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Tobacco Control Directorate Health Canada AL 0301A, 150 Tunney's Pasture Driveway Ottawa, Ontario K1A 0K9

Submitted via e-email to hc.pregs.sc@canada.ca

Re: RBH Submission to the Consultation on the Proposed Tobacco Products Regulations (Plain and Standardized Appearance)

Rothmans, Benson & Hedges Inc. (RBH) welcomes the opportunity to provide its comments on Health Canada’s proposed Tobacco Products Regulations (Plain and Standardized Appearance) (plain packaging regulations).

EXECUTIVE SUMMARY

Canada has a worldwide reputation for improving lives through regulatory policies that keep pace with innovation. As Prime Minister Trudeau has stated, the “Canadian Opportunity” entails an environment in which “policies … encourage science, innovation and research.”1 Accordingly, evidence-based policy is front and centre among the Government’s forward-looking initiatives.

Consistent with Canada’s commitment to principled policy making, Health Canada is approaching the emerging world of vaping products2 with an open mind. Rather than default to the status quo and subject all nicotine-containing products to the same restrictions as apply to cigarettes, Health Canada sees the potential of less harmful products and is proposing a different set of rules for vaping products. To date, however, this pragmatism and attention to scientific evidence are missing with respect to the broader category of products that generate a less harmful aerosol, such as heated tobacco products.

Independent investigations have demonstrated and regulators elsewhere have accepted that the aerosol from heated tobacco — like the aerosol from vaping products — is significantly distinct from cigarette smoke. Rather than grouping any and all products that contain tobacco with cigarettes, the rules for heated tobacco should align with those that will apply to vaping products.

This consultation is the opportunity — perhaps the last opportunity — to correct an incongruous situation that will work against the Government’s aim to reduce smoking prevalence. Here is the state of play:

1. The risks of cigarette smoking are the premise for the recently revised Tobacco and Vaping Products Act (TVPA or Bill S-5) and implementing regulations with respect to cigarettes.

2. Vaping products produce an inhalable aerosol. Vaping products are not risk-free, and many vaping products contain nicotine, which is addictive.3

3. Nonetheless, Health Canada has proposed regulations that differentiate between cigarettes and vaping products because cigarette smoke is distinct from, and far more hazardous than, the aerosol that vaping products generate.

4. Likewise, the aerosol from heated tobacco products is distinct from cigarette smoke, and there is a compelling body of evidence that switching to a heated tobacco product presents less risk of harm than continuing to smoke.

5. The proposed regulations, however, would lump heated tobacco products with cigarettes despite scientific evidence that clearly distinguishes the risks of switching to these products versus continuing to smoke.

Point 5 does not follow the empirical and principled approach Health Canada is proposing for vaping products. The draft regulations impose an ex ante prohibition on differentiated packaging for any product that contains tobacco, whether it exists now or may be developed in the future, even though certain non-combustible tobacco products are in fact a better alternative than continued cigarette smoking. Such a sweeping regulation severely constrains or, worse yet, closes the door on innovation that could improve the lives of smokers and their families. It also conveys to people who smoke — including the many who would otherwise switch to a better alternative — that all tobacco products are as harmful as cigarettes. Canada’s Charter of Rights and Freedoms and basic principles for sound regulation and consumer protection require a different approach.

In allowing differentiation only for vaping products, the proposed regulations also unjustifiably restrict the choice of better products that smokers will have access to. For example, heated tobacco products are more similar in taste and experience to cigarettes, and will appeal to those smokers who may find vaping products unacceptable.

Breakthrough innovations in vaping and heated tobacco products offer an unprecedented opportunity to help an entire population leave cigarettes behind. But an inability to differentiate heated tobacco products from cigarettes will inevitably mean that many Canadians will continue to smoke rather than switch to a less harmful alternative. This concern is especially acute in light of the prohibition on truthful and non-misleading communications about comparative health risks between cigarettes and non-combustible tobacco products.4 Put simply, we ask Health Canada to exercise its regulatory authority to permit differentiated packaging for heated tobacco products, which the evidence shows are better alternatives to continued smoking.

ABOUT RBH

Health Canada knows RBH as a cigarette company, with good reason. After over a century of selling cigarettes in Canada, we now hold approximately 38% of the market and count among our customers around 1.5 million Canadians.

This submission, however, is not about Health Canada’s regulation of cigarettes. Instead, we focus on our smoke-free, reduced-risk products, and on the millions who will continue to smoke cigarettes unless regulatory policy helps them switch to less harmful alternatives.5

Given our history as a cigarette company, Health Canada may read this submission with skepticism. Can we expect a tobacco company to be a leader in developing smoke-free products and in steering people away from cigarettes? We ask all who read this to suspend your skepticism and understand that our entire organization has made a lasting commitment to and large investment in smoke-free products. No one is more keenly aware than we are of the apparent paradox: one of the world’s leading tobacco companies is committed to a future free of cigarettes.

