Category: Clive Bates

  • Nicotine 2040

    Nicotine 2040

    Photo: Artinun

    The market for tobacco and nicotine is transforming—how could it look by 2040?

    By Clive Bates

    “Prediction is very difficult, especially if it’s about the future,” said the great Danish physicist Niels Bohr. The future is a burial ground for expert reputations, but that should never be a reason to shy away from predictions. Much of what we do today will shape the world in 2040, and our view of how the world should be in 2040 should shape what we do today. So let us consider the evolution of the market for tobacco and nicotine products out to 2040. There’s a lot to think about, so buckle up!

    First, three epochs. I see the evolution of the tobacco and nicotine policy as three overlapping epochs covering 1960 to 2040.

    (1) The tobacco control epoch stretched from 1960 to 2010. It was triggered by reports from the U.K. Royal College of Physicians and U.S. Surgeon General. It involved an all-out struggle between public health and the tobacco industry over the multiple harms of cigarette smoking, culminating in the World Health Organization Framework Convention on Tobacco Control, agreed in 2003.  

    (2) The tobacco harm reduction (THR) epoch started around 2000 with the increasing recognition that smokeless tobacco, especially Swedish snus, was much safer than cigarettes and could displace smoking. That epoch took hold in 2010 with the rise of vaping, then heated tobacco, and now nicotine pouches. The THR controversy is focused on reducing the harms associated with smoking and exploiting (or resisting) a massive public health opportunity (or risk). However, this is an interim phase.

    (3) The rethinking nicotine epoch is already underway and beginning to shape thinking about the future. We will need to confront the fundamental question: What is the place of nicotine in society? What does nicotine use mean if few people are smoking and there is not that much harm to reduce? This is already a live question; around half of American vapers aged 18–24 have not previously smoked, though some might have smoked had there been no vapes. We will undo the deep conflation between the relatively benign stimulant nicotine and the harms of smoke inhalation and place it alongside caffeine, alcohol and, increasingly, cannabinoids as legal recreational substances.

    Second, the persistence of the demand for nicotine. Many tobacco control activists have hoped that the relative decline in cigarette smoking would also eventually lead to a nicotine-free society. However, they misjudged the underlying behavioral drivers. The decline in smoking was driven by the harm to health and welfare, reinforced by policy-induced pain, such as taxes, smoking restrictions or “denormalization” designed to create a deterrent to uptake and motivation to quit. However, without the underlying harms, the deterrents are greatly weakened, and there is no justification for a punitive, coercive and stigmatizing policy. We are left to answer the question: Why is there a demand for nicotine? The demand derives from a simple proposition: For some people, nicotine use makes them feel or function better. Looking out to 2040, we should see the demand for nicotine as robust and resilient. The demand for any particular way of taking it is much more fluid or, as economists say, “elastic.” In fact, without the harms of smoking and related deterrents, demand might increase. That may seem unnerving, but should we care if the harms are low or negligible? As a 1991 Lancet editorial put it: “There is no compelling objection to the recreational and even addictive use of nicotine provided it is not shown to be physically, psychologically or socially harmful to the user or to others.”

    Third, technology and innovation. Can smoke-free nicotine products entirely replace smoking to meet all nicotine demand? Many smokers have tried the alternatives and chosen not to switch. There is more to smoking than nicotine self-administration, including the speed and peak of nicotine delivery, other psychoactive agents, sensory experiences such as “throat hit,” flavors and aromas, behavioral and ritual aspects, and perhaps deep brand loyalties that reach right into the individual’s identity. However, the pace of change in alternative technologies has been extremely rapid since the emergence of cigalike vapes at a noticeable scale about 15 years ago. Imagine the product landscape 15 years from now. That will include better versions of the product categories we have today: vapes, oral nicotine, heated tobacco and smokeless tobacco, but perhaps also sprays, inhalers and nasal products. Who knows? Competitive innovation meets consumer demand in novel and sometimes surprising ways. Many public health commentators, and perhaps tobacco industry die-hards, believe that these products will remain a niche alternative for only some smokers. Don’t count on it. Over time, that niche will expand through innovation until it dominates the market. That trend is inevitable and unstoppable.

    Fourth, regulation and markets. The twin forces of consumer demand and innovation will squeeze the cigarette market into contraction and lower profitability. The greatest danger is that the rise of smoke-free alternatives will be treated as a threat, not an opportunity, and be met with prohibitions or excessive regulation and taxation. Although such regulation will aim to reduce nicotine use by constraining supply, its effect will be to switch from lawful commercial supply to illicit, criminal and informal supply. This effect is already visible in supposedly strong regulatory jurisdictions like Australia and the United States, where authorized products from approved suppliers meet less than 10 percent of the vape market. Jurisdictions such as Brazil and India have imposed prohibitions, but all that means is that the regulator is missing in action along with any consumer protection. Prohibitions trigger the nasty triad of more smoking, more illicit vapes and more risky workarounds. Whatever the regulation, there will be supply. Banned products do not simply disappear. Whether the supply is lawful or illegal will become the nicotine and tobacco policy conflict of the coming decade. The market will remain lawful if (and only if) the policies adopted for smoke-free alternatives are risk-proportionate, focus on consumer protection and meet the adult demand for low-risk nicotine.

    “If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee!”

    Fifth, young people and nicotine. By 2040, a more sophisticated discussion of youth nicotine use will emerge. If we accept that adult use of nicotine will persist indefinitely, then we should expect some young people to try it, and for some, it will make them feel or function better. To the extent that youth vaping displaces smoking, it provides net benefits to public health. No reasonable person, including me, wants young people to smoke, vape or use nicotine in any form. However, it is one thing to express an opinion on what is best for young people, but it is quite another to believe this can or should be achieved by various forms of prohibition imposed on adults. Four strategies will emerge to provide reasonable protections to young people. The first will be an imperative to keep the adult nicotine market lawfully supplied and thus inhibit the formation of large criminal supply networks that will also supply youth. The second will be age-secure retailing, drawing on technology and licensing. The third will be controls on marketing, including branding, packaging imagery and flavor descriptors. Finally, we need to be candid and not hysterical in communicating the risks of nicotine use. The global public health problem is not youth vaping but the millions of existing adults who have already been smoking for a decade or more.  

    Sixth, the tobacco control complex. The abstinence-only tobacco control field will face a bruising contest with reality. As the wide range of negative consequences of prohibitions are increasingly visible and articulated scientifically, major funders will become wary and back away. The research funding agencies will become more skeptical. The “realists” will grow in stature and begin to prevail over the “idealists” (see “Realists and Idealists,” Tobacco Reporter, June 2024). Pragmatism will drive out hubris, and grand regulatory schemes will fall into disrepute. The original goal of tobacco control has been to address the range of serious diseases and other harms caused by smoking. But that game is up. In comments to the New York Times almost 20 years ago, the then president of the Campaign for Tobacco-Free Kids, Matthew L. Myers, endorsed a world of nicotine use without significant harm: “The challenge to me is not to eliminate smoking but the death and disease from smoking,” Myers said. “That should be the end goal. If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee! I have to believe that if the marketplace incentives were such that over time, someone could devise a product that would give the same satisfaction as tobacco but didn’t kill them, people would flock to it.”

    Then you’d have coffee! Yes, precisely. But there is no gigantic “coffee control” movement. There is no multimillion-dollar Campaign for Caffeine-Free Kids. As Myers’ statement unintentionally suggests, the tobacco control movement is profoundly threatened by nicotine use without significant harm. Without harm, it has no purpose.

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

    Realists and Idealists

    Image: M-SUR

    We should celebrate ‘realists’ and beware of ‘idealists.’ Idealists do well in the rhetorical world of goal setting, aspirations and optics while realists do better in the real world. The problem is that the idealists obstruct the realists.

    By Clive Bates

    On April 22, the British Medical Journal and a new investigative publication, The Examination, funded by billionaire activist Michael Bloomberg, declared a victory. Their “investigation” had shut down a new continuing medical education program in smoking, tobacco and nicotine offered by the respected medical information provider Medscape. The course had been running for a few weeks and had proved popular with participants. It had been designed to address an essential unmet educational need: the widespread confusion among healthcare practitioners about the causes of disease, the nature of nicotine use and the options available to reduce the harms. It’s hard to imagine more valuable and actionable public health and preventative insights for practitioners. So why close it down? Simple: The initiative had been funded at arms-length by a tobacco company, Phillip Morris International, which played no role in developing the content.

