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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.

June 1, 2024
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.

June 1, 2024
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.

June 1, 2024
Retailers Fined for Selling Elf Bar

Photo: Gevorg Simonyan

The U.S. Food and Drug Administration is seeking civil money penalties (CMPs) from nine brick-and-mortar retailers and one online retailer for selling Elf Bar products.
The FDA previously issued warning letters to these retailers for selling unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.
The agency is now seeking a CMP of $20,678 from each retailer.
“The $20,678 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including February and April of this year,” the FDA stated.
The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.

May 31, 2024
Tobacco-Paid Science Still in Medical Journals

Photo: Tada Images

Tobacco-funded research is still appearing in highly cited medical journals despite attempts by some publications to cut ties, according to an investigation by The Investigative Desk and the BMJ.
The researchers checked the tobacco policies of 10 leading general medical journals and 10 journals in three therapeutic areas especially affected by smoking.
Of those 40 journals, only eight (20 percent) had policies prohibiting studies wholly or partly funded by the tobacco industry. Of the 10 journals in the field of respiratory medicine, six had a tobacco policy, but in oncology, only one did, and in cardiology, none had one. Among the 10 general medicine journals, only the BMJ had such a policy.
But even among the journals that have a policy, the editors struggle to identify subsidiaries or organizations associated with the tobacco companies, according to the researchers. Last year, one of BMJ Group’s titles, BMJ Open, retracted a paper after it became clear that the listed funder receives sponsorship from the Foundation for a Smoke-Free World, a group supported and fully funded by tobacco company Philip Morris International.
(The Foundation for a Smoke-Free World ended its PMI funding agreement in October 2023. More recently, the group rebranded as Global Action to End Smoking and adopted a policy to not seek or accept funding from any industry that manufactures tobacco products or nonmedicinal nicotine products.)
The investigation cites the case of Dutch researcher Wytse van den Bosch, who had a research grant from pharmaceutical company Vectura when the company was bought by PMI in 2021. Nevertheless, his study was still published in the European Respiratory Journal, which said the research was not in breach of its policy as the grant from Vectura was initiated in 2018.
Ruth Malone, professor of social behavioral sciences at the University of California and former editor-in-chief of BMJ Group’s Tobacco Control journal, said that institutions, professionals and scientific journals should refuse involvement with the tobacco industry.
“Anyone who understands the history, extent and nature of the epidemic and the tobacco industry’s strategic efforts to divide the public health community knows that industry money should be rejected,” she said in a statement.
Nicholas Hopkinson, professor of respiratory medicine at Imperial College London, notes that given the industry’s “long-standing history of dishonesty,” it is “very straightforward” that researchers should cut ties to companies after they are acquired by Big Tobacco, as otherwise they would be “working with the tobacco industry” and contribute to their profits.
On May 30, BMJ updated its 2013 tobacco policy. In addition to excluding research funded by the tobacco industry, BMJ journals will also exclude work where authors have personal financial ties to the tobacco industry.
“The updated policy is one action BMJ journals can take to reduce the publication of content which downplays the harms of smoking or hinders the creation of a world free from the harms of smoking,” the publisher wrote in a statement.
“Creating a stronger firewall between the tobacco industry and BMJ content will provide space for editors to curate and publish content that is more independent and trusted and contributes to a healthier world.”

May 31, 2024
John Miller Resigns from 22nd Century

John Miller (Photo: Swisher)

John Miller has resigned as 22nd Century Group’s president of tobacco, effective Aug. 2, 2024.
“I want to thank John for the pivotal role he played in the launch of VLN, leveraging his decades of industry experience to help us achieve national-scale distribution and establishing a retail presence in more than 5,000 stores across 26 states,” said Larry Firestone, chairman and CEO, in a statement.
“He also played a key role in expanding our CMO business, including our exciting Pinnacle launch as a store brand for one of the top convenience store chains in the country. We are now well positioned to continue building on this incredible footprint as we work to achieve our company objectives.”

May 31, 2024
Flavor Bans Threaten Smoke-Free Ambitions

Image: Arcady

The Tholos Foundation has launched three white papers exposing the risks of banning flavors in vaping products at an event in Brussels hosted by Parliament Magazine and featuring contributions from Swedish MEP Johan Nissinen. The reports cover the impact of flavor bans in the real world and best practices to educate adult smokers and restrict underage usage and analyzes the public response to the European Commission’s 2023 public consultation.
Surveys commissioned by the Tholos Foundation and conducted by Ipsos in multiple countries have shown that a significant majority of vapers use flavors other than tobacco to help reduce and quit smoking. Notably, 83 percent of vapers in Germany stated that flavors are crucial in their decision to vape, with similar high percentages reported in Belgium, the Netherlands and Sweden. The research also showed that, in countries where flavors were banned, many vapers went back to smoking or for black market alternatives and references numerous scientific studies confirming that flavors are essential for the effectiveness of vaping products in smoking cessation.
With European elections due to take place shortly, the Tholos Foundation believes it is imperative policymakers take heed of voters’ concerns and reject extensive restrictions on smoking alternatives.
“The evidence is clear: Flavors in vaping products are critical to helping smokers quit,” said co-author Tim Andrews in a statement. “Banning flavors will create a black market and drive people back to smoking. Our reports offer an evidence-based approach that combines rigorous law enforcement, education and technological innovations to reduce underage experimentation while preserving the benefits for adult smokers.
“With the European elections approaching, it is crucial for policymakers to understand the importance of harm reduction strategies. Our findings support a balanced approach that protects public health and helps smokers transition to safer alternatives.”
The Tholos Foundation is an international nongovernmental organization, affiliated with Americans for Tax Reform, dedicated to advocating for consumers.