We are not shuttering or selling the business; our strategy is centred on what is best for our customers, shareholders, and society. RBH and the entire Philip Morris International (PMI) family are devoting our resources worldwide to replacing cigarettes with better alternatives. In that context and with that aim, we respectfully make this submission.

CANADA’S COMMITMENT TO PRINCIPLED REGULATORY DECISION-MAKING

Canada has established itself as a leader in enacting policies that promote useful innovation and improve the lives of its citizens. Essential to the success of those policies are certain regulatory principles that ensure efficient, effective, and sensible market oversight. Those principles are fundamental; they underpin regulation across a wide array of products and industries, and they are integral to Health Canada’s decision-making with respect to tobacco and nicotine products.

REGULATORY PRINCIPLE #1: ENCOURAGE BETTER PRODUCTS

A fundamental principle in regulating consumer products is the notion that manufacturers should be encouraged to make less hazardous products available to consumers when they have the knowledge and ability to do so. Governments and the public health community have repeatedly called on cigarette companies to address the health risks of smoking, including by designing and marketing safer products.6 Indeed, there has been significant concern that cigarettes are somehow outside of the common-sense proposition that, in essence, better is good.7 In that regard, we reiterate RBH’s determination to replace cigarettes with alternatives that meet rigorous criteria for presenting less risk of harm than smoking.

REGULATORY PRINCIPLE #2: FIND THE INNOVATION “SWEET SPOT”8

Regulatory oversight of innovation should aim for a sweet spot that maximizes opportunities while minimizing undesirable scenarios.9 As Prime Minister Trudeau has said, “we want [technology], create it and support it because it improves people’s lives.”10 Similarly, Canada’s “Innovation Agenda” aims to ensure that “Canadian laws, regulations and standards keep pace with rapid change, while protecting consumers.”11 The Innovation Agenda further emphasizes the Government’s “role in promoting innovation as well as a business environment that supports commercialization and the freedom to compete in a global economy.”12

To be sure, innovation inherently presents uncertainties. Regulation must remain contemporary with technological advances that might present benefits as well as risks and “respond quickly to ensure effective oversight of products resulting from these technologies.”13 But excessive caution that constrains progress does not serve the public interest.14 Finding the “sweet spot” is especially important when, as in the present context, new products have the potential to improve consumers’ health. As Health Canada has observed, “[w]ith their enormous innovation potential, emerging technologies can lead to new commercial products, new approaches to protect human health or improvements in health care.”15

In differentiating between cigarettes and vaping products, Health Canada has put the preceding principles into action. But this action alone is not likely to achieve Health Canada’s ambitious goals to reduce smoking prevalence. The same approach — one that preserves space for the benefits of innovation in the broader category of non-combustible products — should differentiate heated tobacco from combustible tobacco. Otherwise, the regulations will miss the sweet spot and impose a significant opportunity cost on the many people who would otherwise abandon cigarettes and switch to a less harmful alternative.

REGULATORY PRINCIPLE #3: REGULATIONS ARE EMPIRICAL

Canadian policy dictates that regulations rest on facts and scientific evidence. In his mandate to the Minister of Science, the Prime Minister was crystal clear when he stated: “We are a government that believes in science – and a government that believes that good scientific knowledge should inform decision-making.”16 When policy is not empirical, the “government makes arbitrary decisions that have the potential to negatively affect the daily lives of Canadians.”17

A good example of evidence-based policy that keeps pace with new products and technologies is Health Canada’s Regulatory Roadmap for Health Products and Food. The Roadmap calls for simpler, more efficient regulations as a means to improve the health of Canadians. A key element of Health Canada’s strategy is a commitment to flexible regulatory frameworks that “place greater emphasis upon regulating across all product lines in a manner that pays attention to the nature of the product, its intended use, and how the consumer or patient is exposed to the product rather than placing all the focus on regulating by the type of product alone.”18

Moreover, the Roadmap calibrates the “level of oversight” to “the type and amount of evidence … [about] the level of benefit and harm the product could offer the consumer and how the chance of serious harm can be reduced or eliminated.”19 Thus, the Roadmap substitutes a forward-looking approach to replace what Health Canada describes as “the older regulatory frameworks that, because of their varied ages and designs, do not have a coordinated, proportional approach to benefit, harm and uncertainty management.”20 The Roadmap is one of many possible examples of Canadian regulatory policy that looks at evidence regarding the risks and benefits of a particular product and takes into account the dynamics of the regulatory context to find the sweet spot in promoting innovation. And, in our view, the Roadmap’s reasoning should also guide Health Canada in setting policy for new types of tobacco products. Rather than constraining these products, tobacco policy should drive manufacturers to develop and commercialize them and thereby bring the benefits of innovations to people who will otherwise keep smoking.

