A type of red dye used in many foods and medicines has been banned by the U.S. Food and Drug Administration, because studies suggest it may cause cancer in rats.
The FDA is revoking its authorization for the use of Red No. 3 dye, which gives products a “bright, cherry-red color.” Food and drink manufacturers have until Jan. 15, 2027 to reformulate their products, and drugmakers have until Jan. 18, 2028 to remove it from their products.
This ban is in response to a 2022 petition that citied two studies linking cancer in male rats to high levels of Red 3 exposure. The way that the dye causes cancer in rats cannot occur in humans, the FDA noted, adding that there has not been scientific evidence to show the dye could cause cancer in other animals or people.
But the Delaney Clause of the Federal Food, Drug, and Cosmetic Act requires the FDA to prohibit additives that can cause cancer in any animals or people. The chemical already was prohibited from being used in cosmetic products more than three decades ago.
“This is a welcome, but long overdue, action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy,” Peter Lurie, director of the Center for Science in the Public Interest group, which led the petition effort, told the Associated Press.
Red 3 is primarily used in candy, cakes, cupcakes, cookies, frozen desserts, frostings and ingested drugs, according to the FDA. Specific products that have listed Red 3 in recent years include some types of Fruit by the Foot, Dubble Bubble gum, Entenmann’s Little Bites, Hostess Ding Dongs, Nestle strawberry milk, Jordan Almonds, Pez candies, Brach’s candy corn, Ringpops, and Tylenol PM, Forbes reported. It is still found in thousands of items on shelves in America, but the FDA estimates that Red 3 is “not as widely used in food and drugs when compared to other certified colors.”
Some companies have taken steps to phase out the use of Red 3 in recent years. Just Born, the Pennsylvania-headquartered company that makes Peeps, told the New York Times in 2023 that only two varieties of its marshmallow candies (pink and lavender) would be made using the dye in 2024. After that, the dye would be phased out of all its products, Just Born said.
The FDA banned the use of Red 3 in cosmetics and topical drugs in 1990.
In 2023, California became the first state to ban the dye in food, citing the rat research as well as a 2021 study that linked Red 3 and other dyes to behavioral problems in some children, the New York Times reported. The California law goes into effect in 2027. Red 3 is already banned for food use in Europe, Australia and New Zealand, except in certain kinds of cherries, the Associated Press reported.
Robert F. Kennedy Jr., who has been nominated by President-elect Donald Trump to lead Department of Health and Human Services, has been a proponent of banning many of the artificial dyes and ingredients found in food and drinks.
