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FDA Approves Gardenia Blue, Urges Accelerated Red No. 3 Phase-Out

The authorization marks a key step in replacing synthetic dyes with natural alternatives ahead of a 2027 ban.

Overview

  • The FDA cleared gardenia (genipin) blue for use at good manufacturing practice levels in sports drinks, flavored and enhanced noncarbonated waters, fruit beverages, ready-to-drink teas and hard and soft candies.
  • In a letter to manufacturers, the agency called for an expedited retirement of petroleum-based Red No. 3 well before its January 2027 deadline.
  • Consumer Brands Association has vowed to remove synthetic dyes from school products by the 2026-2027 academic year, and the International Dairy Foods Association is expected to eliminate artificial colorings from dairy items by the end of 2027.
  • The FDA is reviewing a petition from the Gardenia Blue Interest Group to exempt gardenia blue from soy allergen labeling on the basis that soy protein hydrolysate is undetectable in the final additive.
  • Since April’s initiative under the HHS “Make America Healthy Again” framework, about 40 percent of food manufacturers have pledged to phase out petroleum-based synthetic dyes.