After decades of warnings, the FDA announced Wednesday that Red 3, a synthetic dye linked to cancer in lab animals, will be banned from the U.S. food supply. The decision follows a 2022 petition from food safety advocates and pressure from lawmakers, citing the Delaney Clause, which requires the FDA to ban additives found to cause cancer in people or animals.
Red 3, also known as erythrosine or FD&C Red No. 3, is used in foods like snack cakes, candies, maraschino cherries, and oral medicines. Although the FDA banned it from cosmetics in 1990 due to cancer concerns in lab rats, it remained approved for food and ingested drugs. Under the new rules, manufacturers must remove Red 3 from foods by January 2027 and from oral medicines by January 2028.
“This is a welcome, but long overdue, action from the FDA,” said Dr. Peter Lurie, director of the Center for Science in the Public Interest. “The double standard allowing Red 3 in food but not in lipstick has finally been corrected.”
The International Association of Color Manufacturers defends the dye, citing studies by the UN and WHO affirming its safety at typical consumption levels. Still, consumer advocates argue that removing the dye is crucial, especially for children who consume higher amounts of Red 3 relative to their body weight.
Red 3 is already banned in Europe, Australia, and New Zealand (except for some cherries) and will also be prohibited in California starting January 2027. Many food manufacturers have started reformulating products using natural alternatives like beet juice, carmine (insect-based dye), and pigments from vegetables like purple sweet potatoes and radishes.
While no illnesses have been reported from Red 3, the FDA emphasized its legal obligation under the Delaney Clause. “Evidence shows cancer in lab rats exposed to high levels of FD&C Red No. 3,” said Jim Jones, the FDA’s deputy commissioner for human foods. “While this mechanism doesn’t apply to humans, the law requires us to act.”