    It’s worth pausing to examine what has been achieved here. The objection to tobacco company funding in the case is essentially aesthetic. To some activists, it just doesn’t look right. Tobacco companies involved in ending smoking? Weird! No one has presented material objections to the course content. I have no doubt that it was a sincere effort to raise the lamentable standard of medical knowledge in this area delivered by experienced professionals. The idealists were successful in burning this initiative to the ground. But here’s the point: Like arsonists, they didn’t build anything. They have left nothing where there was previously something useful. The activists have made their impassioned denunciations, expressed their righteous anger and moved on. But it’s an empty victory because the confusion and misinformation remain, and the opportunity to do better for the public and patients has been squandered. 

    I chose this recent example because it illustrates a more general problem with activism. The pursuit of idealistic goals is not necessarily heroic and may not be benign. It can make matters worse with real-world costs for people and the environment. Let’s take three examples from outside the nicotine field to illustrate the point, then return to nicotine. 

    First, the green opposition to nuclear power. In their quest for an idealist vision of a 100 percent renewable system based mainly on solar and wind power, greens have opposed a proven, reliable, low-carbon form of electricity generation. By creating fear and foreboding about nuclear risks, activists and regulators have made the technology exceedingly expensive and difficult to deploy, making fossil fuels relatively more attractive. The French experience from the 1960s shows successful large-scale nuclear deployment, but idealistic opposition has driven the costs upward since then. Finally, idealists are starting to feel the heat from the climate realists.

    Second, activists with an in-principle opposition to genetic engineering recently stopped the deployment of genetically modified golden rice, which is rich in Vitamin A, in the Philippines. Vitamin A deficiency is implicated in up to 500,000 cases of blindness in young children annually in Asia and Africa each year. Maybe it would be better to lift poverty and improve nutrition more systematically, but how long would that take, and how many people would be harmed waiting for the idealists’ more prosperous and just society? Like adding fluoride to water to protect dental health, golden rice would have added Vitamin A to the food supply system, creating widespread health benefits. Now, people will suffer instead.

    Third, local and international nonprofit organizations lobbied tenaciously for Sri Lanka to switch its agricultural system to become exclusively organic, backed up by a ban on the use of agrichemicals. They got their way, but it did not go well. The food supply crashed, the people went hungry and rioted, and the government fell.

    In each case, a noble aspiration, an eye-catching slogan or a grand commitment has stood in the way of making more mundane but pragmatic progress at the expense of human well-being. Some further characteristics are evident:

    • Idealists evade the messy and distinctly realist business of trade-offs, waving away the concerns of realists as a lack of ambition or “industry talking points.”
    • The idealists rarely accept accountability for the unintended consequences of their positions—the fault is with others for not trying hard enough or spending enough to match the idealists’ aspirations.
    • The idealists often receive an easy ride in the media, especially when they evoke youth to make their case. Did anyone ever put hard questions to Greta Thunberg?

    Turning now to the battle between idealists and realists in the world of tobacco and nicotine.

    First, the nicotine-free society. The idealists in tobacco control would like to rid us of this relatively benign recreational drug. Sorry, but that will not happen, and there is no reason why it should. People use nicotine because it makes them feel better, for its pleasurable, functional and therapeutic attributes. However, demonizing nicotine and treating all nicotine products as if they are equally harmful will obstruct the realists’ efforts to address the significant harm caused by smoking. The idealists take each ban and blockage of any nicotine product as progress to their larger goal. How else can we explain the sustained ban on snus in the European Union?

    Second, defending the purity of youth. Though all idealists have been teenagers at some point, few seem to understand them. Some young people have a propensity for risk-taking with drugs, alcohol, sex and other reckless behaviors, and yes, to use nicotine. But the idealists have adopted variants on the mantra “no teen should use nicotine.” Fine, that might be good advice. But what if they go further and try to make that a reality with various forms of prohibition, restrictions and misinformation? The trouble is that the much larger adult market will be bent out of shape by misguided efforts to protect youth. There will be more smoking, more illicit trade and more risky workarounds, including among youth. The realist goal of providing a lawful, acceptably safe, proportionally regulated nicotine market is undermined by the fervor of the idealists, with worse results for everyone.

    Third, the knockout blow. Collectively known as “endgame” measures, these grandiose schemes would abolish cigarettes as we know them, close nearly all retail outlets, impose shrinking production and import quotas, or ban sales to anyone born after a specific date. They have this in common: They won’t be implemented, they won’t work as expected, or they will have little useful effect. But they will obstruct the realists because these ideas divert political, regulatory, scientific capital and creativity into unworkable schemes and away from pragmatic, if humble, measures that will work. Worse, they occupy the imaginary sunlit uplands with a fake utopia, creating a mirage where there should be an achievable destination—a stable, lawful, well-regulated market for a popular drug.

    Fourth, the pursuit of paper tigers. I recently submitted evidence to an inquiry into new legislation in South Africa. The new law had been drafted as model anti-vaping legislation with extreme restrictions and penalties and tell-tale fingerprints of American activists. The contrast between the precision control, on paper, of the new law and the chaotic reality of South Africa’s giant illicit market is matched only by that of Australia’s new legislation that tries to ban vapes even harder, even though over 90 percent of the Australian vape market is already illegal. When the idealists declare a prohibition in law on paper, actual or de facto, it doesn’t make the banned products disappear. However, it does mean that more modest regulation becomes impossible because most of the market is unregulated and illicit.

    Fifth, why don’t they stop making cigarettes? A common idealist theme is that if tobacco companies are serious about health, they should just stop making cigarettes. It sounds superficially plausible and inspiring. In reality, these companies have a legal duty not to destroy their shareholders’ money. If they tried, three things would happen: The management would be fired, the company would be taken over, or the productive assets and brands would be sold as a going concern. All to no effect. The realists recognize the need for a transformation, moving the market to noncombustible nicotine products and diversifying the business into non-nicotine activities in which they have an advantage, keeping their shareholders on board throughout.

    Finally, conflicts of interest (COI). Idealists divide the world into independent and industry science. They see industry conflicts of interest as disqualifying from scholarly societies and journals. Yet, conflicts arise from every funding source or institution with policy preferences. An industry COI may be no more than a sign of having valuable marketable capabilities. The realists want to engage with anyone with specialized knowledge and, with due skepticism, to learn from their insights. The idealists prefer to erase them from the discourse and pursue purity at the expense of knowledge.

    To summarize, the idealists will resist the realists, and everything will be worse.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Tobacco Control’s Nervous Breakdown

    Tobacco Control’s Nervous Breakdown

    Photo: Xalanx

    Innovation in the recreational nicotine market is revolutionizing the tobacco industry and disrupting tobacco control.

    By Clive Bates

    In his groundbreaking 1997 book, The Innovator’s Dilemma, Clayton Christensen defined the concept of “disruptive innovation.” The term is often used carelessly, but disruptive innovation has several characteristics that apply in today’s tobacco and nicotine market. In essence, it is a theory of how entrants to a market can challenge incumbents by focusing on unmet needs using novel business models exploiting simple enabling technologies.

    In the nicotine market, the lithium-ion battery provided a critical enabling technology with sufficient power and energy density to replace combustion with electrical heating to create an inhalable aerosol in a compact and convenient form. Once the concept took off in the early 2010s, the technology rapidly evolved through at least four major generations during the decade. The disruption has never stopped, and the emerging incumbents in the vape industry now face disruption from disposable single-use vape products. It isn’t just technology; the business model has changed and adapted over time, embracing user-driven innovation, new retailing models such as specialized vape shops and international e-commerce, and a pro-health marketing proposition spread through social media.  

    A new wave of innovation is now breaking with the rapid rise of oral nicotine pouches. This newer trend may prove even more disruptive—a low-tech, low-cost nicotine delivery with negligible health consequences, no intrusion on others and none of the stigma attached to tobacco. Through vaping, consumers have deconflated tobacco and nicotine use and are now primed to adopt this technology.

    The regulatory environment also played a critical role, but more for what it didn’t do than what it did. In the United States in 2009, the U.K. in 2010 and the European Union in 2013, there were failed attempts to classify and regulate vaping products as medicines. Several core pharmaceutical regulation concepts are hostile to vaping. Vaping products are not smoking cessation therapies but pleasurable consumer alternatives to smoking that require nicotine delivery equivalent to cigarettes. Medicine regulators are not at ease with pleasure, or what they would call “abuse liability,” yet pleasure is integral to their success as consumer products.

    Let’s delve deeper and ask who is disrupted and how.

