Category: GTNF

  • Thoughtful Progress

    Thoughtful Progress

    Image: PuiZera

    At the recent GTNF in Athens, stakeholders debated how to responsibly advance innovation.

    By Taco Tuinstra

    For a decade and a half now, the Global Tobacco and Nicotine Forum (GTNF) has nurtured engagement worldwide, fostering lively and constructive discussions among its participants. The GTNF’s most recent gathering, Sept. 24–26 in Athens, was no exception. For three days, the Divani Apollon Hotel served as a modern-day Greek agora, the ancient public space where people exchanged ideas and engaged in philosophical discussions with both friends and adversaries. Paying tribute to the host nation’s famous philosophers, the GTNF delegates asked probing questions, contemplated opposing viewpoints and displayed the courage to doubt themselves.

    But even as Athens upheld the tradition of spirited discourse, one of the conference’s most powerful moments was strikingly quiet. On day three of the forum, Carolyn Beaumont, a general practitioner and tobacco harm reduction educator from Australia, concluded her presentation with silence. She then chimed a bell every time a person would have succumbed to tobacco-related disease during that time span. Mindful of the conference’s full agenda, Beaumont played the recording for only a brief period. Had she let it run for the duration of the one-hour panel discussion she took part in, the bell would have tolled 900 times. That’s the equivalent of one death every four seconds, or 8 million deaths—nearly the population of Switzerland—every year.

    The staggering numbers underlined the urgency for the industry to help reduce the harm inflicted by smoking, and how to best achieve that goal was a major focus of this year’s GTNF. The task, of course, is formidable. Smoking is a notoriously difficult habit to kick, witness the fact that 60 years after the U.S. Surgeon General’s landmark report on smoking and health, and following decades of anti-smoking campaigns around the globe, more than 1 billion people continue to light up.

    Much of that is due to the properties of nicotine. The chemical’s uncanny ability to simultaneously stimulate and relax keeps many users coming back despite the widely known health risks of smoking. Illustrating the tenacity of nicotine addiction, another GTNF speaker, the cardio-endocrine physician Rohan Savio Sequeira, shared an anecdote of a patient who woke up from bypass surgery and immediately asked for a cigarette. “That’s the challenge we’re up against,” Sequeira said.

    Photo: Timothy S. Donahue

    But while addictive, nicotine is not the compound that causes the most serious smoking-related diseases. Nicotine may elevate blood pressure and heart rate, but the more significant risks presented by cigarettes, including cancer and chronic obstructive pulmonary disease, stem from combustion. Several GTNF speakers compared the rewards and risks presented by nicotine to those of caffeine. But unlike the most popular method for taking caffeine—drinking coffee—the most common nicotine consumption method—setting fire to dried tobacco leaves and inhaling the smoke—exposes its user to thousands of harmful chemicals.

    While the obvious solution would seem to be for smokers to consume only the nicotine, through patches, for example, the low success rate of nicotine-replacement therapies in cessation suggests there are additional factors that keep people reaching for cigarettes. As multiple speakers pointed out during the GTNF, smoking is about more than self-administering nicotine. Many aspects of the ritual are difficult to replicate. “Pouch and blow me a smoke ring,” Rae Maile, managing director of research at the U.K. investment bank Panmure Liberum, challenged his intellectual sparring partner, Erik Bloomquist, during a GTNF “fireside chat” about the financial side of the nicotine business.

    But innovation is changing the equation. Over the past decade or so, breakthroughs in battery and atomization technologies have allowed manufacturers to construct devices that not only deliver nicotine without the harmful products of combustion but also closely mimic aspects of smoking that many consumers find so appealing—the “throat hit,” the hand-to-mouth motion and, yes, even the ability to blow rings. BAT Group Head of Global Policy Flora Okereke likened the nicotine business’ rapid technological leap to the progress that had played out over a much longer timespan in the automobile business: from Ford’s Model-T to today’s self-driving cars. While not risk-free, these tools, which include e-cigarettes and devices that heat rather than burn tobacco, offer an opportunity to satisfy people’s cravings at a fraction of the risk presented by traditional cigarettes. In 2015, Public Health England memorably announced that vaping was 95 percent less risky than smoking.

    Yet despite their considerable potential, such next-generation nicotine products have not been universally welcomed, with many regulators and health groups, including the influential World Health Organization, more attuned to the risk of attracting new nicotine users than the promise of transitioning adult smokers from deadly cigarettes to less risky consumption tools. Electronic nicotine-delivery systems have also come under fire for generating e-waste and creating fire hazards.

    Much of the Athens GTNF revolved around this conundrum: How can society reap the benefits of cigarette alternatives without attracting consumers who shouldn’t be using those products and without creating other unintended side effects, such as environmental pollution? As suggested by the 2024 conference theme, at least part of the answer lies in “Advancing Responsible Innovation.”

    Acknowledging the fact that tackling the challenges will require the involvement of stakeholders from all parts of society, the conference hosted a whopping 79 speakers, including 30 women, from various professional walks of life. In addition to industry officials, regulators and analysts, the lineup featured health activists, politicians and consumer advocates. There were returning headliners such as the director of the U.S. Food and Drug Administration’s Center for Tobacco Products, Brian King, and numerous first-time contributors, such as Greek Health Minister Adonis Georgiadis, who in a video message encouraged delegates to educate governments so that they could provide their citizens with accurate information about the relative risks of nicotine products.

    Other participating politicians included Morgana Daniele, a member of Lithuania’s Parliament and chair of that nation’s Commission for Addiction Prevention, and Pietro Fiocchi, a member of the European Parliament and vice-chair of the Committee on the Environment, Public Health and Food Safety. The retail sector was represented by Henry Armour, president and CEO of NACS in the U.S., and Panos Panayiotopoulos, general manager and director of the Greek retail association, among other speakers.

    Perhaps the GTNF’s biggest “coup” this year was the participation of Kathy Crosby, president and CEO of The Truth Initiative, a U.S. anti-tobacco group established after the 1998 landmark Master Settlement Agreement between leading tobacco companies and American states seeking to recover the cost of treating sick smokers. The Truth Initiative has been highly skeptical of e-cigarettes, especially because of their uptake by underage consumers. But Crosby courageously elected to engage rather than demonize the industry—a decision that will surely have raised eyebrows among the more uncompromising members of the public health establishment.

    Yet Crosby did not dilute her message. Even as she acknowledged the need for less harmful solutions for smokers who are not ready to leave nicotine behind, she was adamant such products should leave behind their youth appeal. With unauthorized sales accounting for the overwhelming majority of U.S. e-cigarette sales, she urged retailers to remove illegal products from their store shelves immediately. Doing so, she said, would create goodwill and pave the way for constructive dialogue with the public health community. Industry representatives at the GTNF eagerly accepted the olive branch. “The ball is now in our court,” said Jose Luis Murillo, chief regulatory advisor to Juul Labs’ CEO.

    Encouragingly, each link of the supply chain represented at GTNF appeared eager to address underage access. While preventing sales to minors is a legal requirement in many markets, NACS’ chief, Armour, stressed that his organization’s members are motivated not by fear of penalties but because they feel a responsibility toward the communities they serve.

    Of course, that doesn’t mean it’s easy. Sketching the size of challenge, Armour noted that half of the U.S. population—some 165 people—comes to a convenience store every day, with 40 percent of their inventory comprising age-restricted products such as tobacco, alcohol and lottery tickets. Fortunately, technology, such as digital age verification platforms, are increasingly alleviating the burden.

    While the desire to prevent youth access is widely shared among stakeholders, opinions differ on the best way to achieve that objective. Around the world, lawmakers are increasingly resorting to prohibition, banning vape flavors or single-use products, for example—or outlawing new nicotine products altogether.

    That is not the approach favored by most GTNF speakers. Counterfactual Director Clive Bates reminded his audience that people have been using nicotine for at least 12,000 years. “Demand will persist because nicotine provides psychoactive rewards,” he predicted. Banning it, Bates noted, will simply shift demand from legitimate suppliers to law-evading ones, as happened in the U.S., where an onerous product authorization system combined with halfhearted enforcement has handed nearly the entire vaping business to the black market. Dave Dobbins, former chief operating officer of the American Legacy Foundation and now a consultant to Altria Group, cited the example of Bhutan, which in 2004 declared a nationwide ban on sales of tobacco products but was later forced to abandon its experiment under pressure from the illicit market (see “Bhutan’s Tryst with Health Imperialism,” Tobacco Reporter, June 2024).

    Instead of betting on unworkable bans, many GTNF attendees were hopeful that the same innovation that had brought the world less harmful nicotine products would help tackle challenges such as underage consumption. Elaine Round, group head of life sciences at BAT, took the opportunity introduce the GTNF audience to her company’s recently launched Omni platform, an evidence-based, accessible and dynamic resource that shows how science and innovation can combine to achieve a smokeless world. The potential of such innovations was clearly demonstrated in three “big pitch” presentations, a new GTNF event during which companies outlined their solutions to some of the business’ most vexing problems, and answered questions from an expert panel.

    Rhodri James, chief sales officer at Yoti, a digital identity company, described a technology that verifies buyers’ ages by scanning customers’ faces and measuring their skin tone. As people age, James explained, the pigment of their skin changes. Wrinkles, for example, have a different tone than smoother parts of the skin. By determining the differences, Yoti’s technology is able to determine a potential buyer’s age with an almost uncanny accuracy. In tests, the platform performed much better than human store clerks. In addition to speeding up checkouts—and thus reducing “friction” in store transactions—the platform helps defuse what James described as “challenges to the challenge.” Confronted with a customer incensed about being denied a sale, the salesclerk can simply blame the computer. Asked about privacy, James noted that facial age estimation is not facial recognition. The platform, he said, cannot tell who you are—only how old you are.

