Category: GTNF

  • Thank You!

    Thank You!

    Photo: lucky-photo

    The GTNF 2022, scheduled for Sept. 27–29 in Washington, D.C., is made possible by the generous support of these sponsors. For more information about the event, please visit gtnf.org.

    TR Staff Report

    22nd Century Group is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene editing and modern plant breeding.

    The company’s primary mission in tobacco is to reduce the harm caused by smoking by bringing our reduced-nicotine content tobacco cigarettes—containing 95 percent less nicotine than conventional cigarettes—to adult smokers in the U.S. and international markets. 22nd Century Group’s mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

    VLN cigarettes are made with 22nd Century Group’s U.S. grown tobacco, specially developed to contain 95 percent less nicotine. VLN King and VLN Menthol King cigarettes are the world’s first and only combustible cigarettes to receive modified-risk tobacco product (MRTP) authorization from the U.S. Food and Drug Administration.

    In granting the designation, the agency established that VLN cigarettes—which smoke, taste and smell like a conventional cigarette—“help reduce exposure to and consumption of nicotine for smokers who use them.”

    With the FDA’s MRTP authorization, 22nd Century Group can now communicate the key features of VLN cigarettes to adult smokers: helps you smoke less; 95 percent less nicotine; helps reduce your nicotine consumption; and greatly reduces your nicotine consumption. These features are critically important because nicotine has long been known as the primary addictive chemical in cigarettes.

    Visit the company’s website at www.xxiicentury.com.

    Founded in 2009 and headquartered in Shenzhen, China, ALD Group Limited is an innovation-driven enterprise specializing in a full range of next-generation products, including electronic nicotine-delivery systems, CBD vaporizers and heated-tobacco devices.

    As one of the leading vape manufacturers, ALD is capitalizing on years of R&D know-how and manufacturing experience to provide global one-stop service. With a powerful intellectual property system, high-quality assurance, fast delivery service and a strong commitment to social responsibility, ALD serves worldwide clients with the most cutting-edge products. Visit the company’s website at www.aldgroup.com.

    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 globally. Through direct contracts, it is able to provide agronomic expertise and technical guidance to help growers improve the quality and yield of their crops.

    AOI 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 lifecycle 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 throughout the years. For AOI, sustainability is about balance—finding the balance between what the company does and how it does it. Balance between adding value in the communities where it operates and achieving the long-term success for its company, and doing its part to contribute to the success of the United Nations Sustainable Development Goals.

    Visit the company’s website at www.aointl.com.

    Altria Group’s tobacco companies have a long history of leading the industry. Today, adult tobacco consumers are increasingly seeking new options, including those that reduce risk, and their preferences are evolving rapidly. In fact, almost a third of adult smokers aged 21 and up have tried smoke-free products.

    “Our vision is to responsibly lead the transition of adult smokers to a smoke-free future,” writes Altria. “Importantly, we will work within the framework that government, public health and regulatory bodies have established to communicate about reduced-harm choices. And for any tobacco consumer who wants to quit, offers access to a breadth of information from experts on how to do so successfully.

    “The actions that we are taking will create a different Altria—and a different landscape that we believe will benefit today’s adult tobacco consumers, our business and the thousands we employ.

    “That’s why we’re focused on moving beyond smoking by providing more potentially reduced-harm alternatives.”

    Learn more at www.altria.com.

    ANDS’ vision is to put the safest and most credible nicotine-delivery systems within reach of the 144 million adult smokers across the Middle East and Africa. Its mission is to deliver the best-in-class brand distribution, staging and communication while respecting local regulations—and to continuously adapt to the latest consumer trends and technologies in its field.

    ANDS believes that alternative nicotine-delivery solutions should be sold and used only by adult smokers who wish to quit smoking and that minors and nonsmokers should be protected from being exposed to these products. The company has offices in the United Arab Emirates, Kuwait, Saudi Arabia, Jordan and Egypt and is expanding soon to the U.K., the U.S. and the EU.

    Visit the company’s website at www.ands.com.

    BAT is a leading consumer-centric, multi-category consumer goods company that provides tobacco and nicotine products to millions of adult consumers around the world.

    Its purpose is to build “A Better Tomorrow.” It will achieve this by reducing the health impact of its business through a multi-category portfolio of noncombustible products tailored to meet the preferences of adult consumers.

    BAT continues to build on its portfolio of reduced-risk tobacco and nicotine products alongside its traditional tobacco business—including vapor products, tobacco-heating products and modern oral products, which are collectively termed New Categories, as well as traditional oral products.

    The company employs more than 52,000 people, operates in more than 175 markets and has 75 owned manufacturing facilities worldwide. In 2021, the BAT Group generated revenue of £25.7 billion ($30.24 billion) and profit from operations of over £10 billion.

    Visit BAT’s website at www.bat.com.

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

    Visit BMJ’s website at www.bmjpaperpack.com.

    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.

    Visit www.boegli.ch for more information.

    Broughton is an independent global contract research organization (CRO) offering fully integrated end-to-end services to deliver U.S. premarket tobacco product applications, EU medicinal product applications and EU Tobacco Products Directive notifications for next-generation nicotine products including EVPs, MOPs and heated-tobacco products.

    Its in-house laboratories are equipped with high-end analytical instruments to evaluate the chemistry of next-generation nicotine products and facilitate batch release testing ensuring product integrity. The company continues to invest in new science and innovations aligned with global regulatory requirements, and having been granted a U.K. controlled drug license, it also offers a range of services for medicinal cannabis and CBD.

    By partnering with Broughton, clients will know they have access to some of the most experienced consultants in the world with deep industry knowledge combined with regulatory-compliant CRO laboratory facilities. Broughton is committed to supporting clients in the development of safer nicotine products for a smoke-free future.

    Visit the company’s website at www.broughton-group.com.

    Chemular employs a world-class team of tobacco-specific toxicologists, chemists and clinical trial experts in addition to project managers and other various subject matter experts to assist customers with their regulatory needs in the tobacco industry. Chemular offers complete or partial assistance with premarket tobacco product application submissions, EU Tobacco Product Directive fillings, Prevent All Cigarette Trafficking Act compliance, SDS sheet creations, regulatory consulting advice and more.

