so... another pass the buck, "i don't give a damned" responce...
Dear Mr. **PRIVATE NAME**:
On behalf of the Right Honourable Stephen Harper, I would like to acknowledge receipt of your recent e-mail.
Please be assured that your comments have been noted, and that they will receive due consideration from the Honourable Leona Aglukkaq, Minister of Health, whom you also addressed in your correspondence.
Thank you for writing to the Prime Minister.
A. Opalick
Executive Correspondence Officer
for the Prime Minister's Office
Agent de correspondance
de la haute direction
pour le Cabinet du Premier ministre
>>> From : **PRIVATE NAME/INFORMATION** Received : 05 Apr 2011 10:12:28 AM >>>
>>> Subject : Health Canada - Illegal Action >>>>
Dear Mr Prime Minister, Honorable Ministers and Ms May, leader of the Green Party,
Sir's and Ma'am, this is a matter of great concern to me so please bear with me
and please read the entire email as it impacts the lives of thousands of
Canadians who are trying to avoid smoking for good. If you don't mind
I would like to give you a little bit of personal background before I get to the
problem at hand.
When I was 14 in the spring of 1994, I started smoking because it was
cool and my 'buddies' told me it was a great stress reliever. It was
exam period and I was stressed about exams and mad at my parents. That
spring and summer I smoked a cigarette or two a day and enjoyed the head
rush and dizziness that it gave me. Within a year I was smoking half a
pack of cigarettes a day and by time I was 19 I was smoking between one
and two packs a day. My health has steadily declined since then.
Coming onto my 31st birthday in December I had been smoking for almost
17 years now. I have, over the last 8 years, tried to quit smoking at
various times and in various ways. I have tried using Health Canada
approved smoking cessation products such as the Patch, Nicorette gum and
Zyban with absolutely no success. The pills, in particular, put my
mental health at risk as they were causing me depression and I had to
stop taking them.
For the last two years, in particular, I have had various lung function
illnesses, including a 6 month bout with a Pleural Effusion around my
left lung that left me incapable of taking more than half a breath due
to a buildup of fluid around the lung. I have suffered decreased
breathing capability For the last two years. Starting about a year and
a half ago, I became dependant on a twice daily inhaler and, starting in
December of 2010, I had to add a rescue inhaler to my regime of
medication just to be able to cope with routine exertions let alone even
consider physical exercise. These medications, on top of my 25-40
cigarette a day tobacco use, cost me $100.00 a month.
Finally, around christmas-time of 2010, sick and tired of waking up
every morning incapable of breathing and having to use the rescue
inhaler 3 or 4 times a day, on top of the daily inhaler I decided I had
had enough of 'trying' to quit. I had heard of these 'newfangled'
devices that seemed to be effective for a lot of people. I did some
reading up and decided to buy myself my very first Personal Vaporizer (a
PV, also known as an Electronic Cigarette). This device provides the
smoker with a means of getting their Nicotine fix without any of the
4000 harmful chemicals or over 400 known carcinogens that are found in
cigarettes. The liquid nicotine used in PV's contains only products
that have been approved for human consumption by the FDA and Health
Canada for many years.
You may read some literature that says that nicotine causes cancer but
that is a totally false statement. There are several peer-reviewed
studies that show unequivically that nicotine is no more harmful to the
body than caffeine is. Rather the problem is in the combustion process
of tobacco that creates these over 400 carcinogens that are known to
lead to cancer developing in the human body. Since there is no
combustion process with PV's there are no carcinogens produced and no
smoke.
PV's produce only a harmless vapour that consists of the same base
materiel that has been used in music concert and stage fog machines for
years. This base of Propylene Glycol or Vegetable Glycol has food grade
flavorings (oils free), water and nicotine suspended in them to make up
what we know as 'E-juice'. This E-juice is introduced to the PV either
through a cartridge or directly through dripping directly upon the
heating element, the Atomizer.
I have now been smoke free for 12 weeks (as of January 11th, when my
first PV arrived in the mail) thanks to PV's. Within ONE week of
starting up with PV's I no longer needed my rescue inhaler as I was
having no breathing emergencies throughout the day. And within TWO
weeks, I was waking up in the morning and finding that I was able to
breath without the use of my daily inhaler. I quit smoking entirely
about a month and I haven't looked back. I physically feel better and
have regained a fair bit of physical capability. What used to be a
20-25 minute walk to work that left me tired and a bit sweaty now takes
me 10 minutes and I arrive at work feeling as fresh as I felt when I
started. My home no longer smells of stale tobacco, which was only
introduced indoors by the smoke that clung to my clothing.
