First of all, thank you so much. It's an honour and a pleasure to present to this committee again. I am speaking on the use of electronic nicotine delivery devices, commonly known as e-cigarettes.
We have sent some speaker's notes to you. I'm sorry they came at the last minute, but they have been sent.
Very quickly, the title of my presentation is “E-Cigarettes: Disruptive Innovations with Promise and Peril”. I think that's the reason why we need to look at this.
By way of background, I'm a physician who works at the Centre for Addiction and Mental Health. I specifically focus on the treatment of people with tobacco addiction and am currently also running some studies looking at the use of electronic cigarettes by Canadians.
The big problem is that we are stuck in tobacco control in Canada. For example, cigarettes were actually invented over 150 years ago and the technology hasn't changed that much. What has changed is the ability for tobacco companies to mass produce them and cause lots of harm.
The other reason that we are stuck is that the prevalence of smoking has not budged much in the last five years. Currently, the burden of smoking is borne by people who can least afford to smoke, those who have less than high school education, those who have other comorbidities, like mental health and other addictions. The rest of society has benefited from the existing policies, but there's an inequity that has crept into society where approximately 4.5 million Canadians still use tobacco on a regular basis.
We are stuck. We need new innovations and new ways to address it. We've looked at other mechanisms like education, taxation, and smoke-free by-laws. All of those things have been very useful, including creating treatments for smoking cessation.
However, with the advent of e-cigarettes, or electronic cigarettes, as delivery devices that came onto the market, we began to see great demand by smokers. When you spoke to them, they would say to us, “Well, I'll use it when I can't smoke”. On the other hand, many people were looking at it as a way to get the monkey of combustible tobacco cigarettes off their backs. Again, many people believe that it would be safer and less addictive.
When you look at them, not using a scientific approach but a common sense approach, automatically one can say that they appear to reduce harm and the cost. For example, we know they have lower numbers of particles compared to combustible cigarettes. The risk reduction level is not yet fully known.
On average, definitely, smokers are getting much less chemical exposure than they would from cigarettes. And of course, from a cost perspective, approximately, at least in the U.S., what people can get from one e-cigarette is essentially the equivalent of one to two packs per day. So definitely, it becomes much cheaper for them to use.
However, there are some health risks that are emerging that we need to pay attention to. Whether the e-cigarette contains nicotine or not, there are some problems. They come from the device itself and how it's manufactured. If the battery is faulty, for example, fires can occur. They can overheat, and we've seen some examples of that.
If there isn't any safety coating around the heating element you may be aerosolizing or putting heavy metals into people's lungs. With the newer devices that actually can heat up to higher temperatures we may be actually even creating some cancer causing chemicals that are getting into the person's lungs and body.
The other thing that is the big unknown is the propylene glycol. Although it's generally considered safe in humans, it's not necessarily proven to be safe in this repeated exposure that some people might get. But what we do have are increased cases of poisoning, especially in the U.S., where children have been getting their hands on the nicotine cartridges or refillable cartridges and getting toxicity. Of course, there's the issue of second-hand vapour.
Basically, the studies that have been done to see whether e-cigarettes could be a good smoking cessation alternative similar to the medications for smoking cessation are not as good, or are an equivalent at best. E-cigarettes just cannot compete with cigarettes. The switchover is still not complete because many people will use both cigarettes and e-cigarettes.
I think you are going to hear this metaphor many times from some of my colleagues as well. When both products are on the market, people will go to what they know. So that is one of the problems.
We have had examples in Canada. For example, when we had leaded gasoline and had to move to unleaded gasoline, we had to make some really significant shifts and not have leaded gasoline available at the same time as having unleaded gasoline available. Similar things happened with leaded and unleaded paint. So we have a history of making things safe by removing some toxic chemicals. But you can't have both on the market at the same time.
So the story is not completely told around whether e-cigarettes can be useful to quit smoking when you still have cigarettes available on the market.
