Jennewein Biotechnologie GmbH, Rheinbreitbach, Germany, 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 FDA. Jennewein 2’-Fucosyllactose represents the very first HMO being produced by a bacterial fermentation process entering the market in the U.S.
 
Besides the U.S. FDA confirmed GRAS evaluation for use in infant and toddler nutrition; Jennewein Biotechnologie also performed two additional self-affirmed GRAS evaluations for its 2’-Fucosyllactose for use in General Nutrition and for use in Medical Nutrition and Dietary Supplements products.
 
“Receiving this positive acknowledgement from FDA regarding our GRAS notification represents a major milestone for our many years of HMO research. Interestingly our processing aid use for the production, the bacterium Escherichia coli was originally isolated from the feces of a healthy breast fed infant in 1885 by the German pediatrician Theodor Escherich while seeking underlying causes for the much higher survival rates of breastfed compared to formula-fed infants at that time. This research not only led to the isolation of E. coli but also to the discovery of the human milk oligosaccharides (including 2’-Fucosyllactose) in human milk and the recognition of beneficial microorganisms (microbiota). Our research comes full circle by using the very same organism for the production of the first biotechnological produced commercial HMO for use in infant formula,” stated Stefan Jennewein.
 
2’-Fucosyllactose represents the most abundant human milk oligosaccharide (HMO). However, 2’-Fucosyllactose is lacking in cow’s milk and therefore also in current infant formula. Several beneficial function have been attributed to 2’-Fucosyllactose. Besides its prebiotic functions, 2’-Fucosyllactose is said to offer protection against infection by diarrhea-causing pathogens, attenuate inflammation, and promote brain development in terms of learning and memory. These functional benefits underlie the demand for 2’-Fucosyllactose as a functional ingredient in infant formula and therapeutic nutrition products. So far the inclusion of 2’-Fucosyllactose in infant formula or other nutrition products has been limited due to the lack of a scalable and cost effective production process.