Category: Harm Reduction

INNCO Calls for Sensible Policies
Photo: Tobacco Reporter archive
Blanket bans on electronic nicotine-delivery systems (ENDS) are a detriment to low-income and middle-income countries (LMICs), according to the International Network of Nicotine Consumer Organizations (INNCO). In a position paper released today, the group says bans on vapor and heated-tobacco products (HTPs) are an overly simple solution that make the problems that come with combustible cigarette use far worse.
“The hundreds of millions of people who smoke in these countries should have the ability to make decisions about safer nicotine products, particularly when their own health is on the line,” said Samrat Chowdhery, president of INNCO’s governing board. “Overly simplistic policy solutions, such as proposed bans on all ENDS and THR products by the Bloomberg Philanthropies-funded The Union, are being offered as a blunt and impractical tool for a situation that requires pragmatism and nuance, making meaningful and sustainable change more difficult.”

Overly simplistic policy solutions, such as proposed bans on all ENDS and THR products, are being offered for a situation that requires pragmatism and nuance.
Samrat Chowdhery, president, INNCO
The report, “10 Reasons Why Blanket Bans of E-Cigarettes and HTPs in low- and middle-income Countries (LMICs) Are Not Fit for Purpose,” sends a strong warning to organizations and governments that limiting options to reduce harm will only increase the number of people smoking tobacco, inevitably leading to illicit markets and increases in crime. The paper lists the Top 10 reasons the bans don’t work as the following:
Bans are an overly simplistic solution to a complex issue and will not work.
Prioritizing the banning of reduced harm alternatives over cigarettes is illogical.
Reduction and substitution are valid goals for smokers in LMICs.
People who smoke have the right to choose to reduce their own risk of harm.
Reduced harm alternatives can significantly contribute to the aims of global tobacco control.
Lack of research in LMICs is not a valid reason to ban reduced harm alternatives.
The prohibitionist approach in LMICs is outdated, unrealistic and condescending.
Bans will lead to illicit markets with increases in crime and no tax revenue.
Banning reduced harm alternatives leads people back to smoking and greater harm.
Blanket bans in LMICs are a form of “philanthropic colonialism.”
INNCO estimates that there are scores of LMICs in jeopardy of increasing the number of people who smoke cigarettes in their countries unless pragmatic approaches to tobacco harm control are adopted, including the availability of a wide selection of safer nicotine products. Leveraging the paper’s findings, INNCO states that it will work with its global membership to inform policymakers in developing nations to help achieve risk-relative regulations and access to safer THR products, according to a press release.
“Africa is home to some of the highest-ranked smoker countries on the planet,” said Joseph Magero, chairman of Campaign for Safer Alternatives, a pan-African nongovernmental member organization dedicated to achieving 100 percent smoke-free environments in Africa. “While improving overall public health has made great strides in these regions, efforts to directly address smoking cessation and harm reduction strategies have lagged due to limited or no access to safer, noncombustion nicotine products. By denying smokers access to much safer alternatives while leaving cigarettes on the market, policymakers would leave only two options on the table—quit or die.”

By denying smokers access to much safer alternatives while leaving cigarettes on the market, policymakers would leave only two options on the table—quit or die.
Joseph Magero, chairman of Campaign for Safer Alternatives
The paper is supported by other harm reduction advocates as well. Nancy Loucas of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates, a grassroots alliance of THR advocacy organizations, said a blanket ban in LMICs is a form of philanthropic colonialism, suggesting that these countries and their citizens cannot be trusted with any level of self-determination. “Inhabitants are treated as second-class citizens, which is offensive,” she said. “There is no benefit in limiting choice of safer nicotine products but only the potential for increasing harm.”
Francisco Ordonez of the Asociacion por la Reduccion de danos del Tabaquismo Iberoamerica, a network of consumer organizations in Latin America, says that very few low-income and middle-income countries have adopted even the most basic prevention measures suggested by the World Health Organization (WHO).
“Policymakers should embrace harm reduction as a valid goal, particularly in LMICs where access to cessation programs is extremely limited,” said Ordonez. “Replacing combustible tobacco with alternative nicotine products can significantly reduce the risk of harm by at least 95 percent. It works in industrialized nations and can do the same in LMICs.”
March 16, 2021
THR Groups Worried About ENDS Advice

