"Health Products and Food Inspectorate
2301 Midland Ave.
Toronto ON M1P 4R7
March 25, 2011 Ref: C10176
vapables[DOT]com
To whom it may concern:
RE: Importation and Sale of Electronic Smoking Products
This letter is in follow-up to the notice issued by Health Canada regarding the sale of electronic smoking products. A copy of this notice can be found at the following Health Canada Website:
http://www.hc-sc.gc.ca/dhp-mps/prodp..._e-cig-eng.php
Health Canada has grounds to believe that vapables[DOT]com may be selling nicotine-containing electronic smoking products in Canada, without market authorization and without an establishment license.
If you have distributed or sold an electronic smoking product, Health Canada is advising that you immediately stop sale of these products .
At this time, the Health Products and Food Inspectorate (Inspectorate) is requesting writtenconfirmation that your establishment has ceased importing, distributing and selling electronic smoking products. The Inspectorate is also requesting the identity of your current supplier(s) for any nicotine-containing electronic smoking products.
Your written response is requested by March 31, 2011. Your response must be submitted to the Health Products and Food Inspectorate Operational Centre in your region.
Failure to cooperate with these requests will result in more stringent enforcement measures, such as seizures, in accordance with POL-0001: Compliance and Enforcement Policy. The Compliance and Enforcement Policy can be found at the following Health Canada Website:
http://www.hc-sc.gc.ca/dhp-mps/compl..._tc-tm-eng.php
Further information on the requirements of the Food and Drugs Act and its associated Regulations as they pertain to this situation can be found in Appendix and on the Health Canada Website. A public advisory document on electronic smoking products can also be found on this site:
http://www.hc-sc.gc.ca/ahc-asc/media...009_53-eng.php
We look forward to your prompt attention to this matter. Should you have any questions or concerns, please do not hesitate to contact the undersigned.
Sincerely,
Name Removed
Senior Compliance Officer
Ontario Operational Centre
Health Products and Food Inspectorate
Tel: 416-952-2197
Fax: 416-954-4583
encl: Appendix
Appendix
Federal legislation pertaining to the importation, manufacture and distribution of drug products, including electronic smoking products, in Canada is established under the Food and Drugs Act and its associated Regulations. These requirements include market authorization and licensing.
Market Authorization - DIN
Per Section C.01.014.(1) of the Food and Drug Regulations (the Regulations), a Drug Identification Number (DIN) must be assigned to a drug product before it can be offered for sale:
No manufacturer shall sell a drug in dosage form unless a drug identification number has been assigned for that drug and the assignment of the number has not been cancelled pursuant to section C.01.014.6.
Market Authorization - Device Licence
As per section 26 of the Medical Devices Regulations, a class II, III or IV device licence must be issued to a medical device before it can be imported or sold.
Subject to section 37, no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence in respect of that device or, if the medical device has been subjected to a change described in section 34, an amended medical device licence.
No person shall import or sell a medical device unless the person holds an establishment licence.
Establishment Licence Requirement
Per C.01A.004.(1) of the Regulations, an establishment licence (EL) is required to fabricate, distribute, import, package/label, wholesale, or test drug products:
Subject to subsection (2), no person shall, except in accordance with an establishment licence,
(a) fabricate, package/label, distribute as set out in section C.01A.003, import or wholesale a drug; or
(b) perform the tests, including examinations, required under Division 2.
Pursuant to section 44 of the Medical Devices Regulations, importers and distributors of medical devices must hold a medical device establishment licence.
No person shall import or sell a medical device unless the person holds an establishment licence.
