LEGALITIES - knowledge is power!
Unlike other vendors, at Rainbow Vapor we're not content to merely know what we're supposed to do. We're not content to merely talk about what we're supposed to do either. We insist on actually doing what we're supposed to do, in full - walking the walk. And we want you to be informed about what that involves. Can other Canadian vendors say the same?
We've done our homework regarding the laws and regulations which apply to our products. But many other vendors have not - and many vapers remain in the dark as well.
Why is this is a bad thing? Because this mixture of ignorance and non-compliance is what allows Health Canada to continue bluffing and bullying the Canadian vape-industry into hiding - or worse, into shutting down. It's what keeps
sensible regulation - and a brighter, safer future for Canadian vapers - unrealized. It's what allows vendors to
get away with b.s. that they shouldn't get away with. It's what keeps vapers from knowing better, and holding their vendors to account.
We know that many of you are hungry for knowledge about what the law really says.
We know that like us, you're eager to see the day when vaping finally wins - when having successfully overcome the obstacles and opposition, a vapey new future can dawn in Canada. A future where millions of Canadians can easily choose to make the switch from smoking to vaping; where we need no longer worry about this precious gift being taken away. We also know that you aren't well-served by vendors who merely claim to share these goals, and remain vague on demonstration.
That's why we've created this
Legalities area - where we will be asking the pressing questions, and pointing everyone towards the answers. We who make and/or sell these products -
your vendors - are required by law to do the right thing. If we want the Canadian situation to change for the better, we are required to take step #1 - engage Health Canada - and openly, actively win the fight.
The people we sell to -
you, the vapers - would be well-served by knowing just what it is we're supposed to be doing. You have a valuable role to play in the fight, by bringing pressure to bear on vendors who don't comply and aren't truly fighting for you. We won't do all your homework for you. But if you're ready to take step #1 - if you want correct information, comprehension, clarity and the confidence that stems from these things - Rainbow Vapor will show you precisely where to find it.
Let's get started.
Q: Since 2009, Health Canada has claimed that any e-cig product containing nicotine is a drug / new drug, requiring market authorization as such. Is this claim an appropriate one, and valid?
A: Health Canada does indeed make the aforementioned claim, but a closer examination is required. It is the fundamental nature of medicinal products (such as drugs) to make medicinal / therapeutic claims. However, Rainbow Vapor has never attached any such claims to its products (and no responsible member of the vape-industry would ever do so). In the absence of these therapeutic claims, e-cig products with nicotine categorically fail to meet Health Canada's own definitions of drug / new drug.
So: in the absence of therapeutic claims, an e-cig product with nicotine is not a drug or new drug, and does not require market authorization as a drug / new drug. The answer is entirely conditional on the presence or absence of therapeutic claims. Health Canada knowingly
contradicts its own definitions when it ignores this.
In plain English: a non-medical product, which makes no medical claims, cannot be required to seek authorization as a medicine, lol. The very absence of medical claims attached to the product would automatically disqualify it for approval as a medicine. You see? As you may have surmised by now, Health Canada is not lawfully allowed to require products to seek authorization as something that they aren't (and therefore could not possibly receive authorization as).
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Q: Why don't you make medical claims? Aren't e-cigs supposed to help smokers quit?
A: The reason why we at Rainbow Vapor have never attached therapeutic claims to our products is simple: e-cig products are not smoking-cessation medicines or smoking-cessation products. Rather, they offer an infinitely safer way to continue enjoying your habit and recreationally consuming nicotine.
This is one reason why Health Canada's repeated claim - that the safety and efficacy of electronic cigarettes remains untested - is a
lie, unless viewed in the proper context. The safety and efficacy of e-cig products as smoking-cessation products is indeed untested - and will forever remain so, since electronic cigarettes aren't smoking-cessation products. However the safety and efficacy of e-cig products as the consumer products they actually are is something that's well-tested.
Full and careful compliance with all the relevant laws and regulations is the fundamental step needed to ensure that consumer safety issues, vendor liability issues, and product quality issues are all addressed.