Photo: Vaperesso
Vapor advocates have expressed concern about recent recommendations made by the World Health Organization (WHO) study group on Tobacco Product Regulations to prohibit electronic nicotine and non-nicotine delivery systems where the user can control device features and liquid ingredients. The WHO has also called for a ban on vaping systems that have a higher “abuse liability” than conventional cigarettes, for example by controlling the emission rate or flux of nicotine.
Clive Bates
Clive Bates, a tobacco harm expert and former director of Action on Smoking and Health (ASH), called the advice irresponsible and bizarre. “If governments take it seriously, they will be protecting the cigarette trade, encouraging smoking and adding to a huge toll of cancer, heart and lung disease,” he said.
The U.K. Vaping Industry Association (UKVIA) said the WHO is out of touch with growing evidence on the public health potential of vaping. “Certain WHO positions are now so out of date, and so thoroughly refuted by the experts, that they may as well be saying the earth is flat,” said John Dunne, director general at the UKVIA, in a statement. “They deviate dramatically from leading experts, including Public Health England and Action on Smoking and Health.”
Dunne cited the WHO’s assertion that there is “little evidence” for vaping’s role in helping people quit smoking. As early as 2019, clinical trials were finding vaping to be almost twice as effective as nicotine-replacement therapy, he noted.
This month, Public Health England (PHE) found in its Vaping Evidence Review 2021 that smoking quit rates involving a vaping product were higher than with any other method in every single English region.
John Dunne
“For the WHO to hold such contrary views is either bad science or bad faith. Both risk it becoming an enemy of harm reduction,” said Dunne.
“Vaping’s success as an industry, and its potential for public health improvements, is built on empowering personal choice,” he added. “Different systems, styles and flavors give consumers the options they need to leave combustible cigarettes behind. I would urge the WHO to engage with vapers, to hear their stories and discover the life-changing decisions they’ve made in their lives. Prohibition is simply not the answer.”
The WHO is scheduled to hold a summit on vaping, during the Conference of Parties to the WHO Framework Convention on Tobacco Control (COP9) in The Hague in November 2021. Following its exit from the European Union, the U.K. will send a national delegation to the meeting. The UKVIA was among expert guests invited by the All-Party Parliamentary Group for Vaping to advise on the COP9 delegation’s approach.
“The U.K. has a genuine opportunity to promote harm reduction as a valid, progressive strategy for public health on the world stage,” said Dunne. “We must not allow misinformation to undermine this potential, irrespective of the source.”
March 2, 2021
Supports for Innovative THR Approaches

Photo: PMI
A new international survey commissioned by Philip Morris International (PMI) and conducted by independent research firm Povaddo reveals a public appetite for a better approach to reducing the societal harm caused by cigarettes. Seven in 10 respondents (71 percent) believe that encouraging those adults who would otherwise continue to smoke to switch to smoke-free alternatives instead can complement other efforts to reduce harm.
Conducted in December 2020 among 22,500-plus adults in 20 countries and territories, the survey explores attitudes regarding the role of smoke-free alternatives in improving public health. The results reveal broad support for novel approaches to accelerating the decline of cigarette smoking. Specifically, the survey found that: 73 percent of adults agree that governments should consider the role alternative products can play in making their country smoke-free; 77 percent agree that adult smokers should have access to and accurate information about smoke-free alternatives that have been scientifically substantiated to be a better choice than continued smoking; and 67 percent of respondents say that if it is possible to end cigarette sales in their country within 10 to 15 years (through smokers quitting tobacco or switching to better, science-based alternatives), their government should dedicate time and resources to making that a reality.
Three in four respondents (76 percent) believe it is important for governments to dedicate time and resources to reducing smoking rates. However, a majority (58 percent) believe that more regulation and taxation of cigarettes will not be enough to achieve a smoke-free future.
Jacek Olczak
“Smoke-free products have already started to play an important role in lowering smoking rates,” said Jacek Olczak, chief operating officer at PMI, in a statement. “With the right regulatory encouragement, support from civil society and the full embrace of science, I believe it is possible for the public’s call to be answered and for cigarette sales to be a thing of the past in many countries within a decade to a decade and a half.”
Most adults surveyed want to see a shift in the societal approach to tobacco harm reduction, including more collaboration between governments and tobacco companies. Moreover, nearly seven in 10 respondents (68 percent) support tobacco companies working with governments, regulators and public health experts to ensure smokers have access to and accurate information about the better, smoke-free alternatives science has made available. Further, eight in 10 respondents believe both governments (88 percent) and businesses (81 percent) have a responsibility to embrace the latest scientific and technological developments.
March 2, 2021
Innovation and its Enemies

