The US Food and Drug Administration announced on Wednesday that it’s effectively banning Red No. 3, the controversial artificial red dye found in food and drinks that’s been linked to cancer. The FDA is updating its color additive regulations following a 2022 petition from the Center for Science in the Public Interest, a nonprofit advocacy group focused on nutrition and public health. The petition urged the FDA to review two studies indicating that exposure to Red No. 3 caused cancer in male laboratory rats.
The dye has also been linked to behavioral impacts in children, including hyperactivity. The FDA concluded that “further neurobehavioral research is needed to explain potential pathways underlying these sensitivities.” The administration advises concerned parents to check ingredient lists on labels and speak with a family doctor.
Red No. 3, made from petroleum, was first approved for food consumption by the FDA in 1907. It’s widely used in candy, cereals, cakes, frostings, carbonated drinks and many other products in the US, where it gives foods a vibrant cherry-red color. But it’s banned in many other places, including the European Union and Japan. The FDA itself banned Red No. 3 from use in cosmetics in 1990.
The decision follows decades of pressure from advocacy groups and lawmakers to remove the ingredient from the US food supply.
In a press release Wednesday, the Center for Science in the Public Interest applauded the change.
“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 Peter Lurie. “The primary purpose of food dyes is to make candy, drinks, and other processed foods more attractive. When the function is purely aesthetic, why accept any cancer risk?”
Lurie urged parents to avoid not only No. Red 3 but also all numbered dyes, such as Yellow 5 and Red 40.
“If the incoming administration wants to protect children’s health, it should require companies to warn parents of the risks that all synthetic dyes pose to their children — right on the label of the package,” Lurie said.
Manufacturers that use Red No. 3 in food and ingested drugs must reformulate their products by Jan. 15, 2027, according to the FDA’s new guidance. Imported foods that contain the dye will also need to comply with US regulations.
