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october 09 2013 goldman ecigs .pdf



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October 9th, 2013

Dear Ms. Dingwall, Mr. Goodes and Dr. Goldman,
I am writing to you regarding your White Coat, Black Art article ("E-cigarettes: No Smoke...and Mirrors") which was
recently published online by the CBC on October 8th, 2013. I'm writing to express concerns over this article being unduly
biased and misleading to readers about the following:






What e-cigarettes with nicotine are
What their purpose is
Whether or not they are legal and regulated in Canada
What risks (if any) are associated with their use
What should (and should not) be done about them

There were a number of errors in your article which had a significant impact on the story. I sincerely hope that you would
agree that the job of any decent journalist is to uncover the facts – challenge assertions and implications, no matter where
they come from – and report the truth. Fact checking matters.
With that in mind, I'd like to request that you do a more investigative follow-up piece on e-cigarettes in Canada. For that
piece, I'd suggest speaking with a Canadian e-cigarette industry member of note – Ms. Cindy Lanning of Rainbow Vapor
(rainbowvapor.com) in Midland, Ontario. I will include her contact details at the end of this email. I'd also like to suggest
that you peruse the research found in WhatDoesTheLawSay.ca – and test what it says with your own.
**
Faulty Premise vs Facts
Both your article, and the CMAJ editorial that prompted it, are based on a faulty premise from the beginning – that ecigarettes with nicotine are a medicinal smoking-cessation product.
As a practicing physician Dr. Goldman, you should be well aware of how a pharmaceutical medicine (a "drug" or "new
drug") is legally defined as such in Canadian law. You should know full well that in the absence of therapeutic claims (i.e.
medicinal claims), e-cigarettes with nicotine are not medicines / medicinal products. In fact the very absence of medicinal
claims attached to the product would prevent any possibility of "market authorization" as a medicine. Absent therapeutic
claims, these products cannot lawfully be required by Health Canada to seek authorization as medicines.
So what are e-cigarettes with nicotine in the eyes of the law, and absent medicinal claims?
* E-cigarette hardware (batteries, cartridges, USB chargers, etc etc) is a legal consumer product - and as
such, these items are regulated according to various certification standards in existing law.
* E-juice with nicotine (the liquid vapourized by an e-cigarette) is a legal consumer chemical product – and
as such is regulated by the Consumer Chemicals and Containers Regulations, 2001.
Health Canada is not recognizing or enforcing these applicable laws and regulations to e-cigarettes with nicotine – in fact,
in co-operation with others, they are demonstrably lying about which laws and regulations apply.
Why? Because Health Canada has a vested interest in maintaining the status quo (i.e. in seeing that Canadians remain as
ignorant as possible of a legal, regulated, safer consumer alternative to smoking) – so that the government, anti-smoking
groups, big pharma and big tobacco can all keep cashing in on the status quo, where smokers keep on smoking.
As a physician, please ask yourself Dr. Goldman: why would Health Canada and anti-smoking groups prefer to allow real,
deadly cigarettes to be sold in every corner store – but simultaneously wish to prevent Canadians from choosing a safer
alternative which has not been demonstrated to be any more harmful than typical caffeine consumption? Indeed, a
growing body of compelling evidence suggests that the risk from e-cigarette usage is virtually non-existent.
The world has known for decades that at the levels being consumed by smokers or vapers, nicotine itself is no more
harmful than typical caffeine consumption. It's the delivery system for that nicotine that makes a difference. Deadly,
poisonous, tar-filled burning smoke with all kinds of junk in it – or a simple, non-burning vapourized liquid that inhalation
studies have shown is not harmful to inhale.
Ask yourself about the financial rewards that the government, big tobacco, big pharma, and anti-smoking groups all stand
to lose unless smokers are kept in a "quit or die" environment, without a safer consumer alternative. Ask yourself if your
article works to put the profits of said organizations from smokers ahead of the health of Canadians.
**