Photo: Gualtiero Boffi | Dreamstime.com
Understanding the war on vaping
By Clive Bates
How did vaping emerge, and why do so many in public health oppose it? It is a perplexing question, but the explanation starts with innovation.
The essential development was progress with a critical technology—the lithium-ion battery—that made new categories of consumer nicotine product possible in a compact form acceptable to consumers. Driven by the insatiable demand for miniaturization from mobile phones and other portable devices, these batteries have improved to deliver ever greater energy density (essential for good battery life) and power density (essential for rapid heating and responsiveness to human interaction). In one sense, vaping and heated-tobacco products are novel energy technologies. The critical innovation is that they change the heat source used to form the inhalable nicotine-bearing aerosol from combustion to electricity. Burning tobacco generates the heat, and the tobacco smoke is the aerosol, but the products of combustion are also the prime driver of the disease burden. There is no combustion with electrical heating, so no products of combustion and therefore much lower disease risk. This is the fundamental, game-changing innovation.
Once the lithium-ion battery had overcome the primary heat source problem, innovators had at their disposal a platform for further innovation. In his recent book, How Innovation Works, Matt Ridley analyzes the origins of innovation:
“The main ingredient in the secret sauce that leads to innovation is freedom. Freedom to exchange, experiment, invest and fail; freedom from appropriation or restriction by chiefs, priests and thieves; freedom on the part of consumers to reward the innovations they like and reject the ones they do not.”
So in the relatively open regulatory environment of the past decade, we see a wave of intense innovator activity, all tested and selected in the marketplace through rapid introduction and consumer uptake or rejection in a process that mirrors natural selection in ecology. The surge of innovation includes the emergence of a vast range of flavors and branding, refillable devices, mods and tanks, variable power, temperature control and new heating element designs. It brought on “sub-ohm” devices designed for the consumption of large volumes of weak liquids and “pod” devices designed for the consumption of low volumes of high strength liquid from a compact device. Some of the innovation has been elegantly synergistic. For example, the use of acids in pod devices allowed for the formation of “protonated” nicotine salts, which improved pharmacokinetic nicotine delivery to a level that could rival cigarettes. But these acids also facilitate the use of high-strength nicotine liquids by reducing harshness. Higher strengths mean users inhale lower quantities of liquid, so less heating is required, allowing for smaller batteries and a more compact and consumer-friendly format. That has turned out to be a very successful combination.

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Alongside the developments in technology, there have been major commercial and social innovations. Vape shops provide a service that helps people quit, but outside a medical or treatment paradigm without labeling their customers as “patients” suffering from a psychiatric disorder. Innovation has been driven spontaneously through social media with influential product reviewers using YouTube and other social media to exert “selection pressure” on innovators. A vaping subculture of user-driven camaraderie, support, advice, and scientific and engineering insight has flourished and provided users with a sense of purpose and independence of manufacturers and public health activists.
These developments have combined to create a powerful rival “value proposition” to cigarettes and smoking—an alternative way to use the relatively mild lifestyle drug nicotine but without nearly all the lethal side effects. For public health campaigners, it should be a triumph—and recognized as the approaching endgame for the burden of cancer, heart and lung disease, and premature death caused by nicotine consumption through smoking. Isn’t this precisely what we should look for in innovation?
Not everyone agrees.
Despite this promise, thousands of well-funded and dedicated tobacco control activists and academics oppose these developments. The question is: Why? What is driving this opposition?

