Category: Sudhanshu Patwardhan

Bhutan’s Tryst with Health Imperialism

The author standing with a local in front of a pharmacy stocking NRT gums adjacent to a grocery shop officially selling tobacco. (Photo courtesy of Sudhanshu Patwardhan)
Without offering locally relevant cessation tools, prohibition is doomed to fail.
By Sudhanshu Patwardhan
Bhutan, a country that measures its riches in terms of “gross national happiness,” may have become an unsuspecting victim of a new form of imperialism: health imperialism. A blind copy-paste of Western tobacco control policies, worsened by local gold-plating, may have landed Bhutan in a mess. A visit to the landlocked nation gave the author a unique insight into how prohibition of tobacco without offering locally relevant and innovative tobacco cessation tools threaten this Shangri-la.
The Forbidden Kingdom
A series of district-wide tobacco control measures in Bhutan from the 1980s culminated in the declaration of a nationwide ban on the sale of tobacco products in 2004 through a resolution of the National Assembly. Overnight, Bhutan became a poster child of global tobacco control, an emerging David against the Goliath of transnational tobacco companies. Nanny statists got a lifeline, and the “p” word—prohibition—was resurrected after successive failures of over 150 years in alcohol and drug prohibition movements. The Tobacco Control Act of 2010 further enshrined into law restricted access, availability and appeal of tobacco products and gave sweeping powers for arresting those selling or even possessing tax-unpaid tobacco for personal consumption. Bhutan was all set to become a tobacco-free society. A happy nation was also going to become healthier. In theory.
Market Forces Take Over
The roller-coaster ride between 2010 and 2019 is captured in the World Health Organization’s regional office’s 2019 publication The Big Ban: Bhutan’s journey toward a tobacco-free society. A big achievement in this period was visible reduction in public place smoking. Otherwise, the optimistic title belies the details of the failed ban confessed in the publication. It is a classic tale of good intentions scuppered by poor execution. A highlight of the data reported there is the difficulty in enforcing the ban, evidenced by availability of tobacco products below the counter in most shops in Bhutan. Tobacco use among 13-year-olds to 15-year-olds went up from 24 percent in 2006 to 30 percent in 2013 based on the Global Youth Tobacco Survey findings. The severe penalties required by the initial law resulted in more than 80 people being imprisoned between 2010 and 2013. There was growing discontent about the disproportionality of the penalties among the people of a nation gradually moving from a benevolent absolute monarchy to a democratic constitutional monarchy. Public furor and rethinking among the lawmakers resulted in amendments and milder punishments, and the law’s “claws (were) trimmed,” states the WHO report. Between 2010 and 2014, permissible quantity for personal possession was steadily increased for both smoked and smokeless tobacco products. The ban and its enforcement were proving ineffective and untenable. And then Covid-19 happened.
Reversal of a Failed Ban
The government was obviously losing revenue due to the flourishing black market of smoked and smokeless tobacco products smuggled from India and elsewhere. The fear of tobacco smugglers bringing in the Covid-19 virus was enough excuse to act decisively. In July 2021, the government amended the 2010 Act, thus lifting a decade long ban on local tobacco sales.
The pragmatism of the politicians who reversed the ban presents a sharp contrast to the previous prohibitionist policy. Today, sales and consumption continue, and based on the most recent (2019) WHO STEPwise approach to surveillance (STEPS) data, 24 percent of those between ages 15 and 60 currently use tobacco products. Sadly, the ban did not make Bhutan a tobacco-free society. Anecdotally, e-cigarettes are also available now in some grocery stores in the capital, Thimphu, and attracting use among smokers and never-smokers. These are not regulated nor used as smoking cessation tools, presenting another area of concern for public health. A ban may not be the answer for these products either. Regulation that balances current smokers’ needs for safer alternatives versus prevention of uptake by the youth and nonsmokers will be key.
