US regulators on Wednesday banned the substance known as red dye No. 3 from the country's food supply, nearly 35 years after it was banned from cosmetics because of a potential cancer risk.
US Food and Drug Administration officials handed over a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke approval for the food coloring agent red to some candies, snack cakes and maraschino cherries.
The group said it was taking the case as a “legal matter” because some studies have found that the dye caused cancer in laboratory rats. Officials announced a statute known as the Delaney Clause, which requires the FDA to ban any additive found to cause cancer in humans or animals.
The dye is called erythrosine, FD&C Red No. 3 or Red 3. More than three decades ago, the FDA refused to approve the use of Red 3 in cosmetics and external drugs because a study showed that it caused cancer when eaten by rats.
“The FDA is taking action that will remove the approval for the use of FD&C Red No. 3 in food and imported drugs,” said Jim Jones, the FDA's deputy commissioner for human foods. “Evidence shows cancer in male laboratory rats exposed to high levels of FD&C Red No. 3. Importantly, the mechanism by which FD&C Red No. 3 causes cancer in male rats does not occur in people.”
Food manufacturers will have until January 2027 to remove the dye from their products, and manufacturers of imported drugs will have until January 2028 to do the same. Other countries still allow certain uses of the color, but imported foods must meet the new US requirement.
Consumer advocates applauded the decision.
“This is a welcome, but long overdue, action by the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but allowed in candy,” said Dr. Peter Lurie, director of the Center for Science in the Public Interest group, who led the petition effort.
CBC News has asked Health Canada for comment on whether a similar ban will happen here, but has yet to receive a response.
FDA petitioned on color
It is not clear whether the ban will face legal challenges from food manufacturers as there is no evidence to prove that the dye causes cancer when consumed by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf suggested that is a risk.
“When we ban something, it goes to court,” he told members of Congress on December 5. “And if we don't have the scientific evidence, we will lose in court.”
When the FDA refused to approve Red 3 in cosmetics and topical medications in 1990, the color additive was already permitted in foods and ingested drugs. Because research at the time showed that the way the dye causes cancer in rats does not apply to humans, “the FDA did not take action to approve Red No. 3 in food to be revoked,” the group said on its website.
Health advocates for years have asked the FDA to reconsider that decision, including a 2022 petition led by CSPI. In November, nearly two dozen members of Congress sent a letter asking FDA officials to ban Red 3.
Lawmakers cited the Delaney Clause and said the act was especially important to protect children, who consume more of the dye on a body weight basis than adults, the lawmakers said.
“The FDA should act quickly to protect the nation's youth from this harmful dye, used only to give food and beverages a bright red color,” the letter said. “No aesthetic reason could justify its use 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 color will be banned in California starting in January 2027.
The International Association of Color Manufacturers defends the dye, saying it is safe in levels commonly consumed by humans. The group points to research 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; 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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