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The coalition opposing vaping is formidable, drawing together the World Health Organization, major regulators, public health agencies like the Centers for Disease Control and Prevention in the United States, hundreds of academics and research funders, health and medical societies, activist groups and journalists. But why has this coalition directed its firepower against tobacco harm reduction, even though many of the same actors would support harm reduction for illicit drugs, HIV and sexual health?
We should start by considering if the opposition is grounded in a legitimate analysis of public health objectives and an imperative to do the right thing. I believe we can dispose of this explanation quite quickly. If that were the case, we would see much more intellectual energy consumed over trade-offs and agonizing over the likely unintended consequences of policy proposals. There would be a richer discussion of objectives, ethical dilemmas, risk, uncertainty and precaution. Even if that discussion came to a result that opposed vaping and tobacco harm reduction, the analysis to reach that conclusion would look very different to the overconfident assertions seen in practice. For example, the call to “ban flavors,” “raise taxes” or “cap nicotine strengths” would come wrapped in concern for the effects on adult smoking cessation, the welfare of adolescent smokers, illicit trade, home mixing and workarounds, and displacement to other risk behaviors. But we never see this.
A common suggestion is to “follow the money,” with an insinuation that the opponents of tobacco harm reduction are pursuing grants, tax revenues and employment opportunities and may have stakes in rival business models. Money plays a role and may have a reinforcing effect. It allows for the opposition to form at a very large scale. However, it does not explain why the money is aligned with opposition to tobacco harm reduction. I think the money follows the prevailing mindset or group think in the field rather than the other way around.
There are two more promising explanations. First, tobacco harm reduction and its innovation model are profoundly countercultural for tobacco control activists and academics. The tobacco control toolkit is filled with punitive, restrictive and coercive tools, wielded with the daunting authority of health and medical experts. It mainly sees the private sector as the root of the problem and governments or nonprofits as providing the solutions. It is called tobacco control for a reason. In contrast, a public health model that works through the free-play of pleasure-seeking consumers interacting with profit-seeking innovators in a lightly regulated and competitive market does not easily fit within that toolbox or that culture.
The second explanation is institutional inertia. Between 1980 and 2010, funders, academics, activists, regulators, politicians and many committed journalists came together and built a powerful fighting machine to challenge Big Tobacco and drive down smoking. But by 2010, the tobacco wars were becoming stale and somewhat intractable and the troops tired and bored. Innovation such as vaping and heated-tobacco have provided new and revitalizing enemies. Over the last decade, the war on smoking morphed into a war on nicotine. The machine built for fighting smoking swiveled its gun turrets and started blasting away at the new products and their supporters. It did that because that is what those organizations do—it’s in their institutional DNA. The leaders grew up as veterans of the “tobacco wars” and continued their fight on the new fronts. The involvement of the traditional enemy, the tobacco industry, made that much easier given the assumption that there is a permanent irreconcilable conflict between the tobacco industry’s interests and public health.
In the medium term, the outlook is pessimistic. Nik Modi, an investment analyst with RBC Capital Markets, wrote in January 2021, “Now that the e-cig/vapor threat has been neutralized, we are expecting much more stable cigarette category trends.” That is the kind of “win” that should cause a rethink by the victors. But in the longer term, I am optimistic. The change in energy technology marks a fundamental shift in the industry. I do not believe it will be possible to suppress this innovation indefinitely, and the tobacco control coalition will suffer fatal reputational damage if it tries.
In his brilliant book, Innovation and its Enemies: Why People Resist New Technologies, the late Calestous Juma showed how innovations that are commonplace today, such as coffee, margarine and refrigeration, were ferociously opposed when they emerged. Juma says:
“Debates over new technology are part of a long history of social discourse over new products. Claims about the promise of new technology are at times greeted with skepticism, vilification or outright opposition—often dominated by slander, innuendo, scare tactics, conspiracy theories and misinformation. The assumption that new technologies carry unknown risks guides much of the debate. This is often amplified to levels that overshadow the dangers of known risks.”
That describes the opposition to vaping and tobacco harm reduction very well. But it also shows that time and knowledge will ultimately prevail. What a shame that so much more harm will be done while tobacco control activists adjust to disruptive innovation.

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There are two more promising explanations. First, tobacco harm reduction and its innovation model are profoundly countercultural for tobacco control activists and academics. The tobacco control toolkit is filled with punitive, restrictive and coercive tools, wielded with the daunting authority of health and medical experts. It mainly sees the private sector as the root of the problem and governments or nonprofits as providing the solutions. It is called tobacco control for a reason. In contrast, a public health model that works through the free-play of pleasure-seeking consumers interacting with profit-seeking innovators in a lightly regulated and competitive market does not easily fit within that toolbox or that culture.
The second explanation is institutional inertia. Between 1980 and 2010, funders, academics, activists, regulators, politicians and many committed journalists came together and built a powerful fighting machine to challenge Big Tobacco and drive down smoking. But by 2010, the tobacco wars were becoming stale and somewhat intractable and the troops tired and bored. Innovation such as vaping and heated-tobacco have provided new and revitalizing enemies. Over the last decade, the war on smoking morphed into a war on nicotine. The machine built for fighting smoking swiveled its gun turrets and started blasting away at the new products and their supporters. It did that because that is what those organizations do—it’s in their institutional DNA. The leaders grew up as veterans of the “tobacco wars” and continued their fight on the new fronts. The involvement of the traditional enemy, the tobacco industry, made that much easier given the assumption that there is a permanent irreconcilable conflict between the tobacco industry’s interests and public health.
In the medium term, the outlook is pessimistic. Nik Modi, an investment analyst with RBC Capital Markets, wrote in January 2021, “Now that the e-cig/vapor threat has been neutralized, we are expecting much more stable cigarette category trends.” That is the kind of “win” that should cause a rethink by the victors. But in the longer term, I am optimistic. The change in energy technology marks a fundamental shift in the industry. I do not believe it will be possible to suppress this innovation indefinitely, and the tobacco control coalition will suffer fatal reputational damage if it tries.
In his brilliant book, Innovation and its Enemies: Why People Resist New Technologies, the late Calestous Juma showed how innovations that are commonplace today, such as coffee, margarine and refrigeration, were ferociously opposed when they emerged. Juma says:
“Debates over new technology are part of a long history of social discourse over new products. Claims about the promise of new technology are at times greeted with skepticism, vilification or outright opposition—often dominated by slander, innuendo, scare tactics, conspiracy theories and misinformation. The assumption that new technologies carry unknown risks guides much of the debate. This is often amplified to levels that overshadow the dangers of known risks.”
That describes the opposition to vaping and tobacco harm reduction very well. But it also shows that time and knowledge will ultimately prevail. What a shame that so much more harm will be done while tobacco control activists adjust to disruptive innovation.
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).

