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Category: Also in TR

  • 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.).
  • Thoughtful Reflection

    Thoughtful Reflection

    Photo: Tobacco Reporter archive

    Speakers and panelists discussed the nicotine value chain during the InFocus virtual conference.

    TR Staff Report

    Participants in the May 22 InFocus virtual conference took a close look at the nicotine value chain, covering agriculture, synthetic nicotine products and innovation in tobacco harm reduction, among other topics. Below are some of the highlights of the event, which was sponsored by BAT, FEELM, Smoore, Alliance One International and Universal Leaf.

    Michael Strupp, professor of neurology at the Ludwig Maximilian University of Munich, addressed misconceptions about nicotine, stressing that it is not a nitrosamine and does not cause cancer. He emphasized the importance of distinguishing between the nicotine molecule and the substances produced by the combustion of tobacco. Strupp highlighted nicotine’s non-toxic nature and clarified that it is not a pesticide. He further explained that nicotine has potential therapeutic benefits, particularly in the treatment of neurodegenerative diseases such as Alzheimer’s and Parkinson’s as well as certain psychiatric disorders like schizophrenia.

    Strupp pointed out that nicotine can enhance attention and memory, improve mood by inducing euphoria and relaxation and indirectly influence body functions such as heart rate and blood pressure. Strupp discussed how nicotine’s mechanism of action has been well understood for decades, acting on nicotinic acetylcholine receptors in the brain. He explained that nicotine mimics acetylcholine, a neurotransmitter, and its interaction with these receptors can enhance learning, memory and attention.

    Concluding his keynote, Strupp emphasized the significance of understanding nicotine’s effects from a scientific perspective. He illustrated how the dopamine reward pathway is involved in nicotine addiction, with nicotine mimicking the effects of neurotransmitters like acetylcholine and dopamine.

    James Murphy, director of research and science at BAT, reflected on the remarkable transformation within the tobacco industry over his career, particularly with the development of three distinct noncombustible tobacco and nicotine product categories: heated products, vapor products and oral pouches.

    As a model for tobacco harm reduction, Murphy highlighted Sweden, where the widespread adoption of snus has led to a dramatic decline in smoking rates to just 5 percent. This shift has resulted in significantly better health outcomes compared to any other country in Europe, demonstrating the potential impact of noncombustible products on public health.

    Unfortunately, the promise of noncombustible combustible products is not reflected in consumer perceptions. Research findings indicated that a record percentage of consumers (90 percent in one survey) now believe that the risks associated with noncombustible products are equivalent to those of smoking.

    This misperception extends to medical practitioners as well, with a majority surveyed incorrectly attributing nicotine as a direct cause of cardiovascular disease, chronic obstructive pulmonary disease (COPD) and cancer. Murphy emphasized the need for education to correct these misconceptions and overcome barriers preventing adult smokers from switching to lower risk products.

    Murphy concluded by underscoring the importance of basing public health guidance on clear, rigorous science. He called for a unified commitment from all stakeholders to prioritize research and harm reduction strategies. A smokeless world, Murphy argued, is achievable through collaborative efforts focused on the well-being of millions worldwide. By dispelling myths and promoting evidence-based understanding of nicotine and noncombustible products, the industry can make significant strides in reducing smoking-related harm.

    Participants in the “Misperception of Nicotine” panel stressed the need for accurate information and education regarding nicotine, calling for global efforts to correct misconceptions and promote harm reduction strategies effectively. The panelists collectively highlighted the importance of engaging respectfully with all sides of the debate, basing policies on scientific evidence and ensuring transparency in public health communications.

    Moderator Jasjit S. Ahluwalia, professor of behavioral and social sciences and professor of medicine at the Center for Alcohol and Addiction Studies at the Brown University School of Public Health and Alpert School of Medicine, opened the panel by emphasizing the need to shift the narrative around nicotine. He pointed out that nicotine is often demonized despite scientific evidence suggesting that it is not the primary cause of smoking-related diseases.

    Ahluwalia highlighted a troubling public misconception that marijuana is safer than nicotine, which is not supported by science. He stressed that while nicotine will continue to be used, the focus should be on eliminating combustible tobacco products, which pose the greatest health risks. Ahluwalia also noted that e-cigarettes, though not without risk, are significantly safer than combustible cigarettes and do not cause cancer or COPD.

    Ahluwalia called for policies guided by science, advocating for accurate information to be provided to smokers about the benefits of switching to reduced-risk products (RRPs). Engaging with those who disagree is crucial, Ahluwalia argued, as there is much common ground and a shared purpose in harm reduction efforts. He also debunked the myth that nicotine use lowers IQs, stating that such misinformation undermines harm reduction efforts and that governments must play a role in correcting these misconceptions.

    Dave Dobbins, former chief operating officer at the American Legacy Foundation/Truth Initiative and consultant to Altria, underscored the importance of listening to all perspectives in the nicotine debate with kindness. He criticized the current tobacco control efforts, which he believes are often led by individuals who are not directly affected by nicotine use.

    Dobbins highlighted the severe health consequences of smoking, noting that cigarettes can reduce life expectancy by a decade and kill half of their users. He emphasized that nicotine delivery through RRPs is significantly safer than smoking.

    Dobbins called for clear, consistent communication with adult smokers, stressing the need to treat them with respect and provide accurate information about the benefits of vapes and pouches. He asserted that it is the duty of everyone, including cigarette companies, to disseminate accurate information about nicotine. Transparency in the origins and funding of scientific research is crucial to ensure trust and clarity in public health messaging.

    Delon Human, a specialist family physician and president of Health Diplomats, began by identifying himself as both a doctor and a consumer, emphasizing the human aspect of smokers. He expressed concern that a significant proportion of doctors (70 percent to 80 percent) incorrectly conflate smoking with nicotine consumption.

    Human criticized the World Health Organization for its inconsistent and unclear stance on nicotine, which also conflates tobacco use with nicotine use. He stressed the importance of the WHO and related agencies following scientific evidence. Human highlighted Sweden as an example of a country providing accurate information about nicotine use, resulting in significantly fewer cancer deaths due to the use of snus instead of cigarettes. He argued that scare stories about e-cigarettes need to be countered with scientific facts.

    Human pointed out that there is substantial opposition to nicotine within the WHO, which will take time to change. He also criticized Article 5.3 of the WHO Framework Convention on Tobacco Control (FCTC), which excludes the tobacco industry from discussions, arguing that this exclusion damages scientific progress and policy development and ultimately costs lives.

    Sudhanshu Patwardhan, nicotine expert and health tech entrepreneur, highlighted a study from the U.K. showing that 44 percent of doctors incorrectly believe nicotine causes cancer—a misconception common worldwide. He pointed out a significant gap between policy and medical understanding, which he said has real-world implications for smokers seeking healthier alternatives.

    Patwardhan called for a global nicotine literacy project to educate doctors and align public policies with scientific evidence. He emphasized the importance of making doctors champions of reason to communicate safer alternatives to cigarettes effectively.

    Patwardhan also stressed the need for sensible regulation that is supported by and encourages industry involvement. He concluded that educating healthcare providers around the world is key to promoting harm reduction.

    David Jones, a member of the U.K. All-Party Parliamentary Group for Responsible Vaping and deputy chair of the European Research Group, emphasized the critical role of tobacco harm reduction in public health policy, highlighting the U.K.’s pioneering “swap to stop” strategy, which provides vape starter kits to smokers to help them quit. He praised the U.K.’s evidence-based approach, which has significantly reduced smoking rates, but warned against recent proposals that could undermine these achievements.

    Jones argued against banning disposable vapes and flavored products, explaining that such measures could drive consumers to the black market and hinder smoking cessation efforts.

    Jones criticized the WHO for its opposition to RRPs, stating that its stance is not supported by scientific evidence. He called for greater accountability and transparency in international regulatory discussions, advocating for public and parliamentary scrutiny of decisions made by the FCTC.

    Highlighting the importance of flavors in vaping products for adult smokers, Jones cited research showing that nontobacco flavors are popular across all age groups. He argued that banning these flavors would be counterproductive and could lead to increased smoking rates as consumers turn to unregulated alternatives.

    Jones also addressed the potential of heat-not-burn products and nicotine pouches, urging the government to reconsider its stance on these alternatives and commission further research into their benefits. He emphasized that public health policies should provide smokers with accurate information about all nicotine products to support informed decision-making.

    In conclusion, Jones called for a continued focus on tobacco harm reduction, advocating for evidence-based regulations that support smokers in their efforts to quit. He stressed the need for the U.K. to maintain its leadership in this area and to hold international organizations accountable for their policies and decisions.

    Ramsey S. Lewis, Charles and Marilyn Stuber distinguished professor of plant breeding at North Carolina State University, delivered a detailed keynote on the complexities and challenges of developing low-nicotine tobacco varieties. He highlighted the increasing interest in these due to potential regulatory mandates that could require more than a 35-fold reduction in nicotine levels in conventional cigarettes. He emphasized that nicotine accumulation in tobacco plants results from complex interactions between environmental and genetic factors and asserted that genetic modification is the only viable method to achieve the stringent targets suggested by regulatory authorities.

    Lewis outlined the significant difficulties in achieving lower nicotine levels without negatively impacting other critical aspects of tobacco cultivation. He noted that reducing nicotine content often leads to undesirable reductions in yield, increased production costs and severe effects on leaf quality and other chemical properties of the tobacco. He warned against underestimating the complexity of biochemical pathways in living organisms, explaining that modifications in one area can lead to unexpected consequences in another.

    Furthermore, Lewis enumerated the numerous obstacles facing the development of low-nicotine tobacco. These include the feasibility of such projects, the limited availability of suitable varieties, susceptibility to diseases and insects, lower yields and higher production costs. Additionally, he highlighted the challenge of global acceptance of gene-editing techniques and the potential impact this may have on exports. Lewis underscored the need for extensive research and development to overcome these barriers and meet future regulatory requirements effectively.

    Participants in the “Nicotine – An Agricultural Approach” panel provided a comprehensive overview of the agricultural challenges and considerations associated with nicotine regulation. The discussions emphasized the need for continued research and development, thoughtful regulatory approaches and the importance of supporting both farmers and consumers in navigating these changes.