    Greenbutts presented a filter that it claims is biodegradable without compromising performance and taste (see “A Future Without Plastics,” Tobacco Reporter, March 2023). The product addresses a colossal challenge indeed. With 11 billion cigarettes discarded daily, filters are the single most littered item on the planet. As indoor smoking bans have forced consumers outdoors, the problem has only become worse; butts that were previously deposited in ashtrays are now ending up in the environment. Made with cellulose acetate, current filters degrade into nanoplastics, which not only pollute but also end up in the food chain.

    Founded in 2010, Greenbutts has developed a plastic-free, plant based product that is 100 percent dissolvable in water. Importantly, the filter delivers the same sensorial experience as cellulose acetate products at a comparable cost, according to the company. In blind tests performed at trade exhibitions, many smokers chose Greenbutt’s filter, said Chief Strategy Officer Luis Sanches, who added that production could be scaled up easily.

    Greentank shared a solution that offers vapers a more consistent user experience while lowering the risk of creating undesirable compounds during the heating process. In many currently available vapes, the flavor tends to wane as the pod empties. In tests, the Quantum Vape technology delivered 1,000 puffs with virtually unchanged flavor intensity. According to President and Chief Operating Officer Corey Koffler, Greentank was able to achieve this through “cleanroom chip manufacturing technology combined with physics at nanoscale.” Instead of relying on wicks and coils or ceramics, Quantum Vape comprises thousands of microscopic heating tubes on a chip. The system allows Greentank to precisely control both the location and the duration of the heating, thus eliminating hot spots and avoiding the risk of negative chemical reactions.

    The 2024 GTNF highlighted many more examples of such remarkable innovations, which perhaps isn’t surprising considering the amount of money invested. In a discussion among prominent suppliers of vaping hardware, e-liquids and nicotine pouches, company representatives revealed how much their employers spend on research and development. For example, Smoore International Holdings, a leading e-cigarette manufacturer headquartered in China, directs a whopping 10 percent of its revenue to R&D, according to Executive Director Eve Wang.

    While celebrating innovation, GTNF speakers lamented the hurdles preventing society from reaping the full benefits of new technologies. Misguided regulation featured prominently among the delegates’ gripes. According to Health Diplomats President Delon Human, 34 countries ban tobacco harm reduction products outright, leaving the market to combustible cigarettes. In the rest of the world, manufacturers must contend with everything from no regulations to very strict frameworks. Many words were devoted to the burdensome product authorization process in the U.S., which has left law-abiding American consumers with only a handful of outdated products and a thriving black market. The European Union’s continuing ban of snus, too, elicited repeated groans, as did the rapid spread of bans on nicotine pouches.

    Speakers also despaired at increasing restrictions on vape flavors. Konstantinos Farsalinos, senior  researcher at the School of Public Health at the Universities of Patras and West Attica, said that in the name of protecting youth, regulators aimed to make tobacco harm reduction products unpleasant and difficult to access. “But harm reduction will not work if you substitute cigarettes with a product that the smoker does not enjoy,” he warned.

    Misinformation was also mentioned as a challenge by many GTNF delegates. The World Economic Forum lists it as the biggest threat to humanity after climate change, noted Tikki Pang, former director of research policy and cooperation at the WHO. In the nicotine business, misinformation is widespread not only among consumers, many of whom now mistakenly believe that vapes are more harmful than cigarettes, but also among people who should know better: doctors. What medical schools teach their students about nicotine is abysmal, noted Jasjit Ahluwalia, a professor of behavioral and social sciences and professor of medicine at the Brown University School of Public Health and Alpert School of Medicine. In a recent survey, 80 percent of U.S. physicians erroneously indicated that nicotine causes cancer. Speakers agreed that education would be key to help correct misperceptions, although they acknowledged that any such effort by nicotine-related companies would likely backfire due to the industry’s enduring reputational challenge.

    The Athens GTNF also devoted much attention to a key but often overlooked stakeholder in the debate: the consumer. Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates, emphasized the need to humanize the consumers, who she said are too often treated as mere data points. “We are more than statistics,” said Loucas, after sharing her personal story of transitioning away from smoking with the help of e-cigarettes.

    Acknowledging the people that make up the market, tobacco companies appear to be increasingly receptive to that message, as became clear during a keynote by Imperial Brands’ Paola Pocci, whose very title—chief consumer officer—underscores the central role of nicotine users in the manufacturers’ operations. While consumers are similar in their desire for better health, Imperial Brands’ research also revealed that one size does not fit all; they need a variety of product categories to choose from, depending on local regulations and personal preferences, which may vary even depending on the time of day.

    To facilitate the transition to lower-risk products, devices must also be easy to use. As multiple panelists observed, innovation is useless if consumers don’t want the product. Bells and whistles that excite product designers also complicate operations, which in turn could deter users. The success of disposables is a case in point. Single-use vapes have become popular largely due to their ease of use; there are no buttons to push, batteries to charge or apps to pair. All the user has to do is puff—just like with a conventional cigarette.

    Despite the tremendous technological developments of recent years, GTNF panelists agreed that much work remains. Because no player has yet managed to develop a perfect cigarette substitute, the industry must continue to listen to consumers and address their pain points, said Pocci. The fact that cigarettes are still the most popular nicotine product suggests that the industry has not done enough to reduce the harms of smoking, echoed Marina Murphy, senior director of scientific affairs at the Haypp Group—although she also noted that it had done much better than the pharmaceutical sector, which failed to appreciate that people smoke not only to satisfy their nicotine cravings but also for the sensory aspects.

    Even as regulatory frameworks tighten and misinformation persists, the 2024 GTNF once again underlined the industry’s strong commitment to tobacco harm reduction and continued innovation. While the combination of regulatory and societal challenges will keep nicotine companies on their toes, it will also ensure another trove of compelling discussion topics when the GTNF reconvenes at a yet-to-be-announced location in 2025.

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

    Thank You!

    The GTNF, scheduled Sept. 24–26 in Athens, is made possible by the generous support of these sponsors.

    TR Staff Report

    Accorto Regulatory Solutions is a boutique regulatory firm committed to providing unparalleled regulatory and compliance solutions for its global clientele across a range of U.S. Food and Drug Administration-regulated sectors. It specializes in helping small-sized to mid-sized domestic and international companies navigate the regulatory landscape to bring their regulated product concepts to market and ensure ongoing compliance following market authorization.

    Its team has extensive experience in the tobacco harm reduction industry, with a proven track record of delivering high-quality, data-driven FDA regulatory submissions for its clients’ nicotine-containing products. Its bespoke multi-phase submission approach reduces overall project time and cost while ensuring compliance with the FDA’s most current thinking. It strives to be a trusted partner in navigating and overcoming regulatory challenges, driving success for its clients in a complex market.

    Alliance One International (AOI) is a leading independent leaf tobacco supplier. Working with tobacco farmers in 20 countries, AOI is recognized for producing sustainable and traceable leaf tobacco. The company purchases tobacco on five continents and ships to customers in 90-plus countries.

    Through direct contracts, AOI is able to provide agronomic expertise and technical guidance to help growers improve the quality and yield of their crops. The company is dedicated to supporting efforts to address human rights concerns in the tobacco supply chain by using on-farm good agricultural practices assessments to evaluate contracted farmers’ compliance with labor practices. Additionally, the company establishes contract terms and conditions with tobacco farmers related to issues such as forced and child labor, and it conducts social compliance due diligence throughout its tobacco-growing regions.

    AOI’s Sentri track-and-trace platform provides transparency into the life cycle of agricultural products by monitoring information and obtaining data related to the growth, cultivation, harvest, processing, formulation, testing and release of individual batches of products. By obtaining data on products at each stage of the supply chain, Sentri permits proactive decision-making for both the company and its customers.

    AOI believes that everything it does is to transform people’s lives in order to grow a better world. The company’s global ESG strategy was built off its strong sustainability legacy and achievements over the years. Given its diverse global footprint, AOI is well positioned to have a wide-reaching impact on systemic issues. AOI’s sustainability strategy aligns with the United Nations Sustainable Development Goals, and the company is committed to doing its part to help make those goals a reality.

    AlphaScale Technologies develops industrial-grade and high-reliability analog/mixed-signal integrated circuits (ICs) and systems for industrial and consumer markets. The company’s product portfolio includes battery and power management ICs, sensors, LED display drivers, analog-to-digital converters, microprocessors and micro-controller ICs. The company’s solutions focus on addressing the performance, reliability, power and cost challenges. The company’s mission is to be an indispensable provider of highly scalable and highly reliable building blocks for the world’s most demanding electronic manufacturers.

    AlphaScale was founded by a team of seasoned IC designers from Silicon Valley with a proven track record of developing leading-edge analog and mixed-signal ICs and systems. The company has R&D and operation facilities in the San Francisco Bay Area and China.

    Applied Research and Analysis Co. (ARAC) is a social and behavioral sciences research firm that designs, executes and leads scientifically rigorous, customizable Module 6 studies to support manufacturers, regulatory agencies and industry consulting firms.

    ARAC is a fully staffed contract research organization with in-house psychologists, behavioral scientists, statisticians and survey methodologists offering tailored research solutions with unparalleled integrity and an exceptional client experience. In-depth knowledge of U.S. consumer behavior, leveraging in-house internal expertise to deliver quicker, streamlined results to client partners.

    Based in the U.S., ARAC focuses on achieving global market success by combining regulatory expertise, consumer understanding and cultural competency expertise applied to international markets. Its triangular approach focuses on government regulations, the consumer and its clients’ business objectives. This approach has proven successful across a variety of studies, including label development and comprehension, human factors/usability, clinical behavioral studies, specifically randomized experimental trials, TPPI and postmarket surveillance systems.