March 1, 2021
PHE: Vaping is an Effective Cessation Aid

Photo: Marc Bruxelle | Dreamstime.com
Nicotine vaping products were the most popular quit-smoking aids (27.2 percent) in England in 2020, according to Public Health England’s (PHE) seventh independent report on vaping, carried out by researchers at King’s College London. Using a vaping product as part of a quit attempt in local stop smoking services had some of the highest quit success rates—between 59.7 percent and 74 percent in 2019 and 2020. An estimated 50,000 smokers stopped smoking with the aid of a vaping product in 2017.
Despite these trends, 38 percent of smokers in 2020 believed that vaping is as harmful as smoking, with 15 percent believing that vaping is more harmful.
The coronavirus pandemic is likely to have had an impact on smoking and vaping behaviors in both adults and young people. However, it is still too early to assess the full effect of the pandemic, with much of the data examined in this report being pre-pandemic.
Vaping has plateaued in adults and young people since the last PHE report in March 2020. Around 4.8 percent of young people (aged 11 to 18) reported vaping at least once a month—the same as last year—and most of these were either current or former smokers (only 0.8 percent of young people who had never smoked currently vape). Smoking prevalence among young people, including those who smoked sometimes or more than once a week, was 6.7 percent in March 2020, similar to March 2019 at 6.3 percent.
Similar to last year, around 6 percent of adults are current vapers, equating to about 2.7 million adult vapers in England. Smoking prevalence continues to fall and is between 13.8 percent and 16 percent depending on the survey. Vaping prevalence was between 17.5 percent and 20.1 percent among current smokers, around 11 percent among former smokers and between 0.3 percent and 0.6 percent among those who have never smoked. The proportion of vapers who also smoke, or “dual users,” has declined since 2012.
“Our report draws together findings from randomized controlled trials, stop-smoking services and population studies and concludes that nicotine vaping products are an effective way of successfully quitting smoking,” said Ann McNeill, professor of tobacco addiction at King’s College London.
“What is concerning is that smokers, particularly those from disadvantaged groups, incorrectly and increasingly believe that vaping is as harmful as smoking. This is not true and means fewer smokers try vaping.
“The goal for 2030 is to be smoke-free in England. The development of a new Tobacco Control Plan and this year’s review of the Tobacco and Related Products Regulations 2016 is an opportunity to ensure that the regulations around vaping are appropriate. The regulations are also hoped to help smokers to quit while not attracting people who have never smoked.”
February 25, 2021
All-Parliamentary Group Hears Vapor Advocates

Mark Pawsey MP and Chairman of the APPG for Vaping
Prominent tobacco harm reduction advocates Gerry Stimson (Knowledge-Action-Change), Clive Bates (The Counterfactual), John Dunne (U.K. Vaping Industry Association) and Daniel Pryor (Adam Smith Institute) attended a virtual meeting organized by the U.K. All-Party Parliamentary Group (APPG) for Vaping, a collection of MPs and peers focused on e-cigarettes.
The tobacco harm reduction advocates’ input will be used to advise the U.K. delegation to the Conference of the Parties (COP9) to the World Health Organization’s Framework Convention on Tobacco Control, which is scheduled to take place in the Netherlands this November.
Chaired by Mark Pawsey, the APPG is keen for the U.K. to defend its vaping position internationally and to promote the successes of British vaping. The expert witnesses highlighted the considerable public health benefits of harm reduction tools and the potential benefit they could provide around the world.
Tuesday’s evidence session came as the U.K. government continues its own review of tobacco regulations, meaning a busy time for advocates hoping to protect the public potential of vaping.
“I was happy to accept the invitation from the APPG because the UKVIA believe[s] we have an incredible opportunity to spread the word—that innovative, appropriately regulated vaping industries save lives,” said Dunne in a statement. “Post-Brexit Britain is newly independent in forums like COP9, and it means we can drive this positive message home like never before.”
February 10, 2021
Worries About WHO’s Harm Reduction Stance