    Moderator Miranda Kinney, senior vice president of global communications and sustainability at Pyxus International, began the panel by delving into the agricultural aspects behind the tobacco products on today’s shelves, likening their personalized production journey to that of food products in supermarkets. She highlighted the importance of tobacco leaf, noting that it is the essential ingredient in most nicotine products and plays a critical role in supporting consumer satisfaction.

    Kinney emphasized that the tobacco industry supports millions of jobs globally, from farmers and processors to manufacturers, exporters, distributors and retailers, thereby enhancing livelihoods and supporting the economic viability of many developing countries.

    Kinney guided the discussion toward the intricate journey of the tobacco leaf, from the speck of a seed to a substantial industry contributor. She explained that the genetics and breeding of the seed, agricultural production practices, environmental factors and regulatory landscapes all impact the industry today and shape its future. She highlighted recent scientific advancements in genetics, cultivation practices and mechanization, noting their significant impact on farmers, particularly in developing countries where tobacco for novel nicotine products is often grown.

    Addressing regulatory challenges, Kinney pointed out that regulations, such as those proposed by the U.S. Food and Drug Administration on menthol and low-nicotine mandates, present key concerns for the industry. She discussed how potential regulations, particularly from influential regions like the EU and the U.S., could set trends globally. Kinney emphasized the importance of industry collaboration to anticipate and adapt to potential changes, ensuring that all parts of the supply chain are considered. She concluded by stressing the need for collective industry expertise to navigate the future, underlining that the agricultural aspects of tobacco production are intricately tied to the overall industry.

    George Cassels-Smith, chief executive of Tobacco Technology Inc., addressed the potential complications of mixed-crop standards, where only some plants meet lower alkaloid levels. He questioned the practicality and extensive testing required to manage such standards, particularly for plants that do not meet the set criteria.

    Cassels-Smith noted that synthetic nicotine gained a foothold in the U.S. market due to the stringent regulations on tobacco plants, although the regulations on synthetic nicotine have since been tightened. He pointed out that vaping products predominantly use synthetic nicotine, highlighting a significant shift in the industry toward these alternatives.

    He underscored the need for clear and feasible regulatory frameworks that consider the practical implications for producers and the broader industry.

    Lewis opened his remarks by clarifying that his expertise lies in plant breeding rather than addiction or behavior. He highlighted the significant challenges associated with modifying the nicotine content in tobacco plants without causing negative effects on the plants themselves.

    Lewis pointed out that if a regulatory mandate for low-nicotine tobacco were imposed today, the industry would struggle to comply due to the limited availability of viable low-nicotine varieties, which currently number around five and are associated with lower yields.

    He emphasized the complexity of biochemical pathways and the unintended consequences that can arise from genetic modifications, underscoring the need for extensive research and development to meet potential regulatory requirements.

    Carlos Pulcinelli, global project manager at Alliance One International, elaborated on the critical role of alkaloids in plant metabolism, with nicotine being the most significant alkaloid in tobacco. He asserted that it is currently impossible to control or modulate nicotine expression through agronomic practices alone, necessitating substantial investment in research and development.

    Pulcinelli stressed the increasing regulatory pressures facing the industry and the importance of developing the right plant varieties that meet the needs of farmers, regulators and consumers. He also highlighted environmental challenges such as extreme weather, droughts and floods, which complicate efforts to reduce nicotine levels.

    Despite potential changes in product formulations, he argued that the importance of plant alkaloids would remain paramount, calling for a balanced approach to meet these diverse challenges.

    Lea Scott, senior vice president of agronomy and agricultural sustainability for Universal Leaf Tobacco Co., discussed various agronomic practices, such as topping, used to manage alkaloid levels in tobacco plants. He emphasized the economic significance of tobacco farming, which generates approximately $944 million in revenue for the U.S. annually.

    Scott raised concerns about whether low-nicotine mandates might inadvertently encourage the growth of illicit trade, which already accounts for around 11 percent of the global tobacco market. He highlighted the substantial improvements in technology and the development of disease-resistant, high-yielding plant varieties. However, Scott noted that the transition to RRPs, such as heat-not-burn tobacco, would impact farmers by requiring less raw tobacco.

    He questioned whether lower nicotine levels might lead to increased consumption if consumers use more product to achieve their desired effect. Scott stressed that any shift to lower nicotine tobacco must be gradual and carefully managed, given its profound impact on farmers and communities worldwide. He also pointed out the trend of growing tobacco specifically for nicotine extraction into liquid forms, underscoring the importance of supporting both consumers and farmers.

    David Newns, entrepreneur and investor, chairperson and co-founder of Plxsur, highlighted the transformative potential of RRPs in global health outcomes. He noted that RRPs have evolved from a virtually unknown category to one now embraced by mainstream populations. This shift presents a significant opportunity to improve health outcomes worldwide by reducing the risks associated with traditional smoking. Newns emphasized that innovation cycles have been instrumental in driving the growth of the RRP category, transitioning vaping from a niche product to a globally recognized tool for harm reduction.

    Newns acknowledged the challenges associated with disposable vaping products but highlighted their crucial role in helping a large number of smokers switch to safer alternatives. These products have made it easier for smokers to incorporate vaping into their daily routines, facilitating a widespread transition from combustible tobacco. He also pointed out the collaborative efforts between academics and creatives in the vaping industry, dedicated to the mission of harm reduction. He reaffirmed that there is no one-size-fits-all solution, as different consumers have varying needs.

    Focusing on these needs, Newns explained that the universal demand from RRPs is for “more”—more convenience, flexibility, flavor, nicotine and personalization. This desire for “more” drives the continuous innovation within the industry. Looking ahead to GTNF 2024 in Athens this September, Newns expressed his enthusiasm over participating in “The Big Pitch” panel, which will invite innovators to present new and exciting nicotine products to industry leaders, fostering dialogue and shaping the future of RRPs.

  • The Forgotten Frontier

    The Forgotten Frontier

    Photo: fontriel

    Is tobacco harm reduction reaching the Global South?

    By Pieter Vorster and Sudhanshu Patwardhan

    Eighty percent of the current users of risky tobacco products live in the “Global South,” the geopolitical clubbing of low-income and middle-income countries (LMICs) that includes not only Southern Hemisphere nations such as Fiji but also nations that are firmly in the Northern Hemisphere, geographically, like China, India, Russia and Bhutan, along with countries that straddle both segments, such as Uganda.

    A world free of smoked and smokeless forms of risky tobacco products such as cigarettes, bidis, gutkha, mishri, zarda and toombak can prevent a billion premature deaths this century. This can potentially reduce the social, economic and health inequity within and between countries, thus delivering on many U.N. Sustainable Development Goals and taking a step closer to the World Health Organization’s “health for all” ambition. Do manufacturers of tobacco products, as well as businesses delivering cessation products and services, have a role in this?

    Sudhanshu Patwardhan is a medical doctor, nicotine expert and health tech entrepreneur. Pieter Vorster is managing director of Idwala Research, a consultancy aiming to accelerate global tobacco transformation and harm reduction. Both have roots in the Global South and are motivated by the goal of reducing the harms from tobacco, as seen in the Global North. Below, they discuss the challenges and opportunities related to global health equity in a freewheeling dialogue, interchangeably playing the role of interviewer, respondent, expert and devil’s advocate.

    Background

    In June 2023, at the Global Forum on Nicotine in Warsaw, Sudhanshu Patwardhan convened and chaired a workshop of international experts representing diverse stakeholder groups—tobacco control, industry and management consulting. The session was titled “Tobacco Industry Transformation—Is It Really Reaching LMICs?” The panel and the audience, including Pieter Vorster, brought deep and wide expertise in public health, consumer advocacy, regulatory affairs, nicotine supply chains and capital markets. As the first anniversary of the session approaches, it is timely to discuss the developments that have occurred since and what needs to be done going forward to achieve a world free from risky tobacco products.

    Pieter Vorster: Sud, let us summarize the session before we leap forward into what has happened since and what is next. So, in the workshop, you brought up the role of a range of stakeholders in the ecosystem: regulators, industry, consumers and healthcare professionals, to name a few. What are the regulatory challenges in the Global South that significantly impact tobacco cessation and prevention of initiation?

    Sudhanshu Patwardhan: Pieter, smoked and smokeless forms of risky tobacco products are a leading cause of noncommunicable diseases (NCDs) globally and increasingly in the Global South. However, when it comes to tobacco control, there is a serious regulatory capacity gap in the Global South. Most of these countries are still developing locally relevant systems and policies that can best meet their populations’ needs for healthier, happier and longer lives. All these countries are going through a dramatic epidemiological shift—with NCDs overtaking infectious diseases as a leading cause of disease and death. Most of these countries are signatories to the WHO’s Framework Convention on Tobacco Control [FCTC], but the implementation of the FCTC articles is still very selective. For example, most emphasis is on taxation (a proven tool for reducing demand and increasing treasury earnings), advertising restrictions, and campaigns for public awareness and prevention of initiation. Although this is having an impact, progress has been slow. The principle of harm reduction, although explicitly stated as a component of tobacco control in Article 1(d) of the FCTC, has largely been ignored by the WHO to the extent that its guidance on tobacco policy favors a prohibitionist approach toward safer nicotine alternatives and that is being adopted by many countries in the Global South that look to the WHO for leadership on health policy.

    Vorster: Please explain how that is also a regulatory issue.

    Patwardhan: This came up during our workshop. The tobacco industry is innovating into “reduced-risk products” at a breakneck speed, catching up with product innovation from outside the industry (e.g., e-cigarettes) or launching products they have developed through years of R&D (e.g., nicotine pouches and heated-but-not-burned tobacco products). Their ability to launch these products is stymied by local prohibitions in many countries globally. If regulated strictly enough and marketed only to current tobacco users, these products have the potential to reduce tobacco-related harms significantly. Evidence from the U.K., Japan and Sweden is a case in point.

    In an interlinked issue, there is hardly any capacity built for tobacco cessation in the Global South. Most of the pharmaceutical industry or health tech entrepreneurs there are equally unenthused about innovation into tobacco cessation and the massive public health opportunity. They fail to recognize the financial dividend by serving the “base of the pyramid.” So, effectively, nearly a billion people in the Global South—current tobacco users—are consigned to struggle by themselves in their attempts to quit, and most fail.

     An important aspect of “demand reduction” in tobacco control, i.e., enabling access to appealing nicotine-replacement products that can enable and sustain cessation among current adult tobacco users, is therefore not available in most of the Global South.