REGULATORY PRINCIPLE #4: INFORMATION EMPOWERS CONSUMERS TO MAKE BETTER CHOICES

The benefits of product innovation are hypothetical if consumers are in the dark, or confused, about the product’s existence or attributes. Consistent with core principles in Canada and around the world, regulation should, as the United Nations has stated, enable “[a]ccess by consumers to adequate information to enable them to make informed choices according to individual wishes and needs.”21

Consumer protection law in Canada requires all manufacturers to provide truthful and non-misleading information about their products to consumers.22 In parallel, Canadian regulators recognize the importance of designing regulations in a way that enables consumers to get important product information. For example, the Canadian Food Inspection Agency’s guidance on food labeling is designed to ensure consumers are well informed, because “[t]he food label is one of the most important and direct means of communicating product information between buyers and sellers,” and “one of the primary means by which consumers differentiate between individual foods and brands to make informed purchasing choices.”23

Ensuring that consumers have truthful and accurate information is especially important with respect to matters of safety and health. As Health Canada has observed, “[i]nformation is critical to deal with potential harms.” 24 Therefore, even though “different kinds of information may be appropriate for various product types,” when formulating regulation, “common approaches can be taken to ensure that the benefit and safety related information on the label is understandable, complete, and not misleading.”25

Indeed, as the federal agency responsible for improving the health of all citizens, “Canadians look to Health Canada for the trustworthy and timely information they need to make informed choices about which food, health, and consumer products are best for them and for their families.”26 Once again, we emphasize that the same principle should be front and centre in this consultation. Just as regulations should help consumers distinguish among food products, the rules on tobacco products should distinguish between cigarettes and non-combustible tobacco products. The TVPA forecloses communications with consumers about the health risks of non-combustible tobacco products compared to cigarette smoking,27 making it incumbent on Health Canada to exercise its regulatory authority to allow differentiation in packaging so smokers can understand that certain tobacco products, such as heated tobacco products, are fundamentally better than smoking cigarettes.

The four regulatory principles that we have briefly outlined are neither controversial nor new to Health Canada, which has applied them time and again in exercising its authority. Yet, we submit, they have gone missing in this consultation and, if they remain unheeded, Health Canada will foreclose a huge opportunity to reduce smoking prevalence.

THE OPPORTUNITY AT HAND

The preceding regulatory principles all weigh heavily in favour of a policy that will reduce smoking prevalence beyond predicted cessation rates by offering smokers acceptable alternatives to cigarettes. To be sure, there are details to address, but the pragmatic, evidence-based approach that Health Canada has applied to products as diverse as food and vaping products will lead to the optimal outcome. For context, we note a few basic statistics.

Smoking prevalence has decreased significantly in Canada during the last 50 years, from a high of 50% in 1965 to 13% in 2015.28 Yet, approximately four million Canadians continue to smoke cigarettes.29 Government statistics show that annually, only 10-13% of Canadian smokers quit, which means that the vast majority of these smokers will continue to smoke.30 It is these millions of men and women who stand to gain the most from regulations that make it easier for them to switch to less harmful alternatives. They deserve policy that hits the sweet spot; conversely, it would not serve their interests to treat all tobacco products as carrying the same risk as cigarette smoking.

A recent article by highly regarded experts on tobacco policy describes the opportunities that innovation offers and the path to finding the sweet spot in regulating what they term alternative nicotine delivery systems (“ANDS”). According to Professor David Abrams and his co-authors, “[i]f prudently regulated, [less harmful alternatives] provide a great opportunity to disrupt the . . . global smoking-related disease pandemic and offer a proof-of-principle for the potential role of further innovations in ANDS in improving public health.”31 From a regulatory perspective, the “opportunity depends on encouraging increased technological innovation and finding the appropriate balance between product safety, consumer appeal, and regulations targeted specifically to decrease the use of conventional, combusted tobacco products.”32

Canada’s approach to vaping products is an example of regulatory policy that strives to balance the risks and benefits of a product innovation that can improve the lives of smokers. But while it is a positive step, Canada’s approach should consider the needs of all smokers, and maximize the offer of better alternatives to cigarettes. Cigarette smoking is a highly individualistic and sensorial experience in which pleasure, taste, ritual and satisfaction all play a role. Therefore, the best way to maximize the opportunity to switch smokers away from cigarettes is through a diverse portfolio of less harmful alternatives that can appeal to all smokers.

