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 sold in the United States would also have to remove the additive.
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.
A spokeswoman for the International Association of Color Manufacturers, though, said the group disagreed with the agency’s decision, arguing that “no credible safety concerns” related to Red No. 3 in food had been identified.
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.
It is already banned for food use in Europe, Australia and New Zealand, with a notable exception: maraschino cherries.
Although many food manufacturers have been embracing natural food coloring, including those extracted from beets, red cabbage and insects, Red Dye No. 3 is still found in scores of consumer products, like candy corn, yellow rice, mashed potatoes and children’s nutritional shakes. Consumers can find out whether a product contains the dye on the U.S. Department of Agriculture’s branded food database and another created by the Environmental Working Group.
Some companies targeted by consumer groups pledged to stop using Red 3. Just Born, the maker of Peeps, announced that it would discontinue the coloring (in pink and lavender rows of the marshmallow treats) after Easter last year. Other companies have switched to Red Dye 40, including Mars’s use of it in some of its red M&Ms in the United States, according to ingredient lists on the company website. Some M&M’s list carmine or beet coloring rather than Red 40.
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.
Even as health and consumer advocates praised the agency’s decision to ban Red Dye No. 3, they said the decades-long delay highlighted systemic flaws in federal oversight of food additives.
Thomas Galligan, the principal scientist for food additives and supplements at the Center for Science in the Public Interest, said the agency’s failure to act sooner was partly the result of industry opposition to a ban, but also reflected chronic underfunding of food safety at the F.D.A.
“The F.D.A. has a track record of allowing unsafe chemicals to linger in our food supply long after evidence of harm emerges,” he said. “And part of the reason for that is that the agency lacks a robust system for re-evaluating the safety of chemicals that have already approved.”
He added, “A big chunk of the blame also falls on Congress for failing to provide the authority and the resources the F.D.A. needs to do its job to protect public health.”
According to the organization, more than 200,000 pounds of Red 3 were used in food and drug products in 2021. The center advises consumers to avoid all numbered dyes, among them Yellow 5 and Red 40, which are both made from petroleum. Those two are also banned in California.
Some studies have suggested a link between these dyes to changes in children’s behavior. Yellow 5 may cause itching and hives in some people who are hypersensitive to color additives, according to the F.D.A.
The F.D.A. has acknowledged weaknesses in its oversight efforts. Last year, the agency announced a reorganization of its human food programs in order to more robustly address safety and health challenges in food and agriculture.
Brian Ronholm, director of food policy at Consumer Reports, which last year submitted a petition to the F.D.A. calling for a ban on Red Dye No. 3, said there were still scores of other chemical food additives in the nation’s food supply.
“Many synthetic food dyes are allowed in food but haven’t been reviewed for safety by the F.D.A. in decades despite recent studies that have linked the chemicals to serious health problems,” he said. “It’s time for the F.D.A. to catch up with the latest science and get these harmful chemicals out of our food.”