    Founded in 2015 by experts in tobacco, pharma and U.S. Food and Drug Administration compliance, Chemular’s core team combines 50-plus years of expertise in tobacco, medical, pharma, food and cosmetics and has a successful track history with the FDA. Although focused on North America, the company has established a global footprint, including Europe and Asia, enabling it to support clients at all levels, including ingredients, design, software, manufacturing and distribution.

    Visit the company’s website at www.chemular.com.

    EAS Consulting Group is a global leader in regulatory solutions for industries regulated by the U.S. Food and Drug Administration, the U.S. Department of Agriculture and other related federal and state agencies. The EAS mission is to provide quality regulatory advice and service and to represent the best interests of its clients in an ethical, timely and cost-efficient manner.

    The company’s network of over 180 independent consultants enables EAS to provide comprehensive consulting, training and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp and CBD companies.

    EAS Consulting Group is part of the Certified family of companies, which recently merged with Food Safety Net Services. The merger has created a leading U.S. testing and regulatory consulting platform.

    Visit EAS Consulting Group’s website at https://easconsultinggroup.com.

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

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

    FEELM won a Golden Leaf Award at GTNF 2018, the China Patent Excellence Award and the iF Design Award 2020. Vaping devices loaded with the FEELM atomizer have been exported to Europe, America, East Asia, Africa, Oceania and many other countries and regions. The company’s accumulated sales volume has surpassed 3 billion pieces, and its products continue to gain popularity among consumers worldwide.

    Visit the company’s website at www.feelmtech.com.

    The Foundation for a Smoke-Free World is an independent U.S. nonprofit grantmaking organization with the purpose of improving global health by ending smoking in this generation. The foundation funds research (and engages in direct charitable activities) that is nonduplicative and novel, focusing on scientific and regulatory gaps in furtherance of the purposes for which the foundation was formed. The foundation supports its mission through three broad categories of work: health and science research, agricultural diversification and industry transformation.

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

    For more information, please visit www.smokefreeworld.org.

    As parent company of VOOPOO, ICCPP was established on Feb. 10, 2014, and is headquartered in Shenzhen, China, with branches in the U.S., the UK, France and many other places. The company’s vaping products and solutions have been applied in more than 70 countries, covering 100,000 offline outlets and serving more than 36 million consumers.

    With electronic atomization technology development and related products as the core, ICCPP built a full industry chain ecosystem covering all aspects of atomization technology. In September 2021, ICCPP released its groundbreaking Gene Tree microcrystalline ceramic cores, adopting the powder-free concept and innovatively using new environmentally friendly mineral materials to reshape the microstructure of the grain boundary and improve the toughness of the ceramic.

    Visit the company’s website at www.iccpp.com

    Innokin was founded in 2011 with the goal of combining innovation, design and the highest standards of quality to create the best electronic cigarettes and advanced personal vaporizers in the world. Partnering with Aquios Labs U.K., Innokin made water-based vaping possible.

    The company’s vision is to help, inspire and provide the best alternatives to those who want to live smoke-free. Its mission is to create effective alternatives to cigarettes through continuous research and development. The company wants to assist in reducing the world’s dependency on cigarettes and encourage others to find alternatives.

    Innokin’s research and development center has been recognized as the leading vape technology center by local and international authorities. The company has won major international vaping industry awards from Ecigclick, Vaping360, The Vaping Post and several professional vape shows, among other institutions.

    Innokin products are available in more than 80 countries, and the company’s products have changed more than 10 million lives.

    Visit the company’s website at www.innokin.com.

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

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

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

    Visit the company’s website at www.imperialbrandsplc.com.

    Juul Labs’ mission is to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use and combat underage usage of its products. The company believes that vapor products can offer adult smokers an alternative to combustible cigarettes and, in so doing, reduce the harm associated with tobacco.

    Nicotine is addictive and can potentially be harmful. Juul Labs believes that it would be best if no one used any nicotine product, that anyone who smokes should quit and that adult smokers who have not successfully quit should completely switch to potentially less harmful alternative nicotine products.

    Juul Labs does not want any non-nicotine users, especially those underage, to try its products, as they exist only to transition adult smokers away from combustible cigarettes. Juul products are not intended to be used for smoking cessation or other therapeutic purposes.

    Visit the company’s website at www.juullabs.com.

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

    “Kure is proud to have submitted our thorough PMTA applications to the FDA,” the company writes. “These applications detail the high standards we adhere to in all aspects of our business. Moreover, we take our responsibility to our guests and the community we serve seriously and have thus designed and implemented measures to ensure our products never end up in the hands of minors. Kure uses tools such as electronic point-of-service age verification software, secret shopper programs and extensive employee training programs to keep this commitment.”

    Visit Kure’s website at www.kurevapes.com.

    Labstat is a leading nicotine-containing product testing laboratory specializing in analytical chemistry, in-vitro toxicology, microbiology and method development. The company serves clients from all over the world and sets the standard for quality of science, quality of service and the fastest turnaround times in the industry. This leadership role has now extended to cannabis.

    Labstat has been testing nicotine-containing products since 1976. During this period, the company’s scientific personnel have acquired extensive technical experience spanning the entire product life cycle.

    In addition to product stability testing, Labstat offers regulatory testing capabilities, quality management and regulatory consulting, among other services.

    Visit the company’s website at https://labstat.com.

    McKinney Regulatory Science Advisors is an experienced team of internationally recognized scientific, regulatory and business experts that deliver regulatory solutions that position clients for short-term and long-term success. Informed by years of direct experience working with regulatory agencies, its team of regulatory strategists and scientific experts guide clients through regulatory strategy development, product assessment and testing, regulatory application filing and response and postmarket reporting compliance.

    Visit the company’s website at www.McKinneyRSA.com.

    Philip Morris International is a leading international tobacco company working to deliver a smoke-free future and evolving its portfolio for the long term to include products outside of the tobacco and nicotine sector.

    The company’s current product portfolio primarily consists of cigarettes and smoke-free products, including heat-not-burn, vapor and oral nicotine products, which are sold in markets outside the U.S.

    Since 2008, PMI has invested more than $9 billion to develop, scientifically substantiate and commercialize innovative smoke-free products for adults who would otherwise continue to smoke, with the goal of completely ending the sale of cigarettes.