In a recent submission to the U.S. FDA, seventeen public health experts stressed the need for smokers to have access to a “wide range of alternatives,” because “[r]eliance on a narrow range of technology options (NRT or vaping) would potentially exclude smokers with a strong preference for tobacco flavors . . . from switching to a low risk product – and lead to unintended consequences.”33 Alternatives like “heated tobacco products may reach smokers who would be unsatisfied by vaping or medical products.”34

If a diverse offering of less harmful alternatives do not exist — or if they are not sufficiently available, easily identifiable, or known to consumers — many adult smokers are likely to continue to smoke cigarettes, even though this is the most dangerous form of nicotine delivery.

CANADA’S REGULATION OF VAPING PRODUCTS ADHERES TO FUNDAMENTAL REGULATORY PRINCIPLES

Canada’s recently revised Tobacco Strategy and the passage of the TVPA represent a significant evolution in the Government’s approach to tobacco regulation by acknowledging the important role that innovative, less harmful alternatives can play in reducing smoking prevalence. Central to Canada’s Tobacco Strategy is the recognition that “[t]raditional cessation approaches are not the only tools available to help Canadians transition away from smoking cigarettes, the most deadly nicotine delivery system.” 35 Accordingly, the Tobacco

Strategy includes a “harm reduction approach [that] aims to reduce the negative consequences of cigarette smoking by recognizing the potential benefits of using less harmful alternatives.36

The TVPA implements this harm reduction approach by making vaping products available to consumers as less harmful alternatives. It takes account of the facts, which show that the risks of vaping are significantly less than the risks of smoking, and establishes a regulatory framework for vaping products that is distinct from the rules that apply to cigarettes.37 By doing so, it helps consumers understand the advantages of vaping products and maximizes opportunities for switching.

This approach is mirrored in Health Canada’s recent initiative to explore options for future regulations that would permit the use of certain statements in vaping product promotion that compare the health effects arising from the use of a vaping product with those of smoking. Health Canada’s invitation for comments on the proposed comparative claims explains that “[t]he future regulations would support . . . the objective of preventing consumers from being misled about the health hazards of vaping products” and “would be supported by science and expressed in clear terms to ensure that tobacco users are better informed about the relative health effects of using vaping products.”38

Health Canada’s judgment that plain packaging is not appropriate for vaping products also rests on the type of empirical inquiry that is essential to sound policy. Health Canada has explained that its decision not to apply plain packaging to vaping products is based on “[t]he reality … that vaping products simply do not cause the same level of harm as tobacco products do.”39 Therefore, even though the TVPA “has been drafted in a way where [Health Canada] would have regulatory authority to take action around packaging for vaping products, … at this moment there's no intention to plain-package vaping products, given they have a very different profile than tobacco products do.”40 Notably, these observations also led Health Canada to conclude that excluding vaping products from the scope of the plain packaging regulations was constitutionally necessary because Health Canada had insufficient evidence to show that the risks of vaping products outweighed the right of the vaping industry to promote their products.41

In short, Canada’s approach to the regulation of vaping products, as embodied in the TVPA and Health Canada’s proposed plain packaging regulations, and more recently in Health Canada’s proposal to permit certain comparative statements regarding the health effects of vaping compared to smoking in vaping product promotion, adheres to the four principles of regulatory policy discussed above, as well as the Charter of Rights and Freedoms. The same is not true, however, of the proposal to regulate any and all products that contain tobacco in the same manner as cigarettes irrespective of demonstrable differences in risk.

NOT ALL TOBACCO PRODUCTS ARE THE SAME

In writing the rules for vaping products, Health Canada has proceeded with an open mind and interest in the facts. By contrast, the proposed regulations rest on the premise that all products containing tobacco, whether they exist now or may be developed in the future, are as harmful as cigarettes. But the many facts available to Health Canada show exactly the opposite. The facts show that the risks of smoking are orders of magnitude greater than the risks of using a non-combustible tobacco product. The facts also show that switching completely to a heated tobacco product presents less risk of harm than continuing to smoke. If, despite the evidence, the regulations subject every tobacco product to the same suite of rules that govern cigarettes, Health Canada will severely limit rather than maximize the opportunities that heat-not-burn innovation offers. Anti-smoking should not mean anti-tobacco. Non-combustible tobacco products that are less harmful alternatives to cigarettes have a significant role to play in advancing Health Canada’s goal of drastically reducing smoking rates.