Photo: Olgacanals | Dreamstime
In a submission to the U.K. All Party Parliamentary Group for Vaping Inquiry, the International Network of Nicotine Consumer Organizations (INNCO) has expressed its concerns about the World Health Organization’s stance on tobacco harm reduction.
Specifically, INNCO is concerned about the WHO’s treatment of low-risk nicotine products and its refusal to recognize harm reduction principles to lower the disease and premature death caused by use of high-risk forms of tobacco such as combustible cigarettes and certain oral tobacco products.
The U.K. Parliamentary Group’s inquiry is designed to collect evidence and issue a report on the ninth conference of the parties to the WHO Framework Convention on Tobacco Control (COP9), which is scheduled to take place in November in the Netherlands.
The U.K. has taken a pragmatic, humane and effective position on the use of tobacco harm reduction, embracing electronic cigarettes as a complement to traditional tobacco control strategies. Consequently, England has one of the lowest smoking rates in Europe.
Due to the country’s track record in tobacco harm reduction, INNCO believes the U.K. is in a unique position to raise its concerns with the WHO and FCTC.
February 2, 2021
FDA Asked to Prioritize Harm Reduction

Photo: Bacho12345 | Dreamstime.com
The U.S. Food and Drug Administration should encourage harm reduction products and help smokers give up cigarettes, according to Markus Lindblad, head of external affairs at the Haypp Group, the parent company of NicoKick, which describes itself as the world’s largest American e-commerce company in the smokeless industry.
In a letter to Acting Food and Drug Administration (FDA) Commissioner Janet Woodcock, Lindblad encouraged her to prioritize the goal she helped set at the FDA in previous years to enable greater use of healthier harm reduction products and help smokers quit combustible products.
“Our mission at NicoKick is to drive real change in the industry and encourage alternative nicotine enjoyment for adults seeking products other than inhalants,” Linblad wrote.
“We recognize that your focus is understandably on addressing the coronavirus pandemic, but we hope as you lead the Food and Drug Administration that you continue to prioritize tobacco harm reduction products that will produce better health outcomes for millions of American smokers. We can all agree any effort to transition from traditional tobacco products to those that reduce harm to the consumer should be supported and would be an important win for public health.”
February 1, 2021
Youth Smoking Down Despite More Vaping

Photo: Tobacco Reporter archive
Cigarette and smokeless tobacco prevalence among U.S. adolescents declined more rapidly between 2012 and 2019 than in previous periods, according to a new study.
An analysis by the University of Michigan (UM) and Georgetown University shows that past 30-day and daily use of both cigarettes and smokeless tobacco fell more rapidly since 2012, even as e-cigarette use began to increase—leading to historical low levels of both cigarette use and smokeless tobacco among teens in the United States.
“While the increases in e-cigarettes are indeed concerning and is something we need to address and reverse, the decreases in other tobacco products, in particular, cigarettes—the most concerning form of tobacco use—are accelerating,” said lead researcher Rafael Meza, associate professor of epidemiology and global health at UM’s School of Public Health, in an article on the UM’s website.
Utilizing data from the nationally representative Monitoring the Future survey at the UM from 1991 to 2019, Meza and his colleagues examined the use prevalence of tobacco products in the last 30 days among key sociodemographic groups.
They found that daily smoking prevalence among 12th grade boys increased 4.9 percent annually 1991 to 1998 but saw annual declines of 8 percent between 1998 and 2006 and 1.6 percent from 2006 to 2012. However, from 2012 to 2019, prevalence declined at a 17 percent annual rate. Overall, daily smoking prevalence among 12th graders fell to about 2 percent by 2019.
David Levy
“This is an astoundingly low rate, and our goal from a public health perspective should be to keep smoking at this rate or lower,” said researcher David Levy, of Georgetown University’s Lombardi Comprehensive Cancer Center.
Meza said the results are important because while e-cigarettes are concerning on their own, there have been concerns that the increase in vaping could result in an uptick in the use of other tobacco products that could potentially upend the declines seen over the past decades.
“But in contrast, what we found is that the decline in smoking has accelerated,” he said.
December 3, 2020
Changing the Narrative

