Food regulatory agencies in the United States have banned Red 3, a dye used in foods, beverages and medicines, after finding evidence that it causes cancer in mice.

On Wednesday, the Food and Drug Administration (FDA) banned the dye based on a 2022 petition by consumer advocacy groups against its use, which had already been banned in cosmetics for 35 years.

The US Food and Drug Administration said it took the action as a “legal issue” after studies showed the bright red dye caused cancer in laboratory mice. The agency said the decision was rooted in a law called the Delaney Clause, which requires the FDA to ban any additive that causes cancer in humans or animals.

The use of the dye in food has already been banned in Europe, Australia and New Zealand, except for certain types of maraschino cherries that are used in cocktails or desserts.

In 2011, a study by the European Food Safety Authority found no safety concerns due to minimal exposure levels to cherries containing erythrosine, known as E127 in Europe and Red 3 in the United States.

Here’s what we know about the dye and the FDA’s decision:

What is red pigment 3?

Known as FD&C Red No. 3 or Red 3 as erythrosine, is a petroleum-based additive used to give sweets and some cough syrups a cherry red color.

In 1990, the US Food and Drug Administration banned the use of the dye in cosmetics and non-oral medications, including pain-relieving creams, after a study showed it caused cancer when eaten by rats.

In 2022, several consumer organizations and scientists petitioned the FDA to ban all remaining uses of Red 3. In November 2024, nearly two dozen members of Congress sent a letter to FDA officials requesting that the dye be banned.

But the decision taken by the organization also comes amid US President-elect Donald Trump’s choice to lead the country’s health agency, Robert F. Kennedy Jr., calling for a ban on food additives and chemicals.

However, despite the backlash, Red 3 still appears in ingredients in popular snack foods and cakes in the United States, including Betty Crocker’s red icing and Brach’s candy corn candy.

What did the FDA say?

In a statement announcing the decision on Wednesday, the FDA said it was “taking action that would revoke the authorization for use of FD&C Red No. 3 in ingested foods and drugs.”

“Evidence suggests cancer in male laboratory mice exposed to high levels of FD&C Red No.3. More importantly, the way in which FD&C Red No. 3 Cancer in male rats does not occur in humans.”

However, the FDA cited Delaney’s condition as the reason behind deciding to ban the dye despite finding that the way it spreads cancer in mice does not apply to humans.

The provision, which the FDA said was used in 2018 to ban certain artificial flavors, “prohibits FDA authorization of a food additive or color additive if it is found to cause cancer in humans or animals.”

The organization said that manufacturers that use the dye in food will have until January 15, 2027 to reformulate their products.

For drug makers, products must be reformulated by January 18, 2028, to comply with the ban.

What did manufacturers and consumer groups say about the ban?

The National Confectioners Association of America, the leading trade organization for the $48 billion American confectionery industry, said in a statement following Wednesday’s announcement that it “will continue to follow and comply with FDA safety guidelines and standards.”

“Consumers and everyone in the food industry want and expect a strong FDA and a consistent, science-based national regulatory framework. We have said for years that the FDA is the legitimate national regulatory decision maker and leader in food safety.

The Center for Science in the Public Interest, which pushed a 2022 petition to ban RED-3, praised the FDA’s decision, saying the agency “finally addresses a decades-old regulatory failure.”

However, the International Color Manufacturers Association, which advocates for the safe use of natural and synthetic color additives, said that while the FDA “remains steadfast in its commitment to upholding the highest safety standards for color additives,” the amount of Red 3 consumed by carcinogenic mice should be taken into account. Consideration.

“Science has advanced significantly in the past three decades, and it is now a well-accepted principle that test animals fed additives at high concentrations may lead to an increased incidence of tumors, but this does not necessarily indicate that the same effects will be associated with humans.” “He said in a statement.

What other food additives could the Trump administration target?

Kennedy Jr., who is awaiting Senate confirmation to serve as Health and Human Services secretary, has already set his sights on banning additives and other foods.

In October, Kennedy called on cereal companies to “remove dyes from their foods.”

But his stance on seed oils, which include canola, soybean and sunflower oil, has come under significant criticism from nutritionists and scientists.

Kennedy claimed that Americans were “inadvertently poisoned” by seed oils, with beef being considered a better, 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 linked to better health.

He added that suggesting otherwise “only undermines the science.”