The FDA bans Red No. 3 dye due to its link to cancer in rats

The FDA bans Red No. 3 dye due to its link to cancer in rats

A type of red dye used in many foods and medications has been banned by the U.S. Food and Drug Administration because studies suggest it may cause cancer in rats.

The FDA revokes its approval for the use of the Red No. dye. 3, which gives products a “bright, cherry red color.” Food and beverage manufacturers have until January 15, 2027 to reformulate their products, and drug manufacturers have until January 18, 2028 to remove it from their products.


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This ban is in response to a 2022 petition that cited two studies linking cancer in male rats to high levels of Red-3 exposure. The way the dye causes cancer in rats cannot occur in humans, the FDA noted, adding that there is no scientific evidence that 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 ban additives that can cause cancer in animals and humans. The use of the chemical in cosmetic products was banned more than three decades ago.

“This is a welcome but long overdue action by the FDA: eliminating the untenable double standard where Red 3 was banned in lipsticks but allowed in candy,” said Peter Lurie, director of the Center for Science in the Public Interest group. . led the petition effort, the Associated Press said.

According to the FDA, Red 3 is primarily used in candy, cakes, cupcakes, cookies, frozen desserts, frosting and ingested medications. Specific products listed in 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’s still found in thousands of items on shelves across America, but the FDA estimates that Red 3 is “not as commonly used in foods and medications compared to other certified colors.”

Some companies have taken steps to phase out Red 3 use in recent years. Just Born, the Pennsylvania-based company that makes Peeps, told the New York Times in 2023 that in 2024 only two varieties of its marshmallow candies (pink and lavender) would be made with the dye. After that, the dye would be phased out of all of its products, Just Born said.

The FDA banned the use of Red 3 in cosmetics and topical medications in 1990.

In 2023, California became the first state to ban the dye in food, citing rat research and a 2021 study that linked Red 3 and other dyes to behavioral problems in some children, The New York Times reported. The California law takes effect in 2027. Red 3 is already banned for use in food in Europe, Australia and New Zealand, except for certain varieties of cherries, the Associated Press reported.

Robert F. Kennedy Jr., appointed by President-elect Donald Trump to head the Department of Health and Human Services, has been a proponent of banning many artificial colors and ingredients in foods and drinks.

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