The Food and Drug Administration announced Wednesday that it has decided to revoke the approval of Red 3 to be added to foods because of concerns about the food dye’s link to cancer in laboratory animals.

FDA officials telegraphed the decision for months. While the agency has long said it does not believe there is evidence that Red 3 causes cancer in humans, officials said they were forced to do so by a law that requires the agency to remove additives that cause cancer in animals are.

“The Delaney Clause is clear: FDA cannot approve a food additive or color additive if it has been determined to cause cancer in humans or animals. There is evidence that in male laboratory rats, the high concentrations of FD&C Red No. 3 were exposed, cancer occurred,” he said. Jim Jones, the FDA’s deputy commissioner for human foods, referred to the law.

A post on the FDA’s website says that the use of Red 3 in food or drugs “puts people at risk, which is not supported by the available scientific information.”

According to databases from the U.S. Department of Agriculture and the nonprofit Environmental Working Group, as well as nutritional labels, hundreds of food brands, including products ranging from candy and fruit cups to snack chips and tomato sauce, contained Red 3 at some point disclosed by food companies.

Wednesday’s decision follows a petition filed in 2022 by the Center for Science in the Public Interest and a number of other groups calling for the additive to be removed from the market. Food brands have until January 2027 to stop using the dye.

The group has also pushed for California to ban the food dye, which is already banned from use in cosmetics, in 2023.

“The main purpose of food coloring is to make candy, drinks and other processed foods more attractive. If the function is purely aesthetic in nature, why should one accept the risk of cancer?” said Dr. Peter Lurie, president of the Center for Science in the Public Interest, in a statement.

While the group has highlighted Red 3’s link to cancer in its efforts to ban the additive, it is concerns about another health risk – the possibility that artificial food coloring could cause hyperactivity in children – that is driving opposition to it fueled by another dye called Red 40 used in many US foods.

An influential California Environmental Protection Agency review of studies of synthetic food dyes, including Red 3, concluded in 2021 that dyes “may affect the neurobehavior of some children.”

Which foods and drinks contain Red 3?

According to the International Association of Color Manufacturers, Red 3 has been approved by countries around the world for use in at least some foods under other names such as erythrosine or E 127. In Europe, Red 3 is only approved for use in cocktail cherries and candied cherries.

In the United States, Red 3 is used in some candies, including Jelly Belly’s Candy Corn, Tootsie’s Dubble Bubble, and Ring Pop’s Strawberry and Berry Blast flavors. Other foods also use Red 3, like Del Monte cherry blended fruit cups, MorningStar Farms vegetarian bacon strips, and Pillsbury’s birthday cake cookie dough.

Several drinks are also based on Red 3, including Consider’s creamy peach nutrition shake and Nesquik’s low-fat strawberry milk.

In a statement Wednesday, the candy industry committed to following FDA guidance and safety standards. Industry groups have called on the agency to tighten regulation of food additives, raising concerns that a vacuum created by FDA inaction could lead to a frustrating patchwork of state laws for national food brands.

“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 National Confections Association statement said.

Robert F. Kennedy Jr.President-elect Donald Trump’s pick to head the federal department that will oversee the FDA criticized the agency for failing to take action to curb the use of certain food additives.

Kennedy and his allies did it also required Tightening the FDA’s approach to regulating food additives, which critics have derided as a “loophole” allowing access to ingredients. This process differs from artificial colors like Red 3 and Red 40, which must overcome high hurdles to receive FDA approval and are carefully tested for purity before use on the market.