Peering Through an ‘Addiction’ Lens
I first read about the ban’s overall failure in the 2019 WHO report and then heard about the reversal of the ban during the global Covid-19 pandemic. How did Bhutan land in this situation? There is, of course, economics at play: demand, supply and something to do with a genie being out of the bottle. When I put my doctor’s hat on, a key explanation stares at me: lack of quitting support for the existing 120,000 tobacco users. Reams of self-congratulatory publications and numerous WHO awards to Bhutan since the 1990s have focused on success in awareness-building and restricting access and use. The famous case of the Buddhist monk who was jailed for three years in 2011 for the possession of $2.54 worth of tax-unpaid tobacco misses the point that he was very likely addicted to tobacco and may have needed more than punishment to quit. In the absence of availability of tobacco products, it should have been a human right for him to have access to safer nicotine to manage nicotine withdrawals and achieve craving relief. This assessment should not be used to vilify tobacco users. Instead, it should be a reminder to those in tobacco control that preaching to nicotine-dependent users without offering alternatives is not enough and also unethical. A key demand-side reduction measure, to use Framework Convention on Tobacco Control (FCTC) vocabulary, is that of providing tobacco dependence treatment and services. This is covered under FCTC Article 14 but rarely implemented in low-income and middle-income countries (LMICs), Bhutan included. I saw firsthand recently the country’s struggles with rising tobacco use coupled with a lack of cessation products and services.
Tobacco Cessation: The Poor, High-Maintenance Cousin
In Bhutan, like in most LMICs, overall tobacco control is run by public health experts, and tobacco cessation specifically (and separately) falls under the remit of psychiatrists. Neither groups are excited by tobacco cessation for a variety of reasons. Public health professionals often have little or no experience in treating individual patients and have increasingly been sold a unidimensional narrative that the tobacco epidemic is singularly driven by the commercial vested interests of tobacco companies (the “vector”). For them, the tobacco user is a victim of the tobacco industry, should be labeled an addict and then preached at to quit. Psychiatrists, on the other hand, are generally geared toward treating established mental health conditions and severe mental illnesses and even within the “de-addiction” field prioritize substance abuse treatment and alcohol de-addiction over tobacco cessation. Tobacco cessation with nicotine-replacement therapy and other pharmacological interventions are costly and need a level of training and qualification to prescribe—and are therefore cost-prohibitive to be offered at scale. They are also not without their failures, give around 20 percent quit rates at one year in controlled clinical studies and much less success in real-world settings. The success of quitting cold turkey is overrated and often drives policymakers’ wrong beliefs and attitudes about the ease of quitting. Public health tobacco control awareness campaigns and advocacy, on the other hand, are highly visible, scalable, inherently worthy endeavors, and most do not require impact assessment as proof of success. The FCTC’s Article 14 thus remains a neglected tool for reducing harms from tobacco globally and receives little or no funding from international donors and national governments nor any interest from pharmaceutical companies or tobacco companies to innovate in.
Safer Nicotine Not Widely Available in Bhutan
Nicotine illiteracy among healthcare professionals and lack of availability of safer nicotine alternatives can translate into poor quitting among tobacco user patients. From my field visits to pharmacies and discussions with frontline healthcare professionals in Bhutan, I noted that 2 mg and 4 mg nicotine gums have only recently become available in some pharmacies in Thimphu, but patches are not stocked. Patients come and buy these over the counter, but there is little record of how long they take it for, their quit and relapse rates and whether their doctors support them in their quit journeys. Varenicline or bupropion are not available for cessation. When called, the “national quitline,” contrary to the claim of the 2019 and 2024 WHO publications, do not deal with tobacco cessation support. Most of the healthcare professionals in Bhutan receive their undergraduate and graduate training in India, Sri Lanka and other nearby Asian countries. Similar to the rest of the world, doctors in Bhutan are not confident about prescribing nicotine-replacement therapy and may harbor misperceptions about nicotine itself. They have not received any tobacco cessation-related training in the past five years, and nicotine-replacement therapy is not available for free or at subsidized prices anymore, unlike other medications in Bhutan.
Navel-Gazing Time for All?
The backpedaling by Bhutan on the tobacco ban has not been reported or analyzed widely enough. Bhutan’s failure to rein in tobacco sales and increased use, despite a ban, should be a wake-up call for all parties involved. What was touted as a role model for other countries for eliminating harms from tobacco has instead become a cautionary tale for poor policymaking done to pander to international funders and organizations. The undue influence of a select few Western nations in national health policymaking for LMICs is also a matter of concern as the global geopolitical order rapidly morphs. Projects such as FCTC 2030, funded by the U.K., Norway and Australia, continue to churn out reports such as the Investment Case for Tobacco Control in Bhutan (WHO/UNDP, February 2024), ignoring lessons from the ban, mostly unaware of capacity issues on the ground and not addressing the need of current tobacco users for safer nicotine alternatives. Emergent strong economies such as China and India will no longer tolerate meddling by past colonial powers and imperialist nations in their health policies, but neither should other LMICs.
