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.
Conservative
The Chair Conservative Ben Lobb
Good morning, ladies and gentlemen. We're ready to go. It's just a little after 11:00. We extended our start time to accommodate some members who were speaking in the House today on a motion. We are going to start now.
We're pleased to begin our study on e-cigarettes. We have officials from Health Canada here this morning.
Ladies and gentlemen, we'll begin with Ms. Geller. You can make your opening statement, and then we'll start with questions and answers.
Hilary Geller Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Department of Health
Thank you, Mr. Chair, and good morning.
My name is Hilary Geller. I'm the assistant deputy minister of the Healthy Environments and Consumer Safety Branch of Health Canada. I'm joined here today by Suzy McDonald, the associate director general of the Controlled Substances and Tobacco Directorate within my branch; Dr. John Patrick Stewart, executive medical director within the Health Products and Food Branch; and Peter Brander, the acting senior director general of the regions and programs branch, where Health Canada's inspection capacity resides.
We are pleased to be here today to discuss the issue of electronic cigarettes, or e-cigarettes.
Mr. Chair, in recent years Canada and the world have witnessed the emergence of the e-cigarette market. E-cigarettes are devices, some of which resemble conventional cigarettes, that turn a liquid into a vapour inhaled and exhaled by the user. The liquid may contain propylene glycol, glycerin, and such flavours as candy, fruit, menthol, or tobacco flavour, which may be sold separately from the device itself. Some liquids contain nicotine, a toxic and addictive substance, while others do not.
There is a rapidly growing consumer demand for e-cigarettes. While the e-cigarette market barely registered in 2008, there are now more than 450 brands on the global market. ln 2013, the global e-cigarette market was worth approximately $3 billion U.S. Some business analysts project that e-cigarette sales in the United States may surpass those of traditional cigarettes as early as 2020.
E-cigarettes are marketed, sold, and consumed as alternatives to tobacco or as smoking cessation devices. ln some cases, marketing appears to be targeted at youth and young adults through the use of flavours and certain promotional techniques that glamorize their use.
The single greatest challenge with regard to e-cigarettes is that there is a lack of conclusive scientific data on the risks and benefits of these products.
A limited number of studies have shown that e-cigarettes with nicotine may be beneficial for smoking cessation; however, other studies have shown that e-cigarettes may prevent quitting attempts by smokers by allowing them to satisfy their addiction in places where smoking is not permitted, such as public indoor spaces and workplaces.
The health effects of long-term use and exposure to e-cigarette vapour are unknown. What is known is that nicotine is a toxic and addictive substance. The World Health Organization has also identified the potential for fetal and adolescent nicotine exposure to have long-term consequences for brain development.
E-cigarettes have caused injuries due to device or electrical malfunction, and there are documented cases of poisoning, including cases among children, due to ingestion or spilling of nicotine-containing liquids. Variability in the quality of products available on the market has also been observed, with some products containing nicotine while labelled as containing none.
There is also a lack of evidence regarding the risk that e-cigarettes pose to the tobacco control environment, particularly when youth are involved. There are concerns that e-cigarette use may increase the social acceptability of smoking-like behaviour or the re-normalization of smoking, and about whether e-cigarette use could initiate a nicotine addiction that might then lead to tobacco use.
While there is a lack of evidence regarding youth e-cigarette use, we know that youth are using these products. ln a 2013 Ontario study, nearly 15% of students in grades 9 to 12 were reported to have tried e-cigarettes. We know that preventing early initiation of tobacco use is one of the most effective means of reducing tobacco use in adulthood.
This lack of evidence on risks and benefits poses a significant challenge for regulators, as regulatory regimes are generally based on a risk/benefit profile of what is being regulated.
ln the case of e-cigarettes, there is agreement that youth protection is a fundamental objective and that measures should be put in place to ensure it; however, evidence may arise that allowing adult access might have a positive impact on cessation, and so an overly restrictive regulatory approach has the potential to lead to unintended consequences.
Under the current legislative regime, e-cigarettes that contain nicotine and/or that are marketed with a health claim, such as smoking cessation, are subject to the Food and Drugs Act. These products need to be authorized by Health Canada prior to sale, based upon evidence of safety, quality, and efficacy as demonstrated by the manufacturer. To date, no e-cigarette product has been authorized under the Food and Drugs Act. This means that currently the advertisement and sale of e-cigarettes, including e-liquids that contain nicotine or that make health claims, are illegal and may be subject to compliance and enforcement actions.
