Health Canada Approves ESM's NEM

CARTHAGE, Mo.ESM Technologies announced products containing its ingredient, NEM® (natural eggshell membrane), have been approved and granted licenses by Health Canada, and have been issued Natural Product Numbers (NPNs).

In order to support the incorporation of NEM as a medicinal ingredient in finished products for sale in Canada, ESM Technologies LLC submitted a master file to the Natural Health Products Directorate (NHPD) of Health Canada.  This submission included all published and unpublished safety and efficacy studies, in vitro and in vivo, supporting evidence, as well as history of use in people.  ESM also provided evidence that NEM  is of high quality in that it is manufactured following the strict quality standards defined in the U.S. Code of Federal Regulations (21 CFR Part 111) cGMPs (current good manufacturing practice) in manufacturing, packaging, labeling  and holding operations for dietary supplements, including independent, third-party cGMP certification by NSF International (held since 2009). Last year, a product that contains NEM was Certified for Sport® by NSF International.

NHPD deemed the evidence submitted by ESM to be adequate to support the quality, safety and efficacy of NEM and the first (stand alone) finished product incorporating NEM was granted a license in March 2012.  NEM can now be sold with Health Canada approved therapeutic claims permitted only in Canada.