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–(BUSINESS WIRE)–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.

“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

About 2’-Fucosyllactse

2’-Fucosyllactose represents the most abundant human milk
oligosaccharide (HMO). 2’-Fucosyllactose is however 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 offers protection against
infection by diarrhea-causing pathogens, attenuates inflammation, and
promotes brain development in terms of learning and memory. These
functional benefits underlie the great demand for 2’-Fucosyllactose as a
functional ingredient in infant formula and therapeutic nutrition
products. Thus far, the inclusion of 2’-Fucosyllactose into infant
formula or other nutrition products was limited due to the lack of a
scalable and cost effective production process.

About Jennewein Biotechnologie

Jennewein Biotechnologie is a leading company specializing in the
development of novel production processes and the production of scarce
functional monosaccharides and oligosaccharides for nutritional and
pharmaceutical applications. The company produces
human-milk-oligosaccharides for the use as functional food ingredients.


Further information can be found on the company website.


Jennewein Biotechnologie
Amélie Jennewein