    The BAT Group is a leading multi-category consumer goods business that provides tobacco and nicotine products to millions of consumers around the world.

    BAT’s purpose is to create “A Better Tomorrow” by building a smokeless world. A smokeless world built on smokeless products, where, ultimately, cigarettes have become a thing of the past.

    In order to deliver this, BAT is transforming into a smokeless business, with a target for 50 percent of its revenue to come from smokeless products by 2035.

    BAT’s portfolio of smokeless tobacco and nicotine products includes vapor products, heated products and modern oral products, which are collectively termed the “new categories,” as well as traditional oral products.

    The business continues to be clear that combustible cigarettes pose serious health risks, and the only way to avoid these risks is not to start or to quit. To help build a smokeless world, BAT encourages those who would otherwise continue to smoke to switch completely to scientifically substantiated smokeless alternatives.

    BMJ is the world’s No. 1 partner in specialty paper and packaging by responsibly providing high-value products to its customers. With sustainability goals in mind, the company exceeds the industry’s standard through intimate knowledge of customers’ articulated expectations, service excellence, high productivity, high quality and rapid innovation. It is the partner of choice of many leading players in the industry.

    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.

    FEELM, an atomization technology brand affiliated to Smoore, is a high-quality closed system and disposable solution provider that leverages the world’s leading ceramic coil heating technology, faithful flavor reproduction technology and innovative electronic technology. With the vision of “Atomization makes life better,” FEELM continues to extend the boundaries of atomization technology with

    FEELM has won numerous prestigious industry awards, including a Golden Leaf Award and Vapouround’s Award for innovation, and global design awards, such as the IF Design Award, the Red Dot Award and the German National Design Award. Products equipped with FEELM’s ceramic coil, with a total production volume of 3.5 billion, have been sold in more than 50 countries and are widely praised.

    Greentank is a business-to-business technology company that specializes in the design, development and manufacturing of precision-made inhalation devices and atomization technology. Greentank’s latest innovation in atomization is called Quantum Vape, which replaces cotton wick and ceramic heating elements with a state-of-the-art patented Heating Chip (see “Heated Breakthrough,” Tobacco Reporter, June 2024).

    Greentank believes the Heating Chip outperforms all other leading atomization products. For example, it performs better on key safety metrics, such as harmful and potentially harmful constituents and heavy metal testing, than other leading technologies in the market. It also produces superior flavor and a consistent consumer experience.

    The company has won multiple industry accolades and honors, including a Red Dot Design Award and Independent’s Vape Tank and Single-Use Vaporizer of the Year distinctions.

    Founded in 2009, Hangsen International Group is a world-leading supplier of e-liquid solutions integrating R&D, manufacturing, sales and services. Since its establishment, Hangsen has been committed to producing safe and reliable e-liquid products and solutions for the global e-cigarette industry.

    Headquartered in Shenzhen, China, Hangsen has offices and R&D centers in many places around the world. Its business covers more than 80 countries and regions, and it has established a complete global supply chain system. Hangsen also has a production base in Poland.

    The domestic manufacturing center has 6,000 square meters of 100,000-class dust-free workshops, covering a total area of more than 30,000 square meters. It has passed ISO9001, GMP, HACCP, CNAS and other international authoritative certifications. Hangsen can provide a complete supply chain solution for the e-cigarette industry, and the service scope includes design, research and development, production, compliance testing, after-sales and other links.

    As the pioneer of e-cigarette technology, Hangsen has obtained more than 300 industrial technology patents and intellectual property rights.

     The Haypp Group is focused on the global transition from smoking to reduced-risk nicotine product alternatives, especially nicotine pouches. Originating in Scandinavia, the group has extensive experience in the pioneering smoke-free markets of Sweden and Norway and is a leader in the e-commerce sector. The Haypp Group is present in seven countries, where it served more than 1 million active consumers with eleven e-commerce brands in the 12 months to June 2024.

    Imperial Brands is a global consumer organization operating in more than 100 markets and the world’s fourth-largest international tobacco and nicotine company. Its brands include JPS, Gauloises and Davidoff cigarettes, Blu vapes, the Pulze and iD heated-tobacco systems, and Zone oral nicotine pouches. In the U.S., the company’s ITG Brands subsidiary offers a broad portfolio of cigarette and mass-market cigar brands, including Winston and Backwoods.

    Driven by insights and data, Imperial Brands seeks to meet the expectations of adult smokers by putting the consumer at the center of everything it does. The business is also refining its ways of working and its culture to foster a strong challenger mindset among its 25,000 employees worldwide.

    Japan Tobacco International (JTI) was formed in 1999 when its parent company, JT Group, acquired the non-U.S. operations of RJR Nabisco. Since then, the company has achieved over two decades of growth. As a leading international tobacco company, it sells its products in more than 130 markets and is the global owner of both Winston and Camel, the second-largest and third-largest cigarette brands in the world, respectively. JTI’s other global brands include Mevius and LD. JTI is also a major player in the reduced-risk products category with its heated-tobacco brand Ploom, its e-cigarette brand Logic and its Nordic Spirit nicotine pouches.

    Creating fulfilling moments. Creating a better future. This is JTI’s purpose; what inspires every single one of its employees. JTI is committed to serving the needs and demands of its adult consumers, supporting the communities it operates in and making its business not only the fastest growing of its kind but also the most innovative and sustainably run.

    Today, JTI has more than 46,000 employees driving its success all over the world. Headquartered in Geneva, Switzerland, it was awarded Global Top Employer for the 10th consecutive year in 2024.

    Juul Labs is on a mission 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.

    Körber is an international technology group with more than 12,000 employees at over 100 locations worldwide. In its Digital, Pharma, Supply Chain and Technologies business areas, the Körber Group offers products, solutions and services that inspire. The Körber business area Technologies develops customized solutions in the areas of machinery, equipment, software, measuring instruments, flavors and services with a focus on the tobacco, food and beverage industries. Beyond this, its range of offerings includes innovative concepts for battery cell production. With its 25 global production, sales and service locations, the company sees itself as a strategic partner to its customers. Always keeping their goals in mind, the company delivers and integrates outperforming technologies with passion, precision and performance to help them reach their full potential.

    As part of Certified Group, Labstat is committed to delivering high-quality technical solutions that its customers can feel confident in—on time, every time—“so the world can trust in what it consumes.” As one of the world’s largest independent testing laboratories, Labstat specializes in analytical chemistry, in vitro toxicology, microbiology, method development and customized technical services for global clients in the tobacco, nicotine, cannabis, hemp and natural health product categories.

    Reynolds American Inc. (RAI) is a wholly owned subsidiary of the BAT Group and the U.S. parent company of R.J. Reynolds Tobacco Co., Santa Fe Natural Tobacco Co., American Snuff 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.

    Founded in 2009, Smoore is a global leader in atomization technology solutions, covering reduced-risk products, medicinal, special-purpose vaping devices and beauty atomization technologies.

    Continually investing in R&D and leading in manufacturing capacity, Smoore has nine technology research centers worldwide, and its products are available in more than 100 countries and regions.

    With a focus on interdisciplinary atomization research and a diverse product portfolio, Smoore is committed to becoming an advanced platform with the aspiration to make life better.

    SWM International is a leading global provider of highly engineered fine papers, with a deep expertise in natural fiber-based solutions. The company has historically provided solutions for conventional cigarettes, rolling papers, tubes, machine-made cigars and cigarillos as a partner of the tobacco industry.

    Recently, significant investments have been made in next-generation product categories, such as heated-tobacco products, modern oral and recreational cannabis applications. SWM’s unmatched product and capability portfolio and expert service offerings cater to both the combustible and the smokeless markets.

    Driven by innovation, SWM focuses on accelerating the transition toward safer and more sustainable solutions across the industry.

    Global brands across industries rely on Systech to help them achieve compliance, combat counterfeiting and detect diversion. Systech partners with electronic nicotine-delivery system companies to prevent youth usage with age-gating and root out illicit products.

    Systech provides digital traceability and authentication solutions that deliver essential product data, ensure digital connectivity and enable real-time insights across supply chains. With decades of experience in highly regulated industries such as pharmaceuticals and medical devices, Systech delivers solutions that customers trust to bring billions of critical products to the market safely.

    Tamarind Intelligence provides essential guidance and data-based strategic insights to professionals in fast-moving sectors focusing on consumer-facing products. The areas its selects to cover are in opaque regulatory environments and difficult policy areas where businesses need to be on top of industry developments to make informed decisions and optimize their strategy.

    Operating since 2014, the company provides the most accurate information available through consolidated, consistent methodology and research. Its team of lawyers, economists and journalists has long-term expertise in these markets, enabling the company to provide relevant and actionable guidance to its clients. Since the company is independent from the sectors it covers, it gives its clients access to objective analysis often not available to other industry participants.

    Founded in 1975 in Maryland, Tobacco Technology Inc. (TTI) develops customized flavors and casings for smoking products, including cigarettes, water pipe, snuff, snus, chew, kretek, RYO, pipe tobaccos, e-liquids and white nicotine pouches. 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 manufacturing 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 is its manufacturing facility in Assisi, Italy, making TTI products for the EU and Middle Eastern markets.

    In 2022, TTI established Emerald Green Technology (EGT). With the rise of the emergent cannabinoid marketplace, EGT was born as a natural extension of TTI’s family of flavor companies. It offers a vast array of cannabinoid flavor profiles for CBD and hemp products. Infinite cannabinoid possibilities—if you can imagine it, EGT can create it!