Toward Gross National Health
For a nation of around 750,000 people, tobacco use is claimed to kill between 200 people and 400 people every year—all preventable deaths (side note: the data for the same year varies dramatically between two WHO reports). Global tobacco control has failed Bhutanese tobacco users and their families. For a nation built on principles of sustainability, risky forms of smoked and smokeless tobacco products have no place in society. The mountains, the clean air, the happy smiles and peace-loving people of Bhutan deserve to own tobacco control initiatives, not be made to adopt hand-me-down Western ideologies or policies. That will require the doctors and pharmacists in Bhutan to understand the science of tobacco cessation and harm reduction and make quitting sexy. Availability of nicotine-replacement therapy products, innovation in safer nicotine alternatives and improved cessation services will need to be ensured and incentivized by the government. That has the potential to keep their nation happier and healthier for the coming generations.
Disclaimer: The author’s work here or elsewhere is dedicated to using ethical and scientific evidence-based approaches to eliminate harms from all risky forms of smoked and smokeless tobacco products. The article is based on the author’s personal conversations with experts and lay people in Bhutan and from shop visits and an analysis of two of the most recent WHO reports on this topic. The intent of this article is to shine a light on a vulnerable LMIC’s experience with unchecked health imperialism to create insight and debate on the impact and implications of such practices. The author holds utmost respect for the nation, the policymakers and the people of Bhutan.
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
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
The Core of the Confusion

Photo: Westock
The likely origins of the prevailing misperceptions about nicotine—and how that impacts tobacco harm reduction
By Sudhanshu Patwardhan
A widely prevalent misperception prevailing in society is that nicotine in tobacco products causes cancer. This myth and its widespread acceptance even among healthcare practitioners worldwide was recently highlighted by a survey among 15,000 doctors from 11 countries. Nicotine misperception may be the key reason preventing the world from becoming free from risky forms of smoked and smokeless tobacco products. The origins of this misperception may have something to do with south Asia and the nasty oral tobacco products sold there.
The Basis of Tobacco Addiction
To achieve a world free of risky tobacco product use, understanding nicotine’s role in tobacco addiction is crucial. Tobacco addiction—in lay terms, the harmful habit of consumers of risky forms of tobacco to continue consuming despite knowing the harms to themselves and society—is primarily driven by the psychoactive effects of nicotine. The hand-to-mouth action, the action of nicotine on brain receptors, the activation of reward pathways in the brain, the release of neurotransmitters during product use and their eventual depletion, the expectation of the kick of the drug on longer term use, the craving and withdrawal effects that are mitigated by further consumption (or dosing) of nicotine, the social and cultural cues—all these point to a complex interplay. Nicotine is central to this addiction. An addiction that kills over 8 million people worldwide every year, affecting millions more in bereaved friends and families, and sees another 1.3 billion people in the world struggling to quit.
It Is the Smoke, Stupid … or Is It Just?
Over nearly five decades of tobacco control, thought leaders in the West have been enamored by—and have generously quoted—Michael Russell’s statement, “People smoke for nicotine, but they die from the tar” (Russell, British Medical Journal, 1976). He was right in the context of smoked tobacco. Indeed, this insight underpinned the enlightening among some tobacco control researchers in the U.K. and across the Atlantic. That in turn manifested in ground-breaking publications, e.g., the 2001 National Academy of Sciences’ Clearing the Smoke report, the 2007 U.K. Royal College of Physicians’ report Harm Reduction in Nicotine Addiction: Helping People Who Can’t Quit and the 2014 U.K. Royal College of Physicians’ report Nicotine Without Smoke: Tobacco Harm Reduction.”
Indeed, the U.K. medicines agency’s authorization of an additional harm reduction indication for nicotine-replacement therapy (NRT) products from 2010 onward established the world’s first class of licensed tobacco harm reduction products. This is often forgotten by tobacco harm reduction advocates as well as tobacco control enthusiasts around the world, with even lesser understanding of how and why the U.K. arrived at this fork on its journey in addressing tobacco-related harms (Patwardhan, Drug Testing and Analysis, 2022).