    Vorster: So, bans on newer “safer” nicotine alternatives in many countries are causing a strange situation: Risky forms of tobacco are still available everywhere, legally, while reduced-risk products are not? One would have thought that the science underpinning the tobacco harm reduction principle is universal. If it is clearly understood by U.K. policymakers and enshrined in the U.S. Food and Drug Administration’s “modified-risk tobacco product” authorization, why is it not accepted in the Global South?

    Patwardhan: It is important to bear in mind that sound policymaking and regulations cannot be a simple copy-paste from the Global North. Yes, global good practices can be adapted—but there is no substitute for local science to ensure relevance and sustainability. Local research capacity not only helps build the scientific evidence base but also helps society interpret it objectively. That is currently missing in most of the Global South. A glaring example is from my recent attendance at the biannual global meeting of the Society for Research in Nicotine and Tobacco, held in Edinburgh. Out of the over 1,000 delegates there, in my estimation, less than 5 percent of those attending were working on the ground in tobacco cessation and harm reduction in the Global South. The fact that these conferences happen mainly in Europe and the USA also points to systemic bias in funding and research, all skewed to the affluent Western nations. Even conventional tobacco cessation treatments are hardly, if at all, studied and available in the Global South.

    Vorster: Do you mean nicotine-replacement therapy products (NRT)?

    Patwardhan: Yes, that’s a good example. NRT are on the model essential medicines list of the WHO for tobacco dependence treatment. They have also made it to the National Essential Medicines lists of member countries. But the reality on the ground is vastly different and quite frustrating. Little or no local research data on the use of NRT for tobacco dependence treatment exist in most of the Global South. NRT gums, patches and lozenges are much costlier than the tobacco products they are meant to replace during a quit attempt. They are either available at limited points of sale or not at all, and healthcare practitioners are not equipped to advise patients on using these products.

    Vorster: You often talk about nicotine misperceptions among healthcare professionals, and you led the first published research study on this topic in 2013. More recently, the Foundation for a Smoke-Free World-funded SERMO study of over 15,000 doctors from 11 countries also showed that of those interviewed, over 70 percent believed (wrongly) that nicotine in tobacco products causes cancer. How does that impact cessation?

    Patwardhan: From personal experience interacting with numerous frontline clinicians worldwide over the years, I can see how nicotine misperceptions influence their advice to tobacco-user patients. Smoked tobacco and most smokeless tobacco products are harmful due to a wide range of chemicals, including carcinogens, either produced during combustion or added during manufacturing. Nicotine is not a carcinogen; it is, however, the dependence-causing chemical in tobacco products for sure! The misperception about nicotine regarding cancer is a likely cause of hesitance among clinicians to recommend adequate NRT treatment for long enough, alongside behavioral counseling. Cravings for nicotine and withdrawal symptoms can last from weeks to months. Not supporting the quit attempt with adequate dosing of clean forms of nicotine (e.g., NRT) for long enough is very likely to lead to a failed quit attempt or relapse. Countries such as the U.K. have strong regulatory expertise in tobacco control and expertise in nicotine science and have therefore embraced a tobacco harm reduction indication for NRT—i.e., deemed it safer for smokers to consume NRT as long as necessary, for quitting smoking altogether and to prevent relapse.

    Vorster: You make the role of regulators in tobacco cessation loud and clear. What about the industry?

    Patwardhan: The industry is not a monolith. Nor is it just the tobacco industry we are talking about here. The nicotine supply chain has never been so exciting! A significant proportion of the world’s pharmaceutical-grade nicotine comes from companies extracting nicotine from tobacco in India. Many of those companies also supply the increasing demand for nicotine for e-cigarettes and nicotine pouches. Then there is synthetic nicotine, made to pharmaceutical standards, also poised to disrupt the supply chain and potentially free up thousands of hectares of arable land to address food security issues. Some of the large multinational tobacco companies have invested in medically licensed NRT, e.g., BAT and Philip Morris International, blurring the lines between tobacco and NRT companies, potentially expanding the choices available for enabling quit attempts among current tobacco users. However, given the history of the industry, any efforts by the tobacco industry to conduct tobacco cessation training among healthcare professionals would be viewed with suspicion and likely to evoke a reaction from those in public health. There is a clear role and an unmet need for independent organizations to take the lead on this in the interest of public health. Tobacco companies can better focus their resources on conducting locally relevant tobacco cessation and harm reduction research in the Global South. That could potentially better inform regulation and an understanding of harm reduction principles among key stakeholders.

    Now, this is where I get to ask you questions! Given your deep expertise in the tobacco industry transformation process, what do you make of the tobacco companies’ innovation and launches in the context of the Global South?

    Vorster: Although there have been valuable attempts to gauge overall industry transformation, notably the Tobacco Transformation Index, no independent research has been conducted that tracks transformation progress specifically in the Global South.

    Having said that, there have been encouraging, albeit nascent, trends here. During the early years of reduced-risk tobacco product (RRP) launches, multinational tobacco companies focused on countries such as the U.S., Japan, Korea and Europe. More recently, companies like BAT have launched nicotine pouches in Kenya, Pakistan and South Africa and PMI in the Philippines, Pakistan and South Africa. Furthermore, PMI sells heated-tobacco products in a considerable number of Global South markets, including Indonesia in select cities, while BAT has a significant geographical footprint there with vaping products.

    Apart from regulatory measures that prohibit the sale of RRPs in a substantial proportion of these countries, one of the most significant barriers to harm reduction is the cost of these products relative to cigarettes, which is a function of both low cigarette prices and excise tax and relatively high production costs for RRPs. For example, the PKR120 ($0.43) per can, at which BAT and PMI sell nicotine pouches in Pakistan to compete with low-end cigarette prices, is below current production costs of about $0.50 to $0.60 per can. For RRPs to make meaningful inroads in the Global South, it is imperative that costs are reduced significantly and the price differential with all forms of risky tobacco products available locally is decreased substantially. Within this context, it is significant that BAT (followed by PMI) chose to introduce nicotine pouches in Pakistan, which has the second-highest incidence of smokeless tobacco use in the world.

    Patwardhan: Where do large national tobacco companies come into this?

    Vorster: The transformation picture is markedly different beyond the listed multinational tobacco companies. Sadly, this is also where the majority of the world’s consumers of harmful tobacco products resides.

    There exists clear potential for conflicts of interest where state monopolies control the tobacco industry, but these potential conflicts exist well beyond state ownership of tobacco companies through the tax revenues earned from tobacco products. For countries with a significant reliance on tobacco tax revenues, the WHO’s prohibitionist stance on nicotine consumer products has helped justify the banning of less risky forms of tobacco and nicotine.

    In China, the government receives the equivalent of circa 10 percent of General Government Final Consumption Expenditure from tobacco taxes in addition to the substantial revenue it earns from its ownership of the CNTC [China National Tobacco Corp.]. It was, perhaps, no surprise that, in 2022, the burgeoning independent Chinese vape industry was brought under the purview of the State Tobacco Monopoly Administration, leading to its near collapse owing to significant regulatory restraints.

    Indonesia is the second-largest cigarette market in the world after China, and whilst the tobacco industry is privately owned, the government receives some 13 percent of General Government Final Consumption Expenditure from tobacco taxes. RRPs are not banned in Indonesia, but with average cigarette prices around $1.50 per pack, they are not competitive and will likely only appeal to high-end consumers.

    Patwardhan: From the looks of it, the odds are stacked against tobacco users in the Global South: knee-jerk regulation against safer nicotine products, a local versus multinational tobacco companies’ turf war, nicotine misperceptions among healthcare professionals and a lack of locally conducted scientific research in tobacco control and harm reduction. Conducting high-quality, independent research in tobacco control and harm reduction, which can be peer-reviewed and used to inform regulatory and clinical decisions, can change this situation for the better.

    Vorster: Furthermore, despite initiatives such as the Tobacco Transformation Index that assess the overall shift in the industry, a considerable gap persists in independent research focused on monitoring transformation progress specifically in the Global South.

    Patwardhan: Agreed. There is an urgent need for industry transformation, not just in products but also in organizational attitudes toward public health, research and social responsibility in the Global South. It is quite clear to me that the industry must prioritize public health outcomes alongside business interests. It was mentioned in our panel how crucial it is for companies to engage with communities transparently to foster an environment conducive to harm reduction. This includes investing in local communities, conducting local research to global standards and responsibly supporting educational campaigns that accurately inform adult consumers about the risks of consuming tobacco and the evidence-based aids available locally for quitting tobacco use.

    Conclusion

    Eliminating harm from tobacco products is a lofty social, public health, economic and political goal. It needs to be a global goal too. The rapid pace of innovation into safer nicotine alternatives for tobacco cessation is likely to be available and affordable only to the adult tobacco consumers in wealthier “Global North” nations in a well-regulated environment, and this threatens to worsen the inequity already imposed on current tobacco users of the Global South. The industries—not just tobacco but also pharmaceutical as well as new disruptive digital and health tech companies, have much to gain commercially by innovating in the Global South. There are nearly a billion current adult tobacco consumers there waiting for just that!

    Pieter Vorster is managing director of Idwala Research, a consultancy aiming to accelerate global tobacco transformation and harm reduction.
    Sudhanshu Patwardhan is a medical doctor, nicotine expert and health tech entrepreneur from India, based in the U.K. He works on projects around the world to reduce harm from tobacco, especially among the most disadvantaged tobacco user populations.
  • Not Lost Yet

    Not Lost Yet

    Photo: JTI Poland

    While struggling with rising cost and mounting regulations, Polish tobacco companies can cheer the retreat of the illicit market.

    By Vladislav Vorotnikov

    In the next few years, Poland may lose a part of its competitive edge as a regional tobacco superpower owing to controversial European Commission policy. This will happen unless common sense prevails or the government finds the courage to stand up to Brussels, according to market players.

    Poland is one of 12 countries in the EU that grows tobacco. For eight, including Poland, this is a strategic economic sector. Poland is also the largest exporter of tobacco products in the EU, with nearly 10 percent of the country’s agricultural and food exports, 80 percent of which goes to the EU market.

    The last few years have been rough for Polish tobacco growers, primarily owing to surging operating costs in Europe, according to Lukasz Szymanski, owner of Solidus Tobacco, a trading company.

