Category: Clive Bates

  • For the Long Haul

    For the Long Haul

    Photo: BAT

    Sustainability, strategy and survival in the tobacco market

    By Clive Bates

    Before delving into what sustainability means for the tobacco market, we must first ask what the word itself means. A good starting point is an observation of the French philosopher Luc Ferry: “I know that this term is obligatory, but I find it also absurd, or rather so vague that it says nothing.”

    Ferry captures the problem well. It is often taken as a green concept, promoting enlightened practices on energy and emissions, waste and recycling and raw materials in the supply chain. A more evolved definition considers social and economic impacts. This has led to a steady output of sustainability reports from major businesses, increasingly with feedback into operations with a view to improving over time and avoiding the wrong half of sustainability league tables. This is all good, but is it good enough?

    I favor a more hard-nosed definition of business sustainability. It would be a variation of the concept defined by one of the pioneers of sustainable development, Gro Harlem Brundtland, in 1987: “Sustainable development is development that meets the needs of the present without compromising the ability of future generations to meet their own needs.”

    Brundtland was referring to nations or to the whole world, but that formulation can be repurposed for a business. If the goal of a business is to generate shareholder value (the value of its stock and flow of dividends) then a reasonable equivalent would be to sustain and grow shareholder value over the longer term. Ultimately, sustainability is about designing and executing a corporate strategy that builds resilience and long-termism into a business but not at the expense of today’s shareholders. One reason why a tobacco company cannot just pull out of cigarettes and concentrate on new products is that the shareholders would fire the management, the company would be taken over or the cigarette assets sold as a going concern.

    What does this concept of sustainability mean? We can start with what it does not mean: It does not mean the single-minded pursuit of quarterly earnings at the expense of all wider concerns. “Shareholder value” embodies a range of important but less tangible elements that are reflected in the price of a stock. These include numerous market judgments on the future earnings of the company and its resilience to changes in the marketplace. Nor can it be oblivious to the concerns of stakeholders who are not shareholders, including customers, employees, politicians and public health organizations. They frame the operating context and confer the license to operate.

    Here are six questions I would ask any company about its sustainability in the tobacco market:

    1. How robust is the company’s approach to the mitigation of litigation risks? No one really denies that about 8 million people die annually from smoking-related diseases. But who is responsible and accountable for that? Plaintiffs and their lawyers will continue to stalk companies and hold them to account for their past and present behavior. Litigation in the early 2000s had a powerful suppressing effect on shareholder value and at times looked like an existential threat. Part of litigation risk mitigation is to be scrupulously honest in describing products and their risks, to be responsible in marketing and promotion, and to provide a range of low-risk alternatives with encouragement for smokers to switch. The conduct of companies that make products that are harmful and open to abuse will always be under scrutiny, often in the courts of law but always in the court of public opinion.
    2. How resilient is the company strategy to political and regulatory pressures? Governments permit, regulate and tax the most dangerous nicotine products, cigarettes, in every country in the world (even in Bhutan, which recently rescinded its longstanding prohibition of tobacco). While that mandate persists, there will be companies lawfully selling cigarettes. But as the low-risk alternatives rise in popularity, governments will be increasingly emboldened to take stronger regulatory actions against cigarettes, for example, in setting reduced-nicotine standards. Many advocates of such policies now argue that highly restrictive measures are becoming feasible as smokers have a range of low-risk and acceptable alternatives to switch to. Prohibitions without alternatives just lead to black markets. For tobacco businesses, the low-risk alternatives to smoking simultaneously threaten to hasten the end of cigarettes but also provide the opportunity in an emerging, and potentially larger, market for much safer smoke-free recreational nicotine.
    3. How well positioned is the company for changes in consumer preferences? What happens if the pace of migration from high-risk cigarettes to low-risk vaping, heated or smokeless nicotine products accelerates? What if there are tipping points when a critical mass of users makes the alternatives become rapidly ubiquitous? Which companies are poised to prevail? In a fast-moving consumer goods market, companies must ask what the consumer really wants and does not want. It is undeniable that many enjoy smoking, but if we break down that experience into different elements, what do they really want: a satisfying nicotine experience; a sensory experience and flavor; behavioral rituals; a social medium; elements of personal identity and group affinity? How can that be offered without cancer, cardiovascular disease and lung disease? Without stigma and social barriers?
    4. In a changing market, how well is the company positioned to gain or defend market share from competitors? I recently heard a tobacco executive say, “We have 25 percent of the cigarette market, but with our new products, I’m going after the other 75 percent.” That was a sharp reminder that in a radically disrupted market, no one can count on brand loyalty, and even the mightiest brand equities count for little. The aggressively sustainable company looks at disruption and sees opportunity to build future shareholder value. In contrast, the passive profit-seeker may find its grasp on its once-loyal customers is not as strong as it thought. How promising is the company’s portfolio of products in the more febrile markets for smoke-free alternatives? How strong is the product pipeline in R&D? What approach is the company taking to synergistic acquisitions of promising companies and their intellectual property?
    5. Who wants to work for this company? It is a tiresome management cliche to say that “our company is our people.” But it is also right, and especially over the longer term. A sustainable company needs to develop, retain and attract talent at every level and in every area. That is ultimately where its longer term value will be created. The staff in the companies today bear little resemblance to the famously pictured lineup of CEOs testifying to Congress in 1994 (with apologies to industry veterans), but many are younger, sharper and motivated by change for the better. Many see themselves as quiet revolutionaries from within—and not always quiet. The ability to attract top quality, highly motivated staff at affordable salaries will be increasingly about how the companies are looking to the future and how they will ultimately shed their reputational baggage.
    6. Does the board have a convincing vision? In Alice’s Adventures in Wonderland by Lewis Carroll, the Cheshire Cat argues, “If you don’t know where you’re going, any road will get you there.” When the board meets, how often does it raise its collective gaze to the horizon and beyond? When it does this, what does it see and how does that affect what it does today, this month and this year? It makes a big difference if the board sees new products as line extensions and a neat new consumer segment or if it sees a structural transition from smoked to smoke-free nicotine products underway and gathering pace.

    But what is a sustainable vision for the nicotine market? It goes beyond tobacco harm reduction, which is an important phase in the transition from combustible to noncombustible products. For the long term, I expect we will see a stable business model based on a (grudging) societal acceptance that nicotine is a legal and legitimate recreational stimulant with relatively benign side effects (no intoxication, violence, incapacitation, loss of control, etc.). The challenge for the tobacco market is to make this drug available in a way that is acceptably safe. That does not mean completely safe. It means within the normal societal appetite for recreational risks. In this vision, smoking would have declined to minimal levels primarily through consumer preferences for much safer but satisfying alternatives to cigarettes driven by continuing innovation. Regulators could put a thumb on the scale to tilt the market toward the safer products, but they will have no need to use the iron fist of prohibition. It will also require a rethink in public health groups that resist everything the tobacco companies do by default. They believe there is an irreconcilable conflict between the interests of tobacco companies and public health. In my view, they are wrong.

    There are still some who think sustainability is about corporate social responsibility. In the tobacco market, it is more than that: It’s about strategy and survival.

     

    The theme of GTNF 2021 (Sept. 21–23, 2021, in London) is Continuing Change: Innovation & Sustainability.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Fresh Thinking

    Fresh Thinking

    Photo: Olrat

    The WHO and tobacco policy: a seven-point reform agenda

    By Clive Bates

    In the light of the global pandemic, there have been calls to abolish, repurpose or revitalize the World Health Organization. I am firmly in the revitalize camp. Naturally, most of the hindsight has focused on the WHO’s response to infectious diseases. In April 2021, Covid-19 deaths are approaching 3 million worldwide. However, according to the WHO, tobacco-related deaths exceed 8 million annually. So what would new thinking on the WHO’s approach to tobacco policy look like? Here is my seven-point reform plan.

    1. Commit to the goals that make a real difference

    The WHO is the lead agency for Sustainable Development Goal (SDG) 3—“Ensure healthy lives and promote well-being for all at all ages.” This broad goal is broken down into 13 targets, and SDG 3.4 is the target that really matters in tobacco policy:

    “By 2030, reduce by one-third premature mortality from noncommunicable diseases through prevention and treatment and promote mental health and well-being [compared to 2015].”

    This target should become the mission statement for the WHO’s work on tobacco. The WHO should have a laser focus on addressing severe disease—dying in agony of cancer, dropping dead with a heart attack, living in misery with emphysema—reducing real harms as far as possible as quickly as possible. It should not be distracted by dreams of a tobacco-free or nicotine-free society. It is possible to achieve radical reductions in disease burden by switching nicotine use from high-risk combustible tobacco products to low-risk smoke-free tobacco and nicotine products. This is the harm reduction strategy, and it provides a fast-acting way to reduce the drivers of disease among those most immediately at risk.

    2. Embrace innovation in the tobacco and nicotine market

    In theory, the WHO is open to innovation, and it recognizes that: 

    “Health innovation identifies new or improved health policies, systems, products and technologies, and services and delivery methods that improve people’s health and well-being. Health innovation responds to unmet public health needs by creating new ways of thinking and working with a focus on the needs of vulnerable populations.”

    This is a reasonable description of innovation in the technology and business models in the tobacco and nicotine market since 2007. No organization should be suckered by every new idea. Still, there is a pressing duty of curiosity and a moral obligation to see how innovations can be made to work for the greater good. Sadly, the WHO has been an enemy of innovation in this field, displaying indifference to significant opportunities while uncritically embracing prohibitionist or abstinence-only talking points and pseudoscience.

