Almost 35 years ago, Red 3 was banned from cosmetics because of a potential cancer risk. Now, the US Food and Drug Administration (FDA) has finally banned it from food as well.

“The FDA cannot authorize a food additive or color additive if it has been found to cause cancer in humans or animals. Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No. 3,” said Jim Jones, the FDA’s deputy commissioner for human foods. 

It was already banned in Europe

Red Dye No. 3 (also called Erythrosine or simply Red 3) is a pink food dye derived from fluorone and iodine compounds. It’s been used in food, drugs, and industrial applications since its discovery in 1876. In the food industry, it colored candies, ice pops, cake-decorating gels, and even pistachio shells. Yes, even pistachio shells are sometimes dyed by distributors to hide imperfections.

A landmark study from 1990 found that this food coloring is linked to cancer in rats. Due to these concerns, European regulators have drastically reduced its use, almost banning it entirely. Since 1994, the European Food Safety Authority only allowed Red 3 in processed cherries and pet foods. It can also be used in some toothpastes but only up to 25 parts per million.

US regulators also took action, but only partially. In 1990, its use in cosmetics was completely banned in the US. But in foods, it was still allowed.

Granted, it’s not the most popular food coloring. The usual go-to red food coloring in the US is Allura Red AC (or Red 40). Still, Erythrosine was used in some candies, cakes, and gels. It was used, for instance, in Nesquik’s strawberry lowfat milk, Del Monte cherry mixed fruit cups, and Jelly Belly’s Candy Corn.

A petition led to the ban

In 2022, the FDA granted a petition filed by dozens of food safety and health advocates. These advocates urged the administration to revoke authorization for the substance, essentially banning it.

The FDA said that although the cancer effects have not been confirmed in humans, the effects on rats are reason enough to justify the ban.

“The FDA is taking action that will remove the authorization for the use of FD&C Red No. 3 in food and ingested drugs,” said Jim Jones, the FDA’s deputy commissioner for human foods. “Evidence shows cancer in laboratory male rats exposed to high levels of FD&C Red No.3. Importantly, the way that FD&C Red No. 3 causes cancer in male rats does not occur in humans.”

The ban does not take effect immediately. Food producers have until January 2027 to eliminate the coloring from their recipes. Food advocates praised the ban calling it a belated step in the right direction.

“This is a welcome, but long overdue, action from the FDA: removing the unsustainable double standard in which Red 3 was banned from lipstick but permitted in candy,” said Dr. Peter Lurie, director of the group Center for Science in the Public Interest, which led the petition effort.

“The primary purpose of food dyes is to make candy, drinks, and other processed foods more attractive. When the function is purely aesthetic, why accept any cancer risk?” Lurie, president of the Center for Science in the Public Interest, added in a statement. 

However, not everyone was thrilled.

There could still be a court case

At a hearing in December, FDA Commissioner Dr. Robert Califf argued that there’s a risk involved. Because the substance hasn’t been demonstrated to affect humans, it can be attacked in court.

“When we do ban something, it will go to court,” he told members of Congress on Dec. 5. “And if we don’t have the scientific evidence, we will lose in court.”

Ultimately, though, the FDA argued its decision using something called the Delaney Clause.

The Delaney Clause prohibits the approval of food additives shown to cause cancer in humans or animals, regardless of the exposure level. This clause is particularly relevant to Red Dye No. 3 because research has linked its high doses to thyroid tumors in rats.

Many of the products using the dye targeted children, who have a lower body mass. This makes children particularly at risk. In fact, although a connection to cancer hasn’t been demonstrated in humans, an influential review by California’s Environmental Protection Agency of studies on synthetic food dyes concluded in 2021 that colorants “can impact neurobehavior in some children.”

In a statement Wednesday, the candy industry pledged to respect the FDA decision and not contest it.

“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 FDA is the rightful national regulatory decision maker and leader in food safety,” said the National Confections Association’s statement.