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Category: Also in TR

  • Pyxus’ ESG Journey

    Pyxus’ ESG Journey

    Photo: Pyxus International

    Advancing progress on key global issues

    By Pieter Sikkel

     It is hard to believe that our company will soon celebrate its sesquicentennial. To say that our business, the tobacco industry and the world in which we live and work has changed over the course of 150 years would be an understatement. In fact, if we were to solely reflect on the events of just the past few years—from uncertainties generated by a once-in-a-lifetime pandemic, the growing social divide and heightened geopolitical risk to the rapid escalation of climate change—there is no shortness of evolution.

    These global events have led companies and their stakeholders to take a step back and ask, “How are the decisions of today impacting the world of tomorrow?” This sentiment is the driving force behind what we now refer to as ESG—environmental, social and governance: the three key areas used to measure a business’ ethical impact and approach to sustainability.

    Pyxus is uniquely positioned to have a positive impact on key global issues, including climate change, farmer prosperity and human rights, and we have been incorporating sustainable practices into our operations for as long as I can remember. For example, in 1991, we launched the first of our now global reforestation initiatives, helping the forests where we operate to become more resilient in the years to come, and in 2012, we introduced our Agricultural Labor Practices program, setting on-the-farm standards that our contracted farmers must adhere to. We are quite proud of our efforts, but we recognized that the process behind them needed to be enhanced in order to advance progress on key global issues. That is why, in December of 2021, we introduced our ESG framework, providing the connection between our company’s business priorities and our purpose—to transform people’s lives so that together we can grow a better world.

    Pyxus’ ESG framework takes the company’s three sustainability pillars—minimizing environmental impact; support for people and communities; and ethical and responsible business—a step further, identifying relevant focus areas and measurable goals to drive positive change and create long-lasting impacts. For example, one of our 12 focus areas is sustainable agricultural methods and practices. Within that focus area, we have set a goal of zero net global deforestation by 2030 in order to help grow a greener future. To date, our business has planted over 250 million trees worldwide as we work toward achieving our long-term goal.

    In order to best position us for success, our ESG framework is supported by a robust governance and implementation structure, which we have based on an annual cycle of continuous improvement. This allows our business to identify and overcome challenges as they arise, prioritize local-level initiatives and leverage the leadership and skill sets of our employee base while holding us accountable for year-over-year progress.

    Additionally, we have aligned our approach with the United Nations Sustainable Development Goals (SDGs), a call to action to address global challenges. There is increasing evidence that businesses that operate sustainably and in support of the United Nations SDGs—while reporting transparently about their progress—can deliver stronger growth and returns for all stakeholders. With this in mind, we publicly shared our company’s CDP scores, which are determined by data reported as part of the global nonprofit’s annual environmental disclosure process. We will also publish our first Global Reporting Initiative sustainability report later this year.

    Moving forward, our company, the tobacco industry and the world in which we live and work will undoubtedly continue to change, and what tomorrow looks like will be defined by the decisions we make today. Companies, regardless of industry or size, have the opportunity to incorporate ESG into their business operations in order to address global issues and shift the paradigm. We encourage our tobacco industry partners to join us in integrating sustainable, measurable solutions so that together we can grow a better world.

    Pyxus’ ESG strategy includes three key pillars underscored by the company’s purpose of transforming people’s lives to grow a better world:

    Environment: to implement sustainable solutions that further improve the company’s environmental performance and reduce the environmental footprint of the company and its supply chain;

    Social: to support the company’s employees, contracted farmers and the communities where it operates, protecting human rights and providing an equal opportunity for success to all; and

    Governance: to operate responsibly and ethically in every action that the company takes.

    Pieter Sikkel is the president and CEO of Pyxus International.
  • Fighting The Wrong War

    Fighting The Wrong War

    Image: nosyrevy

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

    By Clive Bates

    Yes, the tobacco companies worked hard to acquire a terrible reputation over many decades. With the publication of authoritative reports on smoking and health in the early 1960s, the tobacco companies entered a prolonged existential battle with reality. Emerging science threatened one of the most lucrative cash cows ever milked. What became known as the tobacco wars were fought over doubt, the marshy no-man’s land between ignorance and certainty, and it was ugly. That war essentially ended around the turn of the century with ignominious defeats in the courts and at the hands of the U.S. states’ attorneys general. It became clear that the costs of deceit and obfuscation were just too high. With advancing scientific knowledge, the companies would be left clinging to indefensible positions, and their executives would look increasingly absurd.

    But where are we today? Let us consider six recent developments.

    First, in March 2022, the World Health Organization blocked approval of a new SARS-CoV-2 vaccine even though Canada’s regulator had approved it and despite the Canadian government investing in its development. The WHO’s reason? The vaccine is made by a biotech company, Medicago, in which the tobacco company Philip Morris International holds a minority stake. The WHO argues that this would be to protect health policy from “tobacco industry interference.” The global health agency seemed to care little about suppressing the expanded supply of a new vaccine with possibly innovative benefits to a world that will need Covid-19 vaccines for the foreseeable future. And it didn’t explain how a company could conceivably exert any influence through this implausible route or why it might try.

    Second, in September 2021, tobacco control activists tried to stop a tobacco company, again PMI, from acquiring a pharmaceutical company, Vectura, that specializes in inhalation technologies. When they failed to stop the acquisition, they resorted to bullying directed against the scientists at Vectura, threatening to isolate and marginalize them from the scientific community. The activists argue that such investments “legitimize tobacco industry participation within health debates.” But they did not explain why PMI’s clearly stated strategy of diversification to facilitate its transition out of the cigarette trade would be a bad thing or something that they should try to prevent.

    Third, in July 2021, the board of the scholarly Society for Research on Nicotine and Tobacco (SRNT) voted to ban tobacco industry employees from attending the SRNT’s annual conference. Employees of the tobacco industry were already prohibited from SRNT membership. The SRNT defines the tobacco industry as any company owned (in part or whole) by a commercial tobacco manufacturer, implicitly tainting any effort at pro-health diversification or innovation. Yet, the society’s January 2020 guiding principles declared, “SRNT supports, without bias, the generation, dissemination and facilitates debate of rigorous science to address challenging public health questions regardless of the direction the evidence leads.” The tobacco companies now produce some of the highest-quality science in the field in connection with products that can significantly improve health. The SRNT’s words about open-mindedness and freedom from bias are undoubtedly noble, but they failed in their first collision with reality.

    Fourth, in May 2021, the specialist journal Nicotine & Tobacco Research produced a reasoned argument for accepting the occasional paper from an industry source. “Some feel that the tobacco industry’s history, motives and current activities should exclude them from publishing in the journal. Others feel equally strongly that science should be judged on its merits, irrespective of its origins. […] Our current position requires us to sit with this tension and trust that our editorial and review process, and our policies, will ensure that work can be judged on its merits whilst also allowing reviewers and readers to form a view based on its origins.” But in October 2021, the journal issued an “update,” which was little more than an abject reversal of the reasoned policy it had set out six months earlier. The journal felt compelled to follow the direction set by the board of the SRNT. The quality of the science or contemporary evidence of manipulation of scientific discourse was not offered as a justification. However, racial equity and the diversification of the industry were among the stated reasons.

    Fifth, in May 2021, the leading vape company, Juul, published a series of papers summarizing the behavioral science behind its premarket tobacco product application to the U.S. Food and Drug Administration. A special issue of the American Journal of Health Behavior brought together 13 papers covering everything from switching behaviors to retailer compliance. It was all collected in a single publication and free to read. But such brazen openness provoked fury in the tobacco control establishment. The British Medical Journal quoted Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, saying, “… one thing should be abundantly clear: Research funded by tobacco companies cannot be treated as a credible source of science or evidence. No credible scientific journal should allow a tobacco company to use it for this purpose.” Even United States senators took time off from running the country to protest to the FDA at the impertinence of a company publishing its science in an accessible format. Some of the attacks focused on Juul paying fees to the journal for open publication, though that is a standard publishing model. Perhaps critics believed it would somehow serve the public interest if the 13 papers were paywalled, spread over multiple subscription-only journals and published on different dates? So far, no one has found any material fault with the actual science. So far, none of Juul’s critics has shown any curiosity about the findings and what they mean for public health policy.

    Sixth, since 2017, there have been intense and ongoing attacks on the nonprofit Foundation for a Smoke-Free World. The foundation’s stated mission is “to end smoking in this generation.” But because it was set up with a billion-dollar, 12-year commitment from a tobacco company, it has been the subject of intense hostility. Did anyone stop to ask whether research on ending smoking in this generation might be a good idea? Instead, the WHO and tobacco control mainstream would rather the research was never done and that the money was kept by the company. Why?

    What is Going on Here?

    First, this hostility has nothing to do with bad science or inappropriate influence. The tobacco companies, the larger vaping companies and industry consultants produce very high-quality science. Much of it captures the harms caused by cigarettes and shows how such harms could be reduced. Their regulatory science must convince skeptical regulators and withstand public, professional and legal scrutiny for signs of manipulation. Today, tobacco industry science must be and generally is credible.

    Second, several companies are indeed trying to influence the debate about the evolution of the tobacco and nicotine market. But this is in a direction that would be good for public health. With varying assertiveness, the companies want to diversify from combustible products to much safer noncombustible nicotine products and from nicotine businesses to non-nicotine businesses. They would like to discuss the policy frameworks that would cause this to happen more quickly. Tobacco control activists do not like this argument. It implies a future for their nemesis, Big Tobacco, and a diversion from their path to the “nicotine-free society,” a Utopian ideal typical of the War on Drugs. Rather than confront the science head-on, they would prefer the arguments not to be made or not to be heard.

    Third, their cause is served by framing the tobacco and nicotine issue in the simplifying Manichean certainties of good and evil. This makes for more straightforward stories. It supports a well-worn narrative that describes a predatory industry hooking teenagers into lifelong possession by an addictive drug. That sells well, even though it is a grotesque simplification and misunderstanding of how nicotine use works in reality. It also means tobacco control benefits from “white hat bias,” in which embarrassingly poor science escapes scrutiny and challenge. The result has been a steady debasement of the currency of tobacco control sciences.

