FDA Bans Red No. 3 Food Dye After Decades of Cancer Concerns

Regulators from the Food and Drug Administration on Wednesday banned Red No. 3 dyes from use in food more than three decades after they banned its use in cosmetic products due to the risk of cancer. Manufacturers have until 2027 to comply with the new rules.Erythrosine, also known as FD&C Red No. 3 or Red 3, has been removed from the list of color additives approved for use in foods, oral medicines, and dietary supplements. The FDA said it was approving a 2022 petition filed by a consortium of food safety and health advocates to revoke the chemicals authorization.Officials say they are taking action under the Delaney Clause, a statute that requires the federal agency to ban additives found to cause cancer in people or animals, after numerous studies found lab rats had developed cancer after ingesting Red No. 3.“The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs,” the FDA’s Deputy Commissioner for Human Foods, Jim Jones, said. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”Advocates behind the petitions have praised the decision.“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,” the director of the Center for Science in the Public Interest, Dr. Peter Lurie, said.The FDA banned the dye in cosmetics and topical drugs years ago but allowed it to stay in foods and ingested drugs because research at the time showed that the dye did not affect humans the same way it did lab rats. Ever since then, health advocates have been asking the FDA to reconsider, arguing that children consume more of the dye than full-grown adults via candies, cakes, and other foods.Among the foods that include Red No. 3 are maraschino cherries, puddings, fruit cocktails, candy corn, dyed marshmallows, protein shakes, and alternative vegetarian meats.In November, about two dozen members of Congress sent a letter to the FDA demanding the ban. “The FDA should act quickly to protect the nation’s youth from this harmful dye, used simply to give food and drinks a bright red color,” the letter said.“No aesthetic reason could justify the use of a carcinogen in our food supply,” they added.The International Association of Color Manufacturers have defended the use of the dye as a food additive, saying it is safe at the levels normally consumed by humans.The founder of the blog JunkScience.com, Steve Milloy, said in a post on X that the decades-old report on which the ban is based was not conclusive enough of a study.“The vast majority of rats did not get adenomas [tumors], but the number that did was statistically significant for the males. So does that prove that Red 3 causes cancer? No. Not even close,” he said in the video, pointing out that the tumors were benign. “None of the rats got a dangerous cancer from the experiment.”If he is confirmed by the Senate, President Trump ally Robert F. Kennedy Jr. is poised to take the reins at the Department of Health and Human Services and has been pushing for certain food additives, including dyes like Red No. 3, to be banned in America.“We are betraying our children by letting [food] industries poison them,” he said at a rally in November, after he had ended his independent presidential bid and backed Trump.

FDA Bans Red No. 3 Food Dye After Decades of Cancer Concerns

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