U.S. food regulators have banned the use of Red Dye 3, a dye used in food, drinks and drugs, over evidence it causes cancer in rats.

On Wednesday, the U.S. Food and Drug Administration (FDA) banned the dye, which was banned in cosmetics 35 years ago, based on a 2022 petition from consumer rights groups opposing its use.

The FDA said it had deemed the action a "legal matter" after studies showed the bright red dye caused cancer in laboratory rats. The agency said the decision stems from a regulation called the "Delaney Clause," which requires the FDA to ban any additive that causes cancer in humans or animals.

The dye has been banned from food use in Europe, Australia and New Zealand, except for certain types of black cherries used in cocktails or preserves.

In 2011, a study by the European Food Safety Authority found that because exposure levels in cherries containing erythrosine (known as E127 in Europe and Red 3 in the United States) were so low, there was no safety concern.

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

What is Red Dye 3?

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

In 1990, the FDA banned the use of the dye in cosmetics and non-oral drugs, including pain creams, after a study showed that eating the dye caused cancer in rats.

In 2022, several consumer groups and scientists petitioned the FDA to ultimately ban 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.

But the group's decision comes as U.S. President-elect Donald Trump chooses Robert F. Kennedy Jr. to lead the country's health agency, calling for a ban on food additives and chemicals.

However, despite the backlash, Red 3 continues to appear as an ingredient in popular American snack foods 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 action to revoke the authorization for use in food and ingested drugs" for FD&C Red No. 3.

"There is evidence that male laboratory rats exposed to high concentrations of FD&C Red No. 3 develop cancer. Importantly, FD&C Red No. 3 causes cancer in male rats in a manner that does not occur in humans," the statement added .

However, the FDA cited the Delaney provision as the reason for its decision to ban the dye, even though the way it was found to spread cancer in mice did not apply to humans.

The FDA said the provision, which was used in 2018 to ban certain synthetic flavors, "prohibits FDA from approving a food additive or color additive if it is found to induce cancer in humans or animals."

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

For drugmakers, they have until January 18, 2028 to reformulate their products to comply with the ban.

What do manufacturers and consumer groups have to say about the ban?

The American Confectioners Association, the $48 billion U.S. confectionery industry's leading trade group, said in a statement after Wednesday's announcement that it would "continue to follow and comply with FDA 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 been saying 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 for the 2022 petition to ban Red 3, applauded the FDA's decision, saying the agency has finally "addressed a decades-long problem of regulatory failures."

However, the International Color Manufacturers Association, which calls for the safe use of natural and synthetic color additives, said that while the FDA "remains firmly committed to maintaining the highest safety standards for color additives," consumption of Red 3 needs to be considered to cause cancer in rats.

"Science has progressed significantly over the past three decades and it is now a widely accepted principle that feeding test animals high concentrations of additives may increase the incidence of tumors, but this does not necessarily indicate that the same effects also occur. occurs in humans," it said in a statement.

What other food additives could the Trump administration target?

Robert F. Kennedy Jr., who is awaiting Senate confirmation to become health and human services secretary, has set his sights on banning other additives and food products.

In October, Kennedy called on cereal companies to "remove dyes from food."

But his stance on seed oils, including canola, soybean and sunflower oils, has been roundly criticized by nutritionists and scientists.

Kennedy claimed that Americans were "unknowingly being poisoned by seed oil" and that beef tallow was a better, healthier choice.

However, decades of research have linked seed oils to improved health, Christopher Gardner, a professor of medicine at Stanford University, told The New York Times.

Recommendations made otherwise "just undermine the science," he added.