    This includes the building of world-class scientific assessment capabilities, notably in the areas of preclinical systems toxicology and clinical and behavioral research as well as postmarket studies.

    The U.S. Food and Drug Administration has authorized the marketing of versions of PMI’s IQOS Platform 1 devices and consumables as modified-risk tobacco products, finding that exposure modification orders for these products are appropriate to promote the public health.

    As of June 30, 2022, excluding Russia and Ukraine, PMI’s smoke-free products were available for sale in 70 markets, and PMI estimates that approximately 13.2 million adults around the world had already switched to IQOS and stopped smoking.

    With a strong foundation and significant expertise in life sciences, in February 2021, PMI announced its ambition to expand into wellness and healthcare areas and deliver innovative products and solutions that aim to address unmet consumer and patient needs.

    For more information, please visit www.pmi.com and www.pmiscience.com.

    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.

    To learn more about RAI and its operating companies, please visit www.reynoldsamerican.com.

    Global tobacco and nicotine companies are transforming rapidly. Often, the narrative around the why, what and how of such transformations may not be clearly articulated internally in the business as well as to external stakeholders.

    Addressing these gaps within tobacco businesses and with external stakeholders requires a breadth and depth of knowledge and experience. The Global Health Consortium team offers bespoke 360-degree insights and advisory consultancy to enable industry leaders to embrace and implement tobacco harm reduction across multiple dimensions: consumer, science, policy, strategy and regulations.

    Founded in 2006, SMOORE is a global leader in atomization technology solutions, covering reduced-risk products, medical, pharmaceutical and beauty atomization technologies.

    With interdisciplinary atomization research and a diverse product portfolio, SMOORE is committed to becoming an advanced platform, aspiring to make life better.

    Visit the company’s website at https://en.smooreholdings.com.

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

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

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

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

    Visit the company’s website at www.swmintl.com.

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

    E-LiquiTech (ELT), a TTI subsidiary established in 2016, is dedicated to the development and 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, TTI’s manufacturing facility in Assisi, Italy, produces TTI flavors and casings to offer faster delivery to the company’s customers in Europe, the Middle East and Africa.

    In 2022, TTI established Emerald Green Technology. With the rise of the emergent cannabinoid marketplace, Emerald Green Technology (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!

    Visit TTI’s website at www.tobaccotech.com.

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

    Visit www.turningpointbrands.com for more information.

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

    Today, Universal is a global business-to-business agri-products supplier to consumer product manufacturers, operating in over 30 countries on five continents, that sources and processes leaf tobacco and plant-based ingredients. The company strives to be the supplier of choice for its customers by leveraging its farmer base, its commitment to a sustainable supply chain and its ability to provide high-quality, customized, traceable, value-added agri-products essential for its customers’ requirements.

    Tobacco has been Universal’s principal focus since its founding in 1918, and the company is the leading global leaf tobacco supplier. Through its plant-based ingredients platform, it provides a variety of value-added manufacturing processes to produce high-quality, specialty vegetable-based and fruit-based ingredients as well as botanical extracts and flavorings for the food and beverage end markets. 

    Universal Corp. has a long history of operating with integrity, honesty and a focus on quality. The company is a vital link in the leaf tobacco supply chain, providing expertise in working with large numbers of farmers, efficiently selling various qualities of leaf to a broad global customer base, adapting to meet evolving customer needs and delivering products that meet stringent quality and regulatory specifications. Going forward, Universal will build on its history by seeking opportunities in both tobacco and plant-based ingredients to leverage its assets and expertise. It will continue its commitment to leadership in setting industry standards, operating with transparency, providing products that are responsibly sourced and investing in and strengthening the communities where the company operates.

    Visit the company’s website at www.universalcorp.com.

    U.K.-based Zanoprima Lifesciences was founded in 2014 by leading professionals and scientists from the pharma and life sciences sectors determined to create a cleaner nicotine with full traceability to help reduce and ultimately eliminate the harmful effects of tobacco on the environment, society and health.

    In pursuit of this objective, Zanoprima patented a cost-effective enzymatic process to manufacture an ultra-high-purity synthetic nicotine ((S)-nicotine) devoid of many of the residual impurities in tobacco-derived nicotine. Furthermore, Zanoprima’s synthetic nicotine is odorless and tasteless for use in the vaping sector.

    Zanoprima’s nicotine is produced using “green chemistry” principles—catalytic, renewable resources and water as solvent. In addition, Zanoprima’s groundbreaking technology creates enormous environmental and social benefits fulfilling many of the World Health Organization’s environmental, social and governance goals in the area of tobacco cultivation leading toward a tobacco-free world.

    By applying Zanoprima’s cutting-edge expertise and knowhow, its team has developed a suite of products using its ultra-high-purity (S)-nicotine, including sodium-free snus, protonated (S)-nicotine e-liquid for e-cigarettes, sodium-free next-generation gum and lozenges, transdermal patches and heat-not-burn products as potentially less harmful products than those currently on the market.

    Visit the company’s website at www.zanoprima.com.

    Founded in January 2016 and headquartered in Shenzhen, China, Zinwi Bio-Tech Co. is a high-tech company that develops, produces and sells e-liquids. Zinwi Bio-Tech’s products have been exported to dozens of countries, including markets in Europe, America, the Middle East and Southeast Asia.

    The company’s solutions, especially its nicotine salt technologies, have been well received by consumers worldwide. Zinwi Bio-Tech has been recognized by a number of domestic and foreign authoritative organizations with certifications such as ISO 9001 and CNAS.

    In 2021, Zinwi inaugurated a GMP workshop. With its high-quality products and services, the company has won the recognition of more than 300 brands around the world and has established long-term strategic cooperative relations with many international and domestic brands.

    Visit the company’s website at www.zinwi.com.

  • Ambassador James K. Glassman and Rosemary Leonard

    Ambassador James K. Glassman and Rosemary Leonard

    Photo: Malcolm Griffiths

    Ambassador James K. Glassman, former U.S. undersecretary of state for public diplomacy and public affairs, and Rosemary Leonard, a general practitioner in London, took the opportunity presented by the Global Tobacco & Nicotine Forum to introduce a report that aims to inject new imagination and ambition into the effort to reduce tobacco-related death and disease.

    According to Glassman, the fight against smoking has stalled. “There are more people smoking today than there were 30 years ago,” he noted. The current approach, he said, will only prolong the suffering. If nothing changes, 1 billion people will die of smoking-related diseases this century.