    “Unfortunately, in recent years, we have observed a systematic shrinking of the tobacco-growing sector in Poland. This was caused by systematically rising energy and labor costs, which were the main obstacle for many growers,” Szymanski said.

    Szymanski, who has been in the tobacco business since 2015, selling mostly green tobacco and tobacco in the form of strips primarily to European customers, last year moved to expand activities and open an additional branch in the port of Trieste, Italy, eyeing markets outside the EU, specifically in the Middle East.

    Weak demand in the European market might be a key rationale for Polish tobacco businesses to seek opportunities overseas.

    “For many years, market tobacco purchase prices remained at the same level, which effectively discouraged many farmers from further cultivation,” Szymanski said, adding that since he stepped into the market, he saw a gradual decline in the sales volumes, which, he calculated, nearly halved between 2016 and 2022.

    In the coming years, the lives of Polish tobacco growers could become even more challenging. Market players are increasingly concerned about the fallout of the November summit of the World Health Organization in Panama. This summit, in the opinion of some Polish tobacco businesses, has been perceived as a public declaration of war on the industry.

    “We are afraid that the Polish tobacco industry will be killed by [the] Panama [summit]. The threat of unemployment hangs over us. We do not understand why employees of legitimate businesses should fall victim to international interference in Polish affairs,” said Marcin Klimczyk, chairman of the National Section of Tobacco Industry Workers.

    Polish leaf producction has steadily declined in recent years. (Photo: Solidus Tobacco)

    Bracing for Impact

    At the end of 2023, Polish businesses, united in their concerns, appealed to the government, seeking protection. Among other things, the National Chamber of Commerce, a prominent business union, has questioned the rationale behind participating in the WHO tobacco convention, voluntarily accepting constraints on tobacco business. The organization indicated that the countries not taking part in the initiative, specifically the United States and Great Britain, are more successful in fighting tobacco addiction.

    Accepting new rules will have a heavy impact, not only in Poland but also in the entire EU, players believe.

    “I am surprised that Europe is moving in this direction,” Marek Kowalski, chairman of the Federation of Polish Entrepreneurs, told Rzech Pospolita. “There will come a time when the EU will no longer be competitive on the tobacco market with countries outside it, which will willingly fill this gap.”

    Poland is the world’s largest manufacturer of nicotine sachets, noted Zbigniew Jankowski, a spokesperson from Swedish Match.

    “We are convinced that the implementation of the WHO recommendations by the EC after Panama may lead to a ban on their sale in Europe and, in fact, to the destruction of this fledgling market. Companies will go bankrupt; people will go out of business,” Jankowski said.

    On top of that, many people who have given up cigarettes in favor of less harmful alternative products, such as nicotine sachets, will be deprived of them if the WHO recommendations are implemented. This could have a significant impact on public health and the industry’s revenue.

    Polish tobacco companies are increasingly looking for opportunities overseas.

    Flourishing Industry

    In the long run, new regulations can undermine the investment attractiveness of the Polish tobacco industry, which secures roughly 8 percent of taxes for the national budget.

    In the past few years, the general mood in the Polish tobacco industry was predominantly positive.

    Cigarette volume sales declined by less than 1 percent in 2023 while the value grew due to increased prices, Euromonitor International, a think tank, calculated.

    “In 2022, the influx of refugees from Ukraine strongly revived cigarette sales, but the impact of this factor weakened in 2023. This factor also resulted in lower volume sales of fine-cut tobacco. Meanwhile, novelty nicotine and tobacco products, such as e-vapor products, heated-tobacco products and nicotine pouches, continued to show a significant increase in demand,” said Lina Sidorenke, an analyst with Euromonitor International.

    “Closed-system disposable devices emerged as the big winner with the strongest growth in 2023. Demand for cigars remained stable; however, high demand in Asian markets and the USA has led to fewer cigars being imported to Poland. Despite regular excise duty increases, Poland still stands out in the region for low prices of tobacco products,” Sidorenke said.

    Moreover, Poland has recently achieved drastic progress in fighting against illicit trade in the tobacco market.

    In recent years, the illegal sales of cigarettes in Poland have declined dramatically, Sidorenke claimed.

    “As of 2023, the gray market comprised less than 5 percent of all cigarette volume sales. Poland has demonstrated significant success in combating illicit trade, thanks to a united effort by the police, Border Guard and National [Revenue] Administration,” Sidorenke indicated, adding that in the past, a significant portion of contraband previously originated from Belarus and Ukraine, but the imposition of sanctions on Belarus and the war in Ukraine has led to stricter border controls, resulting in a significant decrease in illegal inflows to Poland.

    JTI Poland has invested heavily in reduced risk product manufacturing.

    Emerging Niches

    The positive developments encourage international giants to pump more money into their Polish operations, primarily eyeing the segment of heated-tobacco products.

    “While sales of traditional tobacco products in Poland are relatively stable, the heated-tobacco products category has been constantly growing in the last five years, accounting for about 11 percent of the entire nicotine market in the country today,” commented Adrian Jablonski, corporate affairs and communications director of Japan Tobacco International Poland.

    “In response to these evolving consumer trends, we introduced Ploom X—JTI’s third-generation heated-tobacco product—to the Polish market in September last year. Our heated-tobacco sticks [HTS] are produced at the state-of-the-art factory in Stary Gostkow, where we have already invested over $200 million in the reduced-risk products factory,” he added.

    Jablonski added that JTI plans to continue to develop the HTS category in Poland, though the company cannot reveal details for competitive reasons.

    However, the segment may also feel the sting of the tightening regulations in the foreseeable future.

    In February 2024, Polish Health Minister Izabela Leszczyna announced that the government was considering a ban on the sale of disposable electronic cigarettes, as reported by the local newspaper Business Insider.

    Leszczyna added that she would like to pursue the fastest possible legislative path to such a measure, given that as many as 64 percent of young people in Poland had “contact” with the product.

    “Single-use e-cigarettes currently dominate the e-vapor product market in Poland. This trend has surged over the past three years. If Poland were to follow the U.K.’s lead and implement a ban on disposable e-cigarettes, it could significantly impact the entire e-vapor market,” Sidorenke said.

    Sidorenke added that while some consumers may transition to other alternatives within the sector, a decline in overall e-vapor market demand is likely.

    Heated-tobacco products in Poland currently face fewer regulatory restrictions compared to combustible cigarettes, with lower taxation and continued availability of flavored products. Despite calls from the European Commission for Poland to adhere to EU regulations prohibiting flavored heated-tobacco products, they remain on sale as of April 2024.

    “However, it’s anticipated that new regulations will be implemented rather soon. It’s worth noting that the market has historically adapted to regulatory changes, as seen after the ban on flavors in traditional cigarettes. Thus, even with a potential flavor ban, the market is expected to adjust accordingly,” Sidorenke indicated.

    In the next five years, the tobacco and nicotine market is expected to advance toward the development of next-generation novelty products, partially at the expense of traditional cigarettes and smoking tobacco, Euromonitor International analysts forecast.

    A negative or uncertain forecast is anticipated for cigars, cigarillos, snuff and pipe tobacco. Beginning May 20, 2024, all tobacco products in Poland will be subject to the track-and-trace system. Previously, the EU track-and-trace system only covered cigarettes and fine-cut tobacco. However, as of May 2024, cigars, cigarillos, snuff and pipe tobacco will also fall under this system.

    “This expansion will impose additional burdens on manufacturers and retailers due to the costs, complexity and compliance requirements. In anticipation, some distributors have already indicated plans to withdraw these items from their offerings after the system comes into effect,” Sidorenke said.

  • A Case for Consensus

    A Case for Consensus

    Photo: pavelkant

    A global alignment on health policy is necessary to make a smokeless world a reality.

    By James Murphy

    With renewed attention on smoking and vaping regulation around the world, now is the time for action that will realize global smoke-free ambitions and ensure cigarettes become a thing of the past.

    Achieving this vision requires a global consensus on the most effective approach to create sustained and lasting changes to consumer behavior—tobacco harm reduction (THR).

    THR is one the greatest public health opportunities today, representing a pathway for hundreds of millions of smokers who would not otherwise quit to transition from combustible tobacco products to smokeless alternatives.

    Countries that have recognized the opportunity THR presents, and which have adopted supportive policies, have seen striking success in reducing their smoking rates. The U.S., U.K. and Japan are all currently witnessing their lowest smoking rates on record while Sweden is on track to declare themselves smoke-free this year—defined as having less than 5 percent daily smokers in the population—16 years ahead of the 2040 EU target.

    These remarkable transformations have been driven by widespread THR acceptance from policymakers, regulators, health officials and consumers in these markets, enabling and encouraging smokers to migrate from combustible tobacco products such as cigarettes to vapor, oral nicotine pouches, snus and heated-tobacco or herbal products.

    The widespread accessibility of smokeless products is essential for the success of THR. However, at present, this is being hamstrung by many countries limiting access to these alternative tobacco and nicotine products. For example, 60 percent of the world’s population live in just 15 countries. Of these, only about 40 percent permit the sale of smokeless products, leaving millions who would otherwise continue to smoke without the option to switch to such alternatives.

    In order to fully realize the public health potential of THR and significantly reduce the more than 8 million deaths attributed to smoking cigarettes each year, regulators around the world should embrace evidence-based science to drive positive public health outcomes. This means implementing a supportive regulatory framework that encourages adult smokers who would otherwise continue to smoke to switch while also protecting consumers with stringent safety standards and preventing underage use.

    In addition, the global success of THR depends on governments and regulators correcting persistent misperceptions of smokeless products compared to cigarettes.

    A University College London-led study published earlier this year highlighted that most smokers in England wrongly believe vaping is at “least as harmful as smoking,” with 57 percent of respondents saying they thought vaping was “equally” or “more harmful.” This echoes trends reported in the U.S., with research showing that perceptions of e-cigarettes as more harmful than cigarettes doubled year on year between 2018 and 2020. Not only are these misperceptions flawed, but they also have significant implications for public health by actively discouraging smokers who would otherwise continue to smoke from making the switch to smokeless products.

    Greater efforts are needed to counter these misperceptions—something that BAT is trying to tackle. As the world’s largest vapor company and a leader in smokeless products, BAT is committed to producing innovative products backed by world-class science and industry-leading product safety and quality standards. BAT’s THR approach is based on the growing body of research and weight of evidence approach that substantiates its belief of the reduced-risk profile of these products compared to cigarettes, which have been accepted by many international public health bodies. BAT publishes its science research to increase understanding of THR and raise awareness with stakeholders.

