STATUS OF ELECTRONIC CIGARETTES IN CANADA signer maintenant

The following demonstrates that Health Canada exceeded its rights and does not meet the regulations it has established itself. We are asking Canadians to please help us reverse the decision of Health Canada, helping us to demonstrate that it oversteps its rights, and to demonstrate the merits of making electronic cigarettes with and without nicotine legal and available for every Canadian wishing to obtain one. Our approach is based on the individual right of every Canadian who wants to get an electronic cigarette to replace traditional cigarette by a less harmful alternative. We therefore believe that this case represents well the type of record that the Canadian should defend because it is not just our business that these laws affect, but all citizens of Canada, which by these laws, have not the freedom to choose themselves a less harmful alternative to cigarettes or other tobacco products that are harmful but still legal.
We want to show the same logic and get the same decision that our American neighbors have obtained in the case opposing the company NJOY to the FDA.
Health Canada insists on not wanting to approve the electronic cigarette in Canada based their decision on the following points.
• The electronic cigarette could pose a risk to their users.
• No studies have demonstrated its safety.
• The electronic cigarette is a new drug.
• The nicotine in the electronic cigarette is a risk.
• To issue a permit to a vendor, distributor or manufacturer, it must demonstrate the safety of the product.
All this is nonsense. First the recommendation of the Electronic Cigarette by Health Canada is this.
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).
The first point says that the promoter must demonstrate the safety of the product, this arrangement only ensures that only large companies could engage in this type of demonstration. No new business will do take the risk to shell out $ 200 000 to $ 500 000 in order to achieve this kind of study and then see all the others establish themselves once the results are released. There is already lots of studies showing that the electronic cigarette is far less harmful than other tobacco product.
Regarding the second point, Health Canada says "unless it is demonstrated that the electronic cigarette is not a new drug." Here's what Health Canada considers a drug:
Are included in drugs any substance or mixture of substances manufactured, sold or represented for use:
(a) the diagnosis, treatment, attenuation or prevention of a disease, disorder of abnormal physical state or its symptoms, in humans or animals
(b) restoring, correcting or modifying organic functions in the humans or animals;
(c) disinfection in premises in which food is kept
From the website of Health Canada http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/ndrugs_ndrogue-fra.pdf
However, if the electronic cigarette sold with or without nicotine, does not or is not intended to any diagnosis, treatment, attenuation or prevention of a disease, disorder, abnormal physical state or their symptoms, in humans or animals, or to restoring, correcting or modifying organic functions in humans or animals, but is just sold with the simple aim of be an alternative to tobacco, it can not be considered a drug.
Nicotine in Canada is considered a drug that is found in Appendix F (Appendix F is a list of medicinal ingredients, its sale is regulated specifically under sections C.01.041 to C.01.049 of the food and Drugs.) except for the following three:
Vol. 140, No. 14 - July 12, 2006
recording
DORS/2006-143 June 22, 2006
ACT OF THE FOOD AND DRUG
Regulations Amending the Food and Drug Regulations (1370 - nicotine lozenge)
C.P. 2006-545 June 22, 2006

Upon recommendation of the Minister of Health, pursuant to paragraph 30 (1) (see footnote a) of the Food and Drugs, The Governor General in Council, the Regulations Amending the Food and Drug Regulations (1370 - nicotine lozenge), below.
REGULATIONS AMENDING THE FOOD AND DRUG (1370 - nicotine lozenge)
MODIFICATION
1. In Part I of the Annex F to the Regulations of the Food and Drug Regulations (see footnote 1), the reference
Nicotine and its salts, for human use except:
a) in natural substances;
b) in the form of chewing gum containing 4 mg nicotine or less per dosage unit;
c) as a transdermal patch with a release rate of 22 mg or less of nicotine per day;
d) in a form to be administered orally by the means of an inhaler delivering 4 mg or less of nicotine per dosage unit.
is replaced by the following:

Nicotine and its salts, for human use except:
a) in natural substances;
b) in the form of chewing gum containing 4 mg nicotine or less per dosage unit;
c) as a transdermal patch with a release rate of 22 mg or less of nicotine per day;
d) in a form to be administered orally by the means of an inhaler delivering 4 mg or less of nicotine per dosage unit, 3
e) in the form of a lozenge containing 4 mg nicotine or less per dosage unit

EFFECTIVE DATE

2. This Regulation effective date is the date of its registration.
SUMMARY OF THE STUDY OF REGULATORY IMPACT
(This statement is not part of the Regulations.)

