Category: GTNF

  • Amanda Wheeler

    Amanda Wheeler

    Photo: Malcom Griffiths

    Continuing the fight

    Amanda Wheeler got involved in the vapor business after a personal tragedy. Despite a cancer diagnosis, she was unable to quit smoking for years—until she discovered vapor products. Eager to share her success with others, Wheeler and her husband, Jourdan, opened JVapes, an e-liquid manufacturer and retail store in Prescott, Arizona, USA, in 2012.

    The business was successful, quickly expanding to multiple locations across three states. Wheeler was helping her customers quit smoking combustibles and became increasingly involved in advocacy.

    In October of 2020, Wheeler and fellow business owner Char Owen created the American Vapor Manufacturers Association (AVM) to help small businesses navigate the U.S. Food and Drug Administration’s onerous premarket tobacco product application (PMTA) submission process. The organization also engaged in federal lobbying and sought to provide reduced-cost scientific testing and expert regulatory compliance advice to members preparing PMTAs.

    The deadline for submitting PMTAs to the FDA was Sept. 9, 2020. Wheeler submitted timely applications and was allowed to keep her products on the market for up to one year while the FDA reviewed her submissions. But on Sept. 9, 2021, Wheeler received a marketing denial order (MDO). The regulatory agency appeared determined to put the company she and her husband had built, along with the industry she passionately defended, out of business.

    That day, the FDA issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The bloodbath continued in the following weeks. At press time, the FDA had issued 323 MDOs accounting for more than 1,167,000 flavored electronic nicotine-delivery systems (ENDS). As of Sept. 28, not a single ENDS had been approved.

    “[The] FDA knew that they didn’t have the time or the resources to give our products fair consideration, but instead of asking for help, they let the 9/9 deadline pass and left the more than 500 companies subject to their decision in an unstable and probably untenable position,” Wheeler explained. “The FDA’s arbitrary ruling effectively criminalizes thousands of long-standing businesses in communities all across the country. Those entrepreneurs now have to junk their inventory, fire their employees, stiff their investors, and defer their dreams.”

    Wheeler said she was standing up for the “little guy”—the thousands of small business owners who manufacture, distribute and retail open system products in vape shops all over the United States. She explained that her business and other AVM members made every attempt within their means to comply with the FDA regulations. It was an expensive process. It was also a system designed for small businesses to fail from the very beginning, she said.

    “My company personally submitted several hundred thousand pages of documents to the FDA in an attempt to comply with this one premarket tobacco application standard. The [FDA’s] decision doesn’t just make a mockery of that earnest work. It also makes the more than 10 million Americans who made the switch to vapor products—in our vape shops, with our liquids—into outlaws, too,” said Wheeler. 

    Wheeler said the FDA, in an act of “regulatory arson,” was creating a tobacco-led monopoly over the vaping industry, as only the companies with the deepest pockets stand a chance to survive the agency’s cumbersome PMTA process.

    She also focused on what she perceived to be one of the biggest challenges facing the industry today: misinformation. “There is one other group I want to address with my time here. It’s the activists and the press who—whether because they are misguided or malicious—spread the falsehoods and distortions that directly led to this tragic outcome,” she said.

    The biggest victims of the FDA’s actions, according to Wheeler, are the vapers who will now struggle to acquire the products that have helped them stay off of cigarettes. Wheeler vowed she would continue to fight for her customers and fellow business owners. “Even through their dismay, I am hearing a constant refrain: We are not going to stand for it,” she noted.

    “We will be at the FDA’s doorstep demanding answers or forcing them through Freedom of Information Act laws and the courts. We are not surrendering our business or abandoning vapers to cigarettes,” she said. “As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”

  • Matt Ridley

    Matt Ridley

    Photo: Malcom Griffiths

    The Importance of Innovation

    Matt Ridley, who is a member of the U.K. Parliament’s upper house, ended his presentation by saying the All-Party Parliamentary Group for Vaping, of which he is a member, had recently urged the U.K. government to attend this year’s Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control and, while there, use its relatively independent post-Brexit voice to argue strongly against the e-cigarette prohibitionists and in favor of scientific evidence and the harm reduction argument. “I don’t know whether we will be listened to by the U.K. government on this, but we are going to try and get this point across because I think it’s … it’s a moral one, and I think we have a duty to try to win the point,” he said.

    This will have gone down well with many of the conference participants, who will have agreed with Ridley’s earlier comment that the WHO’s war on vaping was “positively unhinged” and flew in the face of evidence that it reduced smoking. And here he illustrated his point by quoting Chris Snowden of the Institute of Economic Affairs as saying the WHO had doubled down on its hostility to vaping even as real-world evidence continued to show smoking rates declining as vaping rates increased.

    Ridley’s was the first keynote presentation of the event, and, while it did not contain much else that was new, it ran through most of the underlying issues causing concern to the vaping industry, and it did so with panache. He covered, among other subjects, the assessment of relative risk and its relationship with the concept of harm reduction, innovation and the main ideas that motivated some people, including some public health professionals and politicians, to want to ban the technology underpinning vaping.

    The first motivation, he said, was down to the inappropriate application of the precautionary principle in answer to the question, “What if this technology turns out to have unknown risks?” While that question was valid, he added, in the case of vaping, the answer was that it would be better to take the small risk that there were unknown hazards than the known risks that there were large hazards. The second motivation was a general hatred of all things related to nicotine, which was deeply ingrained in the culture and underlined by the involvement of tobacco companies in the vaping industry.

    The third motivation was self-interest. The pharmaceutical industry had a nice little earner called nicotine-replacement therapy, and since its patches and gums didn’t work very well, the market for them remained limitless. And the fourth motivation was simply down to the urge to ban. Some people loved to disapprove, and they were able to come up with all sorts of specious arguments about why they disliked e-cigarettes and why, therefore, they should be banned.

    Ridley, an author whose books have sold more than a million copies and been translated into 31 languages, added to his output in 2020 with the publication of How Innovation Works, and part of his presentation looked at the way in which innovative products often initially meet with considerable opposition. Margarine, he said, had been opposed by dairy producers, refrigerators by natural ice suppliers, tractors by the people who went under the name of the Horse Association, umbrellas by hansom cab drivers, coffee by vintners and the telephone by what sounded like an old curmudgeon worried that this then-new contraption would destroy private life if it were not restricted. (Of course, with most of us now suffering daily from the debilitating effects of vacuous, secondhand mobile conversations, it might be worthwhile revisiting the old curmudgeon’s complaint.)

    The audience, I think, will have been struck by two things in relation to these examples. One, obviously, is that they are all from the distant past. The other is that whereas nearly all of them involve people trying to protect their self-interests, those self-interests comprised their livelihoods and none of their actions threatened to cause direct harm to others. So while the opposition to these products and services can be likened to the opposition to vaping, there is an important difference because unjustified opposition to vaping does directly threaten the well-being of others: current smokers.

    Given that this session report starts with Ridley’s last words, it might be appropriate if it ends with his first words: a gentle plug for his latest book. It had been co-authored by a brilliant molecular biologist at Harvard, Alina Chan, he said, and it was called Viral: The Search for the Origin of Covid-19. “You can buy it in all good bookstores from the middle of November,” he added helpfully.

  • Stefan Bomhard

    Stefan Bomhard

    Photo: Malcom Griffiths

    Putting consumers first

    Across all industries, the Covid-19 pandemic has been one disruptive force, which drove government intervention, accelerated consumer trends and, as a result, spurred further innovation. The tobacco and nicotine industry, which finds itself in a period of rapid change, has been no exception: Controversial policy led to bans on combustible cigarettes as seen in South Africa, but at the same time, growing health consciousness has led to an increased interest in reduced-risk alternatives.

    Stefan Bomhard, who previously worked in the alcohol industry and joined Imperial Brands as CEO in July 2020 from Inchcape, a global distribution and retail leader in the premium and luxury automotive sectors, shared his views on the longer term transformation of the tobacco and nicotine industry, looking at how stakeholders could collectively be best at making a reality of a healthier future. He observed parallels between the vaping sector and the automotive industry, where manufacturing for many years had been seeking to improve the efficiency of the 160-year-old technology of the combustible engine. “Then climate change became the climate crisis, and the e-engine meant a complete turnaround,” he said.

    Innovation, Bomhard emphasized, can happen only if supported by private sector efforts. As regulation of reduced-risk products (RRPs) edges toward prohibition, unintended consequences such as illicit trade arise. “The industry has to step up and present continuously better choices for consumers,” Bomhard said. “Smokers need to be perceived as informed people who want to make informed choices. There is no single route to tobacco harm reduction, but a billion individual paths.”

    Imperial Brands, which in the past 25 years developed from a domestic player into an international player, sees its role in this development in delivering a better experience for consumers. “From my experience, small players can flourish with the right mindset,” he said.

    While keen to transform the tobacco industry, Bomhard insisted Imperial Brands remains 100 percent committed to combustible cigarettes. “They are the core business for building a harm-reduced company, as they finance the investments in tobacco harm reduction,” he noted.

    To transform Imperial Brands, he explained, additional capacities have been built, including increased research of consumers’ needs. The company hired its first consumer product officer earlier this year. Products will be improved based on the findings of consumer studies. At this point in time, consumers have chosen heated-tobacco products over vaping, according to Bomhard, so Imperial Brands focuses on offering products in that segment.

    Furthermore, a number of new executives have joined Imperial Brands, bringing in new capabilities and contributing to the development of a new, more innovation-headed mindset in the organization. The focus is on the question of how employees can play a practical role in driving innovation, Bomhard pointed out.

