Membrell LLC, maker of eggshell and eggshell membrane-derived products JOINThealth, JOINThealth Plus Antioxidants and BONEhealth, would like to announce the receipt of 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 promulgate that 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(s), dose, potency, non-medicinal ingredients and recommended use(s). 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) so that consumers can trust that the products they purchase are indeed safe and effective. Once Health Canada has determined that the NHP meets this high burden of proof, a product license is issued to the applicant along with an eight-digit Natural Product Number (NPN) which must appear on the product label.
Membrell’s supplier of NEM (Natural Eggshell Membrane), ESM Technologies, submitted a Master File to the Natural Health Products Directorate (NHPD) of Health Canada in order to support the incorporation of NEM (Natural Eggshell Membrane) as a medicinal ingredient in Membrell’s 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 This submission included all published and unpublished safety and efficacy studies, in vitro and in vivo supporting evidence, as well as history of use of the ingredient in people.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) – 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 to be adequate to support the safety and efficacy of NEM. Membrell’s JOINThealth Plus Antioxidants can now be offered to retail stores and pharmacies throughout Canada with the NPN, Health Canada approved uses, and confidence.
Rajiv Jagota with Primary Source, Membrell’s Canadian distributor, comments on the news, “We are excited about this very positive news. The ability to market and sell a product that helps with inflammation and offers unsurpassed anti-oxidant protection offers the consumer a true two-for-one product and gives us a huge therapeutic advantage in the marketplace”.