FDA issues GRAS no objection letter for SweeGen’s Bestevia Reb D stevia leaf sweetener

California-based SweeGen has received a GRAS no objections letter from the FDA for the use of its Bestevia branded Reb-D - manufactured from stevia leaf extracts converted to Reb D using enzymes – for use as a general purpose sweetener for food and beverage applications in the US.

The announcement follows a tie up with ingredients giant Ingredion, which recently became the exclusive global distributor of Sweegen’s stevia-based sweeteners in all markets except China (where it is a non-exclusive distributor).

According to the GRAS notification GRN 715 submitted by Sweegen affiliate Blue California, “The multi-step biosynthesis pathway process to manufacture BESTEVIA Rebaudioside D 95% uses enzymes produced by a strain of Pichia pastoris yeast that contains uridine 5'-diphosphouridine-glucosyltransferase (UGT) enzymes that facilitate the transfer of glucose to small molecules via a glycosidic bond.”

Unlike Cargill’s EverSweet product, which is made using a genetically engineered strain of yeast that converts sugars to the steviol glycosides Reb D+M, the SweeGen process begins with stevia leaf extracts, and then uses enzymes from a genetically engineered yeast to convert them to Reb D, one of the most 'sugar-like' tasting steviol glycosides (the components of the stevia leaf that make it sweet).

In a letter from the FDA dated October 24, 2017, the agency said it had reviewed the application and has no further questions regarding the safety of Bestevia Reb-D.

"Having received the No Objection Letter from the FDA, SweeGen and our valued distribution partner Ingredion are now able to support food and beverage manufacturers in the U.S. as they work to meet consumer demand for reduced- and no-sugar products made with our new, high-purity, great-tasting stevia sweetener,” said Katharina Pueller, director, natural sweetener business of SweeGen.