    Published by the International Commission to Reignite the Fight Against Smoking, the new report calls for society to recognize the power of technology to disrupt and tries to remedy the neglect shown to low-income and middle-income countries (LMICs).

    Smokers famously smoke for the nicotine but die from the tar—the byproducts of combustion. Innovation has resulted in technologies that can deliver nicotine in a device, the e-cigarette, that according to Public Health England and the Royal College of Physicians is 95 percent less harmful than smoking.

    Unfortunately, in all but a few countries, regulatory policy toward tobacco products is confused, contradictory and not based on current scientific knowledge, observed Glassman. 

    Glassman also expressed concern about the high levels of misinformation, not only among the general public but also among regulators and physicians.

    Leonard related the story from her practice about a patient diagnosed with chronic obstructive pulmonary disease. The patient said he had tried everything—the patches, the gum, etc.—to quit smoking but to no avail. When Leonard suggested he try vaping, the patient nearly fell from his chair. Leonard had to reiterate that anything was better than combustible tobacco.

    “Unfortunately, I am in the minority of doctors,” said Leonard. “So many just don’t know the science behind smoking … they know that tar is harmful, but they have this misperception that nicotine is harmful too.”

    Leonard said she was proud of the U.K.’s relative success reducing smoking. “We have moved from being a global leader in tobacco consumption to being a leader [in] tobacco control,” she said. And while there were many factors contributing to that success, including taxation, plain packaging and indoor smoking bans, Leonard said the U.K. had been especially fortunate with Public Health England’s hands-on approach in helping people quit and pragmatic approach toward smoking alternatives.

    “And now we must get the U.K. message to low[-income] and middle-income countries, where most of the world’s smokers reside,” she said. The idea behind the report is to open up a dialogue—to get the message across of how to best help people stop smoking.

    Among other recommendations, the report calls for risk-proportionate tobacco policies and better access to harm reduction in LMICs. It also encourages medical bodies to reestablish the leadership role of doctors in ending smoking and urges tobacco companies to have a clear plan to phase out high-risk combustible products.

  • William Gifford

    William Gifford

    Photo: Malcolm Griffiths

    Speaking through a video link at the 2021 Global Tobacco & Nicotine Forum in London, Altria Group CEO William Gifford explained why he believes it is possible to make more progress in tobacco harm reduction in the next 10 years than has been achieved over the past 50 years.

    Gifford said he was optimistic about the outlook for tobacco harm reduction in the U.S. He was encouraged not only by the U.S. Food and Drug Administration’s commitment to science but also by the growing support of tobacco harm reduction among public health advocates.

    As an example, he pointed to a recent landmark article offering a rare balanced look at vaping in the U.S. Writing in the August issue of the American Journal of Public Health, 15 former presidents of the Society for Research on Nicotine and Tobacco (SRNT) recognized the benefits of vapor products.

    Meanwhile, data from the National Youth Tobacco Survey suggest that underage vaping, while still high, shows signs of decline. Underage use of traditional tobacco products remains at historical lows. The minimum age to purchase tobacco products has been raised to 21, and many states are considering and implementing lower rates of taxation for FDA-authorized reduced-risk products. Risk-proportionate taxation is important, according to Gifford. “We must not impede consumer switching,” he said.

    Despite his optimism, Gifford also detected headwinds. He identified four areas where progress was still needed: correcting misperceptions about nicotine, ensuring that harm reduction is equitable, allowing for real and meaningful scientific engagement between industry and public health, and ensuring that harm reduction is an off-ramp for adult smokers and not an on-ramp for underage tobacco use.

    Nicotine, Gifford reminded his audience, is not the primary cause of disease and death from smoking; rather, it’s the combustion of the tobacco—so it makes sense to transition adult smokers who can’t or won’t quit from the most harmful form of nicotine consumption to a less risky alternative.

    While the risk continuum is today widely embraced by public health, the scientific community and the regulator, many smokers—the people who most stand to benefit—don’t understand the concept. Seventy-three percent of people either incorrectly believe nicotine is the main substance in cigarettes that cause cancer or are unsure. Eighty percent of surveyed physicians in a recent study strongly agreed that nicotine directly contributes to the development of cardiovascular disease, COPD and cancer. Left unaddressed, said Gifford, these widespread nicotine misperceptions could discourage adult smokers from switching to smoke-free tobacco products.

    Industry has an important role to play, he noted. “It’s on us to conduct the science and seek MRTP [modified-risk tobacco product] authorization claims to persuade adult smokers about the benefits of switching to smoke-free products,” said Gifford. “But industry alone cannot correct nicotine misperceptions,” he added. “FDA has said, ‘we need a national debate on nicotine.’ We agree; we think FDA is best positioned to lead it. That’s why we recently asked the agency to launch a targeted public education campaign geared toward adult smokers about nicotine misperceptions.”  

    Access to tobacco harm reduction must also be more equitable, according to Gifford. A recent study among Black, Asian, Hispanic and LBGTQ+ communities revealed that a greater proportion of those groups mistakenly identified nicotine as the chemical that causes cancer. What’s more, Altria’s own data shows that Black, Hispanic and female adult smokers lag behind white male adult smokers in transitioning to smoke-free products.

    A comprehensive approach to harm reduction means that all smokers, regardless of background, demographics or financial means, have equitable opportunities to reduce the harms of smoking, according to Gifford. While not claiming to have all the answers, he insisted that Altria was committed to engaging and listening.

    “We face an unprecedented opportunity for America to lead the way in shifting millions of smokers away from cigarettes if we follow the science, support innovation and clearly communicate scientifically accurate information,” he said.

    Getting the best possible science and data to guide policy decisions, he said, requires more than well-designed studies or lab work; it requires peer-to-peer engagement, review and open-minded inquiry. However, many organizations are seeking to exclude industry from scientific forums and research. For example, the National Institute on Drug Abuse discourages industry participation in harm reduction research. The SRNT recently decided to ban industry employees from attending and sharing their science at its annual conference.

    “In this situation, nobody wins—not science, not good policy and certainly not adult smokers,” said Gifford. “We stand by our science and make it a point to welcome good faith scrutiny. If there is one lesson we all learned during the pandemic, it is the importance of science-driven communications.”

