June 12, 2012
CARTHAGE, Mo.Membrell® LLC received the natural product number (NPN) 80032238 from Health Canada for its JOINThealth Plus Antioxidants containing the ingredient, NEM® (Natural Eggshell Membrane).
All natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations, which came into force on January 1, 2004. These regulations state all NHPs must have a product license before they can be sold in Canada. To obtain a license, applicants must provide detailed information about the proposed finished product to Health Canada, including: medicinal ingredients, source, dose, potency, non medicinal ingredients and recommended uses. Health Canada then conducts a thorough assessment of the NHP to determine whether it is safe, effective and of high quality. The safety and efficacy of NHPs and their health claims must be supported by proper evidence (as determined by Health Canada). Once Health Canada has determined the NHP meets this burden of proof, a product license is issued to the applicant along with an eight-digit NPN, which must appear on the product label.
Membrells supplier of NEM, ESM Technologies, submitted a master file to the Natural Health Products Directorate (NHPD) of Health Canada in order to support the incorporation of NEM as a medicinal ingredient in Membrells JOINThealth product for sale in 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 This submission included all published and unpublished safety and efficacy studies, in vitro and in vivo supporting evidence, as well as history of use of the ingredient in people.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) cGMPs (current good manufacturing practices) in manufacturing, packaging, labeling or holding operations for dietary supplements, including independent, third-party cGMP certification by NSF International (held since 2009).
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