FDA Approves Gardenia Blue Color Additive

The U.S. Food and Drug Administration (FDA) has granted Gardenia Blue Interest Group (GBIG)’s color additive petition to use the color gardenia (genipin) blue in various foods.

The approval comes after FDA and the Department of Health and Human Services (HHS) announced plans to work with the food industry on a voluntary basis to phase out petroleum-based synthetic dyes in April. At the time, the agency noted that it would fast-track the approval of natural alternatives to artificial colors, and has approved four natural color alternatives in that time: Gardenia, galdieria extract, calcium phosphate, and butterfly pea flower extract.

In the past few months, several CPG giants have committed to self-imposed deadlines to phase out all synthetic colors from their products. FDA’s own estimates are that about “40% of the nation’s food industry” committed to removing artificial colors.

“Every day, children are exposed to synthetic chemicals in food that serve no purpose and threaten their health,” said Robert F. Kennedy Jr., HHS secretary. “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 blue is derived from the fruit of the gardenia, a flowering evergreen. The color additive is approved 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, MD. “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.”

Under the Federal Food, Drug, and Cosmetic Act, color additives must be FDA-approved before they are used in foods. FDA determines whether a color additive is safe to use by considering projected human dietary exposure, the additive’s toxicological data, and other information like published literature.

FDA also announced today that it sent a letter to manufacturers encouraging a quicker phase-out of FD&C Red No. 3 in foods and dietary supplements. The current required deadline to do so is January 15, 2027.