rewrite this title The FDA Just Approved a New Blue Food Dye. Is It an Allergen?

This year, food dyes are being put under a microscope. Following the US Food and Drug Administration’s ban on Red Dye No. 3 in January, the administration has since approved three natural food dyes in its stead. Now, in addition to the FDA and Department of Health and Human Services asking food manufacturers to phase out all petroleum-based synthetic dyes from the US food supply, the FDA is asking these companies to fast-track getting rid of Red No. 3 before the 2027 deadline. To help this along, the administration just approved a new blue food dye. 

As the fourth color additive from natural sources approved by the FDA this year, gardenia (genipin) blue has been granted permission to be used in various foods. According to the administration, this blue dye comes from the fruit of the gardenia, a flowering evergreen. It can be used in hard and soft candy, sports drinks, ready-to-drink teas, flavored or enhanced noncarbonated water, and fruit drinks and ades. 

“This expedited timeline underscored our serious intent to transition away from petroleum-based synthetic dyes in the food supply,” said FDA Commissioner Marty Makary in a news release. “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.”

Gardenia (genipin) blue joins the red algae-based galdieria extract blue, butterfly pea flower extract and the white color calcium phosphate as 2025’s new and approved natural food color additives. 

Is gardenia (genipin) blue an allergen?

The FDA approved the use of gardenia (genipin) blue from a petition by the Gardenia Blue Interest Group. According to the FDA’s order, gardenia (genipin) blue is a dark purple or blue liquid made from the mature fruit of the Gardenia jasminoides Ellis plant with soy protein hydrolysate.

Now, you may be thinking: Isn’t soy an allergen? According to the GBIG, the soy protein allergens aren’t expected to be detected in the final color additive because “unreacted protein hydrolysate is removed during manufacturing.”

Because no soy protein allergens will be in the final product, the GBIG is asking to be exempt from food allergen labeling. The FDA is currently reviewing this petition.