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Q: What Canadian laws / regulations are applicable to e-cig products?
A: (Please note that the following is not a comprehensive list.) The
Consumer Chemicals and Containers Regulations, 2001 are a good starting point. The regulations therein most definitely apply to e-juice with nicotine - and Rainbow Vapor verifiably complies with them all, in full. The CCCR 2001 applies because e-juice with nicotine meets the definition of a consumer chemical product. As the contents illustrate, there are a great number of precise (and non-negotiable) requirements we have to fulfill. The labels for our e-juice bottles are a particularly good reflection of these requirements.
Other regulations which apply include the
CCPSA (Canada Consumer Product Safety Act). As with the CCCR 2001, the CCPSA requires vendors to practice due diligence - which is why Rainbow Vapor insists that manufacturers provide CE and RoHS certification for any products we intend to sell. Due diligence is why we regularly submit our e-juices to an independent, accredited laboratory for testing to confirm that 1) our e-juices are contaminant-free, and 2) contain precisely accurate levels of nicotine.
Fundamentally, e-cig hardware consists of consumer products, battery products, and electronic merchandise - therefore, e-cig hardware is subject to the same laws and regulations that any other such electronic merchandise / batteries / etc are subject to. Fundamentally, e-juice with nicotine is a consumer chemical product, and therefore subject to the same laws and regulations that any other consumer chemical product is subject to.
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Q: But wait a minute. Isn't nicotine prohibited under the Food and Drugs Act?
A: No. Nicotine is explicitly exempted from the Food and Drugs Act, by the Food and Drugs Act - "in a form to be administered orally by means of an inhalation device delivering 4 mg or less of nicotine per dosage unit."
Electronic cigarettes are indisputably an "inhalation device." Health Canada does not dispute this fact. At the nicotine levels commonly consumed by vapers, electronic cigarettes indisputably deliver 4 mg or less of nicotine per dose. Health Canada does not dispute this fact.
Health Canada has previously - and rather weakly - attempted to claim that the aforementioned exemption does not apply to electronic cigarettes, due to an alleged difference in "pharmacokinetic profile" between electronic cigarettes and the pharmaceutical inhaler. Yet
1) Health Canada has never provided any scientific evidence to demonstrate this alleged difference in "pharmacokinetic profile."
2) The law does not even mention pharmacokinetic profiles - they have nothing to do with the conditions for exemption.
3) The law does not make any distinction whatsoever between varieties of inhalation devices.
When one considers this precise, explicit exemption of nicotine - in addition to the fact that e-cig products categorically fail to meet Health Canada's own definitions of drug / new drug - it is abundantly clear that the nicotine in our e-juice is not prohibited by the Food and Drugs Act. Health Canada is simply lying when they say otherwise.
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Q: But what constitutes a dose?
A: We hear this question often - usually from vapers worried about whether or not we truly fit the exemption. Any question of what constitutes a dose is answered very simply:
e-juice is a recreational product, consumed one drag at a time. The frequency of these drags varies according to user preference - and the dosage frequency is not restricted by the Food and Drugs Act.
Rainbow Vapor regularly tests its e-juices through an independent, accredited laboratory - so we know
precisely how much nicotine our e-juices contain. We know that at the nicotine levels contained, and when used as intended, it is
not physically possible to receive more than 4 mg of nicotine from a drag - which is how e-juice is intended to be consumed (one drag at a time). If you take a drag on your electronic cigarette, you receive a dose of nicotine. Take another drag, and you receive another dose.
The simple fact that e-cig products are
recreational - and not medicines intended to treat a disease - explains why the dosage frequency is not restricted. There is no standard amount of e-liquid which vapers will consume in a given day - just as there is no standard amount of coffee which coffee drinkers will consume in a given day. What is clear is that:
- when used as intended, e-juice is consumed
one drag at a time;
-
at the nic levels contained, and
when used as intended, a drag cannot deliver more than 4 mg of nicotine
- the
frequency of these drags varies according to user preference
- the dosage frequency is
not restricted by the Food and Drugs Act
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Q: What can I, as a vaper, do to help?
