HEALTH CANADA'S REPLY TO OUR 2ND LETTER ON E-CIGARETTES

See follow up at :
http://cagecanada.blogspot.com/2011/04/e-cigarettes-letter-to-health-canada-re.html

Health Canada’s reply to our 2^nd letter. Their analogy between pharma inhalers and electronic cigarettes namely the way in which the nicotine is absorbed hardly explains why inhaled conventional tobacco products are still lawful, or all energy drinks except for Red Bull that have not yet been approved by Health Canada remain on the shelves for people of all ages to consume. It is obvious that Health Canada is sending the message to all vapers that they should go back to smoking conventional tobacco products until such time as Health Canada gets around to testing the new e-cigarette technology, if ever! May we remind our readers that the only ones who profit from such policies are Big Pharma and Big Tobacco.

Thank you for your correspondence dated July 27,2009, in which you voice your concerns about the availability of electronic cigarettes in Canada. We apologise for the delay in our response.

Electornic smoking products that deliver nicotine are subject to the Food and Drugs Act whether or not they are associated with a smoking cessation claim.

Exemption (d) for nicotine under Schedule F., Part I, of the Food and Drug Regulations targets an inhalation device that differs from electronic smoking products like the electronic cigarette. Therefore, the 4 mg limit set in the exemption to Schedule F for the inhalation device does not apply to electronic cigarette. The nicotine delivered from the exempted inhalation device is deposited in the mouth and absorbed via the buccal membrane whereas the nicotine delivered by the electronic cigarette is delivered directly into the lungs. The absorption of nicotine via the pulmonary route is more complete and more rapid than via the buccal route would lead to a different pharmacokinetic profile. Greater and more rapid absorption of nicotine can lead to a greater risk of poisoning and addiction. In the absence of clinical data showing the pharmacokinetic profile of the substance administered under those conditions, the safety of nicotine inhalation from the electronic cigarette remains unknown.

Your suggestion that Health Canada stipulates recommendations and warnings about the product and guidelines as to what maximum nicotine levels per dose can be marketed would only apply after the safety, efficacy and quality of such a product has been demonstrated. This could only be done after Health Canada has assessed and successfully approved a submission for market authorization. The market authorization process for pharmaceutical products applies to all products in that category. For example, each of the four nicotine products currently exempted under certain conditions from Schedule F status (i.e., chewing gum, transdermal patch, inhalation device and lozenge) have been subject to this process prior to being granted market authorization.

Health Canada is committed to protecting the health of Canadians by ensuring that health products meet requirement for safety, efficacy and quality.

Yours, Truly,

Diana Dowthwaite

Director General