    Fourth, the most profound reason is that tobacco control activists really need an enemy. They frame their work in war-like language, and the leaders had their formative experiences in the tobacco wars of the last century. The Campaign for Tobacco-Free Kids now uses the slogan “Taking on the Toughest Fights for 25 Years.” Fighting wars is what they do, even if this is increasingly at the expense of public health. It is why the WHO and others cling to the principle that there is an irreconcilable conflict between the interests of tobacco companies and public health. That way, there will always be a battle, they always have the prestige of war heroes, and there will always be money, conferences and entire institutions devoted to the struggle. But permanent belligerence will leave us in a slow-moving stalemate. If there is to be a war, can we please make it a common front against disease and death and not a rerun of the battles of the last century?

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Derek Yach on TR’s Special Innovation Issue

    Derek Yach on TR’s Special Innovation Issue

    The renowned global health expert explains how innovation represents the single biggest opportunity to lower the health toll of tobacco use.

    By Taco Tuinstra

    Until recently, few people would have mentioned the words “tobacco” and “innovation” in the same sentence. Even as other legacy industries started disrupting their respective operations, the tobacco industry remained content to milk its tried-and-tested business model and count on the habit-forming properties of nicotine to sustain its business.

    That has changed dramatically over the past 15 years. Advances in technology, together with shifting attitudes, have turned the once-staid nicotine business into a cutting-edge innovator. The modern e-cigarette was not invented by the tobacco industry, but when it started making inroads around 2008, the industry recognized its potential and devoted considerable resources to its perfection. The ensuing disruption to the nicotine business prompted one major financial institution to rank the impact of e-cigarettes in the same league as that of 3D printing.

    And it didn’t stop there. Tobacco companies went on to develop a host of additional reduced-risk technologies, such as tobacco-heating devices. Some even began applying their expertise in agronomy, product development and substance delivery to create nonrecreational products, such as vaccines, pharmaceuticals and therapeutic devices.

    The topic of innovation has always been dear to Tobacco Reporter’s heart. Not only have we covered it frequently in our columns; we have also created a competition dedicated to industry innovation—the Golden Leaf Awards.

    Astonished by the radical transition taking place in the industry, and excited about what it promises for the future, Tobacco Reporter decided to devote an entire issue to the topic of innovation.

    To ensure the topic would be treated with the breadth and depth it deserves, we partnered with one of the world’s most prominent advocates for public health progress through innovation: Derek Yach. Formerly with the World Health Organization and the Foundation for a Smoke-Free World, Derek was deeply involved in the creation of the Framework Convention for Tobacco Control—a document that was prepared when King Combustible still ruled supreme.

    Since leaving the WHO, Derek has spent much of his time encouraging health authorities to recognize the unique public health opportunity presented by innovation, urging them to accommodate, rather than frustrate, new technologies.

    Tobacco Reporter spoke with Derek about Tobacco Reporter’s special issue and the importance of innovation.

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

    Heading for the Exit

    Photo: Matvey Salivanchuk

    Following Russia’s invasion of Ukraine, tobacco companies to retreat from one of the world’s top cigarette markets.

    By Stefanie Rossel

    Amid growing pressure, the four leading international tobacco manufacturers have joined the exodus of U.S. and European companies that has followed Russia’s invasion of Ukraine. In early March, after the United States, the European Union and Great Britain imposed economic sanctions, all major cigarette makers announced that they would suspend operations or pull out of Russia altogether—although some did so less enthusiastically than others.

    After initially announcing it would merely suspend its planned capital investments in Russia, BAT quickly made a U-turn, signaling a far greater retreat. On March 11, the company announced that its ownership of the business in Russia was no longer sustainable in the current environment, which it described as “highly complex, exceptionally fast-moving and volatile.” BAT is in advanced talks to transfer its Russian business to the SNS group of companies, its distributor in the country since 1993. According to SNS, the level of production and the supply and distribution chain would be maintained with a transfer. As a result of the withdrawal, BAT reduced its annual revenue growth outlook to between 2 percent and 4 percent from the 3 percent to 5 percent announced in February.

    BAT’s move came a day after a Russian government commission approved the first step toward nationalizing the assets of departing foreign companies. On March 10, Russia’s economic development ministry published a draft bill that would give state-owned Vnesheconombank and the state export guarantee agency the right to seize the property of foreign firms that left Russian markets of their own accord. The proposed law would treat a corporate decision to exit the business as a criminal bankruptcy and empower authorities to initiate criminal justice proceedings against local management, BAT Chief Marketing Officer Kingsley Wheaton told Reuters in an interview.

    After announcing plans to scale down its operations in Russia on March 9, Philip Morris International in late March specified the concrete steps it would take, saying it was working on options to exit the Russian market “in an orderly manner.” The company stated that it had discontinued some of its cigarette brands offered in the market and suspended its marketing activities. Furthermore, it had canceled all product launches planned for this year in Russia, including the introduction of its new tobacco-heating product (THP), IQOS Iluma, and its plans to manufacture more than 20 billion Terea sticks, the consumables for IQOS Iluma. Production of the latter would have involved an ongoing investment of $150 million, which the company also canceled.

    JTI, meanwhile, limited its withdrawal from Russia to a suspension of all new investments and marketing activities along with the launch of its most recent THP, Ploom X.

    Imperial Brands, which has a relatively small footprint in Russia, announced on March 15 that it had started negotiations with a local third party about a transfer of its Russian assets of operations. “We believe that, in the current circumstances, an orderly transfer of our business as a going concern would be in the best interests of our Russian colleagues,” Imperial Brands wrote in a statement.

    In addition to their actions in Russia, all four cigarette manufacturers temporarily closed their production sites in Ukraine to protect their workforce and have pledged to continue paying the salaries of employees in the affected countries.

    The decision to leave Russia not only has financial consequences, but it also presents practical challenges. (Photo: Tobacco Reporter archive)

    Between a Rock and a Hard Place

    In deciding their course of action, cigarette manufacturers faced a dilemma of choosing either to leave and protect their reputations or to stay and continue to benefit from the world’s fourth-largest tobacco market.

    The decision to leave not only has financial consequences, but it also presents practical challenges, according to Jon Fell, partner at Ash Park Capital. “It’s one thing to say, ‘we’re no longer going to send our luxury handbags or fashionable training shoes to Russia,’ but if, in addition to factories or distribution centers, you have hundreds or thousands of employees in the country—who up until now have been seen as an integral part of your international company—then you have to take difficult and complex decisions, and there’s no obvious easy, right answer,” he says.

    “Sorting the mess out takes time, and you can’t just abandon employees,” adds Fell. “I don’t think the approach of the tobacco industry overall is very different to that of other consumer packaged goods companies, quite a few of whom are continuing to operate in Russia right now—and drawing criticism because of that.”

    Russian cigarette makers sold 206 billion cigarettes with an estimated value of $717 billion in 2020, according to Euromonitor International. The market has been declining at a 6 percent compound annual rate over the past 10 years and almost 7 percent over the past five years.

    At the same time, the country has developed into a promising market for THPs, which, according to Moningstar, accounted for 11 percent of the total tobacco market in 2021, making the country one of the largest markets for these products outside of Asia.

    With a volume share of 38 percent in 2021, JTI has the greatest exposure to Russia of the tobacco multinationals, according to Euromonitor. The company, which in 2018 acquired Donskoy Tabak, has four factories and 4,000 employees in the country. It has invested over $4.6 billion in the past 20 years. In 2020, its tax payments accounted for 1.4 percent of Russia’s state budget. Russia represented almost 16 percent of group volume in 2021, according to Morningstar.

    It’s one thing to say, ‘we’re no longer going to send our luxury handbags or fashionable training shoes to Russia,’ but if, in addition to factories or distribution centers, you have hundreds or thousands of employees in the country, then there’s no obvious easy, right answer.

    Jon Fell, partner at Ash Park Capital

    Costly Exits

    For PMI, Russia accounted for almost 10 percent of cigarette and THP unit shipment volume and around 6 percent of its total net revenues in 2021. With a market share of 26 percent, the company has three factories, more than 100 sales outlets and approximately 4,100 employees in the country. Ukraine, where PMI runs a factory in Kharkiv with around 1,300 employees, represents about 13 percent of PMI’s regional volume and contributed almost 2 percent to PMI’s total net revenues in 2021.

    Morningstar expects PMI’s tobacco volume from Eastern Europe to decline by 45 percent in 2022 with a slow recovery thereafter as the collapse of the ruble is likely to create translational foreign exchange pressure.

    Both Russia and Ukraine are important markets for IQOS, accounting for about 23 percent of PMI’s THP sales. PMI’s shipments of THP consumables in Russia increased from 13.6 billion units to 16.3 billion sticks in 2021 while shipments of cigarettes continued to fall. Considering Russia’s worsening economic outlook in the wake of international sanctions, however, a J.P. Morgan analyst doubted that PMI would still be able to achieve its next-generation product growth targets. Morningstar assumes that PMI’s write-down in case of a market exit could be approximately $7 billion, corresponding to 5 percent of the company’s market capitalization.

    Ukraine and Russia combined accounted for 3 percent of BAT’s group revenue in 2021 and a slightly lower proportion of adjusted profit, the company said on its website. Morningstar estimates that the bulk of net revenue from these two countries, 2.5 percent, was generated by Russia, where BAT, according to Euromonitor, held 25 percent of the market in 2021. Employing some 2,500 people in Russia, BAT has a factory in St. Petersburg and 75 regional offices. Since the company entered the market in 1991, it has invested more than $1 billion in Russia. Morningstar reckons that the value of BAT’s operations will depreciate by around $2.2 billion, or about 2.4 percent of its market capitalization, as a result of its withdrawal from Russia.

    Among the four players, Imperial Brands is a distant fourth, holding 8 percent of the Russian cigarette market. It operates a production site in Volgograd and has a workforce of 1,000. In 2021, the company said, Ukraine and Russia represented in total around 2 percent of net revenues and 0.5 percent of adjusted profits. Due to the limited profit contribution of the two markets, Imperial Brands explained it expected “a relatively small impact” on its constant currency adjusted profit.