    First, the incumbent tobacco companies. In the standard model of disruptive innovation, these giants would be caught off guard by fast-moving entrants bringing new technology to a vanguard of early adopting consumers, rapidly changing the market dynamics. This would be felt most keenly as a loss of “pricing power” (the ability to raise prices to compensate for declining cigarette volumes) and a squeeze on margins and revenue in the profitable incumbent cigarette business. This should happen as the existing customer base of people who smoke is exposed to a wide range of low-cost alternatives without many downsides. So far, I don’t think this squeeze on the cigarette business has happened to anything to the extent it might have and still could, even though the companies have entered these markets and developed heated-tobacco products. The reason is that regulators are slamming on the brakes in response to activist and political pressure—disrupting the disruption. Regulatory excess has combined with activists and academics working tirelessly to nurture false risk perceptions and reinforce doubt about the wisdom of stopping smoking by switching to a reduced-risk product. The tobacco industry has been protected from the most severe disruption with the unintentional help of the tobacco control mainstream.

    Second, disruption has wrong-footed regulators and legislators. In response to rapid changes in the market, regulators and legislators have blundered in without first understanding (or perhaps without caring about) the complex adaptive system in which their rules would be applied. Because the new products function as economic substitutes for cigarettes, we expect three primary responses to excessive regulation: more smoking than there otherwise would be, more illicit trade in the new products, and consumers adopting risky workarounds, such as mixing their own flavored e-liquids. For example, limiting nicotine strength in the European Union made it harder to bring to market the pod devices that have been successful in reducing smoking in the United States. Flavor bans in the United States made vapes less appealing and caused more people to smoke, in some cases including young people. The prescription-only availability of vapes in Australia has led to a chaotic, lawless mess, with more than 90 percent supplied via informal, illegal channels. With their mission to protect the young from vaping, regulators forgot that in a world without vaping, many young people would smoke and, therefore, are benefiting from vaping.

    Third, the rise of the confident consumer. Consumers are the primary beneficiaries of the radical reduction in health and welfare detriments of smoke-free products. We are used to smokers burdened with regret, challenged with stigma and punished by anti-smoking policies. But all of that is driven by the health implications of smoking and the policy response that started in the early 1960s. How does the recreational nicotine consumer change if they are no longer troubled by the health and welfare implications of nicotine use and related policies? Simple economic theory suggests that if the costs and nonmonetary detriments of nicotine use fall, then demand will rise. It is likely, in my view, that there will be new users of nicotine who would never have become smokers in the absence of much safer products. For some, that is profoundly disturbing. For me, it is almost an inevitable consequence of having far lower risks and there being a latent demand for the real or perceived hedonistic, functional and therapeutic benefits of nicotine. Public morality may be shocked, but more people (of any age) using much safer products should not cause a public health crisis—we would be moving to substance use more like drinking coffee.

    Fourth, the existential threat to the tobacco control complex. The public discussion of the emerging landscape of low-risk consumer products seldom focuses on the interest group that is most vulnerable to disruption: the mainstream of tobacco control. It is a complex of interests comprising nonprofit activists, academics, medical and health societies, major institutions (such as the World Health Organization or the U.S. Food and Drug Administration), philanthropists and research-funding bodies. The problem for the mainstream of tobacco control is that without serious harm, the whole movement loses its purpose and its reason to exist. When it comes to low-risk alternatives to smoking, this complex is profoundly confronted by the threat of having nothing to control, no case for intervention and no reason to be. It is a powerful incumbent interest group challenged by new technology, new suppliers and new consumer confidence.

    As a result, the mainstream of this interest group has rejected tobacco harm reduction as a strategy for addressing its own notional goals of reducing death and disease from tobacco use. Instead, it has mounted a rear-guard defense based on a range of strategies, including the following:

    • Falsely implying that noncombustible products are no less risky than cigarettes, that data is too uncertain or short-term, or asserting that reduced risk is no more than a marketing claim of tobacco companies.
    • Asserting that harm reduction is merely a commercial strategy of tobacco companies. The aim here is to attach the reputational baggage of “Big Tobacco” to these new developments. Yet, many independent experts support tobacco harm reduction, and it is good if tobacco companies adopt a business model aligned with reducing health impacts.
    • Excluding or stigmatizing contrarian opinions and creating sealed bubbles open to groupthink. The WHO Framework Convention on Tobacco Control has taken this to new extremes.
    • Shifting emphasis to problematize nicotine rather than the “tar” of cigarette smoke that is the cause of nearly all tobacco-related disease. We are hearing more about “addiction” and less about cancer. Yet, a dependence only meets the definition of addiction if there is serious net harm to the user.
    • A relentless focus on the supposed interests of children without recognizing that would-be smokers among adolescents also benefit from low-risk products and that the demand for nicotine has persisted across generations for hundreds of years. Young people have an interest in the health of the significant adults in their lives as carers, breadwinners and role models.
    • Pressing for prohibitions or equivalent regulation to cigarettes, often with manipulation of language to imply equivalent risk, for example, by stating that heated-tobacco products produce “smoke” or that all tobacco products should be treated the same even though they have very different risks.
    • A blunt refusal to face trade-offs (for example, between the interests of youth and adults) or unintended consequences (for example, increases in smoking) arising from favored policy positions.

    I have watched on in horror as the leadership in tobacco control, albeit with many honorable exceptions, has dogmatically denied and suppressed the opportunity to radically reshape the recreational nicotine market to cause vastly reduced harm and avoid hundreds of millions of premature deaths. It looks like a nervous breakdown is developing in tobacco control in response to profound disruptive innovation. I doubt they will survive it.

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

    Organized Skepticism

    Image: Mintoboru

    How can the science of tobacco and nicotine serve the public good?

    By Clive Bates

    There are almost as many definitions of science as there are scientists, but one that I like is “organized skepticism.” This is one of four norms of the scientific ethos proposed by sociologist Robert K. Merton in 1942. Robert May, the former U.K. government chief scientist, explained organized skepticism as “a journey, over time, toward contingent understanding guided by experimental tests and sceptical questioning.” Skepticism underpins the scientific process, and uncertainty is a pervasive, permanent and evolving feature of scientific understanding.

    How well are we living up to this ideal? I will break science down into five categories: exploration, observation, interpretation, intervention and values.

    Firstly, “exploration.” This is about which research questions are asked—or not asked—in the first place and why. In many ways, this is the most critical part of the scientific process because it can set, shape or sink a policy agenda. It should be driven by organized curiosity, the alter ego of organized skepticism. But too often, the control over the questions is governed by forces other than curiosity in the public interest. Why has there been so little curiosity about the countries with the lowest smoking rates or most rapid declines, such as Sweden? The halving of cigarette sales in Japan in just 10 years has attracted minimal interest (though with some notable exceptions), but why? Are researchers flocking to New Zealand to understand the dramatic decline in Maori smoking driven by the uptake of vaping? No, the research community has been distracted by its favored “endgame” measures.

    Another example is the expenditure of at least $100 million researching “very low-nicotine cigarettes,” mainly through a series of trials. The U.S. Food and Drug Administration’s enthusiasm for rulemaking in this area drove the research. But after a company, 22nd Century, put these products on the market, there was minimal interest in understanding the consumer reaction. Why? Surely, this should inform the nicotine rulemaking process. Poor questions can exclude important issues or contain false, unsurfaced assumptions. For example, the U.K. recently asked the research community “What can we do to reduce youth vaping?” But do they want to reduce youth vaping if it increases adult smoking? What about young people who would be smoking if they were not vaping? The question limits the possible answers and excludes much we should be curious about.

    A final example is the extraordinary lack of interest in the reasons why there is a demand for nicotine and, therefore, why it is likely to persist. In my view, users experience positive hedonistic, functional and therapeutic effects, which underpin the demand. But curiosity in this area has been suppressed beneath a crude narrative of “addiction.”

    Secondly, “observation.” This is the careful business of discovering what is happening through surveys, test measurements, experiments, qualitative studies, etc. Much good work goes on in this area, but it could be far better. Given how much money and public and political concern nicotine attracts, shouldn’t we have better data and faster? The English Smoking Toolkit Survey provides monthly data on nicotine use trends published with only a few weeks of delay between the survey and publication. Why doesn’t every country have a surveillance system like this? Every country has a sizeable share of its population dying from smoking-related diseases; why not have the data to understand the phenomenon? In the energy sector, the International Energy Agency produces in-depth statistics on every aspect of energy use for nearly every country in an advanced Data Explorer. But for nicotine, we have only crude prevalence data and nothing that will show us the evolving trends in nicotine use as it develops and diversifies over the next two decades. The FDA regulates the recreational nicotine market in the United States, yet it has no systematic assessment of how that market is developing. Instead, individual manufacturers must report on their own products. It would be so much better to have one extensive survey, including all the main product types and all those products not authorized but on sale. The FDA’s Center for Tobacco Products receives annual user fees of $712 million yet does not even have a basic and timely picture of the market, including the illicit market, in the products it regulates.

