The Food and Drug Administration (FDA) announced Monday afternoon that it has approved a new blue color additive, gardenia blue.
Gardenia (genipin) blue is derived from the crushed fruit of the gardenia, a flowering evergreen. The color additive is often used in traditional Chinese medicine, as it becomes blue by reacting with soy protein hydrolysate.
Though soy is used to make gardenia blue, the Gardenia Blue Interest Group has asked the FDA to exempt the additive from being declared a potential allergen. In their request, the interest group says that the soy protein is not detectable in the final color additive and therefore will not cause allergic reactions. The FDA says it is still reviewing the request.
FDA Commissioner Dr. Marty Makary has approved the color additive for use in sports drinks, flavored or enhanced non-carbonated water, fruit drinks, ready-to-drink teas, hard candy, and soft candy.
“This expedited timeline underscored our serious intent to transition away from petroleum-based synthetic dyes in the food supply," said Dr. Makary. “Now, by expanding the palette of available colors derived from natural sources, food manufacturers have a variety of options available that will make it easier to end their use of petroleum-based dyes.”
🚨NEW — Gardenia Blue has been approved as the 4th natural food dye to replace replace synthetic, petroleum-based dyes!
— Townhall.com (@townhallcom) July 14, 2025
"Today I am announcing the FDA is improving gardenia blue as a natural food dye with natural ingredients."
MAHA! pic.twitter.com/7m2BrIKRnV
Gardenia blue is the fourth color derived from natural sources to be approved for use in foods by the FDA in the last two months. The three colors derived from natural sources approved in May were: galdieria extract blue, a blue colorant derived from the unicellular red algae Galdieria sulphuraria; calcium phosphate, a white powder; and butterfly pea flower extract, a blue color that can be used to achieve a range of blue, purple, and green shades.
These color additives have been approved as the Trump administration implements the "Make America Healthy Again" initiative, which seeks to phase out all synthetic, petroleum-based dyes from the nation’s food supply.
“Every day, children are exposed to synthetic chemicals in food that serve no purpose and threaten their health,” said Secretary Kennedy. “The FDA’s approval of gardenia blue shows we’re finally putting kids first. Thanks to Dr. Marty Makary’s bold leadership, we’re cutting through industry influence and taking decisive action to Make America Healthy Again.”
About 40 percent of the American food industry has committed to voluntarily phasing out such dyes, according to the Food and Drug Administration. In addition to the new color additive, the FDA also announced that it sent a letter to manufacturers, encouraging them to phase out usage of FD&C Red No. 3 before the required deadline in 2027.