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    3. Implement harm reduction in the Framework Convention on Tobacco Control

    If a reimagined WHO focuses on addressing the drivers of disease and embraces innovation, it follows that a rethink of the design of the Framework Convention on Tobacco Control is necessary. Fortunately, Article 1d of the FCTC defines tobacco control to include harm reduction:

    “(d) ‘tobacco control’ means a range of supply, demand and harm reduction strategies that aim to improve the health of a population by eliminating or reducing their consumption of tobacco products and exposure to tobacco smoke.”

    But making this concept operational means more than trivial tinkering. It means restructuring the treaty to be “risk proportionate.” That means taking a differentiated approach to different tobacco and nicotine products according to risk. The idea is to discourage the use of high-risk products while promoting migration to low-risk products. For example, taxes on cigarettes would be high but low or zero on vaping or heated-tobacco products. Advertising of cigarettes would be prohibited, but the promotion of low-risk products would be permitted but subject to controls on themes, placement and media type. Warnings would be stark, bold and pictorial on smoking products but would be more nuanced risk communication messages on smoke-free products, positioning them as lower risk than smoking but not risk free.

    There is more to harm reduction than switching to reduced-risk products. A broad approach would address the whole spectrum of harms experienced by nicotine users. That includes harms induced by tobacco policy, including regressive taxes, stigma and intrusions into consumers’ autonomy to manage their own risks at their own expense and on their own initiative.

    4. Take a more sophisticated approach to policy appraisal

    Tobacco policymakers must make a realistic assessment of the impacts of their proposals, including the potential perverse consequences. The Royal College of Physicians captured the dangers very well in its 2016 report “Nicotine without smoke: Tobacco harm reduction”:

    “However, if [a risk-averse, precautionary] approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer-friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking.”

    This quite simple idea has yet to gain traction at the WHO. In January 2021, the WHO presented the findings of its expert panel on tobacco regulation to the WHO executive board. Recommendations include banning open vaping systems, banning all promotion of vaping products and treating heated-tobacco products like cigarettes in regulatory and fiscal terms. There is no sign that anyone involved considered how this could all go wrong and amount to regulatory protection of the cigarette trade, encourage smoking and cause more harm.

    A revitalized WHO would become the global expert on both the intended and unintended consequences of tobacco policy and be respected for the quality of its policy analysis and guidance on impact assessment.

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    5. End the drive for prohibition

    Outright prohibitions of low-risk products are a special case of bad policymaking. Through papers for the FCTC Conference of the Parties (for example, FCTC/COP/8/10) or decisions by the COP (for example, FCTC/COP8(22)), the WHO has used its influence to advocate prohibitions of low-risk products. The WHO’s prohibition reflex continues despite decades of evidence that nearly all prohibitions do more harm than good. Take the poster child of tobacco prohibition, the outright ban on tobacco in the Kingdom of Bhutan. Even the WHO has had to acknowledge it has been a dismal failure.

    “Despite efforts on the part of relevant authorities, a tobacco black market, as initially feared, has emerged. Shops that thrive on illicit sale of tobacco and its products have found a way around the law. A steady stream of loyal customers continues to sustain these shops that have, over the years, grown into a network of black market. Recent studies have found Bhutanese youth, who are among the highest in the region to be using tobacco and its products, to be at the center of this burgeoning contraband good. (WHO Country Office for Bhutan 2020.)”

    But that policy failure is compounded when the prohibition applies to much less risky products than the ubiquitously available market incumbent, cigarettes. Why would a health organization applaud India’s government for prohibiting e-cigarettes when India has around 100 million smokers? But the WHO celebrated with a tweet congratulating the country on its ban.

    A revitalized WHO would not be a cheerleader for prohibition. It would play a dignified and diplomatic role, quietly counseling its members against policies that have known and obvious negative consequences.

    6. Rethink the stakeholder landscape

    Some critical stakeholders have been almost entirely excluded from the deliberations of the WHO and the FCTC. This has usually been justified on the spurious basis that they may be acting as agents of the tobacco industry. The most obvious omission is the consumer groups that represent the populations at risk and those likely to be directly affected by policies promoted by the WHO. They can rightly assert “nothing about us, without us” and refer to the inclusive philosophy of the Ottawa Charter on Health Promotion, yet they have no voice and are often treated with contempt.

    The U.N. Framework Convention on Climate Change (UNFCCC) takes a more enlightened approach to stakeholders than the WHO FCTC. The FCTC restricts participation to international groups vetted and approved by the secretariat. It does not allow critical perspectives into its meetings. The UNFCCC, by contrast, welcomes anyone professionally engaged in the field, including climate change sceptics, the automotive trade and the coal industry, to register as observers even though their interests are not necessarily aligned with the objectives of the treaty.

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    7. Show some leadership

    The FCTC was finalized in 2003, and it predates much of the innovation that underpins the harm reduction opportunity. But the problem is not merely with the text, which is a product of its time, but the culture of hostility to these innovations. Bad science and poor policymaking are pervasive in the WHO, the convention secretariat and among many delegates and advisers to the FCTC. The culture is further distorted by the flood of money from American philanthropic foundations with a prohibitionist agenda directly funding the WHO and many of the “civil society” groups that engage with the WHO. This culture will not change without a thorough reassessment at the highest leadership level or, if necessary, revitalized leadership. Too many lives are at stake to allow neglect and negligence at the WHO to deny hundreds of millions of people the opportunities of tobacco harm reduction.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Innovation and its Enemies

    Innovation and its Enemies

    Photo: Gualtiero Boffi | Dreamstime.com

    Understanding the war on vaping

    By Clive Bates

    How did vaping emerge, and why do so many in public health oppose it? It is a perplexing question, but the explanation starts with innovation.

    The essential development was progress with a critical technology—the lithium-ion battery—that made new categories of consumer nicotine product possible in a compact form acceptable to consumers. Driven by the insatiable demand for miniaturization from mobile phones and other portable devices, these batteries have improved to deliver ever greater energy density (essential for good battery life) and power density (essential for rapid heating and responsiveness to human interaction). In one sense, vaping and heated-tobacco products are novel energy technologies. The critical innovation is that they change the heat source used to form the inhalable nicotine-bearing aerosol from combustion to electricity. Burning tobacco generates the heat, and the tobacco smoke is the aerosol, but the products of combustion are also the prime driver of the disease burden. There is no combustion with electrical heating, so no products of combustion and therefore much lower disease risk. This is the fundamental, game-changing innovation.

    Once the lithium-ion battery had overcome the primary heat source problem, innovators had at their disposal a platform for further innovation. In his recent book, How Innovation Works, Matt Ridley analyzes the origins of innovation:

    “The main ingredient in the secret sauce that leads to innovation is freedom. Freedom to exchange, experiment, invest and fail; freedom from appropriation or restriction by chiefs, priests and thieves; freedom on the part of consumers to reward the innovations they like and reject the ones they do not.”

    So in the relatively open regulatory environment of the past decade, we see a wave of intense innovator activity, all tested and selected in the marketplace through rapid introduction and consumer uptake or rejection in a process that mirrors natural selection in ecology. The surge of innovation includes the emergence of a vast range of flavors and branding, refillable devices, mods and tanks, variable power, temperature control and new heating element designs. It brought on “sub-ohm” devices designed for the consumption of large volumes of weak liquids and “pod” devices designed for the consumption of low volumes of high strength liquid from a compact device. Some of the innovation has been elegantly synergistic. For example, the use of acids in pod devices allowed for the formation of “protonated” nicotine salts, which improved pharmacokinetic nicotine delivery to a level that could rival cigarettes. But these acids also facilitate the use of high-strength nicotine liquids by reducing harshness. Higher strengths mean users inhale lower quantities of liquid, so less heating is required, allowing for smaller batteries and a more compact and consumer-friendly format. That has turned out to be a very successful combination.

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    Alongside the developments in technology, there have been major commercial and social innovations. Vape shops provide a service that helps people quit, but outside a medical or treatment paradigm without labeling their customers as “patients” suffering from a psychiatric disorder. Innovation has been driven spontaneously through social media with influential product reviewers using YouTube and other social media to exert “selection pressure” on innovators. A vaping subculture of user-driven camaraderie, support, advice, and scientific and engineering insight has flourished and provided users with a sense of purpose and independence of manufacturers and public health activists.

    These developments have combined to create a powerful rival “value proposition” to cigarettes and smoking—an alternative way to use the relatively mild lifestyle drug nicotine but without nearly all the lethal side effects. For public health campaigners, it should be a triumph—and recognized as the approaching endgame for the burden of cancer, heart and lung disease, and premature death caused by nicotine consumption through smoking. Isn’t this precisely what we should look for in innovation?

    Not everyone agrees.

    Despite this promise, thousands of well-funded and dedicated tobacco control activists and academics oppose these developments. The question is: Why? What is driving this opposition?

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    The coalition opposing vaping is formidable, drawing together the World Health Organization, major regulators, public health agencies like the Centers for Disease Control and Prevention in the United States, hundreds of academics and research funders, health and medical societies, activist groups and journalists. But why has this coalition directed its firepower against tobacco harm reduction, even though many of the same actors would support harm reduction for illicit drugs, HIV and sexual health?

    We should start by considering if the opposition is grounded in a legitimate analysis of public health objectives and an imperative to do the right thing. I believe we can dispose of this explanation quite quickly. If that were the case, we would see much more intellectual energy consumed over trade-offs and agonizing over the likely unintended consequences of policy proposals. There would be a richer discussion of objectives, ethical dilemmas, risk, uncertainty and precaution. Even if that discussion came to a result that opposed vaping and tobacco harm reduction, the analysis to reach that conclusion would look very different to the overconfident assertions seen in practice. For example, the call to “ban flavors,” “raise taxes” or “cap nicotine strengths” would come wrapped in concern for the effects on adult smoking cessation, the welfare of adolescent smokers, illicit trade, home mixing and workarounds, and displacement to other risk behaviors. But we never see this.

