/>i- On July 14, 2025, the U.S. Food and Drug Administration (FDA) announced its approval of the use of the color gardenia (genipin) blue in various foods and beverages at levels consistent with good manufacturing practices. Specifically, FDA has approved gardenia (genipin) blue for use in sports drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy. The color additive petition was submitted by the Gardenia Blue Interest Group (GBIG) in 2021.
- Gardenia (genipin) blue is derived from the fruit of Gardenia jasminoides Ellis, a flowering evergreen shrub. The additive is a dark purple or dark blue liquid or powder that is prepared through the polymerization of genipin with soy protein hydrolase. Because soy is considered a “major food allergen” under the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)), and it is used in the manufacturing process of gardenia (genipin) blue, the color additive requires allergen labeling (21 U.S.C. 343(w)(1)). On September 29, 2022, GBIG submitted a petition to FDA requesting an exemption from this labeling requirement. The petition is currently under review.
- The approval of gardenia (genipin) blue continues FDA’s efforts to provide more color additive options. FDA issued an order revoking the authorization of FD&C Red No. 3 in foods and dietary supplements on January 15, 2025, but gave manufacturers until January 15, 2027, to reformulate their products. On April 22, 2025, the U.S. Department of Health and Human Services (HHS) published an announcement requesting that food manufacturers remove FD&C Red No. 3 prior to the 2027 deadline. Now, following the approval of gardenia (genipin) blue and other colors derived from natural sources on May 9, 2025, FDA is asking food companies to stop using FD&C Red No. 3 in their products “as soon as practically possible.”
- Keller and Heckman will continue to post updates on new FDA color additive approvals.
FDA Approves New Natural Food Dye Derived from Gardenia Fruit
Thursday, July 24, 2025
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