     

    Seeking a Backdoor

    How the multinationals’ retreat will impact Russia’s illicit cigarette market is anyone’s guess. “It’s very hard to know how demand and supply of tobacco products will evolve in Russia given all that’s going on with sanctions, ownership of the industry and, presumably, local purchasing power,” says Fell. “I would certainly think that an increase in the size of the illicit market is a risk, and that’s also going to depend on how long this situation lasts.” Illegal cigarette sales represented 10.7 percent of the total Russian tobacco market in 2021, up from 4.6 percent in 2017, according to Statista.

    Much will depend on how long the conflict continues. Considering the large amounts invested in Russia over the past 20 years, it’s safe to assume that cigarette manufacturers will do their best to minimize their losses. The companies have built strong positions in the Russian market, and there is demand for their products.

    “I’d be surprised if any of the companies—not just the tobacco manufacturers—now exiting Russia are doing so in a way that would prevent their going back in the future, assuming that the war stops at some point, relations are normalized and reentry becomes conceivable,” says Fell. “But arranging that in a way which allows you to say you have exited the country for the time being is no doubt very tricky and is likely to be contributing to decisions taking some time to reach and to be implemented.”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • The Promise of Innovation

    The Promise of Innovation

    Photo: Lezinav

    Nicotine companies are helping tobacco users move from deadly combustible cigarettes to substantially reduced-risk products.

    By Derek Yach 

    Over the past few decades, we have seen unprecedented progress across a wide range of technologies—digital and info tech, biotech, AgroSciences, material sciences and more. These are transforming many sectors considered “legacy,” “dirty” and simply out of fashion. The tobacco sector epitomizes many of the changes underway. The April 2022 edition of Tobacco Reporter highlights the diversity and speed of the change. From finding new uses for the tobacco plant, to ending exposure to toxic substances linked to combustion in cigarettes, to finding ways to design the emerging products to be biodegradable or recyclable, to limiting youth access—innovation pervades this classic, dirty legacy sector.

    Evolution of THR Technologies

    In an insightful article, Mike Huml outlines the role of hobbyists and smokers in seeking solutions to cutting toxic exposures (see “Major Milestones”). Driven by their passion, an entire new set of products with myriad components, a new language and, later, vape stores have arisen. Their role has been crucial in showing what is possible, what is desired and what can be achieved when advances in electronics, aerosolization, batteries and coils are combined into new consumer products.

    Thousands of miles away from where the first large groups of users of these new products live in Shenzhen, China, new companies have taken up the opportunity and drawn on the Silicon Valley-like spirit that pervades the city to develop core components and completed products now at the heart of the e-cigarette and heated-tobacco revolutions. Until recently, companies like Shenzhen Smoore Technology, ALD and other vapor hardware suppliers were unknown in Europe and the United States; today, they are household names in the nicotine business. Their investments in research will increasingly become visible as future products emerge.

    As with any successful innovation, the larger established tobacco companies have invested billions of dollars to create tobacco harm reduction (THR) products that appeal to smokers and pass the muster of regulators, such as the  U.S. Food and Drug Administration. Their continued investment in research, patent filings and product launches mean that we now have over 100 million users of reduced-risk products—but that is less than 10 percent of the real target! More progress requires that state monopolies, who together account for one in two cigarettes sold globally, join the innovators.

    Next Frontiers for Farmers and the Environment?

    Farmers. Advances in our understanding of plant genomics initially helped to produce more environmentally resilient and productive tobacco plants and the ability to adjust nicotine levels. This has now given way to using the tobacco plant to develop a Covid-19 vaccine, a range of pharmaceuticals, wound-healing products and a range of domestic products for clothing, skin care and more! In his article “The Virtuous Weed,” Taco Tuinstra gives a hint of what is to come. These advances, however, will provide only a few tobacco farmers with alternative livelihoods. The speed of switching away from combustibles and high levels of quitting combined with the growth of demand for synthetic nicotine come together to make it more urgent to support the most vulnerable tobacco farmers’ transition to alternative livelihoods.

    THR and the Environment. The growing concern about the impact of plastic pollution on the environment has led to the start of negotiations of a new United Nations resolution on greening plastics. The initiative will take two years to three years, will be legally binding and will push the pace of change in addressing alternatives to plastics like never before. Electronic cigarettes and heated-tobacco products will not escape scrutiny. They contain a wide range of nonbiodegradable components, including plastics, batteries and heavy metals. The rapid increase in disposable vapes and pods has not been accompanied by serious efforts to tackle this problem—until now!

    ALD Group, a Shenzhen-based company, has been actively reviewing various studies and found from the Truth Initiative that 51 percent of e-cigarette users throw their empty pods or disposable devices in the regular trash, 43 percent do the same with their empty batteries, about 17 percent put both in the regular recycling bin, and about the same percentage throw them away or send them for recycling.

    ALD Group’s response is to use biodegradable materials whenever possible and to develop recycling solutions within an integrated environmental management approach based on international standards, such as ISO 14001. The company appears to be adapting best practices from Nespresso on pod design, recycling and disposal as well as from leading beverage companies that have shifted almost exclusively to biodegradable products in the sale of their beverages.

    ALD’s investments in research and development in biodegradability are beginning to pay off. This comes at a time when consumer and regulatory concerns about the environmental impact of risk-reducing product waste have increased.

    Continued Progress on the Transformation Road Demands More Private-Public Partnerships

     In a recent editorial, Nature highlighted the value of industry- academic collaboration in the context of Covid-19 vaccines. This edition shows how massive investments by nicotine companies—large and small—in research, technology development and consumer  insights are delivering alternatives to deadly combustibles and displacing them faster than ever before.

    THR advocate David Sweanor mentions several areas that require additional attention if private-public collaboration is to be achieved: mechanisms for researchers to access industry data and how to apportion intellectual property (see “From Coercion to Empowerment”) None of these are impossible. All require individual companies to find ways to work together on issues of public health and environmental benefit.

    The Nature editorial calls for barriers to collaboration to be dismantled as much as possible. That lesson has yet to penetrate the walls of leading groups like the World Health Organization, academic and research bodies and scientific journals in relation to THR. Bans, prohibitions and ad hominem attacks of tobacco industry and related scientists chills dialogue, slows innovation and seriously hampers progress toward ending smoking and the death and disease it causes.

    This edition shows that despite these barriers, substantial, unstoppable progress is underway—that progress could accelerate if engagement replaced these barriers. The beneficiaries would be millions of smokers seeking better solutions and longer, healthier lives.

    Derek Yach has been a global health expert and anti-smoking advocate for more than 30 years. Throughout his career, he has supported and led smoking cessation research and policy development and has been a strong proponent of harm reduction policies,

    Previously, Yach was the director of the Foundation for a Smoke-Free World, and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.
  • The Virtuous Weed

    The Virtuous Weed

    Artwork: Dan Kurtz

    When tobacco heals instead of hurts

    By Taco Tuinstra

    The health consequences of tobacco use have been well documented. According to the World Health Organization, more than 8 million people worldwide succumb to tobacco-related illnesses, such as lung cancer, heart disease and chronic obstructive pulmonary disease, every year. For every person who dies due to tobacco, at least 30 people live with a serious tobacco-related illness, according to a 2019 policy brief by Tobacconomics.

    Tobacco also carries a significant economic toll. A report prepared by the World Bank Group Global Tobacco Program expected the worldwide economic cost of smoking to reach $1.4 trillion in 2017, equivalent to 1.8 percent of the world’s gross domestic product that year. Little wonder, then, that many view the tobacco plant as evil.

    Yet there is another, decidedly more benign, side to the Wicked Weed. When dried, set on fire and inhaled, the tobacco plant wreaks havoc; when deployed as a “green bioreactor,” the golden leaf has the potential to help address some of the world’s most vexing public health challenges, including, ironically, certain respiratory afflictions.

    Baiya Phytopharm is currently developing a new generation of its vaccine for the omicron variant of Covid-19 and expects to conduct Phase 1 trials in April 2022.
    (Photo: Baiya Phytopharm).

    Among the most striking examples of tobacco’s potential to heal rather than hurt are recent endeavors to develop an inoculation against the novel coronavirus. In February, Health Canada approved Covifenz, a tobacco plant-based Covid-19 vaccination developed by pharmaceutical giant GlaxoSmithKline and Medicago, a biopharmaceutical company backed by Philip Morris International. According to Health Canada, Covifenz is the world’s first vaccine approved for human use that utilizes a plant-based protein technology.

    As it turns out, plants—and especially tobacco plants (see sidebar)—lend themselves exceptionally well to developing pharmaceutical compounds. In many ways, they are better suited to the task than the man-made bioreactors used in traditional vaccine development.

    To create a vaccine, scientists must produce antigens—molecules that trigger an immune response to a specific virus or bacteria. Antigens for conventional vaccines are made by infecting cells from insects, monkeys, hamsters or other sources in the laboratory with a virus or a bit of viral genetic code that tricks the cells into making copies of the virus or antigen. The cells incubate in bioreactors for extended periods of time and then undergo a complex purification process before being packaged into vials.

    Bioreactors are expensive, however, and their operation requires trained personnel. They are also susceptible to contamination, forcing vaccine developers to keep bioreactors growing different types of antigens far apart and under sterile conditions.

    Dahlia Garwe

    Plants are natural bioreactors, according to Dahlia Garwe, the former CEO of the Kutsaga Tobacco Research Station in Zimbabwe. “They are able to perform eukaryotic post-translational modifications that are often essential for biological activity of many mammalian proteins,” she explains. When infected with DNA from Covid-19 or other viruses, plant cells will make millions of copies of virus-like particles that can serve as antigens without being infectious.

    Using plants instead of mechanical bioreactors offers many benefits, notes Garwe. Plants are cheap to grow, easy to manipulate and resistant to contaminations that could present problems for humans. “Green bioreactors do not suffer the same risk of pathogen contamination as seen in mammalian cell culture as there are no known cross-kingdom pathogens,” she says.

    With light as their primary energy source, plants are less expensive to work with than traditional cell culture systems, allowing for inexpensive and nearly unlimited scalability. Because plant systems are robust and inert, they are also easier to handle and purify than other systems.