    A common suggestion is to “follow the money,” with an insinuation that the opponents of tobacco harm reduction are pursuing grants, tax revenues and employment opportunities and may have stakes in rival business models. Money plays a role and may have a reinforcing effect. It allows for the opposition to form at a very large scale. However, it does not explain why the money is aligned with opposition to tobacco harm reduction. I think the money follows the prevailing mindset or group think in the field rather than the other way around.

    There are two more promising explanations. First, tobacco harm reduction and its innovation model are profoundly countercultural for tobacco control activists and academics. The tobacco control toolkit is filled with punitive, restrictive and coercive tools, wielded with the daunting authority of health and medical experts. It mainly sees the private sector as the root of the problem and governments or nonprofits as providing the solutions. It is called tobacco control for a reason. In contrast, a public health model that works through the free-play of pleasure-seeking consumers interacting with profit-seeking innovators in a lightly regulated and competitive market does not easily fit within that toolbox or that culture.

    The second explanation is institutional inertia. Between 1980 and 2010, funders, academics, activists, regulators, politicians and many committed journalists came together and built a powerful fighting machine to challenge Big Tobacco and drive down smoking. But by 2010, the tobacco wars were becoming stale and somewhat intractable and the troops tired and bored. Innovation such as vaping and heated-tobacco have provided new and revitalizing enemies. Over the last decade, the war on smoking morphed into a war on nicotine. The machine built for fighting smoking swiveled its gun turrets and started blasting away at the new products and their supporters. It did that because that is what those organizations do—it’s in their institutional DNA. The leaders grew up as veterans of the “tobacco wars” and continued their fight on the new fronts. The involvement of the traditional enemy, the tobacco industry, made that much easier given the assumption that there is a permanent irreconcilable conflict between the tobacco industry’s interests and public health.

    In the medium term, the outlook is pessimistic. Nik Modi, an investment analyst with RBC Capital Markets, wrote in January 2021, “Now that the e-cig/vapor threat has been neutralized, we are expecting much more stable cigarette category trends.” That is the kind of “win” that should cause a rethink by the victors. But in the longer term, I am optimistic. The change in energy technology marks a fundamental shift in the industry. I do not believe it will be possible to suppress this innovation indefinitely, and the tobacco control coalition will suffer fatal reputational damage if it tries.

    In his brilliant book, Innovation and its Enemies: Why People Resist New Technologies, the late Calestous Juma showed how innovations that are commonplace today, such as coffee, margarine and refrigeration, were ferociously opposed when they emerged. Juma says:

    “Debates over new technology are part of a long history of social discourse over new products. Claims about the promise of new technology are at times greeted with skepticism, vilification or outright opposition—often dominated by slander, innuendo, scare tactics, conspiracy theories and misinformation. The assumption that new technologies carry unknown risks guides much of the debate. This is often amplified to levels that overshadow the dangers of known risks.” 

    That describes the opposition to vaping and tobacco harm reduction very well. But it also shows that time and knowledge will ultimately prevail. What a shame that so much more harm will be done while tobacco control activists adjust to disruptive innovation.

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    There are two more promising explanations. First, tobacco harm reduction and its innovation model are profoundly countercultural for tobacco control activists and academics. The tobacco control toolkit is filled with punitive, restrictive and coercive tools, wielded with the daunting authority of health and medical experts. It mainly sees the private sector as the root of the problem and governments or nonprofits as providing the solutions. It is called tobacco control for a reason. In contrast, a public health model that works through the free-play of pleasure-seeking consumers interacting with profit-seeking innovators in a lightly regulated and competitive market does not easily fit within that toolbox or that culture.

    The second explanation is institutional inertia. Between 1980 and 2010, funders, academics, activists, regulators, politicians and many committed journalists came together and built a powerful fighting machine to challenge Big Tobacco and drive down smoking. But by 2010, the tobacco wars were becoming stale and somewhat intractable and the troops tired and bored. Innovation such as vaping and heated-tobacco have provided new and revitalizing enemies. Over the last decade, the war on smoking morphed into a war on nicotine. The machine built for fighting smoking swiveled its gun turrets and started blasting away at the new products and their supporters. It did that because that is what those organizations do—it’s in their institutional DNA. The leaders grew up as veterans of the “tobacco wars” and continued their fight on the new fronts. The involvement of the traditional enemy, the tobacco industry, made that much easier given the assumption that there is a permanent irreconcilable conflict between the tobacco industry’s interests and public health.

    In the medium term, the outlook is pessimistic. Nik Modi, an investment analyst with RBC Capital Markets, wrote in January 2021, “Now that the e-cig/vapor threat has been neutralized, we are expecting much more stable cigarette category trends.” That is the kind of “win” that should cause a rethink by the victors. But in the longer term, I am optimistic. The change in energy technology marks a fundamental shift in the industry. I do not believe it will be possible to suppress this innovation indefinitely, and the tobacco control coalition will suffer fatal reputational damage if it tries.

    In his brilliant book, Innovation and its Enemies: Why People Resist New Technologies, the late Calestous Juma showed how innovations that are commonplace today, such as coffee, margarine and refrigeration, were ferociously opposed when they emerged. Juma says:

    “Debates over new technology are part of a long history of social discourse over new products. Claims about the promise of new technology are at times greeted with skepticism, vilification or outright opposition—often dominated by slander, innuendo, scare tactics, conspiracy theories and misinformation. The assumption that new technologies carry unknown risks guides much of the debate. This is often amplified to levels that overshadow the dangers of known risks.” 

    That describes the opposition to vaping and tobacco harm reduction very well. But it also shows that time and knowledge will ultimately prevail. What a shame that so much more harm will be done while tobacco control activists adjust to disruptive innovation.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • The Irreconcilable Conflict Principle

    The Irreconcilable Conflict Principle

    Photo: Nataliia Shcherbyna – Dreamstime.com

    The governing idea of tobacco control

    By Clive Bates

    Sometimes defining an iron rule or governing idea and reorganizing our understanding of the world around it can be immensely revealing. Einstein developed the special theory of relativity from an assumption that the speed of light in a vacuum is unwaveringly constant. The most surprising results follow from that. Darwin showed that a simple mechanism, variation and natural selection, could explain much of the astonishing complexity of the natural world. Governing ideas are found everywhere: supply, demand and prices in economics; innocent-until-proven-guilty in criminal justice; and mutually assured destruction in arms control are further examples.

    So, is there a governing idea in tobacco policy? Something that shapes everything and means that the world is understood through rigorous application of that rule? I think there is, but it is playing an ever larger, more polarizing and counterproductive role. The starting point is Article 5.3 of the World Health Organization Framework Convention on Tobacco Control (FCTC). Though often overstated, Article 5.3 is fairly innocuous:

    In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law.

    When read as originally intended by the FCTC drafters in 2003, this aims, quite reasonably, to guard against the improper commercial influence of Big Tobacco on public health policy. There is nothing wrong with that. Many governments would quite happily apply the same principle to Big Oil in climate change policy or Big Pharma in healthcare policy. It is essentially an expression of good practice in policymaking.

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    But Article 5.3 didn’t stop there. In 2008, the concept was developed into Guidelines for the implementation of Article 5.3. Note the title—it does not suggest new treaty provisions are introduced but that the guidelines will implement the treaty as it is. However, the guidelines do more than this. Much more. They set out four guiding principles for Article 5.3, and the first of these is the most troubling:

    Principle 1: There is a fundamental and irreconcilable conflict between the tobacco industry’s interests and public health policy interests.

    Wow—that’s quite a statement. Let us refer to this as the “irreconcilable conflict principle.” First, it is qualitatively different from Article 5.3: It is a finding of fact rather than a principle that governs the process of policymaking. The finding is also permanent and inescapable—under this principle, no matter what the tobacco industry does or becomes, its actions will always be in conflict with public health. This is not merely expressed as a cautionary note from history, a lesson for which there is at least some supporting evidence. It is binding on the future and expressed as a permanent truth.

    I think the irreconcilable conflict principle is the governing idea, the iron rule of tobacco control. I do not wish to imply that this emerged in 2008 or because of these guidelines. The direction of causation is the other way. This was coded into the guidelines because it is the governing idea of tobacco control. In agreeing to this at the urging of tobacco control activists, complacent or complicit bureaucrats greatly extended the reach of the FCTC, apparently without appreciating the potential negative consequences.

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    This means that anything that is in the interests of tobacco companies must, by definition, be bad for public health. It means nothing can be both in interests of public health and the tobacco industry. In the same way that Einstein assumed the speed of light was a constant and his understanding of the world was reshaped around that, so we see tobacco control reshaping its worldview around the irreconcilable conflict principle. The important difference is that Einstein was basically right, and his radical insight advanced human understanding. For tobacco control, this governing idea is wrong—at least some of the time and in several ways. Consider the following implications.

    First, the irreconcilable conflict principle drives implausible explanatory theories. The experience of snus in Sweden clearly challenges the guiding principle: Widespread use of a tobacco product made by tobacco companies is responsible for Sweden’s unusually low smoking prevalence and with that, an unusually low level of cancer and heart disease in the male population. This alone should be enough to justify abandoning the principle. Yet Sweden’s public health establishment has been driven to find ever more desperately implausible reasons to explain the observed reality. These include absurd ideas about the role of Sweden’s generous paternity leave system and Sweden’s involvement in the Second World War. Tobacco control advocates have consistently opposed any lifting of the European Union ban on snus because to do so would be to violate their guiding idea, the irreconcilable conflict principle.

