The FDA bans the use of red dye #3 in U.S. foods and beverages

The US Food and Drug Administration announced on Wednesday that it would effectively ban Red No. 3, the controversial artificial red dye in foods and drinks that has been linked to cancer. The FDA is updating its regulations on color additives 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 asked the FDA to review two studies that suggested exposure to Red No. 3 caused cancer in male laboratory rats.

The dye has also been linked to effects on children’s behavior, including hyperactivity. The The FDA concluded that “further neurobehavioral research is needed to elucidate possible pathways underlying these sensitivities.” The administration advises concerned parents to check ingredient lists on labels and speak to a primary care physician.

Red No. 3, made from petroleum, was first approved for food consumption by the FDA in 1907. In the United States, it is commonly used in candies, cereals, cakes, icings, carbonated drinks, and many other products, giving foods a vibrant cherry-red color. But it is banned in many other places, including the European Union and Japan. The FDA itself banned Red No. 3 1990 the use in cosmetics.

The decision follows decades of pressure from advocacy groups and lawmakers to remove the ingredient from the U.S. food supply.

In a press release Wednesday, the Center for Science in the Public Interest welcomed the change.

“The FDA is finally ending the regulatory paradox that using Red 3 in lipsticks is illegal, but feeding it to children in the form of candy is completely legal,” said CSPI President Peter Lurie. “The main purpose of food coloring is to make candy, drinks and other processed foods more attractive. If the function is purely aesthetic, why take the risk of cancer?”

Lurie urged parents to avoid not only No. Red 3, but also all numbered dyes such as Yellow 5 and Red 40.

“If the new administration wants to protect children’s health, it should require companies to warn parents about the risks that all synthetic dyes pose to their children – right on the package label,” Lurie said.

Manufacturers that use Red No. 3 in foods and ingested medications must reformulate their products by January 15, 2027, in accordance with FDA’s new guidance. Imported foods that contain the dye must also comply with U.S. regulations.