The Food and Drug Administration (FDA) has banned a controversial red dye from food and ingested drugs that has been linked to cancer in animals.
The FDA has decided to rescind its approval of FD&C Red No. 3 — also referred to simply as Red No. 3 — from food and drug supplies more than 30 years after the agency banned it from cosmetics.
The agency’s decision comes less than a week before President-elect Trump is set to take office. He and his pick for secretary of Health and Human Services, Robert F. Kennedy Jr., are expected to make good on promises to crack down on the use of artificial food dyes.
Red No. 3 was approved for permanent use in food and ingested drugs roughly 50 years ago and has been used as an artificial food coloring to give products such as candy, cakes and frosting a bright cherry-red color.
The FDA’s ban on the dye comes two years after advocates submitted a petition to the agency to have it removed from food products, arguing companies should instead use a natural color from food such as beets, red cabbage and black currants.
Studies cited in the petition show that high dosages of the dye can cause cancer in male rats, but the FDA insists Red No. 3 does not cause cancer in humans.
“Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats,” the agency said in a statement.
Some consumer advocacy groups and lawmakers who have tried to pressure the agency into rescinding its approval of the dye lauded the FDA’s decision Wednesday.
“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 Peter G. Lurie, president of the Center for Science in the Public Interest, one of the organizations behind the 2022 petition to the FDA to end the dye’s use.
“The primary purpose of food dyes is to make candy, drinks, and other processed foods more attractive,” he continued. “When the function is purely aesthetic, why accept any cancer risk?”
The administration said it was removing the dye as a “matter of law” citing the Delaney Clause, a federal law that prohibits the addition of any chemical to food that has been shown to cause cancer in humans or animals.
Food manufacturers that use Red No. 3 will have until Jan. 15, 2027, to reformulate their products, while drug manufacturers have until Jan. 18, 2028, according to a statement from the FDA.
Foods imported from other countries will also have to comply with the new U.S. requirement.