Studies
I grant that regular testing is essential to ensure that e-juices with nicotine are compliant with the CCCR 2001, contain
accurate nicotine levels, and do not contain contaminants. But the ingredients in e-liquid are exceedingly simple – and we
know far more about them than many would have us believe. For example, inhalation studies on propylene glycol go back
for decades, to the early 1940s – revealing no concerns of note. There is simply no credible evidence to suggest a
'smoking gun' as it were – or to suggest that there ever will be such.
The 2009 FDA study you referenced is a long-since-debunked antique. It was grossly omissive and misleading then – and
says nothing about e-cigarettes today, in any event. Please see section 3, subsection twelve ("12 - Product Amount") at
the following link for more on the 2009 FDA study and carcinogenic TSNA's.
http://whatdoesthelawsay.ca/category/labels-part-3/
Long story short: the "carcinogens" detected by the FDA in 2009 were tobacco-specific nitrosamines. What
they failed to mention is that these are also present, at comparable levels no less, in FDA-approved nicotine
replacement therapies – a fact you should well know, Dr. Goldman. They also failed to mention how you
would need to vape for decades to receive the same TSNA's that a smoker receives in one day.
As for the Lancet study you referenced, it studied e-cigarettes under the faulty premise of e-cigarettes being a smokingcessation medicine, as opposed to the recreational consumer product that they are. The Hawthorne effect certainly comes
into play in such a study – and the rigid conditions for usage disallowed participants from using the products in a real-life
manner.
The study also failed to take into account many subjective factors which make a significant difference regarding consumer
satisfaction with e-cigarettes – such as flavour preferences, nicotine level preferences, drag lengths, voltage levels, device
aesthetics, and so forth.
**
Lobbyists?
Dr. Goldman, you questioned whether "lobbyists" wanted Health Canada to "relax restrictions on e-cigarettes." Allow me to
answer. Educated advocates, consumers, and responsible members of the industry want Health Canada to a) stop lying
about what these products are, b) stop lying about which laws and regulations apply to them, and c) recognize and
enforce the applicable regulations in law. Were Health Canada to do the above:

– consumers would be demonstrably safer
– the Canadian e-cigarette industry would be held to better account
– the public would at long last realize that these are legal products
– visibility and availability would increase
– millions of Canadian smokers would be far more likely (and able) to switch to this far-safer alternative –
allowing for a drastic reduction in deadly tobacco cigarette use through nothing more than letting consumers
have awareness of, and access to, this choice
At present, there are some industry members right here in Canada who do comply with the CCCR 2001 – do operate
openly – and do have their liquids tested regularly through an accredited laboratory for accuracy and contaminants. But
there are many more who (regrettably) do not, allowing for valid criticism of the industry.
That said, the "lobbyists" you should be concerned about are those from the pharmaceutical industry – and from the
"public health" industry that big pharma showers with money. Pharma desperately wishes to avoid losing a profitable
market for their highly-ineffective NRT products (ditto their dangerously unsafe medicines such as Champix). Another
reason they're none too keen to see consumers taking better care of themselves by recreationally enjoying nicotine via ecigs, is that a drastic reduction in smoking would mean a drastic reduction in smoking-related cancers. Which would of
course, mean less "customers" for pharma's highly expensive palliative pills.
**
Nicotine is Available in Canada from Canadian Businesses
Moving on, your article said that the e-juice with nicotine is coming from the States, UK and EU ("there's no doubt ecigarettes are being brought into Canada from countries with less restrictive laws such as the US...the UK and the EU. The
latter two will soon step up regulation"). The implication is that there are no Canadian producers of e-liquid with nicotine –
and that implication is false.

There are indeed small businesses on Canadian soil which are making and openly selling e-juice with nicotine, and ecigarettes. One such business in Ontario has done so for more than three and a half years. Health Canada tried and failed
to shut them down, because the business is not breaking any laws.
**
More on Medicines Regulation and the EU
I would be the first to agree with you that Health Canada should not allow medicines (especially new ones) to be sold to
the buying public unless they have gone through the proper regulatory screening and authorization processes. If an ecigarette business does attach medicinal claims to their product(s), they should be stopped. This has happened at least
once with a business in Quebec.
But the vast majority of e-cigarettes with nicotine do not claim to be medicines. In fact, scientifically speaking they do not
even function as medicines – a fact which several EU courts have already attested to in conclusive rulings. I draw your
attention to the following quote from Dr. Konstantinos Farsalinos, a Greek cardiologist of note:

