Health Committee on Nov. 27th, 2014

[The Chair, Conservative, Ben Lobb]

Good morning, ladies and gentlemen. We should get started.

We have two panels this morning, one from 11 o'clock to noon, and one from noon to one o'clock.

We have three guests in our first hour.

We have a guest from Scottsdale, Arizona, this morning: Mr. David Graham from NJOY.

Welcome, sir.

While the video conference technology is getting up and working we'll have you go first, and then we'll have our guests here presenting. Then we'll have questions and answers afterwards.

I'd like to thank Mr. Graham for agreeing to appear on a somewhat short notice and on what is an American holiday today as well. Sir, thank you. Happy Thanksgiving. We'll have you done before the football game starts.

Go ahead, sir.

[David M. Graham, Senior Vice-President, Global Regulatory Affairs, NJOY]

Thank you, Mr. Chairman and members of the committee.

My name is David Graham. I'm the senior vice-president of regulatory affairs at NJOY. I have 22 years of experience with nicotine and tobacco policy and regulation. Prior to joining NJOY in 2013, I was with Johnson & Johnson, and with Pfizer before that. NJOY has no affiliation to the tobacco industry. NJOY is America's largest independent e-cigarette and vaping company and has a presence also in the U.K., Germany, France, and Spain.

For reasons I'll explain in this testimony, NJOY has not introduced products into Canada. NJOY is the only major company in the U.S. to offer all form factors: disposable e-cigarettes, rechargeable e-cigarettes, and vaping devices and liquids. The liquids are sold in child-resistant bottles. NJOY is the only company with products in all major channels, including convenience, mass, drugstore, online, and the Vape Shop channel.

We're proud to state that our corporate mission is to make obsolete the tobacco cigarette and, potentially, the death and disease that it leaves in its wake. We are 100% committed to setting the highest standards for corporate responsibility related to the prevention of use of our products by people under the legal age, and for the advancement of scientific evidence related to the potential benefits associated with the use of our products as alternatives to traditional tobacco products.

We look forward to a day when combustion cigarettes are no longer part of the landscape. We are appalled at the toll that the tobacco epidemic has taken and continues to take each year. We share the belief that established tobacco control policies can continue to have an impact, and we believe that the enormous toll from smoking should encourage all of us to consider opportunities to do more than those alone.

In the right hands, electronic nicotine delivery systems, or ENDS, have the potential to play a decisive role. ENDS offer smokers who cannot or will not quit a positive alternative to combustion smoking and provide smokers with the nicotine that they are addicted to without the combustion of tobacco.

As stated in the 2014 United States Surgeon General's Report, “The burden of death and disease from tobacco use in the United States is overwhelmingly caused by cigarettes and other combusted tobacco products; rapid elimination of their use will dramatically reduce this burden.” It also states that “noncombustible tobacco products, used alone, are far less dangerous to individual users than continued smoking...”.

For many years, influential members of the public health community have widely discussed a strategy of tobacco harm minimization, based on the availability of nicotine-containing non-combustion products playing a critical role in ending the tobacco epidemic. Electronic nicotine delivery systems represent a potentially transformative disruptive technology that threatens large and privileged incumbent tobacco companies. Perversely, the absence in Canada of a clear regulatory strategy that is appropriately fit for purpose constrains such innovation from being a meaningful threat to the tobacco industry. Opponents of ENDS may unwittingly be prolonging the status quo, to the tobacco industry's continued advantage.

In other countries, as the committee has heard, electronic nicotine delivery systems are increasingly displacing cigarettes, and their use is overwhelmingly by adult smokers. Early fears that electronic cigarettes would entice young people to initiate with these products and then migrate to combustion products appear unsupported by the data to this point, with the rise in electronic cigarette popularity coinciding with a continued and indeed historic decline in teen smoking in the U.S. To be clear, no minor should be using a nicotine-containing product of any kind.

