Claim on COLD-FX package: 'Recommended Dose for Immediate Relief'
Statements from Afexa Life Sciences, Inc. (former owner of COLD-FX) and
Health Canada regarding the claim, "Recommended Dose for Immediate
Relief":
Afexa Life Sciences Inc. (COLD-FX) statement (Dec. 7, 2011):
Regarding the claim of 'immediate relief':
Before Health Canada created the Natural Health Products Directorate to address NHPs specifically, Cold-FX was approved for sale in Canada with a Drug Identification Number (DIN) and with the claim of offering immediate relief. With the establishment of the NHPD in 2004, Natural Health Products were required to apply for a Natural Product Number (NPN) to take the place of either a DIN, in a few cases like ours, or the absence of regulatory approval in the case of many NHPs. Over the course of 34 months following its establishment, the NHPD assessed the body of clinical evidence supporting Cold-FX's efficacy, and in 2007 granted the product its NPN and approval to make the claim that "Cold-FX helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system."
At that time and in accordance with industry standards, the decision was made to run through all the existing packaging, before beginning to manufacture and subsequently roll out new packaging with the new claim.
Health Canada statement (Dec. 22, 2011):
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.
Note: CBC does not endorse and is not responsible for the content of external links.
Canada has the highest rate of hospital acquired infections in the developed world, and Canada's consumer watchdog wants to know why. Erica Johnson puts hospital cleanliness to the test, and finds a mess that is making you sick.
Going on vacation? Think travel health insurance is going to protect you if something goes wrong? Erica Johnson investigates.
In this special one-hour edition of 'Marketplace,' Tom Harrington tests the skills and ethics of home repair services.
Why are prescription eyeglasses so darned expensive? In an eye-opening report, Tom Harrington focuses in on the outrageously high price of spectacles.
Tom Harrington and the 'Marketplace' team go undercover, targeting the dubious promises of a job search agency.
Tom Harrington reveals the story of how, for many unwilling clients, Canada's largest lawn care company has become a more invasive pest than the ones they promise to get rid of.
Are all airline travel credits created equal? Erica Johnson investigates the credit policies of the top three Canadian airlines.
In this year's Top 10 countdown of Lousy Labels, Erica Johnson finds the truth behind the latest buzzwords on food packaging. It will make you think twice before filling up your shopping cart.
Are forest eco-labels worth the (toilet) paper they're printed on? Tom Harrington investigates.
'Marketplace' blows the roof off of one of Canada's worst landlords. Tom Harrington exposes renter horror stories, and asks: How can the company get away with this?
It's Canada's top-selling cold remedy, but does COLD-FX really do what the company claims? Erica Johnson puts it to the test. Also, what does Don Cherry have to say?
'Marketplace' launches our 39th season with a special one-hour episode that takes on Canada's major store chains.
'Marketplace' showcases its new season, and updates a story we first reported last year on the potential risk of popular birth control pills.