    Thirdly, “explanation.” This is where scientists try to determine cause and effect. Did vaping flavors cause teenage vaping? Does vaping cause heart disease? Do more people quit smoking if they have access to vapes, or are vapes a gateway to smoking? Alas, in this domain, skepticism is too often replaced with its inverse, confirmation bias, and its more assertive counterpart, motivated reasoning. There are strong incentives to find or claim causal relationships, even where none exist. Why is it hard to establish causal explanations? I tend to focus on three main issues.

    1. Confounding. One thing appears to be caused by another, but they are both caused by a third factor. If we observe a 50-year-old vaper for signs of illness, how do we account for the effect of several decades of prior smoking? It is almost impossible to make allowances for that. For conditions that arise from cumulative exposure over decades (like chronic obstructive pulmonary disease or heart disease), it is impossible to isolate the effects of vaping and confounding by prior smoking. Yet, claims are repeatedly made that vaping is a cause of these diseases.
    2. Reverse causation. One thing appears to be caused by another, but the relationship is the other way around. Some studies show that young people who are exposed to vape advertising are more likely to vape. In these studies, “exposure” usually means recall, the ability to remember seeing an advert. But suppose those inclined to vape for other reasons are more interested in vaping ads and more likely to remember them? The vaping causes the recall of advertising, not the reverse.
    3. Poor external validity. The experiment doesn’t adequately reflect reality. Some machine measurements of vaping aerosol show relatively high levels of some toxicants. But they have often been run with power and flow rates that greatly overheat the liquids, creating conditions no users could tolerate. The machine registers a toxic exposure, but no human would ever be exposed to it. In a clinical trial, volunteers with a declared intention to quit are paid to participate. They are given free products and incentivized to use them. But how well does that experiment reflect the impact of a new product on people who buy their cigarettes at a corner shop? Hardly at all. Yet a giant edifice of support for de-nicotinization of cigarettes has been built on such trials. Those affected are more likely to switch to illicit or smoke-free products.

    Fourth, “intervention.” This is the science of deciding what to do or what happened after a policy was implemented. Curiosity and skepticism seem to be actively discouraged in this area of tobacco control research, though with exceptions. One of the largest tobacco control interventions ever is the 2019 ban on vapes and heated-tobacco products in India, which earned a World Health Organization medal. Yet almost nothing has been done to discover what happened, and the WHO continues to promote these prohibitions. I think this is because, for many in that field, the policy and law are the outcomes, not their actual effects on behavior and, ultimately, health. Too many scientists are regulatory literalists, believing that people will do what the regulators hope they will. Armed with observations of harm and explanations for its cause, they wrongly believe that intervention is simply a matter of removing the cause with a law. Not so. An intervention is a disturbance of a complex system of human, technological and economic interactions. It is vulnerable to at least three forms of unintended consequences: first, adverse behavior change (a vape flavor ban causes more smoking); second, workarounds (a vape flavor ban causes people to mix their own flavors using food ingredients); third, illicit trade (an informal economy develops, possibly with organized crime groups extending their portfolio). Intervention always requires a systems approach and an economic appraisal to assess the likely outcomes and their cost-effectiveness or value for money. Far too many biomedical scientists trespass into the economic discipline of intervention without the necessary skills and experience.

    Fifth, “values.” Politicians often declare they are “led by the science.” But no policies can or should ever be determined by science alone. Values or ethics must have a central role—just because something might work doesn’t make it right or acceptable. For example, if we could show that misleading young people about vaping risks reduced youth vaping, would that be an acceptable policy? Should we intervene to stop smoking in private homes? Should children be separated from parents who smoke? Should smokers be denied healthcare for reasons of contributory negligence? There are boundaries to what we find acceptable, whatever the science tells us might work. But different people have different boundaries.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Snatching Defeat from the Jaws of Victory?

    Snatching Defeat from the Jaws of Victory?

    Will the European Union enable or obstruct the market-based demise of the cigarette?

    By Clive Bates

    There are so many genuinely terrible ways to regulate combustible tobacco and smoke-free nicotine products that achieving one of the less terrible ways is a triumph. Unlike the United States, the European Union hasn’t imposed gigantic regulatory burdens that choke the life out of all but the largest companies, relentlessly favoring tobacco majors over their smaller rivals. Unlike Australia, the EU pulled back from regulating vapes as if they were medicines. Australia was once a leader in tobacco control, but now it has become a chaotic fiasco of sluggish declines in smoking and a massive black market. Despite the prohibition campaigns of the World Health Organization, the EU has resisted most forms of prohibition, though with the inexplicable exception of snus. To state the obvious, prohibition doesn’t cause banned products to disappear; it merely removes law-abiding suppliers and hands the residual market to criminals and unregulated informal traders.

    In contrast, the EU has developed a range of measures to address tobacco and nicotine risks that are not especially disproportionate or discriminatory, reasonably precautionary and not particularly prone to harmful unintended consequences. As a result, the EU has a diverse range of lawfully available safer alternatives to smoking and, therefore, the regulatory basis for tobacco harm reduction for the member states that wish to pursue it. By international standards, it is a modest success.

    European elections will be held in June 2024, and a new legislative program will emerge a few months later, with the most intensive legislative activity expected in 2025. So, the question is where next? I am sorry to report that the Brussels hive mind of bureaucrats, politicians and interest groups is on course to turn a modest success into a conspicuous failure, putting millions of lives at risk.

    The EU’s Public Health Aims are Focused on Reducing Disease

    There is a renewed impetus behind EU tobacco policy. In 2021, the EU launched its plan for addressing cancer, Europe’s Beating Cancer Plan. In 2022, it launched a separate plan for addressing noncommunicable diseases other than cancer, known as Healthier Together. Both place considerable emphasis on tobacco, and both stress the “tobacco-free generation” objective to reduce tobacco use to less than 5 percent of adults by 2040 compared to around 25 percent today.

    Regulatory Instruments

    To deliver this agenda, the EU has three main instruments to regulate tobacco and related products, such as e-cigarettes. These are in the form of “directives,” or legally binding agreements that member states will implement in domestic legislation that complies with the terms of the directive.

    1. The Tobacco Products Directive (TPD: 2014/40/EU) governs standards for products, packaging, warnings and several aspects of commerce in tobacco products. This directive also provides for the regulation of e-cigarettes, including advertising and promotion of these safer alternatives. The TPD is under active review following an evaluation of the legislative framework for tobacco control, and a new European Commission (EC) proposal is expected late in 2024.
    2. The Tobacco Advertising Directive (TAD: 2003/33/EC) bans tobacco advertising, promotion and sponsorship with a potential cross-border reach. Member states control fixed advertising, such as billboards. The TAD will likely be revised alongside the TPD to create a unified approach to tobacco and related products, such as e-cigarettes.
    3. The Tobacco Excise Directive (TED: 2011/64/EU) provides a framework for harmonizing tobacco tax design. Member states generally set the levels of excise duty but are subject to minimum levels set in the directive. The TED has been subject to a lengthy review process since 2016. Taxation matters are sensitive with the member states, and each has a veto on any proposals. Controversy struck on Dec. 7, 2022, when new proposals were pulled from publication, as several Eastern European nations noticed that it would create large increases in tobacco prices for them.

    The EU, as a party to the Framework Convention on Tobacco Control, will also form a common position to take into the November negotiations at the 10th Conference of the Parties to the Framework Convention on Tobacco Control in Panama. By endorsing the positions of the WHO, the EU will build momentum for further regulation aligned with the WHO approach.

    The EU also has a range of softer instruments, such as the nonbinding 2009 Council Recommendation on Smoke-Free Environments (2009/C 296/02). In July 2022, the EC issued a call for evidence for a proposal for an updated recommendation that would apply to heated-tobacco products and e-cigarettes.

    The Outlook is Bleak

    It is never easy to see the big picture in the EU through the relentless blizzard of initiatives, consultations, reports, working groups and statements. However, some disturbing developments are emerging.