    In addition to harm reduction, he went on, the industry had other important challenges, inclusive of supporting better lives for farming communities, transitioning to a lower carbon business model and reducing waste. “The future of the industry will without doubt have twists and turns,” he said. “For me, having enjoyed a career in a variety of fast-moving industries, each one of them facing major structural changes, the year with Imperial has enforced my first impression that right now, there is no more dynamic sector than tobacco and nicotine.”

  • For the Long Haul

    For the Long Haul

    Photo: BAT

    Sustainability, strategy and survival in the tobacco market

    By Clive Bates

    Before delving into what sustainability means for the tobacco market, we must first ask what the word itself means. A good starting point is an observation of the French philosopher Luc Ferry: “I know that this term is obligatory, but I find it also absurd, or rather so vague that it says nothing.”

    Ferry captures the problem well. It is often taken as a green concept, promoting enlightened practices on energy and emissions, waste and recycling and raw materials in the supply chain. A more evolved definition considers social and economic impacts. This has led to a steady output of sustainability reports from major businesses, increasingly with feedback into operations with a view to improving over time and avoiding the wrong half of sustainability league tables. This is all good, but is it good enough?

    I favor a more hard-nosed definition of business sustainability. It would be a variation of the concept defined by one of the pioneers of sustainable development, Gro Harlem Brundtland, in 1987: “Sustainable development is development that meets the needs of the present without compromising the ability of future generations to meet their own needs.”

    Brundtland was referring to nations or to the whole world, but that formulation can be repurposed for a business. If the goal of a business is to generate shareholder value (the value of its stock and flow of dividends) then a reasonable equivalent would be to sustain and grow shareholder value over the longer term. Ultimately, sustainability is about designing and executing a corporate strategy that builds resilience and long-termism into a business but not at the expense of today’s shareholders. One reason why a tobacco company cannot just pull out of cigarettes and concentrate on new products is that the shareholders would fire the management, the company would be taken over or the cigarette assets sold as a going concern.

    What does this concept of sustainability mean? We can start with what it does not mean: It does not mean the single-minded pursuit of quarterly earnings at the expense of all wider concerns. “Shareholder value” embodies a range of important but less tangible elements that are reflected in the price of a stock. These include numerous market judgments on the future earnings of the company and its resilience to changes in the marketplace. Nor can it be oblivious to the concerns of stakeholders who are not shareholders, including customers, employees, politicians and public health organizations. They frame the operating context and confer the license to operate.

    Here are six questions I would ask any company about its sustainability in the tobacco market:

    1. How robust is the company’s approach to the mitigation of litigation risks? No one really denies that about 8 million people die annually from smoking-related diseases. But who is responsible and accountable for that? Plaintiffs and their lawyers will continue to stalk companies and hold them to account for their past and present behavior. Litigation in the early 2000s had a powerful suppressing effect on shareholder value and at times looked like an existential threat. Part of litigation risk mitigation is to be scrupulously honest in describing products and their risks, to be responsible in marketing and promotion, and to provide a range of low-risk alternatives with encouragement for smokers to switch. The conduct of companies that make products that are harmful and open to abuse will always be under scrutiny, often in the courts of law but always in the court of public opinion.
    2. How resilient is the company strategy to political and regulatory pressures? Governments permit, regulate and tax the most dangerous nicotine products, cigarettes, in every country in the world (even in Bhutan, which recently rescinded its longstanding prohibition of tobacco). While that mandate persists, there will be companies lawfully selling cigarettes. But as the low-risk alternatives rise in popularity, governments will be increasingly emboldened to take stronger regulatory actions against cigarettes, for example, in setting reduced-nicotine standards. Many advocates of such policies now argue that highly restrictive measures are becoming feasible as smokers have a range of low-risk and acceptable alternatives to switch to. Prohibitions without alternatives just lead to black markets. For tobacco businesses, the low-risk alternatives to smoking simultaneously threaten to hasten the end of cigarettes but also provide the opportunity in an emerging, and potentially larger, market for much safer smoke-free recreational nicotine.
    3. How well positioned is the company for changes in consumer preferences? What happens if the pace of migration from high-risk cigarettes to low-risk vaping, heated or smokeless nicotine products accelerates? What if there are tipping points when a critical mass of users makes the alternatives become rapidly ubiquitous? Which companies are poised to prevail? In a fast-moving consumer goods market, companies must ask what the consumer really wants and does not want. It is undeniable that many enjoy smoking, but if we break down that experience into different elements, what do they really want: a satisfying nicotine experience; a sensory experience and flavor; behavioral rituals; a social medium; elements of personal identity and group affinity? How can that be offered without cancer, cardiovascular disease and lung disease? Without stigma and social barriers?
    4. In a changing market, how well is the company positioned to gain or defend market share from competitors? I recently heard a tobacco executive say, “We have 25 percent of the cigarette market, but with our new products, I’m going after the other 75 percent.” That was a sharp reminder that in a radically disrupted market, no one can count on brand loyalty, and even the mightiest brand equities count for little. The aggressively sustainable company looks at disruption and sees opportunity to build future shareholder value. In contrast, the passive profit-seeker may find its grasp on its once-loyal customers is not as strong as it thought. How promising is the company’s portfolio of products in the more febrile markets for smoke-free alternatives? How strong is the product pipeline in R&D? What approach is the company taking to synergistic acquisitions of promising companies and their intellectual property?
    5. Who wants to work for this company? It is a tiresome management cliche to say that “our company is our people.” But it is also right, and especially over the longer term. A sustainable company needs to develop, retain and attract talent at every level and in every area. That is ultimately where its longer term value will be created. The staff in the companies today bear little resemblance to the famously pictured lineup of CEOs testifying to Congress in 1994 (with apologies to industry veterans), but many are younger, sharper and motivated by change for the better. Many see themselves as quiet revolutionaries from within—and not always quiet. The ability to attract top quality, highly motivated staff at affordable salaries will be increasingly about how the companies are looking to the future and how they will ultimately shed their reputational baggage.
    6. Does the board have a convincing vision? In Alice’s Adventures in Wonderland by Lewis Carroll, the Cheshire Cat argues, “If you don’t know where you’re going, any road will get you there.” When the board meets, how often does it raise its collective gaze to the horizon and beyond? When it does this, what does it see and how does that affect what it does today, this month and this year? It makes a big difference if the board sees new products as line extensions and a neat new consumer segment or if it sees a structural transition from smoked to smoke-free nicotine products underway and gathering pace.

    But what is a sustainable vision for the nicotine market? It goes beyond tobacco harm reduction, which is an important phase in the transition from combustible to noncombustible products. For the long term, I expect we will see a stable business model based on a (grudging) societal acceptance that nicotine is a legal and legitimate recreational stimulant with relatively benign side effects (no intoxication, violence, incapacitation, loss of control, etc.). The challenge for the tobacco market is to make this drug available in a way that is acceptably safe. That does not mean completely safe. It means within the normal societal appetite for recreational risks. In this vision, smoking would have declined to minimal levels primarily through consumer preferences for much safer but satisfying alternatives to cigarettes driven by continuing innovation. Regulators could put a thumb on the scale to tilt the market toward the safer products, but they will have no need to use the iron fist of prohibition. It will also require a rethink in public health groups that resist everything the tobacco companies do by default. They believe there is an irreconcilable conflict between the interests of tobacco companies and public health. In my view, they are wrong.

    There are still some who think sustainability is about corporate social responsibility. In the tobacco market, it is more than that: It’s about strategy and survival.

     

    The theme of GTNF 2021 (Sept. 21–23, 2021, in London) is Continuing Change: Innovation & Sustainability.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Thank You!

    Thank You!

    The 2021 GTNF would have been impossible without the support of these generous sponsors.

    TR Staff Report

    Founded in 2009 and headquartered in Shenzhen, China, ALD Group Limited is an innovation-driven enterprise specializing in a full range of next-generation products, including electronic nicotine-delivery systems, CBD vaporizers and heated-tobacco devices. As one of the leading vape manufacturers, ALD is capitalizing on years of R&D know-how and manufacturing experience to provide global one-stop service. With a powerful intellectual property system, high-quality assurance, fast delivery service and a strong commitment to social responsibility, ALD serves worldwide clients with the most cutting-edge products.

    Alliance One International is a tobacco leaf supplier that offers customers high-quality leaf they can trust. With more than 145 years of agricultural experience and customers in approximately 90 countries, Alliance One International purchases tobacco from a network of more than 300,000 farmers worldwide to produce products that are sustainable and traceable.

    Altria’s tobacco companies have a long history of leading the industry. Today, adult tobacco consumers are increasingly seeking new options, including those that reduce risk, and their preferences are evolving rapidly. Altria’s vision by 2030 is to responsibly lead the transition of adult smokers to a smoke-free future. To that end, it will work within the framework that government, public health and regulatory bodies have established to communicate about reduced-harm choices. And for any tobacco consumer who wants to quit, Altria offers access to a breadth of information from experts on how to do so successfully. The actions the company is taking will create a different Altria—and a different landscape that the company believes will benefit today’s adult tobacco consumers.

    Barrettine Environmental Health has worked with the tobacco industry to develop a combined insect monitoring trap that functions as an early warning detection system for both tobacco beetles and tobacco moths. The MoBe Combo trap is an all-in-one hygiene control system for use during tobacco storage, shipment, processing and manufacture.

    When using the MoBe Combo Mk. 2, there is only one trap to check, which can significantly reduce both product and labor cost. Since the launch of the MoBe Combo trap, the company has introduced several enhancements.

