U.S. regulators on Wednesday banned the additive “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.
U.S. Food and Drug Administration officials approved a petition filed in 2022 by two dozen food safety and health advocates asking the agency to revoke approval of the substance, which turns some candies, snack cakes and maraschino cherries bright red gives color.
The agency said it was taking the action as a “legal matter” because some studies had found the dye caused cancer in lab rats. Officials pointed to a law called the Delaney Clause, which requires the FDA to ban any additives proven to cause cancer in humans or animals.
The dye is available as erythrosine, FD&C Red No. 3 or Red 3 known. The ban removes it from the list of approved color additives in foods, dietary supplements and oral medicines such as cough syrups. More than three decades ago, the FDA rejected the use of Red 3 in cosmetics and topical medications because a study showed it caused cancer when consumed by rats.
“The FDA is taking action to authorize the use of FD&C Red No. 3 in foods and ingested medications,” said Jim Jones, FDA deputy commissioner for human foods. “There is evidence that cancer occurs in male laboratory rats when exposed to high levels of FD&C Red #3. Importantly, the way FD&C Red #3 causes cancer in male rats does not occur in humans.”
Food manufacturers 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 continue to allow certain uses of the dye, but imported foods must meet the new U.S. requirement.
Consumer advocates praised the decision.
“This is a welcome but long overdue action by the FDA: eliminating the untenable double standard where Red 3 was banned in lipsticks but allowed in candy,” said Dr. Peter Lurie, director of the group Center for Science in the Public Interest, which led the petition effort.
CBC News has reached out to Health Canada for comment on whether a similar ban will be implemented here, but has not yet received a response.
The FDA has filed a petition regarding dyes
It is not clear whether the ban will face a legal challenge from food manufacturers, as there is no evidence that the dye causes cancer when consumed by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf pointed out that this was a risk.
“If we ban something, it will be tried in court,” he told members of Congress on December 5. “And if we lack the scientific evidence, we will lose in court.”
When the FDA declined to approve Red 3 in cosmetics and topical medications in 1990, the color additive was already permitted in foods and ingested medications. Because research at the time showed that the way the dye caused cancer in rats did not apply to humans, “the FDA took no action to approve Red No. 3 in food,” it says 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 pointed to the Delaney clause and said the measure was particularly important to protect children, who consume more dye relative to their body weight than adults, lawmakers said.
“The FDA should act quickly to protect the nation’s youth from this harmful dye that is used solely to give food and beverages a bright red color,” the letter said. “No aesthetic reason 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 cherry varieties. The dye will be banned in California starting January 2027.
The International Association of Color Manufacturers defends the dye, saying it is safe at levels normally consumed by humans. The group points to research from scientific committees at the United Nations and the World Health Organization, including a 2018 review that confirmed the safety of Red 3 in food.
Some food manufacturers have already reformulated their products to remove Red 3. Instead, they use beet juice; carmine, a dye from insects; and pigments 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 flavors.
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