    First, the major error of strategy. The EC sees the newer tobacco and nicotine products (heated tobacco, pouches, e-cigarettes) as a threat rather than as an opportunity to reduce cancer and NCDs. There is no sign that it recognizes or is interested in exploiting the radically different risks to health posed by smoked and smoke-free products. It should be treating tobacco products differently and proportionately according to risk. However, it is moving in the opposite direction toward treating all tobacco and nicotine products as if they were cigarettes. The effect will be to protect the cigarette trade, promote smoking, slow the decline of serious diseases and nurture the criminalization of supply and workarounds.

    Second, instead of reversing the absurd and indefensible ban on snus, rumors suggest that the EC may even try to extend this ban to nicotine pouches. Snus has already reduced adult smoking in Sweden to close to the EU’s 2040 tobacco-free target of 5 percent, with measurable improvements in cancer and cardiovascular outcomes. Encouraging “free movement” of pouches would build on the snus proof-of-concept and help to reduce smoking across the EU. Regulation of purity and total nicotine density in pouches makes sense. However, a ban will simply deny users a significant harm reduction opportunity and create an influx of illicit high-strength pouches.

    Third, there are moves to extend the ban on characterizing flavors in combustible tobacco products to all nicotine products. The EC has already done this for heated-tobacco products and could extend severe ingredient restrictions to vaping products. The government of the Netherlands, in alliance with the public health agency RIVM, has adopted a “whitelist” approach of permitting a few ingredients used chiefly to make artificial tobacco flavors. If adopted by the EU, this system would radically constrain the legal vaping market in which consumers are drawn to the diversity and ever-changing range of flavors as an alternative to smoking. At a December 2022 conference presentation in Paris, an RIVM official, Reinskje Talhout, presented on the Netherlands’ approach. After 33 pages of detailed analysis showing how to create a (short) list of permitted ingredients, she included the following slide on “Possible unintended consequences.”

    The challenge is well summarized on this slide. Yet the advocates of broad flavor bans have no response. They have largely ignored the malign market and behavioral dynamics that they are likely to unleash.

    Fourth, changes in the excise regime will dull the consumer economic incentives to switch from high-risk cigarettes to low-risk, noncombustible products. The minimum tax levels envisaged in leaked proposals are far greater than would be implied by the difference in risk compared to cigarettes. If the excise regime were more proportionate to the risk, the tax take would be outweighed by the costs of tax administration, and it would barely be worth raising excise duties. Member states should insist on their right to set zero minimum taxes on noncombustibles as it is their right to pursue tobacco harm reduction domestically. There would also be a scope for setting maximum tax levels for safer products to maintain a material difference in taxation between the highest-risk products and lowest-risk products.

    Fifth, the EC plans to make it harder for European citizens to learn of safer alternatives to smoking by imposing further controls on advertising and promotion and possibly to willfully mislead consumers with packaging and warnings that implicitly exaggerate the risks of low-risk alternatives to smoking. Again, the regulatory tactic is to treat all products as if they are as harmful as cigarettes when what is required is more nuanced risk communication. If the EU follows the direction of the WHO, it will risk drifting into inappropriate restrictions on free speech and legitimate opinion.

    The question for me is why? What fearful autocratic reflex causes the EC to suppress pro-health innovation and see opportunity as a threat? There is an opportunity here for the free movement of goods and services within a well-functioning internal market to deliver a high level of health and consumer protection. The internal market, if allowed to function as intended, could end the cigarette era and epidemic of smoking-related disease. Yet its most ardent champion, the EC, appears unwilling to let the internal market crush the cigarette trade through the power of consumer preference, competition and creative destruction. What a pity.

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

    Eyes on the Ball

    Image: Maksym Yemelyanov

    Senior officials should approach COP10 with skepticism but not cynicism, with clarity about their national goals and with some tough questions about trade-offs, unintended consequences and evidence.

    By Clive Bates

    The tenth session of the Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC) will take place in Panama from Nov. 20–25, 2023. Hundreds of representatives of the 182 parties and further hundreds of observers will descend on Panama to advance the global accord on tobacco control.

    But how should an official government delegate prepare for and approach the meeting? As a former U.K. senior civil servant, I would like to offer some humble advice.

    First, delegates should be clear on their national public health and tobacco policy goals. Governments could set a wide range of objectives: to reduce disease and death, reduce smoking, reduce tobacco use, prevent addiction, achieve a nicotine-free society, focus exclusively on youth prevention, protect nonsmokers or even destroy the tobacco industry.

    Many delegates will be tempted to say, “All of the above.” That might have worked when the FCTC text was finalized in 2003, but it definitely does not work today. The reason is that there are now very significant trade-offs between these goals. For example, an effort to eliminate nicotine may mean fewer smokers switch to lower risk nicotine products, causing smoking to persist for longer and the burden of disease and death to be higher.

    An exclusive focus on youth may mean considerable additional harm to adults given that adults who smoke are at the most immediate risk of serious disease and premature death. A delegate should arrive at the COP with a strong sense of what they want the FCTC to achieve. I believe the proper public health priority should be to reduce disease and death as deeply and rapidly as possible. Setting any other goal implies that a greater toll of disease and death would be justifiable to meet some other objective. The FCTC and COP should focus on making rapid health and welfare gains, especially among disadvantaged populations—every other goal should be subordinate to that one.

    Second, delegates should approach the COP, the FCTC and the World Health Organization with considerable skepticism. Constructive skepticism will be the norm for many experienced officials, but the WHO does not welcome or expect this, especially from delegates from low-income and middle-income countries (LMICs). The WHO expects deference and to be regarded as an authority.

    However, the WHO has not earned and does not deserve the unqualified trust of delegates from its member states. Let me give three reasons why delegates should be skeptical. One: The WHO cannot be trusted to make reliable, evidence-based policy recommendations. For example, the WHO promotes the prohibition of e-cigarettes and heated-tobacco products in situations where far more dangerous smoked tobacco products are freely available and widely consumed. It promotes prohibition without evidence that it will benefit public health, without concern that it will lead to more smoking and without any apparent grasp of the likelihood of illicit trade taking over from a law-abiding supply chain. Two: The WHO cannot be trusted to tell the truth about tobacco and nicotine products. The WHO’s fact sheet on e-cigarettes is full of errors and misinformation, and the agency is unwilling to correct the record or take a balanced view. Three: The WHO is not independent but financially and institutionally compromised by funding from special interest groups. The recently published WHO Report on the Global Tobacco Epidemic 2023, is a good example. The acknowledgements on page xvii show the report was funded by the private foundation of an American billionaire and written with the assistance of many activists funded by the same foundation. Michael Bloomberg’s foundation is a substantial funder of the WHO, and  Bloomberg has been appointed as a WHO Global Ambassador for Noncommunicable Diseases. Delegates should carefully consider this funding and its influence on the WHO’s approach. Bloomberg’s policy priorities may differ from those of parties to the FCTC.

    Third, recognize that the so-called civil society representatives with observer status at the COP are not necessarily neutral guardians of the public interest. They are carefully selected activists, chosen for their allegiance to the WHO and almost always funded by foreign interests. Unlike other conventions, such as the United Nations Framework Convention on Climate Change, the FCTC is highly restrictive on which nongovernmental organizations (NGOs) are permitted as observers to the COP. Only 26 NGOs are currently accredited, and participating NGOs must be approved by the COP, provide evidence that they support the FCTC and show that they are working toward its implementation. A single NGO, now known as the Global Alliance for Tobacco Control, acts as an umbrella for smaller NGOs but only if they meet its membership criteria. The Secretariat assesses their suitability and reports to the COP.

    This severe filter on who is eligible to participate has the effect and likely the intention of excluding any critics or skeptics or even diverse views of how to achieve public health goals through tobacco policy. The selective engagement of observers and NGOs creates an echo chamber and a significant bubble of groupthink in the COP. Through pressure and public shaming, the observers attempt to punish delegates who question orthodoxy or take a more pragmatic approach to the issues under discussion. Experienced diplomats will know they are not in Panama to please unrepresentative, unaccountable, opaquely funded interest groups that are often little more than obedient mouthpieces for foreign donors.

    Fourth, take a hard look at the FCTC policy proposals under discussion at COP10. Through the advanced publication of COP documents, it is possible to see the intent of the WHO and the FCTC Secretariat reflected in the COP documents. Since it was finalized 20 years ago, the FCTC has drifted far from its original purpose: to contain and reduce the health and welfare harms primarily arising from smoking. The 2023 COP10 documents show that much of its energy is now devoted to fighting “harm reduction.” This is a legitimate public health strategy, aiming to capitalize on the rise of much safer ways to use nicotine than cigarette smoking, aiming to dramatically reduce the 8 million deaths annually attributable to smoking.