    Medicago is not the only company that has grasped the promise of plants in the development of vaccines and therapeutics. At least three other organizations are using Nicotiana benthamiana, a close relative of the tobacco plant used in cigarettes, to develop Covid-19 vaccines. In December 2020, the U.S. Food and Drug Administration approved an investigational new drug application for a Covid-19 vaccine by BAT subsidiary Kentucky Bioprocessing (KBP, now part of KBio). The company is currently conducting Phase I clinical trials, which are the first steps in testing the safety and side effects of a pharmaceutical in humans.

    According to BAT, plant-based vaccines have several advantages over serums developed with conventional technologies, including speed and thermostability. Whereas traditional methods can take months to yield the desired vaccine ingredients, KBP’s tobacco plants do so within six weeks. And unlike some of the existing Covid-19 vaccines, KBP’s vaccine candidate has the potential to be stable at room temperature, an important benefit, especially for public health networks in countries with warm climates and few refrigerated trucks and warehouses.

    Fearing supply constraints and “vaccine nationalism” at the start of the pandemic, scientists in Thailand have joined the race as well. Baiya Phytopharm, a plant-produced biologics company, is working with tobacco in part because that crop can be easily and inexpensively cultivated domestically, thus reducing Thailand’s reliance on foreign-made vaccines. According to the Bangkok Post, Thailand has more than 10,000 tobacco growers.

    Waranyoo Phoolcharoen

    In an email exchange, Baiya Phytopharm co-founder Waranyoo Phoolcharoen told Tobacco Reporter that the company had finished Phase 1 clinical trials and was happy with the data. Baiya Phytopharm is currently developing a new generation of its vaccine for the omicron variant of Covid-19 and expects to conduct Phase 1 trials this month (April). If the vaccine candidate does well in subsequent trials, it could be available in Thailand by the end of the year, according to Phoolcharoen.

    Meanwhile, Akdeniz University in Turkey is using a protein produced by tobacco plants to develop a Covid-19 vaccine. Its technology is based on an angiotensin-converting enzyme 2 and can be administered as an injection or through a spray. According to an April 2021 report in Hurriyet Daily News, tests on mice have demonstrated a high level of inhibition of the Covid-19 virus from entering the cell. At the time of publication, Akdeniz University was seeking funding to conduct clinical trials in humans.

    In addition to Covid-19, scientists have sought to tackle many other diseases with the help of tobacco. In response to concerns about bioterrorism following the September 11 attacks in the United States, researchers at the University of Central Florida used tobacco plants to create a protective antigen against anthrax. According to an article published in Environmental Health Perspectives, mice immunized with the agent survived anthrax injections of 1.5 times the deadly dose.

    In 2014, KBP, working in cooperation with the U.S. Biomedical Advanced Research and Development Authority, developed, tested and used ZMapp, an antibody cocktail to treat infection from the Ebola virus, which was raging in west Africa at the time. In under six weeks, KBP completed cGMP manufacturing of each of the three monoclonal antibodies comprising the ZMapp cocktail, which received temporary emergency authorization from the FDA.

    Pushing the envelope further still, Collplant of Israel is using tobacco to generate human tissue and organs. Collplant’s technology allows for the production of large quantities of medical grade human collagen, which is a primary building block for the human body and essential for tissue repair. Physicians use collagen products to treat chronic wounds, burns and other afflictions. Deriving collagen from tobacco rather than from traditional sources, such as cadavers, cows or pigs, offers several advantages, including stable fibrillates, pure molecular structures and no immunogenic responses, according to Collplant.

    While the endeavors described above are only a sample of the many ways in which tobacco is deployed to produce pharmaceutical and other useful compounds, they vividly illustrate the potential of the golden leaf to help solve rather than create problems—a side that is often overlooked due to the health toll extracted by smoking.

    The Green Bioreactor

    While despised in the court of public opinion, tobacco is highly valued among plant scientists.

    For starters, the species has good physiology for research. “Seeds are easily sterilized, and germination is very quick, so generating experimental material is easy,” says David Norman, senior scientist at Demeetra AgBio, a company that is using gene editing for crop trait development and that also works with tobacco (see “Genetic Scissors,” Tobacco Reporter, August 2021). “Tobacco grows fairly fast compared to many plants, to where flowering and mature seeds can be attained in just a couple months.”

    The soft tobacco leaf is ideal for transfection, allowing researchers to easily introduce DNA or RNA into its cells. What’s more, regeneration mechanisms from callus in tobacco are extremely efficient. In addition to allowing genetic modifications on leaf material, tobacco is also easily propagated as a cell culture or protoplast culture. 

    The fact that tobacco is neither a food nor a feed crop makes it even more attractive as a plant for conducting research, according to Dahlia Garwe, the former CEO of the Kutsaga Tobacco Research Station in Zimbabwe. Using tobacco, she says, reduces the likelihood of transgenic material contaminating food or feed supply chains—an important consideration when many consumers remain wary of genetically manipulated foods.

    Tobacco is also well understood from a genetic engineering and molecular biology standpoint; it has been more characterized than any other plant system. Scientists have been researching and genetically modifying tobacco since the early 20th century.

    Meanwhile, biochemists have been able to produce many recombinant proteins in tobacco, with the plants serving as bioreactors for largescale production of pharmaceutical and industrial compounds. “Tobacco can easily take in DNA to produce these compounds when injected into the leaf or through vacuum infiltration of whole plants,” says Norman.

    The vacuum infiltration method, in particular, can be scaled up to infect many plants at one time, according to Norman. “After infiltration, tobacco transiently expresses the DNA introduced for a short while and makes the protein of interest in the leaves.

    “While the protein production in plants may not be that impressive on a per plant scale, up to a few percent depending on the protein of interest, you have to consider the yield per acre for tobacco. On an average acre of tobacco, the yield can be several tons of leaf material. With that scale of leaf material per acre, suddenly those small protein yields add up to being significant and potentially economically viable.”–T.T.

    The Plant-Based Vaccine: A Late Bloomer?

    In February, Medicago’s Covifenz Covid-19 vaccine received the green light from Health Canada, making it the world’s first plant-based vaccine approved for human use. Considering how long scientists have known about the potential of plant-based vaccines—the proof of concept dates back some 30 years—it may seem surprising that the first regulatory approval for such a product was granted only this year.

    While the U.S. Department of Agriculture in 2006 gave the thumbs-up to a plant-derived vaccine to inoculate chickens against the lethal Newcastle disease, most of the projects targeted at human vaccines never even made it to end-stage clinical trials. The FDA did approve Protalix’s plant-based drug to treat Gaucher’s disease in humans in 2012 and in 2014 gave emergency authorization to ZMapp, a plant-based biological medicine manufactured by KBP (now part of KBio) to treat Ebola, but the first was not a vaccine, and the second was approved under special conditions.

    Dahlia Garwe, the former CEO of the Kutsaga Tobacco Research Board in Zimbabwe, suspects the “delay” in approving plant-based vaccines is due to regulatory issues and public perceptions of genetically modified organisms (GMOs). “Most vaccines produced in plants would most likely be classified as GMOs, which automatically makes them ‘undesirables,’” she ventures.

    Kathleen Hefferon, who teaches microbiology at Cornell University, acknowledges that public perception may be part of the problem but believes that many consumers would accept plant-made vaccines just as they have accepted vaccines produced in eggs and mammalian cells. “They are familiar with the GM technology when used for medical purposes,” she says. “It is when it comes to genetic modification in food products that some people seem to raise concerns.”

    Hefferon suspects that the absence of a clear regulatory path represents the greatest obstacle as it may have made pharmaceutical companies wary of investing in this technology. The carrot suspension cell culture that Protalix used for its Gaucher’s disease drug somewhat resembles Chinese hamster ovary cell culture, she notes. “That made it a little easier for regulators.”

    Patrick Doyle, CEO of KBio Holdings, a company set up by BAT to accelerate the development and production of novel treatments with plant-based technology, says it is important to remember that in a normal R&D cycle, medicines and vaccines on average take over 10 years, even when using a proven technology or approach.

    “In fact, as a result of the global health crisis presented by Covid[-19], development, regulatory review and approval timelines were accelerated to support the delivery of much-needed vaccines,” he says. “Before gaining approval for any vaccine, manufacturers must generate sufficient data to demonstrate the efficacy and safety of the candidate and technology, which takes time. For example, the mRNA platform, first discovered in the early 1960s, was a genetic technology that had long held huge promise but only received the first FDA [Food and Drug Administration] emergency use authorization for the prevention of Covid-19 disease in individuals 16 years of age and older on  Dec. 20.”

    According to Doyle, the positive data generated and the subsequent approval of Medicago’s vaccine is both a positive in terms of creating another approved treatment option for Covid-19 and reinforcing the potential of plant-based vaccines.

    Hefferon agrees that Medicago’s success could set the stage for plant-made pharmaceutical commercialization in future years, and her optimism appears to be shared by others. Research and Markets expects the value of the global plant-based vaccines market to reach $2.62 billion by 2028—more than double the 2021 figure. Tobacco companies seem well attuned to the potential as evidenced by PMI’s investment in Medicago and by BAT’s creation of KBio. Doyle says KBio will explore new opportunities to develop its plant-based production system, which has the potential to offer greater speed, thermostability and scale-up opportunity and.

    Hefferon says she’s very happy about the growing momentum for plant-based vaccines. “Too bad it took a pandemic to make it happen.” –T.T.

    Uphill Battle: Tobacco-Backed Vaccines Continue To Face Skepticism From Health Authorities

    While tobacco plants lend themselves exceptionally well to the creation of pharmaceutical compounds, vaccinations and treatments developed by tobacco-backed organizations still face an uphill battle as demonstrated by recent World Health Organization actions.

    During a March 16 media briefing, the WHO’s assistant director-general for drug access, vaccines and pharmaceuticals, Mariangela Simao, said the global health body had paused the process for pre-qualification of Medicago’s new Covifenz Covid-19 shot due to the biopharmaceutical firm’s link to Philip Morris International, which owns about one-third of the Canadian company.

