Press Releases

22.12.2015 US FDA GRAS status for 2′-Fucosyllactose produced by Jennewein Biotechnologie

Jennewein Biotechnologie’s conclusion that its 2’-Fucosyllactose is GRAS for use in infant formula and toddler nutrition is accepted by US FDA

Rheinbreitbach, Germany December 22nd, 2015: Jennewein Biotechnologie GmbH, today announces that it has received acknowledgement from the U.S. Food and Drug Administration (“FDA”) that it has no questions at this time regarding Jennewein’s conclusion that its biotechnological produced human milk oligosaccharide (HMO) 2’-Fucosyllactose is generally recognized as safe (“GRAS”) for use in Infant and Toddler nutrition. FDA based its notification (GRN 571) on information provided by Jennewein Biotechnologie as well as other information available to the FDA. Jennewein 2’-Fucosyllactose represents the very first HMO being produced by a bacterial fermentation process and entering the market in the US.

Besides the US FDA confirmed GRAS evaluation for use in Infant and Toddler nutrition; Jennewein Biotechnologie performed also two additional self-affirmed GRAS evaluation for its 2’-Fucosyllactose for us in General Nutrition and for us in Medical Nutrition and Dietary Supplements products.