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Food Ingredients

FDA bans red no. 3 in food and drugs

Erythrosine color additive causes cancer in male rats, US agency says

by Britt E. Erickson
January 15, 2025

 

An assortment of colorful candy.
Credit: Shutterstock
Candymakers will have to stop using red no. 3 dye in products sold in the US by Jan. 15, 2027.

In a last-minute move before president-elect Donald J. Trump’s second term, the US Food and Drug Administration granted a petition by public health advocates to ban red no. 3 dye, also known as erythrosine, in food and drugs.

The agency cites the Delaney Clause, a 1960 law, as the reason it will no longer allow the bright, cherry red dye in either food or drugs, effective Jan. 15, 2027, and Jan. 18, 2028, respectively. The clause prohibits the FDA from authorizing food additives and dyes that cause cancer in humans or animals.

The Center for Science in the Public Interest and other groups petitioned the agency in 2022 to ban red no. 3, citing two studies that show cancer in male rats exposed to high levels of the color additive.

The biological mechanism leading to those cancers is specific to male rat hormones and does not occur in other animals or humans, the FDA says. Even so, the Delaney Clause requires the agency to revoke the authorization of red no. 3 because it causes cancer in an animal. The FDA banned the dye in cosmetics in 1990 but has been slow to do so in food because of pressure from the food industry, especially confectioners.

The FDA lists “candy, cakes and cupcakes, cookies, frozen desserts, and frostings and icings, as well as certain ingested drugs,” as the primary products that will be impacted by the ban.

“Food safety is the number one priority for U.S. confectionery companies, and we will continue to follow and comply with FDA’s guidance and safety standards,” the National Confectioners Association says in a statement in response to the ban.

Public health groups applaud the agency’s decision. “Today’s action by the FDA marks a monumental victory for consumer health and safety,” Ken Cook, president of the Environmental Working Group (EWG), says in a statement. “For years, Red 3 remained in food products, despite growing evidence linking it to health problems, particularly in kids.”

The EWG and other advocacy groups claim that red no. 3 and other synthetic food dyes are linked to behavioral difficulties, decreased attention span, and memory problems in children. But the FDA says that claims that red no. 3 dye is a risk to people are not supported by scientific evidence.

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