    “The WHO and the U.N. have a very strict policy regarding engagement with the tobacco and arms [industries], so it’s very likely it won’t be accepted for emergency use listing,” said Simao. The WHO persists in its opposition despite Health Canada’s February approval of Covifenz for adults between the ages of 18 and 64.

    In a statement published by the CBC, Medicago said it believes authorization decisions should be based on the quality, efficiency and safety of the vaccine, not who owns shares in the manufacturer.

    “It is our understanding that the WHO has made a decision to pause the approval of the vaccine and that this decision is related to Medicago’s minority shareholder and not to the efficacy and safety of the vaccine, which was demonstrated with the approval by Health Canada,” the statement reads.

    Derek Yach, a global health consultant, was aghast by the WHO’s suggestion that it might reject Medicago’s vaccine based on the company’s relationship with PMI.

    “‘Pikuach nefesh’ is the ethical principle in Jewish law that the preservation of human life overrides virtually any other religious rule,” he said. “Most other religions support a variant of this. WHO violates this ethical principle when it denies people access to a lifesaving vaccine.”

    If the WHO follows through, the vaccine would be the first Western-manufactured Covid-19 shot to be rejected by the global health body, according to Bloomberg. —T.T.

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

    Major Milestones

    Photo: Uwell

    Vaping technology has come a long way. Here are the most impactful breakthroughs from the past 15 years.

    By Mike Huml

    The e-cigarette, which may very well be the most effective harm reduction device ever conceived to address preventable diseases, is built upon the simplest circuit possible. In essence, an e-cigarette is a resistor, a switch and a power source. From this simple circuit, thousands of variations arose over the course of about 15 years. During this Golden Age of regulatory limbo, the vapor industry exploded, and with that came endless innovation and constant refinement, transforming that little cig-a-like into all the products vapers enjoy today. Throughout this process, several innovations stand out as milestones. These innovations would improve the quality, consistency or convenience of the vaping experience. The nature of these changes necessarily contributed to reduced risk and increased uptake among populations.

    The Cig-a-Like

    Photo: Wabeno

    While more an invention than an innovation, the e-cigarettes that were available circa 2008 were not based on a revolutionary concept. Patents for similar but rudimentary e-cigarettes date back as far as the 1930s, but it wasn’t until the new millennium that all the pieces came together into a marketable product. Early adopters of the technology readily admit that first-generation e-cigarettes left much to be desired. What these pioneers agreed on, however, was the potential of these products. By improving the hardware and e-liquids—which could be accomplished with relatively inexpensive and readily available components—those early e-cigarettes could be turned into truly viable alternatives to their combustible counterparts.

    Cig-a-likes provided brutally short battery lives, weak but perceptible vapor, questionable flavor reproduction and a penchant for leaking and “spitback.” Almost immediately, e-cigarette users began tinkering with modifications to these products to mitigate the negative aspects. Cartridge “polyfill” was replaced with aquarium filter to increase absorption and prevent stray fibers from sticking to the bridge of the atomizer. Some wouldn’t be bothered with cartridges at all, nor the inconsistent draw and spitback associated with them, and replaced the cartridge with a “drip tip.” With one or two drops of e-liquid applied directly to the atomizer, the experience became more consistent at the cost of convenience. Longer batteries were soon made available to increase battery life, but it wasn’t until an increase in girth was an option that vapers and manufacturers collectively had an epiphany that would change everything: E-cigarettes don’t need to look like cigarettes.

    The eGo

    Photo: Joyetech

    The eGo, and other similar variations like the Riva, resembled a cigar more than anything. As battery life was a primary turnoff to curious parties, the idea that a battery could last a full day jump-started an entire era of e-cigarette popularity. The eGo could be found in affordable kits at almost every e-cigarette retailer, and it was available in different colors with different atomizers to match. Cartomizers and clearomizers largely replaced the old cartridge-plus-atomizer combination, and with inconvenience slowly becoming alleviated and customization increasing, the e-cigarette market saw a remarkable boom. There was still work to be done, however, as each starter kit required a tutorial and a certain degree of patience. Investment in new technology was still minimal and mostly took the form of variety instead of quality. Customization of appearance was great, but there was still hardly any customization of the vape experience itself. Atomizers of varying resistances were available, and small batch “modding” filled a niche need for higher power with different voltages by stacking batteries in series, but the gap between these two progressions was still wide.

    The Provari and Variable Voltage

    Photo: onVaping

    The Provari from Provape was in a class of its own. Coveted by all vapers, this device was the Cadillac of vaping. It single-handedly popularized the concept of variable voltage. Instead of trying and buying atomizers of multiple resistances, the Provari provided a range of output voltages, effectively allowing the user to adjust the amount of vapor and heat generated by atomizers of most any resistance available at the time. Unfortunately, the Provari was expensive, rare and much larger than the eGo. However, the Provari was rugged, durable and made in America—all features in high demand and low supply. Any mod from the variable voltage era took its cues from the Provari in terms of both performance and aesthetic. Eventually, variable voltage technology worked its way all the way down to the eGo in a new variation known mainly as the eGo Twist. Rampant cloning and intellectual property theft became a real issue during this time, but for better or worse, it led to countless variations of variable voltage devices, including the eGo Twist, eGo Spinner, eGo VV and many others.

    The Tank

    Photo: Uwell

    Up until this point, e-liquid was dripped directly onto an atomizer or absorbed by some type of filler. As power and performance increased, e-liquid was being consumed at a faster rate, and a larger supply was required in order to avoid constant refilling and dry hits. By modifying cartomizers by punching a hole in the casing and inserting it into a clear plastic cylinder, the “carto tank” was born. Early versions had trouble with both leaking and dry hits due to wicking inconsistencies, but again, there was potential. The idea of free-floating liquid in a reservoir changed how innovators thought about e-liquid delivery, leading to popular products such as the clearomizer, which was smaller than a tank but paired perfectly with the eGo’s size, came in a variety of fun colors and could be filled up much faster than a standard cartomizer. At this time, sides were chosen. Team Cartomizer enjoyed more vapor production and a draw that more closely resembled that of a traditional cigarette at the cost of convenience while Team Clearomizer had a range of colors to choose from and a smooth draw at the cost of leaking and dry hits. As time went on, the technologies and methods used to create these early tanks improved into the sub-ohm tanks that we enjoy today. Almost all common sub-ohm tanks take inspiration from both camps, with a vertically oriented coil surrounded by a filler material (cartomizer) housed in a clear tank with free-floating e-liquid. Although a range of preset resistances were available to pair with variable voltage devices during this time, due to generally poor quality-assurance standards, even multiple coils with the same advertised resistances could perform drastically differently from one another, even when fired at the same voltage. To combat this, a new technology had to emerge.

    The Darwin and Variable Wattage

    The Darwin from Evolv flew under the radar, mostly due to its boxy appearance, unique design that favored cartomizers specifically and a general lack of electrical knowledge among nonhobbyist vapers. But make no mistake, the Darwin was a game-changer, and its technology was enthusiastically copied by other manufacturers. To simplify: With a variable wattage device, atomizer resistance no longer mattered. Once a user decided that they enjoyed vaping at 10 watts, an atomizer of any resistance could be attached, and it would always vape the same way. Even minor inconsistencies between atomizers of the same resistance had no noticeable impact on the vaping experience. As variable wattage technology slowly made variable voltage obsolete, stores no longer had to carry extensive varieties of identical cartomizers, clearomizers or other atomizers with different resistances. Vapers no longer had to stalk their favorite retailer in the hopes that their favorite 2.5-ohm cartomizer would finally be restocked. Most importantly, variable wattage directly led to a blanket increase in overall consistency of vapor products.

    The Road Less Traveled—Mechanical Mods, Rebuildable Atomizers and Sub-Ohm Vaping

    Photo: Bedya

    While mainstream vaping was evolving, another phenomenon was taking place. While features, gadgets and color variety appealed to the mainstream, technology simply wasn’t moving fast enough for the hobbyist vaper. They wanted one thing: vapor. Nothing else mattered. Convenience? Safety? What are these words? By removing the internals from the mod formula in order to provide the cleanest, most direct pathway for electricity to flow from the battery to the coil and dropping coil resistance to below 1 ohm, sub-ohm vaping was born. The chips used to regulate mainstream mods provided too many amperage limitations, and hobbyist vapers spent ludicrous amounts of money because they favored craftmanship over new gizmos and pure performance over convenience. Of course, no premade atomizer was available at a resistance below even 1.25 ohms, so the DIY crowd began to, in fact, DIY. Small operations began manufacturing limited runs of solid metal mods and large atomizers in which the coil could be built by the end user. This allowed for maximum performance customization but minimal convenience. Additionally, this setup inherently presented the highest risk potential as there was no board to protect from pulling too many amps from a battery that wasn’t designed with vaping in mind. As such, surprisingly large leaps in battery efficiency and safety resulted from a spike in the demand for high-amperage batteries.

    The DNA Board

    Seeing multiple factions form in the vaping community, Evolv recognized a need. Some mainstream vapers wanted to “chuck clouds” safely and without the hassle of rebuilding and using a mechanical mod, which could be prohibitively expensive. Conversely, some hobbyist vapers ashamedly admitted that it would be nice to be able to enjoy some of the conveniences of “normie” mods without sacrificing too much performance. The DNA20 board finally proved that it was possible to vape sub-ohm coils on a regulated device and to do it safely. Any atomizer with a resistance down to 0.8 ohms could be used up to a maximum power of 20 watts—a far cry from the triple-digit wattages some mechanical mod users were accustomed to, but the DNA20 was a successful first step toward uniting a community that was just beginning to coalesce.

    Around this same time, vaping could no longer be ignored by the media and health officials. Partly exaggeration and partially due to the uptick in the popularity of vaping, reports of varying credibility started making headlines, with media outlets reporting on battery explosions, “popcorn lung” and heavy metal toxicity. Some of those health concerns turned out to be spurious, often due to flawed study designs.

    “This study was conducted by firing a two-ohm clearomizer from three years ago at six volts and measuring the levels of heavy metals and other pollutants,” researchers of such materials might write. “The results show an abundance of heavy metals, formaldehyde and silica particulates.”

