ESM Technologies, the leading supplier of innovative, commercialized eggshell and eggshell membrane wellness ingredients, is excited to announce that products containing their flagship ingredient, NEM (Natural Eggshell Membrane), have been approved and granted licenses by Health Canada and have been issued Natural Product Numbers (NPNs).
“The issuance of an NPN for NEM product is a first step for ESM Technologies in the Canadian market place. The entire process of working with NHPD has been very educational and informative. Now that NEM products have received NPNs, we anticipate consumer access to such products to increase rapidly in the Canadian market. We feel professionals and consumers have been asking for a new joint health ingredient like NEM for many years. NEM is a complete joint health solution offering a smaller dose with faster and better results than other single-nutrient ingredients that have been in the market,” states Micah Osborne, president ESM Technologies.
In order to support the incorporation of NEM (Natural Eggshell Membrane) 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 This submission included all published and unpublished safety and efficacy studies, in vitro and in vivo supporting evidence, as well as history of use of the ingredient in people.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) – Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, including independent, third party cGMP certification by NSF International (held since 2009).
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 of 2012. Jim Bornhold, Vice-President Sales at CK Ingredients, ESM’s Canadian distribution partner, says “We are very pleased that NEM has been granted regulatory approval by Health Canada in a finished dosage format. Canadian natural health product regulations are among the most stringent in the world and receiving this license is a testament to NEM’s high level of scientific substantiation. Expect to see numerous high-profile launches in the Canadian market very shortly”. NEM can now be sold with Health Canada approved therapeutic claims permitted only in Canada.