The biggest concern we have now, especially in Canada, is that because e-cigarettes not containing nicotine are available in any general store with no age restriction, even my five-year-old could walk up to a store and purchase them and practise smoking without any regulatory framework as to what's in that product or whether it has nicotine or not, contaminations, viruses, or bacteria.... We have no idea what people are getting exposed to. There is no quality control or disclosure of contents and even from the same manufacturer from brand to brand we have no way of knowing what's in that e-cigarette.
Currently I am analyzing an e-cigarette that was bought so-called legally by a patient of a family doctor in our community. That person ended up with headaches, vomiting, nausea, and went to the emergency room where, when they tested him, found that the e-cigarette contained marijuana. We are doing further tests to see if in fact that is true, as we certainly have seen the devices and how they can be manipulated to deliver marijuana instead of nicotine.
So we also have this illogical regulation in Canada where e-cigarettes containing nicotine are not legal, but yet neither are they illegal. So basically we know of people who are using home-grown labs to make nicotine or are importing nicotine and then compounding it and selling it because it's not technically illegal to do that. People are easily converting their devices to use nicotine or marijuana.
What are the challenges and concerns we have? One is that this is potentially introducing youths to nicotine addiction. They are overdosing. The e-cigarettes have flavours and there is advertising for them. Although the U.S. data is comforting in suggesting that e-cigarettes may not be leading kids to go on to full-blown smoking, it is still unclear. There is a great potential for that happening.
The biggest concern currently in the absence of regulation is that we are re-normalizing smoking. So many of you, if you have travelled, may suddenly be surprised to see somebody in a restaurant or an airport lounge “vaping” an e-cigarette. Although it may not results in exposure harm, it is socially harmful because it re-normalizes the act of smoking and makes cigarettes attractive and, therefore, it becomes impossible or very difficult to enforce all the gains that we've made in tobacco-free policies.
The other thing that we've noticed is that it undermines people's efforts to quit smoking, because the attractiveness of this moves them away from approved medications or approaches that have been shown to have benefit towards these issues. I guess the biggest unknown question is the long-term health effects, although from a common-sense approach these would definitely be a lot less than cigarettes. Where the long-term harm might occur is if e-cigarettes become a gateway to people then going on to smoking combustible cigarettes.
If in fact we had a situation where people only used e-cigarettes without going on to other forms of cigarettes, then that would be a different matter. But with the availability of cigarettes and the regulations around cigarettes, the market could certainly get pushed using e-cigarettes as a way of getting a whole new generation of so-called replacement smokers for those who have quit or die off. It becomes very challenging to then have a consistent message to people about tobacco control.
However, having said all that, in the short term I'm going to start off with my eight recommendations that we should think about for the long term and the short term.
In the long term, we have to ask ourselves as a society whether we want to have technology that was developed 150 years ago, that has been proven to kill one-half of its users if used as intended by its manufacturers, to continue to be on the market, or do we owe it to the next generation, when we have a potentially viable alternative because of the development of technology, to study it and look at it as a possible way to replace cigarettes on the market?
We can learn what happened with alcohol prohibition. When that happened, clearly people were using moonshine and all sorts of denatured alcohol and that was causing more harm. But it was only when alcohol was legalized and regulated that we saw a dramatic drop in the poisonings related to alcohol and alcohol-related harm. Can we not do a similar thing with a very dirty, although legal, delivery device such as cigarettes and have better technology, better development of technology? Currently, where e-cigarettes are, they're in the early stages, so there are many ways one could look at e-cigarettes much like the early motorcar. You know, the horseless carriage. With what we have today, we're moving on to “electric cars”, etc., so we can see how this can progress to really help and be of value to society.
What do we need to do so that we can start that process? We need to be able to study these products better. Currently, our regulatory framework is through Health Canada where I, as a researcher wanting to study this, would need to have hundreds of millions of dollars to even start the research study. Forget about doing the research study. If only to show safety data and exposure data in animals--of course, it's extremely difficult to get animals to smoke--we would have to do this because they are fitting it into a frame of other medicines. Clearly, looking at e-cigarettes as medicine is wrong-headed, because we know what happens with medicines; they don't replace cigarettes. It actually promotes tobacco industry products in some sense, because it doesn't replace them.
