Thursday 22 January 2015

Canadian Vendors VS Health Canada





Dear Health Canada,

Letters from your department with the subject “Stop Sale and Advertisement of Electronic Smoking Products which contain prescription drug Nicotine”, with a statement that they pose a health risk to Canadians have been sent out to many Canadian Vendors.

It appears that your department has been misinformed about the nature of Vapor products. Electronic cigarettes contain the word “Cigarette” for commercial purposes. Theyare not smoking products, do not produce or emit smoke, involve combustion, nor utilize tobacco. These are also not medical products, as mentioned in your letter.

Your letter emphasizes this incorrect information where you state “A search in the drug product database, ...does not provide a listing for electronic cigarette products,” together with mention of requirements to obtain market authorization and licensing for the sale of drug products and medical equipment.

Canadian Vendors accept and acknowledge that Health Canada has jurisdiction over health products and that health products require market authorization. If Vendors sold such a health product they would seek such an authorization.

Their products are electronic-cigarettes (personal vaporizers). These have no therapeutic or medicinal purpose – either in practise or in any claims made by Vendors for any part of the product. These are recreational devices that function as an alternative to smoking tobacco cigarettes, sold and marketed to adult smokers. They are not cessation products nor do Vendors misrepresent these products as such or make any claims indicating any effect on the health of users.
These products are simply an alternative to smoking that doesn’t involve smoke, tobacco or similarities to smoking products.

Vendors are encouraged by the recent steps of our Federal Health minister’s request, on behalf of Health Canada, to the House of Commons Standing Committee on Health (HESA) to investigate electronic cigarette products, including those with nicotine, and recommend an appropriate regulatory category, which has not otherwise been established in Canada. We Vendors stand beside our colleagues, medical, science and legal professionals in their informational submission to HESA and await the outcome of this very important step forward.

While global federal health authorities have faced the challenge of regulating this new take on a product, creating new categories, facing challenges from industry and public, we Vendors are pleased to know that our government is willing to investigate at an official level, prior to selecting a regulatory category.

Many smokers have switched to e-cigarettes, from tobacco, for the express purpose of personal harm reduction – as there is no known way to make a tobacco cigarette “safer”, other than to switch it for an alternative product. This does not, however, make an e-cigarette a cessation or health product, and it in no way transforms it into a tobacco product. Many people have reduced or quit smoking by riding bicycles, going cold turkey, or chewing everyday gum but that does not turn those into therapies, medicines, or smoking products.

Despite the volumes of peer reviewed scientific / medical evidence (freely available to anyone interested) concluding that e-cigarettes convey very little harm since they avoid burning plant matter, we Vendors do not use that evidence to promote our product.

Health Canada’s published advisory from 2009 implicitly contradicts the evidence when it advises smokers to keep smoking rather than try a safer alternative. We Vendors do stress - despite solid, peer reviewed research by leading scientific, medical and academic practitioners around the globe showing that these products show real promise to radically reduce harm to smokers, we Vendors neither market, nor promote these claims.

With all of that said, these products do not fall within the scope of the Food and Drugs Act as they are very explicitly exempted, and regulatory categories are in the process of determination.

We Vendors would like to see Health Canada work with ECTA, as a stakeholder (as they have been formally informed that ECTA is a stakeholder, in writing) to help set a solid standard for the Electronic Cigarette Industry, which is growing measurably and globally, every day. As individuals, we share a common goal:- to minimize and possibly eliminate (in a perfect world) smoking tobacco products for future generations.

Sincerely,
All Canadian Electronic Cigarette Vendors.