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

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".

About HMOs:

Human milk oligosaccharides (HMOs) are complex sugar molecules that are only present in breast milk. Excluding water, they are the third most abundant constituent of human milk after fats and lactose. More than 200 structurally different HMOs have been identified.

The most abundant HMO is 2′-fucosyllactose, which is produced by about 80% of all lactating mothers at concentrations of up to 3 g/L. Scientific studies have shown that HMOs, and 2′ fucosyllactose in particular, have a positive impact on infant development. HMOs are prebiotic, i.e. they specifically promote the growth of beneficial microorganisms, and at the same time they inhibit the growth of pathogens by directly and indirectly preventing colonisation. Jennewein Biotechnologie launched 2′-fucosyllactose onto the global baby food market in 2015, and several infant milk formula around the world now contain 2′-fucosyllactose.

About Jennewein Biotechnologie:

Jennewein Biotechnologie is a leading international industrial biotechnology company with a range of products in the field of human milk oligosaccharides (HMOs) and rare monosaccharides such as L-Fucose and Sialic acid. The company manufactures an extensive portfolio of innovative HMO products, such as 2′ fucosyllactose, 3′-fucosyllactose, Lacto-N-neotetraose, and lacto-N-tetraose. These rare sugars are used in the food industry (particularly infant milk formulas), the pharmaceutical industry, and the cosmetic industry. The manufacturing process involves state-of-the-art fermentation techniques. In 2015, the US Food and Drug Administration (FDA) granted Jennewein Biotechnologie a license to market 2′-fucosyllactose in the USA. This was followed in 2017 by European Union marketing authorisation under the Novel Food Regulation.