Hi all!
Again, lots of comments overnight. This is good. All of them I appreciated. I very much like Krusin_'s re-word (thank you!) and I would call it the final revision with some additional rewording. Any final thoughts?
PS: I am keeping the authorisation spelled with an s
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February 16, 2013
Food and Drugs Act Liaison Office
200 Eglantine Driveway
Address Locator 1917C
Ottawa, Ontario
K1A 0K9
Dear Sir or Madam:
As of January 30, 2013 my parcel is being held by Canada Border Services Agency Edmonton on recommendation of Health Canada. This letter is to appeal this decision, have the parcel released and subsequently delivered to its destination address. It is being held without support from any Canadian Law or Regulation.
Information pertaining to the parcel:
DHL Waybil: 947706XXXX
CBSA reference: K24 XXXXX
Health Canada reference: XXXXXXXXX
Health Canada has since sent me a letter (see attached HC_Letter.pdf) with the following information as the cause for refusal:
REASON
Food and Drug Regulations -- C.01.045(1)
Subject to subsection (2), no person other than: a practitioner, a drug manufacturer, a wholesale druggist, a registered pharmacist or a resident of a foreign country while a visitor in Canada, shall import a Schedule F Drug.
The reason is fundamentally flawed and incorrect as per the following facts:
• E-cigarettes are not a health product. They are recreational consumer goods and as such do not fall under the Food and Drugs Act. Nicotine Replacement Therapy products (pharmaceutical nicotine products used for the purpose of quitting smoking) make therapeutic claims and therefore are covered under the Act. E-cigarettes make no such claims.
• E-liquid containing nicotine (five 50ml 0.6% nicotine bottles) is explicitly exempt from the Food and Drug Regulations, as per Schedule F:
Nicotine and its salts, for human use, except
(d) in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit
(see attached report NJOY.pdf clearly stating that 1.8% nicotine e-liquid delivers less than 4 mg of nicotine per dose, in the case of 0.6% nicotine liquid this number is obviously lower.)
• As a consumer product e-liquid does not require market authorisation.
• E-liquid containing nicotine is not a prescription drug
It is easy to mistake classification of this product and impose a hold on a package containing such considering Health Canada’s Advisory (number 2009-53) dated March 27, 2009 which may be mistakenly understood as a ban on such consumer products. I cannot stress enough that this is neither a health product nor a Nicotine Replacement Therapy product. (In which case Schedule F of the Food and Drug Act would apply.)
It is my belief that with your help and knowledge, this small error will be solved and the package irrevocably released and passed over to DHL Express for delivery at their earliest convenience. I appreciate your time and effort.
Furthermore, please be advised there are numerous vendors openly selling electronic cigarette products and supplies throughout Canada, with or without nicotine. One such business is the second fastest growing company in the province of Alberta as per a recent interview on CBC Current that aired January 29, 2013. Some vendors do, very occasionally, receive cease and desist letters from Health Canada, but none have been presented with criminal charges as these vendors do not currently break Canadian Law.
Sincerely Yours,
Mr. Bosman