Description
This amendment to Part I of the Annex F to the Regulations allows the Food and Drug status for nonprescription nicotine in the form of a lozenge containing 4 mg or less of nicotine per lozenge. The nicotine lozenge 4 mg is an alternative to replacement therapy nicotine (NRTs), which are used to help quit smoking.
Annex F is a list of medicinal ingredients, its sale is regulated specifically under sections C.01.041 to C.01.049 of the Food and Drugs. Part I of Annex F lists ingredients that require a prescription for human use and veterinary use. Part II of Annex F lists ingredients that does require a prescription for human use, but do not require for veterinary use if so labeled or if in a form unsuitable for human use. Part I of Annex F includes nicotine and its salts, for human use, with the following exceptions:
a) in natural substances;
b) in the form of chewing gum containing 4 mg nicotine or less per dosage unit;
c) as a transdermal patch with a release rate of 22 mg or less of nicotine per day;
d) in a form to be administered orally by the means of an inhaler delivering 4 mg or less of nicotine per dosage unit.

Products as chewing gum, transdermal patches or inhalers are commonly used as part of smoking cessation programs to reduce the effects of nicotine withdrawal.
In 1997, the Coordination Centre of the United Nations Conference on Tobacco or Health recommended that products of nicotine replacement less dangerous, should be more accessible than cigarettes. In 2000, the Initiative for a Tobacco Free Project of the World Health Organization, recommended making effective smoking cessation methods including NRT, more easily accessible to the public.
To reduce faster the rate of decrease in the number of smokers in Canada, the Government of Canada launched in April 2001, the Federal Tobacco Control Strategy against smoking. The Strategy emphasizes partnerships between departments and between government agencies and voluntary health organizations and NGOs. The primary objective of the Federal Tobacco Control Strategy against smoking in Canada is to reduce the number of deaths and illnesses caused by tobacco. The four components of the strategy are those that complement the protection, prevention, cessation and harm reduction.
The withdrawal of lozenges containing 4 mg or less of nicotine of Annex F is based on a review of clinical and safety data contained in a new drug submission. We also conducted a general review of known pharmacological and toxicological properties of nicotine, the reported adverse reactions, studies on the potential for abuse and the documentation provided. Nicotine in lozenge form is available without prescription in the U.S. and the UK. Nothing in the data collected after the going on the market indicates that this product is misused by children or nonsmokers. No report was presented about a misuse, overdose or product dependence.
Solutions considered
The alternative would be not to remove the nicotine lozenge containing 4 mg or less of nicotine in Annex F. This solution was not considered a tool of appropriate risk management. The product description as a prescription medication unnecessarily restrict access to a smoking cessation product safely and efficiently. The benefits associated with the classification of lozenges containing 4 mg or less of nicotine as a nonprescription drug are much more numerous than the risks.
Benefits and Costs
The amendment impacts on the areas listed below.
• Public
The sales without prescription of nicotine lozenge 4 mg or less allows consumers to manage their own plan for quitting smoking and gives them more choice in nonprescription products for this purpose. This may encourage more Canadians to try to quit smoking.
The public may be required to pay directly the product, the nonprescription products are not usually covered under drug insurance plans.
• Provincial Health Care
It provides no cost to public drug insurance plans since most of these plans do not cover nonprescription drugs.
If a greater number of smokers quit, there will be a reduction in the number of patients with smoking-related diseases, which would reduce costs to the health care system.
Consultations
Direct notice of this draft regulation was sent September 3, 2003 to the Provincial Ministries of Health, regulators and associations of medical and pharmaceutical professionals and the pharmaceutical industry with a comment period of 30 days. This proposal was also posted on the website of the Therapeutic Products Directorate. Responses were received from three external stakeholders. All respondents expressed support for this proposal.
A second direct notice of the proposed regulations were sent to provincial departments of Health, regulators and associations of medical and pharmaceutical professionals and the pharmaceutical industry and was published as a notice of intent in the Canada Gazette part I June 13th, 2005 with a comment period of 75 days. This initiative was also posted on the website of Health Canada's website and "Consulting with Canadians." No comments were received.
Compliance and Enforcement
This modification will not change the enforcement mechanisms currently in place under the federal Food and Drug Regulations and the regulations enforced by the Inspectorate Directorate Health Products and Food.
Contact
Project No. 1370
Policy Division
Office of Policy
Therapeutic Products Directorate
1600 Scott Street
Holland Cross, Tower B, 2nd Floor
Address Locator: 310 2C5
Ottawa (Ontario)
K1A 0K9
Phone: (613) 948-4623 (refer to Project No. 1370)
FAX: (613) 941-6458 (refer to Project No. 1370)
Email: regaff_access@hc-sc.gc.ca
Reference to
L.C. 1999, c. 33, art. 347
a reference
C.R.C., c. 870
At point number 3, Health Canada clearly indicates that nicotine is not considered a drug since it is "a form to be administered orally by the means of an inhaler delivering 4 mg or less nicotine per dosage unit "
Since the electronic cigarette is neither a medicine nor a drug, no dosage is established. But we can be considered a "dose" the amount normally used by its users, that is to say between 2 and 4 drops of liquid. A drop is usually about 0.025ml (40 drops per milliliter). The concentration of e-liquid that we recommend never exceeded 20 mg / ml concentration of nicotine. The following calculation indicates the "dose" as used, 2 to 4 drops = 0.05 to 0.1ml. So the amount of nicotine per "dose" is 20 mg / ml X = 0.05 to 0.1 between 1 mg and 2 mg of nicotine per "dose", which is well below the prescribed 4 mg by Health Canada.
From another point of view, we could define such a "dose" by the release time, or the heating time that allows the battery before the automatic shutdown of the latter, which is generally set at 10 seconds. A standard atomizer , fixed to a 3.3 V battery will allow evaporation of one drop of e-liquid within 10 seconds of heating, which normally would be about 4 puffs of vapor.
Note
The word "dose" is used here to determine the quantity of the substance, not as a dose due to a medicine or drug.
Health Canada's claims are:
• The nicotine in the electronic cigarette is a risk.
• The electronic cigarette could pose a risk to their users.
• No studies have demonstrated its safety.

