Re: Concerned about Cold FX, Feb. 14
My name is Michael McDougall, and I’m the senior manager of media relations for Afexa Life Sciences.
We at Afexa co-operated fully with the producers of the show in question, and we are disappointed by the conclusions drawn. Afexa stands behind Cold-FX, the clinical trials establishing the safety and efficacy of the product in helping reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system, and the brand’s proud Canadian heritage.
Cold-FX is a proprietary blend of polysaccharides and oligosaccharides extracted from the root of North American ginseng. Just as willow bark won’t do much for a headache but the aspirin extracted from it certainly will, so it is with Cold-FX, which has been subjected to extensive clinical investigation to measure its effect on the immune system in general, and against colds and the flu specifically.
Cold-FX’s safety and efficacy are supported by more than 10 clinical trials conducted at eight universities and spanning 19 years of research. Published in nine 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. Specifically, among users of Cold-FX the trials found:
• a 25 per cent reduction in the average number of colds and flu
• a 56 per cent reduction in the number of recurrent colds and flu
• a 31 per cent reduction in the severity of symptoms
• a 35 per cent reduction in the duration of symptoms
• an 89 per cent reduction in relative risk of colds and flu among institutionalized seniors
• additional benefit when taken in combination with a flu shot
Regarding the manufacture of Cold-FX, one early step in the extensive process takes place in China because China has a historical and deep expertise in processing ginseng and handles 97 per cent of the world supply.
The facilities shown in the program are actually the plant’s loading dock. The production lines themselves are stainless steel, extremely sanitary and have been audited by Canadian authorities to ensure they meet all Health Canada criteria, as well as by NSF International to ensure Cold-FX is sufficiently free from contamination that even Olympic athletes, with all of the stringent restrictions on what they can consume, securely take Cold-FX every day. Photos of the production line at the facility shown in the program are posted on our website.
After this early stage, the material is returned to Canada for the remainder of the manufacturing process, including Quality Assurance testing against Health Canada-established criteria. 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.
Cold-FX does not contain fecal bacteria. In 2008, the company was experimenting with a liquid formulation of Cold-FX, and at the same time, the company was also contracting the manufacture of a placebo liquid, which contained no active ingredient, for use in a clinical trial. Both batches manufactured, including the placebo, failed testing for microbial content, indicating that the Active Pharmaceutical Ingredient — the Cold-FX powder, also referred to as CVT-E002 — was not the source of the contamination; our internal investigation indicates that the bottles themselves were the likely source. The manufacturing facility which produced both versions of the liquid only ever manufactured liquid formulations, so there was no opportunity for contamination of Cold-FX on store shelves. Testing by both Afexa Life Sciences and Health Canada concluded that Cold-FX continued to meet all applicable safety criteria, and to be safe for human consumption.
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.
Should you or your readers have any questions about this, please contact us at one of the many ways listed here.
Afexa Life Sciences