Metaphorically separating nicotine from its toxic delivery system that burned tobacco allowed Russell and the subsequent generations of public health thought leaders to pave the way for nicotine in cleaner forms to be formulated in various delivery systems, starting with medically licensed nicotine gums, patches and lozenges and culminating in Hon Lik’s invention of the e-cigarette. Heated-tobacco products launched by large tobacco multinationals also entered the market, with companies keen to “unsmoke” the world and phase out combusted tobacco, just like electric batteries in place of combustion engines in automobiles. Or Coke Zero and Pepsi Max instead of Coke and Pepsi. Right? Wrong! This narrative ignores oral tobacco consumption by nearly 300 million tobacco users, living mostly in Asia and Africa, and the attending oral and pharyngeal cancer-related morbidity and mortality.
Smokeless Tobacco’s Harms: A Collective Blind Spot
One estimate suggests that nearly 10 percent of doctors in the U.K. are of Indian or Pakistani origin and a sizeable number from Africa and the rest of Asia as well. There is even a higher proportion of healthcare professionals from these continents in mental health settings. Training in south and southeast Asia or Africa inevitably exposes doctors to patients presenting with the harms of oral tobacco.
Current medical curricula in these countries (or in fact anywhere else in the world) do not go into any level of detail when it comes to treating smoked or smokeless tobacco addiction. During medical education, it is quite common to simply identify the myriad diseases that tobacco is responsible for and to require trainee doctors to advise patients to quit. Which nicotine-replacement therapy to prescribe, why, how to provide behavioral counselling for tobacco de-addiction, the need for follow-up and relapse prevention, the impact of smoking on specific drugs’ metabolism and reduced efficacy are skills and knowledge that are not imparted at any stage of clinical training to doctors, dentists or nurses anywhere in the world.
There are millions of healthcare professionals in Asia and Africa and hundreds of thousands of expatriate doctors and nurses from these continents in Europe, America and the Middle East who have seen oral cancer patients, most likely resulting from oral tobacco use. They have seen firsthand the harms from oral tobacco products.
Unsurprisingly, telling them that tobacco harm reduction can be achieved by going smoke-free or by switching to “smokeless tobacco products” or giving “safer” nicotine alternatives will be perceived as fake news at best, disingenuous and dishonest at worst. Even licensed NRTs are not spared in this misperception, with many clinicians worried about nicotine causing cancer and NRT addiction with longer term use. This may result in inadequate NRT being prescribed for not long enough, thus making relapse more likely.

The use and harm profile of south Asian and African smokeless tobacco products is often not mentioned when championing snus (and therefore smokeless tobacco) as harm reduction. This can only add to the distrust of the industry and tobacco harm reduction advocates by the public health community.
Nicotine Misperception: The Likely Origin Story
There is an unprocessed wrong belief that most health experts and lay people have come to harbor: tobacco = nicotine = cancer. Toxicants, including carcinogens, are delivered during consumption of most tobacco products: from the smoke due to combustion of tobacco in the case of cigarettes/cigars/cigarillos and bidis, or added/formed in the manufacturing and storage of Asian and African oral tobacco products, e.g., chemicals, slaked lime, areca nut-specific nitrosamines and tobacco-specific nitrosamines (TSNAs).
The exception to these is Swedish-style pouched smokeless tobacco (snus). Through decades of evolving manufacturing standards and innovation, concentrations of carcinogens such as TSNAs and other toxicants in Swedish-style snus have been engineered to be minimal. The population level effects of the “Swedish experience” with snus in enabling a transition to a smokefree nation with the attending lowest male lung cancer rates in the EU, are the darling of tobacco harm reduction advocates. However, the use and harm profile of south Asian and African smokeless tobacco products is often not mentioned when championing snus (and therefore smokeless tobacco) as harm reduction. This can only add to the distrust of the industry and tobacco harm reduction advocates by the public health community.
In the absence of a curriculum that does not specifically distinguish nicotine’s psychoactive properties and dependence-causing potential from the toxicants formed or present in smoked or most smokeless tobacco products, healthcare professionals may easily conflate the tobacco products’ harms with nicotine.
Furthermore, their experience with patients from south Asia and Africa makes it logical for them to unconsciously do so. There are already lazy parallels with other widely prevalent addictions afflicting the world: e.g., alcohol. The nuance, however, is lost, that unlike nicotine, ethanol is the psychoactive component as well as the chemical that harms the liver and brain cells.
Lay media add to the confusion. Globally, tobacco control slogans and campaigns have run for decades now, most often using simple one-liner messages against nicotine. There was no need or place for nuance for those wanting to rid the world of the indirect harms of nicotine. It could even be justifiable for some to do so to achieve their utopian prize of a tobacco-free society (not to be confused with a society free from the harms of tobacco, a worthy goal).