    Indeed, the industry developing and producing these products has a critical role to play. But to achieve the conditions required to make a success of THR, an inclusive, open and honest dialogue with all stakeholders is required. That includes policymakers, regulators and the healthcare and medical communities. Unfortunately, this is not yet the case, with the industry all too often excluded.

    We have an opportunity to usher in a new smokeless world, grounded in scientific research and a firm commitment to public health. The solutions are available today. All that is required is for the relevant stakeholders to actively work together to prioritize THR and the well-being of millions of people worldwide.

    James Murphy is the director of research and science at BAT.
  • Unforeseen Costs

    Unforeseen Costs

    Image: Alexandr Byerdugin

    How the Florida e-cigarette registry will harm nonvapers

    By Peter Clark

    This year, many U.S. states have considered imposing heavy-handed registries that aim to ban most vaping products sold today. In Florida, Governor Ron DeSantis wisely refused to follow along with other states. However, his solution—a sort of reverse registry that gives Florida’s attorney general the authority to ban specific products—will create more problems than it solves.

    It’s understandable how many nonvapers would see this law as being reasonable. But there are many unforeseen costs that they will need to bear.

    This law focuses on the dangers of vaping devices attractive to children, but there are many drawbacks to nonvapers. These include state resources wasted on ligation, unfair benefits to tobacco companies and healthcare costs of smokers imposed on all Floridians. 

    HB1007 will run into legal trouble if not correctly applied. Multiple factors need to be satisfied for a vaping product to be restricted. If Attorney General Moody erroneously finds a vaping device to be illegal, this opens Florida up to lawsuits. 

    This impacts Floridians since it costs tax dollars and ties up the court system. The Florida court system is already stressed. Between March 2022–2023, Florida led the country in the number of lawsuits filed. 

    Plus, the courts would require additional tax revenue to adjudicate the influx of claims. Fiscal year 2023 already saw a 7.2 percent increase in the budget over 2022. That budget has soared to $114.7 billion for fiscal 2024–2025. 

    The government should have a compelling interest in restricting sales of e-cigarettes. The public health justification is flimsy at best. 

    Teen vaping is on the decline. It isn’t flavored products that entice kids to start vaping. They vape to rebel and to reduce stress, using nicotine to self-medicate. Targeting flavored electronic nicotine-delivery systems (ENDs) based on a myth theorizing why kids start vaping will jeopardize the health of adult vapers, leaving us with an ineffective policy that burns tax dollars and overloads the courts.

    HB1007 also advantages the tobacco companies. The influx of non-FDA-approved e-cigarettes has severely eaten into the market share of big tobacco. Analysts suggest the only way to remedy slumping cigarette sales would be to “clamp down on disposable e-cig growth.” The CEO of Altria has even described the market as being “overrun” by these devices. 

    Barring vapes that lack FDA approval benefits tobacco companies in two ways. For one, most of the products granted premarket approval were Big Tobacco-owned. In 2022, all the e-cigarettes greenlighted by the FDA were sold by R.J. Reynolds, Altria, and JTI. By the attorney general blocking Big Tobacco’s competition, they can regain some of the sales lost to popular single-use devices like Elfbar.

    Even Florida voters who don’t vape should be concerned about this outcome. Upholding this law gives precedence to similar approval processes for other products. The legislature could pass additional laws to ban the sale of dietary supplements and even food deemed to be harmful. Much like the choice to vape, adults should have the right to evaluate the harm in what they choose to consume for themselves. 

    Florida restricting single-use ENDs would impose higher healthcare costs on Floridians. A study found that only 12.9 percent of vapers polled would abstain from nicotine if their preferred e-cigarette was banned, leaving many e-cigarette users going back to tobacco. The total healthcare cost to Florida from smoking is $10.04 billion, an annual tax burden of $854 per household. These figures do not include the impact of secondhand smoke or the $21.1 billion in lost productivity. 

    If a policy doesn’t directly impact you, it is easy to be apathetic. Banning popular vaping products hurts more than e-cigarette users. It wastes resources, gives tobacco companies an unfair advantage and costs Florida billions in healthcare costs. Even if you have never picked up a cigarette or vape, this law will still negatively impact you.

    Peter Clark is a fellow with the World Vapers’ Alliance. You can follow him on X at @blog_logic.
  • Food for Thought

    Food for Thought

    (Photos: Stuart Mitchell)

    “You couldn’t make it up.” That was how Simon Clark, the director of the Freedom Organization for the Right to Enjoy Smoking Tobacco (Forest), summed up the way in which the U.K. government had, in October last year, renegued on earlier assurances and announced a generational ban on tobacco sales.

    Clark was speaking as co-host of a Beat the Ban lunch held at the Boisdale Restaurant in London on May 21. The proposed ban, currently being pushed through parliament, would make it illegal in the U.K. to sell tobacco products to anyone born on or after Jan. 1, 2009.

    Clark pointed out that this would mean a person of a certain age would be able to buy tobacco while another person, one year, or, in some cases, just one day younger, would not be able to do so legally. Eventually, a person 70 years of age would not be able to buy tobacco legally.

    Forest is opposed to the proposed ban for several reasons, but mainly because it believes the ban would infantilize young adults and increasingly older adults, driving some of them towards the black market and criminal gangs, while doing nothing to stop sales of tobacco products to children, which are already illegal.

    What was extraordinary, Clark said, was that while, in April 2023, the government had made it clear it did not intend to raise the minimum age for the sale of tobacco, in October, the prime minister, Rishi Sunak, announced plans for the generational ban.

    “In our view, the Tobacco and Vapes Bill is a desperate attempt by a desperate prime minister to leave a legacy—any legacy—however unconservative, before the next general election [due to be held this year or, at the latest, January 2025],” said Clark.

    Clark was scathing, too, about the way the bill is being “steamrollered” through parliament. Following a short public consultation before Christmas, the government had announced it would not consider any submissions from groups with links to the tobacco industry, which, for instance, included Forest and even retailers. “To the best of my knowledge, that has never happened before,” he added.

    After its second reading, the bill entered its committee stage, when 17 MPs were appointed to the Committee, 16 of whom had voted for the bill and the other of whom was known to support it. And when it came to inviting people to give oral evidence to the Committee, witnesses were almost exclusively supporters of the bill.

    “Not only has the process been absolutely scandalous, the bill as it stands is illiberal, unenforceable, and has significant unintended consequences,” said Clark. “It will drive the legitimate sale of cigarettes and tobacco underground,” he added, before calling on those so minded to write to their MPs in protest,

    Clark’s co-host, Ranald Macdonald, the founder and MD of the Boisdale restaurants, was unable to attend the lunch but sent a message of support along with a special pleading for the smokers of fine cigars.

    And the 60 lunch guests, who included MPs, parliamentary researchers, think tank staff, retailers, tobacco industry representatives and journalists, heard from a string of speakers representing or simply speaking up for retailers, young adults and a variety of tobacco products, including pipe tobacco and snuff that will also be covered by the bill should it go through. —George Gay

    Editors’s note:

    Hours after this story had been submitted, U.K. Prime Minister Rishi Sunak announced that a general election would be held on July 4, meaning that parliament was due to be dissolved on May 30 and leaving too little time for the tobacco and vapes bill to complete its passage through parliament. This is unlikely to be the end of the matter, however, because the policy underpinning the bill had cross-party support and could well arise like the phoenix in the future.

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.
  • The Takeaways

    The Takeaways

    REDPIXEL

    What did we learn from the E-Cig Summit in Washington, D.C.?

    By Derek Yach

    The E-Cig Summit comes at a time of change in how tobacco harm reduction (THR) products are regarded by those who oppose or support their use as a means of ending smoking. In recent months, new reports, editorials and comments in leading medical journals have highlighted the benefits of vapes for smoking cessation.1,2,3,4 Further, calls for medically licensed vapes have increased from academics who rarely agree on THR policies.5

    Robin Mermelstein, director of the Institute for Health Research and Policy at the University of Illinois, opened the meeting by noting that diverse perspectives are needed for innovations required to end combustible use. With no scientists from the private sector allowed to present research (except for former Center for Tobacco Products [CTP] Director Mitch Zeller, who is currently an advisor to Qnovia), this goal was tough to achieve. And it comes shortly after an editorial in Nicotine and Tobacco Research, the lead journal of the Society for Research on Nicotine and Tobacco, calling for complete exclusion of industry scientists.6 One wonders how widely supported this view is.

    I summarize key inputs from the Summit that address six questions:

    1. What are the major trends in cigarettes and vape use in the United States?

    Rafael Meza of the BC Cancer Research Institute showed that smoking and vaping prevalence in youth has declined. Frequent use (20 days or more over 30 days) is about 6 percent for smoking and vaping in both boys and girls. Among adults in middle age, cigarette consumption has declined in tandem with vaping increasing. Smoking rates, however, have not declined among people over 65 and remain highest among those with the lowest incomes and education. Meza’s projections of future trends are flawed by excluding probable impacts of heated-tobacco products and nicotine pounces joining vapes as providing alternatives to combustibles over the next few years.

    Only 4 percent of all smokers live in the U.S. Resources and debate about global policies are shaped heavily by U.S. federal, academic, nonprofit, philanthropic and private sector perspectives. Global realities need to be brought into summits. To mention two. First, smoking rates exceed 40 percent in men across most Middle East and Eastern European countries and in China and Indonesia. Smoking rates exceed 20 percent in women across Eastern Europe and small island states. These were rates in the U.S. 40 years to 50 years ago. THR provides a route to leapfrog over the road taken by the USA.

    Second, toxic smokeless tobacco products are commonly used, especially across South Asia, and cause about 350,000 oral cancer deaths. Nicotine pouches could well be the route to eliminating this dreadful cancer. A global perspective would place this as an achievable goal.

    1. Is there greater balance in addressing the needs of adults who smoke and those who have early disease compared to what has been a dominant focus in past summits on youth?

    CTP Director Brian King stressed that youth issues remain his priority. In response to Mermelstein, he could not explain why this remains a priority, given extremely low vape use in youth and the absence of convincing evidence that vapes are a gateway to combustibles. In contrast, both the U.K. and New Zealand give priority to ending combustible use in adults.