    The tobacco beetle is often seen as the most significant tobacco pest; however, tobacco moth infestations can also contribute to significant damage to stored tobacco as well as processed and finished stock. With climate control used in many areas of tobacco processing sites, both species have the potential to thrive in all regions of the world. The MoBe Combo trap is effective in monitoring both species or either of the species in isolation.

    BAT is a leading consumer-centric, multi-category consumer goods company that provides tobacco and nicotine products to millions of adult consumers around the world. Its purpose is to build “a better tomorrow.” It will achieve this by reducing the health impact of its business through a multi-category portfolio of noncombustible products tailored to meet the preferences of adult consumers.

    BAT is investing in building a portfolio of reduced-risk tobacco and nicotine products*† alongside its traditional tobacco business—including vapor products, tobacco-heating products and modern oral products, which are collectively termed New Categories, as well as traditional oral products.

    BAT’s ambition is to increasingly transition revenues from combustible products to its New Category products over time. The company employs more than 55,000 people, operates in more than 180 markets and has 79 owned manufacturing facilities in countries around the world. In 2020, the BAT Group generated revenue of £25.8 billion and profit from operations of £10 billion.

    BMJ is the world’s No. 1 partner for specialty paper and packaging materials in the cigarette industry. BMJ produces cigarette paper, plugwrap paper, base tipping paper and printed tipping paper with standard weights of 18 grams to 40 grams per square meter. As a printing packaging company, BMJ represents high-quality packaging utilizing both rotogravure and offset.

    Boegli-Gravures designs, develops and manufactures state-of-the-art embossing tools and solutions for an exacting worldwide clientele. The company’s combination of artistic vision and engineering excellence has brought it recognition as a world leader in high-precision embossing and as an original equipment manufacturer supplier. The secret of Boegli-Gravures’ success lies in the company’s vision and passion for innovation.

    Broughton is a privately owned global contract research organization (CRO) offering fully integrated end-to-end services to deliver U.S. premarket tobacco product applications, EU medicinal product applications and EU Tobacco Products Directive notifications for next-generation nicotine products. Our business culture is to continue to invest in new science and innovations aligned with global regulatory requirements. By partnering with Broughton, clients will know they have access to some of the most experienced consultants in the world with deep industry knowledge combined with regulatory compliant CRO laboratory facilities. Broughton is committed to supporting clients in their development of safer nicotine products.

    CNT is the world’s largest supplier of highly purified nicotine to the pharmaceutical and next-generation products (NGP) industries. With pure nicotine and nicotine polacrilex resin manufacturing capabilities in Switzerland and Northern Ireland, CNT offers 100 percent contingency in supply of these key products. In addition, CNT has now developed an array of new nicotine-containing formulations for use in a broad spectrum of NGP applications, including modern oral (pouch) products. CNT is actively developing new product categories in its “beyond nicotine” strategy, utilizing its knowledge learned in nicotine to explore additional active substances of interest to our customers. CNT is one of the world’s leading suppliers of sustainably produced tobacco leaf.

    Headquartered in Austria, Delfort is a global leader in tailor-made specialty papers. In addition to thin print paper, release base paper, food packaging paper and electrical applications paper, the company manufactures a complete portfolio of top-quality cigarette paper, plugwrap paper, tipping base paper and printed papers. By utilizing pure and certified raw materials with the most advanced equipment, Delfort ensures that its products meet the most stringent quality requirements.

    FEELM is a high-end atomization technology brand belonging to SMOORE, a world leader in atomization. Focused on cutting-edge atomization technology research, FEELM specializes in the development and manufacturing of high-quality atomization devices driven by the FEELM ceramic coil.

    As the research engine of the global electronic atomization industry, FEELM delivers premium experience. Ever since the successful development of the FEELM black ceramic coil in 2016, FEELM has a significant impact on the research and manufacturing of closed vaping products, changing the whole competitive landscape.

    FEELM won a Golden Leaf Award at GTNF 2018, the China Patent Excellence Award and the iF Design Award 2020. Vaping devices loaded with FEELM atomizer have been exported to Europe, America, East Asia, Africa, Oceania and many other countries and regions. Its accumulated sales volume has surpassed 3 billion pieces, becoming more and more popular among worldwide consumers.

    The Foundation for a Smoke-Free World is an independent, U.S. nonprofit private organization that was formed in 2017 to reduce the 8 million annual deaths caused by tobacco use and address the consequences of reduced demand for tobacco farmers. The Foundation’s mission to end smoking in this generation is supported through three core pillars: Health, Science, and Technology; Agriculture and Livelihoods; and Industry Transformation. To achieve its mission on a truly global scale, the Foundation strives to identify and address the unique needs of the developing world as they relate to tobacco cessation and harm reduction. The Foundation is led by Derek Yach, a global health expert and anti-smoking advocate for more than 30 years.

    Funded by annual gifts from PMI Global Services, the Foundation is independent from PMI and operates in a manner that ensures its independence from the influence of any commercial entity. Under the Foundation’s pledge agreement with PMI and bylaws, PMI and the tobacco industry are precluded from having any control or influence over how the Foundation spends its funds or focuses its activities.

    Founded in the mid-1980s, Hall Analytical is a globally respected analytical laboratory based in Manchester, U.K., which specializes in complex trace analytical chemistry.

    The company’s mission is to deliver innovative and high-quality analytical expertise to strengthen its clients’ ability to improve product safety and reduce harm to patients and consumers. To that end, Hall Analytical partners with clients in the pharmaceutical, biopharmaceutical, medical device and consumer sectors to ensure their products are safe and compliant with appropriate regulatory frameworks.

    To support the nicotine reduced-risk product industry, Hall Analytical offers clients a wealth of experience in the analysis of vapor products and heated-tobacco products, supporting their core strategic objective to deliver less harmful, smoke-free alternatives for nicotine consumers.

    Imperial Brands is a global consumer organization and the world’s fourth-largest international tobacco company. Its products include JPS, West and Davidoff cigarettes, Rizla rolling papers and the vapor brand Blu. Imperial Brands operates in 120 markets, including the U.S. where its ITG Brands subsidiary offers a broad portfolio of cigarette and mass market cigar brands, including Winston and Backwoods.

    Driven by insights and data, Imperial seeks to meet the expectations of adult smokers by putting the consumer at the center of everything it does. It is also refining its ways of working and its culture to foster a strong challenger mindset among its 27,000 employees worldwide.

    Imperial is focused on leveraging its tobacco assets in its five priority markets and on building a successful and sustainable next-generation product (NGP) business. This year, it has refocused its NGP strategy behind heated-tobacco and oral nicotine opportunities in Europe and in selective market opportunities in vapor.

    Japan Tobacco International is a leading international tobacco and vaping company, with headquarters in Geneva, Switzerland. JTI began 22 years ago when Japan Tobacco acquired the non-U.S. operations of R.J. Reynolds. Since then, its international workforce of over 40,000 employees has driven two decades of growth. JTI owns some of the world’s best-known brands, including Winston, the No. 2 global cigarette brand, and Camel. Other major international brands are Mevius and LD. The company’s portfolio brings together the rich heritage of traditional tobacco as well as the latest technical and scientific innovation in reduced-risk products.

    Juul Labs’ mission is to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use and combat underage usage of its products. The company believes that vapor products can offer adult smokers an alternative to combustible cigarettes and, in so doing, reduce the harm associated with tobacco. Nicotine is addictive and can potentially be harmful. It would be best if no one used any nicotine product. Anyone who smokes should quit. Adult smokers who have not successfully quit should completely switch to potentially less harmful alternative nicotine products. Juul Labs does not want any non-nicotine users, especially those underage, to try its products, as they exist only to transition adult smokers away from combustible cigarettes. Juul products are not intended to be used for smoking cessation or other therapeutic purposes.

    Kure operates more than 130 retail locations across the United States and several more in Europe. The company is a recognized leader in the vape industry. Kure’s e-liquid line and bar offers custom, bespoke liquids made with the highest quality ingredients to cater to the tastes of every guest. Its tailored in-store service is designed to provide the best support possible to transition from smoking to vaping. Kure offers the latest and greatest hardware to ensure its guests receive only the best.

    Kure has submitted its thorough premarket tobacco product applications to the U.S. Food and Drug Administration. These applications detail the high standards the company adheres to in all aspects of its business. Moreover, Kure takes its responsibility to its guests and the community it serves seriously and has thus designed and implemented measures to ensure its products never end up in the hands of minors. Kure uses tools such as electronic point-of-service age verification software, secret shopper programs and extensive employee training programs to keep this commitment.

    Philip Morris International is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes as well as smoke-free products, associated electronic devices and accessories and other nicotine-containing products in markets outside the U.S.

    In addition, PMI ships versions of its IQOS Platform 1 device and consumables to Altria Group for sale under license in the U.S., where these products have received marketing authorizations from the Food and Drug Administration under the

    premarket tobacco product application pathway; the FDA has also authorized the marketing of a version of IQOS and its consumables as a modified-risk tobacco product, finding that an exposure modification order for these products is appropriate to promote the public health.

    PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements.

    PMI’s smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of June 30, 2021, PMI’s smoke-free products are available for sale in 67 markets in key cities or nationwide. PMI estimates that approximately 14.7 million adults around the world have already switched to IQOS and stopped smoking. For more information, please visit www.pmi.com and www.pmiscience.com.

    Quartz Business Media is the owner and organizer of the largest network of tobacco-related exhibitions and conferences in the world. These include the market-leading series of World Tobacco events, WT Middle East, TABEXPO and World Shisha Dubai.

