FDA approves new blue food dye from gardenia fruit amid health concerns

On July 14, 2025, the U.S. Food and Drug Administration approved a new blue color additive for use in various food products, including sports drinks, flavored water, fruit juices, teas, and candies. This blue dye is derived from the gardenia fruit, a flowering evergreen, utilizing a compound called genipin which is refined and reacted with soy protein hydrolysate. The approval marks the fourth natural color derived from plant sources authorized by the FDA in just two months, following approvals of other natural color extracts such as galdieria extract and butterfly pea flower extract. The Gardenia Blue Interest Group petitioned the FDA for this approval, advocating for the use of natural additives over synthetic alternatives. The organization claims the soy protein used in producing the dye is not expected to be detectable in the final product and should not necessitate labeling as an allergen. The FDA is still reviewing this request despite potential health concerns regarding soy, especially since it is a common allergen. Health Secretary Robert F. Kennedy Jr. highlighted that many children are exposed to synthetic chemicals in food products, which he claims serve no beneficial purpose and could be harmful. He expressed hope that the FDA’s decision reflects a commitment to prioritize children’s health. Additionally, Kennedy has previously called for the removal of artificial dyes from food products, supporting a shift towards natural alternatives to promote a healthier food supply in America. In related developments, the FDA sent a letter to manufacturers suggesting they accelerate the phase-out of Red No. 3, a dye associated with cancer in animal studies, which is mandated for elimination by January 15, 2027. This aligns with efforts initiated months earlier by Kennedy and the FDA to reduce reliance on petroleum-based synthetic dyes in food. As efforts to replace synthetic dyes proliferate among major food manufacturers, some companies like Kraft Heinz and General Mills are on track to eliminate these additives, while others, including Mars, have resisted fully abandoning synthetic colors in their products. The current debate surrounding artificial vs. natural food colorings highlights differing perspectives on food safety and consumer trust as the industry evolves.