The Food and Drug Administration on Wednesday banned the use of red dye No. 3 in food, drinks and drugs, more than three decades after the synthetic dye was first discovered to cause cancer in male laboratory rats.
The dye, a petroleum-based additive, has been used to give candies, sodas and other products their vibrant cherry-red hue. Consumer advocates said the FDA's decision to revoke the authorization is long overdue, given the agency's decision in 1990 to ban the chemical for 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 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 FDA should address.”
From 2027, companies should start removing the dye from their products. Imported foods sold in the United States should also remove the additive.
Although the dye is still used in hundreds of products, many companies have turned to other food dyes, a move that accelerated after California became the first state to ban Red 3 in 2023, 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 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 medications endangers people are not supported by the available scientific information,” Jim Jones, the FDA's deputy commissioner for human nutrition, 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 how the FDA is using its risk- and science-based authority to assess the safety of products in the marketplace,” she said.
However, a spokeswoman for the International Association of Color Manufacturers said the group disagreed with the agency's decision, arguing that “no credible safety concerns” had been identified regarding Red No. 3 in food.
Red dye No. 3 was first approved for use in food in 1907 and was banned in cosmetics by U.S. regulators in 1990. At the time, the FDA cited an industry-conducted 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 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 one notable exception: maraschino cherries.
Although many food manufacturers have embraced natural food dyes, including dyes extracted from beets, red cabbage and insects, Red Dye No. 3 is still found in many consumer products, such as candy corn, yellow rice, mashed potatoes and children's nutritional shakes. Consumers can find out whether a product contains the dye in the U.S. Department of Agriculture's 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 it would stop coloring (in pink and lavender rows of the marshmallow treats). Other companies have switched to Red Dye 40, including Mars' use in some of its red M&Ms in the United States, according to ingredient lists on the company's website. Some M&Ms list carmine or beet coloring instead of Red 40.
Artificial dyes and food additives have been a major target for President-elect Donald J. Trump's Robert F. Kennedy Jr. as health secretary, whose Senate confirmation hearings are set to begin soon.
Even as health and consumer advocates challenged the agency's decision to ban Red Dye No. 3, they said the decades-long delay exposed systemic deficiencies in federal oversight of food additives.
Thomas Galligan, the chief scientist on food additives and supplements at the Center for Science in the Public Interest, said the agency's inability to act sooner was partly the result of industry resistance to a ban, but also reflected the chronic underfunding of food safety at the FDA.
“The FDA has a track record of allowing unsafe chemicals into our food supply long after there is evidence of harm,” he said. “And part of the reason for that is that the agency lacks a robust system for reevaluating the safety of chemicals that have already been approved.”
He added: “Much of the blame also lies with Congress for failing to provide the authority and resources the FDA needs to do its job to protect public health.”
According to the organization, more than 200,000 pounds of Red 3 was used in food and medicine in 2021. The center advises consumers to avoid all numbered dyes, including Yellow 5 and Red 40, both of which are made from petroleum. Those two are also banned in California.
Some research has suggested a link between these dyes and changes in children's behavior. Yellow 5 may cause itching and hives in some people who are sensitive to color additives, according to the FDA
The FDA has acknowledged weaknesses in its oversight efforts. Last year, the agency announced a reorganization of its human food programs to more forcefully address safety and health challenges in food and agriculture.
Brian Ronholm, director of food policy at Consumer Reports, who last year filed a petition with the FDA calling for a ban on Red Dye No. 3, said dozens of other chemical food additives remain in the nation's food supply.
“Many synthetic food dyes are allowed in food, but have not been evaluated for safety by the FDA in decades, despite recent studies linking the chemicals to serious health problems,” he said. “It's time for the FDA to keep up with the latest science and get these harmful chemicals out of our food.”
