Evidence of meeting #37 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was product.
A video is available from Parliament.
11:25 a.m.
Liberal
Geoff Regan Liberal Halifax West, NS
Has Health Canada examined any other jurisdictions to see how they're handling the issue of e-cigarettes, and if so, which ones—if the list is not too long?
11:25 a.m.
Associate Director General, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Department of Health
I think we noted earlier that we'd been looking at what the U.S. in particular has been doing and what the EU has been doing. The EU came out in May with a directive around e-cigarettes. They're looking, essentially, at treating e-cigarettes that have a health claim and contain nicotine as a drug, those that do not have a health claim but contain nicotine as a tobacco product, and those with no health claim and no nicotine as a consumer product. The U.S. is taking a similar approach, using three regulatory regimes to regulate the product overall.
11:25 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
Thank you, Mr. Chair.
Ms. Geller, thank you very much for coming and presenting here today. I very much welcomed your comments at the start.
This may not be a fair question to put to you in your role at Health Canada. It's very true that in fact the manufacturer of any product, before it is approved by Health Canada, would have to undertake their own scientific studies. I'm concerned more about the level of knowledge and scientific evidence available out there, generally speaking.
On the one hand, all lay people hear that the e-cigarette may help people end their addiction to smoking, and that it maintains some of the physical attributes of that addiction and allows them to wean themselves off nicotine, much like the patch, where you would start off with, perhaps, a higher content of nicotine and then eventually lower the content, and hopefully, eliminate all nicotine that you are consuming.
Others say it's quite the opposite, that maybe e-cigarettes are a gateway, that you start using e-cigarettes, perhaps just the ones with glycerine, the ones that have no nicotine, and then ramp your way up, and then start a fulsome addiction to cigarette smoking.
Have you at Health Canada reviewed the scientific literature available? On balance, which side do you think that scientific literature favours?
11:25 a.m.
Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Department of Health
We constantly review the scientific evidence as it comes out. I would say that on this particular issue there's new evidence very regularly that is starting to suggest certain directions, but I don't think anybody would say that we have the weight of evidence yet to be conclusive on any of these key issues. There are a few issues where it is conclusive, and the dangers of nicotine is one of them.
I'd like to turn to Dr. Stewart for a moment to talk about nicotine and our approach to the evidence in making these kinds of decisions.
11:25 a.m.
Executive Medical Director, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
To build on what's just been said, we've definitely been monitoring e-cigarettes, what scientific evidence is out there in the public domain, and looking at it from the context of our regulatory frameworks. We did put out a notice in 2009 that alerted stakeholders to the fact that we felt this was a new drug format, in the sense that it was not the same as nicotine-containing gum or lozenges or patches, that this was a novel route of administration. We put it out so as to caution Canadians that Health Canada did not fully understand comprehensively the safety of this product, and to not seek it out without discussion with your health practitioner. Some e-cigarettes contain nicotine; some of them do not. Some of them contain just propellants or things like propylene glycol. There are some studies looking at the toxicity or the hazards associated with this, but they are certainly not comprehensive.
From the regulatory point of view, if we're looking at providing access to e-cigarettes, for, say, smoking cessation through the Food and Drugs Act and its regulations, then we would want to see evidence of the same sort of detail that we expected with other nicotine replacement therapies when they came in, or other pharmaceutical products that do play a role in smoking cessation.
To date, we have not had that evidence presented to us, and the evidence isn't comprehensive enough that we would feel comfortable that a product could be marketed in Canada with a clear claim that this plays a role in smoking cessation. The level of evidence is not comprehensive, is not population-based. It's not well designed and organized to the state that we would feel comfortable authorizing it. It may play an important role, and we hope that we do find that. I think our due diligence is such that we need to ensure that if anything gets an approval from Health Canada with a claim that there is substantive evidence that supports that, and if Canadians embark on using this product, they know it's going to have a positive impact, and they will not be assuming undue risks or risks that are not well characterized.
11:30 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
In reviewing the scientific literature available, can you provide to us some information about the probability of addiction for e-cigarettes that contain nicotine and those that do not contain nicotine, compared to regular cigarettes?
11:30 a.m.
Executive Medical Director, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
Again, it would be nice to say that there have been well-designed studies that demonstrate this, but to date, there have not. If you just think about an e-cigarette for a minute, it has a liquid in it. The liquid has varying constituents. Some have nicotine in them. Some have nicotine in varying concentrations. They have coils that heat this liquid up. Various manufactured products will deliver different amounts. It depends on the individual, how frequently they're puffing, how much they're drawing in, and other things that come in with it. It's not a straightforward matter—
11:30 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
If I may interject, sir, what are the possible health implications from that e-liquid, whether it's ingested, inhaled, or comes in contact with skin?
