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.