    Gifford related how he’s often asked when the last cigarette will be smoked in the U.S. “The honest answer: It depends,” he said. As variables, he cited industry innovation, regulatory legislative policy, whether adult smokers can get the smoke-free products they like and whether adult smokers get accurate information on smoke-free products.

    “But I am confident we can make real progress if we engage, listen and act,” he concluded.

  • The Fork in the Road

    The Fork in the Road

    Photo: Malcolm Griffiths

    Following the virtual conference in 2020, which had been forced online by the coronavirus pandemic, the GTNF was pleased to once again welcome delegates in person in 2021. The Rosewood Hotel in London hosted 162 delegates Sept. 21–23, with an additional 720 participants following the speeches and discussion panels online.

    The event attracted both industry representatives and stakeholders from other sectors, including government, civil society and the legal profession. In addition, GTNF 2021 generated considerable interest among the media, with representation from prominent outlets such as The Wall Street Journal, Bloomberg and Le Monde.

    Below is a sampling of the 2021 GTNF keynotes and panel discussions. For additional coverage of the event, please click here.

    To read what delegates had to say about the ninth Conference of the
    Parties to the Framework Convention on Tobacco Control that is scheduled
    to take place this month, please click here.

    Matt Ridley: The importance of innovation

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

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

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

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

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

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

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

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

    Advertisement

    Stefan Bomhard: Putting the consumer first

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

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

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

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

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

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

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

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

    Advertisement

    Panel: What is Next for Tobacco and Nicotine

    The vaping industry faces many challenges. The road to a viable future for these products must pass through sensible regulations based on science. In the current environment, unfortunately, this will be challenging, according to speakers on the GTNF plenary panel The Fork in the Road: What is Next for Tobacco and Nicotine. Misperceptions surrounding nicotine and vaping products, the panelists agreed, are furthered by the mass media’s “wonton disregard” for the science behind the tobacco harm reduction potential of electronic nicotine-delivery systems (ENDS).

    One speaker noted that in addition to many countries banning or erecting insurmountable barriers to vaping products, well-funded anti-nicotine activists are attacking the people who are bringing reduced-risk products to adult combustible cigarette smokers trying to quit smoking. These groups are opposed to the tobacco harm reduction that science and innovation can bring.

    All of these activities together only serve to enhance the vaping industry’s problem: the massive public misperception that vaping is as deadly as smoking cigarettes. The fact that a significant number of physicians mistakenly belief that nicotine, rather than combustion, is responsible for smoking-related illness, bodes ill for the perceptions among the general population. “If physicians believe this, imagine the views of the average smoker in Kenya or Chicago, Illinois, or in Australia,” one speaker said.

    While anti-nicotine activists have done their share to misperceptions, the vaping industry too is partly to blame, according to one panelist. The ENDS industry can do a lot more than feel helpless or complain, this speaker noted. Innovation in harm reduction cannot occur without the vaping industry’s support. That means responsible marketing, combating illicit trade, limiting youth access and making sure that the ENDS industry is doing what it can to prevent underage use.

    Panelists also expressed concern about the direction of the vapor market in the wake of the U.S. Food and Drug Administration’s marketing denial orders (MDOs), with some describing a “Wild West” scenario. After receiving MDOs, some companies have turned to synthetic nicotine because that product currently is outside of the agency’s jurisdiction. A panelist said that the FDA’s “scorched earth” approach to flavored products is only creating bigger problems in the market, adding that if a market isn’t regulated, there is still going to be an unregulated illicit market that has the potential to be more deadly than that for combustible tobacco.

    “Nobody wants kids to take up the products … it’s a very significant responsibility that we in industry be there to be the stewards of that concept in generating science and evidence,” a panelist said. “We should all be proud of the good science that is being generated … that is our responsibility: to generate and publish and participate in the scientific debate and pursue reasonable regulation. What is reasonable? I don’t know. It’s not going to be nothing. We all have to get over it and figure out what is the right way forward so we can go back to helping the consumer and making sure we’re only serving smokers who are looking for alternatives to combustibles.”

    Advertisement

    Amanda Wheeler: Continuing the fight

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

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

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

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

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

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

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

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

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

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

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

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

    Joe Murillo and Todd Cecil: The regulator’s view

    When the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for vapor products, the industry was understandably shocked. Many companies that had submitted timely premarket tobacco product applications by Sept. 9, 2020, had expected to first receive a deficiency letter and not immediately an order to remove their products from the market. Some MDO recipients complained the agency had “moved the goalposts” by suddenly requiring studies that it had previously said were not required.

    At least three companies have filed lawsuits over their MDOs. All are accusing the agency of making “arbitrary” decisions and not reviewing the submitted data according to the statutes. In a “fireside chat” between Joe Murillo, chief regulatory officer for Juul Labs, and Todd Cecil, deputy director of the Office of Science for the FDA’s Center for Tobacco Products, during the recent GTNF in London, Cecil acknowledged the missing data that caused the flurry of MDOs is not required by the statutes that regulate tobacco products.

    When asked what the “level of expectation” the FDA had in deciding whether to issue a deficiency letter or an MDO after a premarket tobacco product application (PMTA) was moved into scientific review, Cecil said that the agency followed “a randomized approach” to choose the applications the FDA would work on.

    “The randomized approach identified a number of manufacturers’ products that went into this scientific review, and we … evaluated them from top to bottom,” he said. Cecil noted the agency began to see in some applications that “tended to have problems or missing materials that we needed in terms of benefits [of flavors]; that we learned we have to have that benefit piece … that evaluation that we spent several months working on taught us what we had to look for to be able to [conduct] a full scientific review.”

    Cecil said that the agency just figured “if we know going right in that there are pieces missing, why will they go through a deficiency process and with a very short turnaround expecting to get back a full study that wasn’t completed previously?” So, instead of issuing a deficiency letter as required by statute, the FDA just handed out MDOs because the agency knew that it would take a company a significant amount of time and expense to conduct the new required longitudinal and cohort studies. Cecil was then asked why the agency filed the applications in the first place.

    “We had to make a determinant how can we streamline this evaluation and determine those products that have at least the bare minimum for us to do a real and complete evaluation,” Cecil said. “This evaluation is not a standard. It is not a de facto standard or anything else. This is information that we need to see, but it’s not a requirement. An RTF [refuse to file] are those things that are required by the statute. And these studies are not necessarily required by the statute.”

