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• Critics argue the cancer risk evidence is based on outdated studies with high dosages in rats, while industry groups warn reformulation could increase product costs.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.