The maximum public health benefit will be achieved by mitigating the risks to youth without constraining the ability for e-cigarettes to effectively compete with combustion cigarettes among adult smokers. Bans on sales to minors are essential, and we support that. Paradoxically, children could be the biggest losers from an effort in their name to restrict adult access to ENDS. Too many of today's children will adopt smoking, grow up, and die prematurely from cigarette-caused disease if present trends continue. The best thing we can do for the health of our children is ensure that they grow up in a world in which neither their parents nor any of their other role models are smoking deadly combustion cigarettes.

Providing smokers who cannot or will not quit with a positive alternative may be the long-sought solution to an intractable public health problem that has cost millions of lives. More and more members of the public health community here and abroad are beginning to make their voices heard in support support of this technology.

We need to approach regulation in this category with our eye on the prize and in a manner that is guided by science rather than emotion or suspicion. There's too much at stake to do it any other way.

Proportionate regulation of ENDS is essential. NJOY has long supported the need for such regulation, engaging directly with regulators in the U.S., Europe, and Canada and urging that such regulators and policy-makers take into account the unique characteristics of ENDS as distinct from combustion tobacco products or pharmaceutical products.

We do not question the legal jurisdiction of Health Canada in regulating nicotine delivery systems, whether electronic or not, especially where therapeutic claims are to be made, such as relief of craving or withdrawal symptoms, or as an aid to cessation. In our view, in such cases it's clearly within the authority of the minister, under the Food and Drugs Act and its regulations, to determine whether or not and under what circumstances such products can be marketed for sale in Canada.

In fact, rather than seeking to circumvent such jurisdiction, NJOY took an early position that it will only introduce products in Canada if (a) we're granted authorization to do so by Health Canada's natural and non-prescription health products directorate, the NNHPD, which currently regulates nicotine delivery systems in the form of nicotine patches, gum, or other such products, or (b) an alternative and appropriate regulatory and legal pathway is confirmed by this government for ENDS. We do not seek to bring a nicotine-containing product to Canada as long as the federal government declares that to be illegal.

Our efforts to find a way forward with NNHPD to determine what data will be required for efficacy, safety, and quality have been substantial but unfortunately have resulted in us being no clearer now than we were more than a year ago on what evidentiary goals they expect us to meet. Adding to our concern and frustration is the fact that since NJOY first started discussions with Health Canada, the unregulated market for e-cigarettes has continued to grow. Nevertheless, we are determined to achieve our mission of rendering combustion cigarettes obsolete and to do so in a responsible and legal way.

For that reason, we're very pleased that your committee has taken this matter up and has dealt with it in such an orderly and systematic fashion. We're hopeful that your recommendations will assist the minister as she sets out to provide a policy framework that will enable us to achieve our mutually held public health goals in a practical and efficient manner.

To that end, we believe that we can provide important evidence to help inform the proper regulation of this new category of products, so I will close with three specific recommendations that I respectfully submit to the committee and that we have submitted to the minister in prior correspondence earlier this year.

Firstly, grant immediate access to any manufacturer that has an active product licence application filed with the NNHPD today. There's important information to be obtained from real-world marketing of ENDS that should inform the development of a new regime.

Issuance of a marketing authorization will allow companies like NJOY to provide post-market information to the government, which it can then use to appropriately develop the new oversight and regulatory regime for these products. Indeed, the minister currently has the authority under the Food and Drugs Act to make regulations respecting marketing authorizations, including establishing the eligibility criteria for any such authorizations, which could involve the collection and provision of post-market safety data.

In addition, this approach could be used to facilitate a progressive approach to licensing ENDS that could evolve as the understanding of this product category grows and as additional data is gathered further to approval and within a post-market setting. For example, this may allow initial approval of a regulatory submission for a claim such as relief of craving/withdrawal and additional claims such as smoking cessation as further evidence becomes available.

Secondly, recognize that ENDS are different from combustion tobacco products and should not face equivalent restrictions. To the extent that the government may intend to fit the oversight and regulation of ENDS into the existing tobacco regime, it really is important to recognize that ENDS are fundamentally different from combustion tobacco products. It would be inappropriate to impose all existing elements of a regulatory regime that was developed for a completely different product with a hugely different risk profile. Regulation should be evidence-based and fit for purpose, not simply a copy-and-paste from one type of product to another.

