The Food and Drug Administration on Wednesday banned the use of red dye No. 3 in foods, drinks and drugs, more than three decades after the synthetic dye was 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 FDA’s decision to revoke the authorization was long overdue, given the agency’s decision in 1990 to ban the chemical’s use in cosmetics and topical medications.
Under federal rules, the FDA is prohibited from approving food additives that cause cancer in humans or animals.
“This is wonderful and long overdue news,” said Melanie Benesh, vice president for government affairs at the Environmental Working Group, one of several organizations that have petitioned the agency to take action on the additive. “Red dye 3 is the lowest hanging fruit when it comes to toxic food dyes that the FDA should address.”
Starting in 2027, companies will 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 switched to other food colors, 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 diseases. The dye has also been linked to health problems 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 foods and ingested drugs puts people at risk is not supported by available scientific information,” Jim Jones, FDA 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 will abide by the agency’s decision. “The revocation of the authorized use of Red No. 3 is an example of the FDA using its risk- and science-based authority to review the safety of products on the market,” he said.
First approved for use in foods in 1907, red dye no. 3 was banned in cosmetics in 1990 by US regulators. At the time, the FDA cited an industry-led study that found the chemical caused thyroid cancer in male rats, but estimated it could cause cancer in fewer than one in 100,000 people. In addition to banning dyes in cosmetics, the agency has pledged to do the same with foods.
Artificial colors and food additives have been a prime target for Robert F. Kennedy Jr., President-elect Donald J. Trump’s pick as health secretary, whose confirmation hearings before the Senate will begin soon.