The FDA bans the use of Red Dye #3 in food and beverages in the US

US Food and Drug Administration announced on Wednesday that effectively bans Red No. 3, the controversial artificial red dye found in foods and drinks that has been linked to cancer. FDA Updates Its Color Additive Regulations After 2022 Petition from the Center for Science in the Public Interest, a nonprofit group focused on nutrition and public health. The petition urged the FDA to review two studies showing that exposure to Red No. 3 caused cancer in male lab rats.

The dye has also been linked to behavioral effects in children, including hyperactivity.

Red No. 3, made from petroleum, was first approved for consumption by the FDA in 1907. It is widely used in candies, cereals, cakes, frostings, sodas, and many other products in the United States, where it gives foods a vibrant cherry-red color. But it is banned in many other places, including the European Union and Japan. The FDA itself banned the use of Red #3 in cosmetics in 1990.

The decision comes after 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.

“Finally, the FDA ends the regulatory paradox of Red 3 being illegal for use in lipstick but perfectly legal to feed to children in candy form,” said CSPI President Peter Lurie. “The primary purpose of food coloring is to make candy, beverages, and other processed foods more appealing. When the function is purely aesthetic, why accept any cancer risk?”

Lurie urged parents to avoid not only number red 3, but all numbered dyes, such as yellow 5 and red 40.

“If the next 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 using Red No. 3 in foods and oral drugs, must reformulate their products by January 15, 2027, according to the new FDA guidelines. Imported foods that contain the dye will also have to comply with US regulations.