Thirdly, and finally, any consideration of an alternative non-medicinal pathway with transition provisions that would legitimize products that are currently on the market prior to requiring compliance by a future date should grant similar legitimacy to manufacturers that have sought approval through the existing regulatory process.

Mr. Chairman, if it will assist you and your colleagues on the committee, I am prepared to provide you with a copy of our letter to the minister, which I have here.

We welcome this committee study, Mr. Chairman. We hope the work will chart a path forward for a proportional and appropriate regulatory pathway or pathways, whether medicinal, non-medicinal, or both. There is an urgent need for clarity, and NJOY stands ready to work with the committee, Health Canada, the public health community, and other independent companies that may have a shared goal to “obsolete” combustion cigarettes.

Thank you, sir.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

Next up, in person, we have the Electronic Cigarette Trade Association of Canada, with Daniel David.

Go ahead, sir.

[Daniel David, Chair of the Board, Electronic Cigarette Trade Association of Canada]

Thank you. It's an honour to be here and speak with you today.

My name is Daniel David and I am here as a representative of the Electronic Cigarette Trade Association of Canada. The Electronic Cigarette Trade Association is a self-regulatory organization that has been actively implementing stringent but appropriate consumer product regulations to electronic cigarettes since 2011. We currently represent over 25 individual Canadian businesses, each with multiple locations and/or avenues of distribution.

We recognize the need for regulation that exceeds the requirements for consumer products and have developed a living program that addresses these issues. This program currently includes a 230-page guide with policies and procedures that range from business operations to laboratory testing. While there are time and topic limitations at this meeting, we hope to participate in future discussions. It is our goal and sincere hope that the information we have already collected can form a basis for a working relationship for the future between regulators and industry.

Electronic cigarettes actually comprise two separate products: the device and the e-liquid. The device consists of two components, the first being the body, commonly referred to as the battery, and the second being the top, which is commonly referred to as an atomizer. Many of these devices are manufactured according to FCC or CE quality standards, and these certifications are a requirement for all active members.

E-liquid is a recipe combining USP-grade propylene glycol and vegetable glycerin, along with food-grade natural and artificial flavours and, optionally, nicotine. E-liquid is carefully monitored by the ECTA for accuracy, the existence of preventable risk elements, and other contaminants. We believe this type of precautionary and consistency testing should be required in any future electronic cigarette regulation.

The ECTA requires that all e-liquids sold by members be properly labelled in accordance with the consumer chemicals and containers regulations. Since that regulation was not designed with e-liquid in mind, the ECTA has adopted additional requirements, such as nicotine levels where applicable, allergen warnings, batch numbers, and wording or symbols indicating that the product is not for use by minors. Since we published this standard, many non-ECTA manufacturers have also adopted it.

An often-repeated fear is that electronic cigarettes will renormalize smoking and the use of tobacco products following years of gains in de-normalizing. This fear is based on speculation, and there is no evidence to support it. The basis of the argument may appear reasonable at first; however, when examined more closely, there are specific reasons why renormalization should not be an issue of concern.

The vast majority of electronic cigarettes sold in Canada are five to twenty times larger than tobacco cigarettes. They come in various shapes and colours and are made of metal. While they mimic the physical procedure of smoking, they do not taste or smell the same and they don't deposit smoke in the air or produce a passive discharge. The length of use is at the discretion of the consumer. Users and bystanders do not confuse these products with tobacco and understand them as a tobacco-free, reduced-harm alternative.

Smoking tobacco has been and will continue to be de-normalized at a social level for very real and significant reasons. The public is now acutely aware of the damaging and deadly health effects of first-hand and second-hand smoke. The smell of tobacco smoke is generally repulsive to most people. Additionally, it stains surfaces and leaves a bad smell on clothing and breath and in homes and vehicles. There is and will continue to be a negative social stigma attached to smoking tobacco for these reasons.

