US regulators on Wednesday banned the dye called Red 3 of the country’s food supply, almost 35 years after being excluded from cosmetic products due to a potential cancer risk.
Food and Drug Administration officials granted a petition filed in 2022 by two dozen food safety and health advocates, who urged the agency to revoke authorization of the substance that makes some candies, maraschino cakes and cherries a bright red hue.
The agency said it was taking the action as a “matter of law” because some studies found the dye caused cancer in lab rats. Officials cited a law known as the Delaney Clause, which requires the FDA to ban any additive that may cause cancer in people or animals.
The dye is known as erythrosine, FD&C Red No. 3 or Red 3. The ban removes it from the list of approved color additives in foods, dietary supplements and oral medications, such as anti-inflammatory syrups. cough. Over thirty years ago, the FDA refused to allow Red 3 to be used in cosmetics and external medications because a study showed it caused cancer when consumed by rats.
“The FDA is taking action that will revoke the authorization for use of FD&C Red No. 3 in food and ingested drugs,” said Jim Jones, FDA deputy commissioner for human foods. “Evidence shows cancer in male laboratory rats exposed to high levels of FD&C Red No.3. It is important to note that the way FD&C Red No. 3 causes cancer in male rats does not occur in humans.
Food manufacturers will have until January 2027 to remove the coloring from their products, while ingested drug manufacturers will have until January 2028 to do the same. Other countries still allow some uses of the coloring, but imported foods must meet the new U.S. requirement.
Consumer advocates welcomed the move.
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“This is a welcome, but long overdue, action by the FDA: removing the unsustainable double standard in which Red 3 was banned in lipstick but allowed in candy,” said the Dr. Peter Lurie, director of the Center for Science in the Public. Interest, who led the petition effort.
It is unclear whether the ban will face legal challenges from food manufacturers because no evidence has determined that the dye causes cancer when consumed by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf suggested this was a risk.
“When we ban something, it will be taken to court,” he told members of Congress on December 5. “And if we don’t have scientific proof, we will lose in court.” »
When the FDA refused to allow Red 3 in cosmetics and topical medications in 1990, the color additive was already allowed in ingested foods and medications. Because research has shown that the way the dye causes cancer in rats does not apply to humans, “the FDA has not taken action to revoke the authorization of Red No. 3 in foods.” , the agency said on its website.
Health advocates have been calling on the FDA to reconsider this decision for years, including the 2022 petition led by CSPI. In November, nearly two dozen members of Congress sent a letter demanding that FDA officials ban Red 3.
Lawmakers cited the Delaney Clause and said the action was particularly important to protect children, who consume more dye based on their body weight than adults, the lawmakers said.
“The FDA should act quickly to protect the nation’s youth from this harmful dye, used simply to impart a bright red color to foods and beverages,” the letter states. “There is no aesthetic reason that could justify the use of a carcinogen in our food supply.”
Red 3 is banned for food use in Europe, Australia and New Zealand, except in certain types of cherries. The dye will be banned in California starting in January 2027.
The International Association of Color Manufacturers defends the dye, saying it is safe at levels typically consumed by humans. The group points to research conducted by scientific committees run by the United Nations and the World Health Organization, including a 2018 study that reaffirmed the safety of Red 3 in foods.
Some food manufacturers have already reformulated their products to remove Red 3. Instead, they use beet juice; carmine, a dye made from insects; and pigments from foods such as purple sweet potato, radish and red cabbage, according to Sensient Food Colors, a St. Louis-based supplier of food colors and flavors.
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