    The FDA has also been facing an unprecedented amount of scrutiny on how its handling of regulation of electronic nicotine-delivery system (ENDS) products and the PMTA process. Numerous health groups, anti-nicotine groups, states attorneys general and even members of Congress have criticized the FDA and demanded action. When asked if the FDA’s actions were influenced by these groups, Cecil said the agency focuses on science.

    “We’re science-based,” he said. “We need look at what is presented to us in the application and in the laboratory. That is what we’re most focused on. If there is new data out there and that new data is brought to our attention through one of these [groups], then that’s fine. We would be happy to get those up and understand the bigger picture, all of the data … We need to evaluate those as scientifically or make a determination based upon that science.”

    Only 100,000–200,000 products remain under FDA review. Of the 6.7 million submitted PMTAs, all others have received either a refuse-to-accept, an RTF or an MDO response. Cecil denied the agency was making a “categorical policy decision as opposed to an application-by-application decision” about flavored products. “We are stating that we understand that there is a significant youth initiation risk that comes from flavored ENDS products,” he said. “We are, in fact, reviewing all of those, and what we have found as we’ve done our reviews is that none of the literature is sufficient to demonstrate that there is not a youth initiation risk for individual flavors.

    “We see that tobacco has a lower initiation risk. We see that menthol has some issues with it, and we are going to be evaluating that as we go forward. However, all of the data points to the flavored products as having significant youth initiation concerns. So what we’re looking for is an adequate indication that there’s a benefit on the other side of the equation. This is not a decision that we aren’t going to accept flavored products. Absolutely opposite. We need to ensure that there is concrete and robust data that demonstrates that there is an existing user benefit for those products.”

    Cecil declined to say when more MDOs would be issued or when the agency would rule on major products, such as Juul, NJOY, blu and Vuse. “We continue to work diligently,” is all he would say. “There are a number of products that are well along. But no, I can’t tell you how many are those ones, but there are some that we’re hoping to move forward in the short term.”

    The FDA’s recent action against flavored e-liquids does not mean that the FDA will never approve a flavored e-liquid, according to Cecil. He said that the rejected applications just lacked the required information that those products met the agency’s “appropriate for the protection of public health” standard. “You are welcome to reapply once you have addressed the issues that we provided to you,” he said. “And we will reevaluate that at a future date.”

    Investment Panel: A New Case for Tobacco

    Despite the rough ride for tobacco stocks in recent years, the investment case for tobacco and nicotine remains strong, according to the participants in the Global Tobacco and Nicotine Forum (GTNF) 2021 investors panel. Under the direction of Eric Bloomquist, four prominent tobacco analysts—Jonathan Fell of Ash Park Capital, Rupert Wilson of Strategic Business Consulting, Pieter Vorster of Idwala Research and Gaurav Jain of Barclays—debated the outlook for tobacco in a rapidly changing business environment. Even as the industry suffered from Covid-19-related fallout, its legendary pricing power remained intact and continued to deliver profit growth and cash flow. With supply chain disruptions affecting many sectors, tobacco has even become a safe hiding place again, one panelist ventured.

    That said, some companies have clearly done better than others. Those with greater exposure to noncombustible products are attracting higher valuations than those with a lower portion of their revenues coming from that business, and the panelists debated whether that discrepancy would prompt investors to pressure the underperformers to “get their act together.” Not everybody was convinced. As one participant pointed out, shifting the world’s 1.1 billion smokers to noncombustibles is a very long-term project. “Realistically, there is time for the companies who don’t have the right strategy to eventually get there,” he said. A word of caution was also uttered against compromising the cash flow machines: The transition to less risky nicotine products requires lots of investment, and many of those funds are still generated by sales of traditional cigarettes.

    Speculating on possible mergers and acquisitions, the panelists considered a reunification of Altria Group and Philip Morris International unlikely in the near future. As one participant pointed out, PMI has publicly committed to deriving more than 50 percent of its net revenues from smoke-free products by 2025. Because Altria currently receives a smaller share of its earnings from such offerings than does PMI, it would be harder for the combined entity to meet PMI’s target. What’s more, many PMI investors like the fact that they can currently choose whether or not they want exposure to the uncertain U.S. market—an option that would no longer be available after any merger.

    One panelist suggested Swedish Match as an acquisition target for PMI. After the recently announced separation of its cigar business, Swedish Match would offer PMI attractive complementary smokeless businesses, such as snus and modern oral, the panelist said. Others contemplated the possibility of spinoffs by Imperial Tobacco, which has announced greater focus on its core markets. The problem here, noted one panelist, would be the buyer: With all large tobacco companies keen to reduce their dependence on combustibles, there is no obvious taker for such a business—at least not among the publicly listed firms. This, in turn, led to speculation about the designs of China’s State Tobacco Monopoly, which is not accountable to shareholders—but the panelists quickly agreed it was futile to figure out “what is happening in China.”

    The discussion then turned to the impact of environmental, social and governance (ESG) initiatives on investors. Would tobacco companies’ efforts to transition smokers away from deadly combustibles prompt investors who might otherwise have shunned the sector to take another look? Panelists agreed that the Foundation for a Smoke-free World’s Tobacco Transformation Index, which evaluates tobacco manufacturers on efforts and actions relating to tobacco harm reduction, could prove to be a valuable tool for investors. Companies that are doing the most in this area are already enjoying the best valuations, one panelist pointed out. They also pointed to the entrance into the market of new nicotine companies that offer no combustibles, such as RELX and SMOORE, which have broadened the options. PMI’s recent acquisitions of pharmaceutical companies, such as Vectura, could also generate interest from a new class of investors, the analysts ventured.

    At the same time, the panelists acknowledged the challenges facing tobacco companies in escaping the tobacco “taint.” Many financial websites offer investors a dropdown menu with the option to exclude “tobacco”—a broad label that includes both companies wedded to traditional cigarettes and firms at the forefront of transitioning smokers away from such products.

    One panelist detected a marketing opportunity. Its premise would be simple: Rather than pretending tobacco companies don’t exist, such a fund could offer to invest in their depressed stocks and help them change. “That would be a useful approach for the world and an interesting proposition for investors,” he said.