E-cigarettes that do not contain nicotine and do not make health claims are legally available without authorization by Health Canada and are subject to the Canada Consumer Product Safety Act.
While these acts address human health or safety concerns, they do not prevent marketing and sales to youth. They do not address risks to the tobacco control environment, nor do they prohibit the addition of flavours that may appeal to youth.
Canada's compliance and enforcement approach for e-cigarettes is led by the regions and programs branch. Examples of our approach include the issuance of a compliance letter requesting that parties stop selling or advertising illegal e-cigarettes, the refusal of non-compliant commercial and personal shipments at the border, and the issuance of import alerts for repeat commercial offenders.
To give you an idea of recent compliance activity, from April 1 to the end of June of this year, almost 740 commercial or personal shipments were recommended for refusal. During the same period our laboratories tested 91 e-cigarettes that claimed to contain no nicotine or had no nicotine information on the packaging, and almost half of the samples actually did contain nicotine.
Mr. Chair, the Government of Canada is not the only jurisdiction seized with the issue of e-cigarettes. This issue is also a concern to our provincial and territorial counterparts. In fact there has been significant federal-provincial-territorial collaboration over the last year, including discussions at a recent federal-provincial-territorial meeting with ministers of health. No province or territory has yet taken action to regulate e-cigarettes; however, Nova Scotia, Quebec, British Columbia, and Alberta have indicated plans to do so.
This issue is also receiving attention internationally. In April of this year, the United States Food and Drug Administration announced a proposal to regulate e-cigarettes with nicotine but without health claims as tobacco products. Under this approach, e-cigarettes with nicotine and health claims would continue to be regulated as therapeutic products. This proposal is currently being consulted on and is not likely to result in a new regulatory framework for a number of years. In March of this year, the European Union approved a revised tobacco products directive that subjects e-cigarettes containing small amounts of nicotine but without health claims to tobacco-like restrictions. E-cigarettes with higher concentrations of nicotine may be available if approved under therapeutic products frameworks. Member countries may also choose to regulate e-cigarettes with any concentration of nicotine as therapeutic products.
Mr. Chair, there have also been a number of reports published on e-cigarettes. I would like to briefly mention two of those. The first is a report published by the World Health Organization in August of this year. The report noted that regulations by member states are needed to impede e-cigarette promotion, minimize potential health risks to e-cigarette users and non-users, prohibit unproven health claims, and protect existing tobacco control efforts from commercial and other vested interests of the tobacco industry. The report also recommended that legal steps should be taken to end the use of e-cigarettes indoors in public places and workplaces.
The second report I'll mention was also published in August of this year by the American Heart Association. The AHA offered policy recommendations for areas in need of focus such as the inclusion of e-cigarettes in smoke-free air laws, preventing youth access, restrictions on the marketing and advertising aimed at youth, taxation of e-cigarettes at a rate high enough to discourage youth use, labelling, and quality control over manufacturing and standards for contaminants.
Together, these two reports address the scope of the challenge of the issue of e-cigarettes and provide a wide range of areas for possible regulatory intervention.
Mr. Chair, what I've attempted to do with my remarks today is to provide a high-level overview and some context on the issue of electronic cigarettes. What becomes clear when discussing this issue is that in many cases there are as many unknowns as there are knowns. The lack of evidence with regard to the dangers these devices might pose to users or bystanders, whether there are potential benefits, and what impact their presence will have on tobacco control objectives all contribute to the challenge of establishing an appropriate regulatory framework.
Thank you again for the opportunity to appear before you today to discuss this important issue.
My colleagues and I would be happy to answer questions that you and members of the committee may have.
Merci.
Conservative
NDP
Libby Davies NDP Vancouver East, BC
Thank you very much, Chairperson. Thank you to the officials for coming today.
This of course is our first meeting of looking at this issue, so it's interesting to get an overview of what's going on. I have to say that I've been following this story, particularly in the media, because there have been quite a few news stories about the issue, particularly over the last year but maybe even before that. You're correct that there is sort of a debate going on between organizations, or health care professionals and scientists, who seem to be taking the approach that we should be really cracking down on e-cigarettes. Then there are others taking an approach that they could be seen as a smoking cessation tool, sort of a harm reduction tool. There is obviously debate out there.
