Is Red Dye 3 banned?

Countries where Red Dye 3 is banned or restricted

Why Red Dye 3 is flagged

The FDA revoked Red Dye 3 authorization in January 2025, marking the first synthetic food dye ban by the FDA since Red Dye 2 in 1976. The revocation was triggered by the Delaney Clause, which mandates revocation of any food additive found to cause cancer in animals regardless of dose. The carcinogenicity data stems from studies showing that high doses of erythrosine caused thyroid follicular cell tumors in male rats. The mechanism is indirect: erythrosine suppresses thyroid-stimulating hormone (TSH) feedback by elevating thyroxine (T4) levels, causing chronic TSH suppression that promotes thyroid cell proliferation and ultimately tumor formation. This is a rat-specific mechanism related to their thyroxine-binding protein system, which differs from human biology. EFSA's 2011 comprehensive safety assessment concluded erythrosine was unlikely to be genotoxic at typical food use levels and set an ADI of 0.1 mg/kg body weight — one of the lowest for any food color. EFSA restricted EU use to cocktail cherries only (max 200 mg/kg). The high iodine content (58% by weight) raises concerns for thyroid-sensitive individuals. Excessive erythrosine intake could theoretically contribute to iodine overload and thyroid disruption, particularly in individuals with hyperthyroidism or Hashimoto's disease. The FDA had been aware of the rat thyroid tumor data since 1990 but delayed action for 35 years. Advocacy groups including CSPI petitioned for a ban since 1983. The January 2025 revocation finally addressed this long-standing regulatory gap.