United States food regulators have banned Red Dye 3, a dye used in food, beverages and medicine after it was shown to cause cancer in rats.
On Wednesday, the Food and Drug Administration (FDA) banned the dye based on a 2022 petition by consumer advocacy groups against its use, which was already banned in cosmetics 35 years ago.
The FDA said it took the action as a “legal matter” after studies showed the bright red dye caused cancer in lab rats. The decision, the agency said, was rooted in a statute called the Delaney Clause, which requires the FDA to ban any additive that causes cancer in humans or animals.
The dye is already banned for food use in Europe, Australia and New Zealand, with the exception of certain types of maraschino that are used in cocktails or candied.
In 2011, a study by the European Food Safety Agency found no concern about minimum exposure levels for cherries containing erythrosine, known as E127 in Europe and red 3 in the US.
Here’s what we know about the dye and the FDA decision:
What is red color 3?
Known as erythrosin, FD&C Red No. 3 or Red 3 is a petroleum-based color additive used to give candy and some cough syrups a cherry red color.
In 1990, the FDA banned the dye from use in cosmetics and non-oral drugs, including pain relief creams, after a study showed it caused cancer when eaten by rats.
In 2022, several consumer organizations and scientists petitioned the FDA to finally ban all remaining uses of Red 3. In November 2024, nearly two dozen members of Congress sent a letter to FDA officials requesting a ban on the dye.
But the decision by the organization also comes amid US President-elect Donald Trump’s choice to lead the nation’s health agency, Robert F. Kennedy Jr., calling for a ban on food additives and chemicals.
Yet despite the backlash, Red 3 continues to appear in the ingredients of popular American snacks and cakes, including Betty Crocker Red Decorating Icing and Brach’s Candy Corn candy.
What did the FDA say?
In a statement announcing Wednesday’s decision, the FDA said it is “taking actions that will revoke the approval for use of FD&C Order No. 3 in foods and ingestible drugs.”
“Evidence Shows Cancer in Male Laboratory Rats Exposed to High Levels of FD&C Red No.3. It is important that the way in which FD&C Order No. 3 causes cancer in male rats but does not occur in humans,” the statement added.
However, the FDA cited the Delaney Clause as the reason why the decision to ban the dye was made despite the discovery that the way it spreads cancer in rats does not apply to humans.
The clause, which the FDA said was used in 2018 to ban certain synthetic flavors, “prohibits FDA approval of a food additive or color additive if it is found to cause cancer in humans or animals.”
The organization said manufacturers who use the color in food will have until January 15, 2027 to reformulate their products.
For drug manufacturers, products must be reformulated by January 18, 2028 to comply with the ban.
What have producers and consumer groups said about the ban?
The National Confectioners Association, the leading trade organization for the $48 billion U.S. confectionery industry, said in a statement after Wednesday’s announcement that it “will continue to follow and adhere to FDA guidelines and safety standards.”
“Our consumers and everyone in the food industry want and expect a strong FDA and a consistent, science-based national regulatory framework. We’ve said for years that the FDA is the true national regulatory decision maker and leader in food safety.”
The Center for Science in the Public Interest, which pushed a petition to ban Red 3 in 2022, praised the FDA’s decision, saying the agency finally “addressed a decades-long regulatory failure.”
However, the International Paint Manufacturers Association, which urges the safe use of natural and synthetic paint additives, said while the FDA “remains unwavering in its commitment to maintaining the highest safety standards for paint additives,” the amount of Red 3 they consume should take into account that rats cause cancer.
“Science has advanced significantly over the past three decades and it is now a well-accepted principle that experimental animals fed high concentrations of additives can increase the incidence of tumors, but this does not necessarily mean that the same effects will apply to humans,” the statement said.
What other food additives might the Trump administration target?
Robert F. Kennedy Jr., who is awaiting Senate confirmation to take over as Health and Human Services secretary, has already moved to ban other additives and foods.
In October, Kennedy called on cereal companies to “get the colors out of their food.”
But his stance on seed oils, which include canola, soybean and sunflower oils, has come under significant criticism from nutritionists and scientists.
Kennedy argued that Americans were being “unknowingly poisoned” by seed oils, with beef tallow being a better and healthier option.
However, Christopher Gardner, a professor of medicine at Stanford University, told The New York Times that decades of research have proven that seed oils are associated with better health.
He added that suggesting otherwise “just undermines the science.”
