United States food regulators have banned Red Dye 3, a dye used in foods, drinks and medicines, after finding evidence that it causes 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 based on a law 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 use in food in Europe, Australia and New Zealand, with the exception of certain types of maraschino cherries used in cocktails or candied.

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

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

What is Red Dye 3?

FD&C Red No. 3 or Red 3, known as erythrosine, is a petroleum-based coloring additive that gives candy and some cough syrups a cherry red color.

In 1990, the FDA banned the dye’s use 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 groups and scientists petitioned the FDA for a final ban on all remaining uses of Red 3. In November 2024, nearly two dozen members of Congress sent a letter to FDA officials calling for a ban on the dye.

However, the decision taken by the organization is also related to the decision of US President-elect Donald Trump to head the country’s health authority, Robert F. Kennedy Jr., who is calling for a ban on food additives and chemicals.

But despite the backlash, Red 3 still appears in the ingredients of popular U.S. snacks and cakes, including Betty Crocker’s Red Decorating Icing and Brach’s Candy Corn candies.

What did the FDA say?

In a statement announcing the decision on Wednesday, the FDA said it was taking “actions to authorize the use of FD&C Red No. 3 in food and medication taken”.

“There is evidence that male laboratory rats exposed to high concentrations of FD&C Red No.3 developed cancer. Importantly, the way FD&C Red #3 causes cancer in male rats does not occur in humans,” the statement continued.

However, the FDA cited the Delaney clause as a reason for the decision to ban the dye, even though it noted 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 has been determined to cause cancer in humans or animals.”

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

Drug manufacturers must reformulate their products by January 18, 2028 to comply with the ban.

What do manufacturers and consumer associations say about the ban?

The U.S. National Confectioners Association, the leading trade group for the $48 billion U.S. confectionery industry, said in a statement following Wednesday’s announcement that it will “continue to follow and comply with FDA’s guidance 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 have said for years that the FDA is the rightful national decision maker and leader on food safety.”

The Center for Science in the Public Interest, which spearheaded the petition to ban Red 3 in 2022, praised the FDA’s decision, saying the agency had finally “addressed decades of regulatory failure.”

However, the International Association of Color Manufacturers, which promotes the safe use of natural and synthetic color additives, said the amount of Red 3 used by rats must be considered to cause cancer.

“Science has made significant progress over the last three decades and it is now a generally accepted principle that laboratory animals given additives at high concentrations can lead to an increased incidence of tumors, but that does not necessarily mean that the The same effects also apply to humans,” it said in a statement.

What other food additives could a Trump administration target?

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

In October, Kennedy called on grain companies to “remove the dyes from their food.”

But his position on seed oils, which include canola, soybean and sunflower oil, has been heavily criticized by nutritionists and scientists.

Kennedy claimed that Americans had been “unknowingly poisoned by seed oils,” with beef tallow being 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 “just undermines the science.”