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A cupcake with bright red frosting.

FDA revokes use of red dye found in candy, medicine and more

January 16, 2025

The use of a red dye most commonly found in brightly colored desserts and candies was revoked Wednesday by the U.S. Food and Drug Administration (FDA).

The dye was found to cause cancer in male laboratory rats in two studies, according to an FDA news release. The Delaney Clause of the Federal Food, Drug and Cosmetic (FD&C) Act prohibits the use of any food or color additive that can cause cancer in humans or animals.

The FDA says there is no evidence that FD&C Red No. 3, which is also found in medicines and supplements, causes cancer in humans.

“(C)laims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information,” an FDA news release said.

Food and drug manufacturers have until Jan. 15, 2027, and Jan. 18, 2028, respectively, to eliminate FD&C Red No. 3, also known as erythrosine, from their products. Products imported from foreign nations must also be free of the dye.

The FDA’s action Wednesday was prompted by a 2002 petition to revoke the red dye that was endorsed by more than 20 organizations including the Center for Environmental Health, the Center for Food Safety, Breast Cancer Prevention Partners and the Children’s Advocacy Institute.

The International Association of Color Manufacturers (IACM), based in Washington, D.C., expressed confidence in the safety of Red No. 3 in a statement Wednesday and said it “remains steadfast in its commitment to upholding the highest safety standards for color additives used in consumer products.”

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