The problem arises when nicotine, the very chemical that is vilified in the prevalent anti-tobacco narrative, when delivered in clean systems is recognized as a key solution for the 1.3 billion users of risky smoked and smokeless tobacco products. E.g., the World Health Organization has NRT on its model essential medicines list for treating tobacco dependence.
Nicotine: An Orphan Drug
Eighty percent of the world’s users of risky tobacco products, nearly 900 million people, live in low-income and middle-income countries (LMICs). Most of them do not have access to affordable and appealing safer forms of nicotine-replacement products, including NRT. A majority of healthcare professionals in those countries wrongly believe that nicotine in tobacco products causes cancer. In these countries, tobacco cessation treatments are either unavailable or delivered by healthcare professionals who are not trained in the art and science of nicotine replacement and behavioral interventions.
For too long, pharma and tobacco companies have shied away from owning nicotine, with pharma perhaps worried about the optics of selling a psychoactive substance with such global harms, albeit due to the dirty delivery system it is currently sold in. Tobacco companies care about their own brand and product and may prioritize brand building over broader product-agnostic market conditioning about nicotine. The result is that a large swathe of countries that lack the sophistication or the academic rigor and experience of the U.K.’s tobacco control community or the U.S.’ Food and Drug Administration find themselves accepting hand-me-down anti-tobacco-harm-reduction rhetoric.
Light at the End of the Tunnel?
A rush to launch new nicotine products globally without adequate disentanglement between tobacco and nicotine education will only lead to more knee-jerk reactions and bans. That shall slow down any ambition to make the world smoke-free, or to be more precise, free from risky tobacco products. Achieving nicotine literacy through education and practice may be the much-needed game changer. In theory, most countries, including LMICs, have NRT on their national essential medicines list.
That does not necessarily translate into actual availability and affordability for cessation. Anyone truly invested in tobacco harm reduction should recognize that much groundwork needs to be laid first to get the new generation of healthcare students and future practitioners to be nicotine confident—starting with NRT. Tobacco cessation, underpinned by tobacco harm reduction principles, should be taught, practiced and experienced in LMICs through well-regulated healthcare ventures and partnerships.
Consumers, healthcare practitioners and governments first need to see the success with cessation using conventional NRTs but also recognize the need for a wider choice of safer nicotine alternatives to wean off the 1.3 billion current tobacco users. Only then will the conditions be ripe for companies to responsibly market their nicotine innovations to adult tobacco users in such markets.
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.

November 13, 2023
From Plantations to Nicotine ’Plants’

Photo: Taco Tuinstra
Synthetic nicotine could help promote global food security.
By Sudhanshu Patwardhan
The tobacco industry is undergoing rapid transformation. Companies are increasingly offering safer nicotine alternatives to current consumers of risky forms of tobacco. Is it time for them to reassess their supply chains to procure nicotine from nonagricultural sources and in the process free up land for growing crops that can feed the world’s 8 billion people? A study of the economics of tobacco cultivation and nicotine consumption may give us practical answers.
Millions of hectares of rich, fertile land are used for growing tobacco to meet the nicotine needs of over 1.1 billion tobacco users globally. Except for Swedish-style snus and tobacco used in novel heated-tobacco products, most of the tobacco grown eventually harms public health due to the toxicants arising out of its curing and manufacturing (e.g., tobacco-specific nitrosamines, added chemicals in smokeless tobacco products) and use (e.g., harmful smoke components). On May 31, the World Health Organization marks World No Tobacco Day (WNTD) with an interesting theme: “We need food, not tobacco.”
Last year, for the first time ever, two U.N. bodies—the WHO and the U.N. Environment Programme)—published a list of the environmental harms from tobacco-related farming, manufacturing, supply chain and consumption. Tobacco-related harms to the environment start from the seed and go well beyond the cigarette and bidi smoke. The WHO notes that globally, an additional 200,000 hectares of land is cleared annually for growing tobacco and curing tobacco leaves that are used in making smoked and smokeless tobacco products. Rich and diverse natural habitats, including pristine rainforests, are being lost to meet the global tobacco demand. It is estimated that 3.7 liters of water are used to make one cigarette. Worldwide, trillions of cigarettes are sold and burned annually. The environmental pollution is not limited to the emitted smoke and the ash but also the cigarette butt litter that refuses to decompose for years. In South Asian countries, spitting smokeless tobacco imposes an additional burden on health and leaves unsightly marks in buildings and roads. Even the pharmaceutical grade nicotine used in medically licensed nicotine-replacement products and e-liquids for vaping products is obtained predominantly from tobacco plants.