    Founded in January 2018, Relx is Asia’s leading e-cigarette brand. Relx’s mission is to empower adult smokers through technology, product and science ethically. Relx independently develops its e-cigarette products at its CNAS-standard R&D center and continues to make significant investments in R&D, e-liquid testing and new product development to deliver the best possible experience to its adult users. To protect minors from accessing e-cigarette products, Relx developed the guardian program, a companywide initiative that stretches from product development to sales and marketing, leveraging cutting-edge facial recognition technologies, GPS data and cloud technologies. The company has attracted global talent from Uber, Proctor and Gamble, Huawei, Beats and L’Oreal.

    Reynolds American Inc. (RAI) is an indirect, wholly owned subsidiary of BAT and is the parent company of R.J. Reynolds Tobacco Co., American Snuff Co., Santa Fe Natural Tobacco Co., R.J. Reynolds Vapor Co. and Modoral Brands. RAI’s vision is to build “A Better Tomorrow” by reducing the health impact of its business through offering a greater choice of innovative products for adult tobacco consumers.

    SMOORE is a global leader in offering vaping technology solutions, including manufacturing vaping devices and vaping components for heat-not-burn products on an ODM basis, with advanced R&D technology, a strong manufacturing capacity, wide-spectrum product portfolio and a diverse customer base. According to Frost & Sullivan, SMOORE is the world’s largest vaping device manufacturer in terms of revenue, accounting for 18.9 percent of the total global market in 2020.

    Through its innovative and pioneering vaping technology solutions, SMOORE operates two principal business segments: research, design and manufacturing of closed system vaping devices and vaping components for leading global tobacco companies and independent vaping companies; and research, design, manufacturing and sale of self-branded open system vaping devices, or APV, for retail clients.

    SMOORE owns a series of tech brands, including FEELM, CCELL and METEX, and the product brand Vaporesso.

    SWM is a leading global provider of highly engineered papers, films, nets and nonwovens for a variety of applications and industries. As an expert in manufacturing materials made from fibers, resin and polymers, the company provides critical components that enhance the performance of their end products.

    The company’s engineered papers group has been serving the tobacco industry for decades with highly technical papers and reconstituted tobacco leaf. SWM continues to innovate, with a special focus on heat-not-burn products, using its advanced paper and reconstitution technologies to meet the demands of this emerging product category. SWM’s versatility and portfolio are designed to deliver satisfaction while meeting stringent specifications.

    In recent years, SWM has diversified to include films, nets and nonwovens offered through its advanced materials and structures (AMS) segment. The AMS platform serves a variety of industries with the same focus on technical expertise, operational excellence and customer collaboration that have long been SWM’s hallmark traits.

    SWM and its subsidiaries manufacture on four continents, conduct business in over 90 countries and employ approximately 5,000 people worldwide.

    Founded in 1975, Tobacco Technology Inc. (TTI) exclusively develops and manufactures customized flavors, including casings, for the global tobacco industry: cigarettes, cigars, water pipe, snuff, snus, chew, kretek, roll-your-own, pipe, hemp and dissolvables. TTI also offers consulting services to facilitate flavor, process and product development.

    E-LiquiTech (ELT), a TTI subsidiary established in 2016, is dedicated to the development and manufacture of the highest quality e-liquids in addition to offering both bottle and cartomizer filling services. ELT is also the exclusive global distributor to the tobacco industry for Zanoprima, a research-driven, innovation-led life sciences company, offering SyNic high-purity synthetic (S)-nicotine in pure, bitartrate and polacrilex resin form.

    TTI Flavors, TTI’s subsidiary in Assisi, Italy, will start production of flavors, casings and e-liquids in the fall of 2021 to offer faster delivery to the company’s customers in Europe, the Middle East, Africa and Russia.

    Turning Point Brands continues to grow and evolve to meet changing consumer preferences. Along with a tobacco portfolio that features iconic, historic brands, such as Zig-Zag and Stoker’s, the company has expanded into the vapor and tobacco alternative segments with innovative brands such as VaporBeast, VaporFi and Marley. A highly effective sales force and distribution network ensure that consumers, retailers, partners and shareholders benefit from these products.

    For over 100 years, Universal Corp. has been finding innovative solutions to serve its customers and meet their agri-products needs. The company built a global presence, solidified long-term relationships with customers and suppliers, adapted to changing agricultural practices, embraced state-of-the-art technology—and emerged as the recognized industry leader.

    Today, Universal Corp. is a global business-to-business agri-products supplier to consumer product manufacturers, operating in over 30 countries on five continents, that sources and processes leaf tobacco and plant-based ingredients. Tobacco has been the company’s principal focus since its founding in 1918, and Universal Corp. is the leading global leaf tobacco supplier. Through its plant-based ingredients platform, Universal provides a variety of value-added manufacturing processes to produce high-quality specialty vegetable-based and fruit-based ingredients for the food and beverage end markets.

    Universal Corp. has a long history of operating with integrity, honesty and a focus on quality. It is a vital link in the leaf tobacco supply chain, providing expertise in working with large numbers of farmers, efficiently selling various qualities of leaf to a broad global customer base, adapting to meet evolving customer needs and delivering products that meet stringent quality and regulatory specifications.

    Going forward, Universal will build on its history by seeking opportunities in both tobacco and plant-based ingredients to leverage both its assets and expertise. The company will continue its commitment to leadership in setting industry standards, operating with transparency, providing products that are responsibly sourced and investing in and strengthening the communities where it operates.

    Zinwi Biotech was founded with the desire to offer the “nature flavor” e-liquid product to its clients. The company is sensitive to new trends. When nicsalt appeared as a game changer, Zinwi became one of the first suppliers with its own formula to meet the market needs.

    The merging of cutting-edge technology and boundless creativity, in turn, generates innovative flavoring solutions that serve 400-plus customers worldwide, resulting in a significant share on nicsalt juice used for electronic nicotine-delivery systems.

    With heavy investment in R&D, Zinwi in the future won’t limit itself as an e-liquid or nicsalt manufacturer but will also provide flavoring technologies that enrich food, healthcare and medicine products and other products that will help take humans’ lives to the next health level. Visit the company’s website

    * Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk-free and are addictive.† BAT products as sold in the U.S., including Vuse, Velo, Grizzly, Kodiak and Camel Snus, are subject to FDA regulation, and no reduced-risk claims will be made as to these products without agency clearance.

  • U.K. Relaxes Travel Restrictions

    U.K. Relaxes Travel Restrictions

    Photo: Jason

    The U.K. government announced on July 28 that passengers arriving from “amber” countries who have been fully vaccinated in Europe (EU Member States, European Free Trade Association countries and the European microstate countries of Andorra, Monaco and Vatican City) and the U.S. will not have to quarantine when entering England as part of a range of new measures designed to continue to drive forward the reopening of international travel set out as part of the second Global Travel Taskforce checkpoint review.

    From Aug. 2, 2021, passengers who are fully vaccinated in the EU with vaccines authorized by the European Medicines Agency (EMA) or in the USA with vaccines authorized by the Food and Drug Administration or in the Swiss vaccination program will be able to travel to England without having to quarantine or take a day eight test on arrival.

    Amber arrivals who have been fully vaccinated in the U.S. and European countries will still be required to complete a pre-departure test before arrival into England alongside a PCR test on or before day two after arrival. Separate rules will continue to apply for those arriving from France. Those vaccinated in the U.S. will also need to provide proof of U.S. residency. Passengers from all countries cannot travel to the U.K. unless they have completed a passenger locator form.

    The relaxation of travel restrictions comes ahead of the GTNF, scheduled for Sept. 21–23, 2021, in London.

    For more information, visit gov.uk.

  • Thoughtful Reflection

    Thoughtful Reflection

    The first virtual GTNF was a resounding success. More than 1,650 delegates from at least 51 countries logged in to participate in the conference. Over the course of four days, and in three times zones, regulators, public health officials and industry representatives shared their views on “Sustainable change through innovation and regulation.” Following is a sampling of the keynotes and panel discussions.

    Kingsley Wheaton: “A whole of society approach to policymaking”

    British American Tobacco’s (BAT) Chief Marketing Officer Kingsley Wheaton called for meaningful change in the way that global tobacco and nicotine policies are developed. He stressed the need for a United Nations-style “whole of society” approach to policy development and emphasized the benefits that this more inclusive tobacco harm reduction approach could deliver. BAT’s purpose, he said, is to build “a better tomorrow” by reducing the health impacts of its business.

    Earlier this year, the company announced a bold aim: to have 50 million consumers of noncombustible products by 2030. To this end, BAT has invested substantially in “a range of vibrant new noncombustible categories for adult consumers,” according to Wheaton. Its portfolio of potentially reduced-risk products now comprises vapor, tobacco-heating and modern oral offerings.

    Innovation is focused not only on products but also on how BAT engages with consumers. Wheaton said the company has rapidly adopted new technologies and digital capabilities in consumer markets. In the U.S., for example, BAT recently launched a vapor subscription service. After just three months, subscribers accounted for half of the company’s U.S. e-commerce revenue.

    BAT’s new products have clearly resonated with consumers. In 2019, noncombustibles reached 10 percent of group revenues, with the growth in volume and value shares continuing to accelerate in all three categories. Just five years after launching Vype in the U.K., nearly a third of BAT’s revenue in that market is now from vapor products. In Japan, Glo now accounts for nearly half of the group’s business.

    However, said Wheaton, growth would have been even more dramatic had more policymakers around the world supported the company’s new category development with proportionate, risk-based regulation. “Many significant markets remain in ‘regulatory lock,’” he said.

