Electronic smoking 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. To date, no electronic smoking product has been authorized for sale by Health Canada.
Market authorization is granted by Health Canada following successful review of scientific evidence demonstrating safety, quality and efficacy. This evidence is provided by the sponsor seeking market authorization.
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.
For more details, go to Health Canada’s website.
Originally published in the July 28, 2009, issue of The Link
