Supplement Regulations Processes in Canada and Silver Hydrosol's Classification as a Trace Element
In order to sell a natural health product in Canada, a product license application must be submitted to the Natural and Non-Prescription Health Products Directorate (NNHPD) to obtain a product license. The license is required by the Canadian NNHPD Regulations.
Sufficient data must be provided by the sponsor in the application for the NNHPD to assess the natural health product’s safety, quality and efficacy when used under its recommended conditions.
Applications for Argentyn 23® and Sovereign Silver were supported by technical evaluations of all specifications, including identity, composition, purity, quality, strength and stability, in addition to safety and efficacy demonstrated by results from human clinical studies. It took over 3 years for Health Canada to properly assess both products for safety* and efficacy*.
Health Canada, the Canadian Federal Health Agency, recognized Natural Immunogenics’ silver hydrosol’s safety* and efficacy* in 2012. The Risk Assessment division of Health Canada classified Argentyn 23 and Sovereign Silver in the Trace Element category, as “an element essential for the maintenance of good health.”
Sovereign Silver and Argentyn 23 were the first form of colloidal silver products approved for ingestion by any Federal agency in the world.