    Yes, all vapers knew that dry hits were bad, but they were also repulsive to experience, and so these studies didn’t accurately reflect how users were using vapor products in the real world. However, it brought up a decent point. Vaping was regarded as safer than smoking, but it could always be safer. Having gone through a couple iterations of their DNA board, Evolv released their newest chipset that would change the industry yet again.

    Temperature Control

    Photo: EcigaretteDirect

    The DNA40 was an improvement over the DNA20 and the DNA30 in terms of power output and other functionality, but more than that, it was the progenitor of every temperature control device available today. When using a coil comprised of nickel, the DNA40 could calculate the temperature of the coil by measuring the change in resistance due to heat. Since it could calculate the temperature, it could maintain said temperature by adjusting the wattage by way of voltage in order to effectively eliminate dry hits. The chemical changes caused by overheating e-liquid, wire and wicking material now had a safeguard in the form of temperature control. This technology was naturally copied and can be found on almost every modern vaping device. Even pod systems use a simple version of temperature control technology. Several years after the release of the DNA40 and seeing an increase in demand for high-wattage devices, the DNA200 was released with a refined version of temperature control that could use additional wire types but that also included a revolutionary piece of software called eScribe.

    eScribe Software

    Available for free to anyone with a PC or Mac, eScribe provides not only the most comprehensive suite of features and customization options for vapers who use devices with a DNA board but also tools for researchers and scientists studying the health effects of vaping, allowing them to plot and record data with ease. The user features include custom screens, easy firmware updates, additional profiles and more. However, with more and more attention being brought upon vaping, particularly the health element, eScribe is the perfect tool for anyone to conduct their own studies and experiments. Everybody from the curious hobbyist vaper to large health institutions can access the features in eScribe and easily troubleshoot their device or go as far as to conduct large-scale studies.

    Pod Systems and Nicotine Salt

    Photo: Bantham

    Sometimes, things come full circle. With vaping technology reaching a plateau due to an overall increase in quality across the board, becoming more affordable and accessible on beginner-focused devices and inevitably facing government regulations, it became easy to provide a small device that delivered on the promise that cig-a-likes made years before. Although pod systems generally still don’t resemble analog cigarettes in appearance, the vape experience has never been closer to feeling like smoking. Years of trial and error, innovation and refinement led to the widespread popularity of these inexpensive, simple devices. Additionally, while liquid nicotine had been the standard prior to the existence of pod systems, nicotine salts provide a level of nicotine comparable to smoking but without the overly harsh throat hit and pungent flavor of e-liquid that contains a large percentage of liquid nicotine solution. Together, pod systems and nicotine salt e-liquid provide a foolproof package that anybody can pick up at a local retailer, fill up and begin using immediately and with no prior knowledge of vaping or its underlying electrical concepts. Meanwhile, synthetic nicotine is presenting new opportunities given its lower levels of contaminants and its suitability for standardization of safety and quality.

    Thanks to years of innovation, we are inundated with vaping products that not only provide a consistent, convenient and enjoyable alternative to smoking but that are also safer, more so than vaping used to be. As vapers looking back on the past decade, it’s clear that every technological innovation for the sake of a better vaping experience was also an innovation in harm reduction. The original cig-a-like was a proof-of-concept that demonstrated immense potential and got innovators excited for future prospects. The eGo addressed pressing needs of users but also directly led to a decrease in smoking, a net positive for public health. Moving from fixed voltage to variable voltage to variable wattage saw a directly linked connection to increased consistency and overall product quality while continuing to appeal to more and more people. Mechanical mods and sub-ohm vaping sparked a demand for safer and more efficient battery technology, which has huge implications for many other technological industries. With temperature control technology and eScribe, we see an answer to the health concerns, warranted or not, from health agencies and others. Pod systems bring everything full circle, utilizing all the advances in vapor technology while maintaining a simple, no-hassle design reminiscent of the original e-cigarette—where it all started.

    Vaping technology has come a long way in a short 15 years. What started as a hobby of passionate vapers triggered a wave of innovations, first pursued by independent entrepreneurs and later turbocharged by the investments of well-resourced traditional tobacco companies. This has resulted in mass production of safer nicotine products, giving smokers a welcome alternative to deadly combustibles. While the majority of consumers are now embracing standardized products, the hobbyists will likely continue innovating, further pushing the boundaries of technology in what was once considered a staid business.

    Mike Huml is a professional vapor hardware reviewer. An enthusiast vaper since 2009, he is always trying to get his hands on the newest, shiniest mod. Huml has evaluated countless vaping devices over the years, but you’ll usually find him with a mechanical mod and RDA in-hand, surrounded by an aura of fog. His personal motto: “Happiness is a warm coil.”
  • Preventative Measures

    Preventative Measures

    Photo: Metamorworks

    Innovations in technology and regulation could help ease the concerns surrounding youth access to vaping products.

    By Timothy S. Donahue

    Most tobacco control experts agree that vaping is safer than smoking combustible cigarettes. The primary concern for anti-vaping groups, legislators and regulatory officials isn’t where e-cigarettes fall on the continuum of risk; it’s about preventing youth access to nicotine products, whether underage is defined as under age 21, as it is in the United States, or as under age 18, as it is in many other markets. The best way to prevent youth access is through innovative technology, according to vapor industry experts. Technology and regulatory policies will both be required for the vaping industry to satisfy its skeptics.

    Technological innovations have been the vaping industry’s primary contribution to battling youth access. Several companies have developed devices that use biometrics, such as fingerprint and facial recognition. The OBS Cube FP Kit, for example, uses fingerprint recognition to prevent unauthorized use. However, a 2020 review by ecigclick.com found the fingerprinting function complicated to configure. “The instruction manual is total pants … it really is,” the reviewer wrote. “So far, I haven’t worked out how to use the fingerprint stuff; there are diagrams in the book which relate to bugger all on the actual device.”

    Juul Labs launched its C1 in Canada in 2019. The device paired with an Android smartphone to limit who could use it and to provide monitoring of what and how often the user vaped. Juul says the C1 could only be used if people passed age verification and facial recognition checks. The C1 also had a system that could be set to automatically lock when it was not being used or was away from the phone to which it was linked.

    Juul Labs then launched the Juul2, which had many of the same child safety features as the now discontinued C1. The Juul2 can also recognize and authenticate proprietary Juul2 pods when they’re attached, limiting the ability to use counterfeit pods or refill pods with other substances, such as THC.

    The OBS Cube FP Kit, for example, uses fingerprint recognition to prevent unauthorized use. (Photo: OSB)

    Steven Yang, senior director of FEELM R&D, says that FEELM has incorporated designs into its products that prevent misuse by children, for example, by requiring the user to follow a specific sequence of procedures to activate the device. 

    “With a number of [the] industry’s leading patents, FEELM is exploring ways to integrate Bluetooth, fingerprint, airflow switch, sensor and other electronic technologies to create a child lock on products,” Yang says, adding that many Chinese vaping industry leaders have already adopted ID verification and facial recognition technologies.

    “FEELM’s strategic partner and China’s leading vape brand, RELX, has initiated Sunflower System in 2019. Based on AI and big data, the Sunflower System is integrated into different scenarios, such as RELX chain stores and the RELX app to prevent minors from purchasing vaping products,” explains Yang. “The Sunflower System has been extended to all RELX chain stores in China to ensure each purchase order is traceable. Moreover, through big data and GPS, the Sunflower System can automatically filter the addresses that do not meet the legal requirements of opening a vape store—for example, near schools.”

    Project Sunflower consists of adopting ID and facial recognition technologies to ensure that only adults can purchase products in its Chinese stores, according to RELX. Minors are not allowed to enter RELX stores, and in-store face-scanning cameras send alerts to RELX store staff if a suspected minor enters the store. Any suspected minor that is not able to present legal, valid ID proving his or her age is asked to leave the RELX store.

    Upon purchasing a product, RELX customers also need to verify their age through a facial recognition process that matches the customer’s face with the photo on the customer’s Resident Identity Card,” says a RELX representative. “This process is to ensure that the person in the store is using their own valid identification and not attempting to impersonate an adult.”

    While facial recognition measures are widely used and accepted in China, they may encounter resistance elsewhere. Chris Howard, vice president, general counsel and chief compliance officer for E-Alternative Solutions, a U.S.-based e-cigarette manufacturer, says that consumers have generally accepted biometric controls in phones, tablets and other devices that use fingerprints or faces to unlock the screens.

    Those who are tech savvy would likely welcome such an alternative in their vaping products, he says. However, traditional cigarettes don’t have any electronic controls to prevent unlawful use, so if vaping regulations follow tobacco rules, that would limit these types of innovations. 

    RLX Technologies has deployed facial recognition technologies to ensure that only adults can purchase its products in the company’s Chinese stores. (Photo: RLX Technolgies)

    “The idea that such a requirement would be necessary for vapor products to receive marketing orders seems unlikely. It is important to remember that adult smokers may be unwilling to deal with an electronically locked tobacco product,” says Howard. “While some may enjoy the novelty, many may just use a tobacco product—likely higher risk—that is easier to use. Many questions surround the use of biometrics in products. There are legal privacy issues, which would increase the cost of such devices.”

    Manufacturers must also remain aware of regulatory restrictions in the markets they operate within, according to Yang. FEELM has developed protocols to help retailers and distributors comply with local guidelines. Yang says the company attaches clear warning labels on its closed-system vaping devices and includes language in user manuals stating that the products are intended for use only by adults.

    “We also focus to ensure that the retail stores in which our products are sold have mechanisms in place to verify the age of the consumers purchasing products manufactured by us so as to comply with local laws and regulations in relation to age restriction,” Yang says. “Moreover, our website and our major customers’ web stores require visitors to enter their age before entering the websites.”

    While technology is an important component of a comprehensive strategy to prevent youth access, experts note that the industry and its regulators should also acknowledge technology’s limitations. Having grown up with smartphones, online social networks and e-commerce, today’s youngsters are the most digitally savvy generation to date. While the technical solutions to deter underage access may deter some, sufficiently motivated young buyers are likely to overcome such measures with relatively little effort.