    Second, the irreconcilable conflict principle is shifting the goals of tobacco control. With the rise of vaping, tobacco control objectives have steadily shifted from tackling the health consequences of smoking, something that can be eliminated with technology. Now they increasingly stress opposition to nicotine use itself, something that is intrinsic to the industry. In this way, the industry can always be at fault and the inviolability of the principle maintained.

    Third, the irreconcilable conflict principle distorts science. If your iron rule is that nothing good ever comes from tobacco companies, then you are motivated to develop science demonstrating conflicts with public health. So, we see more scientists claiming that there is no difference in risk between smoking and vaping or that the data are so uncertain that nothing is or can be known about relative risk. Both are plainly wrong. Randomized controlled trials (RCTs) show vaping is more effective for smoking cessation than nicotine-replacement therapy. After years of lamenting the paucity of vaping RCTs, tobacco control activists have pivoted to express doubts about their validity or redefined quitting smoking to mean quitting nicotine.

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    Fourth, the irreconcilable conflict principle has made mainstream tobacco controllers into enemies of innovation. The U.S. Food and Drug Administration (FDA) recently granted the right to a tobacco company to claim that its heated-tobacco product was a reduced-risk product after concluding that it was appropriate for the protection of public health. A calamity: that would violate the irreconcilable conflict principle. Predictably, this triggered a backlash of denial and desperate arguments to show that the FDA was somehow mistaken and that there was no benefit to public health even though FDA was merely allowing a statement of the obvious to be made.

    Fifth, the irreconcilable conflict principle has created a self-amplifying echo chamber in tobacco control. Suppose there are people in public health who do think that some of the things done by tobacco companies are positive. Under the guiding principle, how can that be unless such people have a conflict of interest or are in some way working to further the interests of Big Tobacco? We can see this in some of the extraordinary efforts that tobacco control fora have made to exclude these dissonant voices. That includes the hurdles to achieving observer status at the FCTC itself and attending major events like the World Conference on Tobacco or Health. This conference has eligibility criteria explicitly based on the irreconcilable conflict principle and contains a catch-all exclusion for anyone who “works to promote tobacco products, their sale or to limit their regulation.” What if you think (like me, for example) that it would be good for public health if smokers switched to snus or heated-tobacco products and that regulation should be proportionate to risk rather than “unlimited”? The aim is to define this norm-challenging perspective as pro-industry and therefore anti-health and thereby to keep it out of earshot. An Australian anti-tobacco activist has even proposed an “Article 5.3 for civil society,” in which “reinforcing Big Tobacco’s pariah status” would be the purpose.

    Sixth, the irreconcilable conflict principle distorts rather than protects policymaking. Those who adhere to the principle cannot recommend policies that would encourage low-risk nicotine products at the expense of cigarettes as that would be to accept that they have a role in public health. So we see that tobacco control activists and many academics have adopted hostile regulatory paradigms for reduced-risk products: prohibition, pharmaceutical or equivalence to cigarettes. All are designed to reject the notion of any benefit from reduced-risk tobacco products. When Bloomberg Philanthropies recently advertised a new round of tobacco control grants, it stressed the “passage and implementation of Article 5.3” and linked this to Michael Bloomberg’s preferred MPOWER policy framework for tobacco control. Mr. Bloomberg is on record favoring vaping prohibition, and he sees no role for reduced-risk products. Perhaps public health policies now need to be protected from these vested interests?

    There should be one guiding principle for tobacco control: to reduce harm to the greatest extent and as quickly as possible. The irreconcilable conflict principle is a relic of the past and fails a modern reality check. It is the reason why tobacco control activists may now be doing more harm than good.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • The Endgame Revisited

    The Endgame Revisited

    Photo: Tobacco Repoter archive

    It is time to confront the fundamental confusion about the public health aims for tobacco and nicotine policy.

    By Clive Bates

    In 2013, the journal Tobacco Control published a supplement, “The Tobacco Endgame,” setting out various ways in which various experts thought a tobacco-free society could be attained. Ideas included annually increasing age limits, a cap and trade system, outright prohibition, taking control of the industry and making it put itself out of business, and removing most of the nicotine from cigarettes. In the intervening seven years, most of these ideas have not progressed at all. And rightly so, as I argued in a detailed critique, these policies are mostly impractical or excessively coercive and would fail if tried. The only one that attracted any real interest was the idea of lowering nicotine concentrations in cigarettes to make the product subaddictive (i.e., to eliminate the main reason people smoke). But even this de facto prohibition has not fared well. After backing the idea in 2017, the U.S. Food and Drug Administration (FDA) dropped the reduced nicotine rule from its regulatory plan in 2019. The most senior researchers engaged in the idea recently acknowledged that its viability would depend on the availability of credible safer alternatives to smoking.

    So, all this begs the question, where is the endgame now? Or maybe the more interesting prior question is: endgame for what? What will end and what, if anything, will continue? Does the endgame mean the end of tobacco and nicotine use? Or is the endgame, as I believe, the final stages of a transition—a shift from an unsustainable to a sustainable nicotine market?

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    At the heart of this question is a fundamental confusion about the public health aims for tobacco and nicotine policy. This dispute is rarely surfaced and never resolved but confronting it has now become unavoidable. At least five objectives can be identified in tobacco control: (1) reducing disease and premature death; (2) eliminating smoking and smoke exposure; (3) eliminating tobacco; (4) destroying the tobacco industry; and (5) achieving the nicotine-free society or “ending nicotine addiction.” When the consumer nicotine market was supplied almost exclusively by cigarettes, it was possible for activists to say, “all of the above.” Activists could get away without having to declare or even recognize their underlying aims or to face the trade-offs and tensions between them.

    No longer.

    Even in the 1990s, splits in tobacco control were already emerging over snus, an obscure Scandinavian oral tobacco product. The faction interested in reducing disease was intrigued by Sweden’s abnormally low smoking rate. Toxicology and epidemiology suggested that substantially lower rates of disease in Swedish men were due to use of snus as an alternative to smoking. For that group, the harm reduction potential of snus had great potential. However, the faction interested in the end of tobacco saw the European Union’s ban on snus (other than in Sweden) as a win and incremental progress toward their goal of the tobacco-free society. Thirty years later, snus remains banned in the European Union despite undeniable evidence that snus reduces smoking and by doing so, reduces individual and population harm. This willingness to forego major public health benefits should tell us something fundamental: The dominant tobacco control faction is engaged in a war-on-drugs mission and not, as often assumed, a public health crusade. It is trying to forge a path toward a nicotine-free society with little concern for the collateral damage inflicted to health on the way to meeting its goal.

    However, the rise of vapor and heated-tobacco products in the last 10 years means this is no longer a localized conflict. The harm reduction “proof of concept” of snus can now be generalized to an experience much closer to smoking in every respect other than harm to health. Add in the recent developments in oral nicotine pouches, which will make snus-like products more acceptable to a much larger population, and the diverse portfolio of smoke-free alternatives to smoking is starting to look quite formidable. The products available to nicotine users have changed beyond recognition in the last 10 years. If we project forward through another 10 years or 20 years of innovation in these new categories, imagine how the market could look in 2030 or 2040.

    This is the opening phase of the technology disruption now roiling the industry. But it is also disrupting the tobacco control community by surfacing the tensions between its objectives. In particular, we are seeing the goal of the “nicotine-free society” coming to the fore, with an increasing stress on nicotine and the inclusion of goals to end nicotine use or “nicotine addiction” where there was previously an aim to pursue the end of smoking or to prevent disease.

    Even many public health supporters of “tobacco harm reduction” see the smoke-free products as an expedient and effective way of helping to stop smoking—a sort of pimped-up nicotine-replacement therapy. And that is a good argument, as far as it goes. But it doesn’t really settle the question of our collective attitude to nicotine over the longer term.

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    To look ahead, let’s consider the situation in Norway where daily smoking among 16-year-old to 24-year-old women has fallen from 15 percent to only 1 percent in just 10 years, according to 2019 data from Statistics Norway. Have they stopped using nicotine? No, they have been using snus from the outset. By 2019, daily snus use was at 14 percent in this group. That group is now using nicotine without ever starting to smoke, and they probably never will. Harm reduction supporters argue that this is “a win” for public health because without the use of snus, many of these young women would otherwise be smoking. But how will that argument look in 10 years or 20 years when cigarette smoking may be well on the way to obsolescence?

    Here we need to confront the deeper question about nicotine that goes beyond harm reduction in which the cigarette is the reference point for harm. The concept of harm reduction feels unsatisfactory in this context—what if no one uses a harmful product to start with? If there is going to be a long-term market for nicotine, the question becomes how to regulate a recreational nicotine market based on consumer-appealing products with risks that are within our normal appetites for risk? I believe the product portfolio is now evolving toward how it could look over the longer term—smokeless and electrically heated tobacco and nicotine products. I don’t expect the combustible products to disappear but to become a niche interest—like vinyl records in a world dominated by digital music streaming.

    For some in tobacco control, this is a nightmare vision. This is not the nicotine-free society that has been their ultimate endgame. But if the harms are not particularly large and the drug is popular, why should governments stop people using it? Drug use is pervasive in human society and throughout history, perhaps started by our hominid ancestors millions of years ago. Nicotine, a relative newcomer, was domesticated between 6,000 years and 8,000 years ago. To say that a drug should be legal and available in relatively safe form is not to endorse its use or somehow to recommend it but to acknowledge that some people may wish to use it, and there isn’t a good reason to stop them by force of law. That idea has both philosophical and practical underpinnings. The philosophical foundation recognizes adult autonomy and the right to indulge in risky behaviors that do not harm others. The practical experience of prohibitions is that they do not work (a new supply chain is established by criminals) and cause serious harms to the individual and to wider society.

