US regulators on Wednesday banned a dye called Red 3 from the country’s food supply, nearly 35 years after it was banned in cosmetics due to a cancer risk.
FDA officials approved a 2022 petition by more than two dozen food safety and health advocates, who urged the agency to revoke the license for the substance that gives some candy, snack cakes and maraschino cherries a bright red color.
The agency said it took the action as a “legal issue” because some studies have found that the dye causes cancer in laboratory mice. Officials cited a law known as the Delaney Clause, which requires the U.S. Food and Drug Administration to ban any additive found to cause cancer in humans or animals.
The dye is known as erythrosine, or 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 cough syrup. More than three decades ago, the U.S. Food and Drug Administration refused to allow Red 3 to be used in cosmetics and externally used medications because one study showed it caused cancer when rats ate it.
“The FDA is taking action that will revoke the authorization for use of FD&C Red No. 3 in ingested foods and drugs,” said Jim Jones, FDA deputy commissioner for human foods. “Evidence suggests cancer in male laboratory rats exposed to high levels of FD&C Red No. 3. Importantly, 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 dye from their products, while ingested drug makers have until January 2028 to do the same. Other countries still allow certain uses of the dye, but imported foods must meet new U.S. requirements.
Consumer advocates praised the decision.
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“This is a welcome but long overdue action from the FDA: removing the unsustainable double standard in which Red 3 was banned in lipstick but allowed in candy,” said Dr. Peter Lurie, director of the Public Science Center group. Interest, which led the petition effort.
It is not clear whether the ban would face legal challenges from food manufacturers because evidence has not determined that the dye causes cancer when consumed by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf noted that this presented a risk.
“When we ban something, it will go to court,” he told members of Congress on December 5. “If we don’t have the scientific evidence, we will lose in court.”
When the FDA refused to allow Red 3 for use in cosmetics and topical medications in 1990, the color additive was already allowed in foods and ingested medications. Because research at the time showed that the way the dye causes cancer in mice did not apply to humans, “the FDA took no action to revoke the license for use of Red No. 3 in food,” the agency said on its website.
Health advocates have for years asked the FDA to reconsider this decision, including a 2022 petition led by CSPI. In November, nearly two dozen members of Congress sent a letter calling on FDA officials to ban Red 3.
Lawmakers cited Delaney’s requirement and said the measure is especially important to protect children who consume the dye on a body weight basis more than adults.
“The FDA must act quickly to protect the nation’s youth from this harmful dye, which is simply used to give foods and beverages a bright red color,” the letter said. “There is no aesthetic reason that can justify the use of a carcinogen in our food supply.”
Red 3 is banned for food use in Europe, Australia and New Zealand except for certain types of cherries. The dye will be banned in California starting in January 2027.
The International Color Manufacturers Association 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 review that reaffirmed the safety of Red 3 in food.
Some food manufacturers have already reformulated products to remove Red 3. Instead they use beet juice; Cochineal, a dye made from insects; The dyes are from foods such as purple sweet potatoes, radishes and red cabbage, according to Sensient Food Colors, a St. Louis-based supplier of food colors and flavorings.
& Edition 2025 The Canadian Press