    The central question, according to Wheaton, is how to accelerate acceptance of tobacco harm reduction as a genuine public health policy—just as it is recognized within the WHO Framework Convention on Tobacco Control (FCTC) and by the U.S. Food and Drug Administration (FDA). “This is not a debate of us versus them but rather about evidence, education and the science underpinning tobacco harm reduction,” he said.

    Wheaton insisted the industry should be part of the debate. Worldwide, 1.1 billion people consume tobacco and nicotine products. “To exclude manufacturers from that conversation is like cutting off one’s nose to spite one’s face,” he said.

    Yet the WHO continues to believe that the tobacco industry cannot be a partner in effective tobacco control, advocating for tobacco companies to be excluded from any dialogue with government. Wheaton called this a paradox. “How can this approach and Article 5.3 of the FCTC realistically be implemented when the largest cigarette manufacturer on earth is wholly owned by a WHO member state?” he said, referring to the treaty’s provision against tobacco industry influence on policymaking and the fact that the China National Tobacco Corp. is a state monopoly.

    “We need a system that acknowledges the expertise and the ambition of companies like BAT to deliver a better tomorrow—one that is clear about harm caused by smoking yet recognizes more holistically and consistently where the real public health gains can be made, by actively supporting consumer choice and the role of tobacco harm reduction,” said Wheaton.

    Despite the challenges, Wheaton was confident that role of combustible products in BAT’s business would continue to decline. “People will gradually forget what the ‘t’ in BAT stands for,” he predicted. The company’s goal is to meet the consumer needs that combustible cigarettes historically satisfied—socialization, connectivity, concentration and relaxation. “Those needs can be met by alternative nicotine solutions in many ways, so we’ll see a burgeoning of innovation and categories as we grasp how to meet those underlying consumer needs that smoking has historically met.”

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    Panel: The future of nicotine

    There are several reasons why people use nicotine. According to Neal Benowitz, professor of medicine, biopharmaceutical sciences, psychiatry and clinical pharmacy at the University of California San Francisco, those reasons include pleasure, stimulation and mood modulation. However, many users don’t understand the adverse effects and risks associated with different delivery mechanisms.

    “Clearly, the decision involving long-term use of the drug for individuals or society depends, at least in part, on adverse health effects. For example, the casual use of cocaine or heroin are discouraged by society because they are hazardous to health,” explains Benowitz. “We know nicotine, per se, is much less hazardous than cigarette smoking, regardless of potential health concerns. That’s a successful argument for electronic nicotine-delivery systems [ENDS].”

    Benowitz said that one of the major questions surrounding tobacco control is whether society can accept nicotine use if the harms were reduced. He says that possibility exists. “The FDA can be a big part of making this happen … there is a misconception surrounding the harm of nicotine compared to combustible products,” which are more deadly than ENDS.

    While acknowledging the validity of Benowitz’ point, Michael Cummings, professor of psychiatry and behavioral sciences at the Medical University of South Carolina, cautioned against the unintended consequences of regulation. Banning a specific delivery mechanism for nicotine, he said, presents a risk. Cummings referred to the FDA’s vision, formulated in 2017, of a world where cigarettes would no longer create and sustain addiction and where adults who need or want nicotine could get it from less harmful alternative sources.

    “But it seems like we’re going the wrong direction … If we adopt regulations to ban the sale of vaping products as some states and many countries around the world have done, what would be the effect? Well, the effect is that cigarette sales will go up,” said Cummings. “That’s a bad thing. Regulating vaping products like they’re cigarettes—which they’re not—banning flavors, banning internet sales … [these actions] would have a detrimental effect of actually driving up cigarette sales to the detriment of the lower risk products.”

    Also speaking during the GTNF panel, Clifford E. Douglas, director of the Tobacco Research Network and an adjunct professor of health management and policy at the University of Michigan School of Public Health, said that consumers clearly need a much better understanding of the true nature, including the relative risk, of different tobacco and nicotine products.

    “This includes the fact that nicotine is the root cause of the epidemic of tobacco-related illness and death because it hooks in smokers and keeps many smoking who otherwise would quit,” he explained. “While complete information on all the potential risks and benefits of [vapor products] is not yet available, there is sufficient information … to end deadly combustible tobacco use, [which is] responsible for approximately half a million deaths a year and 30 percent of all cancer deaths in the United States.”

    Asked by moderator Clive Bates, director of Counterfactual Consulting, whether there was a regulatory environment possible that incorporated the relative risk of the different types of nicotine-delivery systems, Stefanie Miller, managing director of FiscalNote Markets, said, “no.”

    “[There is] no trust among the general public for companies that produce a product containing nicotine, and that is largely based on a misconception around the difference between nicotine and combustible tobacco use,” she said. “After predatory behavior and negligence of tobacco companies in the 20th century, most people see this as very black and white. Tobacco companies are bad, and anti-tobacco efforts are purely good,” said Miller. “I think [everyone] who’s tuned in right now knows that the situation is far more nuanced and … the regulations are not accommodative of that nuance.”

    Benowitz says that another major problem with the message on less-risky nicotine products is that there is very little science on the long-term effects of ENDS products. “We have an array of new products, any of which are inhalable,” he said. “We have a lot of short-term data that is promising in terms of reduced exposure in the short term, but we really don’t know about the future long-term consequences.”

    Miller added that cigarette manufacturers could help change the misconceptions surrounding nicotine. It’s the large manufacturers who could make it a goal to end combustible nicotine-delivery systems. “If you’re really clear about setting a strategic goal, and then you do everything possible to accomplish it, you’re more likely than not to win,” she said. “I think that this is [an] important enough [goal] to try.”

    Benowitz said that regulators need to help consumers better understand that the regulators support a shift to less-risky products. He says that only then can the goal of getting rid of combustible products be accomplished.

    “We’re not doing this because nicotine is bad,” he said. “We’re doing this because nicotine sustains harmful cigarette smoking … there are other products that [can deliver] nicotine that are much less harmful.”

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    Suzanne Wise: Achieving sustainable growth

    Suzanne Wise, senior vice president of corporate affairs and communications at Japan Tobacco International (JTI), considered the question of how to achieve sustainable growth.

    Understanding consumers is the key to success, she said—but the way people consume is changing rapidly and accelerated by the Covid-19 crisis. To meet the challenge, JTI has been moving from a highly centralized model to a more decentralized one. This allows the company not only to increase speed to market but also helps it put the consumer at the center of its transformation.

    She cited the example of Germany, where JTI sells Winston-branded tobacco in buckets for make-your-own (MYO) consumers. Mindful of consumers’ increasing sensitivity about plastic waste, JTI reengineered its packaging. The Winston bucket now uses 16 percent less plastic than before without comprising on convenience or consumer appeal.

    While 16 percent may not sound impressive, it translates into 78 tons of plastic that has been taken out of the packaging of one product line in one country every year, according to Wise. “It’s a big deal,” she said.

    Wise noted that JTI’s ability to achieve meaningful and sustainable growth relies on three pillars: its ability to innovate, a sensible regulatory environment and consumer acceptance of new products. Data and behavioral insights confirm that while some consumers are interested in reduced-risk products (RRPs), the majority still want to buy traditional tobacco products. Despite the rapid growth of next-generations products, cigarettes still accounted for 86 percent of total global tobacco sales by value in 2019. “That means we must innovate for both RRPs and combustibles,” said Wise.

    In 2019, JTI ranked among the Top 100 companies for European patent applications filed. While many filings were for RRPs, 60 filings focused on combustibles, covering areas such as packaging, filters and flavorings. The company has also invested in agronomy, developing new seed varieties to increase crop productivity, lower the levels of certain undesirable constituents and benefit growers, for example.

    Wise then stressed the importance of a balanced regulatory framework, one that protects consumer choice, encourages rigorous quality standards while maintaining a level and competitive playing field. “Less regulation can lead to more innovation but also encourages inappropriate risk-taking,” she said. “When that comes at the cost of quality and safety, the negatives outweigh the positives.”

    She cautioned that in the absence of a robust regulatory framework, there was no place for short-term opportunism. “Otherwise, we risk putting off consumers, destabilizing the industry and attracting knee-jerk regulation to counterbalance the actions of those looking for a quick return,” she said. Wise pointed to California, which recently became the second U.S. state to ban flavored tobacco and vapor products—a political decision with no scientific basis that risks fueling illegality, she said.

    The industry’s ability to innovate is tempered by consumer acceptance of new products, Wise noted. She cited several innovations, including early smokeless cigarettes in the late 1980s, which, for a variety of reasons, failed to take off. She stressed the importance of consumer choice and the ability of adult consumers to make informed decisions. “It is counterproductive for government to prevent the industry from sharing information about their products and then making decisions on behalf of consumers and not treating them like adults,” she said.

    Last year’s Evali crisis in the United States demonstrated how vulnerable the industry is to misinformation, according to Wise. A mysterious outbreak of lung illness spawned a media frenzy—“cat nip for the media,” as Wise put it—and a severe regulatory backlash, with authorities restricting vaping before the cause had been determined. Evali was later attributed to vitamin E acetate in THC products sold through informal channels, but by that time, the damage had been done. Nielsen figures showed a staggering 25 percent drop in global retail vapor sales in the months following the crisis.

    While acknowledging that standing up for smokers and consumer choice might be perceived as bold in some quarters, Wise insisted it was the right thing to do. “We don’t encourage smoking; we know that it is bad for health,” she said. “We believe in freedom of choice: the right to choose cigarettes or RRPs or to quit. That’s what we mean by a consumer-centric approach; it reflects reality.”

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    K.C. Crosthwaite: Seizing the historical harm reduction opportunity

    K.C. Crosthwaite, chairman and CEO of Juul Labs, described the historic opportunity provided by new technologies for tobacco harm reduction and the barriers that need to be overcome to realize it. “We have today what was never available before: the tools and technology to end the era of smoking,” he said.