    Prohibition does not even protect adolescents. Despite federal prohibition, past-30-day use of cannabis among U.S. 12th graders has been over 20 percent for at least a decade. The recent U.S. lung injury outbreak that hospitalized 2,800 and killed 689 was largely a consequence of reckless criminal behavior in the illicit supply of cannabis (THC) vapor products.

    As a drug, nicotine is relatively innocuous—it doesn’t cause serious disease, intoxication, overdose, violence, road accidents, sexual vulnerability, incapacitation or family breakdown. Perversely, this relative safety becomes a serious tactical problem for the war-on-drugs tendency in tobacco control. If the prospects of cancer, lung disease and heart disease are greatly diminished, why should people fear nicotine? It is even possible that more people will take up nicotine if the consequences of using it are much less dreadful—that would be the economist’s assumption. Harm (from smoking) is the most persuasive reason not to use nicotine, and that reason is going up in a puff of vapor. In a weirdly inverted way, the greatest threat to the nicotine-free society is the availability of relatively safe nicotine products. I think that explains why so much strenuous, even desperate, effort is going into finding serious harms in smoke-free products though, beyond reasonable doubt, there are none.

    The theme of this year’s online GTNF 2020 is “Sustainable change through innovation and regulation.” It will be a great opportunity to discuss the future of nicotine in greater depth.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • The Unlikely Savior?

    The Unlikely Savior?

    Smoking, nicotine and Covid-19: What is going on?

    By Clive Bates

    Photo: maja7777 from Pixabay

    The world is enduring the worst crisis since the 1940s, and people are desperate for some good news. Could that good news come from a most unlikely source? Could smoking, or more precisely nicotine, have benefits in controlling the symptoms of Covid-19, the disease caused by the coronavirus SARS-CoV-2? There is emerging, though inconclusive, evidence that nicotine may have protective effects in preventing severe symptoms of Covid-19. If this turns out to be true, it would be extraordinarily good news—nicotine in its medical and recreational forms is widely available and easily affordable.

    The picture is quite complicated, but discussion should start with clarity about which outcomes may be improved. There are at least four relevant stages: infection (simply contracting the disease, often with mild symptoms); hospitalization (serious symptoms); admission to an intensive care unit (ICU) (life-threatening symptoms); and finally death. If there is a protective effect, the data suggest it reduces the number reaching hospitalization. For the purposes of fighting the pandemic and returning to economic normality, preventing the onset of symptoms serious enough for hospitalization is the highest priority.

    There are two main strands of evidence that suggest a protective effect: the apparent underrepresentation of smokers in Covid-19 hospital admissions and evidence from human biology.

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    Evidence from Covid-19 hospital admissions

    Most Covid-19 studies recording hospitalization and smoking status show smokers are strikingly underrepresented compared to the number that would be expected given smoking prevalence in the population. Being a smoker appears to make it less likely that a Covid-19 sufferer will end up in the hospital. There are many doubts and questions about the reliability of this data, but the effect is remarkably consistent across countries where the data is available. Greek cardiologist Konstantinos Farsalinos and his collaborators examined the literature available on April 25, 2020, to assess the smoking status of those entering the hospital with Covid-19 (see Farsalinos et al., “Prevalence of Current Smoking and Association with Adverse Outcome in Hospitalized Covid-19 Patients: A Systematic Review and Meta-Analysis”).

    An unexpectedly low prevalence of current smoking was observed among hospitalized patients with Covid-19. Hospitalized current smokers had higher odds compared to noncurrent smokers but lower odds compared to former smokers for an adverse outcome.

    These data suggest that fewer smokers are entering the hospital than we might expect, but once they are admitted, their outlook is worse. This is consistent with other findings showing a worse outlook for smokers once hospitalized. (For example, Vardavas and Nikitara, “Covid-19 and Smoking: A Systematic Review of the Evidence.”)

    Notably, in the largest study that assessed severity, there were higher percentages of current and former smokers among patients that needed ICU support, mechanical ventilation or who had died and a higher percentage of smokers among the severe cases.

    These authors did not draw attention to just how few smokers there were among the patients to start with—but that is the remarkable fact picked up by Farsalinos and his group. So, what could be going on? Farsalinos and colleagues have a theory:

    “The possibility that nicotine may have a protective effect in Covid-19, which may be masked by smoking-related toxicity and by the abrupt cessation of nicotine intake when smokers are hospitalized, should be explored.”

    So, it may be that nicotine is protecting smokers up to the point where they are admitted to the hospital. However, all respiratory wards require smoking cessation on admission, so smokers make an abrupt withdrawal from nicotine use. To understand what is happening, it is necessary to separate the effects of decades of smoke exposure, which may be causing underlying vulnerabilities through cardiovascular disease and other stresses, from the effect of nicotine, which may be protective. These two effects of smoking—one harmful, one protective—could be pushing against each other and may become relevant at different points in the progression of the disease.

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    Evidence from human biology—does nicotine suppress the “cytokine storm”?

    So far, this could all be wishful thinking based on poor quality data. However, the second line of evidence means it should be taken very seriously. This provides biological plausibility based on cell-level insights into the mechanism through which nicotine could provide a protective effect. A range of papers have explained the possible mechanism, starting with the renowned French neuroscientist Jean-Pierre Changeux who pioneered research on nicotine receptors in the 1970s (Changeux et al., “A Nicotinic Hypothesis for Covid-19 with Preventive and Therapeutic Implications”). This was followed by an in-depth peer-reviewed publication by Farsalinos and colleagues (Farsalinos et al., “Nicotine and SARS-CoV-2: Covid-19 May be a Disease of the Nicotinic Cholinergic System“).

    These theories converge on the role nicotine can play in suppressing the most dangerous symptom of Covid-19, a dramatic immune system overreaction to the virus, a so-called “cytokine storm.” Inflammation is a normal response to infection as the body responds with a series of immune reactions to neutralize invading pathogens. In this model, it is not the virus itself that does the harm but the body’s own immune system triggered by the virus into an excessive response that causes extreme inflammation and damage to the lungs or other organs and ultimately death.

    These technical papers suggest that severe Covid-19 symptoms arise from damage to the internal signaling and control system known as the cholinergic anti-inflammatory pathway. This system originates in the brain and makes use of the Vagus nerve, the signaling chemical, acetylcholine and nicotinic acetylcholine receptors throughout the body. Under this hypothesis, nicotine moderates the malfunctioning of the anti-inflammatory control system by inhibiting the release of pro-inflammatory cytokines.

    While Covid-19 is clearly new, the idea that nicotine may have therapeutic effects, including on inflammatory diseases rooted in the brain, is not new. In May 2020, researchers at Oxford University published a new finding from the 65-year study of British doctors started by Sir Richard Doll and Sir Austin Bradford Hill in 1951 confirming years of research suggesting smoking (in practice, nicotine) has a protective effect against Parkinson’s disease (Mappin-Kasirer et al., “Tobacco Smoking and the Risk of Parkinson Disease”). A 2013 paper by the U.K.’s bioweapons defense lab at Porton Down highlighted the role nicotine could play in controlling the cytokine storm and moderating some severe respiratory diseases (D’Elia et al., “Targeting the ‘Cytokine Storm’ for Therapeutic Benefit”).

    “Nicotine […] is able to suppress the production of proinflammatory cytokines by mimicking the binding of acetylcholine. It has been demonstrated that nicotine can selectively reduce the inflammatory response in a number of infection scenarios, including Legionella pneumophila and Chlamydia pneumoniae infection.”

    Following their observation that smokers were underrepresented in Covid-19 admissions to the Pitie-Salpetriere Hospital in Paris (Miyara et al., “Low Rate of Daily Active Tobacco Smoking in Patients with Symptomatic Covid-19”), French researchers are now planning a clinical trial of nicotine-replacement therapy for Covid-19.

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    Where does that leave policy and practice?

    With the Covid-19 pandemic raging everywhere, policymakers are in a position analogous to trying to repair an aircraft while flying it. It is not known for sure whether nicotine is protective against the more severe forms of Covid-19, just that it is suggested by data on hospital admissions and that it is biologically plausible. Yet decisions made today in hospitals and advice given to smokers and vapers could have life-saving or life-threatening consequences. The usual approach to such uncertainties would be to wait for more evidence and then make better-informed recommendations, but that is no different in practice to acting as though there is no protective effect.

    It would be wrong to advise people to continue to smoke because of the longer term health implications and the underlying vulnerabilities to Covid-19 caused by smoking. But if people are advised to quit nicotine, they may be losing a protective effect at the point of their greatest vulnerability. The way to resolve this dilemma is to make a working assumption about the effect of nicotine based on what is known and what remains uncertain taking account of the consequences of making the wrong assumption. Recommending continued nicotine use in a situation where it turns out there is no protective effect does not seem likely to cause serious problems. Conversely, advising or requiring nicotine users to stop using nicotine only to find later that nicotine was protective may cause lethal harm. On a precautionary basis, policymakers should probably assume there is a protective effect until proven otherwise.

    It follows that health professionals should advise smokers to quit smoking using any method that works but to maintain the use of nicotine—either by using nicotine-replacement therapy, vaping or some form of low-risk noncombustible tobacco—at least until there is a more complete understanding of the role nicotine plays. Vaping as an alternative to smoking should be encouraged not banned or locked down. What about people like me, who have never used nicotine and have no wish to—what should we do? Well, if I came down with Covid-19, I’d consider trying nicotine as a precautionary measure. What is there to lose?

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • After the Split

    After the Split

    What does Brexit mean for tobacco and vaping?

    By Clive Bates

    The U.K. government has banned the word Brexit—or at least insisted the word is used only to describe a joyful event that happened in the past. Having promised in the U.K.’s December general election “to get Brexit done,” Prime Minister Boris Johnson has declared that Brexit was officially “done” when the United Kingdom left the European Union on Jan. 31, 2020.