    King repeated his advice to adults who smoke: first use Food and Drug Administration-approved cessation medications and only then FDA-authorized reduced-risk products. Dual use is not supported. This advice is not in line with current evidence presented at the conference or multiple reports.1,2,3,4,5 Vapes are the most effective means to quit. Dual use lowers overall risks.

    Scott Sherman of New York University stressed that the ultimate goals of tobacco control are to prevent the burden of tobacco-related disease. About 70 percent of people smoke when diagnosed with chronic obstructive pulmonary disease, peripheral vascular disease, schizophrenia, alcohol use disorders and several cancers, to name some major outcomes. The majority are still smoking years after their diagnosis. Sherman believes such patients would benefit from trying vapes. There are few studies in this area. He outlined a small pilot study of patients with chronic diseases comparing vape use to nicotine-replacement therapy (NRT) use that motivates for larger studies. Patients with early-stage chronic diseases who are between 40 years and 55 years of age who quit are likely to yield major health benefits.

    1. Is there evidence of the benefits of nicotine pouches, snus and heated-tobacco products as cessation interventions to complement studies of vapes? And are there studies comparing these products to NRTs and medicated solutions?

    There are few such studies. Jamie Hartmann-Boyce of the University of Massachusetts and the Cochrane Collaboration presented a Cochrane review using indirect methods to compare a range of interventions. Vapes, NRTs and cytosine showed the strongest evidence of cessation effectiveness compared to other medications and interventions. She stressed the need for more high-quality studies. Public, philanthropic and industry funders should invest in such research among populations and countries where smoking and toxic smokeless tobacco rates are extremely high.

    1. Were the benefits of using biomarkers to demonstrate the effects of switching from tobacco products to THR options on proxy health outcomes discussed?

    Zeller mentioned new real-world evidence using biomarkers that suggest benefits of dual use (of vapes and combustibles) in terms of proxy health outcomes. Mike Cummings briefly mentioned the need to use biomarkers of exposure and outcome to accelerate knowledge about THR impact on health outcomes. As an epidemiologist, I have long felt that we need to complement self-reporting and mortality-based studies with use of 21st century biomarkers that allow for more accurate assessment of exposure and earlier determination of outcomes. Tobacco industry scientists currently lead in developing and using biomarkers. Their extensive list of peer-reviewed publications should be cited and used by academics.

    1. There have been important discussions recently in the New England Journal of Medicine (NEJM) and JAMA about the benefits of medical licensing THR products. What are the views of the regulators, industry and academics in going this route and, more broadly, in supporting vapes as an effective way to quit?

    Zeller believes improved medically approved tobacco harm reduction products are part of increasing access for adults to reduced-risk products. Nancy Rigotti of Mass General Hospital stated that a medical pathway is needed despite no medically approved products being available. Her views are based on knowledge that physician practices have widespread impact on their patients and on policies. She is concerned that the U.S. Preventive Services Task Force, the American Cancer Society, the Centers for Disease Control and Prevention, and the American Heart Association are still unclear about the benefits of vapes as being the most cost-effective means of achieving cessation. Their statements are either ambiguous or explicitly oppose vape use for cessation. She restated her NEJM call for clinicians to strongly advise patients who smoke to try vapes.2

    King did not address this, and he deflected issues related to cessation to the FDA’s Center for Drug Evaluation and Research (CDER). The lead FDA tobacco chief should have an integrated approach to ending smoking that involved the CTP and the CDER. That is the spirit of the messages in recent influential journals by leading academics and former FDA heads.3,5 Further, the FDA 2015 CDER guidance on alcohol shows how it accepts abstinence and harm reduction endpoints used for drug approvals. It seems time that the CTP and the CDER could learn how well this is working to end the harm of tobacco use.

    Both Neal Benowitz and Clive Bates of Counterfactual Consulting said we need to address the benefits of nicotine as a range of new products become available. This has implications for future medical licensing and recreational use. We need innovative ways to tease nicotine effects from combustible smoke effects to make progress on the regulatory front and to inform messaging to health professionals and smokers. A recent paper by Jasmine Khouja and her colleagues that used biobank data and multivariable Mendelian Randomization elegantly showed that most harms of smoking are unrelated to nicotine.8 Hopefully, work looking at the benefits of nicotine for Parkinson’s disease will follow. I recommend readers watch this space.

    1. Can THR practices outside of the U.S. inform U.S. policy?

    Like the U.S., adult smoking rates in the U.K. and New Zealand have declined as vaping has increased. Deborah Arnott of Action on Smoking and Health (ASH) U.K. indicated that dual use has followed the path seen years ago when NRTs were introduced and regarded this as a transitional route to eventual cessation. This is an important insight for U.S. policymakers to acknowledge.

    The U.K.-proposed legislation includes a ban on disposables, a new tax on e-liquid (which may reduce illicit trade from China and will maintain a differential tax relative to cigarettes) and measures to reduce the appeal of vaping to children in ways that allow adults to have continued access. Arnott supports vape promotion approaches that have more clinical and fact-based features and other policies that regulate proportionate to risk.

    Ben Youdan of ASH New Zealand showed that for years, New Zealand and Australia had similar rates of decline in adult smoking. Over five years, however, adult rates have diverged, with New Zealand rates falling faster. He believes this is based on differences in vape policies and messaging. New Zealand media and policies support vaping to quit, especially among the Indigenous population. Martin Dockrell of the U.K. Department of Health and Social Care described U.K. government-funded programs to provide vapes to homeless people, people with mental illness and other groups with high smoking rates. The hope is that these initiatives will lower social class inequalities in chronic diseases that are strongly driven by differences in smoking rates.

    Ben Youdan stated that Australia “treats people who vape as criminals or as sick people incapable of self-determination.” The result of this is that 90 percent of vapes on the Australian market are illicit while cigarette access is universal. The opposite is true in New Zealand.

    King mentioned that the FDA is committed to health equity. The FDA should learn from the U.K.’s and New Zealand’s vape policies.Concluding Comments

    The extent of misinformation was a topic that pervaded sessions. Alex Clark of the Consumer Advocates for Smoke Free Alternatives Association gave examples of how the FDA’s youth education campaigns have contributed to negatives views about vapes and nicotine. This could accelerate with the deployment of Chatbots that are explicitly programmed to spread misinformation about vapes and nicotine, the latest WHO one being a notable worrying example.9 Researchers need to rapidly engage computer scientists in building AI-driven ways to address misinformation continuously and at scale before the digital space is dominated by those who oppose harm reduction. This could draw upon the promising results of correcting misbeliefs about nicotine causing cancer and about vapes reported by Andrea Villanti of Rutgers.

    For several years, E-Cig Summits and related standalone vape meetings have led thought leadership about the value of tobacco harm reduction. With the growth of a spectrum of reduced-risk products now available, is it time to consider transitioning such meetings into opportunities to address emerging ways to end smoking and the use of toxic smokeless tobacco products through a wider range of products? That would encourage comparative studies and for a deeper examination of how consumers use products throughout the day. It would also allow for policy discussions that focus more on harnessing a wider community of users and innovative companies to compete to accelerate an end to smoking.

    David Levy of Georgetown University and Bates both made these point very strongly by placing the needs and interests of consumers first and seeing competition between companies and products as beneficial to meeting consumer needs to improve their health.

    For that to succeed, future conferences will need to adopt Mermelstein’s opening words in practice and end boycotts and bans of industry scientists so that all actively developing innovative ways to make progress can debate the best ways forward together.

     

     

     

    A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.

    References

    1. Electronic cigarettes for smoking cessation – Lindson, N – 2024 | Cochrane Library
    2. Electronic Cigarettes for Smoking Cessation — Have We Reached a Tipping Point? | New England Journal of Medicine (nejm.org)
    3. Bolstering FDA Pathways for Reducing Death and Disease from Tobacco | JAMA Health Forum | JAMA Network
    4. E-cigarettes and harm reduction: An evidence review | RCP London
    5. How the FDA Can Improve Public Health — Helping People Stop Smoking | New England Journal of Medicine (nejm.org)
    6. Commercial Tobacco and Nicotine Industry-Funded Research Has No Place in SRNT and Nicotine & Tobacco Research | Nicotine & Tobacco Research | Oxford Academic (oup.com)
    7. https://www.fda.gov/files/drugs/published/Alcoholism—Developing-Drugs-for-Treatment.pdf
    8. Estimating the health impact of nicotine exposure by dissecting the effects of nicotine versus non-nicotine constituents of tobacco smoke: A multivariable Mendelian randomisation study – PubMed (nih.gov)
    9. Philanthro-colonialism: Bloomberg and the WHO — Marc Gunther
  • Mastering the Maze

    Mastering the Maze

    Photo: Istock

    Toxicological considerations to be considered when bringing HTPs to market

    By Malcolm Saxton

    Heated-tobacco products (HTPs) are a type of reduced-risk nicotine device that offers a similar experience to combustible cigarettes but can help reduce exposure to potentially harmful toxicants. With the pressure on manufacturers to develop safer, smoke-free alternatives, Malcolm Saxton, senior consultant for chemistry at Broughton, which operates a dedicated facility to help manufacturers bring HTP products to market, shares insight into the testing and toxicology associated with HTPs.

    In combustible cigarettes, temperatures can reach up to 950 degrees Celsius. As well as liberating the nicotine, this process breaks the tobacco down to produce over 8,000 known chemicals. However, in HTPs, tobacco is not burnt—the maximum temperature is 350 degrees Celsius, providing enough heat to liberate nicotine and aroma without being high enough to result in combustion. Instead, a pyrolytic process known as torrefaction takes place, which is the same process that occurs when roasting coffee beans to release flavor.

    The absence of combustion substantially reduces the number of chemicals released, with harmful and potentially harmful constituents (HPHCs) in HTP aerosols shown to be significantly reduced from cigarette smoke. Data from the Philip Morris International Scientific Update showed a 90 percent to 95 percent reduction in the average levels of HPHCs in the aerosol of IQOS,1 the leading HTP brand, compared with combustible 3R4F reference cigarettes. In addition, there is thought to be little youth appeal.

    Due to their reduced-risk profile and similarity in experience to smoking combustible cigarettes, interest in HTPs is growing, and IQOS now has around 20 million users worldwide.

