LEGALITIES - knowledge is power!
Credibility is everything. And every credible industry is subject by law to some oversight and regulation. This is a good thing, because consumers deserve to know that they're buying trustworthy products.
Unfortunately, when it comes to the e-cigarette industry in Canada, the government of Canada is not being honest about what our products are - or what the law really says about them - or what the law requires of this industry. But regardless of what the government says or doesn't say, the law itself still speaks clearly and truthfully. Businesses still need to operate with credibility and legal compliance. So at Rainbow Vapor, we're not content to simply know what we're supposed to do, or merely talk about what we're supposed to do. We insist on knowing, speaking about and doing what the law says we're supposed to do in full - on walking the walk.
We want you to be informed about what that involves. Because your access to vaping is what's at stake.
It's because we've done our homework that we know which laws and regulations do apply to our products, and which don't. Regrettably, many other vendors cannot say the same - and many vapers remain in the dark as well. Why is this is such a bad thing? Because allowing lies to go unchallenged is holding vaping back. Health Canada is not being honest about the regulatory fit for electronic cigarette products. In contradiction of their own definitions and the laws of Canada, they claim that any e-juice with nicotine is an unapproved medicine, and that e-cigarettes are unapproved medical devices. If e-cigarette vendors do not:
a) recognize these lies when they see them
b) learn what the law says is applicable
c) follow the applicable laws in full, and
d) do so openly
- then the lies will continue to remain (for all intents and purposes) unchallenged. That will allow Health Canada to continue bluffing and bullying the Canadian vape-industry into hiding - or worse, into shutting down. It will continue to keep sensible, existing regulations from being formally recognized as applicable, and being enforced. It will continue to keep a brighter, safer, stable future for Canadian vapers from being realized.
We know that many of you are hungry for knowledge about what the law really says. Like us, you're eager to see the day when millions of Canadians can more easily choose to make the switch from smoking to vaping; when we need no longer worry about this precious gift being taken away. But this industry needs credibility to make that day happen. We also know that you aren't well-served by the vendors or groups who merely claim to share these goals, but remain vague or confused on details and demonstration. That's why this Legalities area was created - a place to ask the pressing questions, and point everyone towards the answers.
Some have asked: why we would want to help our competitors? The answer is simple.
The vape industry is all about variety. Taste is subjective; personal preferences are subjective. No one single vendor will ever have what everyone wants. At Rainbow Vapor we have our own niche, and we're glad our customers like what we do. But we're not going to be every vaper's cup of tea - and even if we were, one voice is not enough. To survive, the entire industry needs credibility. So we've provided this information publicly and freely to everyone. Anyone who is receptive to the truth and reaches out for help will find a friend in us.
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 know what we're selling - engage Health Canada - and openly, actively win the fight.
The people we sell to - you, the vapers - need to know just what it is we're supposed to be doing. You have a valuable role to play in this, by bringing pressure to bear on vendors who won't comply and aren't truly fighting for you, or for themselves. 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 an unapproved medicine (i.e. a "drug" or "new drug"), requiring market authorization from Health Canada 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 ("drugs") to make medicinal / therapeutic claims. However, Rainbow Vapor has never attached any such claims to its products, and for that matter 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 a "drug" or "new drug."
This means that in the absence of therapeutic claims, an e-cigarette product with nicotine is not a medicine (i.e. a "drug" or "new drug") and does not require market authorization as a medicine. The classification of these products - that is, determining whether or not e-cigarette products with nicotine fit the legal definition of a medicine - is conditional on the presence or absence of therapeutic claims. Health Canada knowingly contradicts its own definitions when it ignores this.
In even plainer English: a non-medical product, which makes no medicinal claims, cannot be required to seek authorization as a medicine, lol. The very absence of medicinal / therapeutic claims attached to the product would automatically disqualify it for approval as a medicine. You see? As we're sure you can grasp, 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).
Q: Why don't you make medicinal 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 of any kind. Rather, e-cigs are a consumer alternative - offering a safer way to continue enjoying your habit and recreationally consuming nicotine.
Many smokers do switch altogether from smoking to vaping, because they prefer e-cigs. Yet the fact that some do engage in "dual use" (i.e. using both tobacco cigarettes and electronic cigarettes) provides further proof that any smoking-cessation claims would be false, and utterly inappropriate to attach to e-cig products. Using a safer, recreational, consumer alternative to smoking does not mean that said alternative caused you to "quit smoking" - it simply means you've chosen to use a safer alternative, period. Whether you switch fully or not from smoking to vaping is entirely up to you.
This is one reason why Health Canada's repeated claim (that the safety and efficacy of electronic cigarettes remains untested) is grossly misleading, unless viewed in the proper context. The safety and efficacy of e-cig products as medicines (i.e. smoking-cessation products) is indeed untested - and will forever remain so, since electronic cigarettes aren't smoking-cessation products. The safety and efficacy of e-cig products as the consumer products they actually are is what's really at issue.