There is uniform agreement among scientists and policy makers that tobacco and nicotine-containing products sit on a continuum of risk. Cigarettes are the most harmful because they burn tobacco and generate smoke. As Health Canada explains in its website for consumers: “Many of the toxic and cancer-causing chemicals in tobacco and the tobacco smoke form when tobacco is burned.”42 This is consistent with the conclusions of other regulators, including the U.S. FDA, which has concluded that “[c]igarettes are the tobacco product category that causes the greatest burden of harm to public health as a result of the prevalence of cigarette use and the toxicity and addictiveness of these products.”43

In contrast, innovative non-combustible products such as heated tobacco products and e-cigarettes do not burn tobacco or generate smoke, and therefore are much less harmful than continued smoking, even if they contain tobacco. As Professor Abrams and colleagues note, “[a] diverse class of alternative nicotine delivery systems (ANDS) has recently been developed that do not combust tobacco and are substantially less harmful than cigarettes.”44 These alternatives “have the potential to disrupt the 120-year dominance of the cigarette” and “may provide a means to compete with, and even replace, combusted cigarette use, saving more lives more rapidly than previously possible.”45

Professor Abrams and colleagues acknowledge that the great potential of less harmful alternatives to cigarettes does not rely on the presence or absence of tobacco in a product, but rather on “nicotine [being] decoupled from lethal inhaled smoke.”46 Heated tobacco products do not combust tobacco, and therefore the aerosol from those products contain very little of the harmful chemicals found in cigarette smoke. This distinction between cigarette smoke and the much less hazardous aerosol generated from a heated tobacco product has led public health experts to observe that “[i]t would take unknown and implausible mechanisms for these products not to be much less harmful than cigarettes [because i]t is beyond dispute that exclusive use of [a heated tobacco product] as an alternative to cigarette smoking creates substantially lower exposures to harmful or potentially harmful agents.”47

Independent analyses also confirm that the aerosol from heated tobacco products is less toxic than cigarette smoke. Comparing heated tobacco products with cigarettes, Public Health England (PHE) has found that “heated tobacco products are likely to expose users and bystanders to lower levels of particulate matter and harmful and potentially harmful compounds (HPHC).”48

The U.K. Committee on Toxicity, an independent advisory committee to the UK Department of Health, independently assessed two heated tobacco products. The Committee concluded that “it is likely that there is a reduction in risk, though not to zero, to health for smokers who switch completely to heat-not-burn tobacco products.”49 More recently, the Science & Technology Committee of the U.K. House of Commons reached a similar conclusion, stating that “‘[h]eat-not-burn’ products contain tobacco which is heated rather than combusted, and [are] therefore likely to be less harmful compared to conventional cigarettes.”50

The German Federal Institute for Risk Assessment (BfR) also conducted an independent assessment of the same heated tobacco product that RBH currently sells in Canada. According to the BfR, “[l]evels of major carcinogens are markedly reduced in the emissions of the analyzed [heat-not-burn] product in relation to the conventional tobacco cigarettes.”51 BfR further acknowledged that “monitoring these emissions using standardized machine smoking procedures generates reliable and reproducible data which provide a useful basis to assess exposure and human health risks.”52

Finally, in the context of PMI’s application to the U.S. FDA for authorization to market a modified risk tobacco product — the same heated tobacco product RBH is selling in Canada — an advisory committee to the FDA agreed, by a vote of 8-1, that “[s]cientific studies have shown that switching completely from cigarettes to the [tobacco heating system] significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”53

Taken together, these independent reviews confirm many of the statements that Health Canada is currently exploring for use in relation to vaping products.

To reiterate: Certain non-combustible tobacco products differ in the risk of harm they present, a fact that is supported by scientific evidence.54

SUBJECTING ALL TOBACCO PRODUCTS TO PLAIN PACKAGING IS INCONSISTENT WITH FUNDAMENTAL REGULATORY PRINCIPLES

Regulatory measures are tools to influence consumer behaviour and decisions. Therefore, in drafting the plain packaging regulations, Health Canada must ask itself several fundamental questions. Should Health Canada exercise its authority to require plain packaging for all tobacco products?55 Does the evidence show that all tobacco products present the same risks? If not, is there a different regulatory approach that would enable differentiation of less harmful alternatives from cigarettes? Is there a way to write the regulations so they will remain current with science and innovation?

Health Canada’s proposed regulations do not answer these fundamental questions. Despite the scientific evidence that shows that some non-combustible tobacco products, such as heated tobacco products, are less harmful alternatives to smoking, the proposed plain packaging regulations do not account for fundamental differences as between tobacco products. Moreover, none of the plain packaging studies cited by Health Canada in its regulatory impact analysis relates specifically to non-combustible products such as heated tobacco products.56

Reasonable minds might well differ on the quantity or quality of evidence that a regulator needs when designing the regulations for a particular product. On the other hand, there should be no disagreement that sound regulation is fundamentally an empirical process and, as such, should not mix, let alone interchange, ideological views with facts. And when the topic is tobacco, it is especially important to separate hyper-charged rhetoric and pre-conceived notions — from whatever side of the table — from the data. Acerbic point-counterpoint too easily distracts from calm consideration of what matters most — reducing the number of people who smoke.

