E-CIGARETTES - LETTER TO HEALTH CANADA RE A RECENT FDA DECISION

** Note ** July 22, 2011 - See reply to our letter at http://cagecanada.blogspot.com/2011/07/playing-with-words-health-canadas-reply.html

April 30, 2011

Ms. Diana Dowthwaite

Director General Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003C
Ottawa, Ontario K1A 0K9

Dear Ms. Dowthwaite,

In the U.S.A., the recent FDA decision to not regulate electronic cigarettes as therapeutic or medical devices brings us once again to request that Health Canada reconsiders their controversial stand on banning the import and marketing of electronic nicotine delivery devices commonly known as e-cigarettes.

The last letter we received from you on this matter in October 2009, advised us that electronic smoking products are subject to the Food and Drugs Act whether or not they are associated with a smoking cessation claim. 

The Food and Drug Act clearly defines a ‘’drug’’ to include any substance or mixture of substances manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
(b) restoring, correcting or modifying organic functions in human beings or animals…’’

It defines ‘’devices’’ as  ‘’any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
(b) restoring, correcting or modifying a body function or the body structure of human beings or animals…’’

These are almost word for word the same definitions given to drugs and devices in the U.S.A. Federal Food, Drug, and Cosmetic Act.

After careful consideration, the FDA reached the decision to abide by a Court of Appeal ruling and agreed to not categorize e-cigarettes as medical or therapeutic devices providing that they are not marketed as such either explicitly or implicitly.  

The logic followed by the Court of Appeal and finally accepted by the FDA is precisely what we argued in our July 27, 2009 letter to Health Canada. We are relieved to see that our vain efforts to get Health Canada to reconsider their intransigent position, was neither unreasonable nor incoherent since the FDA now also sees it our way.

The FDA is making a commitment  to work with stakeholders in an effort to ‘’best protect and promote the public health’’.   We feel that it is with the same resolve that Health Canada should consider its outright and unjustified ban on electronic nicotine delivery devices. 

Trusting that Health Canada will do the right thing,  we remain,

Yours Truly,

Iro Cyr

Vice-President 

C.A.G.E. Canada

Read past correspondence with Health Canada on this issue:

E-CIGARETTES - LETTER TO HEALTH CANADA

CORRESPONDENCE WITH HEALTH CANADA ON THE E-CIGARETTE BAN 

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

Read FDA decision: 

Regulation of E-Cigarettes and Other Tobacco Products