Nearly 35 years after it was prohibited from cosmetics due to possible cancer risks, U.S. regulators on Wednesday banned the dye known as Red 3 from the country’s food supply.
In 2022, two dozen food safety and health groups petitioned the Food and Drug Administration to revoke authorization for the ingredient that gives several candies, snack cakes, and maraschino cherry their vivid red color. The petition was granted.
Because of some studies showing the color caused cancer in lab rats, the FDA said it was taking the move as a matter of law. The Delaney Clause, a law that mandates the FDA to prohibit any ingredient that is shown to cause cancer in humans or animals, was highlighted by officials.
The dye is referred to as Red 3, FD&C Red No. 3, or erythrosine. It is no longer permitted as a color additive in meals, dietary supplements, or oral medications like cough syrups as a result of the ban. Because Red 3 was shown to cause cancer in rats, the FDA refused to approve its usage in cosmetics and topically applied medications more than thirty years ago.
According to Jim Jones, the FDA’s deputy commissioner for human foods, the agency is moving to revoke the approval for the use of FD&C Red No. 3 in food and swallowed medications. Male laboratory rats exposed to elevated amounts of FD&C Red No. 3 have been shown to develop cancer. Crucially, FD&C Red No. 3 does not cause cancer in humans in the same manner that it does in male rats.
Manufacturers of ingested medications have until January 2028 to remove the dye from their goods, while food manufacturers have until January 2027 to do so. While some uses of the dye are still permitted in other nations, imported foods must adhere to the new U.S. regulation.
Advocates for consumers applauded the ruling.
Dr. Peter Lurie, director of the organization Center for Science in the Public Interest, which spearheaded the petition effort, commented, “This is a welcome but long overdue action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy.”
Since there is no proof that the color causes cancer when ingested by people, it is unclear if food makers will oppose the prohibition in court. FDA Commissioner Dr. Robert Califf indicated that was a concern during a hearing in December.
He informed members of Congress on December 5 that “if we do ban something, it will go to court.” Additionally, we will lose in court if we lack the scientific proof.
Red 3 was previously approved as a colorant in meals and swallowed medications when the FDA rejected its use in cosmetics and topical medications in 1990. The FDA has stated on its website that it did not take action to rescind the license of Red No. 3 in food since studies at the time demonstrated that the dye’s mechanism of causing cancer in rats does not applicable to people.
For years, health advocates, including CSPI’s 2022 petition, have urged the FDA to reexamine that ruling. Nearly two dozen members of Congress demanded in a letter issued in November that Red 3 be banned by the FDA.
Citing the Delaney Clause, senators stated that the legislation was particularly necessary to protect youngsters, who are consuming more of the dye per bodyweight than adults.
The letter urged the FDA to take immediate action to shield the country’s children from this dangerous dye, which is only used to give food and beverages a vivid red hue. The use of a carcinogen in our food supply could not be justified for aesthetic reasons.
With the exception of several types of cherry, Red 3 is prohibited for use in food in Europe, Australia, and New Zealand. Legislators in Tennessee, Arkansas, and Indiana have submitted measures to restrict the use of specific colors, especially in foods served in public schools, while California will outlaw the dye beginning in January 2027.
The dye is safe at amounts normally consumed by humans, according to the International Association of Color Manufacturers. The group cites studies conducted by World Health Organization and United Nations scientific committees, such as a 2018 assessment that confirmed Red 3’s safety in food.
Red 3 has already been eliminated from some food manufacturers’ goods through revised formulations. Sensient Food Colors, a St. Louis-based provider of food coloring and flavorings, claims that they substitute it with beet juice, carmine, an insect-derived dye, and pigments from foods including red cabbage, purple sweet potatoes, and radish.
— The Associated Press’s Jonel Aleccia
This report was contributed to by Kimberlee Kruesi.
The Robert Wood Johnson Foundation and the Science and Educational Media Group of the Howard Hughes Medical Institute provide support to the Associated Press Health and Science Department. All content is entirely the AP’s responsibility.