    It is by now widely accepted that smokers smoke for the nicotine but get sick from the “tar”—the byproducts of combustion. Nicotine is delivered on a continuum of risk, explained Crosthwaite. Traditional cigarettes are by far the most dangerous delivery device because of the tobacco smoke, which is associated with cancer, respiratory illnesses and other diseases. On the other end of the scale are nicotine replacement products that supply “clean” nicotine.

    Juul Labs’ Juul system delivers nicotine without burning tobacco, which puts it at the lower end of the risk continuum. This summer, Juul Labs submitted a premarket tobacco product application for its Juul system to the FDA, which, if approved, would allow the company to continue marketing the product in the United States.

    Crosthwaite believes the Juul system is “appropriate for the protection of the public health” as required by the FDA. Over the past five years, he said, 2 million U.S. adults have switched completely away from combustible cigarettes using Juul products. At the same time, Crosthwaite acknowledged that harm reduction for adult smokers cannot come at the cost of underage use. Juul Labs has been criticized for contributing to an increase in teen vaping in the U.S. Upon becoming CEO about a year ago, Crosthwaite vowed to “reset” the company. “Juul has learned lessons of past,” he said. “We are now more disciplined and focused on responsible stewardship of products.”

    While the possibilities offered by reduced-risk products for tobacco harm reduction are considerable, Crosthwaite warned that the world is at risk of losing the opportunity due in part to the precarious regulatory landscape. Around the globe, regulatory frameworks tip the balance in favor of cigarettes. “One-third of the world population lives in countries that ban nicotine vapor products,” he said. “As a result of these restrictions, and despite being available for more than a decade, vapor products account for 3 percent of cigarette sales worldwide.”

    Meanwhile, cigarettes—the riskiest category—are readily available everywhere.

    On top of that, many smokers are confused about the risks compared to cigarettes. Misconceptions about these products are at an all-time high, according to Crosthwaite. In some surveys, 80 percent of respondents incorrectly indicated that nicotine causes cancer.

    Crosthwaite called for risk-proportionate regulation that would allow reduced-risk products to compete with cigarettes. Among other things, that means they must be able to deliver nicotine levels that are sufficiently satisfying. In that context, Crosthwaite criticized the EU cap on nicotine levels in e-liquids, which he said may inhibit smokers from switching by making e-cigarettes a less appealing option.

    Regulatory pathways must include minimum quality and safety standards, he said. But they cannot be so burdensome that they become de facto barriers to market. Crosthwaite called for collaborative action by governments, civil society, public health bodies and industry to realize a risk-proportionate system. “If we get this right, we can accelerate the end of the age of the cigarette,” he said.

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    Panel: Comparative Regulations: Who is getting it right and ‘WHO’ could be doing better?

    The first panel discussion in the GTNF’s Asia time zone compared nicotine regulations around the world. Chris Allen, chief scientific officer at Broughton Nicotine Services, noted that regulation should be driven by sound science, not politics. “That is not always the case,” he said. Regulations, he added, should also be progressive. “They should allow innovation and have the ability to evolve,” he said. “If today’s aviation regulations were in place 100 years ago, air travel as we know it now may not have been possible.”

    Moderated by RAI Services’ senior vice president of scientific and regulatory affairs, Mike Odgen, the panel explored the question of who is getting regulation right and who could do better. A consensus emerged that while no one was doing everything correctly, some regulatory bodies were doing a better job than others.

    Citing 7 million tobacco-related deaths annually worldwide, Derick Yach, president of the Foundation for a Smoke-Free World (FSFW), said the goal of regulators should be to reduce the harm caused by tobacco as quickly as possible. “Governments are failing us,” he said, before singling out some “green shoots” of decent policy decisions. Yach pointed to the EU’s decision to exclude tobacco harm reduction (THR) products from its recently enacted ban on menthol cigarettes; the U.K.’s integration of THR into cessation at the clinical setting and the U.S. FDA’s decision to grant modified-risk orders to IQOS and general snus.

    “Yet the World Health Organization, which should be putting it all together, is making little progress,” he noted. According to Yach, THR is part of the definition of tobacco control. The concept featured prominently when work started on the Framework Convention for Tobacco Control (FCTC). “Instead, we are hearing calls for bans on THR products in low-[income] and middle-income countries where the health consequences of combustible products are the harshest,” he lamented. 

    Trade law consultant Abrie Du Plessis urged tobacco and vapor companies to share their input as the EU starts evaluating novel tobacco products in preparation for its next Tobacco Products Directive (TPD). By May 2021, the EU is required to publish a report on novel tobacco products and propose amendments to the TPD. Enacted in 2014, the current directive does not address the harm reduction potential of such products. The rapporteurs will be looking into the impact of novel products on uptake among young people and nonsmokers and their contribution to cessation, among other issues.

    Whatever new regulations the EU adopts may reverberate beyond the single market. According to Du Plessis, the upcoming report is required to consider rules at the international level. However, the Conference of the Parties to the FCTC, which was scheduled to take place this month in the Netherlands, has been postponed to November 2021. As a result, the sequence of events has been overturned; the FCTC will meet after the EU report. “This means the EU may lead the FCTC rather than the other way around,” says Du Plessis.

    The panelists agreed that the regulatory processes around the world were too sluggish considering the tobacco-related mortality and morbidity. “If smoking wasn’t killing the number of people it is, it would probably be justified to go about this rulemaking in a very leisurely way,” said Yach. He contrasted the glacial pace for tobacco to the Covid-19 response where “every rule in the book is stripped because this is a fast-moving pandemic.”

    “Yet there is no difference between the two except in timing,” said Yach, referring to the death tolls extracted by tobacco use and the coronavirus. “If we took the Covid-19 approach, the goal should be to strip away the regulatory nonsense to get lifesaving products into the hands of people in the quickest, safest possible way. Then we would see progress at lightning speed rather than what is now a trickle.”

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    Panel: Scientists Talk

    The second panel discussion during the 2020 GTNF in the Asia time zone featured top scientists from the leading tobacco companies discussing the role of science in the tobacco and nicotine business.

    Moderated by Teo Forcht-Dagi, honorary professor at Queens University, the panel included Maria Gogova, vice president of regulatory sciences and regulatory affairs at Altria Client Services; Ian Jones, R&D principal scientist at Japan Tobacco International; David O’Reilly, director of scientific research for British American Tobacco; and Joe Thompson, chief scientific officer at Imperial Brands. 

    Asked to identify the most salient scientific issues facing the tobacco and nicotine industries, the panelists named the communication of science and data gaps, among other topics.

    Today’s alternatives to combustible products represent an unprecedented opportunity to reduce the risks of smoking, but without consumer trust in the product, the opportunity will not live up to its potential.

    Jones summarized the challenge by quoting Anne Roe. “Nothing in science has any value to society if it is not communicated,” the American psychologist reportedly said. “It helps if it’s understandable too,” Jones added, quoting a coworker this time.

    Despite the substantial and growing body of evidence that vaping is less harmful than smoking, an increasing number of consumers believes the opposite. Between 2014 and 2016, the share of U.S. adult smokers who perceived vaping as being equally or more harmful than smoking increased from 44 percent to 68.4 percent, according to the PATH study.

    Such misconceptions are fueled by flawed studies and sloppy media coverage, according to Thompson. For example, a 2019 research paper erroneously linked e-cigarette usage among adults to heart attacks, generating sensationalist headlines. Its authors were later forced to retract the study, but by that time, the damage in terms of public perception had been done.

    O’Reilly noted that most people’s understanding of tobacco and disease is about 30 years out of date, causing them to confuse nicotine with products of combustion. He said it was depressing to see how even many medical and scientific professionals misunderstand the issues, mistakenly attributing cancer and respiratory diseases to nicotine, for example. “It is one thing for the public to struggle with nuances of nicotine toxicology, but the misperceptions of our colleagues in [the] scientific and medical world must be addressed,” he said.

    The panelists agreed the industry should step up its science communications and use all available channels (while noting that some channels are off-limits) to get its message across. Jones called on the industry’s communicators to be open, transparent and take the time to understand their audience. “Don’t sit on your pedestal and try to bedazzle everybody,” he said. O’Reilly said the automotive industry provided a good analogy to describe the tobacco industry’s transformation to the public. “Moving away from combustion will benefit public health,” he said.

    The panel then turned its attention to data gaps—what we don’t know. A recent review by the Committee on Toxicology that advises the U.K. Department of Health was broadly supportive of vaping but also pointed to the lack of information on the performance of cigarette alternatives over time. This presents a challenge not only because of the sector’s age—many products simply haven’t been around for long enough to conduct epidemiological studies—but also because it is hard to follow people over time. Contrary to the traditional cigarette business where smokers typically stay with the same product and brand for the duration of their smoking “career,” vapers change products frequently, either due to evolving technology or changing preferences. So tracking them is difficult.

    While acknowledging the data gap, Gogova said the absence of epidemiology should not be used as an excuse to foreclose tobacco harm reduction opportunity and/or the authorization of modified-risk claims, as doing so would leave the field to combustible cigarettes—the riskiest option.

    Despite the relative youthfulness of the vapor sector, O’Reilly said it was time to start considering population-based studies. “We are in a different space today then at the start of the GFNF in terms of science. In a number of countries, the uptake of alternative products has been going on for some time now.”

