The Food and Drug Administration on Wednesday banned the use of Red Dye No. 3 in food, beverages and drugs, more than three decades after the synthetic coloring was first found to cause cancer in male laboratory rats.
The dye, a petroleum-based additive, has been used to give candy, soda and other products their vibrant cherry red hue. Consumer advocates said the F.D.A.’s decision to revoke the authorization was long overdue, given the agency’s decision in 1990 to ban the chemical for use in cosmetics and topical drugs.
Under federal rules, the F.D.A. is prohibited from approving food additives that cause cancer in humans or animals.
“This is wonderful news and long overdue,” said Melanie Benesh, vice president for government affairs at the Environmental Working Group, one of several organizations that petitioned the agency to take action on the additive. “Red Dye 3 is the lowest of the low-hanging fruit when it comes to toxic food dyes that the F.D.A. should be addressing.”
Beginning in 2027, companies would have to start removing the dye from their products. Imported foods would also have to lose the additive to be sold in the United States.
Although the dye is still used in hundreds of products, many companies have been switching to other food colorings, a move that accelerated after California in 2023 became the first state to ban Red 3 along with three other food additives that have been linked to disease. The dye has also been linked to health concerns for children.
In announcing the ban, the agency downplayed the risks to humans, saying that researchers had not found similar cancer risks in studies involving animals other than male rats. Claims that the use of Red Dye No. 3 “in food and in ingested drugs puts people at risk are not supported by the available scientific information,” Jim Jones, the F.D.A.’s deputy commissioner for human foods, said in a statement.
Sarah Gallo, senior vice president of product policy and federal affairs for the Consumer Brands Association, a trade group, said food and beverage companies would comply with the agency’s decision. “Revoking the authorized use of Red No. 3 is an example of the F.D.A. using its risk and science-based authority to review the safety of products in the marketplace,” she said.
First approved for use in food in 1907, Red Dye No. 3 was banned in cosmetics in 1990 by U.S. regulators. At the time, the F.D.A. cited an industry-conducted study that found that the chemical caused thyroid cancer in male rats but estimated that it might cause cancer in fewer than one in 100,000 people. Along with prohibiting the dye in cosmetics, the agency pledged to do the same with food.
Artificial dyes and food additives have been a primary target for Robert F. Kennedy Jr., President-elect Donald J. Trump’s pick for health secretary whose confirmation hearings before the Senate are set to begin soon.
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