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.
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?
The policy work is focused in a couple of areas.
We are examining the Food and Drug Act, the Tobacco Act, and the Controlled Drugs and Substances Act and are going through an exercise concerning how we can use our current tools.
The gaps in how we can regulate a unique product like electronic cigarettes are emerging. We have discussed some of those challenges today and certainly we have seen them internationally pointed to as well, because these are a unique product.
We would have serious concerns about some parts; about others we're not so sure. So we are engaged in an exercise of trying to devise some sort of unique, we think, regulatory regime that would appropriately fit the risks and the benefits and the unknowns of this new product category.
I'll just note in that regard that at the FPT health ministers' meeting, Nova Scotia made a very useful proposal, to devise in cooperation with the provinces and territories a new regulatory regime that would have all those fundamental characteristics of youth protection, access for adult smokers, etc., that we have been discussing this morning.
We are in the process of working through the various options, the pros and cons, and the most efficient and effective way to regulate what is a completely new product category for us.