You say that basically going back as far as 2008, so say about six years, this has been emerging. I'm a bit surprised that Health Canada hasn't taken a more proactive approach. You talk about the studies and that they sort of go on both sides. You say on page 3 that other studies have shown that e-cigarettes may prevent a quit attempt by smokers by allowing them to satisfy their addiction in places where smoking is not permitted and then you also raise the issue of youth. It seems to me the obvious response is.... Of course, a regulatory approach would deal with that. It's not like it's an unknown or something that can't be dealt with.
I've got two questions. Has Health Canada actually considered banning e-cigarettes? If not, has Health Canada made any move to regulate them? If so, how far down the line are you? Or are you really just letting the status quo be the status quo and focusing on your enforcement, your non-compliance elements that you noted on page 6? I just feel like it's sort of a passive response that we're getting. But this has been around for six years, so I assume that Health Canada is going somewhere on this and it would be helpful to know where you're going on it and what you've done so far.
Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Department of Health
I propose to give part of the answer and then turn it over to my colleague, Peter Brander, who can talk a little bit about our compliance enforcement approach that we have taken over the last number of years.
The challenge that we face as a regulator is you need to be evidence-based in terms of what you do and what your approach is. Obviously part of the evidence is the scientific work. That scientific work has truly just been emerging over the last number of years and it certainly hasn't caught up. I would say the prevalence of use in the market has well outpaced the state of the science.
I think it's also important to note that we do have a regulatory framework in place. We do have the Food and Drug Act. We can act and we have acted. Peter will be able to tell you a bit more of that story. We also have the consumer product safety framework. We've seen reports from abroad, but we haven't had reports here of exploding e-cigarettes, leaking cartridges, etc. We do have the regulatory authority to act. I think it's important to understand that there is a regulatory framework that allows us to take action today, but it's the touch that you want to take that relies on the science.
NDP
Libby Davies NDP Vancouver East, BC
Before your colleague answers, I certainly understand that you have the authority to take a regulatory approach. I just find it not quite credible that somehow you're waiting for this committee to do something. I mean, surely you guys must be heading one way or the other. Is it really the status quo and you're just focusing on compliance? Where are you going on this?
Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Department of Health
No, I certainly don't want to create the impression that we've been waiting. We've been working with our provincial and territorial counterparts for a number of years now. We have a very detailed work plan with them that involves sharing the science and the regulatory approaches, because we don't exclusively act in this domain. That's the provinces and territories--
NDP
Libby Davies NDP Vancouver East, BC
--so you're saying that B.C., Ontario, Quebec, and Nova Scotia, which you mentioned, if they're heading in the direction of a regulatory approach around use, smoking inside, youth, the actual products whether nicotine is involved.....
Are you saying you are developing a regulatory approach?
Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Department of Health
Certainly, we've been developing the policy work that one has to do to propose a regulatory approach in cooperation with the provinces and territories as the science evolves. In the meantime, we've been using our existing tools.
NDP
Libby Davies NDP Vancouver East, BC
I'm not so interested in the compliance that's going on, because I understand what you're doing there, but it's really where you're headed. Do you have a timeframe in working with the provinces and territories? Are you saying that within six months, a year, or eighteen months you're going to have this policy work done and will start working on a regulatory approach? You must have a game plan.
I think if the committee can have an understanding of that it helps us look at where we need to go as well.
Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Department of Health
I would mention that at the federal-provincial-territorial health ministers meeting only last month this was on the agenda. Certainly, ministers gave direction to accelerate the cooperative approach that we have with the provinces and territories, so we are doing that.
We are also informed by what the U.S. and the EU are doing. I think it's interesting to note that they use three different pieces of legislation. The proposal is to deal with electronic cigarettes, depending on whether there is nicotine and whether there is a health claim involved.
The reports that we are seeing both from the WHO, the American Heart Association, and others all tend to be lining up toward recommending a similar approach.
Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Department of Health
We don't have a specific fixed end date, but what I can tell you is that all the work is happening.
Conservative
Liberal
Geoff Regan Liberal Halifax West, NS
Mr. Chairman, I am sitting in today on behalf of a colleague, Dr. Hedy Fry. I don't have the medical background that she does, of course, but I do have an interest in this issue and I know someone who is trying to quit smoking and is using e-cigarettes in the hope that will help.
What is the evidence in terms of assisting people to stop smoking actual cigarettes by using e-cigarettes?
