Health Canada approves Cold-fX claims
Health Canada will allow the manufacturers of the patented natural remedy Cold-fX to claim it is proven to reduce cold and flu symptoms by boosting the immune system.
Edmonton-based CV Technologies Inc. announced Thursday the federal government has approved wide-ranging new health claims for Cold-fX, which the company says is the first treatment of its kind and a top seller among cold and flu remedies.
Shares in the company roared ahead $1.08 or59 per cent to close at $2.90Thursday on the Toronto Stock Exchange.
Cold-fX has been endorsed by several physicians and some high-profile athletes, including Olympian Clara Hughes, the National Hockey League and the league's players' association.
The federally approved treatment claim for the product, which now has a licence and natural product number, states Cold-fX "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.
Jacqueline Shan, president and CEO of CV Technologies, said in a statement that the product, which has undergone more than 10 years of research and seven clinical trials, should attract interest from the medical community.
Because Cold-fX is a patented product, it was issued a natural product number 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 that are not supported by specific research on their particular product.
The government safety review confirmed the safety profile of Cold-fX with no known side effects or drug interactions for generally healthy individuals. This is very rare as most approved medicines, including over-the-counter cough and cold products, are associated with some adverse side effects.
Health Canada established new regulations effective Jan. 1, 2004, to monitor and manage the natural health products industry. The new rules are being phased in over six years.