Red No. 3 first caused concern in the 1980s when some animal studies showed a link between the dye and thyroid tumors in male rats. The FDA then banned Red No. 3 in some external- use products such as cosmetics in the 1990s; however, Red No. 3 was still permitted in some foods.

Christi Evans, Oklahoma State University Extension food safety specialist, said manufacturers have until Jan. 15, 2027, to reformulate their products and remove Red No. 3 from their ingredients. Products imported from outside the United States must also abide by the new regulations.

“This change was based on a petition from consumer advocacy groups who petitioned the FDA’s authorization of Red No. 3 as a food additive or color additive if it has been found to induce cancer in humans or animals,” Evans said. “Two studies cited in the FDA petition showed cancer in male laboratory rats that consumed high levels of Red No. 3. However, researchers haven’t established a direct link between Red No. 3 and cancer in humans because the exposure levels from foods are much lower than the levels that caused health issues in animal studies.”

Evans said one way to avoid artificial dyes is to choose foods that aren’t processed and are in their natural state. Foods such as fresh fruits and vegetables, whole grains, and seeds and nuts are healthy options.

“I recommend always reading food labels on packaged products to better understand what you’re eating,” she said. “The food labels not only provide consumers with a list of ingredients, they also show nutrition facts that can help people make informed decisions about the foods they eat.”

Red No. 40 is another dye found in a variety of food products on the market, but the new legislation only pertains to Red No. 3. Consumers are urged to read the ingredients on the food products they purchase to determine if they contain Red No. 3.

“With Valentine’s Day approaching, consumers may be purchasing more sweet treats such as candy, cakes, frozen desserts and more,” Evans said. “Some companies already shifted away from Red No. 3, and with the new regulations from the FDA, other companies must now follow suit.”

OSU Extension uses research-based information to help all Oklahomans solve local issues and concerns, promote leadership and manage resources wisely throughout the state’s 77 counties. Most information is available at little to no cost.

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