In response to my request for stories out there of experiences dealing with Health Canada I received one from Erin Morales (thank you Erin). Erin is a former 2 pack a day smoker who after failing multiple attempts at all the authorized methods of quitting (Nicorette, patch, Champix) was able to find switching the only effective solution and has been vaping and not smoking for almost three years now (and how often have we heard just such a story).
And though there are a few things to discuss re their interaction I will start with just this one small point (more in posts to follow).
Having experienced shipments making it through, others being obviously opened and retaped and sent through and others stopped, she decided to appeal one of the stopped shipments.
Making the usual good arguments re e-cigarettes being a recreational and not therapeutic good, etc. she appealed to the Food and Drugs Act Liaison Office. Health Canada responded with a letter detailing reasons for refusal including the following:
Nicotine in this form (bottled liquid) is not a substance exempt from Schedule F. A Drug Identification Number (DIN) and a prescription from a doctor are required for importation of this product.
The fact that this product is not explicitly intended as a therapeutic product does not impact on its status as a prescription substance or a drug under the Food and Drug Regulations.
Nicotine treats or mitigates the symptoms of nicotine addiction and modifies organic functions in humans. Thus, it meets the definition of a drug in section 2 of the Food and Drugs Act:
Most of the responses from Health Canada have made these same points though it doesn’t hurt to also make the same counter arguments. I quite like the 2nd paragraph where the explicit intended use does not seem to factor into affecting the official status of a substance. In other words this is simply a defense of a categorization (anything we declare is a therapeutic product is one because we declare it is one).
The lack of substance to the claim is clear in the 3rd paragraph where it easy to substitute any number of terms to meet the condition.
Anything you eat or imbibe or inhale, will modify organic function so though the phrase reads like an additional argument, all it really is is blah blah blah, which leaves us with saying that nicotine treats or mitigates the symptoms of nicotine addiction. This is like saying the real purpose of food is not for sustenance but to allay hunger.
The last point is fairly important since defining nicotine use only in terms of addiction (that is you only use if because you use it and derive no benefit at all from it) flies in the face of the fact that millions of people use it because it improves some aspect of their lives.
I drink coffee every day because I really enjoy it – just the taste of it makes my day a better one – I don’t drink it to mitigate my caffeine addiction. And don’t you know it also modifies my organic function!
As we have discussed on the phone, the Food and Drugs Act Liaison Office offers informal dispute resolution services to help clarify communication and to enhance openness and transparency in decision-making. The Office does not review regulatory decisions, make scientific determinations or comment on the scientific basis for a decision. Currently, there is no formal appeals mechanism within Health Canada to review this regulatory decision.
This is last bit restates the idea that any resolution services exist to explain the process but not to question any truth values in the content being addressed by the process. So the message is that even if Health Canada ignores all the evidence about an area, which they seem to be doing with e-cigarettes, or if they just get it plain wrong, there is no way for informed members of the public to enter in a discussion about that.
Health Canada is a bureaucracy and as such fairly immune to individual appeals such as Erin’s. In the long run what we have to work at is appealing and influencing those who Health Canada has to listen to. But it is still useful to speak to Health Canada even if they are quite deaf. Every bureaucracy is maintained by individuals and some of them are already with us. Every letter has the potential to add some more.