    Bringing an HTP to market

    Most countries do not have specific regulations for HTPs but regulate them in the same way as either combustible cigarettes or alternative tobacco products. In the EU and U.K., HTPs are regulated by the Tobacco Products Directive and the Tobacco and Related Products Regulations, respectively, which carry stringent requirements for testing, packaging and more.

    In the U.S., HTPs are regulated using the premarket tobacco product application (PMTA) or the modified-risk tobacco product (MRTP) process, with the PMTA being the established route to market. There are very few products that have been submitted and granted a PMTA or an MRTP from the U.S. Food and Drug Administration, which is required to make reduced-risk claims.

    To have the best chance of approval, it can be beneficial to work with a partner that offers a fully integrated service that covers product development, extractables and leachables, testing and characterization, toxicology, stability studies and regulatory consultancy. In addition to freeing up internal capacity, outsourcing testing and toxicological assessments can help streamline the product design and regulatory application process, benefiting from the partner’s previous experience.

    Toxicological Considerations

    HTPs are intended to be a smoking cessation tool, so they must be tested to ensure a reduced toxicological risk compared with conventional combustible products. In addition, the individual toxicological risk profile should be understood to establish that new hazards are not introduced or that current ones have not increased. The first three stages of evaluating an HTP typically include evaluating product design, testing aerosol chemistry and performing a toxicological assessment.

    The product design will vary based on the type of HTP, which can be electrically heated, carbon heated or aerosol heated. Heating mechanisms can comprise a resistive heat-blade system or may use induction heating. Product design is important in achieving an appropriate yield and aerosol cloud without increasing risk, and iterative testing can help ensure optimal design. Working with a partner who understands the intricacies of product design and how it impacts toxicological risk and regulatory approval can ensure manufacturers get it right the first time.

    The composition of the HTP aerosol will depend on the product design, including the materials in the hardware, as well as the ingredients, such as flavors. Desk-based toxicology, including a literature search, can help assess whether listed ingredients and materials are associated with anything that is of high concern.

    Aerosol testing requirements vary according to the purpose of testing and the regulatory framework being followed. At the most basic, the European Union and U.K. require a minimum of tar (nicotine-free dry particulate matter), nicotine and carbon monoxide. Other priority toxicant lists for cigarettes have been developed by a number of organizations, including the FDA, Health Canada and the World Health Organization Study Group on Tobacco Product Regulation. The most widely accepted list of HPHCs to test in the aerosol of HTPs, both for regulatory submission and for producing evidence of potential harm reduction, is the PMI-58, a list developed specifically by PMI to focus on analytes most relevant to IQOS and, more generally, HTPs.

    Analytical chemists will design a testing protocol that includes all relevant parameters for regulatory approval. For example, PMTAs typically require more data than other markets, and the testing package may need to be more rigorous as a result.

    The aerosol HPHC profile forms the basis of risk reduction characterization for various human diseases, such as cancer and respiratory disease, and can be contextualized against a combustible cigarette to establish the level of harm reduction. Exposure assessments can be generated from product-specific data, by looking at how the product is used in the market, or by using data from the literature.

    Compiling the relevant analytical testing and toxicological information for an HTP can be a challenging task. Working with an expert partner can make the process easier, reducing strain on your resources and complementing the skills of your in-house team.

    Malcolm Saxton is senior consultant at Broughton.

    Citation

    1Afolalu EF, Langer P, Fischer K, Roulet S, Magnani P. Prevalence and patterns of tobacco and/or nicotine product use in Japan (2017) after the launch of a heated-tobacco product (IQOS): a cross-sectional study. F1000Res. 2021 Jun 25;10:504. doi: 10.12688/f1000research.52407.2. PMID: 35528952; PMCID: PMC9069173.

  • The Great Scramble

    The Great Scramble

    Buyers have been paying record prices to secure their shares of Brazil’s smaller-than-expected tobacco crop.

    By Taco Tuinstra

    On March 21, a ferocious storm tore through Brazil’s southernmost state, Rio Grande do Sul. The wind flattened numerous outdoor pavilions at the Expoagro exhibition in Rio Pardo, forcing its organizer, tobacco growers’ association Afubra, to close the event for a day and repair the damaged stands. In a more welcome development, the tempest brought relief from the heat wave that had been making life tough for those toiling in the region’s numerous fields and leaf processing facilities.

    But while Expoagro reopened to large crowds and the temperature dropped to more tolerable levels in the wake of the storm, other pressures on the industry continued unabated throughout the selling season. Alliance One Brazil Leaf Production Director Samuel Streck, who has worked in the business for two decades, described this year’s crop as the most challenging in his career, and his view was echoed by many other industry veterans throughout the Brazilian tobacco sector during Tobacco Reporter’s visit to the region in March.

    A significantly smaller-than-expected crop, acute labor shortages and record-high prices, along with heightened scrutiny of tobacco farming in the wake of the 10th Conference of the Parties (COP10) to the Framework Convention on Tobacco Control (FCTC), have kept the Brazilian leaf sector on its toes this year.

    Having been forced to temporarily cease operations due to storm, Afubra’s Expoagro reopened to large crowds. (Photos and videos: Taco Tuinstra)

    Low Yields, High Quality

    It wasn’t supposed to be that way. When planting for the 2023-2024 crop started in May last year, the industry predicted a volume increase of about 10 percent over the previous season, when the country’s growers harvested some 605.7 million kg of all tobacco types, according to Afubra.

    At first, the weather conditions appeared to validate that assessment, but then El Nino hit. The recurring weather phenomenon, which typically boosts precipitation in South America, had been anticipated but turned out much more intense than normal. From mid-July until the end of November, El Nino dumped unprecedented volumes of rain on southern Brazil, leading to flooding in lower lying areas. Accompanied by many sunless days, the wet conditions depressed yields not only in Rio Grande do Sul but also in Santa Catarina and Parana, the three southern states that together account for 98 percent of Brazil’s tobacco production. (The remaining volumes grow primarily in Bahia and are used to make cigars.)

    Crop

    Hectares planted

    Production (million kg)

    Leaf export earnings

    2023

    261,740

    605.7

    $2.66 billion

    2022

    246,590

    560.18

    $2.24 billion

    2021

    273,356

    628.49

    $1.31 billion

    2020

    290,397

    633.02

    $1.47 billion

    2019

    297,310

    664.36

    $1.99 billion

    2018

    297,460

    685.98

    $1.85 billion

    2017

    298,530

    705.93

    $1.96 billion

    2016

    271,070

    525.22

    $2.01 billion

    2015

    308,260

    697.65

    $2.06 billion

    2014

    323,700

    731.39

    $2.35 billion

    2013

    313,575

    712.75

    $3.09 billion

    Sources: Afubra/SindiTabaco

    Instead of a 10 percent boost, the industry was now looking at a 20 percent drop in volume from 2023. By late March, Afubra was expecting about 470 million kg of flue-cured Virginia (FCV) and roughly 40 million kg of burley.

    But even as the excessive rainfall slashed yields, it worked wonders for leaf quality. Brazil’s 2024 crop boasts good color, uniformity and smoking properties, according to buyers. High oil levels give this year’s leaf a better visual appearance than in 2023. What in the previous year was predominantly light orange to orange is this year orange to deep orange, observed Kohltrade in a recent crop report. “It’s perfect, in my opinion,” said Kohltrade Account Executive Simone Velasques.

    And it’s not just looks that set this crop apart; the tobacco smokes exceptionally well, according to Eduardo Renner, president and CEO of CTA-Continental. “That’s also the feedback we are getting from customers,” he said. On the flipside, the rain also suppressed nicotine levels in this year’s tobacco. According to Jay Barker of YTL, the excess rainfall has resulted in below-average chemistries across the board. Because the wet season followed three consecutive dry ones, the gap in nicotine levels between the current crop and the previous one is greater than normal, which may challenge some customers in creating their desired blends.

    Andie Spies of Hail and Cotton (left), and Eduardo Renner at CTA’s Venancio Aires headquarters

    Chasing Tobacco

    The combination of low volume and high quality, along with a persisting post-Covid-19 tobacco shortage at the global level, sparked a scramble among tobacco companies in Brazil to secure their requirements. As a producer of sought-after flavor tobacco, Brazil has only two true competitors on the world market—Zimbabwe and the United States. Zimbabwe, where El Nino brought drought instead of rain, is also looking at a smaller crop this year (albeit from a record volume in 2023), according to that country’s Tobacco Industry and Marketing Board. United States FCV production, meanwhile, has been stable for three years at just below 140 million kg, TMA figures suggest.

    The shortage has been aggravated by the fact that last year some customers didn’t buy everything they needed because they were expecting cheaper tobacco this year. Coming out of the pandemic, many customers adopted a wait-and-see approach, carefully managing their stocks to avoid buying at high prices. Now, with inventories running out, those who didn’t buy last year had to buy this year.

    According to local traders, Brazil’s leading tobacco buyers alone needed more leaf than the entire volume that was expected to come to the country’s market in 2024. Throughout the season, the vertically integrated companies—BAT, Philip Morris International, Japan Tobacco International and China Tobacco—were buying far above list prices, paying top rates for all grades and leaving independent traders with no choice but to follow their lead.

    Simone Velasquez (center)

    The result has been an unprecedented escalation of leaf prices and an acceleration of deliveries. In mid-March, farmers were receiving up to $5.50 per kilogram of green tobacco, according to Kohltrade. For processed leaf, customers were paying up to $9.50 for grades that cost perhaps $5 only three years ago. “Prices are up, up, up,” observed Afubra President Marcilio Drescher.

    Daison A. Kohl, who grows 2.7 hectares of tobacco in Vale do Sol, said he has never in his time on the farm witnessed such high prices and such fierce competition. Unlike many of his neighbors, Kohl contracts only with one buyer. Yet throughout the buying season, his phone rang nearly daily with representatives from other companies asking him to sell his leaf to them instead.

    Kohl had to disappoint them all. “It doesn’t matter how much they offer; the tobacco is just not there,” he said. Merchants have been telling their customers a similar story. Whereas in a more typical year, they may exaggerate and say, “there is no tobacco” as a price negotiation tactic, this season it is simply a statement of fact.

    The scramble for tobacco has also greatly accelerated the purchasing process, leaving some receiving stations struggling to keep up with the influx of leaf. At the time of Tobacco Reporter’s visit, leaf merchants were expecting farmers to run out of tobacco by the end of April—two months earlier than in 2023. “Customers who come late to Brazil may not find what they are looking for,” warned Velasques.