    Open Mic: Tackling the Hard Questions

    One of the panelists at the final session of the Global Tobacco and Nicotine Forum (GTNF) 2021, the Open Mic, indicated that he and his colleagues were spending a lot of time trying to validate innovative ways of substantiating tobacco harm reduction. He was responding to a question about whether breaking through to those so far unconvinced about the harm reduction credentials of new-generation tobacco/nicotine products would require more research or whether a different approach was needed. It was obvious that regulators would want to see the results of high-quality studies, he said, but what was not so obvious was what kinds of studies were needed. It was known, however, that if somebody stopped smoking tobacco, they benefited from a whole world of physical improvements that could be measured; the problem was how to measure those changes effectively and in a timely manner.

    The Open Mic session lasted one-and-a-half hours and provided event participants with the opportunity to ask some challenging questions, one of which touched on the fact that in some tobacco markets, up to 35 percent of smokers are occasional or nondaily smokers, most of whom don’t use other nicotine products on days when they don’t smoke. Given this, what was the role of nicotine in moving people away from combustible products?

    One response suggested that the issue of addiction or dependence was oversimplified, as though all smokers were the same and all were addicted, an idea that was not entirely true. There had been overexposure of the problem of addiction and dependence, especially in relation to young people, when, in fact, some people were able overnight and without withdrawal symptoms to quit a smoking habit that had lasted up to 40 years. It was time for the book of addiction and dependence to be rewritten.

    Another panelist took the view that the issue of the spectrum that took in addiction, dependence and pleasure was complex, and focusing on it as if it were the main moral question that had to be grappled with was not helpful. Having such a focus was to miss the target. The target should be to reduce risk and to reduce disease. In fact, the important moral question was do physicians and members of the scientific medical community give smokers an additional option or not? Do they provide them with proper guidance on how to quit but give them the right to choose, or do they condone only the methods of which they approve?

    Broadly speaking, the Open Mic session included three panelists from the world of science and healthcare and three from the world of business, one of whom appeared remotely from China. The session started, however, with a comment from one of its two moderators, who said the 2021 GTNF was the first conference she had been at where the consumer was front and center. But there was a sting in the tail. Some consumers, she added, those who still used traditional tobacco products, were not at the center except in the sense that they were the subject of discussions on how to get them to move to one of the many new-generation products coming onto the market. In a way, the suggestion seemed to be: Where was the “T” in GTNF?

    A corollary to this question came up later when it was asked whether committed traditional tobacco users should be continually bombarded with information by those wanting them to quit or switch to less risky products or whether, at some point, it should be accepted that since they were determined to continue with their habit, they should be left alone to enjoy it. Nobody got to grips with this question, perhaps because it was too raw or because this “hard core” of smokers would make up the 5 percent who would still exist in countries that had “eliminated” smoking. Although one panelist made the point that in a relatively free world, people should be allowed to do what they wanted to do with a legal product, most merely suggested that new-generation products and the messages around them should be improved, presumably until even the hard core of smokers came on board.

    There is clearly a problem with such communications, however. One simple but insightful question asked where a smoker looking to quit should go for advice. This presents a conundrum because the tobacco/nicotine and pharmaceutical industries have financial interests in the outcome, many healthcare professionals are ill-informed and social media is crawling with conspiracy theories. One panelist made the point that it could turn out that your friend who had already benefited from switching from consuming traditional tobacco products to using new-generation products could prove to be the most important medical adviser you would ever consult.

     

  • David Levy

    David Levy

    Photo: Malcolm Griffiths

    In his keynote speech, David Levy, professor of oncology at Georgetown University in Washington, D.C., looked at the divide between public health and the industry, which, he indicated, judging from GTNF discussions, might not be as great as he had thought—although, it might be greater in some parts of the market than in others. One of the topics perhaps most overlooked in the discussion about harm reduction, he pointed out, was market structure and competition, which generally play an important underlying role. “They are not only important in understanding the use pattern itself but also in the interaction between public health policies and the industry,” he said.

    Levy distinguished between the industry before 2005 and after. Pre-2005, it was clear to the U.S. Federal Trade Commission, and in general, that cigarettes were a distinct market. Since the 1950s, the industry had become increasingly concentrated, with Altria gaining a 40 percent-plus market share, making it a dominant player. The industry of that time was also characterized by high barriers to entry—it effectively controlled retail shelf space, thereby limiting competition, introduced predatory pricing and used a coupon system for customer loyalty. The lines were clearly drawn; there was stability. Tobacco control had a number of policies, and their target was clear.

    Around 2005, the market started to change. Price sensitivity of consumers increased. U.S. smokers started to switch to other products, at first to little cigars and later to vaping. The market suddenly became much broader than cigarettes. “One of the most important changes was that sales of vape products took place on the internet and in vape shops—a whole new arena,” Levy explained. “Both [sales points] also played an important role in providing information on the new products.” Levy doesn’t expect the heated-tobacco products sector to see the same competition as e-cigarettes. The current tobacco market, he pointed out, showed an exceptionally steep decline in youth and young adult smokers, which have fallen by 60 percent since 2013. Levy called this a vital alteration.

    He predicted stricter policies toward cigarettes worldwide, including the introduction of health warnings, menthol bans and a higher selling age. “Pressure on cigarettes will increase,” he said. For vape products, Levy forecast, the future was uncertain. The outlook for the industry remains unclear in the wake of the marketing denial orders issued to tobacco companies after Sept. 9, according to Levy. “I don’t think it’s the final word from the Food and Drug Administration,” he said. Levy suggested the industry accept the uncertainty—which he thought was here to stay—and embrace change. The United Kingdom and New Zealand with their progressive tobacco harm reduction policies provided examples for others to follow. “Things will slowly change,” said Levy.

  • Science

    Science

    Photo: Malcolm Griffiths

    Regulators globally are becoming more understanding of what they expect next-generation tobacco products to accomplish. Regulators want manufacturers to demonstrate, on a product-specific basis, whether the vaping products are a benefit to combustible cigarette smokers. More importantly, manufacturers must ensure that vulnerable populations such as youth are not using these products.

