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25.11.2019 Jennewein Biotechnologie obtains US-FDA GRAS status on alternative 2’-fucosyllactose fermentation strain.

Nov. 25th. 2019, Jennewein Biotechnologie GmbH, Rheinbreitbach, the leading manufacturer of human milk oligosaccharides (HMOs), announces that the U.S. Food and Drug Administration (FDA) issued a “no question” response letter to Jennewein’s supplement of its GRAS Notice GRN571, thereby acknowledging that the HMO 2’-fucosyllactose, a key ingredient in advanced baby formula, made by an alternative bacterial production strain is also Generally Recognized As Safe (GRAS).

In its November 6., 2016 response to GRN 571, FDA had no question on the safety of 2’-fucosyllactose being produced by an Escherichia coli strain bearing a high temperature induced lactase activity to remove residual lactose from the manufacturing process. In their recent letter of November 08, 2019, FDA also had no question regarding the safety of 2’-fucosyllactose being produced by an E. coli strain that does not possess said high-temperature expressed lactase activity. The letter responding to the supplement to GRN571 will be publicly accessible at www.fda.gov/grasnoticeinventory.

The CEO of Jennewein Biotech, Stefan Jennewein, stated: “We are pleased by the FDA’s letter which provides Jennewein Biotech with an option to use different bacterial strains in manufacturing and offering 2’-fucosyllactose in the US, thereby securing supply of the US market with 2’-fucosyllactose at reasonable costs for our customers”.