Vapour produced from e-cigarettes dissipates in seconds, thus it is far less noticeable than smoke. Vapour has none of the characteristically offensive and lingering odour produced by tobacco smoke, nor does it have any of the associated health risks linked to second-hand smoke.

Regarding the risk of children using e-cigarettes, implementing an age restriction on the purchase of these products is the most impactful step that regulators can take. Virtually every vape shop that I know of in Canada already posts signs and will I.D. people who appear to be under the age of 25 years This has been a requirement for all active members since our foundation.

E-cigarettes do not renormalize smoking. They are fundamentally different from tobacco cigarettes, and their significant harm-reduction potential only serves to continue the de-normalization of smoking.

Most countries are encountering difficulties classifying e-cigarettes into existing regulatory frameworks. Three product classifications that have been attempted have been tobacco products, pharmaceutical or medicinal products, and consumer products. Issues have arisen within each category. These issues are contributing to confusion, misinformation, lack of communication, and the rise of an unregulated and/or semi-regulated industry globally.

With respect to tobacco regulation, first and foremost, the grassroots movement of the electronic cigarette industry hates tobacco more than anyone, as we are acutely aware of the health impact. Regulating electronic cigarettes as tobacco would result in their being perceived as part of the problem rather than a potential solution.

Tobacco regulation was designed to discourage use by any means possible due to the negative health effects. Electronic cigarettes do not fit this category. In fact, given the opportunity to thrive as an industry, electronic cigarettes have the plausible potential to completely eradicate the use of tobacco cigarettes.

Many additives identified as flavouring agents are banned in tobacco products. Banning e-liquid flavours represents an effective ban on e-cigarettes, as all e-liquid is flavoured, including tobacco flavours. Under tobacco regulation, there's a very real risk of increased involvement by tobacco corporations in this industry. These corporations do not have the same incentive of seeing the product as a means of reducing and eventually eliminating tobacco use. Tobacco regulation simply does not work for non-tobacco products. The restrictions placed on tobacco, when forced on e-cigarettes, result in a less harmful alternative becoming less accessible and less appealing and provide a competitive advantage for tobacco cigarettes.

I'll turn to pharmaceutical and medicinal regulation. Regulating electronic cigarettes as medicinal or as alternative health products is the most devastating and harmful option to consider. Such attempts have been successfully challenged in courts in the United States, Norway, Germany, and Estonia. Medicinal regulations are created to address specific needs and requirements for treatments and medical therapy intended to address existing diseases and conditions. The process for medicinal approval, either as a natural health product or a medicine, contains requirements that this product, in all its presentations, is unable to meet. Electronic cigarettes were not invented—nor designed—in any way that would support this process.

I'll now speak about consumer product regulation. Regulating electronic cigarettes as a general consumer product provides the most appropriate current regulatory fit. However, blindly adopting this regulation without modification presents some challenges. Consumer regulation does not usually require age restrictions, laboratory testing guidelines, and ongoing investigation into the safety profile of the elements of any liquids that are inhaled.

The consumer chemicals and containers regulations work for e-liquid labelling but are still inadequate without modification, which is why ECTA requires additional labelling. The reason that none of them mention categories that will work for e-cigarettes is simple: they were designed before e-cigarettes were on the market as a unique and new product. Any types of established regulations are prohibitively restrictive, inappropriate, or inadequate.

A new and unique regulatory structure for electronic cigarettes and e-liquid is the most appropriate way forward. Custom regulations would permit the industry, science, and public health to collaborate on information on an ongoing basis to ensure that, should any element of the product pose issues, it can be immediately addressed and regulations applied consistently. This regulation would establish quality control standards for hardware, appropriate labelling and testing requirements for e-liquid, and age and marketing restrictions, along with domestic e-liquid manufacturing standards.

It's important to recognize that in Canada no producer or vape shop is in any way affiliated with or owned by tobacco corporations. In fact, our industry was founded by smokers acutely aware of the deadly nature of tobacco and in search of a less harmful alternative. We care about the health effects of our products and share the goal of a smoke-free Canada.