11:30 a.m.
Executive Medical Director, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
Again, it depends on what it contains. And again, I don't think there's been a comprehensive evaluation of this. Certainly, the paper from the WHO explored some of the concerns around hazards of it. Nicotine itself, as we mentioned earlier, is quite toxic. If taken in doses of significant quantity, it can be fatal. As far as we know early on, the propylene glycol constituents seem to be an irritant to the airways and may cause problems for asthma and other things. But again, in order to be able to say with comfort or clarity that this is an acceptable risk, we need to have properly designed studies that demonstrate efficacy as well as a well-characterized frequency of adverse events.
11:30 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
Thank you.
And some provinces have taken steps, or are looking at taking steps, but inasmuch as cigarettes were originally regulated by many municipalities in sort of a hodgepodge system, are you aware of any municipalities that have currently taken steps to regulate e-cigarettes?
11:30 a.m.
Associate Director General, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Department of Health
A number of municipalities have taken action to ban e-cigarettes in places where smoking is not allowed, so anywhere there is a smoking ban there is now also an e-cigarette ban, and those municipalities go across the country. Most recently—I think just yesterday—Saskatchewan announced too.... There have been some out in British Columbia. We're starting to see that municipalities are in fact stepping up, but just with regard to smoke-free spaces.
11:30 a.m.
Conservative
Eve Adams Conservative Mississauga—Brampton South, ON
And so are these bans on e-cigarettes that do not contain nicotine, or only those that do contain nicotine?
11:30 a.m.
Associate Director General, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Department of Health
They're bans on e-cigarettes overall, whether or not they contain nicotine. The outside user, and in fact sometimes even the person using the product, can't tell whether or not there's nicotine in that product, so it's a global ban.
11:30 a.m.
Conservative
11:30 a.m.
Conservative
11:30 a.m.
Conservative
David Wilks Conservative Kootenay—Columbia, BC
Thank you, Chair.
And thanks for being here today.
I guess I look at it from the enforcement side, from my background. I just see that we're lacking, terribly. Mr. Brander, you mentioned warning letters and seizure actions. I'm assuming they fall under the FDA and other regulatory bodies. Could you explain to me a little more about that? If we have seizure actions that are available, then that would mean to me there are other opportunities available through Health Canada that they've looked at. If there's a seizure action I think there's something wrong.
11:35 a.m.
Acting Senior Director General , Regions and Programs Bureau, Department of Health
Seizure activity would take place at the border. In the early days there were a number of seizures that had taken place. The approach has shifted. As we're aware of product coming across the border it is actually not allowed to enter the country, thereby negating the need for us to seize products.
The remainder of our approach, as I mentioned earlier, is complaint-based and risk-based. We exercise our authority under the Food and Drugs Act, so we have inspectors across the country. They examine the risk. They prioritize their activities based on the risk.
11:35 a.m.
Conservative
11:35 a.m.
Acting Senior Director General , Regions and Programs Bureau, Department of Health
That's part of the challenge in looking at e-cigarettes. The science or the lack of science that's out there makes it difficult to accurately define the risk of those activities. Those inspectors work across a broad range of activities, doing inspections in areas such as pharmaceutical drugs, medical devices, biologics, radiopharmaceuticals, and natural health products, including e-cigarettes. The risk is looked at across that broad spectrum of activities and actions are determined based on that.
11:35 a.m.
Conservative
David Wilks Conservative Kootenay—Columbia, BC
So of the 450 brands that, as said in the initial statement, are on the market, how many of those are created in Canada? Do you know?
11:35 a.m.
Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Department of Health
We don't have that kind of market intelligence.
11:35 a.m.
Conservative
David Wilks Conservative Kootenay—Columbia, BC
So that would also mean, since we've stopped seizure.... Correct me if I'm wrong. We've stopped seizure actions at the border?
11:35 a.m.
Acting Senior Director General , Regions and Programs Bureau, Department of Health
As we're aware of shipments coming across the border we work with Canada Border Services Agency to stop those shipments from entering the country.
11:35 a.m.
Conservative
David Wilks Conservative Kootenay—Columbia, BC
It would seem to me if we have 450 brands available on the market and we have a significant usage in any...I can walk into any Peoples Drug Mart and buy it...that our seizure actions probably aren't what they should be.
