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.

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Critics argue the cancer risk evidence is based on outdated studies with high dosages in rats, while industry groups warn reformulation could increase product costs.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