This week, the U.S. Food and Drug Administration (FDA) announced the revocation of the approval for the artificial colorant Red No. 3, commonly found in various food products and medications. This decision came after a petition was filed in 2022 by the Center for Science in the Public Interest alongside other advocacy groups, citing cancer findings in animal studies. Red No. 3, derived from petroleum, has been linked to cancer development in laboratory rats.

Red No. 3 imparts a vibrant cherry-red color to products like candies, Maraschino cherries, and strawberry-flavored milk beverages, as well as in some over-the-counter cough syrups. Food and pharmaceutical companies are required to eliminate this dye from their products by January 15, 2027, and January 18, 2028, respectively.

Advocates for food safety have long pushed for the ban of Red No. 3 due to its potential carcinogenic effects in humans and evidence suggesting that similar artificial colorings could be linked to behavioral issues in children, such as attention deficit hyperactivity disorder (ADHD).

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Scientific American consulted with various experts to discuss the reasons behind the banishment of this red dye, the levels of exposure that might be harmful, and how it stacks up against other food dyes.

What is the name of the dye being banned?

The dye in question is officially known as Red No. 3.

In which products is it found?

Red No. 3 is present in various candies, fruit drinks, snack foods, Maraschino cherries, and strawberry-flavored milk. It is also an ingredient in some medicinal products like cough syrups.

Why is it being banned?

Laboratory studies showed male rats developed thyroid tumors after being exposed to high levels of Red No. 3. Although the FDA noted that the mechanism causing cancer in rats does not apply to humans, and human and other animal studies have not shown similar effects, the dye was prohibited under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. This law prevents the FDA from approving any food or color additive shown to cause cancer in humans or animals.

Other synthetic dyes, like Red No. 40, have also been implicated in contributing to hyperactivity in children.

What took the U.S. so long to prohibit this substance in foods?

Although the use of Red No. 3 has been banned in cosmetics and topical drugs since 1990, and the European Union restricted its use in food (except in cocktail cherries) since 1994, it took longer for the U.S. to act. In 2023, California also implemented a ban. According to Sheela Sathyanarayana, a professor at the University of Washington and Seattle Children’s Research Institute, the FDA has historically concentrated more on medications and infectious diseases like Escherichia coli, rather than on additives and environmental contaminants.

With the recent establishment of a new office for food chemical safety under the Biden administration, there is hope for more comprehensive assessments of various exposures, from food additives to environmental contaminants, Sathyanarayana noted.

How dangerous is consuming this dye?

Studies involving rats used dye dosages far exceeding typical human consumption, making it difficult to establish a harmful level for humans. Human studies are typically epidemiological and rely on recollections of diet, which can be unreliable.

Dr. Melinda Ring from Northwestern University’s Osher Center for Integrative Health suggests that the safe daily intake of Red No. 3 should not exceed 0.1 milligram per kilogram of body weight. She equates this to about 12 red gummy bears for a child and 36 for an adult, based on average concentrations. However, she advises that it might be healthier to avoid artificial dyes altogether due to the cumulative effect of toxin exposure.

Are other artificial dyes also harmful?

While Red No. 3 is one of the most heavily studied, other dyes like Red No. 40 have been linked to health risks, including behavioral disorders such as ADHD. With the ban on Red No. 3, it remains to be seen if the FDA will act against other similar dyes, according to Tracy Crane, an associate professor at the University of Miami’s Sylvester Comprehensive Cancer Center.

Is it wise to avoid foods with artificial dyes?

Generally, it is advisable to limit consumption of foods and medications containing artificial dyes. “I always advise moderation,” says Crane. “It’s better to avoid putting synthetic substances into your body. If it wasn’t made by nature that color, it’s likely synthetic.” There are safer natural alternatives, such as dyes derived from beets, carrots, or even insects.

Artificially colored foods often target children with their bright, attractive hues. “We need to shift our expectations of what food should look like,” Crane emphasizes.

Moreover, foods containing artificial dyes often have high sugar content. “For cancer prevention, it is advisable to consume less than 10 percent of calories from added sugars,” states Hannah Manella, a registered dietician at Northwestern Medicine.

Many of these products are also ultraprocessed, and some studies have associated such foods with various diseases and health issues. “Opting for whole, unprocessed foods or scrutinizing ingredient labels can help consumers minimize exposure to synthetic dyes and other environmental toxins while promoting a cleaner, safer food supply,” adds Dr. Ring.

*Editor’s Note (1/17/25): This sentence was updated post-publication to include Tracy Crane’s affiliation with the Sylvester Comprehensive Cancer Center.