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(AP) — U.S. regulators on Wednesday banned a dye called Red 3 from the nation’s food supply. This is the first time in about 35 years that it was banned from cosmetics due to its potential cancer risks.
Food and Drug Administration officials filed a 2022 petition by 20 food safety and health advocates asking the Food and Drug Administration to revoke the approval of a substance that gives some candies, snack cakes and maraschino cherries their bright red hue. The petition was granted.
The agency said it was taking the action as a “matter of law” because several studies have found that the dye causes cancer in laboratory rats. Officials cited a law known as the Delaney Clause, which requires the FDA to ban additives found to cause cancer in people or animals.
This dye is known as erythrosine, FD&C Red No. 3 or Red 3. The ban removes the dye from the list of approved color additives in foods, dietary supplements, and oral medications such as cough syrups. More than 30 years ago, the FDA refused to approve Red 3 for use in cosmetics and topical drugs because studies showed it caused cancer when eaten by rats.
“FDA is taking steps to revoke the authorization for the use of FD&C Red No. 3 in foods and oral drugs,” said Jim Jones, FDA’s deputy commissioner for food. “This shows that exposed male laboratory rats are developing cancer.” Importantly, the mechanism by which FD&C Red No. 3 causes cancer in male rats does not occur in humans. ”
Food manufacturers have until January 2027 to remove dyes from their products, while manufacturers of ingestible medicines have until January 2028 to do the same. Other countries still allow certain uses of dyes, but imported foods must meet new U.S. requirements.
Consumer advocates praised the decision.
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“This is a welcome but long-awaited action from the FDA. Red 3 is banned in lipstick but allowed in candy, which is an unsustainable double-edged move.” Eliminate the standards,” said Dr. Peter Lurie, director of the Center for Public Science. Interested party who led the petition campaign.
It is unclear whether the ban will face legal challenges from food manufacturers, as there has yet to be any evidence that the dye causes cancer if ingested by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf suggested that was a risk.
“If you ban something, it’s going to go to court. If you don’t have scientific evidence, you’re going to lose in court,” he told lawmakers on December 5.
When the FDA disapproved the use of Red 3 in cosmetics and topical drugs in 1990, the color additive was already approved for use in food and ingested drugs. Because studies at the time found that the mechanism by which the dye caused cancer in rats did not apply to humans, “FDA took no action to revoke the approval of Red No. 3 in food,” the agency said on its website. Ta.
Health advocates have been asking the FDA to reconsider its decision for years, including in a 2022 petition led by CSPI. In November, nearly 20 lawmakers sent a letter to FDA officials calling for a ban on Red 3.
Lawmakers cited the Delaney provision and said the measure is especially important to protect children, who ingest more dye than adults based on their weight.
“FDA must act quickly to protect our nation’s youth from this harmful dye, which is used solely to give food and beverages a bright red color,” the letter reads. “No aesthetic reason can justify the use of carcinogens in the food supply.”
Red 3 is prohibited for consumption in Europe, Australia and New Zealand, except for certain types of cherries. The dye will be banned in California starting January 2027.
The International Color Industry Association defends the dye as safe for normal human consumption. The group points to studies by a scientific panel run by the United Nations and the World Health Organization, including a 2018 review that reaffirmed the safety of Red 3 in food.
Some food manufacturers have already reformulated their products to remove Red 3. I use beet juice instead. Carmine, a dye made from insects. Sensient Food Colors, a St. Louis-based food coloring and flavoring supplier, says it also contains dyes from foods such as purple potatoes, radishes and red cabbage.
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