Moreover, evidence-based policy making entails careful consideration of new evidence or changes in science and innovation so that regulations preserve rather than foreclose opportunities.57 In the case of vaping products, the Minister of Health has characterized this approach as precautionary:

[W]e are taking a precautionary approach. While we recognize that these products may be less harmful, until the science fully evolves and there is a clear understanding of the potential harms from vaping, we want to make sure that Canadian legislation is sufficiently cautious to protect the overall health of our citizens.58

The preceding statement bears directly on the approach and reasoning that should also apply to heated tobacco products. First, Health Canada acknowledges the inherent uncertainty of vaping products, given that they are a new innovation. Second, uncertainty about the potential harms from vaping did not result in a decision to place the same restrictions on vaping products as cigarettes. Third, despite uncertainty, Health Canada enabled Canadian smokers’ access to vaping products and information about them through differentiated regulation that recognizes vaping products are less harmful alternatives to smoking. Fourth, Health Canada determined that it was better to use its regulatory authority to address any new evidence or concerns regarding vaping products if and when they arise, rather than block the innovation.59 From our perspective, the preceding methodology is a textbook example of pragmatic, empirical policy making.

Rather than allow for similar flexibility in the regulation of less harmful tobacco products, Health Canada is proposing plain packaging regulations that apply to a product based on a static definition — whether that product contains tobacco — and not in a way that reflects the specific benefits and risks of that product (e.g., the composition of the aerosol compared to cigarette smoke), or how innovation or scientific evidence may develop in the future.

By doing so, Health Canada will impose an ex ante prohibition on differentiated packaging for any product that contains tobacco, whether that product exists now or could be developed in the future. In fact, manufacturers will have little, if any, incentive to develop and commercialize less harmful tobacco products in Canada if there are no means to differentiate those products from the most harmful tobacco product available, i.e., cigarettes.

The TVPA prohibits truthful communications about the relative health risks of non-combustible tobacco products compared to smoking cigarettes.60 If the plain packaging regulations require all products that contain tobacco to look the same, smokers will have even less information on which to make an informed decision as to whether they should switch from cigarettes to a less harmful tobacco product, because smokers will be unable to differentiate among competing tobacco products.

In fact, a mandate that all tobacco products look the same is likely to convey to smokers that non-combustible alternatives, like heated tobacco products, are as risky as cigarettes, even when they are not. This misperception carries the further unintended outcome of prolonging smoking, which is unquestionably the opposite of what anti-smoking policy aims to achieve. Professor Abrams and co-authors made this point forcefully in a recent publication: “Treating all tobacco or nicotine products as equally harmful and regulating them as such supports the long term viability and continued sale of cigarettes and the associated deaths.”61 Instead, regulations should ensure that smokers have access to truthful and accurate information that allows them to differentiate between tobacco and nicotine products and make better decisions for their health.62

In short, the proposed regulations for tobacco products do not comply with fundamental regulatory principles. They are not based on the best available scientific evidence; they do not allow for flexibility to address the rapid pace of innovation in the tobacco area; they inhibit innovation in less harmful alternatives; and they will frustrate smokers’ access to information that could enable them to make better choices.

CONCLUSION

Canada has proven itself to be a leader in pursuing regulatory policies that foster innovation to improve the lives of its citizens. Health Canada’s regulation of vaping products is one such example. Although vaping products are not risk-free and there may be uncertainty around this new product category, Health Canada has nevertheless proposed regulations that differentiate between cigarettes and vaping products because cigarette smoke is far more hazardous than the aerosol that vaping products generate. Health Canada should take the same approach for non-combustible tobacco products like heated tobacco products, which, while also not risk-free, produce an aerosol that is much less hazardous than smoke. There is neither an imperative nor reason to impose a one-size-fits all approach to tobacco products that shuts the door to evidence that certain tobacco products are indeed less harmful than smoking. On the contrary, as the proposed rules for vaping products demonstrate, the TVPA gives Health Canada the authority to decide when and how to apply further packaging restrictions to tobacco products, including the possibility of applying different regulations to different types of tobacco products. Health Canada has the expertise and authority to find the sweet spot that will yield maximum social benefits. RBH urges Health Canada to reconsider its proposal and to write the plain packaging regulations in a way that is forward-looking and evidence-based and that preserves the possibility to differentiate between the most harmful forms of tobacco consumption and better alternatives that could further the government’s goal of reducing the harms from smoking as soon as possible. Canadian smokers deserve sensible regulations.

1 “The Canadian Opportunity”, Address by Hon. Justin Trudeau at World Economic Forum in Davos, Switzerland, Jan. 20, 2016.