The risks of the electronic cigarette is much less than traditional cigarette. All agree that the electronic cigarette is more desirable than cigarettes. Numerous studies exist and demonstrate it and some researchers are actively working on studies, such as Dr. Michael Siegel of Boston University School of Public Health.
There are even studies which demonstrate that there are more harmful effects associated with smoking cessation by a smoker than if he could replace tobacco with an alternative nicotine (http://www.casaa .org / harmreduction / casaa.asp? pageID = 31).
One study (http://www.ncbi.nlm.nih.gov/pubmed/20414766) published on the PubMed website of the U.S. National Library of Medicine, shows the real benefits of nicotine on humans, unlike the bad press made on the latter in order to discourage people from smoking.
Here are the results of a study (http://www.biomedcentral.com/1471-2458/11/786) conducted at the University of Catania in Italy, demonstrating the effectiveness of the electronic cigarette to maintain smokers or former smokers away from cigarettes.
In the U.S., the FDA has attempted the same maneuver as Health Canada.
In September 2010 the FDA attempted to regulate (http://usgovinfo.about.com/b/2010/09/14/fda-to-regulate-electronic-cigarettes.htm) the electronic cigarette as drug delivery device (medicine). However, on December 7th 2010 the Court of Appeal decided otherwise Unless the electronic cigarettes are advertised as therapeutic, to help quit smoking, the FDA had no authority to consider the electronic cigarette as a drug delivery device.
As I like to point out, we do not sell e-cigarettes as methods to stop smoking or replacement therapies for nicotine; we sell them as an alternative to smoking, that's all.
Vaporium inc. makes no promises, no advertising on the benefits of the electronic cigarette, does not prescribe any method of treatment of smoking, does not promote boasting a more "healthy" smoking or any other promise, promotion or advertising on our products,, except to say that it can be an alternative to smoking. Vaporium does not sell products to minors. Vaporium recommends consulting a doctor to anyone suffering from any medical condition whatsoever before using our products. We are not qualified to offer suggestions or ask any medical procedure whatsoever.

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