Any slogan that simply calls for more food instead of tobacco oversimplifies the economics of tobacco.
This year’s WNTD theme intends to put a spotlight on the arable land locked in tobacco plantations that could instead provide food security to the world’s 8 billion people. Indeed, hunger and lack of nutritious food kill millions of people worldwide every year. Feeding the ever-growing world population without denuding forest land remains a big challenge for reasons ranging from environment and climate change to biodiversity. Therefore, in a world with finite arable land, repurposing tobacco farms for growing food are an obvious target for policymakers, environmentalists and economists.
Sadly, the WNTD theme creates a false dichotomy, unnecessarily pitting tobacco farmers against a hungry world. Alas, one cannot simply switch tobacco farms and farmers to grow alternative food crops with a snap of a finger. Global demand for tobacco continues relatively unabated, thus keeping suppliers invested in a profitable crop. It is also important to remember that tobacco is an unusually hardy plant. Not all food crops can withstand conditions that the tobacco plant can endure. Unlike edible vegetables and fruits, the produce from tobacco plantations is a leaf that is included as a raw material for further processing into a product, thus not subjecting the farmers to the whims and shameful wastage due to strict size and shape requirements of western supermarket buyers. The tobacco leaf markets are utility focused and well supported through longstanding relationships among stakeholders across a sophisticated global supply chain and have lifted millions out of poverty. Any slogan that simply calls for more food instead of tobacco oversimplifies the economics of tobacco.
The health harms from risky forms of smoked and smokeless tobacco products such as cigarettes, cigars, bidis, hookah, gutkha, khaini, mishri, zarda, etc. are already well known. That knowledge has not made these products or their use obsolete—even today, over a billion people around the world consume these risky products, and more than half of them die prematurely as a result. Nicotine is addictive but is not the cause of tobacco-related cancers, cardiovascular disease and lung disease.
Many doctors harbor misperceptions about nicotine, wrongly believing that nicotine in the tobacco products causes cancer.
The invention of nicotine-replacement therapy (NRT) products over three decades ago, in the form of nicotine gums, skin patches, lozenges and mouth sprays, was crucial in realizing nicotine’s role as a medicine in helping quit tobacco and finding these products a place on the WHO’s model essential medicines list. NRT enables smokers and smokeless tobacco users to better manage their cravings and withdrawal symptoms. Still, quitting tobacco and preventing relapse remains a big challenge globally for a variety of interlinked reasons: (i) Pharmaceutical investment and innovation in improved tobacco cessation tools and products has been lacking in recent years, (ii) universal access to affordable and appealing nicotine-replacement products remains poor, and (iii) healthcare professionals around the world are not adequately trained on how to advise their patients to use nicotine-replacement products.
In fact, many of the doctors themselves harbor misperceptions about nicotine, wrongly believing that nicotine in the tobacco products causes cancer. This limits doctors’ ability to confidently support their patients’ tobacco de-addiction journey using nicotine-replacement principles. The obvious question then is: How do we ensure that current users of tobacco get all the help they can from their healthcare advisers and governments to make quitting tools accessible, affordable, appealing and available? If done at a global level, quitting success will further inspire confidence among consumers, healthcare practitioners and policymakers to accelerate the decline of the demand for tobacco.
The WHO Framework Convention on Tobacco Control (FCTC) is often elegantly simplified as a treaty for demand reduction, supply reduction and harm reduction strategies. The largest demand arises from the billion-plus cohort of current users of risky tobacco products—and that’s where affordable cessation support and safer nicotine alternatives offer the highest likelihood of practical harm reduction. So, for the agricultural transformation much needed to free up arable land, a global reduction in demand for tobacco will be a key economic driver over time for farmers to actively seek other viable alternatives. It would then be crucial to provide government support and subsidy over a phased reduction in tobacco farming.
The FCTC dedicates two entire articles in the original treaty text to alternative livelihoods for those in the supply chain and addressing environmental impact—Articles 17 and 18. Particularly in implementing those two articles, little progress has been made in the past 20 years since the treaty came into force. That is because even lesser success has been achieved on a ground-level implementation of the FCTC’s Article 14 that calls for tobacco dependence treatment provision at a national level.