Can we create a framework that allows an expedited study of these products so we can actually study them legally with nicotine-containing products, and have an integrated approach so we can study it while we are adding to the evidence base in Canada to make better refinements to the product? We need to look at it clearly because of the huge public health nature of smoking.
To this day, we still have approximately the size of the town of Belleville—that's about 35,000 Canadians—dying every year from tobacco-related illnesses. We know that if smokers stop smoking, within a year their risk of dying is reduced by at least half. So we could see some very immediate benefits if we started having people switching over. You'll hear from my colleagues in the U.K. that 7% of the population there has switched exclusively to electronic cigarettes.
We could have some really huge impacts if we had an investment in studying these products in this way, making sure we had products that met quality assurance standards. They would have to meet certain standards for hygiene, cleanliness, and in what they deliver being consistent from product to product, meeting some sort of standard and having some inspectors going in to make sure these were not being manufactured around children, and to make sure that people are wearing masks and are not coughing into the liquids they're preparing, etc.
Immediately, we need to prohibit e-cigarette vaporizing where smoking is prohibited. We have made so many gains in society and to shift backwards would be a shame, because we would lose all the benefits to health care workers and to workers who work in these places by protecting them from being exposed to these compounds. Clearly, we need to have a policy right away that restricts e-cigarettes from minors. If nothing else, how is it possible that a five-year-old could go into a convenience store and buy an electronic cigarette simply because it says it doesn't contain nicotine? When they do studies on electronic cigarettes right now that claim not to have nicotine, they do find traces of nicotine, because their manufacturing practices are not meeting standards. They get contaminated.
What can we do to restrict sales to minors? How do we prevent the advertising?
If you see the advertising of e-cigarettes in the U.S., it is certainly becoming an undermining effort to helping kids stop or not to start. We certainly need to educate people about the risk, especially youth and pregnant women. Most importantly, we need to have a detailed surveillance and monitoring system that can tell us what people are using and what harms they're coming to.
I'll stop now and take any questions.
Thank you very much for your attention.
Thank you to you and the committee for the invitation here to give evidence. I do so as professor of epidemiology at the University of Nottingham. I'm director of the UK Centre for Tobacco and Alcohol Studies, a research network based in the U.K. for alcohol policy and practice, and I chair the Royal College of Physicians' tobacco advisory group. It was in that role that I led the production of a report called Harm Reduction in Nicotine Addiction
, which was published in 2007 and called for exploitation of the opportunity to provide smokers with alternative sources of nicotine to reduce the death and disability caused by tobacco smoking. We used as our proof of concept that it can work the experience that the Swedes have had with oral tobacco, which has resulted in very low levels of smoking prevalence and very low cancer rates.
That approach was accepted by the U.K. governments. The outgoing Labour Government published a policy strategy document that included harm reduction, and then the incoming coalition government a year later did the same thing. We've had an environment of encouragement of alternative sources of nicotine for smokers for some years in this country.
Electronic cigarettes came along just at the time that the RCP report was published in 2007. So it wasn't covered in that report but essentially went a long way towards fitting the bill of what we felt was needed to encourage smokers to use less harmful sources of nicotine—something that's socially acceptable, affordable, available in the same points of sale as tobacco cigarettes, and something that works as a tobacco substitute. It's probably fair to say that the early generation electronic cigarettes were less effective than the later generation ones, but the fact remains that these have proved extremely popular in the U.K. and many other countries since.
Earlier this year with Dr. Bogdanovica, I published a report for Public Health England, which is available on their website and which I think has been accepted by Public Health England, the organization that supervises public health in our country, as the sort of background policy or principle of electronic cigarette use and public health. The report concluded that smoking kills. We have 10 million smokers in the U.K. I don't know what the figure is in Canada, but five million of those are going to die unless they stop smoking tobacco. Although we're doing our best with conventional tobacco control policies, the prevalence of smoking is coming down steadily but slowly. Most of those smokers are alive today. Therefore five million of those smokers are alive today. Most of those will die from their smoking before existing policies touch them.