    But Brexit is not, in reality, done at all. Far from it. Almost every aspect of the future relationship between the U.K. and the EU remains to be negotiated: terms of trade in goods and services, food, farming, fishing, pharmaceuticals, financial services, aviation, aerospace, automotive, energy, immigration, data protection and sharing, security and justice cooperation—the list is endless and will consume British politics for years.

    Buried deep in that list is the question of the U.K.’s approach to those aspects of tobacco regulation that are under EU jurisdiction but now revert to control by the U.K. government.

    Given the U.K.’s stated intent not to extend the transition period beyond the end of 2020, it will all need to be done in a breathtakingly short timetable.

    Where does this leave tobacco and vaping? Unfortunately, the only truthful answer at this point is “we just don’t know.” The statements of politicians are unreliable—more like populist banter or strutting negotiating postures than declarations of genuine intent. However, we can take a look at the options.

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    What is the most important EU legislation that covers tobacco?

    In the EU, jurisdiction over tobacco is split between the now 27 member states and the European Union. Some matters are regulated at the EU level and others (for example, age restrictions or smoking or vaping in public places) are regulated at the national or subnational level. There are three main areas in which the EU has jurisdiction: cross-border tobacco advertising, a framework for tobacco excise duties, and tobacco product regulation, which is meant to harmonize product regulation to facilitate trade within the EU’s internal market with a high level of health protection.

    Advertising

    The EU’s tobacco advertising regime prohibits any form of tobacco advertising, promotion or sponsorship that is capable of crossing a border (TV, radio, internet, newspapers, etc.). It does not apply to fixed advertising such as billboards or advertising in shops. The U.K. legislation goes further than required by the EU directives and bans almost all tobacco advertising, whether transboundary or fixed. Outside the EU, Parliament could potentially change this legislation, for example, to allow the advertising of reduced-risk products such as heated or smokeless tobacco products based on a pro-health harm reduction argument. The EU law on the advertising of vapor products is implemented by the Tobacco Products Directive (TPD), and this imposes more or less the same restrictions on vapor advertising as the Tobacco Advertising Directive applies to cigarettes. In the case of vaping, however, the U.K. has used its national discretion to allow fixed advertising, which is governed by a code set up by the U.K. Committee of Advertising Practice.4 The U.K. could, at least in theory, apply this code to all advertising for vapor products, including transboundary advertising. Again, the justification would come from the government’s determination to reach its 2030 smoke-free goal.

    Excise duties

    The tobacco excise directive mainly harmonizes definitions and sets limits for different components of tobacco excise duty. This directive is not especially constraining on U.K. excise policy options for, say, cigarettes or hand-rolling tobacco. However, the U.K. may wish to establish particular categories in its excise framework for vaping, heated tobacco, smokeless or oral nicotine products. Even while still a member state of the EU, the U.K. has been free to do this. I doubt that Brexit will make much difference to U.K. excise duty policy unless the EU moves in a direction that is especially hostile to tobacco harm reduction—for example, by requiring nonzero minimum duties on vaping or duties on heated products that approach those on cigarettes. Tax changes in the EU require unanimity among the EU’s member states, so the U.K., as a member, would have had a veto on tax changes hostile to tobacco harm reduction.

    Product regulation

    The most fertile ground for U.K. divergence from the EU’s regulatory system would be to revise or remove the many rules in the TPD that are pointless or counterproductive. Firstly, and most obviously, the U.K. should lift the ban on snus. This prohibition, with its origins in a 1980s U.K. moral panic over Skoal Bandits,6 has no scientific, ethical or pragmatic basis and is probably the worst piece of EU legislation ever written. The prohibition on claiming that “a particular tobacco product is less harmful than others” should be replaced as it is obviously unrealistic. Other areas for divergence could be those aspects of regulation that needlessly harass vapers or otherwise degrade the vaping experience and, in doing so, function as a de facto protection of the cigarette trade—for example, the limits on tank size and refill containers, insert leaflets, excessive warnings, limitations on nicotine strength, and the restrictions on transboundary advertising and online retailing. The U.K. has the means to shape a truly world-leading, risk-proportionate approach to tobacco and reduced-risk products.

    At least as important as rolling back poor regulation in the existing directive, the U.K. may choose to diverge to avoid even worse regulation that may lie ahead. By May 2021, the European Commission has to review the functioning of the 2014 TPD and, in light of that review, make proposals for new measures. Statements from European politicians and officials do not suggest that a pro-tobacco harm reduction epiphany is imminent, and vaping advocates can expect the next TPD to become more restrictive and intrusive, not less. For example, there may be restrictions on flavorings, packaging, ingredients or internet commerce. In pursuit of its “smoke-free 2030” goal, the U.K. could decline to implement counterproductive future measures.

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    But what will the U.K. actually do?

    You may have noticed a lot of use of “could,” “may” and “potentially” in the discussion above. This is because it is not yet clear if or how the U.K. would use its theoretical freedom to regulate unilaterally. This prompts a further series of questions.

    Will the U.K. ultimately have the option to diverge from the EU?

    Modern trade agreements do more than just eliminate tariffs and quotas; they also try to reduce nontariff barriers such as incompatible regulation. We do not yet know whether the U.K.’s eventual trade agreement with the EU will allow for divergence. The EU’s concern is to establish “a level playing field,” preventing the U.K. from competing with the EU by lowering environmental and labor standards or by allowing state subsidies that would lower the cost of production. That wouldn’t necessarily include the tobacco legislation, but it is still possible that the U.K. will agree to comply with EU tobacco regulation for one particular reason. This is that the TPD will continue to apply in Northern Ireland (part of the U.K.) as part of the peacekeeping effort to keep an open border between Northern Ireland and the Republic of Ireland (part of the EU). The problem for Prime Minister Johnson is that divergence from EU regulation hardens the inevitable internal border that forms between Northern Ireland and the rest of the U.K. And that, to say the least, is a political minefield.

    Even if the U.K. has the option to diverge, will it use it?

    There will be many advantages to remaining in step with the EU (for example, reducing trade friction and having a single set of business standards), so U.K. politicians will have to carefully weigh whether the costs of divergence will be worth the benefits. On the other hand, they also need to show that there was a purpose to Brexit and that better regulation is possible. But would they choose the highly controversial issue of tobacco policy to make the case for liberalizing regulation? I doubt it would be the first choice.

    Out of the room

    Leaving the EU means that U.K. officials and ministers are now excluded from developing legislation and policy at the EU level. It also means that the U.K. public no longer has elected Members of the European Parliament to appeal to if the EU institutions come up with terrible proposals.

    Yet because regulatory divergence will have costs, it is possible that the U.K. will continue to comply with these directives. Brexit will have impacts on the EU too. With the exit of the U.K., the pro-harm reduction movement in Europe has lost its strongest ally and the buttress against the “abstinence-only” policy. That will have knock-on effects internationally because the EU is a highly influential player in the World Health Organization Framework Convention on Tobacco Control. So, as the U.K. assumes its new independent status, it may find itself entangled with European Union regulation but no longer allowed in the room where the real decisions are made.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Merchants of Doubt

    Merchants of Doubt

    Photo: Airdone – Dreamstime.com

    In the vaping debate, falsehood flies and the truth comes limping after it

    For those of us who support the public health strategy of tobacco harm reduction, it has been a tough few months. Several crises emerged suddenly and the boundaries between them have become blurred: an outbreak of severe lung injuries and deaths, a sharp rise in youth vaping in the United States and the claim that e-liquid flavors are the problem and should be banned.

    The satirist Jonathan Swift summed it up pretty well in 1710:

    “Falsehood flies and truth comes limping after it so that when men come to be undeceived, it is too late; the jest is over, and the tale hath had its effect; like a man, who hath thought of a good repartee when the discourse is changed, or the company parted; or like a physician, who hath found out an infallible medicine, after the patient is dead.”

    What can be done? Falsehood has certainly flown, but could the truth at least break into a jog? Let us examine these crises and try to determine what is true and what is false.

    Vaping causes severe lung injury and death: true or false?

    As of early December, 2,291 vaping-related lung injury hospitalizations and 48 deaths had been recorded in the United States. Many have assumed nicotine e-liquids are implicated. Because the problem emerged in a specific place (the United States) and at a specific time (from July 2019), it was already clear in July 2019 that this was a specific supply chain problem. It had not affected vaping before and had not affected the millions of vapers in the rest of the world. It soon emerged that the cases were dominated by specialized vapes used for cannabis THC oil. The focus should, at that point, have narrowed to the illicit THC vape suppliers with a clear message exonerating commercial nicotine liquids. Instead, major public health agencies became “merchants of doubt,” maintaining that any vapor product was suspect. However, the chance of a parallel problem occurring in the legal and regulated nicotine e-liquid supply chain at the same time, in the same geography and with the identical symptoms is vanishingly small. 

    A minority of the users afflicted had denied or refused to confirm use of THC, so there was some doubt. Of course there was doubt! People do not readily admit to using illicit substances because it can get them into trouble with parents, at school or college, or with their employer. Whenever actual tests were done or when users were pressed harder to tell the truth, THC vaping reliably emerged.

    The mystery doesn’t end there because THC oil itself is not the issue—there are many THC vapes that do not cause this problem. The investigation narrowed further to identify vitamin E acetate as one likely cause. This is used as a thickener to cut expensive THC oil for economic reasons. This is a lipid, a fatty substance that can have exactly the effect on the lungs that has been seen. There is no question of this being added to nicotine liquids. It is not soluble in nicotine liquids and would serve no purpose as there is no reason to thicken nicotine liquids.

