U.S. regulators on Wednesday banned the dye Red 3 from the country's food supply, nearly 35 years after it was banned from cosmetics due to its potential cancer risk.
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 supplies some candies, snack cakes and maraschino cherries a shiny red hue.
The agency said it was taking the motion as a “legal matter” because some studies had found the dye caused cancer in lab rats. Officials pointed to a regulation often known as the Delaney Clause, which requires the FDA to ban any additives that cause cancer in humans or animals.
California had already banned the dye, and a law is scheduled to return into force in January 2027.
The dye is obtainable 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 similar to cough syrups. More than three many years ago, the FDA rejected using 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 drugs,” said Jim Jones, FDA deputy commissioner for human foods. “There is evidence that male laboratory rats exposed to high concentrations of FD&C Red No.3 developed cancer. 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 identical.
Imported foods must meet the brand new US requirement. Red 3 is banned for food use in Europe, Australia and New Zealand except in certain cherry varieties.
Consumer advocates praised the choice.
“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 within the Public Interest, which led the petition effort.
It shouldn’t be clear whether the ban will face a legal challenge from food manufacturers, as there isn’t any evidence that the dye causes cancer when consumed by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf identified 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 colour additive was already permitted in foods and ingested medications. Because research on the time showed that the way in which the dye caused cancer in rats didn’t apply to humans, “the FDA took no action to approve Red No. 3 in food,” said the authority said on his 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 necessary to guard children, who eat 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.”
The International Association of Color Manufacturers defends the dye, saying it’s protected at levels normally consumed by humans. The group points to research from scientific committees on the United Nations and the World Health Organization, including a 2018 review that confirmed the security 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 similar to purple sweet potatoes, radishes and red cabbage, in accordance with Sensient Food Colors, a St. Louis-based supplier of food colours and flavors.
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