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4mo ago

FDA Bans Red Dye No. 3 Over Cancer Concerns in Lab Rats

The federal prohibition, effective in 2027, follows decades of advocacy and aligns with California’s earlier ban on the synthetic additive.

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red cake on a plate
A boy holds a wrapped Dubble Bubble Bubble Gum candy in his hand, a product that uses Red Dye # 3, in this illustration photograph on December 27, 2024. The US Food and Drug Administration (FDA) on January 15, 2025 announced a ban on Red Dye No. 3, a controversial food coloring long known to cause cancer in animals, decades after scientific evidence first raised alarm. (Photo by ROBERTO SCHMIDT / AFP) (Photo by ROBERTO SCHMIDT/AFP via Getty Images)

Overview

  • Red Dye No. 3, a synthetic food coloring linked to cancer in male lab rats, will be banned in food, beverages, and ingested drugs by 2027 under FDA regulations.
  • The ban follows a 2022 petition from advocacy groups and builds on state-level actions, including California's 2023 prohibition of the dye and other additives.
  • The FDA cites the Delaney Clause, which prohibits additives found to cause cancer in humans or animals, as the basis for its decision to revoke the dye’s approval.
  • Critics argue the cancer risk evidence is based on outdated studies with high dosages in rats, while industry groups warn reformulation could increase product costs.
  • Advocates highlight broader concerns about synthetic dyes' potential neurobehavioral effects in children and call for stricter FDA oversight of all artificial food colorings.