    Universal Corp. is a global agricultural company with over 100 years of experience supplying premium ingredients and innovative solutions to meet its customers’ evolving needs and precise specifications. Through its diverse network of farmers and partners across 30 countries on five continents and its commitment to sustainability, the company is a trusted provider of high-quality, traceable products. It leverages its extensive supply chain expertise and state-of-the-art agri-product capabilities to provide a range of products and services designed to drive efficiency and deliver value to its customers.

    Founded in 2016 and headquartered in Shenzhen, China, Zinwi Biotech Co. is a high-tech company that specializes in providing integrated solutions, including research, production, sales and services, to global e-cigarette manufacturers and brands. Today, Zinwi Biotech is one of the world’s leading e-liquid companies owing to its strong research and development, strict quality control procedures, stable product quality and large client network.

    With innovation at its core, Zinwi Biotech focuses heavily on product research and development. In addition, it focuses on reduced harm technology innovation and application. In 2020, Zinwi Biotech established its Atomization Technology Research Center focused on breaking technological barriers and obtaining patents.

    In terms of production and quality control, Zinwi Biotech has gained a number of certificates, including the National CNAS Laboratory Certification, ISO9001, ISO14001 and ISO45001, along with the American GMP Certification. Its products are sold through the network of clients to many countries and regions in Europe, America and the Middle East and have been unanimously recognized by more than 300 brands.

     

  • Changing the Conversation

    Changing the Conversation

    Photo: Sayan

    From Sept. 19 to Sept. 21, 2023, stakeholders from around the world gathered in Seoul to discuss the challenges and opportunities in the nicotine business, particularly as they relate to tobacco harm reduction. Attracting delegates from all parts of the globe, the event featured a wide variety of experts, including public health professionals, consumer advocates and financial analysts along with top regulators, such as the director of the U.S. Food and Drug Administration’s Center for Tobacco Products, Brian King. Below are highlights from the conference.

    Additional GTNF 2023 session summaries >>

    Keynote: Kingsley Wheaton (given by Jonathan Atwood)

    During GTNF 2023, BAT’s global head of business communications, Jonathan Atwood, told attendees how BAT’s five-step plan for regulation could support achieving the right balance between harm reduction and the unintended consequences of access, including underage use.

    “As an industry, we stand at an important crossroads. There is much confusion as to the way forward. Consumers are slightly confused. Doctors are slightly confused. Regulators are slightly confused and are struggling to enforce the laws they have written,” said Atwood. “What’s too often missed is the opportunity that tobacco harm reduction presents. The opportunity for a more progressive environment where both tobacco harm reduction and the role of [vaping products] is far better understood.”

    Speaking on behalf of Kingsley Wheaton, BAT’s chief strategy and growth officer, Atwood said that reckless players in the market need to be penalized when they do not abide by the rules. He said the five suggestions are the areas that regulators should explore and then establish “smart regulation” that is right for their market.

    “When I talk about smarter regulation, I mean regulation that is evidence-based, concentrated by nature, and achieving its policy aims while also avoiding unintended consequences. Greater partnership is required to achieve this,” Atwood said. “We must join forces externally with regulators and policymakers to try and create catalysts for positive change if smoke-free ambitions are to be met. Sustained and lasting changes to consumer behavior are difficult. However, it is consumer choice that offers the greatest hope for making a cigarette obsolete.”

    Atwood said that the five areas were where smarter regulation could be applied to the vapor category to build a “more progressive environment” for tobacco harm reduction. He said the recommendations would need to be applied to the entire market and combined with greater enforcement. The five steps Atwood outlined included:

    • On-device technology and functionality: Vapor products should be accessible only to adults. Both underage prevention and restriction is crucial. On-device technology, when applied and enforced across entire markets, could help in this regard.
    • Flavors: More recognition is needed that flavors are an important driver of adoption for smokers seeking alternatives. However, flavors in vapor products should not particularly appeal to anyone underage.
    • Manufacturing and import level: ensuring that noncompliant products cannot reach the market in the first place.
    • Right to sell: Where no restrictions exist already, regulators may want to look at who should be able to sell vapor products and where. Reasonable safeguards at the point of sale would help ensure these products are sold only to adult consumers. Solutions such as retail licensing and facial recognition technologies should be seriously considered.
    • Enforcement and penalties: Governments must wield their power and ensure consumers are purchasing legitimate products. Such measures should be rigorously enforced, and those who fail to comply should face meaningful sanctions.

    Atwood said BAT was calling upon governments, regulators and industry peers to rally toward a sustainable and progressive environment in which vaping products are sold and marketed responsibly.

    “The time for boldness is now. The time to change the conversation is now. The time to change the outcome is now. The opportunity for change is here. It is not about relaxing regulations. It’s about recalibrating them to align with the evidence and aspirations of millions seeking a better alternative to smoking,” said Atwood. “We have the opportunity to redefine the future of public health, and it begins with smarter regulation that reflects the reality of smoking alternatives and provides smokers the freedom to choose less risky products.”

    Panel: Putting Consumers First

    Toward the end of the Putting Consumers First panel held during September’s Global Tobacco and Nicotine Forum in Seoul, South Korea, Matt Drodge, research director at Walnut Unlimited, made the point that while nicotine consumers were all different, they all wanted to be able to make informed decisions about whether to continue smoking combustible cigarettes or when and how to make the transition to new nicotine products.

    Of course, nicotine users can make such transitions only in countries where regulations allow them to do so, and the moderator of the panel, Nancy Loucas, public health policy expert and executive coordinator of the Coalition of Asia Pacific Harm Reduction Advocates (CAPHRA), made the point that the panelists represented countries forming a continuum of nicotine regulation.

    Panelist Samrat Chowdhery, former president of the International Network of Nicotine Consumer Organisations, told participants that he felt unhappy about representing India, a country that had put consumers last by effectively banning vapes. Chowdhery said this is a pity because India does not have a strong or widely used public health network, so prevention, including through the use of safer alternatives, is vital, as it is in other parts of the developing world where 80 percent of tobacco users live.

    Fiona Patten, leader of the Reason Party and former member of the Legislative Council of Victoria, who was unable to attend the GTNF in person and instead recorded a video message, apologized for representing Australia, a country that she said is leading the way on what not to do around tobacco harm reduction. Patten said that Australia’s “so-called medical model” of regulation is so onerous that 99 percent of Australians who are looking for a safer way to consume nicotine are being forced onto the black market.

    Alex Clark, CEO of the Consumer Advocates for Smoke-Free Alternatives Association, who also did not attend the event, but appeared via a live link, said the premarket tobacco product application (PMTA) system in the U.S. appears to consumers to be acting as a very tight bottleneck on the products they have access to; no flavored products have been authorized through the system, only variations of tobacco. Beyond the PMTA system, there was also concern that a methodical state-by-state, municipality-by-municipality effort to severely restrict the availability of lower risk products would continue. Clark said that while he hopes that in the future people will be able to find products they can trust, he questioned why there has to be a delay. What is needed now is to disseminate the idea that nicotine users are not just data on a spreadsheet and to get that message out, elevating it up the chain to the regulator.

    Clarisse Yvette Virgino, a Philippines-based member of the CAPHRA, had a more positive tale to tell because a “wild journey” that had seemingly been headed toward prohibition had ended with regulation. The regulations were somewhat burdensome, however. Retailers had a lot of rules to comply with, and there was a problem when it came to consumer choice because manufacturers had withdrawn certain products, such as juices, rather than go through the process of complying with what were stringent requirements.

    Panel: Reinforcing Scientific Research

    During the Reinforcing Scientific Research panel held as part of September’s Global Tobacco and Nicotine Forum in Seoul, South Korea, New Zealand-based Marewa Glover, director of the Center of Research Excellence on Indigenous Sovereignty and Smoking, made the point that the forum had heard many times how there is a need for tobacco and nicotine policies to be grounded in science and, therefore, evidence-based. There is, in fact, no disagreement on this point between tobacco control officials and tobacco harm reduction (THR) advocates, she said. However, care needs to be exercised because a form of evidence has been appropriated by some opposed to THR, and they are driving a broad social change agenda aimed at instituting a utopia where, for instance, no one would ever use drugs. They used scientific platforms loaded with people who shared their views to spread their ideology. They redefined the meanings of words so that unproven assertions became facts and facts became lies. To combat such views, she added, it is necessary for THR advocates to produce demonstrably robust research as part of a project that includes a communication strategy identifying stakeholders and how the information is to be gotten to them.

    Glover had been asked three questions by moderator, Mark Littlewood, director general of the Institute of Economic Affairs: What needed to be done to reinforce scientific research into tobacco and nicotine?; who should form the audience for the research findings?; and how should the findings of junk science be challenged?—questions he also posed to the rest of the panel.

    Kai-Jen Chuang, professor in the Department of Public Health at Taipei Medical University, explained that THR is not taught as part of medical degrees in Taiwan and therefore is not a well-recognized term, even though harm reduction principles are engaged in other areas. In fact, vapes were banned in Taiwan on March 22 this year. What is taught is health promotion and, more latterly as part of social-work courses, disaster reduction. He pointed out, nevertheless, that health promotion, disaster reduction and THR have similar goals, so those from outside Taiwan wishing to engage at conferences with public health officials over THR principles should present their papers, translated into Chinese, as health promotion studies. Nevertheless, he warned that it would be difficult, because of their training, to convince public health people of all stripes of the efficacy of using new technology to reduce the harm caused by smoking. The starting point for getting across messages about THR, he added, should be scholars with open minds, and from there, the focus could move to journalists and politicians.