Suzy McDonald Associate Director General, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Department of Health
As Hilary noted earlier, the evidence is not clear on whether or not these products assist folks to quit smoking. There has only been one randomized control trial done by Bullen and that indicated that the quit rates were similar to other nicotine replacement products. There are a number of other studies ongoing that have mixed reviews around the ability of these products to help folks quit smoking.
I think the second piece of information that's interesting to look at is whether or not the products create dual use within smokers, as opposed to helping folks quit, that folks continue to smoke a regular tobacco product and then use e-cigarettes as a secondary mechanism. What we do know is that quitting tobacco outright has a much better overall impact on your health than continuing to smoke even some products in the long term. But the bottom line is that we do not have the evidence yet to demonstrate that these products definitively help folks quit smoking.
Liberal
Geoff Regan Liberal Halifax West, NS
I missed the very start and I didn't hear what scientific or medical qualifications the panel or you may have, or whether this has been advice by the department. Can you clarify that, just so I understand?
Associate Director General, Controlled Substances and Tobacco Directorate, Healthy Environments and Consumer Safety Branch, Department of Health
I'm the associate director general of the controlled substances and tobacco directive. My colleague here, Dr. Patrick Stewart, might want to add a few things to that, but that's the information we have.
Liberal
Geoff Regan Liberal Halifax West, NS
I will let you answer that, but maybe you can answer this as well. Is there any doubt in your mind that for someone who is trying to stop smoking, an e-cigarette is less harmful than an actual cigarette with tobacco in it that's lit and burning and there is smoke produced?
Dr. John Patrick Stewart Executive Medical Director, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
Maybe I'll answer the first question a little bit more substantively.
The intuitive assumption is that yes, this product may assist with smoking cessation as have other nicotine replacement therapies that are out there. But the fact is that this is a novel route of administration. The nicotine replacement therapies that are now marketed have provided evidence that they do have a positive impact and an understandable safety profile. They deliver the nicotine through a different route, through the skin or the oral mucosa. The rate of rise in nicotine in those products is slow and predictable. When these products were marketed they came in with clinical studies around blood levels and the addiction potential of the product, as well as efficacy of treating smoking cessation.
This is a new product. It is actually delivering the nicotine into the lungs. What the e-cigarette does is generate a vapour that has very, very tiny droplets that allow the nicotine to get into the pulmonary tissue. Some studies that have been done show that you have a much more rapid absorption of the nicotine, so you have much more of a cigarette-like effect of nicotine coming into your bloodstream and distributing it very quickly. It more mirrors not only the craving but the reward that you get from a cigarette.
The other thing is that we don't know the addictive potential of this. The concern is that intuitively it may play a role but actually it may be as addictive as, if not more addictive than, cigarettes. Before we run off and plan a regulatory framework we need to look at what the science is telling us and not introduce risks we don't understand.
Liberal
Geoff Regan Liberal Halifax West, NS
Would I be right to assume, from your opening comments, that the assessments Health Canada have concluded are not studies that Health Canada itself has initiated, but reviews of medical studies? Is that accurate? Not that there's anything wrong with that, but just so I understand. Health Canada hasn't initiated an assessment other than examining the literature and the studies.
Executive Medical Director, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health
That is correct.
Just to clarify, under the Food and Drugs Act and regulations, if a manufacturer of, say, an e-cigarette or any health product wants to gain market access, it's up to them to carry out the research to demonstrate that the product has efficacious effects on the disease they're trying to treat, that it doesn't introduce unrealistic or intolerable safety issues, and that it can produce a product in predictable quality. In getting market access in the current framework in Canada, it's up to the manufacturers to develop that evidence and bring it in to the regulator. If it's reviewed and felt to be acceptable for a proposed indication, then it will get a market authorization.
Liberal
Geoff Regan Liberal Halifax West, NS
How is Health Canada currently handling the stores that are selling e-cigarettes, on the one hand, those that contain nicotine, and on the other hand, those that don't?
Peter Brander Acting Senior Director General , Regions and Programs Bureau, Department of Health
Since 2009 Health Canada's been very clear in advising Canadians not to purchase or use these cigarettes. As Hilary has mentioned, their safety, quality, and efficacy remains unknown, and they may pose a health risk.
Our compliance and enforcement approach for these products is complaint-driven and risk-based. It includes site visits, warning letters, stop-sale requests, and customs refusals and/or the seizure of products. We continue to monitor the sale of these products as well as non-compliant retail locations and websites. We're taking actions in accordance with our compliance and enforcement approach.