    The panel also pondered the question of how to recruit scientists. Fortunately, the industry’s transformation has made that task easier in recent years. Many scientists are attracted by the opportunity to help reduce the harm caused by smoking. According to O’Reilly, scientists could arguably do more to avoid a billion premature deaths by joining the tobacco industry than by signing up for academia or other sectors. As Jones explained, science is about curiosity, about wanting to learn more, ask questions and pull things to pieces to see how they work. Unlike the situation 20 to 30 years ago when tobacco science had stagnated, the transformation that the industry is undergoing provides all of that.

    Encouragingly, all panelists reported that scientists today have a big seat at the table inside tobacco companies’ board rooms. Science is viewed as fundamental, they said. It makes sense: One of the greatest challenges to sustainability for the industry is achieving tobacco harm reduction that is based in sound science. Without science, the industry has no foundation to transform itself and continue its operations.

    Panel: One billion voices: Grassroots consumer rights advocacy

    The panel discussion “One billion voices” debated the difference consumer advocates can make in promoting harm reduction and risk-proportionate regulatory frameworks. Clarisse Yvette Virgino, member of the Coalition of Asia Pacific Harm Reduction Advocates, provided a powerful example of consumer advocacy in action. The Philippines had originally intended to ban electronic nicotine-delivery systems (ENDS). Through active discussions with lawmakers, consumer groups and their allies managed to avert prohibition.

    Plenty of challenges remain, however. Philippine law classifies e-cigarettes and tobacco-heating devices as tobacco products, which means they are subject to similarly strict restrictions. What’s more, damaging misperceptions persist, with many inaccurately viewing ENDS as equally or more harmful than cigarettes. The government closely toes the anti-harm reduction line set out by the WHO, and President Rodrigo Duterte has repeatedly made negative comments about vaping. 

    The situation is worse in India where the government last year banned e-cigarettesand tobacco-heating products, denying the country’s 110 million smokers access to less harmful alternatives. Samrat Chowdhery, president of the International Network of Nicotine Consumer Organizations, bemoaned the exclusion of nicotine consumers from the debate. “Once somebody starts using a tobacco product, their experiences and opinions no longer matter,” he lamented. The ban has spawned a thriving black market—but without the quality controls that were in place previously, according to Chowdhery. It has also driven many vapers back to smoking.

    India’s hostility to harm reduction extends to oral products. The country boasts a huge smokeless market with offerings such as gutka and pan masala. As Chowdhery points out, however, not all smokeless tobacco products are created equal; the segment has its own risk continuum, with snus and modern oral products at the low end of the scale and Indian smokeless near the top. “Indian smokeless is extremely deadly,” he says. “It is linked to about 350,000 premature deaths annually.”

    The availability of less unhealthy smokeless alternatives should make India ripe for substitution. “Unfortunately, Indian tobacco control is trying to conflate risk, using the example of Indian smokeless to claim that all smokeless tobacco products are bad,” said Chowdhery. The other obstacle is price: Indian smokeless is extremely cheap—cheaper even than bidis, the most used form of smoked tobacco in India. “So if you look at converting gutka and pan masala users, then the price point has to be where consumers can afford it,” he said.

    The panel debated the challenge of communicating the benefits of cigarette alternatives. Heneage Mitchell, director of Factasia, said his organization was constantly struggling to counter misinformation. Erroneous headlines depicting vaping and smoking as equally harmful have a huge impact, he said, but it is difficult to get publishers to retract their stories. And unlike their adversaries, vapor advocates have limited resources. “They have billions; we have pennies,” said Mitchell, comparing his finances with those of the WHO and Bloomberg Philanthropies. Lacking budgets, consumer advocates are relying on social media to make their voices heard—but the way those platforms are designed means that activists are often finding themselves in echo chambers, preaching to the choir. “There is no magic bullet,” Mitchell said.

    Making matters worse, some 50 percent of the world’s tobacco production is controlled, through whole or partial stakes in tobacco companies, by governments that have signed the treaty. “That makes the FCTC an institutional tobacco trader lobby,” said Chowdhery. Tellingly, when Canada and the EU in 2018 supported making the FCTC proceedings transparent, they were countered by countries such as Thailand and India, which have substantial interests in their tobacco industries.

    Despite the formidable obstacles to harm reduction, the panelists took heart from the fact that consumers are becoming more vocal. The personal experience with lifesaving devices has made many eager to speak up. Chowdhery said he was encouraged to see how many so-called experts are now facing pushback from consumers who are “calling bullshit.”

    Moderator Alex Clark, CEO of the U.S. Consumer Advocates for Smoke-Free Alternatives Association, and Australian tobacco harm reduction advocate Andrew Thompson urged vapers and their supporters to leverage their power as voters. “Tobacco control needs to get off the tracks and get on the train,” said Thompson.

    Hiroya Kumamaru: The Japanese experience

    Hiroya Kumamaru, a cardiovascular surgeon and vice director of AOI International Hospital in Kawasaki, Japan, discussed the remarkable decline of smoking in Japan following the introduction of heated-tobacco products (HTPs) in 2014.

    Smoking is the biggest cause of disease and premature death in Japan, ahead of other prominent causes such as hypertension and diabetes. In 2010, 157,000 people in Japan died from smoking-related diseases, including malignancies and respiratory afflictions.

    The economic damage is substantial too. The Japan Health Economics Research Group estimates the annual loss due to smoking at ¥4.3 trillion ($40.81 billion), mainly in the form of lost working hours, cleaning cost, fire safety expense and medical expenditures. This figure far outweighs the positive impact on Japan’s economy of smoking, which the research group puts at ¥2.8 trillion (primarily tax income) per year.

    Japan has long struggled with stubbornly high smoking rates. In 1989, more than 50 percent of men and about 10 percent of women smoked, according to the National Health and Nutrition Survey. In recent years, however, the figure has started to come down dramatically. Between 2015 and 2019, domestic cigarette sales decreased from 180 billion sticks to 120 billion sticks—a drop of more than 30 percent. The share of smokers over the age of 20 is now below 18 percent in Japan.

    Experts attribute the decline to the introduction of HTPs, which satisfy smokers’ cravings but likely present a lower risk to their health. Kumamaru cited research by Bekki et al. of Philip Morris International’s (PMI) IQOS HTP, which showed that the nicotine concentration in the smoke—the part that provides the satisfaction—was almost the same as that of conventional cigarettes while the concentration of tobacco-specific nitrosamines (TSNAs) and carbon monoxide—components associated with illness—were one-fifth and one-hundredth of those in conventional cigarettes, respectively.

    Since their debut in 2014, HTPs have captured 24.3 percent of all tobacco sales in Japan. More than a quarter of Japanese smokers have embraced HTPs, with at least 70 percent using these products exclusively. Among men in their twenties and thirties, more than 50 use HTPs, according to the Japan National Health and Nutrition Survey (2018), which was published in January 2020.

    Meanwhile, Japan’s overall smoking rate continues to decline, which suggests the new products are enticing smokers to switch rather than recruiting new users. PMI data show an insignificant share of new smokers started because of its HTP product, IQOS, in 2017. According to Kumamaru, this shows there is no “gateway” effect from having HTPs on the market.

    While impressed by the impact of HTPs on smoking rates, Kumamaru said he had even greater expectations of the tobacco harm reduction potential of vapor products. Manufacturers have hesitated to launch e-cigarettes in Japan in part because of regulatory issues, but he nonetheless expected launches in the vapor segment soon.

    Click here to read more session summaries from the 2020 GTNF.

  • Colin Mendelsohn

    Colin Mendelsohn

    Colin Mendelsohn, board member and founding chairman of the Australian Tobacco Harm Reduction Association, detailed “the very sad state” of vapor regulation in his country. Australia, he said, is the only Western democracy to effectively ban nicotine liquid.

    Australia classifies nicotine as a dangerous poison in the same category as arsenic, and consequently, its sale and use are criminal offenses unless accompanied by a doctor’s prescription. Violators of the nicotine ban face penalties of up to AUD45,000 ($32,230) and up to two years imprisonment, depending on the state. The law makes an exception for nicotine-replacement products and cigarettes, ironically allowing users to consume nicotine by combusting tobacco leaves—the riskiest delivery method—but not by vaporizing e-liquid, which is generally believed to be less harmful to health.

    Vapor products are also subject to the tobacco law and the therapeutic goods law. Among other things, this means vapor companies are not allowed to advertise or display their products, and consumers cannot vape in their personal vehicles when there are children present. The therapeutic goods law allows vapers to import products for personal use with a doctor’s prescription, but this remains very much a theoretical scenario. “People aren’t doing it,” said Mendelsohn.

    The hostile climate to vaping is extracting a serious human cost. Mendelsohn displayed a graph comparing the development of smoking rates in the U.S., the U.K. and Australia. After 2013, when vaping became widespread, the declines accelerated in the U.S. and the U.K. but flatlined in Australia. Whereas the share of smokers decreased by a full percent per year in the U.S. and 0.8 percent per year in the U.K., the annual decline in Australia stagnated at 0.3 percent—one third of the rate in the other countries. In 2019, the smoking rate was 14.7 percent in Australia, 13.9 percent in in England and 13.7 percent in the U.S.

    “We can’t say for sure it’s all due to vaping, but vaping is playing a major role because Australia is doing everything else,” said Mendelsohn, referring to the country’s draconian tobacco control policies. “We have very strict tobacco control laws, the highest cigarette prices in the world, plain packaging—and yet smoking is not changing.”

    Other unintended consequences of the ban include black market sales, the relocation of Australian businesses to New Zealand (from where they sell their products to Australia) and a thriving do-it-yourself business in which vapers import nicotine to create their own e-liquids (and occasionally get poisoned by their concoctions.)