“The nicotine in electronic cigarette does not change the physiology of the smoker’s organism because he
already takes nicotine from cigarettes. So, he is not exposed to a new substance, he just receives the same
substance by a different product or mechanism. Obviously, no change in physiology is expected. In fact,
nicotine in Nicotine Replacement Therapies (NRTs) also produces no change in physiological mechanisms.
The mechanism of action is through “de-sensitization”. That is, we administer the same substance that
causes the addiction, and by gradually decreasing the dose we “de-sensitize” the individual, reducing his
need for the substance.
On the contrary, oral medications like varenicline and bupropion, act by antagonizing the effects of nicotine.
This is a change in physiology (they attach to the receptors where nicotine should attach, and thus prevent
nicotine from attaching there). By using electronic cigarette you continue to be exposed to nicotine, thus it
does not treat the addiction.”
Your article also mentioned that the EU is planning to "step up regulation" of e-cigarettes. Yesterday the European
Parliament voted on the Tobacco Products Directive (a directive that e-cigarettes had no business being included in in the
first place, but I digress). What you didn't tell readers...
...is that they voted against medicinalising e-cigarette products with nicotine . They voted against the very action that the
CMA wishes Health Canada to unlawfully take.
They voted against disallowing flavourings in e-liquid with nicotine. They voted against an unreasonable limit on the
nicotine levels that consumers can access. What they voted for was for existing consumer product (and consumer chemical
product) laws and regulations to be recognized and enforced. They also voted for some advertising restrictions, which are
of debatable value.
Vapers in the EU (vapers are people who use electronic cigarettes) could not be happier with this victory. Had we lost,
there would have been an enormous benefit to big tobacco, big pharma and parasitic anti-smoking groups. But vapers won
– so yay. It's a win for public health, for lawful legislation, for consumer choice, and for sanity.
**
The Tobacco Industry
I grant that there are valid discussions to have about the tobacco industry's toe-dipping into the e-cigarette market. It is
entirely reasonable to be concerned over whether they really care about harm reduction (given that e-cigarettes present
the greatest threat ever to the continued profitability of deadly tobacco cigarettes).
But Big Tobacco did not create electronic cigarettes. They merely purchased a piece of the pie, and it's by no means the
largest or the most viable piece either.
More importantly, it is unethical and nonsensical to suggest that nicotine (outside of deadly cigarettes) should only be sold
as a medicine by big pharma – especially when framed in the context of concerns over big tobacco having a piece of the ecig pie. The generic nature of what an electronic cigarette does – coupled with a huge, ever-growing variety of devices,
juices, and accessories – prevents anyone (including big tobacco) from getting a lock on the market, or stifling
competition.
**

Conclusion and a Request for a Follow-up Article
In conclusion: I would like to again request that you do a more investigative follow-up piece. For that piece, I would
welcome you to speak with an e-cigarette industry member of note – Ms. Cindy Lanning of Rainbow Vapor
(rainbowvapor.com).

Ms. Lanning lives in Midland, Ontario, where she has been openly selling e-cigarettes and e-cigarette
products with nicotine for more than three and a half years. In fact her primary business is to create e-juice
with nicotine. She is very aware of the truth regarding the legalities of this – has had numerous
communications with Health Canada about her business – and to this day, is still open for business.
Ms. Lanning laments the fact that many others in the Canadian e-cigarette industry do not seem eager to
learn what the law really says, and effectively challenge the myths out there – or take the legal steps to
obtain credibility which she has taken. She readily admits that in the eyes of the law (and common sense),
not everyone in the industry is doing what they're supposed to do – and she wishes Health Canada would
call them on it. Feel free to ask her why she thinks Health Canada hasn't done so yet.
Cindy is a champion for this industry, knows her way around the law – and as a vital player in this story, she
deserves to have her voice heard on your program. CBC has (for all intents and purposes) told the public
that she is a criminal. For your sake, for hers, and for the public's – we need to shed the light of truth onto
the topic of e-cigarettes in Canada.
By speaking with you for a follow-up piece, Cindy hopes to help clear up the waters which Health Canada
and various others have evidently muddied, by using facts. Unlike many others, she will encourage you –
heartily – to please fact-check whatever she tells you, because she's not afraid of the truth. The simple fact
that she does what she does, and is still open for business, lends credence to the assertion that's she not
just (pardon the pun) "blowing smoke."

Cindy can be reached by phone, email or Skype – and her contact details have been sent to your producers at White Coat,
Black Art (Ms. Dingwall and Mr. Goodes) today via email. Thank you for your time, and for getting back to us.
Kind regards,

Rachel Steen
Toronto
Note: I do legal research for Rainbow Vapor, and occasionally assist with media outreach such as this – which is why
you're receiving this response from me.

P.S. To any Canadian with an interest in the topic of electronic cigarettes, their legalities here, etc – I invite you to peruse
the research at WhatDoesTheLawSay.ca , and test what it says with your own research. There's also a new Myth vs Fact
Quick Sheet there, for your convenience. Thank you.


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