The U.S. Food and Drug Administration announced a ban on Red No. 3, an artificial food coloring linked to cancer in animal studies, effective Jan. 15, 2027.

The dye, found in products ranging from candy to cold medicine, has been scrutinized for decades. This move follows the FDA's 1990 prohibition of the dye in cosmetics due to its carcinogenic effects on lab rats.

The decision, announced on Wednesday, comes in response to a 2022 petition by consumer advocacy groups, including Consumer Reports, Public Citizen and the Environmental Working Group, urging the FDA to eliminate Red No. 3 from the American diet. The agency acknowledged the dye induces cancer in male rats and is subject to the Delaney Clause, a regulation banning substances shown to cause cancer in humans or animals from being used in food.

"Red Dye 3 poses an unacceptable risk to our health, especially when safer alternatives are readily available," said Brian Ronholm, director of food policy at Consumer Reports, as reported by Bloomberg. Advocacy groups have argued that banning the dye will encourage manufacturers to adopt safer ingredients already in use in Europe and other countries.

Children's Products Loaded With Red Dye No. 3

The dye, widely prevalent in U.S. supermarkets, seems to be especially used to color food items consumed by young children. An analysis by the healthy food app GoCoCo revealed its presence in 26% of baking decorations, 16% of chewing gum, 13% of candy and 11% of cookies.

Products such as Brach's candy corn produced by the Ferrara Candy Co., Betty Crocker sprinkles made by General Mills Inc GIS and strawberry Ensure from Abbott Laboratories ABT contain Red dye No 3. It is also used in medications, including Takeda Pharmaceutical Co. Ltd.’s (NYSE: TAK) Vyvanse, a medication used to treat attention deficit hyperactivity disorder, which affects seven million U.S. children and teens. Store-brand heartburn remedies from Costco Wholesale Corp COST and Rite Aid also contain Red dye No 3.

"If you can't put it on your skin why would you eat it?" said Linda Birnbaum, former director of the National Institute of Environmental Health Sciences and the National Toxicology Program, in an interview with Bloomberg last month. "Bright red dye is completely unessential. We don't need bright red candies."

The industry expressed support for the FDA's regulatory authority. "Our consumers and everyone in the food industry want and expect a strong FDA," the National Confectioners Association said in a statement.

Ferrara and General Mills have indicated their readiness to meet the new standards. Ferrara has already begun reformulating products.

While the ban marks progress, advocates like Scott Faber of the Environmental Working Group are urging the FDA to tackle other dyes, including Red No. 40 and Yellow Nos. 5 and 6, linked to hyperactivity and other health concerns.

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