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Monday, 5 October 2009

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 2nd 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

7 comments:

Anonymous said...

Rather nice site you've got here. Thanks for it. I like such topics and anything connected to them. I definitely want to read a bit more soon.

Anonymous said...

We need to band together and do something about this. This is totally unfair, even a child can recognize the deception involved here. Isn't there a way to take Health Canada to court or something like in the States with the FDA just recently being defeated by Njoy. I know the US value personal rights more and Canada is a communist country but this is so blatantly unethical it just stinks. Where are all the lawyers? Something needs to be done about this. Health Canada protecting Big Pharma and Big Tobacco makes me want to puke but there must be a way for people to fight these scumbags and their unjust policies. C'mon, it's been 2yrs already!

CaptainJimBob said...

If would be nice to know if anyone has tried getting authorization. They do say then have not authorized anyone but did not state anyone tried. Suppose after that would the makers of the e-cigarette have to apply or would it be the makers of the e-juice?

C.A.G.E. said...

Good question CaptainJIMBob, but I do believe a couple of distributors have asked for authorization. I don't know which ones. I believe the main problem resides in that such authorization is very costly because it is the distributors themselves that have to produce the evidence that they are harmless. It is also a very lengthy process, and in the meantime it condemns vapers to go back to smoking and takes away the choice to a safer alternative from smokers.

I am dealing with Health Canada only on the citizens' level. CAGE has no financial interest whatsoever in this matter. We are unable at this time to tell you what the dealings between Health Canada and the various manufacturers/distributors are. Plus I do believe that this would probably be confidential information that Health Canada would not be permitted to divulge to third parties such as ourselves.

Iro Cyr

Jossy said...

Quote HC "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."

How are tobacco products exempt from this distinction?

IMHO we need to make alot of noise over this issue and allow this product to come to Canadian markets. How do I get involved?

C.A.G.E. said...

Yes we need to make a lot of noise.

Write to Health Canada and get your family and friends to also sign your letter. Send it snail mail rather than e-mail. Registered is even better.

Speak to your G.P. about e-cigarettes. Educate him/her on what exactly they are and ask him to get involved to educate his peers and put pressure on Health Canada. Let them know that they are not more or less harmful than nicotine inhalers and much less harmful than tobacco cigarettes. Invite him/her to look them up if they don't believe you or better still have the documentation printed out for him/her.

If you can buy one take it everywhere with you. As long as it does not contain nicotine it is legal. Get people interested in them and especially hospitality industry owners who might just think it's a wonderful idea to attract back the smokers they lost due to the smoking bans. Carry a letter with you and have them sign it.

Cheers
Iro

C.A.G.E. said...

Have you read our latest letter to Health Canada at http://cagecanada.blogspot.com/2011/04/e-cigarettes-letter-to-health-canada-re.html

Iro