That burden of morbidity and mortality falls particularly on disadvantaged people, the socially and economically disadvantaged, those with mental health problems, and various other isolated groups in society. Electronic cigarettes provide a substitute that many of those people find acceptable. We have found that by switching as a lifestyle choice rather than something that's medicalized involving a commitment to quit smoking, a couple of million of our smokers in the U.K. are now occasional or regular users of electronic cigarettes and about 700,000 are now exclusive users. Seven hundred thousand people quitting smoking by swapping to an alternative source over the course of about four years is more than our National Health Service smoking cessation services have achieved in over a decade.
We therefore feel that electronic cigarettes and the products that are in development that follow them into the market offer huge potential health benefits, which will be accrued particularly by the most disadvantaged in society. But they also pose risks to society. A number of them—too many to list here—include renormalization of smoking, concerns over long-term safety, use by the tobacco industry to re-engage in tobacco policy, use as a dark marketing tool by tobacco companies, promotion to children to establish new generation of nicotine addicts and many other risks. We feel that all of these deserve concern, but all of those can be managed and it would be a mistake to throw the baby out with the bath water by restricting electronic cigarettes so severely as to prevent the benefits to existing smokers.
Already in this country electronic cigarettes are being used by many more people than use conventional nicotine replacement therapies. The latest evidence from the Smoking in England website, which is a rolling survey of smokers, is that the prevalence of use has levelled off and is about one in five smokers.
On the pros and cons of how these products can be regulated, I can only comment on what's happening in the U.K., where we currently cover them under general sales regulations and which do not require demonstration that the products work. So a smoker can go out and spend a lot of money on one of these things and get no nicotine from it. Nor do we have guarantees of their safety. I think most people accept that this is an unsatisfactory situation. We do have legislation in progress and voluntary agreement recently accepted to stop advertising and selling to children.
The MHRA, our medicine regulatory agency, has recognized these nicotine products as a good thing for public health and stepped back from defining them as medicines a year or so ago, but have offered what they call right-touch regulation of medicines as a route to market for manufacturers. The idea was that the right-touch regulation would be a simplified version of medicines regulation or licensing. In my opinion it isn't working out that way and it remains extremely cumbersome.
From 2016 or 2017, depending on which products, all electronic cigarettes will come under the control of the European tobacco products directive, which will impose limits on emissions and amounts of nicotine delivered according to standards that have yet to be set. We have no idea what they will involve, but they will limit the maximum dose delivered by the products so as to render them ineffective. That's unsatisfactory regulation and we don't have a suitable way out.
Going back to the original RCP report, what we argued was that the only solution to this is to regulate nicotine differently from other products, and that tobacco and non-tobacco products should all come into a consistent system. This allowed market freedoms in direct proportion to the relative safety of the product, therefore making cigarettes extremely unaffordable and difficult to get hold of, but making it increasingly easy to get hold of nicotine substitutes. I would like to see us doing that, but I don't think it's going to happen.
A final thing that is very important to the monitoring of electronic cigarettes, and realizing the potential they offer, is that you must have very effective monitoring or prevalence monitoring in place. In the U.K. we have that on a relatively small-scale survey. If we do this then it's possible to see where the abuses are and to deal with them early. At the moment in the U.K., use among smokers, as I've said, is about 20% exclusive use to the exclusion of cigarettes and about 7% of smokers. Use among children and young people is almost entirely limited to those who smoke, with about 1% or 2% of young people who are non-smokers ever experimenting with the product. At the moment the impression is that electronic cigarettes are providing a very powerful force for the good in English public health, and we hope that can continue.
I was saying it is an honour to be able to present testimony to this committee on electronic nicotine delivery systems, ENDS, of which electronic cigarettes are the better known type. My testimony is presented on behalf of the World Health Organization, based on its report on ENDS, which was prepared in response to the request made by the Conference of the Parties of the WHO Framework Convention on Tobacco Control. This report was presented at the sixth session of the COP, Conference of the Parties, which just took place two weeks ago. A copy of this report in English and French has been provided to the committee. My testimony will refer also to the decision adopted by the sixth session of the COP on ENDS, also provided to the committee.