George Cassels-Smith
(Photo: TTI)
George Cassels-Smith hopes ELiquiTech’s new synthetic nicotine will help change the debate between the nicotine industry and regulators.
By George Gay
After reading a recent story by Timothy Donahue about SyNic, a synthesized form of nicotine that is said to be as pure as ultrapure, tobacco-derived nicotine, I had the opportunity of asking George Cassels-Smith, the CEO of eLiquiTech, the company with sole distribution rights for SyNic to the tobacco and electronic nicotine-delivery system industries, what the point of this new product was. Of course, I didn’t put it as bluntly as that, but I was interested in understanding why it was deemed necessary to launch a purer version of nicotine when tobacco-derived nicotine was available that already met the presumably exacting standards of the regulators overseeing the pharmaceutical industry and its various nicotine-replacement therapy products.
His answer could be summed up as “Why not?” Of course, he didn’t put it as bluntly as that. After all, it had taken five years to develop SyNic in a program requiring the input of people with 40 years’ experience in synthesizing drugs and 30-plus patents to their names, working with sophisticated equipment under highly controlled conditions.
Nevertheless, “Why not?” is a persuasively simple response, and it comes in a range of expanded forms. At one end of the range, it has to do with the nicotine consumer. Cassels-Smith said that, today, just about everybody has lived in environments in which we were exposed to toxic pollution over which we had little or no control; so the smart thing to do was to reduce our exposure to toxins wherever we did have such control. For instance, if you were going to consume nicotine, why not consume the purest form available?
Meanwhile, at the other end of the range, you become caught up in something more complex: in the politics of tobacco—which, by the way, Cassels-Smith dislikes intensely but in which, inevitably, he finds himself entangled. He believes—perhaps “hopes” is a more accurate description—that SyNic might form part of a campaign to change the debate between the tobacco and nicotine industries on the one hand and regulators on the other. At the moment, regulators see tobacco and nicotine users only from the point of view of the harm they cause to themselves and the people around them, which leads those regulators to have as their ultimate goal the elimination of tobacco and nicotine consumption.
But as Cassels-Smith says, if that is the position taken by regulators, there has to be room for a debate about the use of tobacco and nicotine products that don’t expose people to toxins and harm. All the concerns that regulators had could be removed by providing scientific proof that the user was not harming himself and that there was no secondhand exposure, said Cassels-Smith. An example might be where a consumer used a nicotine pouch manufactured with SyNic nicotine.

A product with potential—on multiple levels
Skewed playing field
This sounds persuasive, but one obstacle to such a debate’s getting started is the lack of a level regulatory playing field when it comes to the different products offered by the pharmaceutical and tobacco industries as a means of meeting the needs of those with nicotine cravings. Cassels-Smith said that, over the years, the advice for the use of pharmaceutical-industry-produced nicotine gum had gone from specifying occasional use and then quitting to, if necessary, chewing it all the time, anytime; and there was no reason why this latest advice for nicotine gum should not apply to nicotine pouches. “I believe in a clean nicotine-delivery future,” he said during a telephone conversation in October. “All the stimulation without any baggage.”
At this point I asked whether Cassels-Smith was talking about a very limited range of tobacco- and nicotine-industry products, but he assured me that the ability of SyNic to deliver cleaner products was not as limited as might first be thought. He sees the opportunity and possibility, given the right regulatory framework, for the development of, for instance, many products based on the heat-not-burn principle whereby thermal processes applied to tobacco using temperatures below that needed for combustion was able to deliver the same taste and nicotine satisfaction as a traditional cigarette but without the tar. And he spoke enthusiastically of vapor devices based on SyNic that also were thermally regulated.
Cassels-Smith conceded, however, that SyNic’s impact on traditional cigarettes would be limited only to providing for a delivery that was a little cleaner with higher levels of nicotine, which was what people smoked for, limiting the intake of other compounds. But in almost every other type of tobacco and nicotine product, it could be used almost exclusively to create a much more compelling argument with regulators—an argument that said the consumers of this product were healthy people who were not being made unhealthy by consistently using this product.
Political minefield
The trouble is, as things stand, there is no level playing field, something that was being reflected in the reaction to SyNic, which, when I spoke with Cassels-Smith, was due for launch within a couple of weeks. Whereas the pharmaceutical industry was looking at the new product secure in the knowledge that it could substitute SyNic for whatever nicotine it was then using without having to resubmit its consumer products for fresh regulatory approval (the synthesized nicotine molecule is identical to the tobacco-derived nicotine molecule), the mood within the tobacco and nicotine industries was different. Although, in theory, tobacco and nicotine companies could also make a straight substitution of the nicotine used in products with premarket tobacco authorization or premarket tobacco product applications (PMTAs) before the U.S. Food and Drug Administration, they were wary of doing so in case they were seen to be making medical claims for those products, which would put them on the wrong side of the regulations and might lead to the FDA categorizing those products as drugs.
And this concern about the interpretation that might be put on the inclusion of SyNic in tobacco and nicotine products was at the base of one of the major issues that was clearly of concern to Cassels-Smith. Given that SyNic is a nicotine that offers the very highest level of purity, it would seem that the ethical thing to do would be to make it as widely available as quickly as possible so that the maximum good was delivered to the maximum number of people. But this is not going to happen—at least not immediately. SyNic will not be made available in the U.S. to consumers or to companies without premarket tobacco authorization or PMTAs under review by the FDA; and outside the U.S., it will be made available only to companies working within the regulations of the countries in which they sell their products.
Why is this? Alas, we are back in Cassels-Smith’s least favorite world—the world of politics. He readily acknowledges the important work that a lot of independent, medium-sized and smaller-sized companies have put into creating products that effectively wean people from cigarette use, and he anguishes over the fact that because many of these companies do not have the resources to submit PMTAs, in effect, they are now being “thrown under the bus.” “Somewhere in the sensibilities of this American, that is anti-capitalist and anti-health,” he said. “I would vastly prefer a published set of standards to guide the industry.”
But Cassels-Smith finds himself in one of those “we are where we are” situations. If he allowed sales of SyNic to individuals and companies without premarket tobacco authorization or PMTAs under review, the FDA, given its definition of a “tobacco” product, might take the view that eLiquiTech was using a nontobacco-derived nicotine to try to circumvent the agency’s authority. At the same time, in the U.S., a state could quickly ban SyNic if the authorities there decided, for whatever reason, that this product might undermine their ultimate goal of creating a smoke-free, nicotine-free world. Add to that the fact that selling SyNic to companies without premarket tobacco authorization or PMTAs under review might not go down well with those companies that have gone through the costly process of creating a PMTA, and it is easy to see how Cassels-Smith finds himself having to tiptoe through a political minefield.
“In my heart of hearts, I want to sell it to everybody because a high tide raises all ships,” said Cassels-Smith. “But my problem is that it is too political an issue right now in the U.S. And rather than having the whole technology killed, I want to sell it to responsible manufacturers, get it widely accepted and then maybe there will be a chance for everybody else. But the product needs to survive to allow nicotine users to take it to the next dimension.”

