FDA Bans Use Of Red Dye No. 3 In Foods—What To Know About The Chemical

The Food and Drug Administration has announced it will ban the use of artificial food coloring Red No. 3, which has been linked to thyroid cancer in animals, after years of prodding by parents and health advocates, one state ban and action by dozens of other countries.

Three buckets of Dubble Bubble bubble gum.

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Key Facts

The FDA announced Wednesday it will ban the use of Red Dye No. 3 in food products and ingested drugs, decades after it was banned in cosmetics and externally applied drugs for its link to thyroid cancer in animals.

Manufacturers who use Red No. 3 in food or medications will have until Jan. 15, 2027 or Jan. 18, 2028, respectively, to reformulate their products, and the ban applies to all internationally made products imported into the U.S.

Red No. 3 or erythrosine, a color additive made from petroleum, could previously be used in foods in small amounts as approved by the FDA on a per-case basis.

The FDA has considered a petition to ban the additive since 2022 and, in that time, California became the first state to outlaw the sale of foods with Red No. 3, while lawmakers in 10 other states introduced legislation to do the same.

Even in its announcement of the ban, the FDA reiterated its position that the additive doesn’t necessarily put humans at risk, explaining the way the dye causes cancer in rats “does not occur in humans” and noting exposure levels for the dye are typically much lower in people than in the studied rodents.

Robert F. Kennedy Jr., President-elect Donald Trump’s pick for health secretary, has also vowed to crack down on the use of food dyes if he’s confirmed, claiming the dyes cause cancer and A.D.H.D. in children.

Red No. 3 is significantly more regulated in other parts of the world, including in the European Union, where it is only authorized for use in cocktail and candied cherries, and in Korea, where the use of most synthetic colors is prohibited in certain foods eaten mostly by children and teenagers.

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What Foods Have Red Dye 3?

Candy, fruit juice and other snack foods are the most common sources of the dye, which is still found in more than 2,800 items on American shelves. Products that have listed red 3 in recent years include some types of Fruit by the Foot, Dubble Bubble chewing gum, Entenmann’s Little Bites, Hostess’ Ding Dongs, Nestle strawberry milk, Jordan Almonds, Pez hard candies, Brach’s candy corn and some flavors of Ringpop, according to the the Environmental Working Group and the Center for Science in the Public Interest (one of the petitioners looking to ban the dye). Grocery store chains Albertson’s, Kroger, Meijer’s, Target and Walmart all use Red 3 in some of their house-brand products, and other items like Betty Crocker’s loaded mashed potatoes, Vigo saffron yellow rice and Don Pancho green and blue tortilla chips also list the dye as an ingredient.

What Medications Have Red Dye 3?

Some common medicines that contain Red No. 3 include Tylenol PM, gabapentin and doxycycline. Red No. 3 is also an inactive ingredient in the capsule shell of the popular A.D.H.D. drug Vyvanse.

What Are The Problems With Red No. 3?

Decades-old studies found that Red No. 3 causes cancer in laboratory animals, specifically thyroid cancer in rats, but the FDA has said those studies “have limited relevance to humans” because cancer isn’t caused in the same way in both species. There aren’t studies that show Red No. 3 causes thyroid cancer in humans. Other research has linked the additive to behavioral health issues, like attention deficit hyperactivity disorder, particularly in children. Clinical trials over the last two decades have shown that children who consumed juices containing food dyes experienced a small but significant increase in hyperactivity, but the link wasn’t considered strong enough for the FDA to require warning labels about their potential effects on children. In 2021, California state scientists and researchers from the University of California reviewed dozens of trials and came to a similar conclusion, that food dyes can interfere with normal behavior in some children.

Crucial Quote

“There’s a reasonable suspicion that food dyes may be harmful, at least for some kids,” Joel Nigg, a professor of psychiatry at Oregon Health and Science University, told The New York Times. “So why expose them to it?”

Big Number

215,780. That’s how many pounds of Red No. 3 was used in 2021 by the food and drug industries, according to the FDA.

Surprising Fact

On a body weight basis, children 2 to 5 years old consume about twice as much of the red dye through food as the general population, according to the FDA.

Key Background

The Food and Drug Administration banned red dye No. 3 for use in cosmetics and externally applied drugs in 1990 due to findings from unpublished animal research that linked the chemical to thyroid cancer, but it is still approved for use in food, ingestible drugs and dietary supplements. Any use of the dye has to be approved by the FDA, down to the specific batch added to foods. Companies are only allowed to use the additive from batches of the product that the agency has analyzed a sample of and found that it meets the requirements for safety and purity. Red No. 3 also has to be declared in the ingredient lists on all food labels containing the additive. In 2022, a host of health groups including the Center for Environmental Health, Environmental Defense Fund, Public Health Institute and Healthy Babies Bright Futures filed a petition with the FDA asking it revoke the right to use Red. No 3 in all foods and ingested drugs, calling the additive “unsafe.”

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