US regulators have banned Red No. 3 from the nation’s food supply, nearly 35 years after it was prohibited in cosmetics due to potential cancer risks.
The Food and Drug Administration (FDA) granted a 2022 petition filed by over two dozen food safety and health advocates urging the removal of Red 3 from foods, dietary supplements, and oral medicines like cough syrups. The dye, also called erythrosine or FD&C Red No. 3, gives some candies, snack cakes, and maraschino cherries their bright red colour.
The ban is based on the Delaney Clause, which mandates the FDA to prohibit any additive linked to cancer in humans or animals. Studies have shown that Red 3 caused cancer in laboratory rats, leading to its removal from the FDA’s approved list of colour additives.
Jim Jones, the FDA’s deputy commissioner for human foods, noted the evidence linking the dye to cancer in male rats. However, he clarified that the mechanism through which the dye causes cancer in rats does not apply to humans. Manufacturers must eliminate the dye from food by January 2027 and from ingested drugs by January 2028. While other countries still permit certain uses of Red 3, imported foods must now comply with the new US regulations.
Dr Peter Lurie, director of the Center for Science in the Public Interest, welcomed the move, describing it as long overdue. He criticised the inconsistency of banning Red 3 in lipstick while allowing its use in candies.
Despite the ban, questions remain about potential legal challenges from food manufacturers. FDA Commissioner Dr Robert Califf warned that insufficient scientific evidence could lead to court disputes. When Red 3 was banned from cosmetics in 1990, it was already approved for use in food and medicines. The FDA previously refrained from banning the dye in foods, citing differences in how it affects humans versus rats.