Cold-Fx was initially licensed by Health Canada on February 13, 2007 with the following claim: helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system. Details of the product's terms of market authorization can be found in the Licenced Natural Health Products Database at the following link: http://webprod3.hc-sc.gc.ca/lnhpd-bdpsnh/info.do?lang=eng&licence=80002849

It was brought to Health Canada's attention that the Market Authorization Holder for COLD-FX may be promoting their products using advertising claims that are not consistent with the current terms of market authorization (TMA) for this product.

The matter was reviewed and it was determined that the claim "Stops Cold or Flu in its tracks" is not in accordance with the TMA for Cold-Fx. As a result, Health Canada has contacted the company requesting corrective actions. It is expected the company will comply.

In 2000, Cold Fx was assigned a Drug Identification Number (DIN) by Health Canada's Therapeutic Products Directorate with an authorized claim of "Traditional Herbal Medicines for the relief of cough due to colds". That DIN has since been deactivated. A claim of 'immediate relief' was not authorized.

Cold-Fx licensed by Health Canada's Natural Health Products Directorate on February 13, 2007 with the following claim: helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system. Details of the product's terms of market authorization can be found in the Licenced Natural Health Products Database at the following link: http://webprod3.hc-sc.gc.ca/lnhpd-bdpsnh/info.do?lang=eng&licence=80002849

Since its authorization in 2007, 'helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system' remains the only approved claim assigned to this product.  

It is Health Canada's expectation that natural health products are sold in accordance with their Terms of Market Authorization. Any necessary changes to labels are expected within a reasonable period of time (e.g. the lesser of next label run or 12 months) if no risk to the health and safety of Canadians is identified. Product license holders should take the necessary steps to ensure compliance with these expectations.

The Presence of E-Faecium in a finished natural health product is unacceptable.

A complaint regarding fecal contamination prompted the sampling. A Health Canada laboratory performed a microbiological examination of several samples to determine whether they were non-compliant.

Six of the seven samples tested had lot numbers beginning with the number '08'.  The testing did identify low levels of bacteria in the samples, but the levels were within the approved specifications for non-sterile products such as these, and therefore did not pose a health risk.

It's important to note that had Health Canada identified a level or type of bacteria that would have caused a risk to the health and safety of Canadians, we would have taken immediate and appropriate action. The tests conducted by Health Canada are able to detect many different types of bacteria, neither Enterococcus faecalis nor Enterococcus faecium were isolated from any of the samples tested by Health Canada.

Based on currently available information, the presence of E. hermannii in a finished natural health product would be unacceptable

Our earlier language was perhaps too black and white and did not accurately convey the science behind acceptable levels
 
After laboratory assessments were conducted by Health Canada scientists of the product on the Canadian marketplace, a low level of the bacteria Escherichia hermannii was found.   Following a thorough assessment by Health Canada Scientists, it was determined that the level found presented the lowest risk to health and safety of Canadians and, as such, no recall was initiated.

It is important to note that all health products have benefits and risks.  When health products are found on the market that pose an unacceptable level of risk to health, Health Canada takes appropriate steps to mitigate and manage these risks.