    The problem with opposing harm reduction is that it is likely to cause harm increase. Hostile strategies for novel and emerging products are evident in the documentation. For example, an anonymously authored paper by the WHO for COP10 suggests three main strategies are in use: (i) falsely denying any health or reduced-risk benefits; (ii) treating low-risk products in the same way as high-risk products for the purposes of regulation; and (iii) positioning these products as no more than a tobacco industry survival strategy while ignoring the fact that such products have been deemed appropriate for the protection of public health by the U.S. Food and Drug Administration and that command considerable support in the public health community. Other documents reveal underhand tactics. For example, in a paper on definitions, the Secretariat tries to argue that the aerosols from vaping products should be classified as “smoke,” a scientifically baseless claim. But the purpose of this maneuver is to apply provisions in the FCTC that relate to “smoke” and “smoking” to products that do not involve combustion and are smoke-free. The problem with this approach is that, in practice, it will function to protect the cigarette trade from competition from much safer alternatives, implicitly promote smoking and cause more disease and death.

    Fifth, ask the tough questions. As the physicist Richard Feynman said, “I would rather have questions that can’t be answered than answers that can’t be questioned.” That is a good way for delegates to approach COP10. Government officials should not be expected to have all the answers, but they should have the best questions. In the tobacco control field, four questions will help guide any delegate through the policy discussion. One: Who disagrees with this and why? Much of the research and evidence in this field is contested among independent experts. It is not just in dispute between the WHO and the tobacco industry. Delegates should be aware of and insist on seeing all sides of the debate. Two: What are the trade-offs? Are the needs of adult smokers being ignored? Have they considered the implications of anti-vaping measures on young people who would otherwise smoke? Three: What are the plausible unintended consequences? Will strict policies on vaping lead to increased smoking, the development of black markets or consumers starting to make their own do-it-yourself products? Four: Where is the evidence? The original idea of the FCTC was to help all countries adopt evidence-based tobacco policies that had been tried and tested. Now the WHO and the Secretariat want to use Article 2.1 of the FCTC to promote untried measures for which there is no supporting evidence.

    I hope delegates find the COP10 meeting fruitful, but constructive skepticism from senior delegates will be healthy in the longer term and help to restore the FCTC’s credibility.

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

    Clive Bates

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.). On this page we feature a selection of his contributions to Tobacco Reporter.

    Nicotine 2040

    The market for tobacco and nicotine is transforming—how could it look by 2040?

    Eyes on the Ball

    Officials should approach COP10 with clarity about their national goals and with tough questions about trade-offs, unintended consequences and evidence.

    Clive Bates

    Read the work of Tobacco Reporter’s special contributor Clive Bates.

    Changing Gear

    Clive Bates on how the tobacco industry can accelerate transformation

    Fighting The Wrong War

    The automatic criticism of everything associated with tobacco is not merely misguided; it has the potential to do real harm.

    Fresh Thinking

    The World Health Organization and tobacco policy: a seven-point reform agenda

    The Endgame Revisited

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

    A rhetorical gambit

    The absence of long-term studies does not justify stifling potentially less harmful nicotine products.  

    Hold your fire

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

  • Changing Gear

    Changing Gear

    Photo: Taco Tuinstra

    How the tobacco industry can accelerate transformation

    By Clive Bates

    In the unlikely event that I am appointed CEO of a large tobacco firm, this is what I would do to accelerate the transformation of the business.

    First, I would ask if we really do want to transform the business and, if so, why. Until the board, thousands of staff, investors and stakeholders understand our rationale, what chance is there of bringing them on the journey? This is a more vexing question than it might appear at first sight. Perhaps we would be better off as we are? After all, we make terrific margins on cigarettes; we have tremendous pricing power courtesy of the tax authorities; we are embedded in a comfortable oligopoly that knows how to make money; and, of course, it helps that the product is addictive, and the customers are loyal to our brands.

    In contrast, the transformation is toward a volatile and diverse market, intense competition holding down margins, the ever-present danger of being caught flat-footed by rival innovation, fickle customers pursuing the next new thing and the potential for illicit entrants flooding the market. Why would we want that? The answer is that we don’t get to choose. Even if we could join forces with all other tobacco companies, we cannot individually or collectively hold back this transformation and restore the situation as it was before 2010. This is because consumer preferences and competition from nontobacco companies drive it. The ship has sailed. Our only viable strategy is to compete ferociously for market leadership in the new product categories. We need to deepen our explanation of the drivers of transformation and set out our transformation rationale clearly and rigorously. For inspiration, we will look to the scholars of creative destruction, diffusion of innovation and corporate strategy: a little more Harvard Business Review and a little less New England Journal of Medicine.

    Second, we need to sell high-quality, compliant products that people want to buy as alternatives to cigarettes and make good money by doing it. Apologies if this is a statement of the obvious, but it is the core function of businesses undergoing a market transformation. Everything else is froth. Fortunately, the impetus for this is all too clear: competition and the threat of rivals converting our cigarette smokers to their smoke-free products and, equally, the opportunity to convert their customers to become ours. Some in public health suspect that Big Tobacco would like to hold back innovation and slow down the rate of transformation. However, Big Tobacco is an imaginary construct comprising companies that compete intensely. A company that tries to hold back innovation will not fare well at the hands of its innovative rivals. The aggregate effect of all the companies pursuing competitive advantage in new product categories will be the primary driver of transformation. Ironically, the primary drag on transformation will be legislators, regulators and tobacco control activists intervening to throttle innovation and uptake of new technologies. Yet, it would be a mistake to rely on “useful idiots” to protect the cigarette business. Their attitudes and ideas could change with as little as the stroke of a philanthropist’s pen.

    Third, we should engage with the environmental, social and governance (ESG) investing community. ESG is the new language for “ethical investment.” There are really three types of ESG investing: (1) taking stakes in virtuous companies that do not trigger exclusion criteria, of which “tobacco” would always be one. This route is closed. (2) To back emerging world-changing companies, though these are difficult to spot in advance and few in number. (3) So-called “engagement investing,” where ESG investors buy into companies with a significant problematic health, social or environmental burden and pursue improvements. By reducing negative footprints, this form of investing has the potential to do more material good for society than the other two. For tobacco companies, ESG engagement would endorse a transformation strategy with external validation and accountability.

    Fourth, we must master the future of nicotine and its place in society. Nicotine is a popular recreational stimulant for a reason and not just because it is “addictive.” Tobacco companies have been understandably shy about discussing nicotine and why there is a demand for it. But companies are in the consumer nicotine business—it is the reason they exist and why they have a future. As consumer nicotine products are becoming smoke-free and far less harmful, the main deterrent to nicotine use—the health risks of smoking—is becoming weaker. The decades-long controversy about tobacco is shifting its focus from severe smoking-related diseases, such as cancer and chronic obstructive pulmonary disease, to concern about nicotine use and addiction. Most people understand and accept why there is a demand for alcohol and caffeine, and many understand the demand for cannabis. But who really understands the demand function for nicotine once this is no longer conflated with smoking? People use nicotine for pleasure and stimulation, to modulate mood, stress and anxiety, and for a range of cognitive improvements. Nicotine may interact beneficially with various health conditions, including attention-deficit/hyperactivity disorder and Parkinson’s disease. As a society, we should not be recommending or endorsing nicotine use, but we should surely have a better understanding of why people use it.

    Fifth, to the extent possible, we should agree with other transformation-minded businesses on the optimal regulatory and fiscal approach. We routinely state that excise and regulation should be “risk-proportionate,” but what do we mean by that in more detail? How should we approach contentious issues, such as youth uptake? We should be (and be seen to be) leading the thinking and marshalling of the evidence base for risk-proportionate regulation. This requires some careful judgements: we must avoid erecting excessive barriers to entry to smaller players, or we risk looking (and being) predatory, and our approach will be dismissed as cynical and expedient and generate opposition among potential allies. The regulatory environment may evolve over time and may contain dependencies. For example, some of the stricter measures to address cigarettes must be accompanied by readily available and well-understood pathways to smoke-free products.     

