US regulators on Wednesday banned an additive called red dye No. 3 in the nation's diet, nearly 35 years after cosmetics were banned because of their cancer risk.
US Food and Drug Administration officials granted a 2022 petition filed by a dozen food safety and health advocates, who urged the agency to withdraw approval of a substance that gives candies, snack cakes and maraschino cherries a bright red color.
The agency said it is taking this step “as a matter of law” because other studies have found that the dye causes cancer in lab rats. Officials cited a law known as the Delaney Clause, which requires the FDA to ban any additives found to cause cancer in humans 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 food, nutritional supplements and oral medicines, such as cough medicines. More than three decades ago, the FDA refused to approve the use of Red 3 in cosmetics and topical drugs because studies showed 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 foods and ingested drugs,” said Jim Jones, 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 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 absorbed drugs have until January 2028 to do the same. Some countries still allow certain uses of the dye, but imported foods must meet the new US requirement.
Consumer advocates have praised the decision.
“This is a welcome, but long overdue, action from the FDA: to remove the uncontrollable double standard where Red 3 was banned from lipstick but allowed in candy,” said Dr. Peter Lurie, director of the group Center for Science in the Public. Interest, which led to the request.
CBC News has requested comment from Health Canada on whether a similar ban will take place here, but has yet to receive a response.
The FDA has applied to the dye
It is not clear whether the ban will face legal challenges from food manufacturers because 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 dangerous.
“If we ban something, it will go to court,” he told members of Congress on December 5. “And if we don't have scientific evidence, we will lose in court.”
When the FDA refused to allow Red 3 in cosmetics and topical drugs in 1990, the color additive was already approved for food and ingested drugs. Because research at the time showed that the dye's carcinogenicity in mice did not work in humans, “the FDA did not take action to revoke the approval of Red No. 3 in food,” the agency said on its website.
Health advocates for years have asked the FDA to revise that decision, including a 2022 petition led by CSPI. In November, nearly two members of Congress sent a letter demanding that FDA officials ban Red 3.
Advocates cited the Delaney Clause and said the act was more important to protect children, who consume more dye per body weight than adults, law enforcement said.
“The FDA must take immediate action to protect the nation's youth from this dangerous dye, which is used to give food and beverages a bright red color,” the letter said. “There is no aesthetic reason that can justify the use of a carcinogen in our food.”
Red 3 is banned for food use in Europe, Australia and New Zealand except for certain types of cherries. 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 commonly used by humans. The group points to research by scientific committees used 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 modified products to remove Red 3. Instead they use beet juice; carmine, a dye made from insects; and pig foods such as purple sweet potato, radish and red cabbage, according to Sensient Food Colors, a St. Louis of food colors and flavors.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. AP is solely responsible for all content.
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