FDA bans Red Dye No. 3 from nation's food

U.S. regulators on Wednesday banned the dye called Red 3 from the nation’s food supply, nearly 35 years after it was barred from cosmetics because of potential cancer risk.

Food and Drug Administration officials granted a 2022 petition filed by two dozen food safety and health advocates, who urged the agency to revoke authorization for the substance that gives some candies, snack cakes and maraschino cherries a bright red hue.

The agency said it was taking the action as a “matter of law” because some studies have found that the dye caused cancer in lab rats. Officials cited a statute known as the Delaney Clause, which requires FDA to ban any additive found to cause cancer in people or animals.

The dye is known as erythrosine, 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 medicines, such as cough syrups. More than three decades ago, the FDA declined to authorize use of Red 3 in cosmetics and externally applied drugs because a study showed it caused cancer when eaten by rats.

Food manufacturers will have until January 2027 to remove the dye from their products, while makers of ingested drugs have until January 2028 to do the same. Other countries still allow for certain uses of the dye, but imported foods must meet the new U.S. requirement.

It’s not clear whether the ban will face legal challenges from food manufacturers because evidence hasn’t determined that the dye causes cancer when consumed by humans. At a hearing in December, FDA Commissioner Dr. Robert Califf suggested that’s a risk.

When the FDA declined to allow Red 3 in cosmetics and topical drugs in 1990, the color additive was already permitted in foods and ingested drugs. Because research showed then that the way the dye causes cancer in rats does not apply to humans, “the FDA did not take action to revoke the authorization of Red No. 3 in food,” the agency has said on its website.

Health advocates for years have asked the FDA to reconsider that decision, 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.

Red 3 is banned for food use in Europe, Australia and New Zealand except in certain kinds of cherries. The dye will be banned in California starting in January 2027, and lawmakers in Tennessee, Arkansas and Indiana have filed proposals to limit certain dyes, particularly from foods offered in public schools.


(AP Photo Haven Daley)