    Sixth, we must be more assertive scientifically. Just as the industry’s science provides high-quality insights into tobacco harm reduction and reduced-risk products, it is increasingly excluded from conventional publishing platforms and scientific fora. The exclusion is not accidental or merely a misunderstanding based on historical industry malpractice. Nor is it likely to change. It is because a significant share of the academic community rejects the strategy of harm reduction and, therefore, the science that supports it. For many, it is seen as “the nicotine maintenance survival strategy of Big Tobacco” and thus to be opposed, whatever its benefits to health and welfare. The way to address this is to fully embrace the ideas and principles of the open science* movement. The industry could produce or sponsor publicly accessible scientific resources that are category-wide, such as living reviews of biomarker or toxicology studies or informative behavioral research. We should engage credibly, respectfully and systematically to challenge poor-quality science, misleading interpretations and policy recommendations that go far beyond the science that supposedly justifies them. The lack of accountability and redress in tobacco control science has created cavalier attitudes to scientific rigour that would not be acceptable within the industry. Consistent with an open science approach, we should acquire and release all relevant market data to the independent research community and allow them to interpret it. If substitution effects are real and a transformation is proceeding, this is the best form of validation.

    Seventh, we may need an organizational vehicle to advance the transformation agenda for the industry as a whole. The tobacco industry is not homogenous. Many companies, notably the state-owned monopolies, are not interested in transformation and profit mightily, at least in the short term, from the prohibitions promoted by the World Health Organization and its fellow travelers. Yet, all the tobacco multinationals generally recognize the transformation imperative and decline to be seduced by the Bootlegger and Baptist implicit bargain with tobacco control activists. This group must find its voice—not as a conventional trade association but as a cross-industry body dedicated to an idea. It would delineate the territory of common category-wide interests (e.g., greater public understanding, a common regulatory agenda, marketing standards, environmental issues, scientific engagement, etc.) from inter-company competitive interests (pricing, product launches, etc.).

    Finally, something we should not do. We should resist the temptation to use regulation for short-term gain by supporting regulation that helps us and hinders our competitors. Over the longer term, our opponents will selectively adopt the restrictive and reject the permissive measures we back. What appears to help us today may harm us a couple of years from now as we develop new products or acquire new businesses. Our goal should be an enduring fiscal, regulatory and communications environment that works for smoke-free categories as a whole. That will create a rules-based context for competition between companies and an attractive alternative to illicit trade.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Beyond Tobacco Harm Reduction

    Beyond Tobacco Harm Reduction

    To see clearly into the decades ahead, we need to rethink nicotine.

    By Clive Bates

    There is no doubt that tobacco harm reduction is a powerful and effective public health strategy. It takes the widely understood public health concept of harm reduction (see drugs, alcohol, HIV and so on) and applies it to the enormous burden of harm created by smoking. We already have enough science and experience to know that this strategy works. Two conditions must be met: (1) The new noncombustible nicotine products must be much less risky than smoked products; (2) these low-risk products must displace the high-risk combustible products. Let us briefly consider these two questions.

    Are the noncombustible products much less risky? We know from biomarker data and considerable additional supportive evidence that noncombustible nicotine products are, beyond reasonable doubt, much less dangerous than smoking. There should be no serious dispute about this. Though some activists stress long-term uncertainties in risk, those are as likely to turn out to be negligible as to turn up unwelcome surprises. The simpler and more controllable chemistry of the smoke-free products will allow for regulation and product modifications if risks do ultimately emerge. Though there are studies showing various effects on the body, there is little to suggest that these amount to material risks. The human body is not defenseless: World-famous epidemiology shows that regular smokers who quit before age 40 avoid nearly all the long-term mortality impacts. That is not intended as a recommendation to smoke for 25 years but to apply some perspective to the much lower exposure from noncombustible products.

    Do the low-risk smoke-free products displace the high-risk combustible products? There is now a wealth of triangulating evidence from multiple sources showing that noncombustible products can and do displace combustibles. The most persuasive evidence is the experience of snus in Scandinavia. In Sweden and Norway, smoking has become marginalized on average and has dwindled to very low levels among younger age groups. Nicotine use, however, remains typical of other European countries. The Cochrane review assessed 78 studies, including 40 randomized controlled trials, and concluded in November 2022, “There is high‐certainty evidence that [e-cigarettes] with nicotine increase quit rates compared to NRT [nicotine-replacement therapy].” Population trend data shows an accelerated decline in smoking coinciding with the rise of vaping. Quasi-experimental studies compare the effects of price and regulatory differences to show that e-cigarettes function as economic substitutes for cigarettes.

    In one sense, we are advancing well on tobacco harm reduction; we know it works, and there is potential to avoid millions of premature deaths. But we could be doing much better. The main barrier to deeper and faster worldwide progress is dogmatic resistance from misguided tobacco control activists, reflexive hostility from public health agencies and regulators, pervasive misinformation about risks and a blizzard of negative media coverage driving a moral panic about adolescent vaping. As I have argued, many tobacco control interests need tobacco or nicotine use to be harmful or they lose their purpose, prestige and money. If there is no harm to address or abusive corporations to thwart, there is little point in their work. Tobacco harm reduction directly threatens their interests, and they have responded accordingly.

    So why do we need to move “beyond harm reduction,” as I suggest in the title above? Why do we need to “rethink nicotine”? The answer is that tobacco harm reduction is an unsatisfactory and incomplete framework for understanding the direction and destination of the consumer nicotine market. Without a rethink of nicotine, the rancorous arguments will continue.

    Harm reduction implies that there must be harm to reduce. It suggests that reducing harm is the underlying justification for allowing the availability of reduced-risk nicotine products. That tends to focus attention on the benefits of the product-switching choices of existing smokers. But also, it classifies the uptake of nicotine products by current nonusers, whether adults or adolescents, as problematic and a basis for justifying restrictions or prohibitions designed to curtail use. The United States Tobacco Control Act embodies this idea through its public health standard: New nicotine products seeking premarket tobacco authorization must be evaluated as “appropriate for the protection of public health” (see Section 910(c)(4)).

    Implicit in this view is that no one wants to use nicotine, and new smoke-free products should function as a souped-up smoking cessation aid for which there would be little justification without smoking.

    But no one thinks of other common psychoactive substances in this way. At the launch of a new craft beer, does anyone ask, “is this appropriate for the protection of public health?” Of course they don’t—it’s beer! We do not agonize over routine and perhaps compulsive morning caffeine consumption because we are not concerned about dying from coffee-related diseases. Increasingly, legislators recognize that cannabinoids are widely used and that society would be better off if these were regulated and taxed rather than outlawed.

    The critical concept in rethinking nicotine and going beyond tobacco harm reduction is the demand for nicotine. Is this demand really involuntary and just driven by addiction? Or do people experience real or perceived benefits that create the demand? Nicotine has been found to improve certain cognitive functions, including attention, memory and processing speed. It can temporarily increase alertness and focus, making users feel more mentally sharp. Nicotine stimulates the release of neurotransmitters, which can help regulate mood, helping users feel more relaxed, feel less anxious or experience an improved sense of well-being. Some evidence suggests that nicotine may have potential therapeutic benefits for conditions such as Parkinson’s disease, attention deficit hyperactivity disorder, schizophrenia and other conditions. For those seeking scientific citations, a fully sourced list is available via the Safer Nicotine Wiki, an outstanding living library curated by tireless citizen scientists. 

    How does our approach change if we accept that, at least for some people, nicotine provides functional benefits or even just a pleasurable sensation that they enjoy? If we look beyond the harm reduction approach to smoking, we must address the consumer demand for nicotine as a recreational stimulant. Once we recognize a demand for the product, we need to have a mature conversation about how this demand will be met in the future. The attempt to control demand by prohibiting supply has never been a conspicuous success. There are many reasons why lawful and regulated products are better for consumers and wider society than nurturing an informal or criminal supply chain via prohibitions.

    The future of the nicotine market is becoming much clearer now: Consumer nicotine will be available through a range of noncombustible nicotine products, including vapes, oral nicotine and heated or smokeless tobacco. The regulatory challenge shifts from harm reduction to making nicotine products available that may have minor risks but fall within the normal societal tolerance for risk. Instead of asking, “is this appropriate for the protection of public health?,” in the future, we would ask, “are the risks associated with this product acceptable for recreational nicotine use?” Our approach to adolescent nicotine use would more closely resemble our approach to alcohol: measures to discourage use and restrict sales, but not a moral panic.

    The evolving demand curve for nicotine is complicated by both the harms of smoking and the dependence-forming properties of nicotine. The great harms of smoking and the pressures of the policies, such as taxation, to reduce smoking have suppressed the demand for nicotine. That is changing. When nicotine can be used with minimal risk, then it is likely that latent demand will be released. People who would have otherwise been deterred from using nicotine by the harms and stigma of smoking may be inclined to try nicotine in much safer forms.

    In formal definitions, such as the Addiction Ontology’s, a dependence becomes an addiction only when there is “serious net harm.” Addiction is defined as “A mental disposition toward repeated episodes of abnormally high levels of motivation to engage in a behavior, acquired as a result of engaging in the behavior, where the behavior results in risk or occurrence of serious net harm.”