    Leaf tobacco exports have earned Brazil an average of more than $2 billion annually over the past decade.

    Labor Scarcity

    For the growers, the 2024 marketing season has been a mixed bag. Even with record per-kilo prices, the additional income may not make up for the reduced weight that they are bringing to market, according to Afubra. Kohl, who suffered a 26 percent drop in yield from last year, said that as long as the companies continue paying above list prices, his operation will remain profitable this year. “But if they resort to paying list prices, it will be a problem,” he said.

    While the cost of inputs such as fertilizer have been coming down from their Covid-19-induced and Ukraine war-induced spikes, a long-running shortage of labor has worsened in recent years, impacting both farmers and tobacco factories. But whereas tobacco buyers can mechanize operations such as rack loading and stripping, farmers have fewer options. With an average property size of 10.5 ha and an average area devoted to tobacco of only 3.29 ha, according to Afubra, the typical tobacco farm in southern Brazil is simply too small to justify the investment in equipment. What’s more, many of the tobacco growing activities lend themselves poorly to mechanization. There are no machines for delicate tasks such as sucker control and topping, for example.

    Meanwhile, aware of their growing scarcity, farmhands have started driving harder bargains. In Vale do Sol, they have organized themselves in collectives, forcing farmers to negotiate with groups instead of individuals, according to Kohl. To guarantee a group’s labor throughout the growing season, he must pay a premium on top of the already inflated salaries.

    Determined to control their cost of production, Kohl and his wife, Solange, carry out many of the tobacco farm activities, including land preparation, themselves. They hire labor for the first, second and third reapings, when the leaves are still thin and easily damaged and speed is of the essence. “If we don’t harvest quickly during that time, we will lose quality,” said Kohl. From the fourth reaping onward, the tobacco is thicker and less fragile, allowing the Kohls to harvest by themselves and save money on labor.

    Their workload has been lightened a bit by a recent switch from bundles to loose leaf. In the past, growers in Brazil would classify their tobacco according to quality and color and then tie the leaf into bundles—a laborious process that could take up to two months. As demand increased, some buyers told farmers to skip this step and deliver the tobacco in loose form instead. The practice spread rapidly and has now been adopted by all merchants. After drying the tobacco, the farmer can take his tobacco directly from the barn to the bale and put it on a truck, not only saving time and labor but also greatly accelerating the speed of delivery.

    While some buyers at first worried about how the new practice would impact processing, those concerns turned out to be manageable. “Loose leaf is not necessarily the best way to receive tobacco in terms of the feeding table and the presentation of each grade, but we quickly realized it’s possible,” said Streck. According to Renner, the process remains the same. “You can still tip and thresh the leaf because it is straight laid.”

    Farmer Succession

    The Kohls are happy with the change to loose leaf, as it allows them to focus on other farm activities. As they work their fields, they are occasionally joined by their oldest son of 34, who has no interest in farming but feels a duty to help on some evenings after he’s done with his day job. Their middle son (25) by contrast “does not even want to see the tobacco,” according to Kohl, while their youngest (8) is too little to work on the farm. (Brazilian law requires tobacco workers to be at least 18 years of age, and following intense industry-led awareness campaigns, the country’s sector today is considered a role model in in eradicating child labor.)

    The Kohls’ family dynamics hint at another challenge facing Brazil’s tobacco business: farmer succession. Like their counterparts around the world, many rural youngsters in Brazil aspire to work in the city, which has led to an exodus of skills and talent from the countryside. “Keiner will die Finger mehr dreckig machen”—nobody wants to soil their fingers anymore—observes Solange, who, like many people in southern Brazil, is more conversant in German than English as a foreign language.

    A 2023 survey conducted by the Federal University of Rio Grande do Sul at the request of the Interstate Tobacco Industry Union (SindiTabaco), revealed that with an average monthly income of BRL11,755.30 ($2,234.75), tobacco farming families in southern Brazil are relatively well off, earning considerably more than the average Brazilian family. The Kohls, for example, live in a spacious, well-built home equipped with plenty of conveniences and some luxuries, including a small swimming pool. Within agriculture, too, the golden leaf continues to generate the best returns, according to industry sources, contradicting the narrative pushed by certain nongovernmental organizations that tobacco leaves growers in poverty.

    Nadia Fengler Solf

    But while the earnings from tobacco farming exceed those of other crops, the golden leaf is also more demanding. Unlike some other agricultural products, the farmer cannot just plant it and watch it grow. A good tobacco farmer, notes Kohl, must constantly keep an eye on the plants. “The weather can change things very quickly,” he said. “If rain comes, it puts the leaves on the plants and—boom—they become big overnight. And if you don’t go in and take the flowers off and the wind comes, it can topple the plants.”

    With no one lined up to take over the farm, the Kohls’ tobacco volumes will disappear from Afubra’s production statistics after they retire. “We have another 10 years, and then we’ll be gone,” said Kohl. Unfortunately for tobacco buyers, their situation is not exceptional. According to the University of Rio Grande do Sul study, 27 percent of the growers in southern Brazil have no succession plan.

    Acutely aware of the demographic drain, the tobacco industry has been looking for ways to keep young adults in the countryside. Originally set up by SindiTabaco and its associate companies to help combat child labor in rural Brazil, the Growing Up Right Institute (also see “Alternatives for Adolescents,” Tobacco Reporter, April 2021) now also runs programs educating young people on the verge of adulthood about the opportunities on the farm. By teaching youngsters how to optimize farm operations through technology and professional management, the institute hopes to convince them that they can live good lives in the countryside.

    According to program manager Nadia Fengler Solf, the initiative has had some success. Upon graduation from the program, she said, many students have a completely new perspective on the possibilities in the countryside. Some decide to develop their family properties, investing in new technologies and diversifying their business, while others elect to pursue degrees in agriculture.

    Solagne Kohl (left) and Daison A. Kohl grow 2.7 hectares of tobacco near their home in Vale do Sol. According to a study commissioned by SindiTabaco, tobacco growers are considerably better off financially than the average Brazilian.

    COP Fallout

    But even as the industry is working to keep farmers interested in tobacco, others are campaigning to steer them away. At COP10 in Panama, delegates vowed to step up action on Articles 17 and 18 of the treaty, which call for the promotion of economic alternatives for tobacco workers and the protection of the environment and health of tobacco workers, respectively. According to a speaker at this year’s Americas Regional meeting of International Tobacco Growers’ Association in Santa Cruz do Sol, the Panama COP could be the first to have a direct impact on the farm.

    SindiTabaco President Iro Schunke dismisses the talk about alternative crops in Southern Brazil as unrealistic. “If we had another crop that generates the same income, farmers would have switched long ago on their own accord,” he said. Part of the problem, he explains, is the small average size of farm properties. “To replace the money from one hectare of tobacco, you need to grow 7 hectares of soybeans or 10 hectares of maize.” The pressure for diversification, meanwhile, is unnecessary, according to Schunke. “Tobacco farmers in Brazil are diversified already,” he said. While generating between 60 percent and 70 percent of the average grower’s income, tobacco claims only 20 percent of their property, according to SindiTabaco. Part of the money earned from tobacco is used to plant supplemental crops.

    “If we had another crop that generates the same Income, farmers would have swItched long ago on theIr own accord.”

    Iro Schunke, president, SindiTabaco

    Brazil was one of the most vocal proponents of stricter tobacco controls at COP10, a position that Schunke considers odd, given that leaf tobacco accounts for 11 percent of Rio Grande do Sul’s exports, employs more than half a million farmworkers and earned Brazil an average of more than $2 billion annually through exports over the past 10 years (see chart). Schunke attributes the government’s tough stand to pressure from nongovernmental organizations and the exclusion of tobacco stakeholders from health policy debates along with an ideological aversion to capitalism.

    Some suspect the government’s position is driven partially by ignorance, with bureaucrats in faraway Brasilia unaware of how much rural communities in the south of the country depend on the golden leaf. “Although hostility against tobacco from agencies all over the globe is the new status quo and the path of least resistance, the fact is, the economic impact to the communities where tobacco is prevalent is very significant,” says Barker.

    Santa Cruz do Sul Mayor Helena Hermany believes that Brazil’s national health surveillance agency, Anvisa, grossly underestimates and misrepresents the industry’s economic significance. More than 50 percent of the city’s revenue comes from tobacco, she told participants in the ITGA Americas meeting. “If tobacco does well, we all do well,” she said.

    If tobacco does well, we all do well.

    Helena Hermany, mayor of Santa Cruz do Sul, Rio Grande do Sul, Brazil

    It terms of sustainability, the tobacco industry is also performing much better than it is given credit for. “We are doing quite well in terms of soil protection, reforestation and the prevention of child labor,” said Drescher. For example, Brazilian farmers are self-sufficient in curing energy, sourcing wood from dedicated plantations rather than indigenous trees.

    According to Renner, sustainability is already an integrated part of everything the tobacco industry does. “Whatever we supply must cover these three capital letters,” he said, referring to the environmental, social and governance considerations that the abbreviation stands for. “What we do for our people, our clients, in our operations and in the communities we work with … our suppliers need to do for us.”

    As they prepare for next season in the wake of this year’s short crop, industry stakeholders are keen to avoid a wild swing in the other direction. Emboldened by the high prices and keen to recover their lost volumes, many growers are likely to increase their plantings for the 2024–2025 season. Kohl, by contrast, is cautious, worrying that a surplus next year will depress prices, and he plans to plant the same hectarage as last year.

    Others predict that the era of cheap Brazilian tobacco is over, not only due to demand-and-supply factors but also as a result of the considerable investments the local industry has made in sustainability. These investments should serve Brazil well as it moves into the new era, giving the country a competitive advantage against origins with less robust practices. At the same time, leaf merchants insist that the effort should be supported throughout the supply chain. ESG initiatives, after all, come at a cost that should be reflected in leaf prices. “It must be sustainable for all parties,” insisted Renner.

    Taco Tuinstra is Tobacco Reporter’s editorial director. Based in Raleigh, North Carolina, USA, he coordinates the work of staff writers and contributors. On his watch, Tobacco Reporter has won several awards for editorial excellence. Since joining the magazine in 1997, Taco has visited more than 75 countries to meet industry representatives in their markets and to report tobacco news firsthand.