While 37,000 Canadians die every year from smoking-related diseases, there is not one single report of a fatality or disease caused by electronic cigarettes in the 10 years since their introduction to the global market. The fact is simple: people smoke for the nicotine but die from the smoke. Electronic cigarettes do not produce smoke or the related disease.

Fifty-three of the world's leading medical and clinical research scientists have very clearly recognized the benefits of electronic cigarette use for smokers and have spoken to this in a letter addressed to Margaret Chan of the World Health Organization. I will quote a statement from this letter:

Tobacco harm reduction is strongly consistent with good public health policy and practice and it would be unethical and harmful to inhibit the option to switch to tobacco harm reduction products. As the WHO's Ottawa Charter states: “Health promotion is the process of enabling people to increase control over, and to improve, their health”. Tobacco harm reduction allows people to control the risk associated with taking nicotine and to reduce it down to very low or negligible levels.

After eight years on the Canadian market and over 100 clinical and laboratory studies worldwide, there is no evidence that electronic cigarettes cause deadly or harmful effects to its users or have any risk of concern for bystanders.

To illustrate and summarize many of the studies that have been performed, we have submitted a 27-page report by Dr. Farsalinos, a lead researcher on the effects of electronic cigarette use. In this report, Dr. Farsalinos and his team from the Onassis Cardiac Surgery Center have addressed the most pressing issues surrounding electronic cigarettes and provide a science-based response.

In summation, the ECTA was founded by a handful of electronic cigarette vendors who recognized the need to protect Canadian consumers and regulate the industry to an appropriate standard. Public health organizations and Health Canada do not have the opportunity to fully dedicate the necessary resources to evaluate electronic cigarettes. Because of that resource restriction and the lack of industry and product knowledge, it is only natural that they look for the bad, as opposed to performing a true and fair analysis.

Over the last several years, we've been fully dedicated to this task, and we continue to develop our standards by reviewing all of the information available, be it research, regulations, or common sense. We do not look at the good or the bad but rather the collective whole of what is continually a growing pool of information. We would like nothing more than to work with the governing bodies and policy-makers and to open and conduct discussions and investigations into the wealth of information currently available, including clinical, medical, and laboratory studies.

Right now, Canada has a unique opportunity to lead the world in tobacco harm reduction by developing comprehensive e-cigarette regulation that is designed using all available evidence and in consultation with the industry and lead researchers. We believe that electronic cigarettes represent our best chance to achieve the goal of a smoke-free Canada.

I would like to add that there is a sense of urgency to develop these regulations, not only to protect youth and consumers, but also to provide guidance to provincial governments.

Thank you very much for your time.

[The Chair, Conservative, Ben Lobb]

Thank you very much.

Next up we have Shawn Wells from TVC Liquids.

Go ahead, sir.

[Shawn Wells, Owner, TVC Liquids]

Thank you, Mr. Chair and members of the committee, for this opportunity to express my views and the facts on e-cigarettes.

It's an honour to be invited here for the first time by the committee and to have the opportunity to offer another perspective on vaping. I'm so proud of the committee for investigating what I believe to be a better, less harmful alternative for adults who choose nicotine.

What we must understand here is that vaping is an entirely new product category, industry, and culture. This simple and effective technology offers the nearly 13 million Canadian ever-smokers—current and former smokers combined—a less harmful choice when choosing nicotine. There are already volumes of data from the millions of online comments and studies conducted since 2003, data that render vaping into a health category similar to that of a cup of coffee.

In regard to understanding the term “e-cigarettes”, where the initial confusion really started is with the word “e-cigarettes”, which leads one to believe that the device is emitting smoke. However, it's not smoke but vapour. The word “e-cigarette” can often serve to mislead the public: that it is a new variation of a cigarette. Just as electric cars produce less harm to the environment, vaporizing technology produces less harm to the user and to the environment around them.