    Riccardo Polosa, professor of internal medicine at the University of Catania and founder of the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), said there is a need to reinforce quality science that has good repeatability. Repeatability, he added, is currently in crisis and not just in respect of tobacco control science, so the CoEHAR has established a comprehensive repeatability program pertaining to research into toxicity and biology in respect of combustion-free, nicotine-containing products. The program involves setting up and researching in seven laboratories with the same equipment and the same procedures to come up with super strong findings. Another thing that is needed, Polosa said, is to shift the focus from risk to harm. Relative risk has been studied for a decade now, and it is an easy win if combustible products are compared with combustible-free products. So now is the time to look at the absolute risk and show that it is low and that the level of harm is super low. This would provide a better position from which to convince governments, regulators and the public. Polosa had some good news on junk science, which he said is easy to debunk because it is junk, though this takes energy and time and requires a willingness to do it. A global network of scientists is actively rebutting junk science articles, though the challenge now is to speed up this process of rebuttal.

    Picking up on an earlier comment about uncertainty, Konstantinos Farsalinos, research fellow at the Onassis Cardiac Surgery Center, made the point that uncertainty is inherent in science and essential to human progress. There is nothing wrong with uncertainty provided that it is not used to maintain the status quo, especially where the status quo has failed miserably. It is important, also, that uncertainties are not used as the basis for decision-making, which needs to be based on current knowledge. But one problem being faced today is that current knowledge is not being used to make decisions [about THR]; rather, decisions are being made on the back of the abuse of uncertainties [that the long-term use of THR strategies are unknowable at this stage]. Revisiting the 1986 Ottawa Charter for Health Promotion by the World Health Organization, Farsalinos said, it is obvious that it was basically talking about harm reduction in our everyday lives. Everything, even medicine itself, was a harm reduction science because it was not possible, probably, to cure any disease besides certain infections. We were treating diseases and reducing the adverse effects and consequences of diseases. This was all known. What is needed now is the reinforcement of the applicability of scientific data, of which there is a lot, on decision-making, something that has not happened in many parts of the world. Finally, Farsalinos said that he has had bad experiences in rebutting junk science even though he has been successful. Basically, he had run into a wall behind which people had decided what they believed and were casting around for the data to support their predetermined views. With science, you have to do the opposite of that, he said.

    Keynote: Brian King

    When Brian King speaks, people come to listen. The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) director’s keynote address was easily the best attended session of GTNF 2023. King’s speech served as an overview of the current state of the CTP and an outline of the center’s main priorities over the next few years.

    King said that the CTP has made considerable progress in reducing combustible cigarette smoking in the United States, which he contends as one of the most remarkable public health achievements of the past century. He hopes that those declines continue, given that “we do know” that combustible smoking is responsible for the overwhelming burden of death from using combustible tobacco.

    Tobacco use continues to cost the U.S. government a considerable amount of money—to the tune of $600 billion per year from both direct healthcare costs and lost productivity, according to King. He said there are important human health benefits as well as financial benefits for regulators to continue to focus on reducing combustible use in the United States. As a part of this focus, he said, the CTP is continuing to make inroads when it comes to premarket tobacco production application review.

    “We have a new director of our Office of Science who has jumped in headfirst to continue to fiercely lead our 550-plus scientists on application review …. We have processed 99 percent of those and continue to finalize the remaining 1 percent. I’m hopeful that in the coming months and years, we will get back to what was intended to be a premarket approval process,” said King. “In the meantime, we have authorized 23 e-cigarettes, all tobacco flavored. So, it is possible. We have had successful authorizations. But again, I can’t reinforce enough the importance of providing that sound and robust science to inform on potential authorization.

    “And it is possible, as you can see. There will be more authorizations in the future, but it’s important that we have that science to support those decisions. As I noted earlier, we also continue to fold in the nontobacco nicotine work into our broader portfolio around regulation. We did receive a million applications, which I don’t think anyone anticipated. I will say that we are making great numbers. We are 99.9 percent through with the review of those. I will say that 100 percent is very imminent.”

    King said that when it comes to products that are illegally on the market (having received a marketing authorization and are not currently under review by the CTP), the CTP is mindful of the importance in exercising all authorities that it has to ensure that people are complying with the law. He said that the FDA has given retailers the information they need to comply with the law through a list of authorized products (the 23 products that have been authorized for sale). The CTP also continues to ramp up efforts in terms of training, education and outreach across the supply chain, particularly to retailers.

    “We also continue to do surveillance inspection investigations. This is something that occurs on a daily basis. We have arrangements with all 50 states and territories to continue to do investigations. We have issued many warning letters for flavored disposable e-cigarettes, which we know are particularly popular for youth,” said King. “There’s been a variety of blitzes that have occurred monthly throughout the summer. I will say there are more to come. We are going to continue to conduct those blitzes and making sure that we are routinely monitoring, particularly with a focus on those products that we know have high youth appeal.

    “On balance, we are also continuing to do work around issuing import alerts. I was a little tickled by all the attention that the import alert on Elf Bar got. That’s nothing new, folks. We’ve been doing that for many years. It was suggested it was something seismographic, but we’ve been doing import alerts for quite some time. And we do use those as, again, another tool in our toolkit to make sure that we are addressing not only the products that are already in the country but preventing illegal products from entering the country.”

    As of Sept. 31, the FDA has issued over 1,200 warning letters for online investigations. For manufacturers, the CTP has sent more than 800 warning letters, with more than 750 letters for e-cigarettes. Beginning earlier this year, the FDA also issued the first civil money penalties against manufacturers for violations for illegal e-cigarette sales. He said civil money penalties will remain a part of the CTP’s tools to combat illicit sales.

    “We also issued the first six injunctions in coordination with the Department of Justice. I got a lot of flak for that as well about enlisting the Department of Justice. And I will remind folks that the FDA doesn’t have an independent litigation authority. If folks do not comply with the law, we will escalate further, as has been evidenced by these actions, which again are going to be part of our broader portfolio moving forward,” said King. “Everyone is going to be held accountable across the supply chain. We do want to make sure that we address the bad actors in a meaningful way. We also continue to pursue no tobacco sale orders among retailers as well. This has traditionally been issued for underage sales. But again, we’re committed to using the full scope of our authorities granted through Congress.”

    King added that education is also a priority for the CTP. The center is ramping up efforts to address misinformation in the continuum of risk for nicotine products. He mentioned that he recently wrote a commentary where he highlighted the importance of opportunities and considerations for addressing misperceptions in nicotine. “There is science that exists in that there are misperceptions around the continuum of risk and also nicotine. And so, we do have opportunities that are present, but we have to follow the data-driven pandemic-based approach,” he explained. “That said, I’m putting my money where my mouth is …. We’re working with the National Institutes of Health for a funding opportunity to get more data on public health communication messaging about the continuum of risk.

    “And as noted in that funding announcement, we’re looking for data both for the target population, which is called smokers, but also unintended populations, particularly youth. This is several million dollars on an annual basis, and we look forward to that kickstarting and getting data to inform our work.”

    King said the CTP will also continue to gather input from the industry and the public. The CTP is creating a new office within the Office of the Center Director and is looking to hire a new director for Policy and Partnerships. “That posting is public,” he said. “And I’m looking forward to seeing those who have applied and getting someone in that seat to meaningfully oversee the product regulation portfolio across the center, particularly as we get that strategic plan in place.”

    During the closing of his address, King said that he continues to be big on communication and stakeholder engagement. He expects to provide the industry with more opportunities for communication with the CTP. “I know that you’ll see in the future an evolution of our messaging. Both through our press releases, our social media and our [overall] messaging to make sure that we are clearer, simpler and more digestible,” he said. “I’ve been a bureaucrat for many years, but that doesn’t mean that I can’t communicate effectively with the general public. I think we can do better. I know we can do better.”

    Keynote: Hiroya Kumamaru

    Hiroya Kumamaru, vice director at Japan’s AOI Universal Hospital, gave a 15-minute overview of the current status of harm reduction in Japan.

    Quoting 2019 figures, Kumamaru said that, as in many other countries, smoking is the biggest cause of death in Japan, though high blood pressure is not far behind and is catching up, probably because of the aging of Japanese society.

    On top of this, he put forward the economic argument for reducing smoking, which, he said, while having a positive annual impact on the economy of ¥2.8 trillion ($18.76 billion), mainly through taxation, had a negative impact of ¥4.3 trillion mainly due to loss of labor because of smoking-related diseases, the medical costs associated with smokers and passive smokers, cleanups and fire-related expenses.

    Kumamaru told how, about 15 years ago, he had started working in a small clinic in the center of Tokyo, where he became involved in a national smoking cessation program that was based on a three-month-long series of five visits by smokers to doctors. Although a lot of effort was put into the program, and nearly 60 percent of the participants at his clinic went on to complete the five outpatient visits, nine months after the end of the program, nearly half of those who had appeared to have quit started smoking again, a result he described as “disappointing.”

    He then compared this with what had happened after the start of sales of heated-tobacco products (HTPs) from 2016. By 2019, almost one-third of male and one quarter of female tobacco consumers were using HTPs, a result that he described as “amazing.” As a result, total cigarette and HTP consumption was heading down while HTP consumption was increasing.

    In part, his amazement sprang from the fact that while this was happening in Japan, it appeared not to be happening at the same level elsewhere, and he didn’t know why this was the case. For example, Japan’s smoking rate was decreasing at a faster rate than that of Australia, which had introduced very strict smoking restrictions but banned the sales of HTPs.