    The inclusion of serious net harm is to limit the definition to conditions “that merit a treatment and public health response.” But what if there is no serious net harm? It follows that there should be far less public health concern about nicotine use.

    To move beyond harm reduction, we need to recognize that the demand for nicotine runs deeper than the demand for smoking and will outlive cigarettes. Then the challenge is to develop a regime that allows for nicotine products with acceptable risk and to be lawfully available to those who wish to use them. Despite the dogmatic rear-guard action of tobacco control activists, traditional tobacco control is being steadily overtaken by the strategy of tobacco harm reduction. But tobacco harm reduction is an interim stage in the evolution toward a full rethink of the place of nicotine in society. To see the pathway to the future of nicotine, it is essential to look out toward the destination.

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

    Surfing while Juggling

    photo: Anna Berdink

    Five types of innovation

    By Clive Bates

    Where does innovation in the tobacco and nicotine field come from? Is it the far-sighted senior executive assessing the needs of the evolving market and committing R&D budgets to realize the corporate vision? Or is it the genius scientists and engineers toiling 24/7 in the labs to invent the wonder product that will become The Next Big Thing?

    Both are caricatures, of course, but neither explains how innovation really works.

    In his brilliant book, How Innovation Works, author Matt Ridley points out that “Innovation is not an individual phenomenon but a collective, incremental and messy network phenomenon.” For those involved, I would say it is more like surfing while juggling than a straightforward path from idea to implementation. To see why, let’s look at five types of innovation in the tobacco and nicotine market.

    First, disruptive innovation. The most prominent recent case of disruptive innovation in the tobacco and nicotine field is the rise of electrical heating as an alternative to tobacco combustion to create an inhalable nicotine-bearing aerosol. Though the Chinese inventor Hon Lik is usually credited with inventing the e-cigarette, the truly disruptive innovation came before and from outside the tobacco and nicotine industry. It is what makes the e-cigarette and modern heated-tobacco products possible. The critical disruptive innovation was the lithium-ion battery. By the 2000s, battery technology had steadily progressed to achieve a sufficiently high power and energy density, allowing rapid heating and an adequately long life between recharges within a compact form factor. Developments in battery technology were driven by the demands of the giant and ultra-competitive markets for mobile devices like smartphones and tablets.

    For decades, the intense heat, complex reactions and chemical cocktail generated by the combustion of tobacco leaf at 900 degrees Celsius in the burning coal of a cigarette were unmatched and unmatchable as a means of delivering nicotine to the lungs. The combination of electrically heated coil and e-liquid to generate an aerosol is now competitive. The disruption of the dominance of the cigarette, currently underway and likely to last two decades to three decades, is driven by a fundamental energy transition that degrades the advantage of combustion.

    I refer to the second type as system innovation. This is the consequential economic, regulatory and public health reaction to the initial disruption and may involve hundreds of innovative responses. For example, the emergence of e-cigarettes triggered a creative response in the Stop Smoking Service in the city of Leicester, U.K. Under the leadership of its manager, Louise Ross, the service changed its practice to embrace vaping as a low-risk alternative to smoking that could appeal to many smokers who had previously been beyond the service’s reach. Through the power of example, that experience led to further innovation at the National Centre for Smoking Cessation and Training and with the government’s support to guidance on e-cigarettes issued by the National Health Service.

    But this innovation did not happen linearly, driven only by personal inspiration. It is best seen as “emergent,” arising from a wide range of concurrent changes and influences triggered within the public health ecosystem. The disruptive innovation also led to system innovations in regulation, such as the 2014 European Union Tobacco Products Directive. In 2016, the U.S. Food and Drug Administration’s deeming rule brought vaping products into the definition of tobacco products and under the jurisdiction of the Tobacco Control Act. The initial disruptive innovation also led to innovation in the business models of tobacco companies, but also in the tactics of their traditional adversaries. Tobacco companies started moving their business toward a future in noncombustible nicotine products, and the anti-tobacco groups shifted their focus from preventing disease to fighting nicotine addiction.

    For tobacco and nicotine companies, the disruptive innovation and the system responses it triggers are like a “big wave,” both prized and feared by top surfers. Like a wave, the companies didn’t create it and can’t control it, but their challenge is to catch it, ride it well and not wipe out. The case of Kodak and its destruction under the breaking wave of digital photography is probably the most cited case of an innovation wipeout. But it doesn’t have to be a technology shift. In the 1970s, deregulation in the aviation sector enabled the emergence of the innovative low-cost airline business model. It wasn’t long before major airline incumbents were going under as that big wave gathered pace.

    The disruptive and systems innovations generate a changing paradigm: a big wave of opportunity or destruction that businesses must learn to surf. But why does innovation feel like juggling while surfing? The juggling reflects the frenetic activity of keeping a company moving, in financial balance and ahead of its rivals while it navigates a radically changing context. This brings us to three further types of innovation: the innovation occurring within the changing paradigm.

    So, the third type of innovation is evolutionary. It resembles the Darwinist process of evolution in nature. Here, the consumer provides what evolutionary biologists call selection pressure, and innovation emerges from incremental improvement through trial and error, mirroring what biologists recognize as mutation and natural selection. It will usually be incremental, but its impact will not always be gradual. Evolutionary innovation can make radical inroads into a market by solving a particular problem or exploiting an opportunity.

    A good example is pod-based vaping products using nicotine salts. Salts change how nicotine is absorbed in the airways and allow users to consume smaller volumes of higher strength liquids. The effect of the salts is to allow high-strength nicotine liquids to be used without undue harshness with a smaller battery and tank, enabling a compact and convenient device. This addressed the challenge of providing a convenient and discreet product with effective nicotine delivery. It was wildly successful—at least where regulators allowed it.

    I have seen much handwringing about the recent rise of disposable vaping products. But this is another case of evolutionary innovation. The disposables solve the problem of finding a quick and convenient way into vaping for smokers in the early or tentative stages of switching away from smoking. They are simple to use, low cost and convenient. They don’t require an upfront investment in a device, so they lower the cost of consumer trial and experimentation. Like many innovations, these products have downsides, such as the waste generated. But this is manageable and must be set against the potential benefits and in context with other waste material flows.

    The fourth type of innovation is adaptive. This is a variation of evolutionary innovation, but it arises in response to regulation. Ultimately, it is driven by meeting consumer preferences, but it is triggered by regulatory interventions that would otherwise compromise the consumer experience—ether by design or as an unintended consequence. One example is the mentholation cards that emerged after the European Union ban on menthol-flavored cigarettes. These are inserted into cigarette packs to infuse nonmenthol cigarettes with menthol flavor. Another case is the “shortfill” e-liquid containers that became popular as a workaround to overcome the European Union ban on e-liquid containers of more than 10 mL volume. Much larger containers of nicotine-free vaping liquid are sold only partially filled, allowing the nicotine to be added later—often from nicotine liquids stronger than permitted in the EU.

    As the FDA imposed ever more burdensome regulation on nicotine vapes, small companies introduced synthetic nicotine products because the law confined FDA jurisdiction to nicotine derived from tobacco. This example also illustrates the arms race fought between adaptive innovators and responsive regulators. By March 2022, the FDA had prompted Congress to amend the Tobacco Control Act to apply to nicotine derived from any source, not just tobacco. Adaptive innovations can come with novel risks. For example, regulated bans on flavored e-liquids may lead to consumers adding food or aromatherapy flavoring agents not necessarily intended for vaping.

    The fifth type of innovation is user-driven. The early vaping enthusiasts were hybrid producer-consumers, interacting on user forums with a strong problem-solving ethos and a hands-on approach to product design and construction. Users created innovations like “squonkers” or “squonk mods” to facilitate dripping, a niche style of vaping, by incorporating a flexible liquid bottle into the design of the vaping device. But the most impressive innovations from the user side have been social and community in nature. The vaping forums and vape meets created an elaborate technical and moral support infrastructure. This online community blossomed into vape shops as centers of expertise, personalization and encouragement. The vape shops are now de facto cutting-edge stop-smoking services but with a very different offer to the more clinical settings of traditional services. Even the biggest corporate beasts benefit and learn from user innovation. They should take care not to crush it.

    Innovation is a fluid and dynamic business phenomenon with many simultaneously moving parts embedded in an unpredictably evolving, threatening or promising context. Surfing while juggling is hard and risky, but it is no longer a choice in the tobacco and nicotine business.

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