ENDS are the subject of a health debate among bona fide tobacco-control advocates. Whereas some experts welcome ENDS as a pathway to the reduction of tobacco smoking, others characterize them as products that could undermine efforts to denormalize tobacco use. ENDS, therefore, represent an evolving frontier, filled with promise and threat for tobacco control. ENDS deliver an aerosol by heating a solution that users inhale. The main constituents of the solution by volume, in addition to nicotine when nicotine is present, are propylene glycol, with or without glycerol and flavouring agents.
The global ENDS market is presently formed by about 500 brands, which use liquids presented in close to 8,000 flavours. Transnational companies have entered the ENDS market and are increasingly dominating it. Questions related to the use of ENDS as reflected in the WHO report have been articulated in three groups include whether ENDS pose health risks to users and non-users, whether they are efficacious in helping smokers to quit smoking and ultimately nicotine dependence, and whether they interfere with existing tobacco-control efforts and implementation of the WHO FCTC.
When talking about the health risk of ENDS it is important to know that the battery voltage, unit circuitry differences, and the type of solvent used in the liquid result in considerable variability of the level of nicotine and other constituents they deliver, including the formation of toxicants in the emissions.
In the area of risks to health I would like to say three things.
In terms of risks from nicotine inhalation, a key concern with nicotine is its capacity to affect the brain development of foetuses, children, and adolescents; hence, our recommendation to regulate ENDS in a way that avoids initiation of ENDS by these groups.
In terms of health risks resulting from chronic inhalation of toxicants from ENDS, conclusive evidence about the association of ENDS use with specific diseases will not be available for years or even decades, given the relatively recent entry of ENDS into the market and the lengthy lag time for onset of some diseases of interest such as cancer. However, evidence based on the assessment of the chemical compounds in the liquids used and in aerosol produced by ENDS indicate that average ENDS use produces lower exposures to toxicants than combustible tobacco products, although some ENDS can produce levels of some carcinogens that are similar to that produced by cigarettes. Hence our recommendation is to regulate ENDS in a way that minimizes risks for users and avoids the initiation of ENDS use by non-smokers.
In terms of risks to bystanders, they are exposed to the aerosol exhaled by ENDS users, which increases the background level of some toxicants, nicotine as well as fine and ultrafine particles in the air, although at levels lower than that of conventional cigarette emissions. It is not clear if these lower levels in exhaled aerosol translate into lower exposure, as demonstrated in the case of nicotine. Despite having lower levels of nicotine than in second-hand smoke, the exhaled ENDS aerosol results in similar uptake as shown by similar serum cotinine levels. It is unknown if the increased exposure to toxicants and particles in exhaled aerosol will lead to an increased risk of disease and death among bystanders as does the exposure to tobacco smoke.
However, epidemiological evidence from environmental studies shows adverse effects of particulate matter from any source following both short-term and long-term exposures. The low end of the range of concentrations at which adverse health effects have been demonstrated is not greatly above the background concentration, which means that there is no threshold for harm and that public health measures should aim at achieving the lowest concentrations possible. Hence, our recommendation is to protect non-users in indoor public places.
In terms of ENDS as an aid to quit smoking, although anecdotal reports indicate that an undetermined proportion of ENDS users have quit smoking using these products, the evidence for the effectiveness of ENDS as a method for quitting tobacco smoking is limited and does not allow us to reach conclusions at this point. Hence, our recommendation is to impede unproven health claims about ENDS.
From the point of view of the impact of ENDS on existing tobacco-control effort there are several concerns.