In recent years, many advances in chemistry and chemical engineering have resulted in new processes and patents issued for synthesizing nicotine from nontobacco raw materials. If the correct isomer of nicotine—the S-isomer—can be manufactured at scale using these processes, that can be revolutionary and indeed game changing. Using such synthetically manufactured nicotine, nicotine-replacement products that are innovative, suitably regulated and where necessary medically licensed can thus be introduced globally for tobacco cessation at low cost and in product formats appealing to current adult smokers and smokeless tobacco users. Agricultural transformation and enhanced food security will naturally follow this purely on economics principles.
Sudhanshu Patwardhan is a British-Indian, U.K.-licensed medical doctor who is passionate about helping people quit risky forms of tobacco. For the past two decades, he has lived and worked in three continents, doing senior roles in research, strategy and policy in the pharmaceutical and tobacco industries.

In his early years in tobacco harm reduction, his team of clinical researchers and lab scientists set the foundations for the assessment of reduced-risk products, now accepted by regulators and the industry as the definitive approach for duty of care and regulatory compliance. At Nicoventures, a wholly owned subsidiary of British American Tobacco, he was instrumental in enabling the first e-cigarette company acquisition by a global tobacco business. In his policy role there, Patwardhan shaped the creation of a global key opinion leader network in consumer advocacy and public health champions. .

With the British Standards Institution, Patwardhan led the creation of the world’s first vaping products’ standards for safety and quality in 2015 and the BSI Online Age Checking specifications in collaboration with the Westminster-based Digital Policy Alliance in 2018. .

In 2018, he co-founded the Centre for Health Research and Education that now has a team of over 40 medical and public health experts globally working in cancer prevention. Patwardhan splits time between the U.K. and South Asia on tobacco harm reduction projects that address the needs of the most disadvantaged tobacco users.

July 1, 2023
Broadening the Scope
Image: alexlmx
Tobacco harm reduction initiatives should also cover e-waste management, say experts.
Contributed
E-waste is an emerging unintended environmental consequence of the revolution in electronic nicotine-delivery systems, threatening to undermine a technological innovation in public health. This conversation examines the intersection of regulatory policy, consumer behavior and the vaping products’ industry and hopes to map a sustainable path for the future.
In the discussion below, John Dunne from the U.K. Vaping Industry Association (UKVIA) brings in the vaping industry perspective, Pieter Vorster brings expert views on global tobacco and nicotine industry transformation, and Sudhanshu Patwardhan (Sud), a nicotine expert and health-tech entrepreneur, proposes a broader definition and scope of tobacco harm reduction (THR).
Sudhanshu Patwardhan
Patwardhan: We know that in the U.K. and the European Union, where they are regulated, vapes, or e-cigarettes, are classed as waste electrical and electronic equipment (WEEE). Ideally, consumers in these countries should dispose of vapes at a household recycling center or at the shop where they bought the device. Manufacturers are also required to make recycling options available. Many consumers, however, are unaware that single-use vapes can or should be recycled. Incorrect disposal of these items can potentially release plastic, electronic and hazardous chemical waste into the environment and represent a fire hazard. How big is this issue currently? Does the industry have numbers contrasting sales to recycling?
Dunne: In the U.K., around 459 million e-cigarettes of all kinds are purchased each year, of which 168 million, or 37 percent, are single-use vapes. Approximately 43 percent of all vapes purchased are recycled, although this number is likely much lower for single-use (“disposable”) products:
Twenty-three percent of e-cigarettes are recycled in-store when consumers buy a new one.
Twenty percent are recycled at a local authority recycling center.
On the face of it, the 43 percent recycled figure for e-cigarettes compares favorably with the 31.2 percent of waste electrical and electronic equipment in the U.K. that was recycled or reused in the U.K. in 2021. However, vaping products’ relatively short lifespan means more waste is generated.
Patwardhan: Good to get that broader electronic products-based perspective and the product use life cycle nuance with regards to e-cigarettes. Obviously, there is a still a gap between current practices by consumers versus what would make e-cigarettes environmentally sustainable in the long run. Pieter, do you think there are any good examples of industry players showing some leadership in this?
Vorster: All three tobacco companies that sell single-use vaping products in the U.K.—BAT (Vuse Bar), Imperial (Blu bar) and PMI (VEEBA), for example—advise consumers not to put them in household waste and offer free returns services on their websites. This information is displayed on the webpages where these items are sold. Consumers who don’t buy these products online need to read the package insert. They are advised that the product should not be placed in household waste but collected separately for recovery and recycling. The package insert also directs users to the manufacturer’s website for details of its recycling program. Whether consumers ever read these inserts is open to debate!
