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The FDA Just Approved a New Blue Food Dye. Is It an Allergen?

UNITED STATES, JUL 14 – The FDA approved gardenia blue to replace synthetic dyes as part of a health initiative, with about 40% of the food industry committed to phasing out petroleum-based colors, officials said.

  • On Monday, the U.S. FDA approved gardenia blue, a new natural food dye derived from gardenia fruit, for use in various beverages and candies.
  • This approval follows a broader FDA and HHS effort led by Secretary Robert F. Kennedy Jr. to phase out petroleum-based synthetic dyes, including urging a faster removal of Red Dye No. 40.
  • Gardenia blue is produced using soy protein hydrolysate, and the Gardenia Blue Interest Group has petitioned the FDA to exempt it from soy allergen labeling, claiming allergenic proteins are removed during manufacturing.
  • FDA Commissioner Marty Makary emphasized that the accelerated approval reflects a strong commitment to eliminate synthetic dyes from the food supply, while Kennedy highlighted that the decision demonstrates a renewed priority on protecting children's health.
  • This marks the fourth natural color additive FDA approved this year, and the actions suggest continued industry shifts and regulatory pressure to replace synthetic dyes with natural alternatives in U.S. foods.
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KBZK broke the news in on Monday, July 14, 2025.
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