A: Plenty! There are a lot of well-meaning but disengaged vendors out there. So first and foremost - with step #1 under your belt, you can significantly pressure your vendors to get their act together. Speak with your words, and with your wallets. Make this the most important issue, and make sure they understand you feel this way. If you care about being able to easily, legally purchase compliant vape-products within Canada - then the compliance of your vendors (or lack thereof) should matter immensely to you.
Either a vendor is fully complying with all the relevant laws and regulations, actively engaging with Health Canada, and fighting for you (and themselves) -
- or they aren't. It's really as simple as that. What have we seen for years now? Confusion amongst vendors, who hide their nicotine and are either afraid or unprepared to engage Health Canada. Vendors who are failing to comply with virtually any of what they're supposed to comply with. Vendors who do not even
understand what it is they're supposed to comply with, or why. Vendors who fail to intelligently seek out that understanding - who fail to
respond at all (much less respond successfully) to Health Canada's nonsense.
But it is vendors who make and/or sell these products - and so the responsibility is on us. Health Canada certainly isn't going to stop its nonsense of its own volition. The ball is in the vendors' court. As a vaper, you should care deeply about whether we are successfully responding to Health Canada's nonsense.
Vendors = your access to vaping.
Do you want to see a greater availability of (and visibility of) e-cig products within Canada? Or do you want to see the availability and visibility of e-cig products in Canada decrease for no good reason - leaving you reliant on attempting to sneak in what you can from distant shores?
You can see why we are pleased to answer the question
"what Canadian laws / regulations are applicable to e-cig products?" - because knowing
the answer lets you the customers start putting real pressure on your vendors. Pressure to smarten up and win this fight for everyone concerned. When Canadian vendors fail to lawfully, intelligently respond to Health Canada's nonsense - those vendors are just as much to blame for the vape-situation in Canada as Health Canada is. No one - not Health Canada, and not a vendor - can defensibly claim ignorance of the law as their reason for failing to recognize and comply with it. Nor should they.
At Rainbow Vapor, step #1 - correct information, comprehension, clarity and the confidence that stems from these things - is something we've achieved. We've applied it carefully - and in full - to our products, and to our business. We're engaging Health Canada - eagerly and openly. We're successfully fighting for you, for ourselves - for vaping. Wouldn't it be nice if others were as well?
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Q: Won't regulation increase the cost of vape-products for vapers?
A: Consider first that it is neither realistic - nor desirable - for any industry to be unregulated. (Would you feel comfortable with an unregulated, uninspected food industry?) A lack of regulation is precisely what those who oppose vaping want - so that they can carry on voicing doubts about quality control, and their "we don't know what's in the vapour" lines. Regulation
takes away those arguments. Regulation also provides consumers with the assurance that the products they purchase are accurate, contaminant-free, and meet the standards' certification required by law. Most importantly:
regulation already exists. Rainbow Vapor knows it - understands it - and abides by it, in full.
Have our prices increased because of it?
No.
Each vendor is free to lower, raise, or maintain their own pricing at any given time. Hence we can only speak for ourselves at Rainbow Vapor. But there's no intrinsic reason that regulation should increase costs for consumers. In fact, there is every reason to believe that regulation will (in time) make prices more competitive in Canada than they presently are.
Consider: the current misclassifications by Health Canada (and the subsequent product seizures from the Canadian Border Services Agency) place a significant burden on vendors - not only in lost time and money, but in keeping us from achieving the kind of market visibility that we all desire. These losses and limitations hurt vendors, and inevitably impact the final retail price of the products you buy from us.
Now imagine a day when legally-compliant vendors no longer have to worry about unlawful border seizures. A day when the market visibility for our products is 1000 times what it is today. 10,000 times! Far from raising prices, when we are freed from unlawful border losses, and able to significantly increase our customer base - it will inevitably impact prices for the better.
The question you should ask yourself - and pointedly ask your vendors - is "are my vendors actively, successfully working to bring about a better day? Or are they merely bemoaning their present circumstance on a forum somewhere, failing to do anything about it?" It's time to move forward - together.
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