    The truth: The lung injuries are a serious problem, but they are nothing at all to do with commercially available nicotine e-liquids. The ultimate problem here is a black market supply chain opportunistically experimenting with novel and untested formulations with no accountability for health consequences. To pretend otherwise is to cause three harms: sending a diluted and contradictory message to THC vapers that may put more lives at direct risk; frightening regular nicotine vapers back to smoking and smokers away from vaping with longer term health consequences; and promoting bad policy responses, like flavor bans, that will tend to increase black market activity and make the problem of adulteration in the supply chain more likely and vaping more risky.

    There is a youth vaping epidemic: true or false?

    The falsehoods here lie in the interpretation of the headline statistics—what you see if you drill down into the data. First, the headlines. In the United States, vaping among high school students rose from 11.7 percent in 2017 up to 20.8 percent in 2018 and on to 27.5 percent in 2019. A dramatic rise by anyone’s standard and undoubtedly a cause for concern.

    But there are three other factors to consider in a drill down. The headline figures refer to any use of an e-cigarette, even a single puff, in the past 30 days, so what is the breakdown between infrequent and frequent use? How many of the frequent vapers also use other tobacco products? For them, vaping may be beneficial. The rise in youth e-cigarette use has been described as an “epidemic of nicotine addiction.” How many show signs of dependence?

    The data to address these questions is only available for 2018, but this breakdown of the headline 20.8 percent vaping figure provides a useful illustration:

    NYTS 2018 data

    Percentage of high school students using e-cigarettes Total = 20.8%

    High school students

    No past tobacco use

    Any past tobacco use

    Frequent e-cig use: ≥ 20

    days per month

    0.6%

    5.2%

    Infrequent e-cig use: ≤ 19

    days per month

    4.7%

    10.3%

    First, most adolescent vapers (72 percent) are not frequent users and therefore provide less reason to be concerned. Second, most of the frequent adolescent vapers (90 percent) were already tobacco users. Only 0.6 percent of high school age vapers are both frequent users and have no prior history of tobacco use—and it is also important to recall that smoking is much more harmful than vaping, but in 2018, 13.9 percent had used any combustible product in the past 30 days. Smoking remains the bigger problem.

    Turning to the third question of dependence, the analysis of U.S. youth e-cigarette data by epidemiologists Martin Jarvis and colleagues (Epidemic of youth nicotine addiction? What does the National Youth Tobacco Survey reveal about high school e-cigarette use in the USA?) shows little sign of teenage vaping uptake causing nicotine addiction.

    “Data from the National Youth Tobacco Survey do not support claims of a new epidemic of nicotine addiction stemming from use of e-cigarettes …. Among current e-cigarette users who had never tried tobacco products, responses consistently pointed to minimal dependence.”

    The truth: Many young Americans are trying vaping, but most are not vaping frequently, and it isn’t an especially dangerous youth behavior compared to smoking, using illicit drugs and using alcohol excessively. The frequent or daily vapers are mainly those using other tobacco products. For them, vaping may be a beneficial diversion from smoking. There is reason for concern, but there should not be an overreaction.

    The rise in U.S. youth vaping is driven by flavors: true or false?

    At one level, it is obvious that e-liquid flavors are important—if vendors could only sell unflavored products, there would be few buyers of any age. E-cigarettes are an inherently flavored product in much the same way that pizza would not be pizza without a topping.

    There is much to suggest that flavors form part of the appeal, but they are not the main reason why young people take up vaping. The story is far more complicated: The more credible academic work (e.g., see Nicksic et al. 2019) suggests uptake of vaping is driven by replacing cigarettes and by the “wider social environment.” Flavors are a factor, but they are far from the most important factor. The most recent official analysis of U.S. youth data included reasons for youth vaping uptake (MMWR Table 6). The most important reason given was “I was curious about them,” cited by 56.1 percent of exclusive e-cigarette users. “They are available in flavors, such as mint, candy, fruit or chocolate” came a distant third at 22.3 percent.

    The idea of limiting flavors to just tobacco flavor would be like limiting pizza toppings to allow only a simple Marherita. In both cases, it would kill the category and shut down all the vape shops. The likely response would be an uptick in smoking, a black market in flavored products, home flavor mixing and more international internet trade. No one would gain, and many would lose.

    The high score for curiosity raises an intriguing question. Has the barrage of breathless media coverage, official school-based anti-vaping campaigns, parent mobilization and political outrage actually been a stimulus for youth curiosity about vaping? Is the reaction part of the cause? We can safely assume that no one involved will fund that research.

    The truth: The reasons young people take up vaping are similar to the reasons they take up smoking and can include unpredictable and largely uncontrollable fads and fashions. Vapor products would be nothing without flavors, and banning them would have a range of harmful effects and do little to protect youth from actual harms. If governments want to control flavors, they should focus on flavor descriptors and branded imagery that are aimed at adolescents, not the actual flavors themselves.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • A rhetorical gambit

    A rhetorical gambit

    The absence of long-term risk assessments does not justify stifling the development of new, potentially less harmful nicotine products.

    By Clive Bates

    It’s a common refrain: “We just don’t know the long-term risks of vaping.” Those who oppose the transition of the consumer nicotine market from combustible to noncombustible products will often argue, correctly, that there are no long-term studies of the safety and health impacts of vaping or heated-tobacco products. What is wrong is to assume this is a slam-dunk clincher and that the argument should end there. Let us examine this claim in more detail.

    First, it is a statement of the obvious. We have not yet invented time travel and cannot venture forward to 2050 to find out what happened to life-long vapers. There will be no long-term studies until the long term has elapsed and the studies have been done. We have had about 10 years of science on vaping, and the story is positive so far, but we will not have 40 years of studies until 2050.

    Second, at least for now, almost everyone who vapes or switches to a heated-tobacco product is currently or has recently been a smoker. For that reason, long-term data on vaping will be “contaminated” with health consequences of prior smoking, and this will be difficult to untangle. It will be possible to follow cohorts of those who never smoked prior to vaping, but at present, these are a small fraction of the total user population. I hope that share will grow (there should be no need to go to a safer form of nicotine via the most dangerous) but that is not something the authorities wish to encourage.

    Third, some activists argue that it took years for us to discover the health risks of smoking. Smoking took off in the early 20th century, but it was not until the 1960s that the U.K. Royal College of Physicians and the U.S. Surgeon General issued their blockbuster reports on smoking and health. Surely, we should expect discoveries to emerge over decades. But this perspective ignores the march of scientific progress over the past 60 years. Today’s field of systems toxicology would be unrecognizable to the boffins of the 1950s. If cigarettes were invented today, a modern lab would need about half a day to establish the extraordinarily high risk, and that includes writing up the paper. We would not need to wait 40 years to declare that a hypothetical newly introduced cigarette would be very harmful to health.

    Fourth, it is true that we do not have long-term epidemiology for vaping, but that does not mean we know nothing. There is a lot of data that helps us assess what long-term risks are likely to be. These come from chemical analysis of the vapor aerosol and measurements of toxins in the blood, saliva and urine of users of the products. We are also seeing more measurements of improving indicators of health in users who have switched from smoking to smoke-free products. The totality of what we do know is impressive, and it all points toward much lower risks over the long term.

    Fifth, some analysts advocate a “precautionary approach” to address long-term but uncertain risks. This would mean some mix of prohibition, taxation, regulation and off-putting communications to deter use until someone can prove that the products are safe—or safe enough. The precautionary principle is perhaps the most shamelessly abused concept in all of policy-making (though it is a crowded field). The precautionary principle is not a free pass to ban anything with uncertain risks. It is really a sophisticated form of risk assessment that requires taking account of the consequence of both action and inaction and the consequences of being wrong. Given that smoke-free products are alternatives to smoked products, and we know beyond doubt that these are harmful, then there is every possibility that obstructing access to what looks like a much safer product will do more harm than good. In what I regard as the most important passage in its 2016 report, Nicotine without smoke: tobacco harm reduction, the Royal College of Physicians captured this challenge:

    “A risk-averse, precautionary approach to e-cigarette regulation can be proposed as a means of minimizing the risk of avoidable harm, e.g., exposure to toxins in e-cigarette vapor, renormalization, gateway progression to smoking, or other real or potential risks.

    However, if this approach also makes e-cigarettes less easily accessible, less palatable or acceptable, more expensive, less consumer-friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking. Getting this balance right is difficult.”

    Generally, the precautionary principle is most applicable where the risks are novel, systemic, irreversible and cause uncontrollable destabilization—for example, introducing new species or pathogens into an ecosystem or increasing the heat in the atmosphere. Vaping risks are not like this.

    Sixth, it is often assumed that “no long-term studies” implies there are bound to be risks but we just haven’t found them yet. However, it may turn out that the risks are negligible or well within the range of voluntarily accepted risks associated with living a normal enjoyable life. It is even possible that there may be health-protective effects that go beyond ameliorating the risks of smoking. It is possible, for example, that nicotine may have protective effects against some forms of neurodegenerative disease.

    Seventh, it is possible that unexpected risks will emerge. But it is likely that many plausible risks can be dealt with through regulation. For example, a recent study by Farsalinos and Lagoumintzis investigated the toxicity of flavor compounds used in e-liquids. It found that “one chemical (methyl cyclopentenolone) was found at a maximum concentration 150.7 percent higher than that needed to be classified as toxic.” There is an obvious regulatory response: Stop the use of this compound or ensure it is used only in concentrations well below the toxic threshold. This response is possible with vapor products because the vapor aerosol is more or less a heated version of the e-liquid, so controlling ingredients and contaminants in the e-liquid will also control human exposure. The same is not true for cigarette smoke. Vapor products generally operate below 300 degrees Celsius, but the temperature in the burning tip of a cigarette can exceed 900 degrees Celsius. At these higher temperatures, there is much more energy to break chemical bonds and to create thousands of new “products of combustion,” which can react with each other to create still more compounds. The combustion process of cigarettes is far more complex and chaotic than the heating process of vapor products and leaves the cigarette designer with only limited options to control toxic exposures. This is one reason why industry engineers have struggled to make a “safer cigarette.”