We really have to look at combustion versus vaporization, because these are two completely different processes. Combustion is a high-temperature, exothermic chemical reaction between a fuel and an oxidant, whereas evaporation is a phased transition from the liquid phase to a vapour. It produces a non-toxic vapour with a pleasant odour.

With respect to looking at our harm reduction benefits, when we're looking at smoking tobacco in public we have three major ways that it's harmful: direct harm, as smoking tobacco is directly harmful; indirect harm, which is directly harmful to the bystanders; and in regard to role models, which means that young people who see smoking can believe that this is a normal adult activity, and it may influence them to smoke themselves.

On the other hand, vapour liquid in public is non-harmful in at least three major ways: in direct vaping, properly made liquids are directly non-harmful to the user compared to cigarette usage; indirectly, the vapour is not a constant, like smoke, and as well, the exhaled vapour is not harmful to bystanders; and with respect to role models, young people who see vaping can be educated on the product and nicotine delivery options and believe that it is not okay to be smoking.

Vaporizers are not the same as cigarettes, period.

When looking at the culture, it's critical to have a thorough understanding of the culture and the small businesses that have developed vaping in Canada. Vaping culture is not about a multi-billion dollar stronghold on addiction. Vaping culture is anti-smoking. When someone chooses to vape, they do not simply go for a vape or design their lives around vaping, as they might with a cigarette. Vaping culture rejects wholeheartedly the habits of smoking and therefore cannot contribute to smoking renormalization.

Again, as Mr. David was stating, there are four to five main ingredients in vapour liquid. Most of these ingredients have been proven to not be harmful. Delivering nicotine is very low risk and has not been clearly shown to cause any disease. Nicotine has been shown to have many health-related benefits. It can be presented in any strength, ranging from 1 mg to 24 mg—milligrams—and a comparison of the amount of nicotine delivered in 10 puffs of vapour shows that it is the equivalent of one puff of a traditional cigarette.

The whole problem with nicotine is that it happens to be found in cigarettes. People can't disassociate the two in their minds. Nicotine has benefits, if anything, and may actually have an anti-oxidant effect. One of the functions of nicotine receptors is to moderate the entry of calcium into cells. The presence of nicotine increases the amount of intracellular calcium, which appears to improve cellular survival. When it comes to dosage levels and nicotine, Health Canada clearly indicates that nicotine is not considered a drug since it is in a form to be administered orally by the means of an inhaler delivering four milligrams or less of nicotine per dosage unit. This is quite standard knowledge, especially out there on the Internet.

When it comes to productive vaping regulations around the world, we have to look at Germany, the Netherlands, and even Heathrow Airport, which permits the use of electronic cigarettes within its premises. The pro here is the ability to align with businesses and track them, with equal cooperation from vaping companies, so everyone is on the same page for distributing these product choices safely to consumers. As Australia does, we should discourage smoking and encourage vaping.

When it comes to contrary vaping regulations around the world, we can look at the U.S., Singapore, and New Zealand. The foundation of those regulations is a grouping of vaping with tobacco or a pharmaceutical product, which causes vaping to be restricted to only two options. This shuts down cooperation with vaping companies and eliminates the possibility of providing a less harmful choice to adult Canadians.

We really need to have a plan. We need to have a plan to understand and support the choice of lesser harm, the choice of vaping in Canada. We need to encourage our cities to support vaping by providing unbiased education so adults can make their own decisions. Grouping vaping with tobacco is counterproductive to lessening the harm of cigarettes.

In conclusion, I have a few solutions. We're looking at vaping as a consumer chemical product that provides adults with hundreds of options and can provide a significantly better option for Canadians. There is no significant risk apparent to either the direct user or to bystanders. The closest comparison I have come up with when doing my research is to coffee and its range of flavoured coffee options available in different strengths.

I have a number of suggested solutions: the creation of vapour company registration to track the products and stores and to lay the framework for labelling and nicotine indication; proper bottling using LDPE or glass bottles with childproof and tamper-proof caps; age restriction with advertising guidelines; the creation of an online forum such as, perhaps, vaper.gc.ca, to register a vaping company; and the publishing of an official registered vaping company directory, which the public can see, to ensure that quality guidelines are met and that approved products are supplied by registered vaping companies in Canada.