Independent U.K. brands are not far behind either; Riot Bar and Blo Bar have also introduced comprehensive recycling schemes. Blo also offers consumers one free Blo Bar for every 10 disposable vapes of any brand sent to them for recycling. Most online retailers in the U.K. offer disposal and recycling advice, and VPZ, the U.K.’s largest vaping retailer, has announced that it is introducing a comprehensive return and recycling program in its stores before the end of March.
Patwardhan: It sounds like manufacturers are, in theory, offering the recycling option to consumers. Do we know if consumers know that these options exist? Perhaps there is an education piece that needs to be carried out by key actors in the supply chain, including manufacturers, as well as by the broader regulatory agencies? Do the regulators need to intervene, or does the industry need to act? Or both, and others?
John Dunne
Dunne: Recycling vapes is not straightforward and needs collaboration between adult vapers, retailers, manufacturers, regulators and companies in the waste management sector, which are involved in the current Producer Compliance Schemes under the WEEE regulations. We are liaising with DEFRA [U.K. Department for Environment Food and Rural Affairs] and the Office for Product Safety and Standards and calling upon our members and the wider industry to innovate products that are easier to recycle.
Patwardhan: Talking about multi-stakeholder initiatives, we are on the cusp of another VApril, an annual British feature in April to showcase vaping as a means to stop smoking. As we have seen with a series of successive publications from U.K. health and related authorities and charities—e.g., the 2016 Royal College of Physicians’ Nicotine Without Smoke report—e-cigarettes/vapes are a potential force for good by helping smokers quit smoking. The THR creds of e-cigarettes in the context of current adult smokers are not in doubt. However, this emerging narrative on environmental harms from disposable vapes presents a unique challenge to those in public health and policy, does it not, Pieter?
Pieter Vorster
Vorster: Indeed, Sud. To date, opponents of tobacco harm reduction have often relied on questionable science that is unlikely to withstand rigorous evaluation, as evidenced by numerous retractions in recent years. On the other hand, the science underlying the potential environmental and health risks posed by the inappropriate disposal of reduced-risk products isn’t subject to the same constraints. Furthermore, the emotional appeal for the “environmental harms” narrative from these products has a much broader and vocal activist constituency—thus threatening to undermine the public health arguments of THR. In short, it represents a potentially potent weaponizable tool for those opposed to THR.
Patwardhan: I can see that the recent developments in Scotland, where an environmental activist highlighted the problem of vape littering, and separately, the decision of a large British supermarket chain to stop selling disposable vapes, signal a change in public perception and attitudes toward the product. It is as if an argument is being built in this narrative about disposables being harmful to the environment and are a lost cause as such, as well as the anecdotal observation that disposables are used by a much younger cohort, possibly those underage as well as those who have never smoked cigarettes before. If true, surely that is one issue to address through stronger regulations, especially with regards to preventing youth access and mandatory recycling requirements and refund schemes, right?
Dunne: Preventing the sale of vaping products to minors is one of the industry’s most fundamental challenges, and our members are united behind this goal. We have recently updated our “Preventing Underage Sales Guide” to give retailers all the information they need so they don’t inadvertently sell to someone under 18. However, we need the support of the government, regulators and enforcement authorities to ensure that unscrupulous retailers who knowingly sell to young people face the full force of the law. We believe that there is a need for increased fines for rogue traders, licensing of vape retailers and a national test purchase scheme. In fact, the UKVIA’s Youth Access Prevention Task Force will propose so to regulators this month. Regarding e-waste, the industry also recognizes its environmental responsibilities, and we are working with regulators, waste management experts, product manufacturers and retailers to find a workable solution.
Patwardhan: This is a most fascinating discussion where we find innovative 21st century nicotine products that have huge positive public health potential getting caught into an orthogonal field of great import in global public policy: sustainability and environment. In concert, responsible behavior by industry and retailers, better regulation and enforcement—and not prohibition—and consumer adoption of e-waste management solutions may well be the answer. In fact, we can go one step further and challenge all stakeholders—industry, regulators, public health and consumers—to embrace proactive e-waste management as another opportunity to reduce harms from a transforming tobacco and nicotine products’ landscape whilst maximizing the societal benefits from this shift in consumer behaviors.
May 1, 2023