May 31, 2024
Yields Up in Bangladesh

Photo: Tobacco Reporter archive

Tobacco yields per hectare in Bangladesh have increased more than 20 percent over the past five years thanks to improved agricultural practices, reports The Daily Star.
In 2018–2019, growers harvested an average of 2.04 tons per hectare. By the 2022–2023 season, the figure has increased to 2.46 tons per hectare, according to the Department of Agricultural Extension (DAE). In 2009–2010, per-hectare production was only 1.41 tons, according to World Bank data, which means per-hectare tobacco production has gone up by about 73 percent in 14 years.
The gain has been achieved by the introduction of high-yielding varieties and the application of chemical fertilizers and pesticides, according to experts.
Tobacco is a major cash crop in Bangladesh, the world’s 12th largest tobacco grower as of 2020, according to the University of Bath. In 2022–2023, the country grew 65,227 tons of tobacco on 26,475 hectares, representing roughly 1 percent of the total arable land in the country, DAE data show.
The domestic tobacco industry generated more than BDT325.02 billion ($2.77 billion) in revenue from cigarette sales in the most recent fiscal year, an 8 percent increase from the previous year, according to NBR data. Bangladesh also exports a significant volume of unmanufactured tobacco. In 2022, Euromonitor International estimated the Bangladeshi tobacco market to be worth nearly BDT420 billion.
According to a study by the Policy Research Institute of Bangladesh, tobacco farmers earn around 30 percent more than nontobacco farmers. The return from tobacco is about 18.6 percent higher than that from rice and about 33 percent higher than that from jute.
Critics blame tobacco production for its impact on soil, water and air. According to the World Health Organization, each cigarette emits nearly 14 grams of CO2 over its life cycle. Producing 300 cigarettes requires about one tree for curing leaf and making cigarette papers. In the case of Bangladesh, tobacco farming accounts for over 30 percent of annual deforestation, according to a study by PATH Canada.

May 31, 2024
WVA Raises Alarm About Misperceptions

Photo: WVA

The World Vapers’ Alliance (WVA) marked World Vape Day with a protest in front of the World Health Organization’s in Geneva today. Participants in the event urged the global health body to listen to consumers and acknowledge the scientific evidence supporting vaping, nicotine pouches and similar products as valid harm reduction tools.
The consumper group says it is concerned about the rampant “misperception epidemic” surrounding tobacco harm reduction. Recent research by Ipsos for the think tank We Are Innovation shows that 74 percent of smokers worldwide wrongly believe that vaping is as harmful or more harmful than smoking. This misconception, fueled by misinformation, is preventing millions from switching to a scientifically proven less harmful alternative, according to the WVA.
“The WHO [World Health Organization] has turned World No Tobacco Day into a propaganda day,” said WVA Director Michael Landl in a statement. “Sweden is about to become smoke-free thanks to alternative nicotine products.
“The WHO needs to stop fighting alternative nicotine products and start backing them as keys to a smoke-free future. The WHO’s false claims are fueling a deadly misperception epidemic. Smokers deserve the truth: Vaping is significantly less harmful than smoking. Accurate knowledge could save millions of lives.”

May 30, 2024
UKVIA Warns Against Vape Taxes

Photo: VPZ

The U.K. Vaping Industry Association (UKVIA) has warned that the Conservative Party’s proposal to tax vapes based on nicotine strength, predicted to increase the cost of some products upward of 300 percent, threatens to undo the work that the category has already done in saving millions of smokers’ lives.
In its submission to the government’s vaping duty consultation, the association argues that by making higher strength vaping more expensive, the proposed tax regime will place an unfair financial burden on nicotine-dependent smokers who are trying to quit. The UKVIA points to the fact that smokers are already significantly overestimating the risks of vaping compared to smoking and that a measure that discourages the use of sufficient nicotine to facilitate a quit attempt is likely to have the effect of decreasing the rate of successful quit attempts.
The association also argues in its submission that as smokers are disproportionally from lower socioeconomic backgrounds, the effect of introducing an excise duty for nicotine-containing vapes, the most appealing form of e-cigarette for smokers, will be dramatic and potentially fatal.
This conclusion is supported by HM Revenue and Customs (HMRC) Research Report Number 740, Understanding the Vaping Market, which found that less affluent adults were “more likely than average” to report being current vapers and revealed that 32 percent of current vapers are motivated to use these products over cigarettes due to cost savings. The same HMRC report also highlighted that the doubling of the prices of vaping could result in 62 percent of current users reducing how much they vape.
The UKVIA is calling for the proposed taxation of vapes to be based on e-liquid quantity and not based on nicotine strength. It believes a specific sales tax on all vaping products and nicotine levels at the rate of £1 ($1.25) per 10 mL would be far more effective in achieving the duty’s stated objectives.
Smokers who smoke more or are more nicotine reliant need higher concentrations of nicotine, at least initially, according to the UKVIA. The association feels they should not be deterred from quitting by having to pay an extra premium to buy the higher concentration nicotine e-liquids that they need.

While a tax on vapes may be inevitable, it does need to be effective and not counterproductive.

John Dunne, director general, UKVIA

“While a tax on vapes may be inevitable, it does need to be effective and not counterproductive,” said UKVIA Director General John Dunne in a statement. “In recent years, millions of smokers have managed to quit through using vaping products, and discouraging others from making the switch would have disastrous, and in many cases fatal, consequences.
“The industry therefore urges the government not to unfairly discriminate against nicotine-containing vapes, which are the most popular devices for a reason. It would be far more valuable for the government to instigate a vape licensing scheme, for which we have long been calling; such a scheme would deter rogue retailers, protect our children and help a heavily under-funded Trading Standards to police retailers by raising £50 million a year from the industry.”

May 30, 2024