The U.S. Food and Drug Administration is taking steps to remove the synthetic dye Red No. 3 from food and beverages, decades after it was linked to cancer risks. Originally approved in 1907, the additive has been a staple in many popular foods, including candy, cereal, cherries and dietary supplements.
In 1980, studies raised alarms about its potential to cause cancer, specifically after high doses of the dye were shown to induce tumors in male rats.
Though the research prompted concern, the FDA did not take immediate action, citing the effects on humans were not shown. However, in recent years, advocacy groups and lawmakers have pressed for stronger action against the dye, prompting the FDA to revisit its stance.
On Wednesday, Jan. 15, the FDA announced plans to remove Red No. 3 from the list of approved color additives, citing the Delaney clause, a law banning any food additives known to cause cancer in both people and animals.
The Center for Science in the Public Interest, which led a petition in 2022 urging the FDA to take action, applauded the move, but called it long overdue. The group pointed to the fact that the dye had already been banned in cosmetics, but remained legal in food and drinks, until now.
“At long last, the FDA is ending the regulatory paradox of Red 3 being illegal for use in lipstick, but perfectly legal to feed to children in the form of candy,” the group said in a statement.
In addition to pressure from advocacy groups, nearly two dozen lawmakers recently called on the FDA to take action for the sake of children’s safety, with their letter stating, “No aesthetic reason could justify the use of a carcinogen in our food supply.”
Other countries, including Japan, Australia and New Zealand, have already restricted or banned the use of Red No. 3 in food products. Now, the U.S. is moving to follow suit.
The FDA is giving manufacturers until 2027 to remove the dye from their products, with an additional year for drug makers to comply with the new regulations.