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 in an appropriate and ongoing manner.
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.
Canadian businesses are also required to perform due diligence - especially when they import products from abroad. Rainbow Vapor takes this requirement seriously. For example: we insist that manufacturers provide valid CE and RoHS certifications for any products we intend to sell. We also submit our e-juices - on a regular, ongoing basis - to an independent, internationally accredited laboratory for testing. The purpose of this testing is to confirm that 1) our e-juices are contaminant-free, and 2) that they contain accurate levels of nicotine, precisely matching the level described on the label.
In the eyes of the law, e-cig hardware is a consumer product (consisting of batteries, cartridges, electronic merchandise, etc). As such, it is subject to the same laws and regulations that any other such electronic merchandise / batteries / etc are subject to.
In the eyes of the law, e-juice with nicotine is a consumer chemical product. As such, it is subject to the same laws and regulations that any other consumer chemical product is subject to (i.e. the Consumer Chemicals and Containers Regulations, 2001).
Q: But wait a minute. Isn't nicotine prohibited under the Food and Drug Regulations?
A: No. Nicotine is explicitly exempted in the Food and Drug Regulations, by the Food and Drug Regulations - "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 - though if they disputed this with a vendor who regularly tests their e-liquids, they would look very foolish (see next question / answer for more on that).
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 Drug Regulations. Health Canada is simply lying when they say otherwise.
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 Drug Regulations.
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; a drag is a dose
- 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 Drug Regulations
Q: What can I, as a vaper, do to help?
A: Plenty! There are a lot of well-meaning but disengaged vendors out there - and regrettably, some short-sighted ones who are not well-meaning at all. If you want greater access, visibility, and the freedom to choose to vape instead of smoke, then you need to find out who your friends in the industry really are.
With step #1 under your belt, you can help non-compliant vendors see what needs fixing. Help them to see how much vaping matters to you - help them to see how credibility is everything, and how credibility means compliance. Speak with your words - and if necessary, with your wallets. Your purchasing power is a tool with which you can pressure the industry to do the right thing. Make this the most important issue, and make sure that's clearly understood. If you care about being able to easily, legally purchase trustworthy vape-products within Canada - then nothing should matter more to you than the credibility of your vendors (or lack thereof).
Many vapers feel uncomfortable at the thought of criticizing anything that their vendors are doing (or are failing to do). But remember: you're not finding fault with vaping. You’re asking vaping in Canada to be as credible as it can be (and should be), so that it will survive. 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. Worse still, vendors who fail to intelligently seek out that understanding.
But it's vendors who make and/or sell these products; the responsibility to answer our critics is on us. No matter how plainly the law says what it says, Health Canada is pretending otherwise. And Health Canada certainly isn't going to voluntarily put an end to its dishonesty. So the ball is in the vendors' court - we have to force the issue.
Vendors = your access to vaping.
As a vaper, ask yourself: should you should care if we vendors are effectively challenging those who oppose e-cigarettes? Do you want to see a greater availability of (and greater visibility of) e-cig products within Canada? Or do you want to see the availability and visibility of e-cig products in Canada continue to decrease for no good reason - leaving you reliant on attempting to sneak in what you can from distant shores?
You can see why we care so much about letting you know what the law says and who needs to do what. Because knowing the answer lets you the customers start putting real pressure on those who can make a difference - the industry. Pressure to smarten up and win this fight for everyone concerned. When Canadian vendors fail to lawfully and intelligently challenge Health Canada's dishonesty, those vendors are just as much to blame for the deplorable situation in Canada as the government 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, we've worked hard to achieve a correct understanding of the law, and its application to our business. We've worked hard to be as credible as we can be. We're engaging Health Canada, eagerly and openly. In short: we're successfully fighting for you, for ourselves - for vaping. Wouldn't it be nice if others were as well?
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.
Note from Cindy: I invite you to watch (or re-watch) the interviews I've given on VP Live. My first appearance was in February 2013 and titled "Nicotine and Canada: The Truth." It begins at the 21:24 mark, and continues through to the 1:24:32 mark. (Yes it's long, lol.) My second appearance was in August 2013: "What The Law Says." It starts at the 19:27 mark and continues through to the 1:24:37 mark.
I'm truly honoured to have been invited not once but twice! I cannot thank Dimitris Agrafiotis and the entire VapeTeam enough for that, and for providing me with a platform to get the truth out there; Canadians need an engaging dialogue regarding vaping, regulation and what the law says. These are my first appearances in such a venue, but will certainly not be my last! In future interviews, I will be even bolder and clearer. Vaping matters too much - it's too precious - to do any less.
Hope you enjoy the videos.
~ WORK IN PROGRESS, more questions and answers to come! ~