2 The Tobacco and Vaping Products Act (TVPA) defines “vaping products” as: (a) a device that produces emissions in the form of an aerosol and is intended to be brought to the mouth for inhalation of the aerosol; (b) a device that is designated to be a vaping product by the regulations; (c) a part that may be used with those devices; and (d) a substance or mixture of substances, whether or not it contains nicotine, that is intended for use with those devices to produce emissions. It does not include devices and substances or mixtures of substances that are excluded by the regulations, tobacco products or their accessories. TVPA § 2.

3 Health Canada, Webpage on Vaping (“If you are not a smoker, vaping can increase your exposure to some harmful chemicals, that could negatively affect your health. Vaping could also expose you to nicotine which is addictive.") (accessed Sept. 5, 2018).

4 TVPA § 20.1.

5 The best choice for health is to quit or not to start smoking. Therefore, RBH’s smoke-free strategy is focused on those smokers who would otherwise continuing smoking and thus would benefit the most from switching to products that evidence shows are less harmful alternatives to smoking.

6 See, e.g., ASH UK, The safer cigarette, Mar, 3, 1999.

7 Id.(“Even in the unique case of tobacco, where it is assumed and accepted that the product will cause great harm to its users, the smoker should still expect the manufacturer to reduce harmfulness of the product if this is possible.”)

8 Abrams, D. et al., Harm Minimization and Tobacco Control: Reframing Societal Views of Nicotine Use to Rapidly Save Lives, 39 Ann. Rev. Pub. Health 193 (2018).

9 Id.

10 “The Canadian Opportunity”, Address by Hon. Justin Trudeau at World Economic Forum in Davos, Switzerland, Jan. 20, 2016.

11 Innovation, Science and Economic Development Canada, Positioning Canada to Lead: An Inclusive Innovation Agenda (accessed Sept. 5, 2018).

12 Id.

13 Health Canada, Webpage on Emerging Technologies (accessed Sept. 5, 2018).

14 See, e.g., Eichler, H. et al, The risks of risk aversion in drug regulation, 12 Nature Reviews Drug Discovery 907 (2013).

15 Health Canada, Webpage on Emerging Technologies (accessed Sept. 5, 2018).

16 Minister of Science Mandate Letter (Nov. 12, 2015).

17 Liberal Party, Openness and Transparency (accessed Sept. 5, 2018).

18 Health Canada, Regulatory Roadmap for Health Products and Food (2012).

19 Id.

20 Id.

21 United Nations Conference on Trade and Development, Guidelines for Consumer Protection (2016).

22 See, e.g., Competition Act § 74.01.

23 Canadian Food Inspection Agency, Webpage on Food Labelling and Advertising (accessed Sept. 5, 2018).

24 Health Canada, Regulatory Roadmap for Health Products and Food (2012).

25 Id.

26 Health Canada, Health Canada – a partner in health for all Canadians (accessed Sept. 5, 2018).

27 TVPA § 20.1.

28 Propel Centre for Population Health Impact, Univ. of Waterloo, Tobacco Use in Canada: Patterns and Trends (2017).

29 Health Canada, Canada’s Tobacco Strategy (2018).

30 Propel Centre for Population Health Impact, Univ. of Waterloo, Tobacco Use in Canada: Patterns and Trends (2017).

31 Abrams, D. et al., Harm Minimization and Tobacco Control: Reframing Societal Views of Nicotine Use to Rapidly Save Lives, 39 Ann. Rev. Pub. Health 193 (2018).

32 Id.

33 Abrams, D. et al., Submission to Tobacco Products Scientific Advisory Committee on Modified Risk Tobacco Product Applications for IQOS System (Dec. 14, 2017).

34 Id.

35 Health Canada, Canada’s Tobacco Strategy (2018).

36 Id.

37 See Health Canada, Webpage on Tobacco and Vaping Products Act (accessed Sept. 5, 2018).

38 Email from Health Canada to RBH, September 4, 2018.

39 Proceedings of the Senate Committee on Social Affairs, Science & Technology, Issue No. 21 (Apr. 12, 2017).

40 Id.

41 Id. (“We are able to put those restrictions on plain packaging around tobacco products because the Charter allows us to do that when the evidence is absolutely abundant that the public health risks associated with these products outweigh the rights of the industry to be able to promote themselves. In the case of vaping products, we are not dealing with the same type of balance in terms of firm evidence of harm and that being outweighed by the ability of an industry to be able to promote itself.”)

42 Health Canada, Webpage on Vaping (accessed Sept. 5, 2018).

43 Tobacco Product Standard for Nicotine Level of Combusted Cigarettes, Advance Notice of Proposed Rulemaking, 83 Fed. Reg. 11818, 11825 (Mar. 16, 2018).