    Notwithstanding Japan’s success with lowering smoking rates, many people in Japan remained skeptical about HTPs and raised issues about the unintended use of these products: dual usage, initiation, relapse and what is called in Japan the gateway effect of youth initiation. But these turned out not to be significant issues. Kumamaru said about 20 percent of smokers use HTPs and cigarettes, which is not that many. And initiation or re-initiation has been at a very low level, with two years of surveys recording a 2 percent factor in the first year and 1.3 percent in the second. In particular, youth initiation is low, and there has been no increase in initiation among younger people due to the launch of HTPs.

    Kumamaru said that interesting data from Italy, Korea and Japan pointed to the fact that consumers of HTPs have better outcomes than smokers in respect of chronic obstructive pulmonary disease and cardiovascular disease while the exposure to carcinogens associated with HTP use is just 3 percent of that of smoking.

    He ended his presentation by saying that Japan could look forward to a better future because of HTPs, though it is necessary to keep carrying out surveys and probably starting a long-term clinical study. 

    Additional GTNF 2023 session summaries >>

  • Panel: Economics of Harm Reduction

    Panel: Economics of Harm Reduction

    The panel was moderated by economist and author Sinclair Davidson, who argued that through irresponsible fiscal policy on tobacco and nicotine products, the Australian government had created a well-organized illegal market that would be impossible to eliminate even if the government changed course.

    The market for next-generation products (NGPs), Tim Phillips, managing director of Tamarind Intelligence, said, is a complicated, quickly moving sector, which today has a significant global volume of over $50 billion and more than 100 million users. Market development heavily depends on product regulation. In North America, vape products dominate the market, with a small but growing portion of nicotine pouches. In Europe, the Middle East and Africa, vapes are still growing but at a slower pace while heated-tobacco products (HTPs) are establishing themselves in some markets. In the Asia-Pacific region, HTPs are the most popular NGPs. Despite overall increase, the global NGP market still has headroom compared to the combustible cigarette market with its value of $800 billion. Phillips suggested that in 10 years’ time, vape products and HTPs could overtake combustible cigarettes, but he pointed out regulatory issues, consumer confidence and the debate about disposable vapes as headwinds for the sector. The latter issue, he added, could be solved through innovative technologies.

    James Lambert, director of economic consulting Asia at Oxford Economics, warned that a harsher regulatory and fiscal stance on reduced-risk products (RRPs) could create negative economic and health consequences over time. Bans of RRPs will favor the illicit trade, especially in markets where illicit trade is difficult to manage and mitigate and where price sensitivity is higher. For optimal policy, Lambert proposed three key principles: Tailoring the restrictions of use to different market segments to eliminate youth use and at the same time provide adult smokers access to options; differentiating the treatment of RRPs from conventional tobacco products to incentivize the adoption of healthier alternatives; and finding constructive policy stances that include regulatory and fiscal measures to incentivize innovation of less hazardous products.

    Comparing the U.S. tobacco market pre-2005 and after, David Levy, professor of oncology at Georgetown University, said that the advent of Juul in 2018 was a game changer that fueled competition among the cigarette industry, which had reluctantly ventured into vape products and independent players. At the same time, nicotine pouches were growing, like vapes taking market share from cigarettes. Levy predicted that HTPs will become more popular and are likely to be favored by tobacco companies because they are more profitable and because the companies have a first-mover advantage. He expected competition among HTP manufacturers and nicotine pouch manufacturers to intensify and wondered whether the Food and Drug Administration, in its focus on a menthol cigarettes and cigars ban, would recognize the role of harm-reduced substitutes.

    Paul Blair, regional director of external affairs at Philip Morris International, emphasized that there is no one-size-fits-all approach to the transformation opportunities and needs of the tobacco industry. The industry, he said, must be aware of three areas. First, supply: Companies have to take the risks of transformation to meet consumer demand. Second, demand: Consumers will continue to want to quit or are looking for less hazardous products, regardless of any stringent regulations on reduced-harm products. Third, an affordable and accessible marketplace: Cost incentives to quit smoking are extremely important to consumers even in high-income countries as smokers are often from low-income and middle-income groups. A tax differential between RRPs and combustible cigarettes is hence essential, Blair stated, both in the signal it sends to consumers and businesses and because of the cost differential in this journey. To further reduce the U.S. smoking rate, which presently stands at 11 percent, Blair recommended making available a wide range of RRPs and creating a favorable public policy environment.

    Anna Choi, assistant professor in the Department of Public Administration at Sejong University, presented the results of her study on the role of vape products and HTPs in encouraging smokers in South Korea to switch from combustible cigarettes.

    A huge tax hike on cigarettes of about 40 percent in 2015, she said, significantly depressed cigarette consumption. A subsequent health ministry report implying that RRPs were potentially even more dangerous than smoking impacted negatively on the electronic nicotine-delivery system (ENDS) market.

    Since 2017, RRPs and combustibles have been taxed at almost the same rate, eliminating the cost advantage of the former. Despite this, ENDS’ market share increased from 2 percent in 2017 to 17 percent in 2023.

     

  • Panel: Regulation: International Perspectives

    Panel: Regulation: International Perspectives

    Regulation of nicotine products is at a tipping point, said David Bertram, director at EUK Consulting, who moderated the panel. Generational bans and mandatory nicotine reduction for combustible cigarettes have been introduced, whereas taxation of flavors and the move against disposable vapes have the potential to threaten the whole next-generation products (NGPs) category. Panelists provided overviews of the regulatory situation in their respective countries.

    Dave Dobbins, former chief operating officer of the American Legacy Foundation/Truth Initiative, criticized the U.S. Food and Drug Administration’s authorization process for novel products as lacking order. He called for the agency to “clear the field.” “The FDA has two choices: either a market serviced by unregulated actors that don’t have to report to the agency and don’t follow its rules, mandates and instructions or a robust market of approved products that fulfill the demand for adult consumers, and then the FDA can focus its enforcement on actors targeting youth.” The agency, he added, could use its power of post-market surveillance and regulation. Dobbins was concerned that the FDA was paralyzed by fear, making it unable to analyze the benefits of reduced-risk products (RRPs) for adult smokers.

    Adam Afriyie, member of Parliament for Windsor, U.K., said his country was in the pole position in tobacco harm reduction (THR) because of five factors: operating according to the principles of THR and encouraging the good instead of the perfect; treating RRPs as consumer products not medicine; encouraging public bodies to spread the word; trying to de-politicize the issue; and applying pragmatism as a response to changes. Pointing out that the U.K. government was currently consulting on disposable vapes and underage vaping on the base of evidence, he argued that it would only ban the products if this made sense from a point of view of harm reduction to the environment, children and healthcare. Regarding the upcoming tenth Conference of the Parties (COP10) to the Framework Convention on Tobacco Control, Afriyie said he was encouraging his contacts to help the U.K. delegation feel sufficiently emboldened to stress that THR needs to be the principle behind regulation and that a greater degree of transparency is required in how decisions at the COP are made.

    In its traditionally heavy regulation of nicotine products, Australia has always been driven by health considerations, according to Kezia Purick, member of the Northern Territory Legislative Assembly for Goyder, Australia. Tobacco-related diseases are the single biggest cause of death from behavioral risks in the country, with the disadvantaged indigenous population being affected most. Australia banned all tobacco advertising in 1976 and was the first country to introduce plain packaging in 2012. Nicotine vape products are available only from pharmacies with a doctor’s prescription. Health Minister Butler’s approach to ban all disposable vapes is primarily driven by concerns about the rising popularity of vaping among young school children. Purick expects regulation of RRPs to become ever stricter in the future.

    Marina Foltea, managing director at Trade Pacts Consultancy, outlined the complex policy-making process in the European Union. Directives, such as the Tobacco Products Directive (TPD), are binding for all 27 member states and have to be transposed into national law to take effect. The revision of the present TPD2, which already has strict requirements for combustible cigarettes and sets clear product standards for vape products, is currently being discussed. The regulation of tobacco products in the EU is regarded as a model by many countries. However, Foltea said, she didn’t see any explicit recognition of THR in the EU system. “But if you already have this category in the TPD, this means some indirect recognition,” she noted.

    Douglas Ming Deng, head of the NGPs Industry Study at Yunnan University, reminded his listeners of Asian diversity and the resulting differences in regulation of NGPs across countries. South Korea and Japan, he emphasized, have set up good tobacco control systems together with the provision of suitable RRPs, thus becoming blueprints for other countries to follow. He noted that the industry had changed more rapidly in the past 20 years than it had in the century before, meaning the sector was no longer static but dynamic. “As a consequence, regulators, consumers and the industry don’t know each other as they did in the combustible era,” Deng said. “Regulators should study the industry and vice versa.”

  • Investor Panel

    Investor Panel

    This year’s panel looked at how investors view the industry’s transformation and the challenges regulations hold for the further proliferation of reduced-risk products. Among the multinational players, Philip Morris International leads the pack regarding performance of smoke-free products. In the first half of 2023, 34.1 percent of its revenues were generated by such offerings. The acquisition of Swedish Match has catapulted PMI forward in the smokeless category. At BAT, the segment accounted for 16.6 percent of revenues. It was followed by Imperial Brands, with 3.7 percent, and Japan Tobacco, with 3.2 percent. With an operating margin of around 39 percent in 2022, PMI also achieves higher profitability from the category than BAT and JT, which plan to break even by 2024 and 2028, respectively.

    With the introduction of its heated-tobacco product (HTP) brand IQOS in Japan in November 2014, PMI started a success story—reduced-risk products (RRPs) currently account for 37 percent of the country’s tobacco market. Using its first-mover advantage, PMI today holds around 72 percent of the HTP market followed by BAT with 18 percent. JT, which was relatively late to launch Ploom Tech in its domestic market, stands at 10 percent.

