The Food and Drug Administration on Wednesday banned the use of Red Dye No. 3 in food, drink and medicine, more than three decades after synthetic coloring was first found to cause cancer in male lab rats.
The dye, a petroleum-based additive, has been used to give candy, soda and other products their vibrant red hue. Consumer advocates said the FDA’s decision to revoke the license was long overdue, given the agency’s decision in 1990 to ban the chemical from 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 great news and it’s long overdue,” said Melanie Benesh, vice president for government affairs at the Environmental Working Group, one of several organizations that called on 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 must address.”
From 2027, companies will have to start removing the dye from their products. Imported foods sold in the United States will also have to 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 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 in 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. The claims that the use of Red Paint No. 3 “in food and in drugs that are consumed puts people at risk are not supported by available scientific information,” Jim Jones, FDA’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 will comply with the agency’s decision. “The revocation of the authorized use of Red No. 3 is an example of the FDA using its risk-based and science-based authority to review the safety of products on the market,” he said.
A spokeswoman for the International Paint Manufacturers Association, however, said the group disagreed with the agency’s decision, arguing that “no credible safety concerns” related to the red No. 3 in food.
First approved for food use in 1907, Red Dye No. 3 was banned from cosmetics in 1990 by US regulators. At the time, the FDA cited a study conducted by industry that found the chemical caused thyroid cancer in male rats, but estimated it could cause cancer in fewer than one in 100,000 people. Along with banning the dye in cosmetics, the agency has pledged to do the same for 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 those derived from beets, red cabbage and insects, Red Dye No. 3 is still found in dozens of consumer products, including corn, yellow rice, mashed potatoes and children’s nutrition shakes. Consumers can find out if a product contains the dye in the U.S. Department of Agriculture’s branded food database and another created by the Environmental Working Group.
Some companies targeted by consumer groups have vowed to stop using Red 3. Just Born, the maker of Peeps, announced it would discontinue the coloring (in pink and lavender lines of the marshmallow treats) after Easter last year. Other companies have turned to Red Dye 40, including Mars’ use of it in some of its red M&Ms in the United States, according to ingredient lists on the company’s website. Some M&M’s list carmine or beet coloring instead of Red 40.
Artificial dyes and food additives have been a primary target for Robert F. Kennedy Jr., President-elect Donald J. Trump’s health secretary whose Senate confirmation hearings are set to begin soon.
Although health and consumer advocates praised the agency’s decision to ban Dye Red No. 3, said the decades-long delay highlighted systemic flaws in federal oversight of food additives.
Thomas Galligan, chief scientist for food additives and supplements at the Center for Science in the Public Interest, said the agency’s failure to act earlier was partly the result of industry opposition to a ban, but also reflected chronic underfunding of food safety to the FDA.
“The FDA has a history of allowing unsafe chemicals to remain in our food supply long after evidence of harm has emerged,” he said. “And part of the reason for that is that the agency doesn’t have a robust system for reevaluating the safety of chemicals that have already been approved.”
He added, “A large part of the blame also falls on Congress for failing to provide the authority and resources FDA needs to do its job of protecting the public health.”
According to the agency, more than 200,000 pounds of Red 3 were used in food and medicine in 2021. The center advises consumers to avoid all numbered dyes, including Yellow 5 and Red 40, which are both made from petroleum . These two are also banned in California.
Some studies have suggested a link between these dyes and changes in children’s behavior. Yellow 5 may cause itching and hives in some people who are hypersensitive 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 nutrition programs to more robustly address safety and health challenges in food and agriculture.
Brian Ronholm, director of food policy at Consumer Reports, who last year petitioned the FDA to ban Red Dye No. 3, said there are still many other chemical food additives in the country’s food supply.
“Many synthetic food dyes are allowed in food, but have not been tested for safety by the FDA for decades, despite recent studies that have linked the chemicals to serious health problems,” he said. “It’s time for the FDA to catch up with the latest science and remove these harmful chemicals from our food.”
