FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice. It is the fourth color derived from natural sources approved by the FDA for use in foods in the last two months.

The FDA action is in line with U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr.’s priority to work with industry to phase out the use of all synthetic, petroleum-based dyes from the nation’s food supply as part of the administration’s broader effort to Make America Healthy Again.

Since Secretary Kennedy announced a series of measures in April to work with industry to phase out petroleum-based synthetic dyes in food, about 40 percent of the food industry has committed to a voluntary phase-out of such dyes.

“Every day, children are exposed to synthetic chemicals in food that serve no purpose and threaten their health,” Secretary Kennedy said. “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.”

Gardenia (genipin) blue is derived from the fruit of the gardenia, a flowering evergreen. The FDA has approved the color additive for use in sports drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, 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 FDA Commissioner Marty Makary, M.D., M.P.H. “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.”

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 shades including bright blues, intense purple, and natural greens.

Under section 721 of the Federal Food, Drug, and Cosmetic Act, color additives must be FDA-approved before they may be used in foods. The FDA determines whether a color additive is safe to use by considering the projected human dietary exposure to the color additive, the additive’s toxicological data, and other relevant information, such as published literature. Once the FDA approves a color additive, any manufacturer can use the coloring in accordance with the conditions of use.

In addition to approving a new color additive, the FDA also announced today that it had sent a letter to manufacturers encouraging them to accelerate the phase-out of FD&C Red No. 3 in foods, including dietary supplements, sooner than the January 15, 2027, required deadline. This earlier phase-out was another of the series of measures introduced by Secretary Kennedy in April.

“The FDA believes that accelerating the phase out of the use of FD&C Red No. 3 in foods will help further the goal of Making America Healthy Again,” the FDA said in the letter.

On Friday, July 11, Consumer Brands—a national trade association for manufacturers of consumer packaged goods—announced their voluntary commitment to encourage the makers of America’s food and beverage products to remove certified Food, Drug & Cosmetic (FD&C) colors from products served in schools nationwide by the start of the 2026–2027 school year.

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