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Why the FDA banned the common food dye Red No. 3

Studies in rats link high exposure to cancer, but there’s little science on its harm to people 

A red gummy bear sits on a jumble of yellow, white and red gummy bears. The red color may be due to Red No. 3, a dye now banned by the FDA.

Some gummy and other candies get their bright color from the synthetic food dye Red No. 3, which the FDA has now banned.

mikroman6/Getty Images

By Meghan Rosen

The cherry-red synthetic dye Red No. 3 is no longer allowed in foods, drinks and drugs. 

On January 15, the U.S. Food and Drug Administration banned the dye, which is primarily used to color sweet treats like candy, cakes, cookies and baking decorations like rainbow sprinkles, as well as in certain ingested medications. Consumers today may also find Red No. 3 in other products, including sausage, tortilla chips and popcorn, according to a searchable U.S. Department of Agriculture database. 

The FDA’s announcement stems from a 2022 petition that cited studies linking high Red No. 3 exposure levels to cancer in rats. But the evidence that Red No. 3 is harmful is not clear-cut. Human exposure to the dye is typically far less than the amount used in the rat studies, for one. And other studies — performed in animals and humans — have not reproduced these results.

Claims that Red No. 3 in food puts people at risk “are not supported by the available scientific information,” the FDA said in its announcement. Legally, though, the FDA can’t authorize the use of food or color additives that cause cancer in humans or animals. That’s according to the Federal Food, Drug and Cosmetic Act’s Delaney Clause, which was enacted in 1960. 

The move follows California’s ban of Red No. 3 in 2023, and the state’s 2024 ban of six other synthetic dyes in foods served by the state’s public schools. Concern over those dyes’ potential tie to neurobehavioral issues in kids, not cancer, drove those policy changes. Though there, too, gold-standard evidence of a causal link is lacking, Amy Gilson, Deputy Director for External and Legislative Affairs at California’s Office of Environmental Health Hazard Assessment in Sacramento, told Science News in October. 

Even if the dyes pose zero risk to humans, they don’t bring much to the table beyond enticing colors. They’re not preservatives, and they have no nutritional value. 

Consumers should not expect to see grocery shelves purged of products with red dye any time soon. Food manufactures will have two years to come up with new Red No. 3–free products, while drug manufacturers have three years to comply. 

Citations

U.S. Food and Drug Administration. FDA to revoke authorization for the use of Red No. 3 in food and ingested drugs. Released January 15, 2025.

About Meghan Rosen

Meghan Rosen is a staff writer who reports on the life sciences for Science News. She earned a Ph.D. in biochemistry and molecular biology with an emphasis in biotechnology from the University of California, Davis, and later graduated from the science communication program at UC Santa Cruz.