The FDA has banned Red 3, also known as Erythrosine, from foods, supplements, and ingested medicines. The Associated Press confirmed the decision on Wednesday.
Food makers must remove the dye by January 2027. Drug manufacturers have until January 2028 to comply. Imported foods will also need to meet the new standards.
“The FDA is taking action to remove the authorization for FD&C Red No. 3 in food and ingested drugs,” said Jim Jones, the FDA’s deputy commissioner for human foods.
Jones explained the decision stems from evidence of cancer in lab rats exposed to high levels of Red 3. However, he noted, “The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”
The dye, made from petroleum, creates a bright cherry-red color in foods and medicines. The FDA described it as a synthetic color additive.
The petition to ban Red 3 pointed to the Delaney Clause, which prevents the FDA from labeling any additive as safe if it’s linked to cancer in humans or animals. This same dye was removed from cosmetics 35 years ago for cancer concerns.
“This is a welcome, but long overdue, action,” said Dr. Peter Lurie of the Center for Science in the Public Interest, which led the petition. He criticized the double standard allowing the dye in candy but banning it in lipstick.
Nearly 3,000 foods contain Red No. 3, according to Food Scores, a database by the Environmental Working Group. Products like candy and jello will soon need reformulating.
The push to ban Red 3 started in 2022 with a petition from 24 organizations and scientists. Their efforts finally led to this significant FDA decision.