    In South Korea, the world’s second-largest HTP market after Japan, PMI’s first-mover advantage was shorter lived as KT&G responded with the introduction of Lil only six months after IQOS had entered the market. The HTP category now represents 19.2 percent of South Korea’s tobacco market, with KT&G being the leading player with a share of 47 percent followed by PMI (41 percent) and BAT (12 percent).

    In addition to Japan and South Korea, Sweden and the U.K. provide examples of how a tobacco harm reduction approach can lower smoking rates. Using these countries as models for others, however, is difficult as the conditions for the success of RRPs vary. In Japan, for instance, HTPs are under the authority of the ministry of finance and looked at from a taxation point of view. They are also boosted by the fact that nicotine vaping is prohibited. In the U.K., government and health bodies have been supportive of RRPs, which played a significant part in the success of the category. Furthermore, there’s a significant price gap between combustible cigarettes and RRPs in the U.K., which nudges consumers toward the latter. In Sweden, the transition to less hazardous products was driven by consumers without government support.

    In general, publicly listed, multinational companies are pushing transformation harder than privately held, single-country companies as demonstrated by the Tobacco Transformation Index, which ranks the world’s 15 largest tobacco companies on their relative progress toward harm reduction. In many countries where the latter are operating, RRPs are banned and the cost of cigarettes is low, so there’s little incentive for these companies to change.

    Companies with a strong exposure to the U.S. market, such as Altria, BAT and Imperial, continue to face regulatory uncertainty. Investors, however, want clarity. In August, the U.S. Food and Drug Administration missed another deadline to finalize its long-anticipated rule prohibiting the use of menthol in cigarettes. The recent Udall-Reagan report on FDA proceedings called for more clarity to ease the burden on the agency and increase efficiency, but panelists were pessimistic that the FDA will put recommendations into practice.

    The upcoming tenth Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control is expected to bring new, illogical restrictions on RRPs, judging from proposals published in advance, such as a redefinition of aerosol as smoke. Panelists feared that with an “any risk is bad” approach, RRPs will increasingly be treated like combustible cigarettes.

     

  • Fireside Chat: Talking About COP10

    Fireside Chat: Talking About COP10

    The upcoming 10th meeting of the Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC), which will take place this November in Panama, was the theme of a “fireside chat” moderated by Chris Kodderman, director of Kodderman Public Affairs.

    The disinformation that is making physicians skeptical about reduced-risk products and the misinterpretation of the FCTC’s Article 5.3 are the two biggest impediments to tobacco harm reduction (THR), said global health advocate Derek Yach, who was significantly involved in shaping the FCTC treaty. In his prework on the FCTC, Yach related, he invited tobacco companies to hear directly from them how the complex health problems relating to tobacco could be solved. “We never built on that, and then the shutters came down.”

    Flora Okereke, head of global regulatory insights and foresights at BAT, said the opportunity in COP10 lay in the fact that both the industry and public health have the same goal: getting people off cigarettes. In addition, she reminded her audience that the treaty mentions THR, which seems to suggest that it’s possible for countries to explore alternative ways of reducing smoking apart from handling the demand and supply side. “That provision has never been talked about in COP,” said Okereke. “We now have an array of reduced-risk products, consumers who have indicated that they can live with these products, and countries with experiences that are proof that adopting this THR approach as a policy has led to a decline in smoking rates.”

    Recent WHO documents, reports and statements suggest that the global health body is skeptical about the role of smoke-free alternatives in smoking cessation and concerned about underage access—a sentiment that will likely be echoed by the convention secretariat at COP10, Okereke said. “However, the treaty makes it clear that the power for decision-making is within the parties, insisting that decisions are made by consensus. If parties wanted to share their positive experience with THR, this is an opportunity for them to start requesting an independent team to evaluate the role of these products. All they would have to do is use their mandate effectively and withhold their consensus.”

    Yach pointed out that by developing guidelines on Article 5.3, the secretariat went beyond their legal briefs. “All of the guidelines that include words such as ‘banning,’ ‘demonizing,’ [and] ‘excluding’ in my view are against international law,” said Yach. “We have allowed these guidelines to slip away as if they are facts, but they’re not, and they need to be challenged legally. The member states are the best to do this.”

    At COP10, Yach recommended, countries with positive experiences with THR should share the positive changes that their policies have brought about. He also called for the industry to come together in a consortium to take concerted action. “It is long overdue that tobacco companies, despite competition, recognize that there are some areas where they must come together and present a united front that, I believe, would build confidence in their long-term intent.”

    For this approach, Yach singled out two areas: “A commitment made between the industry to prevent youth access would be very powerful.” In addition, he said, referring to an example where pharma giant Merck collaborated with the WHO to eliminate river blindness disease in West Africa and committed to making the drug forever, the tobacco industry should harness the use of nicotine pouches and snus. “This way, they could eliminate oral cancer in South Asia,” said Yach. “If they were to make that bold statement that they want to do this with the WHO, member states and all other private and nongovernmental organizations together, this would be a surprising and bold move that would get people to take note, particularly the people in these countries who are dying at the rate of 350,000 per year.”

  • Keynote: Ming Deng

    Keynote: Ming Deng

    Douglas Meng Deng, head of Next-Generation Products (NGPs) Industry Study at Yunnan University, provided an Asian view of regulation and innovation in NGPs. Evidence from bibliometrics, he pointed out, had shown that the number of articles and the frequency of citations on tobacco harm reduction (THR) have been steadily increasing. There has been dualization and dichotomy of studies of the role of NGPs in THR. Studies are either carried out by academic institutions or by the tobacco industry, and there is hardly any cooperation among multinational tobacco companies.

    In his research of NGP regulation in Asia, Deng focused on the five countries with the largest populations and the largest number of smokers. In Japan, Deng explained, e-cigarettes containing nicotine were regarded as drugs, requiring a prescription from a doctor, which resembles a ban. By contrast, nicotine-free e-cigarettes are a niche product that can be commercialized without any flavor restrictions. In terms of tobacco taxation, heated-tobacco products (HTPs) are favored. The country has seen a decline in cigarette sales along with a surge in HTP combustible sales. Studies published in BMJ have stated a decrease in hospitalizations for chronic obstructive pulmonary disease and ischemic heart disease following the introduction of HTPs in Japan.

    China implemented a comprehensive regulatory framework for NGPs called “1+2+N” in October 2022. It allows tobacco-flavored products only. Manufacturers, brand owners and retailers are obliged to obtain licenses. Electronic nicotine-delivery systems are subject to premarket review and approval, and HTPs are regulated as cigarettes. “E-cigarette penetration in China was never above 2 percent, and it has been decreasing further since the regulation was introduced,” Deng said. “The portfolio performance of listed vape companies has fluctuated drastically.”

    Indonesia permits HTPs and e-cigarettes, allows online sales and regards national standards as an endorsement rather than mandatory. Multinationals’ HTPs have gained significant traction, Deng stated, showing that the country could potentially become a hub for NGPs in Asia.

    By contrast, India has chosen to ban e-cigarettes and HTPs completely with its 2019 E-Cigarette Act. Offenders face penalties including a one-year jail term or a fine of inr100,000 ($1,202) or both. “The ban has led to a flourishing illicit market,” Deng said. “Insufficient controls together with weak age verification will probably raise the question about the effect of both tobacco control and THR in the country.”

    Properties of NGPs, which the World Health Organization’s Framework Convention on Tobacco Control (FCTC) began discussing at its fourth Conference of the Parties (COP4), are still vague within the FCTC context, an ambiguity potentially leading to regulatory loopholes among member states.

    Deng highlighted two innovations in the field of HTPs. South Korean KT&G’s Lil Aible integrates an artificial intelligence of things application in its heated-tobacco units while combining features of both vape products and HTPs. “The convergence of the two technologies may represent a future trend.”

    NSC of China offers a product with an oxygen-free environment in which sticks are being heated, potentially offering a superior smoking experience, Deng explained. “Both developments underscore a fundamental principle in NGPs: understanding customer needs.”

    Deng recommended that the next Conference of the Parties (COP10) to the FCTC, which will take place in Panama this November, clarify the harm reduction properties of NGPs. The FCTC itself, he said, should also undertake rigorous, evidence-driven research and faster communication with the industry.

    For state-level regulators, Deng proposed introducing the regulator’s sandbox into NGP regulation and shifting from the “wait and improve” approach to “test and innovate.” “Regulatory sandboxes, commonly used in the financial sector, allow NGPs to be regulated at a close loop and encourage enterprises to innovate at the same time,” Deng said. “Regulators may monitor testing in real time while enterprises can get regulatory feedback simultaneously and adjust R&D accordingly.”

    Deng called for the industry to engage in evidence-based and science-based studies and actively pursue publication. Multinationals, he argued, should cultivate the market through patent openness. “The industry is ready to enter the next curve of entrepreneurship, but it should keep in mind to innovate toward THR, not for youth, and facing ESG. Entrepreneurship and rapid commercialization of NGPs in Asia [are] the tobacco industry’s future, provided it can seamlessly integrate into the global tobacco value chain.”

    He urged stakeholders to recognize that the diversity and multitude of cultures and languages in Asia demands a nuanced approach. “The multinationals should leverage the expertise of local Asian talents to solve issues specific to the region.”

  • Bonus Content: Brent Taylor

    Bonus Content: Brent Taylor

    Brent Taylor, managing director of consumer marketplace insights and innovation at Altria Client Services, emphasized that his company wanted to make sure that the adult consumer’s voice is heard and embedded in all of Altria’s decision-making regarding regulation, innovation and science discussions for tobacco harm reduction (THR). The latter, he pointed out, rests on three pillars: youth smoking prevention, cessation support and switching adult smokers to reduced-risk products. The U.S. currently has 42 million adult tobacco users, of whom 28 million smoke combustible cigarettes, 6 million consume smokeless tobacco, 8 million smoke cigars, and 14 million use e-cigarettes.