44 Abrams, D. et al., Harm Minimization and Tobacco Control: Reframing Societal Views of Nicotine Use to Rapidly Save Lives, 39 Ann. Rev. Pub. Health 193 (2018).

45 Id.

46 Id.

47 Abrams, D. et al., Submission to Tobacco Products Scientific Advisory Committee on Modified Risk Tobacco Product Applications for IQOS System (Dec. 14, 2017).

48 Public Health England, Evidence review of e-cigarettes and heated tobacco products 2018 (Feb. 2018).

49 Committees on Toxicity, Carcinogenicity and Mutagenicity of Chemicals in Food, Consumer Products and the Environment, Statement on the toxicological evaluation of novel heat-not-burn tobacco products (Dec. 2017).

50 U.K. House of Commons, Science and Technology Committee, E-Cigarettes, 7th Report of Session 2017-2019 (Aug. 17, 2018).

51 Mallock, N. et al., Levels of selected analytes in the emissions of “heat not burn” tobacco products that are relevant to assess human health risks, 92 Archives of Toxicology 2145 (2018).

52 Id.

53 Tobacco Products Scientific Advisory Committee (TPSAC) Meeting (Jan. 25, 2018), available here. On January 24-25, 2018, experts from PMI and Philip Morris USA Inc. presented to TPSAC before the U.S. FDA. The meeting was part of the FDA’s review of PMI’s request to commercialize IQOS in the U.S. as a “modified risk tobacco product.” Although TPSAC did not agree with some of the specific language of the proposed consumer communications, it confirmed that the evidence submitted by PMI supported the statement that switching completely to IQOS significantly reduces exposure to harmful chemicals. TPSAC recommendations and votes are not binding on the U.S. FDA.

54 RBH’s parent company, Philip Morris International (PMI), has conducted a rigorous scientific assessment of its tobacco heating system, IQOS, incorporating elements of multiple disciplines, including aerosol chemistry and physics, in vitro, in vivo and systems toxicology, clinical studies, as well as pre-and post-market assessments of consumer perception, behaviour, and actual use of IQOS. Many of these studies have already been provided to Health Canada, and RBH is also providing a dossier of PMI’s scientific assessment of IQOS together with this submission. The totality of PMI’s scientific research and findings to date demonstrate that switching to IQOS is less harmful than continued smoking.

55 Section 17 of the TVPA gives Health Canada the authority to make regulations specifying the information that may appear on the package of a tobacco product, and in what form and manner, but does not mandate that Health Canada require plain packaging for any tobacco product, much less all tobacco products. Therefore, Health Canada retains the authority to decide when and how to apply further packaging restrictions to tobacco products, including the possibility of applying different regulations to different types of tobacco products. TVPA § 17(a), (a.2).

56 Tobacco Products Regulations (Plain and Standardized Appearance), Canada Gazette, Part 1, Vol. 152, No. 25 (June 23, 2018), available here. Likewise, the public opinion research conducted by Environics on behalf of Health Canada regarding plain packaging only involved questions about cigarette packaging. Environics, Qualitative and Quantitative Research on Standardized Cigarette Design Elements and Cigarette Packages, Final Report (Mar. 22, 2017).

57 See, e.g., Health Canada, Regulatory Roadmap for Health Products and Food (2012) (“[T]here is a progression in the knowledge about a health product or food over its full life-cycle. This increase in knowledge reduces the uncertainty associated with the benefits and harms of a product and can lead to improved health outcomes for Canadians. As a consequence, it is logical to regulate in a manner that reflects the full life-cycle.”).

58 Blair, B., House of Commons Debate on Bill S-5, 42nd Parliament, 1st Session, Vol. 148, No. 229, at 14950 (Nov. 3, 2017).

59 Choinière, D., Proceedings of the Senate Committee on Social Affairs, Science & Technology, Issue No. 21 (Apr. 12, 2017) (“Because it's an emerging market, we included [in Bill S-5] a new . . . provision [that] addresses future packaging elements that could be put in place through regulations. . . . [T]here are no plans to go there. It's an emerging market so we're giving ourselves the tools to react to the future.”).

60 TVPA § 20.1.

61 Abrams, D., et al., Managing nicotine without smoke to save lives now: Evidence for harm minimization, Preventative Med. (2018).

62 Kiviniemi, M. & Kozlowski, L., Deficiencies in public understanding about tobacco harm reduction: results from a United States national survey, 12 Harm Reduction J. 1, 2 (2015) (“Given the scientific consensus that cigarettes are the most deadly form of tobacco use, the public has a right to a clear understanding of this fact and efforts should be made to impart an understanding of the differential health risks for various tobacco/nicotine products.”).