CORRESPONDENCE WITH HEALTH CANADA ON THE E-CIGARETTE BAN

PLEASE READ FOLLOW-UP TO OUR 2ND LETTER AT: http://cagecanada.blogspot.com/2009/10/health-canadas-reply-to-our-2nd-letter.html

We received a reply to our letter to Health Canada on the e-cigarette ban. Following are the explanations of Diana Dowthwaite the Director General at the Inspectorate for Health Products and Food Branch, as to why e-cigarettes have been condemned by them as well as our reply to hers.

Dear Ms. Cyr

''Thank you for your correspondence dated May 12, 2009, in which you voice your concerns about the availability of electronic cigarettes in Canada.

Electronic cigarettes contain nicotine, which is a highly addictive and toxic substance. Health products containing nicotine fall within the scope of the Food and Drugs Act. Nicotine products currently on the market, such as nicotine gum, patches, inhalers and lozenges, have obtained market authorization from Health Canada. Like these products, electronic cigarettes require market authorization before they can be imported or sold in Canada. The market authorization process exists so that Health Canada can evaluate the evidence of safety, efficacy and quality provided by persons seeking market authorization for a product.

Although electronic cigarettes are being marketed as a safer alternative to conventional tobacco products and, in many cases, as an aid to smoking cessation, the risks they may pose, their benefits, their efficacy and their quality are unknown. Nicotine is a highly addictive and toxic substance, and the inhalation of propylene glycol, which is the substance that produces the simulated smoke, is a known irritant to the upper respiratory tract. For more information about nicotine and addiction, please visit our Health Canada website (http://www.hc-sc.gc.ca/hlvs/tobac-tabac ... nd-eng.php ) To date, no electronic smoking products have received market authorization from Health Canada.

Health Canada is committed to protecting the health of Canadians by ensuring that health products meet requirements for safety, efficacy and quality. Yours Truly, Diana DowthwaiteDirector General



Dear Ms. Dowthwaite,

Thank you for replying to our queries and criticisms about the banning of electronic cigarettes in Canada. However, your reply requires further clarification and explanations.

You inform us that products that contain nicotine fall within the scope of the Food and Drugs Act since they are marketed as health products . May we respectfully point out to you that despite the fact that some e-cigarette distributors do in fact market their product as a smoking cessation aid, many others market it as a nicotine delivery substitute without any claims of helping tobacco smokers quit their conventional cigarette habit. That all manufacturers and distributors have been banned from marketing their product because of the actions of a few lacks coherence.

In the Food and Drugs Act Schedule F, Part 1, it is indicated that nicotine inhalers with a maximum of 4 mg per dosage are exempted from the prescription regulation. We in turn consulted the specifications for the popular Ruyan e-cigarette, and found that one 16 mg cartridge, which is the equivalent of 300 puffs or 20 cigarettes, has a 3 mg nicotine yield, which is 1 mg below the level that would categorize the product as a regulated prescription drug. Surely then it must fall under the category of an OTC product much like the presently approved inhalers and other pharmaceutical nicotine products mentioned in schedule F, which do not retain any patent rights. Furthermore, according to the Food and Drugs Act, Schedule A, nicotine addiction is exempted from the advertising regulation.

If Health Canada is truly concerned about the health of Canadian citizens, why don't they stipulate strong recommendations and warnings about the product and guidelines as to what maximum nicotine levels per dose can be marketed in order to have the product conform with the schedule F exemptions instead of enacting a complete ban of a product that has proven to be very popular with the public worldwide? This would be similar to the treatment of energy drinks, which, except for Red Bull, are still pending evaluation from Health Canada, yet continue to be readily available to minors and adults alike.

If there exists some reason for e-cigarettes to be treated according to a different standard than other products, we request that you kindly inform us of these reasons. Otherwise, e-cigarettes should remain available to the public until Health Canada can substantiate its hazard claims since e-cigarettes are neither a health product nor a prescription drug, and are therefore legally unregulated at the outset, with the burden of proving any harmful effects resting upon Health Canada.

Iro Cyr for C.A.G.E., Citizens for Civil Liberties, mychoice.ca