    According to an Altria survey, over 50 percent of adult smokers are interested in switching to a less hazardous alternative. To understand the barriers that keep many of them from changing, Taylor, a former smoker himself who had successfully switched to smoke-free products six years ago, in 2021 set up Project 2021, a deep ethnographic research study that followed 21 consumers for 21 days on their journey away from cigarettes. Participants were asked to catalogue their behavior via video diaries daily, and study investigators had check-ins with them routinely to understand how this journey was going for them. After three months and six months, respectively, there were follow-up interviews to examine the long-term impact that short experience had on consumers.

    After six months, 16 of the 21 participants had switched completely to smoke-free alternatives. The balance significantly reduced cigarette consumption—down, for example, from one pack per day to one or two cigarettes. “It’s all about the mindset,” Taylor said. “Consumers will only be able to make this change if they want to make this change.” The survey also showed that external factors can influence smokers on this journey—having had a bad day, for instance, would make them go back to using a cigarette. Becoming smoke-free was liberating and opened new opportunities for participants, allowing them to move into a smoke-free apartment or date nonsmokers, for example.

    The study made clear that a support system was required in the journey to becoming a nonsmoker and that the experience was emotional and complicated, with many ups and downs through their daily life, all of which affected their success. “There’s no single way that each of these consumers approach this journey,” Taylor explained. “To accelerate THR, we need to recognize that smokers are not a monolith but represent a vast cross section of adults, different races and incomes, different genders. We need to make sure that we identify which types of clusters exists among that population so that we can design messaging and products that really cater to these different types of people.”

    Altria also looked at usage moments of cigarettes. “Smokers use cigarettes either to detach from the world to take a break or to engage with other people,” Tayor said. “If you layer these two areas, there are barriers and motivators for switching across each. We need to think of a portfolio of products to address the needs of consumers throughout the day. The tobacco space is starting to behave like the beverage category, with a proliferation of options for consumers. They might choose a different product first thing in the morning versus throughout their workday versus in the evening.”

    To help them transition to reduced-risk alternatives, he added, smokers are very much in favor of THR over prohibitionist methods. They also want options in the marketplace and choose different products, also throughout the day. Misperceptions of nicotine, however, are widely spread, with 80 percent of adult smokers believing that nicotine is a carcinogen. “The key is to always start with the consumer and build empathy with adults who smoke. The highest form of knowledge is empathy. It allows us to step into the shoes of others so we can create real change.”

  • Panel: Youth Use

    Panel: Youth Use

    Youth use is everyone’s responsibility. It’s also the name of the GTNF panel that focused on how to balance preventing youth use with helping combustible cigarette smokers move toward less risky nicotine products. The panel’s moderator, Stacy Ehrlich, partner at Kleinfeld Kaplan and Becker, encouraged panelists to debate whether abstinence is a realistic or appropriate goal when attempting to combat youth use.

    “Hopefully, speakers will address that and whether and how to communicate with youth and children about relative risks and progress. I think an interesting question is: Are youth an unintended population for these communications?” said Ehrlich, referring to the U.S. Food and Drug Administration’s acknowledgment that e-cigarettes are less harmful than combustible cigarettes. “Should we be communicating with underage individuals about consumer risk?”

    All the panelists were given the opportunity to make a short presentation. Jasjit Ahluwalia, professor of behavioral and social sciences and professor of medicine at the Center for Alcohol and Addiction Studies at the Brown University School of Public Health and Alpert School of Medicine, said that tobacco addiction is a pediatric disease and noted that many diseases resulting from tobacco use were effectively human caused, such as chronic obstructive pulmonary disease, as 95 percent of cases were the result of tobacco use.

    He also stated that youth use of tobacco and nicotine was unethical as young people are uninformed consumers. However, he noted that communicating risk to this group was complicated. He said that tobacco prevention campaigns are key.

    “This is something that we know [is] important to effectively educate youth,” said Ahluwalia. “I’m mindful of the importance of the issue of spillover … this is, again, a careful area where I think it’s important that we’re mindful of what the impact is on the intended population and mitigating risk for the unintended population, which in this case, I believe is adult smokers that you want to make sure that they’re not scared away from using an e-cigarette that could potentially be beneficial for them to transition completely from combustibles.”

    Ahluwalia also highlighted the vast amount of misinformation that had been communicated through anti-vaping/smoking campaigns, noting the role of the media in misrepresenting the science behind vaping products. He stated that the industry needed to focus on innovating safer and better products. He also called for the FDA to approve new smoking cessation medications. Lastly, Ahluwalia stated that a goal of zero youth use was unrealistic and unreasonable.

    Brian King, director of the FDA Center for Tobacco Products, explained that youth prevention continued to be a critical part of the FDA’s portfolio since nine out of 10 adult smokers started smoking below the age of 18. He noted that the youth were using a variety of different products, with the use of e-cigarettes being particularly prominent.

    “Youth prevention is a key component of FDA’s portfolio … we do see kids using a variety of different products. But right now, the focus is primarily on e-cigarettes,” explained King. “We’ve seen an evolution within even that product class as well, which I think is important for us to consider as we talk about what the inherent risks of these products are, particularly when it comes to dependency. That said, although we’ve seen declines in e-cigarette use, which again, we’ve noticed, is a good thing, among the kids who are currently using e-cigarettes, we’re seeing increased signs of dependency.”

    King said the FDA is held by the standard of being “appropriate for the protection of public health.” This is not like the other centers at the FDA, such as the Center for Drug Evaluation and Research (CDER), which has a “safe and effective standard.” In therapeutics, the CDER wants products to be safe for people to use but also effective at treating the ailment.

    “When it comes to tobacco products, the U.S. Congress has given us appropriate for the protection of public health, where we have to weigh the benefits and the risks. That said, the risks are typically focused on youth initiation. And we have made decisions based on that,” King told attendees. “The primary reason you’re seeing a variety of negative actions that have been taken on e-cigarettes is because of the prominent youth use of these products. It certainly is possible to mitigate that risk. For example, we know that youth have very little [interest in] tobacco-flavored e-cigarettes, which are the products that have been authorized to date because that benefit of adults has been able to outweigh the risk of kids.”

    Colin Mendelsohn, general practitioner and founding chair of the Australian Tobacco Harm Reduction Association, said that current vaping policy is largely driven by fears over youth vaping. The scientific evidence of vaping is being overlooked. He stated that children should not vape or smoke; however, he acknowledged, it is inevitable that some will. Mendelsohn argued that most youth vaping was experimental, with frequent vaping being rare.

    “I think policy around e-cigarettes is largely driven by youth [and] flavor. And I think it should be driven by the evidence, not by emotion and moral values,” he said. “What I’m going to talk about is actual evidence, or at least the best evidence we have today. Kids shouldn’t vape or smoke. They shouldn’t be using alcohol or useless drugs. Of course, they do lots of things they shouldn’t do.”

    Mendelsohn said his research showed that only 3 percent of children who had vaped were frequent vapers, with half of those also being smokers. This evidence, he said, showed that vaping was not a gateway to smoking. He said that the opposite was true, and vaping was diverting kids away from smoking combustible cigarettes.

    “I think we all agree that vaping is not a significant gateway to smoking,” said Mendelsohn. “If there were a significant gateway, we would expect to see smoking rates going up. And of course, they’re going in the opposite direction. In the U.S., when vapes became popular, smoking rates continued to decline. In fact, they declined faster than they ever had compared to the historical period before 2013 since vaping became available.”

    Stefanie Miller, vice president of external engagement at Juul Labs, said one of the reasons why she wanted to join Juul Labs is that she gets to say that Juul has a problem with youth use. “We don’t need to skirt around that. So I’m going to talk to you about what this company has done to successfully deal with youth using the product,” she said. “We took what we consider a three-pillar approach … it has been a productive initiative that we’ve taken …. It’s limiting underage appeal, restricting underage access and enforcing against third parties, enforcing against illicit products.”

    Miller said Juul Labs is also using technology and innovation to help in the company’s fight against youth use. However, Juul Labs is also looking at how initiatives that are put in place to prevent youth use impact adults making the switch from combustible cigarettes. “We’re also considering what these interventions would do to make it potentially more difficult for an adult smoker to have access to a less harmful product, which is not the goal of our company,” said Miller. “We’re trying to walk this really careful line, both from the innovation but also the point-of-sale intervention along these three lines.”

    Many of the questions coming from the audience were directed at King concerning the FDA premarket tobacco product authorization process. For example, Fadi Maayta, the CEO and co-founder of Alternative Nicotine Delivery Solutions (ANDS), a Dubai-based vaping product manufacturer, asked King to explain why the agency does not do more to incentivize law-abiding players. The FDA’s current penalty framework, he argued, penalizes good and bad players alike.

    King said he understood Maayta’s frustration. There are numerous good players in the vaping industry that don’t have the issues of youth uptake, he acknowledged. The reality, however, is that the U.S. Congress wrote the Tobacco Control Act and prescribed very specific processes that the agency is required to do by law, said King.

    “That said, the intent is not to penalize everyone … but we do have to follow the law in terms of implementing the regulations that have been required by us. And that includes a premarket tobacco product process and a rigorous scientific assessment …. We also have to enforce the law, and we are a free market paradigm. So there’s no safe harbor. If you don’t have authorization, your product is subject to enforcement compliance,” explained King. “That said, are there opportunities to streamline those processes? Absolutely. And that’s what we’re looking at. There are efficiencies that I think we can gain by looking at our processes to make it more streamlined moving forward.”