    Eighth, a common variant on the “we just don’t know” argument is that public health was badly caught out with “light and mild” low-tar cigarettes. These appeared to be safer and even had some public health endorsements as a harm reduction approach. These products appeared to be safer only when smoked by machines with fixed smoking regimes. It turned out that real humans adjusted their smoking behavior by blocking filter ventilation holes or drawing more frequently and deeply on the cigarette. Smokers adjusted their behavior—a process known as compensation—to achieve their desired dose of nicotine. And with the nicotine, they got the exposure to toxins in the smoke and were no better off. The situation with smoke-free products is very different. Low-tar cigarettes mostly just diluted smoke with air—the ratio of toxins to nicotine barely changed. Vapor products work by dramatically reducing the ratio of toxins to nicotine in the aerosol. So for a given dose of nicotine, a vaper will receive a much lower exposure to toxins than a smoker. The “light and mild” argument is misusing an analogy that does not hold true in reality. We should not use a mistake in the understanding of light cigarettes to justify a mistake in the understanding of smoke-free products.

    My concern is that the argument about the lack of long-term studies is essentially tactical: a rhetorical gambit designed to create an insurmountable evidence hurdle that will apply indefinitely. I do not believe it is a sincere attempt to grapple with inevitable uncertainties and to make the best decisions possible with the available evidence. To test the sincerity of those making this argument, I have devised what I call “the snus test.” Snus is a form of oral tobacco popular in Scandinavia. So my question is: Do you accept that the long-term evidence for snus use in Scandinavia shows it has reduced smoking prevalence and the burden of disease? If the answer is “no” and some other justification is offered, it is clear you are not dealing with a sincere truth seeker.

    The theme of this year’s Global Tobacco and Nicotine Forum (GTNF)  is “More choice, less risk.” The GTNF will be held Sept. 24–26, 2019, in Washington, D.C. See www.gtnf.org for more information.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Hold your fire

    Hold your fire

    In debating the relative health risks of various nicotine products, one consideration trumps all others.

    By Clive Bates

    What is the best alternative to smoking cigarettes? Unless we are allowed the answer “not smoking cigarettes,” then sadly this is the wrong question. We are already seeing commentators and companies declaring they have the best product or being champions of vapor products, heated tobacco or snus—as though preferred product choice was like supporting a football team.

    So, let’s be clear. There best alternative product to cigarettes is the one that works for a particular individual, at a particular time, in a certain setting, in a given jurisdiction. That will differ between people, and the same person will have different preferences at different times. There just isn’t a single best product.

    The most important distinction from a health and public policy point of view is whether or not the nicotine product is combustible—i.e., whether the product is designed so that dried and cured tobacco is set on fire and the resulting smoke is inhaled. Almost everything else is incidental, a second- or third-order issue.

    Choice and risk in the nicotine market

    We are now seeing a spectacular expansion of choice in reduced-risk alternatives to smoking. Within the broad category of smoke-free products we can identify four subcategories (see figure). Within each of these four, there is rapidly advancing diversification driven by innovators, consumer demands and regulators.

     Pure NicotineTobacco
    Heated Aerosol

    Vapor products, e-cigarettes, tank systems,

    e-hookah

    		Heated-tobacco products, hybrids
    UnheatedGums, lozenges, films, synthetic snus, NRTsSmokeless tobacco, snus, snuff

    These products represent a disruption in the tobacco and consumer nicotine marketplace. Even long-established products like snus are taking on a new role as awareness of the “Swedish experience” grows and the products are repackaged as “modified-risk.” These products are quite different from each other but, in my view, we should treat these smoke-free products in more or less the same way for policy, fiscal and communications purposes—as a broad noncombustible category of consumer alternatives to smoking.

    There is nothing inherently superior in health terms about nontobacco products such as e-cigarettes compared with tobacco products such smokeless tobacco. Some appraisals, for example, Nutt et al, 2014, have suggested that e-cigarette use would be safer than smokeless tobacco use. But why? Smokeless tobacco does not involve lung exposure, but vaping does—couldn’t that create different risks than those posed by smokeless products? I’ll guess it is because the authors instinctively ranked any tobacco product as being inherently more dangerous than any nontobacco product because of some hunch about the “dirtiness” of tobacco itself. But there is no scientific basis for that.

    The aerosol generated by heated-tobacco products may be more chemically complex than typical e-cigarettes—and potentially more hazardous. But is this difference a material concern for policymakers? I think it should make little difference. Heating hardly matters as long as there is no burning—that is, as long as the temperature of the tobacco stays safely below 350 degrees Celsius, the temperature at which combustion occurs. What matters is that the products are all much safer than smoking—the differences between the various smoke-free products matter much less than the difference between smoked and smoke-free products. Imagine there was a scale of harm ranging from 1 to 100, with combustible cigarettes being 100. Suppose noncombustible products are in the range of harms from 1 to 5. The relative difference between smoke-free products could be a factor of five—a large range—but in practice this is in a tiny absolute range at the extreme end of a spectrum of risks that includes smoking.

    Some may object that, for public health reasons, we should concentrate on whatever noncombustible products is the least harmful and propose that as the preferred alternative to smoking. Why have any additional risk if it is unnecessary? While that logic is superficially attractive, it would not in practice reflect the public health optimum. To put it bluntly, the perfectly safe product that no one wants to use is of little value from a public health point of view. This is the reason why pharmaceutical nicotine products have not been a conspicuous consumer success, even though some are licensed for continued use for nicotine maintenance. For an alternative to smoking to succeed in public health terms, there has to be both substantially lower risk and people have to want to use it instead of smoking. For minor absolute differences in risk, then it will be worth making trade-off to widen the appeal.

    Appeal and product diversity

    This brings us to the fundamental point about tobacco harm reduction: appeal matters. And consumer appeal is what the consumer decides is appealing. For some, a product that is as close as possible to their smoking experience could be their ideal choice—and so they may choose a heated-tobacco product. Others may be trying to distance themselves from their life as a tobacco consumer and will welcome a fruit-flavored vapor product. For some nicotine users, the discreet use of a nontobacco oral product might be useful when smoking or vaping is inappropriate. In some jurisdictions, high taxes or regulations may shape consumer preferences, for example by making e-cigarettes more affordable than heated-tobacco products. For some, trying new flavors, products and techniques may be part of the experience, and industry innovators, if permitted, will find endless ways to cater to curiosity.

    These consumer preferences may also change in response to marketing, to new studies and media stories, or through advice from other users or vape shops. Preferences are shaped by the environment as well as the consumer. What users find appealing may also change with the time of day or with the progress of a journey from smoking to being smoke-free lasting months or years. Nothing is fixed; product and brand loyalty is fluid.

    How should all these diverse preferences be met? From a public health perspective, what each company does is less important than how the market as a whole presents diverse product choices to the consumer. We need a market that provides a wide range of attractive products, with a rapid pace of innovation and responsiveness to evolving consumer tastes. The shape of that market will depend in large part on regulation.

    Regulation to support a diverse marketplace

    The main threat to consumer choice in the smoke-free market is excessive and disproportionate regulation. The system defined under the U.S. Tobacco Control Act and administered by the U.S. Food and Drug Administration is a case in point. The premarket tobacco product application (PMTA) process is extremely burdensome, very slow and highly opaque. There are few firms that have the resources and capabilities to clamber over these extraordinarily high regulatory barriers to entry. The likely result will be extreme market concentration, dominated by large companies with the means to cross-subsidize their reduced-risk products from ongoing cigarette sales. There will be relatively few products, and these will be simple designs that can be more easily evaluated. The market will shift toward products that appeal to regulators rather than to consumers.

    The challenge is to create a smoke-free marketplace that is shaped more like the beer market. That means a few super-brewers like Anheuser-Busch InBev with global brands, but with a range of medium-sized national and regional breweries, and a long tail of microbreweries making exotic beers catering for every imaginable taste. To shape the reduced-risk consumer nicotine market this way demands “risk-proportionate” regulation (see “The Principle of Proportionality,” Tobacco Reporter, December 2018) in which the regulatory burdens, controls, and taxation reflect the risk to the consumer. This would create the conditions for a flourishing smoke-free industry: low barriers to entry, a high degree of competition and a rapid pace of innovation.

    Quantifying risk in a diverse market

    If consumers have more choice but less risk, we have new challenges in understanding and measuring the overall health impact of the tobacco market. For a thought experiment, imagine you have a choice between two patterns of consumption for a community: 20 percent smoking and no one vaping or 10 percent smoking and 30 percent vaping. In the latter case, there is twice the nicotine prevalence but half the smoking prevalence. Which would be the better outcome for public health? In my view, the option with lower smoking prevalence is by far the better public health outcome, even though there are twice as many users.

    We need a more nuanced approach to characterizing the overall impact of the tobacco market—something better than smoking or tobacco-use prevalence. In its response to a consultation on “healthy people” indicators in the United States, the National Tobacco Reform Initiative advocates use of “harm weighting” in characterizing tobacco use, creating an index of tobacco use that takes account of the differences in risk between different products. This would help to focus minds on the real public health problem: that problem is combustion and smoke.

    “More Choice, Less Risk” is the theme for the 2019 Global Tobacco & Nicotine Forum (GTNF), to be held Sept. 24-26 in Washington, D.C. Visit www.gtnf.org for details.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).