Clinical Evidence Supporting the Efficacy of COLD-FX
COLD-FX’s safety and efficacy is supported by more than 10 clinical trials conducted at 8 universities and spanning 19 years of research. Published in 9 peer-reviewed medical journals including Pediatrics and The Canadian Medical Association Journal, these trials were conducted with approval from Health Canada and/or the FDA.
Four randomized, double-blind, placebo-controlled clinical trials (the gold standard of clinical evaluation) have evaluated COLD-FX for the prevention of acute upper respiratory tract infections. The results of these trials support COLD-FX’s safety and efficacy in helping reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system. It was the totality of this evidence that was evaluated by Health Canada in the licensing process, and which resulted in the granting of an NPN (product license for natural health products) to COLD-FX in 2007.
An Impeccable Record of Safe Use
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.
Afexa’s research-driven model led to the discovery, development, and successful commercialization of a number of natural health products, though some product-candidates have been unsuccessful at meeting our stringent criteria. Consequently, these have neither been released by the Company nor launched in the market. There is no relation between those product-candidates and our currently commercialized products. No product that failed to meet Health Canada regulations has ever been released for sale by the company.
Made in Canada
From its discovery in Alberta to its development in partnership with seven Canadian universities, COLD‑FX is made from North American ginseng, all of which is grown in North America and 90 percent of which is grown in Canada. None of the ginseng used to make COLD-FX is grown in China. All but one early step in COLD-FX's extensive manufacturing process take place in Canada, and all employ Canadian technology and expertise.
China has a historical and deep expertise in processing ginseng, handling 97 percent of the world supply, and it is for this reason that the extraction process occurs outside of Canada. After this step the material is returned to Canada for the remainder of the manufacturing process, including Quality Assurance testing against Health Canada-established criteria, and every stage of the process meets or exceeds all applicable Canadian manufacturing regulatory requirements. A total of 42 quality tests are conducted on each batch of COLD-FX.
Afexa Life Sciences is proud of COLD-FX's Canadian heritage, its impeccable safety profile, and its proven efficacy in helping to reduce the frequency, severity and duration of colds and flu by boosting the immune system.