Recently, the companies that I purchase my PV's and E-Juices from have
been issued warning letters from Health Canada(HC) with threats for
non-compliance and they have been forced to close up shop or face
seizures of their entire stock. Now we get to what could make literally
thousands of Canadians go back to smoking Cigarettes. This illegal act
by HC will, in my own personal opinion, lead me to death within 15
years, either from Emphysema or Chronic Obstructive Pulmonary Disease.
A bit of background to what is perpetrating this frustrating and ILLEGAL
action by HC follows:
In March of 2009 HC issued a advisory not a ban to 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'. Since March of 2009 HC has remained quiet
on this matter and up until recently have actually told people that they
have no problem with people buying and using these products.
On March 25th 2011 HC sent emails out to many Canadian PV and E-juice
vendors which states the following:
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 <http://www.hc-sc.gc.ca/dhp-mps/prodp..._e-cig-eng.php>
Health Canada has grounds to believe that you 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 written confirmation 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 <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 <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.
The problem lies in that PV's are not medical devices in any manner but
are a smoking alternative in the same way that snus or chewing tobacco
are alternatives to combustible tobacco. They are not being used,
touted or sold as medical devices and there are no medical or health
claims being made by any of the companies, yet HC has deems it fit to
shutdown Canadian vendors who provide us with a better alternative to
burning tobacco and inhaling it.
Interestingly, The FDA has tried to have PV's classified as a Drug
Delivery Device in the US and has now lost two cases in US Federal and
US Federal Appeals Courts. In both Cases, PV's have been declared to be
tobacco products and NOT medical devices or Nicotine Replacement
Therapy.
Do we really need to go through this lengthy and costly process in
Canada as well only to come to the same results at the cost of Canadian
health?
Sir's and Ma'am, Health Canada is illegally overstepping and ignoring their very
own rules when it come to PV's and nicotine bearing E-Juice. Nicotine in
Canada is a Scheduled F drug and is exempt from restriction when
consumed or used in the manners as stated below (which was copied from
Page not Found - Page non trouvé <http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/page-502.h>
tml ):
Nicotine is exempt from Schedule F classification (you don't need a
prescription etc) - specifically, as follows. I'm quoting from the link
above, in navy blue to distinguish it, and with bold emphasis on (d):
Nicotine and its salts, for human use, except
(a) in natural substances;
(b) in the form of a chewing gum containing 4 mg or less of nicotine per
dosage unit;
(c) in the form of a transdermal patch with a delivery rate of 22 mg or
less of nicotine per day;
(d) in a form to be administered orally by means of an inhalation device
delivering 4 mg or less of nicotine per dosage unit; or
(e) in the form of a lozenge containing 4 mg or less of nicotine per
dosage unit
Heath Canada considers one dosage unit for a cigarette to be one 'drag'
or 'puff' as some would call it. Essentially each time you inhale
through the cigarette, you are getting 'one dosage unit'. You can not
exceed the Health Canada imposed limit of 4 mg's per dosage unit with an
Electronic Cigarette with one puff in the concentration levels that are
found in commercially available E-Juice. Most Ejuice is available in
concentrations of between 0mg/ml up to roughly 38mg/ml. Each ml can
roughly be broken down into 20 drops. In my particular usage, 2 drops
will last roughly 3-5 minutes of active inhalation, which is about the
same amount of time that the average person spends inhaling a cigarette.
In the strongest commercial dosage, this will deliver, over a 3-5 minute
period roughly 3.8 mg of nicotine. Generally most people 'vape'
E-juices at concentrations of about 18mg/ml to 26mg/ml. with the same
formula listed above, this leads to between 1.8mg and 2.6mg. Keep in
mind that this is NOT ONE drag or Puff, and you can see that PVs
typically deliver much less than half of the limit set by Health Canada
yet they are banning this product and blatantly ignoring the laws that
they have set as the standard.
Sir's and Ma'am, for the sake of thousands of Canadians I am asking you to look
into this matter of illegal action by Health Canada on our behalf. We
do not want to go back to Cigarettes and if health Canada effectively
bans this product many will go back to smoking and that is what we most
want to avoid. Below I have included a link to The Consumer Advocates
For Smoke-Free Alternatives Association. There is a lot of good
information that can be found there and if you require it I can provide
you with more. In the seven years E-Cigs have been on the market not
even one illness has been attributed to them, even anecdotally.
CASAA | The Consumer Advocates for Smoke-Free Alternatives Association
<CASAA | The Consumer Advocates for Smoke-Free Alternatives Association <http://casaa.org/> >
Mr Prime Minister, Honourable Minister's and Ms May, in closing, I and thousands of grateful Canadians would like
to thank you for your time in this matter and hope that you can and are
willing to help us in our struggle with Health Canada and help keep us
off of cigarettes for good and capable of living to see grandchildren.
Sincerely
**PRIVATE NAME/INFO**
They should not have a problem with nicotine.