I want to close with one quote from Professor Gerry Stimson, who is a professor at Imperial College London. He said:

If the WHO gets its way and extinguishes e-cigarettes, it will not only have passed up what is clearly one of the biggest public health innovations of the last three decades that could potentially save millions of lives, but it will have abrogated its own responsibility under its own charter to empower consumers to take control of their own health, something which they are already doing themselves in their millions.

Now that a lesser-harm option is available, why can't we offer this product choice to adult consumers? Why wouldn't we do the best we can in order to provide that choice?

We thank the committee for its time and consideration. We are pleased to answer any questions about vaping and the benefits to the health of Canadians in this exciting time.

Thank you.

[The Chair, Conservative, Ben Lobb]

That's well done. We're right on time.

First up, we have Ms. Davies.

Go ahead.

[Libby Davies, NDP, Vancouver East, BC]

Thank you very much, Chairperson.

Thank you, witnesses, for being here today. I think the presentations that you made were very interesting and articulate. I have a couple of questions.

First of all, I think it's clear that we do need to have a regulatory approach of some sort. I guess what we're going to be discussing when we finish our study is what that regulatory approach would look like.

Mr. Graham, what I take from your presentation is that NJOY wants to play by the rules, even if the rules don't yet exist. In fact, you're calling on us to make sure that the rules do exist.

I'm curious to know why you think it's taking so long. As I understand it, NJOY has been putting forward proposals. In fact, you gave your three recommendations. I didn't get them all, so it would be helpful if you actually would send in your brief, because I didn't get all the nuances of what you were saying. I'm curious to know if you can offer us any thoughts on why this is taking so long when, as a company, you have been wanting to have a legal pathway, as you call it. You want to have granted authorization, and you want to have a regulatory approach. I'll let you answer that.

Second, Mr. David and Mr. Wells, on hearing you speak, particularly Mr. David, I have to say that I have echoes in my head of the whole debate around natural health products, which many MPs are very familiar with. When you say you don't want to be regulated as a tobacco product under the tobacco control regulations, that you want to be separate, this is exactly what we heard on natural health products. In fact, we're still hearing that they didn't want to be associated with drugs. They wanted to be a separate category. I'm curious about that.

I do worry about the comparison to coffee. Coffee is actually the most common addiction in our society. It is a very addictive substance, although it doesn't harm you. Well, it can make your heart race; you can get heart arrhythmia from caffeine. The problem happens when you try to withdraw from caffeine. Anybody who's tried it will know how absolutely severe it can be physically. I understand where you're going with your comparison to caffeine, but maybe you want to come up with another comparison.

Those are the two questions.

Mr. Graham, I would also like to ask for any thoughts you may have about why this is taking so long, given that you've actually been pushing. Also, in terms of a new category, I think it would be helpful if you spelled out more of what you mean by a new category of regulation. You talked about general consumer products, but I don't think you were suggesting that it be under that. I think you were suggesting something separate.

Those are my questions.

[David M. Graham]

Thank you.

In connection with the work of the NNHPD, it's our view that this directorate is experienced in the regulation of existing products but is struggling with the way to set the expectations for this new class of products. I believe we would have an approval by the national health products directorate today if the product we submitted to them formed a similar profile to nicotine gum and nicotine patches in delivering the same amount of nicotine with the same profile. They're very comfortable with that framework.

The fact that e-cigarettes provide somewhat more nicotine and do so in a different way, involving also the inhalation of nicotine, leads the agency to look toward prescription pharmaceutical guidelines for medicinal inhalers and consider whether to address standards related to pharmaceutical products. Yet they are unable, through their agreement, it seems, to take into account the risks that would be associated with someone continuing to smoke.

I feel that half of the problem is the agency's or the directorate's lack of clarity as to what standard they should be setting and enforcing in this phase. The information we've had suggests that they are looking for further guidance from the minister's office as to the standard of evidence that should be required, and also even reassurance as to whether they can be regulated as a natural health product or if they have to be a prescription product or even a tobacco product.