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Changing the narrative
As we came to the end of our conversation, Cassels-Smith said he wanted people to know that he wasn’t against natural nicotine, which he had described earlier as having an impurity profile that was “still quite safe.” But he added that he was very much in support of a new alternative that could change the narrative with regulators worldwide.
I would guess, however, that making such a change is not going to be easy, in part because of something Cassels-Smith alluded to above: the fact that the tobacco/nicotine debate largely concerns the regulators and the pharmaceutical industry while all but excluding the tobacco and nicotine industries.
While reading up on nicotine before my conversation with Cassels-Smith, I was taken with the following sentence in a scientific paper: “This review aims to summarize literature on various modes of nicotine-replacement therapy methods currently used to treat nicotine dependence and to give an overview about future possible approaches to treat tobacco use disorder.” This is another example of the medicalization of tobacco and nicotine use, which often has it that tobacco and nicotine users are “patients” who have to be treated by doctors prescribing pharmaceutical products—often nicotine-based products.
There is some truth in the idea that a consumer is a patient if she goes to a doctor seeking help to quit her habit, but I’m sure that those who don’t would not consider themselves to be suffering from a “tobacco use disorder,” whatever that might be. Take Cassels-Smith, for instance. He is an ex-smoker who now uses nicotine pouches, which he has in his mouth almost constantly; and this is what he told me about his habit: “Do I think I’m doing myself harm?” he asked. “No, because I’m taking the cleanest forms of nicotine that I can. Do I think it [tobacco/nicotine] is much maligned? Absolutely. Do I try and speak out as much as possible? Absolutely. But sometimes I believe I am talking to people who don’t want to find a solution; they just want to call it a problem and get rid of it.”
Despite all this, Cassels-Smith ended on a positive note, saying that SyNic was a tool that could change the narrative. And partly, his positive outlook might be down to the fact that these are early days. One important nontobacco application for SyNic might turn out to be its use in nicotine patches. These patches could be used long-term by people trying to ameliorate the symptoms of Alzheimer’s disease, but long-term use can cause skin irritation among the older people who typically suffer from this disease. SyNic is said to be smoother on the skin and therefore allows for the necessary long-term use. As Cassels-Smith said, there are many different ways in which SyNic could be used, and there are “other unique things that I cannot mention right now because they are still in the process of being patented.”
George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.

December 1, 2020