    Regulatory Response

    Taxation has long been the preferred deterrent to youth access by regulators. Studies suggest, however, that increasing taxes doesn’t always have the desired impact. Instead, these measures discourage combustible smokers from switching to a safer alternative, according to a study by Steve Pociask and Liam Sigaud for the American Consumer Institute Center for Citizen Research. The researchers state, “overzealous or poorly designed restrictions [like tax increases] on vaping, combined with misleading information about e-cigarettes’ actual health risks, are deterring smokers from pursuing a potentially life-saving alternative.”

    Tim Andrews, director of Consumer Issues for Americans for Tax Reform, says that increasing taxes on reduced-risk tobacco alternatives will not reduce youth access but punish adult vaping consumers, leading many back to deadly combustible cigarettes.

    “Paradoxically, by creating a booming black market, which, by definition, possesses none of the rigorous age verification processes required by legal retailers, vapor taxes may increase not decrease youth access,” he says. “Youth vaping has plummeted in recent years due to increased enforcement of existing law. [According to the U.S. Centers for Disease Control and Prevention, only 3.1 percent of high school students vape daily.] Adequate and appropriate enforcement of existing law—not increasing taxes—is what will continue to drive this number down.”

    Tobacco harm reduction advocates also stress the importance of risk-proportionate pricing along with proper education about the products available to encourage smokers who cannot or will not quit nicotine to consider alternatives that are less harmful than cigarettes. By taxing the most harmful products—combustible cigarettes—at significantly higher levels than reduced-risk alternatives, regulators can nudge consumers to the least unhealthy options.

    Chris Howard

    Other innovative regulatory responses to youth vaping have had mixed results. Outside taxation and Tobacco 21 laws in the U.S., any effectiveness seems hard to prove. Research suggests that there are few studies available that show what impact differing regulatory actions have on youth vaping. A study published in BMC Public Health, “Policies that limit youth access and exposure to tobacco: a scientific neglect of the first stages of the policy process,” examined 200 international peer-reviewed articles. The researchers found that scientific evidence on the policy process for youth prevention initiatives were scarce.

    “The processes influencing the adoption of youth access and exposure policies have been grossly understudied. A better understanding of the policy process is essential to understand country variations in tobacco control policy,” the researchers wrote. They then went on to suggest that “policymakers can adopt and implement various supply-side policies to limit youth access and exposure to tobacco, such as increasing the minimum age of sale, limiting the number or type of tobacco outlets or banning the display of tobacco products.”

    Howard questions whether regulations limiting the number of tobacco outlets/vape shops or display bans would materially impact youth access. “Which companies should lose their business licenses?  Should only major chains, with arguably more control over storefronts, be permitted to sell tobacco products?” Howard asks. “How will removal of businesses prevent youth from obtaining tobacco products? Yes, there will be [fewer] stores to find products [at], but that doesn’t mean youth vaping will decline. During the ‘youth vaping epidemic,’* Walmart, arguably the largest retail footprint in the U.S., removed vapor products from its stores—is there evidence of reduced youth vaping as a result? Finally, banning tobacco product displays may impact youth exposure to products but would also reduce adult smokers’ exposure to different, potentially less harmful products.”

    Incentivizing Success

    There may be more innovative options to consider in controlling youth access. Another potential avenue to curb youth access may be to require manufacturers to offer incentives to retailers to maintain good practices. B2B sales discounts or incentives for meeting certain standards is likely to go a long way toward limiting youth access, according to Howard.

    “Manufacturers can incentivize limiting the number of products in a transaction to prevent straw sales, passing compliance checks, tobacco sales training and participating in the We Card program to encourage retailers to ‘up their game’ in preventing youth access,” he says.

    States are slowly becoming more innovative in their regulatory approach to youth vaping. Hawaii, for example, is considering the passage of a law that would require its Department of Health (DOH) to coordinate with its Department of Education (DOE) to establish a “take back” program for students to “voluntarily dispose of electronic smoking devices, flavored tobacco or synthetic nicotine products, and tobacco products in their possession.” If passed, the rules would also require the DOH and DOE to coordinate quarterly meetings with students on addressing the youth vaping epidemic.

    Many industry experts agree that the vaping industry, tobacco control community and regulators should be working together to solve the problem of youth uptake. However, that seems unlikely. It could be argued that the world’s most prominent regulator, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), should be bringing stakeholders together to seek out common solutions to these problems. That hasn’t happened, according to Howard.

    “It appears CTP felt compelled to use a club, as opposed to a scalpel, to excise youth vapor use. Banning flavored pods and blanket denials of millions of PMTAs [premarket tobacco product applications] for flavored products through sweeping MDOs [marketing denial orders] removed most industry stakeholders in just about a month,” says Howard. “While much of this was thrust upon CTP by outside forces, it is hard to imagine, when they can completely control the issue, why would CTP now resort to compromise solutions?

    “CTP and the tobacco control lobby both detest those bad actors that market their products without regard to this important issue. Companies that actively follow the rules detest these bad actors too.  CTP, tobacco control and the ethical side of the industry should join forces to root these bad actors out.”

    *The surge in U.S. teen vaping was mainly a U.S. phenomenon. The most recent Centers for Disease Control and Prevention data suggest that episode is largely over, with both youth smoking and vaping at low levels. See https://www.cdc.gov/mmwr/volumes/71/ss/ss7105a1.htm?s_cid=ss7105a1_w.
    Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
  • All in the Mind

    All in the Mind

    Photo: andriano_cz

    A human-centric health ecosystem could unleash tobacco harm reduction’s full potential.

    By Stefanie Rossel

    In their efforts to end the era of combustible cigarettes, governments, public health authorities and other stakeholders today have a much larger toolkit at their disposal than they did at the turn of the millennium—at least in theory because only a fraction of available strategies are currently being employed.

    Due to increasing connectivity, the Fourth Industrial Revolution has brought rapid changes to technology, industries and society. It is also transforming the healthcare system—insurance companies seeking to promote a healthy lifestyle by asking their customers to use wearable devices that record physical activity and calorie intake are just one example.

    In order to better deal with today’s complex challenges, healthcare has in recent years become more human-centric, striving to understand human needs and how design—both the process of designing and the outcome of that process—can respond to these needs. “Design” in this context refers not only to products, services and procedures but also to strategies and policies.

    A human-centric health ecosystem (HCHE) involves understanding people and their needs, engaging stakeholders throughout the design process and systematically addressing interactions between the micro-level, meso-level and macro-level of sociotechnical care systems as well as the transition of individual interests to collective interests.

    This new approach to healthcare requires a holistic systemic approach, major organizational change and well-designed, dedicated interventions, such as products, services or procedures to be used by patients, caregivers and medical professionals to facilitate and implement the system.

    The role of the patient in this system changes accordingly: Instead of being a passive recipient of medical directions, he or she becomes a well-informed, responsible patient, intrinsically motivated to actively contribute to the success of his or her treatment. In contrast to the traditional approach, he or she doesn’t simply passively comply with instructions and wait for professionals to solve their problems but makes use of a technology-enabled ecosystem with an embedded choice architecture that encourages the desirable behavior and seeks support from a variety of sources.

    This healthcare model is shifting the focus from treatment toward prevention. Centralized, capital-intensive diagnostics facilities will be aided and perhaps even replaced by individual, on-demand or continuous inexpensive and readily available technologies, such as the mentioned wearables. Sensors in these devices generate data that enable disease prevention with the help of machine learning. Diagnostic and treatment data could be collected in a global database that practitioners can access but that is owned by the patients. Finally, instead of applying homogeneous therapies across groups of patients with similar health issues, treatments are likely to become more personalized.

    Behavioral Triggers

    The novel concept also holds promise for the prevention of noncommunicable diseases (NCDs), for which tobacco use is one of the greatest risk factors. The U.K.’s progressive tobacco harm reduction (THR) strategy, for example, incorporates many HCHE components. It has established a comprehensive infrastructure that includes institutions and healthcare professionals to help smokers to switch to less hazardous products or quit nicotine altogether. In 2017, the U.K. launched a Tobacco Control Plan that stresses the importance of innovation and less harmful alternatives. According to studies, the U.K.’s approach has been able to reduce smoking prevalence from around 20 percent in 2011 to between 13.8 percent and 16 percent in 2021.

    But the HCHE model offers further opportunities. Focusing on the individual and his or her perceptions, intentions and behaviors influencing personal health results, it is a demand-driven structure. Personal health outcomes, in turn, will ultimately influence population health. A fully developed HCHE environment uses a vast range of behavioral triggers that can encourage healthy decisions and eventually impact the incidence and prevalence of NCDs.

    At the 2017 World Economic Forum (WEF) in Davos, Willis Towers Watson published a white paper assessing the progress in preventing NCDs with the help of behavioral economics as part of the Human-Centric Health project. According to the white paper, mortality rates due to NCDs are projected to increase from 38 million to 62 million by 2040. While NCDs presently impact mostly high-income countries, they are growing fastest in low-income and middle-income countries.

    Participants in the Human-Centric Health project were tasked to develop and disseminate knowledge and tools for behavioral changes that would lead to long-term healthier lifestyles. The experts were also asked to identify public-private cooperation opportunities across nontraditional health and healthcare stakeholders, for which the WEF could provide a platform. The project touched upon smoking cessation but did not make use of the THR concept.

    Making Healthy Choices

    Human decision-making depends heavily on heuristics, mental shortcuts that can facilitate problem-solving in situations of limited knowledge and time. Heuristic processes are based on experience, thus enabling people to quickly make the thousands of decisions they must make every day. Not all precepts of behavioral economics, though, lead to choices that support good health. The WEF white paper reviews some of the more powerful principles in behavioral economics that may contribute to healthier behavior within the HCHE if being applied appropriately.

    “Present bias,” for example, is a strong motivator: Humans tend to assign greater value to payoffs that are closer to the present time than those that occur further in the future—if people want something, they want it immediately. A strategy for health improvement should thus present choices that combine a current pleasure with a behavior that will lead to better health in the future and emphasize the near-term advantages of healthy behavior rather than the benefits that might be achieved later. A case study described by the white paper suggested glycemic control in diabetes patients reliant on food banks could be improved by providing clients with diabetes-appropriate food, blood sugar monitoring, primary care referral and self-management support.

