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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.

This photograph from Oct. 14, 2015 shows FDA offices in Maryland.
The Food and Drug Administration seal is seen before the Health and Human Services Secretary Robert F. Kennedy Jr. news conference on the FDA's intent to phase out the use of petroleum-based synthetic dyes in the nation's food supply at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. The U.S. Food and Drug Administration has granted use the color gardenia (genipin) blue in various foods. Additionally, ice cream could also be shedding artificial food dyes in years to come. 
Health and Human Services Secretary Robert F. Kennedy Jr. speaks during a news conference on the FDA's intent to phase out the use of petroleum-based synthetic dyes in the nation's food supply at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. The U.S. Food and Drug Administration has granted use the color gardenia (genipin) blue in various foods. Additionally, ice cream could also be shedding artificial food dyes in years to come. 
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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.