    Despite the unwelcoming environment, Mendelsohn is cautiously optimistic that things may improve for Australian vapers after Health Minister Greg Hunt tried to ram a ban on nicotine imports through Parliament and suffered a major backlash. Opponents “melted the phone lines” to their members of Parliament, according to Mendelsohn. Twenty-eight backbenchers sent a letter to health minister; a petition against the proposed legislation gained 70,000 signatures in three days; and 95 percent of vapers indicated in a survey that the decision would influence their vote.

    In the end, the minister backed down. The plan has been delayed by six months; a streamlined version will be introduced on Jan. 1, 2021. According to Mendelsohn, vaping has become a political decision. “We are not going [to] change the bureaucrats, but the politicians are getting it—and they will decide,” he says. “One consideration that will weigh heavily in their considerations is that vapers vote. We now have a lot of vapers who will vote according to this issue. As we know from the U.S., vaping for many voters is a ‘single issue.’ If you know vaping will save your life, you will pick the party that supports you.”

    In addition, notes Mendelsohn, lawmakers have become more receptive to the evidence supporting vaping as less risky than smoking. “The decision will be made in Canberra, and we hope the politicians will stand up for this. So far, the evidence is promising.”

     

  • Alex Clark

    Alex Clark

    In the early days of e-cigarettes, the U.S. Food and Drug Administration (FDA) began seizing the next-generation products. In response to the federal action, a group of enthusiasts and dedicated vapers became concerned that consumers would lose access to the potentially lifesaving technology. That led to the creation of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA). Alex Clark, CEO of CASAA, said the organization soon started building an army of consumers dedicated to keeping vapor products on the market.

    “We truly are a grassroots consumer organization,” explains Clark. “We speak from the heart. And it is our needs as consumers, as people who are choosing a better path in the way that we consume nicotine and tobacco products; that’s where we’re speaking from, and that’s what sets our policy agenda.”

    Speaking during the Global Tobacco & Nicotine Forum (GTNF) in late September, Clark disclosed that CASAA does accept donations from a variety of stakeholders, including industry stakeholders, but the organization does not have any policy, legislative messaging or financial agreements with any of its supporters. Clark says that the conversation surrounding vaping is centered in harm reduction and that is the mission of CASAA.

    “Vaping … has become this conversation about tobacco harm reduction, [it] is a consumer-driven movement. I don’t think there’s anything groundbreaking in that statement,” he said. “But I bring it up because I believe—and I think many of us believe—that the industry and policymakers need to be reminded of that—that as people who used to smoke, we have endured years of other people telling our story.”

    CASAA grew as a community organization through its “tight feedback loop” between consumers and independent manufacturers. Clark likened the early days of the not-for-profit organization to the local food movement where “if you wanted to know where your cheeseburger came from, you could drive down the road” and visit the farm.

    “I think we can all come to embrace that spirit and that side of the industry as an asset, not necessarily something that needs to be regulated to within inches of its life,” Clark said. “As consumers, we are very deeply afraid that is what’s going to happen. That as larger firms are able to make it through the [premarket tobacco product application (PMTA)] process, that we [will] lose that very important retail experience to be able to walk into a vapor shop and learn about the products but also discuss the challenges that we’re facing in transitioning away from smoking.”

    Clark says that a major concern for CASAA and its supporters is that the U.S. Food and Drug Administration (FDA) PMTA process is too expensive and arduous for small business owners. He says the organization worries that if only large tobacco companies can sell vapor products, consumers will lose the ability to have a place to learn and understand the choices available, through different types of products, to help them stop smoking.

    Clark mentioned a study that evaluated the long-term success rates of quitting smoking for people who visited specialty vape shops versus people who bought their products at convenience stores. That study found that consumers that visited vape shops were more successful at stopping smoking. “They were more likely to transition completely, and they were more likely to stick with the products for longer,” said Clark.

    Because of the success vape shops have had at helping people quit smoking, they began to move away from the stigma they carried in local communities early on as being businesses where “potentially unsavory elements go to get their drugs,” according to Clark. He says that, today, vape shops are seen for what they are: a contact point for public health messaging and people who smoke. “People who are looking for a way to move away from combustible tobacco visit vape shops, and it’s a very casual setting,” he says. “It’s a place where people can feel safe and welcome and [are] able to just share our stories with one another. It is very helpful, and it really looks a lot like a community support [group for smokers].”

    Clark said this distinction is important for regulators and anti-vaping groups to understand. Smokers began making the decision to quit using cigarettes by switching to vapor products of their own accord. There was not a government agency telling them that e-cigarettes had the potential to help them quit deadly smoking, and small, family-owned vape shops are where the conversations and mass conversions began.

    “We have made this decision on our own, which is a bit challenging to the dominant narrative painting people who smoke as victims. I, honestly, don’t feel like a victim,” he says. “I started smoking in the mid-’90s. Certainly, I was subject to all kinds of messaging about why I shouldn’t smoke. Not only why it would be negatively affecting my health but [also] why it was essentially a character flaw and I was a bad person.”

    Clark says vape shop owners need to help keep vape shops available to smokers by taking steps to continue to change people’s perceptions of them. Owners need to keep their shops clean and sanitary. Don’t have such a thick cloud of vapor when opening the door that potential customers are driven away. Vape shops should have an open and welcoming environment.

    “You need to have a place for your customers to talk with one another. People behind the counter need to be very knowledgeable about the products that they are selling. Regulations [need to allow] people [to] have candid conversations about these products. As it stands now, I think even sharing your personal story about making the switch while standing behind the cash register could get people into a lot of trouble,” he says emphatically. “There’s a lot of room for regulations to improve in terms of allowing people to receive important information and also the education that needs to happen among people working in vape shops.”

    People often internalize messages that are intended to encourage them to change their lives for the better, according to Clark. He says people also internalize messages about being deficient. Some of the rhetoric surrounding vaping and the misinformation about its harms is detrimental to public health. Vape shops create an environment where people feel comfortable discussing their goal of quitting cigarettes. Anti-vape groups, however, are putting these “safe zones” for smokers in jeopardy.

    “We have already seen the legislative agenda of the anti-vaping, anti-nicotine campaigns, which is to go after flavors, which very obviously shuts down vape shops and takes away that very important element of providing a space for people to come together and support one another,” Clark told attendees. “We must be prepared to take on these fights at the local and state level.”

    Fighting the types of legislative challenges that the vapor industry is facing is complicated. Clark says that when attempting to tackle many legislative issues in the United States, it is like dealing with 50 different countries. “Certainly, you can see this in our patchwork of responses to the [Covid-19 pandemic],” he says. “Within those 50 countries, we have 39,000 local governments and all of these are potential pressure points where anti-nicotine activists will promote anti-harm reduction policies. If we don’t stand up for ourselves, we can’t rely on other people to do it for us, and we cannot surrender our voice to either anti-tobacco activists or the tobacco and nicotine industry.”

  • Hiroya Kumamaru

    Hiroya Kumamaru

    The Japanese experience

    During the recent GTNF, Hiroya Kumamaru, a cardiovascular surgeon and vice director of AOI International Hospital in Kawasaki, Japan, discussed the remarkable decline of smoking in Japan following the introduction of heated-tobacco products (HTPs) in 2014.

    Smoking is the biggest cause of disease and premature death in Japan, ahead of other prominent causes such as hypertension and diabetes. In 2010, 157,000 people in Japan died from smoking-related diseases, including malignancies and respiratory afflictions.

    The economic damage is substantial too. The Japan Health Economics Research Group estimates the annual loss due to smoking at ¥4.3 trillion ($40.81 billion), mainly in the form of lost working hours, cleaning cost, fire safety expense and medical expenditures. This figure far outweighs the positive impact on Japan’s economy of smoking, which the research group puts at ¥2.8 trillion (primarily tax income) per year.

    Japan has long struggled with stubbornly high smoking rates. In 1989, more than 50 percent of men and about 10 percent of women smoked, according to the National Health and Nutrition Survey. In recent years, however, the figure has started to come down dramatically. Between 2015 and 2019, domestic cigarette sales decreased from 180 billion sticks to 120 billion sticks—a drop of more than 30 percent. The share of smokers over the age of 20 is now below 18 percent in Japan.

    Experts attribute the decline to the introduction of HTPs, which satisfy smokers’ cravings but likely present a lower risk to their health. Kumamaru cited research by Bekki et al. of Philip Morris International’s (PMI) IQOS HTP, which showed that the nicotine concentration in the smoke—the part that provides the satisfaction—was almost the same as that of conventional cigarettes while the concentration of tobacco-specific nitrosamines (TSNAs) and carbon monoxide—components associated with illness—were one-fifth and one-hundredth of those in conventional cigarettes, respectively.

    Since their debut in 2014, HTPs have captured 24.3 percent of all tobacco sales in Japan. More than a quarter of Japanese smokers have embraced HTPs, with at least 70 percent using these products exclusively. Among men in their twenties and thirties, more than 50 percent have abandoned cigarettes in favor of HTPs, according to the Japan National Health and Nutrition Survey (2018), which was published in January 2020.

    Meanwhile, Japan’s overall smoking rate continues to decline, which suggests the new products are enticing smokers to switch rather than recruiting new users. PMI data show that fewer than 0.1 percent of new smokers started because of its HTP product, IQOS, in 2017. According to Kumamaru, this shows there is no “gateway” effect from having HTPs on the market.

    While impressed by the impact of HTPs on smoking rates, Kumamaru said he had even greater expectations of the tobacco harm reduction potential of vapor products. Manufacturers have hesitated to launch e-cigarettes in Japan in part because of regulatory issues, but he nonetheless expected launches in the vapor segment soon.