    Another behavioral trigger is loss aversion: People sense the pain of loss more deeply than the pleasure of gain. Recently, this insight has been used in initiatives to encourage smoking cessation: Smokers received a payment at the outset of the program, which they would be forced to pay back if they failed to keep their commitment to quit smoking.

    Health choices can also be influenced by framing—by expressing the consequences of disease in survival rates rather than mortality rates, for example—even if the results are equal. The HCHE system may emphasize benefits that can be achieved through a specific action or the ease of healthy behavior compared with other activities people voluntarily decide on.

    The HCHE system also takes advantage of the knowledge that humans respond better to narratives than logic or statistics. By telling compelling stories that people can relate to, health practitioners can drive healthier behaviors. Of course, facts must be given accurately, but data alone don’t necessarily drive change.

    Humans are also subject to social norms—a person married to or friendly with smokers is more likely to smoke than a person without such relationships, according to the white paper. Findings like this, however, can also be used to achieve a positive effect—for example, by incorporating social media and influencers into information campaigns or asking people to make public commitments to future change.

    Choice architecture and defaults can nudge people toward healthier decisions. In a realm of choices, humans tend to stay with a default as it takes less energy than making an active decision and allows them to focus on more important concerns. A prominent display of healthy food in shops, for example, can thus help people make healthier choices.

    Humans’ tendency toward “irrational optimism” and “depletion” are additional behavioral triggers that can be taken advantage of to stimulate desirable behaviors. Including a lottery element in health incentives will generate attention at low cost. As people only have a limited span of attention, health improvement efforts should focus on measures with the most potential benefit while requiring the least cognitive effort of the targeted population.

    Stakeholders

    A successful HCHE, the white paper argues, resembles a consumer purchase model in which informed buyers express demands that support their well-being and stakeholders succeed by recognizing and meeting those demands. The paper identifies three actors that can greatly impact NCDs—insurers, retailers and technology.

    Insurers can contribute to the HCHE by providing health assistance, for instance, through health coaching, paying healthcare claims and providing incentives, such as rewards to encourage smoking cessation. They can also provide information about achieving and maintaining health, including health risk assessments, biometric screening and education.

    Next to increasing their inventories of healthy items, retailers, who act as a principal source of consumer products and therefore exercise particularly powerful influence over dietary quality, can provide access to selected health services, such as vaccinations on-site, and work with policymakers to develop pricing policies that encourage consumption of healthier foods and beverages. In the case of tobacco, the white paper recommends a reduced inventory, citing the example of CVS Caremark, a U.S. retailer that in 2014 stopped selling cigarettes.

    While CVS Caremark’s sales declined during the following year, its decision reduced total cigarette sales by 1 percent across 13 U.S. states while nicotine patch purchases increased by 4 percent immediately after tobacco sales ended.

    Health-related technology, the third component mentioned in the report, refers to the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve or prevent a health problem and improve the quality of lives.

    For patients suffering from chronic obstructive pulmonary disease or asthma, for instance, tracking usage of inhalers that provide vital medication can be challenging. An estimated 70 percent to 90 percent of patients use their inhalers improperly, thus delivering insufficient levels of medication to their lungs. In late 2018, the U.S. Food and Drug Administration approved the first digital inhaler with built-in sensors that detect when the inhaler is used and measure breathing. The sensors connect to a smartphone app, recording data that can be shared with doctors who can evaluate a patient’s inhaler usage. There are many ways that these technologies could be adapted for e-cigarettes, heat-not-burn devices and related products.

    The technology sector is also where reduced-risk tobacco products (RRPs) come into play as the gap between recreational and therapeutic inhalers is narrowing. Among recently published patents for nicotine vapor devices and heated-tobacco products, most cover therapeutic innovations, including vaping products that employ sensors (see “In the Pipeline,” page 20).

    The combination of new technologies and behavioral economics allow for healthy choices to be the easier choices. Laws that regulate products proportionate to their risk compliment and support this.

    Properly integrated into the HCHE, RRPs could drive tremendous progress in public health. The private sector has already realized the potential of RRPs as a smoking cessation tool. It is time for regulators to follow their example.

     

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • What’s Next for Synthetic Nicotine

    What’s Next for Synthetic Nicotine

    Nveed Chaudhary (Photo: Broughton)

    Broughton’s Nveed Chaudhary explains how the FDA’s new powers to regulate synthetic nicotine will impact the industry.

    Contributed

    In mid-March, the U.S. Congress moved to close the loophole on the use of synthetic nicotine in electronic nicotine-delivery systems (ENDS) in the United States, bringing it into line with tobacco-derived nicotine products. In this article, Nveed Chaudhary, chief scientific and regulatory officer at Broughton, an independent life sciences contract research organization, explains what this regulatory change means for the next-generation nicotine-delivery industry in the U.S. market.

    What has happened in the U.S., and when will the changes take effect?

    The U.S. Congress has extended the Food and Drug Administration’s authority over tobacco products to include synthetic nicotine in products such as vapes, heated products and oral nicotine pouches. This will bring these products into line with tobacco-derived nicotine next-generation nicotine-delivery products. The new regulation was passed as part of a U.S. lawmaker’s long-term spending bill signed into law by President Joe Biden on March 15. It takes effect immediately, and manufacturers of synthetic nicotine vapes and oral nicotine pouches have 60 days from March 15 to submit a premarket tobacco product application (PMTA) dossier to keep their products on the U.S. market.  

    Was the industry expecting this regulatory change?

    The ENDS industry had been watching U.S. regulators with interest around this issue for some time and expected a change to come at some point. The speed with which it has been passed took the industry by surprise. It was included in a long-term spending bill that contained hot-button issues like funding for Ukraine, Covid support and regular government running expenses, enabling it to be passed without debate or amendment. That being said, U.S. lawmakers would possibly argue that ENDS manufacturers have had almost two years since the PMTA regulations were published to start collecting data on their products.

    What is synthetic nicotine?

    Synthetic nicotine, also called tobacco-free nicotine, is a synthesized form of nicotine produced via a chemical process instead of extraction from tobacco. Recent improvements in manufacturing processes have enabled producers to mimic the enantiomeric ratio of tobacco-derived nicotine. Synthetic nicotine is not new, with it first synthesized in 1904, but the production on a mass scale is relatively recent. Most e-cigarette manufacturers do not use synthetic nicotine because it tends to be more expensive than tobacco-derived nicotine. There is also far less infrastructure to create synthesized nicotine from scratch than the well-established facilities for harvesting nicotine from tobacco plant materials.

    Why have U.S. regulators chosen to close the synthetic nicotine loophole now?

    Previously, the FDA defined “any product made or derived from tobacco and intended for human consumption, including any component, part or accessory of a tobacco product” as a tobacco product. Under this description, e-cigarettes containing tobacco-derived nicotine e-liquids were subject to the PMTA regulatory framework while those containing tobacco-free nicotine were not. However, some U.S. lawmakers and nonprofit organization lobbyists have long discussed closing this loophole because it enabled manufacturers to introduce tobacco-free nicotine products to the market without regulatory oversight. Following the publication of the recent National Youth Tobacco Survey (NYTS) data, there is particular concern about the youth usage of synthetic nicotine disposable vape products, e-liquid flavors and marketing, which the FDA has had no authority to challenge. As we saw with tobacco-derived nicotine ENDS products, there is rightly intense scrutiny around products that are found to be attractive to youth, and this has become an area of significant political focus in the U.S. The fact that it appeared that some manufacturers were using the loophole to get around regulatory control is likely to have increased the speed with which lawmakers felt they had to act.

    What can synthetic nicotine manufacturers do now?

    If a product is already on the market in the U.S., manufacturers have 60 days to file a PMTA. If a manufacturer was in the process of commercializing a new synthetic nicotine product in the U.S., they have a 30-day window to launch the product and then 30 days to file their PMTA. This 60-day deadline for data submission will be very challenging for most tobacco-free nicotine ENDS manufacturers to meet but may not be impossible. At Broughton, we are currently in discussions with several clients about the regulation and what they will need to do to submit a PMTA within the timeframe allowed.

    Is it possible to prepare a PMTA dossier within this short timeframe?

    We believe it is, but manufacturers need to act immediately, and there are no guarantees of success. Especially as many of the manufacturers who submitted PMTA dossiers for their tobacco-derived nicotine ENDS products still don’t know if they have passed the FDA requirements to be awarded a marketing authorization. The first question is how much data a synthetic nicotine ENDS manufacturer already has available about their product and then to build analytical studies to fill gaps to file an adequate submission in the timeframe available. There is always a possibility that the FDA wants to close this NGP (next-generation product) market area completely, but that seems unlikely. It’s more likely they want to ensure that tobacco-free nicotine products are regulated in the same way tobacco-derived nicotine products are. Responsible manufacturers should welcome this opportunity to prove their product’s quality, safety and efficacy in relation to tobacco harm reduction objectives.

    What will be the long-term impact of FDA authority over synthetic nicotine products?

    The industry has been debating how governments will respond to regulating synthetic nicotine products for some time. It isn’t made from tobacco, but how else could lawmakers regulate it? It’s a classic dilemma for regulators; needing to respond to a technical innovation quickly, having less information than the industry it’s regulating, and then relying on existing regulation to act quickly and fill the gap. This has been the problem for the entire next-generation product category. We believe that all nicotine-containing products, regardless of tobacco-derived nicotine or synthetic-derived nicotine, should be treated in the same way. Regardless of where the nicotine comes from, the impact on population health needs to be measured in a consistent way. Synthetic nicotine is still not cost-effective to manufacture, and only a few companies currently produce synthetic nicotine due to patents around the manufacturing process. It’s estimated that synthetic nicotine is up to 13 times more expensive to manufacture than tobacco-derived nicotine. It will be interesting to see if ENDS manufacturers now abandon using synthetic nicotine because of the regulatory change or stick with it. A large part of this may be decided by how the FDA evaluates the PMTA submissions they receive and if there appears any difference in how synthetic nicotine and tobacco-derived nicotine PMTA applications are evaluated.

    This article was contributed by Broughton, an independent life sciences contract research organization.