One is that ENDS could be a gateway to nicotine dependence and smoking for youth. The likelihood and significance of this effect occurring will be the result of a complex interplay of individual, market, and regulatory factors and is very difficult to predict. They can only be assessed with empirical data which at present are limited. These data show that young, never smoker users of ENDS is about 1% in the few countries which have data. In some countries this figure does not seem to grow while in at least one country, Poland, ever use of ENDS among never smokers between 15-19 years-old has gone up from 1.6% to 7.1% in three years and current use has gone up from 0.6% to 2% coupled with a significant increase of smoking in this age group.
Another concern is the aggressive marketing of ENDS by some tobacco companies to be used in smoke-free environments as a way to break the enforcement of smoke-free policies.
A third and final concern is the role of the tobacco industry that is at the same time marketing conventional and electronic cigarettes in order to dominate the ENDS market and to preserve the status quo in favour of cigarettes for as long as possible. The industry’s historic interest in smokeless tobacco products outside some Nordic countries, for which similar benefits to ENDS were made, was because they could be used, as declared in their own documents, in smoke-free environments and could be promoted to young, non-tobacco users to create new forms of tobacco use. All of this is while they were simultaneously pretending to be part of the solution to the smoking epidemic because they present ENDS as the solution to the epidemic that they themselves have created.
After consideration of the report and extensive deliberations of the COP of the WHO FCTC during the week of October 13, 2014, the 179 parties to the WHO FCTC decided unanimously to welcome the WHO report, invite parties to take careful note of it, and request WHO for an update to be presented in two years. They also decided to invite parties to consider taking measures to at least achieve the following objectives in accordance with national law: first, prevent the initiation of ENDS by non-smokers and youth with special attention to vulnerable groups; second, minimize as far as possible potential health risks to ENDS users and to protect non-users from exposure to their emissions; third, prevent unproven health claims from being made about ENDS; and fourth, protect tobacco control activities from all commercial and other vested interests related to ENDS including the interests of the tobacco industry. It was also going to invite parties to consider prohibiting or regulating ENDS, including as tobacco products, medicinal products, consumer products, or any other categories, as appropriate, taking into account a high level of protection for human health. Finally, they urged parties to consider banning or restricting advertising, promotion, and sponsorship of ENDS, as well as to comprehensively monitor the use of ENDS.
Thank you for your attention.
I'll be glad to respond to any questions you may have about issues pertaining to...[Inaudible--Editor].
In Canada smoking is at an all-time low. We've dropped from 22% to 16% in the last decade.
We're obviously primarily and especially concerned with adolescents taking up smoking, because it does lead them onto a path of lifelong smoking—but smoking by them is also at record lows. We're only at 7%. Of Canadians aged 15 to 17, only 7% smoke. I believe that on an international basis we're leading the world in banning flavoured cigarettes, and we prohibit companies from advertising directly to children.
I want to follow up on the concern of one of my opposition colleagues about smoking e-cigarettes with or without nicotine in public places. I guess my concern is twofold. One, even if there is nicotine in that e-cigarette, I am less concerned about the fact that there is a dramatic decrease over combustible cigarettes, because I think the expectation that Canadians ought to have, certainly for ourselves and for our children, is that they should be in smoke-free environments altogether.
Additionally, I think we also want to de-normalize smoking. Children are particularly susceptible to social cues, so if they just see the behaviour.... You can remember that entire concept that smoking in movies just seems rather cool, or the fact that it seems rather normal that you would be out in a restaurant, a public place, or a place of work and people are out there smoking an e-cigarette, with or without nicotine. I think it sends a terrible message to youth, and I think we want to de-normalize that.
I think that's a separate conversation, though, from whether or not we want to offer adult choices to folks and provide e-cigarettes for sale in Canada with nicotine content. I would hope that as a nation we would encourage those who ban cigarettes currently from banning all e-cigarettes, with or without nicotine, because I think we genuinely do want to target adolescents and ensure that they aren't picking up on this habit and that we're not normalizing it.
Would you have any comment, though, on the concept of e-cigarettes with nicotine and ensuring that we have smoke-free places as opposed to just lowered output? Currently in Canada, we're banning that. You can't just go and smoke in a restaurant. I'm very concerned that you would be recommending that there isn't much harm there. Could you perhaps extrapolate?