Despite our efforts with some very specific recommendations as to how they could put forward proper data development, the agency is really not providing us with any more guidance. We're at a stalemate at this point. The best information we've had is “keep giving us information, keep talking to the public health community, and at some stage maybe we can move forward”. I think we need to hear from your committee and we need to hear from the minister on it.

[Libby Davies, NDP, Vancouver East, BC]

Mr. David, could you respond to my question about your separate sort of category and how you see that working?

[Daniel David]

Yes, certainly. The fact of the matter is that electronic cigarettes have so many different aspects that need to be regulated. So much more research needs to be done and continues to be done. One aspect is e-liquid testing. For example, there's e-liquid flavouring. The flavouring that's used in e-liquid is food-grade flavouring, but nobody has ever evaluated the effect of food-grade flavouring on inhalation. That needs to be continuously tested, but our regulatory frameworks don't really support that effort.

We've also been advised that fitting this product into a natural health product category doesn't really work. It would require a health claim that we don't want to make. We don't want to make a health, therapeutic, or cessation claim.

[Libby Davies, NDP, Vancouver East, BC]

I'm not suggesting that you be part of the natural health product category. I was just saying that what you were saying reminded me of that debate we had.

[Daniel David]

Oh, sorry. Okay.

[Libby Davies, NDP, Vancouver East, BC]

I'm not suggesting that you go there. It's the same kind of debate that we're having.

[Daniel David]

The reason—

[The Chair, Conservative, Ben Lobb]

Mr. David, could you please wrap up briefly? Our member's time is up. Then we'll get some more questions answered.

[Daniel David]

Sure. The reason I recommended a dedicated category is due to all of the unique challenges regarding electronic cigarettes, from the manufacturing standards of the e-liquid, to testing, to further research on the effects of the elements in e-liquid, monitoring that, and making sure we can continue to make this product even safer for the future.

[The Chair, Conservative, Ben Lobb]

Thank you.

So everybody does know, I have here the letter from NJOY that was sent to the minister and also Mr. Graham's prepared comments for today. I think the clerk has them now. They'll be translated and distributed so that all committee members have them in both official languages.

Now we have Mr. Lunney.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Thank you, Mr. Chair.

Thank you to our witnesses for joining us today.

We've heard a fair bit of testimony already, including testimony from a number of health experts. For this committee member, at least, and probably for a number of our colleagues, I think we certainly see a benefit from e-smoking, and, if you will, for the addicted smoker and for smoking cessation programs, but there's a whole broader discussion here about.... I think I heard one of you talk about how we should be discouraging smoking cigarettes and encouraging vaping. I think that's a very different discussion, because there are a lot of unknowns about vaping.

The first question I have I'll direct to NJOY. Are you using a range of flavours with your products as well?

[David M. Graham]

Yes, sir. We use both tobacco flavours and non-tobacco flavours, which seem to be important in helping people transition away from combustion tobacco-smoking.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

I understand that one of our witnesses said that all e-products have flavours, but cotton candy, coconut...? What some of the other ones we heard about here were? We heard about cookies and cream and candy floss. Do you have products that contain flavours like that?

[David M. Graham]

We do not have such flavours with such descriptors. Prior to introducing non-tobacco flavours into the marketplace, we conducted a study commissioned by the University of Pennsylvania—

[James Lunney, Conservative, Nanaimo—Alberni, BC]

I just want to know whether you are targeting young people with your flavours.

[David M. Graham]

No, we have evidence that demonstrates that the flavour descriptors of our products do not appeal to non-smoking teens, but do appeal to smoking adults. I'd be happy to submit that evidence.

[James Lunney, Conservative, Nanaimo—Alberni, BC]

Yes, we might like to hear it.

But some members of your association are marketing products with names like those. Are you seriously trying to come before a committee to suggest that there are adult smokers addicted to nicotine who would prefer a cotton-candy flavour?