Health Canada, the Canadian government regulatory agency, has approved wide-ranging new health claims for COLD-fX®, the most popular cold/flu remedy in Canada. After an extensive review, the Natural Health Products Directorate (NHPD) -- a division of Health Canada responsible for evaluating the safety, efficacy and quality of natural health products (NHPs) -- has issued COLD-fX with a much sought after license to sell to the public with specific science backed claims.
The comprehensive treatment claim for COLD-fX® approved by Health Canada states that the product "helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system." Comprehensive therapeutic claims require support by the highest level of scientific evidence: randomized, double-blind, placebo-controlled clinical trials.
"This is our strongest point of medical recognition to date, and coming from the government authority whose responsibility it is to help Canadians maintain and improve their health, this approval should give great confidence to consumers," said Dr. Jacqueline Shan, co-founder of CV Technologies, a University of Alberta spinoff company that developed COLD-fX.
Shan, who is also president, CEO and Chief Scientific Officer of CV Technologies added, "There are two novel therapeutic aspects to COLD-fX. First, COLD-fX is one of the very few medicines -- drugs or natural health products -- that Health Canada has approved for daily use as a preventative medicine. Second, COLD-fX can be taken to provide symptom relief for colds and flu."
Shan added that Health Canada reviewed all of CV Technologies published and unpublished data on COLD-fx before approving the claims.
The NHPD issues product licenses in several categories. Because COLD-fX® is a unique patented product, it was issued an NPN in the non-traditional category, which requires the highest level of scientific evidence. In contrast, claims with the term "traditional" are not based on scientific evidence and products in the "monograph" category have claims which are not supported by specific research on their particular product.
"There's no cure for the common cold," Dr. Shan stated. "So, in medicine the traditional strategy is if you can't treat the disease, you treat the symptoms. The COLD-fX strategy is to boost your immune system to help you avoid getting a cold or the flu in the first place, or if you do get one, to fight it more effectively."
The NHPD's safety review confirmed the safety profile of COLD-fX with no known side effects or drug interactions for generally healthy individuals.
Health Canada established new regulations effective Jan. 1, 2004, to monitor and manage the NHP industry. CV Technologies was the first company in Canada to launch and complete a trial under the new regulations. These regulations are being phased in over a six-year period as the NHPD reviews supporting safety, efficacy and quality information for all natural health products.
Although there are grey areas between the definitions of drugs and natural health products in general, the major distinction is that natural health products are derived from natural sources. Natural health products require the same degree of scientific evidence as drugs to support their claims. Natural health product regulations are also similar to drug regulations with requirements for standardized labeling, good manufacturing practices, and specification requirements for finished products and post-market surveillance for potential adverse effects.
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