In addition to chemical and immunological tests to ensure every batch of COLD-FX is effective, every batch is also tested to ensure the content is in accordance with all applicable Canadian regulations for natural health products. Afexa’s standards for Quality Assurance cover and exceed all standards established by the Natural Health Products Directorate branch of Health Canada. COLD-FX is manufactured in sanitary, controlled, and government-audited facilities, and submitted, in Canada, to further testing against our rigorous standards prior to being released for distribution. Only lots meeting Health Canada’s and Afexa Life Sciences’ very tight specifications relating to safety and clinical efficacy have ever been released. A total of 42 quality tests are conducted on each batch of COLD-FX.
As a company committed to research and development, Afexa has continually experimented with new therapeutics, formulations, and formats. In the development of a new liquid product in 2008, the Company discovered, through its rigorous testing and Quality Assurance processes, that the new formulation did not meet acceptable standards, so development was discontinued and the product-candidate destroyed. Through discussion with the Health Products and Food Branch Inspectorate, a series of independent tests of randomly sampled commercially available product found all
COLD-FX samples to be well within established standards and did not identify a risk to safety. No product that failed to meet Health Canada regulations has ever been released for sale by the company.