To whom it may concern,
Please be informed that Health Canada has announced the regulatory requirements applicable to electronic cigarette products in Canada. Related information is available on Health Canada's Web site via the following URL addresses:
Public Advisory
ww.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2009/2009_53-eng.php
Notice to Stakeholders
web.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/notice_avis_e-cig-eng.php
If you require further information, please consult the web sites listed above for the appropriate contacts at Health Canada.
Regards,
Health Canada
WELL I DONT UNDER STAND THIS EMAIL AT ALL AND THE LINKS DONT WORK DOES THIS MEAN I CAN STILL SELL
I added just a letter or so to your URL's & got them to work, just added a "w" in front of what you posted.
Health Canada Advises Canadians Not to Use Electronic Cigarettes
Here is the text from the above article:
Health Canada Advises Canadians Not to Use Electronic Cigarettes
Advisory
2009-53
March 27, 2009
For immediate release
OTTAWA - Health Canada is advising Canadians not to purchase or use electronic smoking products, as these products may pose health risks and have not been fully evaluated for safety, quality and efficacy by Health Canada.
These products come as electronic cigarettes, cigars, cigarillos and pipes, as well as cartridges of nicotine solutions and related products. These products fall within the scope of the
Food and Drugs Act, and under the
Act, require market authorization before they can be imported, advertised or sold. The sale of these health products is currently not compliant with the
Food and Drugs Act since no electronic smoking products have been granted a market authorization in Canada.
In recent months, a number of electronic cigarettes, cigars and pipes as well as cartridges of nicotine solutions and related products have been marketed in Canada, and
through the Internet. Most of these products are shaped and look like their conventional counterparts. They produce a vapour that resembles smoke and a glow that resembles the tip of a cigarette. They consist of a battery-powered delivery system that vapourizes and delivers a liquid chemical mixture that may be composed of various amounts of nicotine, propylene glycol, and other chemicals.
Nicotine is a highly addictive and toxic substance, and the inhalation of propylene glycol is a known irritant. Although these electronic smoking products may be marketed as a safer alternative to conventional
tobacco products and, in some cases, as an aid to quitting smoking, electronic smoking products may pose risks such as nicotine poisoning and addiction. Please visit the Health Canada website for further information about
nicotine and addiction.
While no electronic smoking product has yet been authorized for sale in Canada, Health Canada has authorized the sale of a number of smoking cessation aids, including nicotine gum, nicotine patches, nicotine inhaler, and nicotine lozenges.
Electronic smoking products, including their nicotine cartridges, must be kept out of the reach of children at all times, given the risk of choking or nicotine poisoning. Nicotine is hazardous to the health and safety of certain segments of the population such as children, youth, pregnant women, nursing mothers, people with heart conditions, and the elderly.
Persons importing, advertising or selling electronic cigarette products in Canada must stop doing so immediately. Health Canada is providing information to interested stakeholders on how to apply for the appropriate market authorizations and establishment licences.
Canadians who have used e-cigarette products and are concerned about their health should consult with a health care practitioner.
Complaints involving electronic smoking products can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675, or by writing to:
Health Products and Food Branch Inspectorate
Health Canada
Address Locator: 2003C
Ottawa, Ontario K1A 0K9
You can also contact a
Health Products and Food Branch Inspectorate Regional Operational Centre.
Please visit the Health Canada website to view the
Notice to Stakeholders regarding E-Cigarettes.
For the second link change the "web to "www"
Notice - To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada
Here is the text from the second link:
Notice - To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the
alternate format help section.
(PDF Version - 21 K)
March 27, 2009
Our file number: 09-108446-55
To All Persons Interested in Importing, Advertising or Selling Electronic Smoking Products in Canada
Electronic smoking products (i.e., electronic products for the vaporization and administration of inhaled doses of nicotine including electronic cigarettes, cigars, cigarillos and pipes, as well as cartridges of nicotine solutions and related products) fall within the scope of the
Food and Drugs Act. All of these products require market authorization prior to being imported, advertised or sold in Canada. Market authorization is granted by Health Canada following successful review of scientific evidence demonstrating safety, quality and efficacy with respect to the intended purpose of the health product. This evidence is provided by the sponsor seeking market authorization. To date, no electronic smoking product has been authorized for sale by Health Canada.
In the absence of evidence provided by the sponsor establishing otherwise, an electronic smoking product delivering nicotine is regulated as a New Drug under Division 8, Part C of the
Food and Drug Regulations. In addition, the delivery system within an electronic smoking kit that contains nicotine must meet the requirements of the
Medical Devices Regulations. Appropriate establishment licences issued by Health Canada are also needed prior to importing, and manufacturing electronic cigarettes.
Health Canada is aware that some electronic smoking products have been advertised and sold in Canada without market authorization from Health Canada. Persons who may be importing, advertising or selling
electronic smoking products without the appropriate authorizations are asked to stop doing so immediately. Products that are found to pose a risk to health and/or are in violation of the
Food and Drugs Act and related
Regulations may be subject to compliance and enforcement actions in accordance with the Health Products and Food Branch Inspectorate's Compliance and Enforcement Policy (POL-0001).
If you wish to submit a complaint about the advertising or sale of a health product without market authorization, please contact the
Health Products and Food Branch Inspectorate.
The following Web links are provided for your information:
"How to Submit a Trade Complaint"
Applications and submissions for drugs and health products
Establishment licensing requirements
Sponsors interested in seeking market authorisation for electronic smoking products may contact Health Canada's Therapeutic Products Directorate for information about the drug submission process at:
SIPDMail@hc-sc.gc.ca.
Hug,
Teresa
