U.S. regulators last week banned the use of the dye known as Red 3 in the nation’s food, nearly 35 years after it was banned in cosmetics because of a potential cancer risk.
U.S. Food and Drug Administration officials have granted a 2022 petition filed by two dozen food safety and health advocates urging the agency to revoke approval for the substance, which gives a bright red hue to some candies, pastries and maraschino cherries.
The agency said it was taking the action as a “matter of law” because some studies have found the dye causes cancer in lab rats. Officials cited a statute known as the Delaney Clause, which requires the FDA to ban any additive that causes cancer in people or animals.
The dye is known as erythrosine, FD&C Red No. 3, or simply Red 3. The ban removes it from the list of approved color additives in foods, dietary supplements and oral medications, such as cough syrups. More than three decades ago, the FDA refused to authorize Red 3 for use in cosmetics and externally applied drugs because a study showed it caused cancer in rats that ingested it.
“The FDA is taking action that will eliminate the authorization for use of FD&C Red No. 3 in foods and ingested 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. It is important to note that 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 manufacturers of ingestible drugs have until January 2028. Other countries still allow certain uses of the dye, but imported foods will have to comply with the new U.S. requirement.
Consumer advocates praised the decision
“This is a welcome, if long overdue, action by the FDA: removing the unsustainable double standard in which Red 3 was banned in lipstick but allowed in “We are not going to ban Red 3 in our sweets,” said Dr. Peter Lurie, director of the Center for Science in the Public Interest (CSPI), which led the petition effort.
It is not yet known whether the ban will face legal challenges from food manufacturers, since evidence has not found 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 will go to court,” he told members of Congress on Dec. 5. “And if we don’t have the scientific evidence, we will lose in court.”
When the FDA refused to allow Red 3 in cosmetics and topical medications in 1990, the dye was already allowed in ingestible foods and medications. Because research then showed that the way the dye causes cancer in rats does not apply to humans, “the FDA took no action to revoke the authorization of Red No. 3 in foods,” the agency noted on its website.
Health advocates have called for years for the FDA to reconsider that decision, including a 2022 petition led by CSPI. In November, nearly two dozen members of Congress sent a letter demanding that FDA officials ban Red 3.
The lawmakers cited the Delaney Clause and said the action was especially important to protect children, who consume more of the dye based on their body weight than adults, the lawmakers said.
“The FDA should act quickly to protect the nation’s youth from this harmful dye, used simply to give foods 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, with the exception of certain types of cherries. It will be banned in California starting in January 2027.
In favor
The International Color Manufacturers Association defends the substance, saying it is safe at concentrations typically consumed by humans. The group points to research by scientific committees operated by the United Nations and the World Health Organization, including a 2018 review that reaffirmed the safety of Red 3 in foods.
Some food manufacturers have already reformulated products to remove Red 3. They instead 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 supplier of food colors and flavors.