    During the lunchtime GTNF panel “Science Driving Innovation,” one speaker also mentioned that manufacturers must be more conscious about the environmental impacts of vaping products too. The environment is a big issue in the minds of governments, regulators and society as a whole. The panelists agreed that vaping manufacturers should produce products that are environmentally sustainable.

    “Think about all the batteries that go to waste every time an e-cigarette is disposed of. What are we doing as an industry to address the fundamental questions that society and regulators are concerned about?” a panelist asked. “We need to start thinking about what views of science we need to really put our investments in [and start] focusing on going into the future.”

    Another major industry concern that should be addressed through innovation is youth initiation. One panelist said this topic should be a primary focus of scientific efforts relating to vaping products. Reduced-risk products must exist for adult smokers, so it’s imperative that the industry proactively addresses the underage use issue. “If we don’t, others will try to do it for us, and then collectively, we will all compromise the potential that [we are focusing on during the conference] today,” one panelist said. “It’s a critical balance. It’s important that we offer adult smokers an alternative, and we can also combat underage use. We can do both, and we must because there’s too much at stake if we don’t.”

    Another speaker discussed her company’s global retailer compliance monitoring program. The company sends thousands of “mystery shoppers” into U.S. retail outlets that sell its vaping products and collects data around whether the retailers are abiding by federal age verification laws and/or other local policies.

    “What we found is that retailers need help. There’s a lot going on in this world. We help them by providing information on how they’re performing, education and training, and we can also assist in changing their existing point-of-sale technology,” she said. “It can actually prompt the clerks to check ID when they’re selling an interesting new product. And it alleviates the mental burden on their end.”

    Another concern for the industry that can be addressed through innovation is improving nicotine delivery and satisfaction. That satisfaction delivered by products today is not enough to sustain the large number of people we want to see switching from cigarettes to electronic nicotine-delivery systems.

    “To achieve meaningful harm reduction, we need these products to appeal to and be affordable to most adult cigarette smokers. Which means those consumers would need to like the product and be able to afford the product,” a speaker said. “They need to be able to trust these products, and it requires a significant investment in innovation if you want to do it properly.”

  • Innovation

    Innovation

    Photo: Malcolm Griffiths

    Innovation is grounded in regulation. Regulators can either embrace innovation as a tool to support harm reduction, or they can regulate them to the point that any innovation is impossible to bring to market. During the GTNF panel Innovation as the Path to Progress, one speaker explained that the U.S. Tobacco Control Act was written with the goal that the state of public health will change over time. The idea is that as smokers quit and product standards are implemented, many may migrate to products lower on the risk continuum. As a result, as the state of public health changes, the products that the U.S. Food and Drug Administration determines to be appropriate for the protection of the public health (APPH) will also change.

    “If you think about the significance of the innovation of the e-cigarette, today we have major companies that are in the tobacco space talking about eliminating combustion altogether,” a panelist noted. “We have companies giving up their entire combustible segments, and that would not have happened, in my opinion, had it not been for the innovators.”

    Making innovative progress in the vapor industry is measured by transitioning adult smokers to noncombustible products, according to the panel. However, there are many avenues to accomplish this goal as well as numerous obstacles. One speaker offered the audience three focus areas that he described as the pillars of innovation. The first pillar is product innovation. “If the product is not satisfying, people are not going to switch,” the speaker said. “In order to get there, we will need a very disciplined, science-based approach in understanding some of the questions underlying satisfaction. As we think about innovation and product innovation, it’s important for smokers to have a range of products to choose from.”

    The second pillar is scientific innovation. There must be a comprehensive assessment of science to demonstrate that a product is APPH, and while all novel products tobacco products must be held to this high standard, it is rigorous and takes time. There are innovations in scientific methodologies that must be made, the speaker explained.

    The speaker cited dissolution methods to understand nicotine release profiles and computation of toxicology as examples of tools that can help accelerate this pathway for getting products in the market. “Along with that, I think that regulators have an opportunity to create some innovative processes,” the speaker said. “For example, establishing product standards that will hopefully help these products be reviewed in an expedited manner, and most importantly, get them in the hands of consumers.”

    The third pillar is communication. The industry needs to make clear the benefit to smokers by switching to noncombustible products. The industry needs to address the misperceptions surrounding nicotine and the wrong assumption nicotine causes cancer. “This clouds the decision-making process of adult smokers,” the speaker said. “As manufacturers in the U.S., we have to seek FDA authorization before we can communicate a modified-risk or modified-exposure order. That, too, is important but time-consuming and resource intensive. This is a responsibility for everybody to explore innovative communication approaches that can address these misperceptions.”

    Another area ripe for innovation in the electronic nicotine-delivery system industry is environmental sustainability. For example, e-cigarette batteries contain heavy metals. The industry must innovate battery technology that will reduce their products’ environmental impact. Responsible disposal of any product is important. Regulation can also impact environmental issues. In the U.K., for example, requiring 10 mL bottles instead of larger bottles creates more waste.

    Finally, synthetic nicotine also offers innovative advancements for next-generation products. “I think that when we talk about moving away from combustion, that is one thing, but when we talk about moving away from tobacco—in other words, giving consumers a truly tobacco-free option—that’s where science comes in,” a panelist explained. “The promise that is involved with synthetic nicotine is significant. They need to research it closely and recognize that it does provide certain benefits that perhaps the tobacco-derived nicotine does not.”

  • Frank Han

    Frank Han

    Photo: Malcolm Griffiths

    During a keynote address for GTNF, Frank Han, senior vice president of Shenzhen SMOORE Technology Co. and CEO of its FEELM business division, said that there are exciting innovations—big and small—happening every day in the vaping industry. Vaping products using FEELM atomization technology have now reached millions of users in more than 50 countries.

    “Vaporization technology is still just at the beginning; we could welcome the opportunity for innovation to create a better life together … Basic Science Innovation has been the cornerstone for sustainable growth; it is the science of atomization that we need to build as the foundation supporting the industry,” he said, speaking through an interpreter. “As a firm believer of innovation, SMOORE has integrated disciplines like engineering thermodynamics and biomedical sciences into our atomization research.”

    SMOORE has been actively learning to understand and assess the long-term health effects of vaping, according to Han. The company currently has seven research centers between the U.S. and China, “bringing in global talents” from different backgrounds. In addition to in-house R&D resources and efforts, SMOORE is also focused on partnering with leading universities to transform the company’s scientific discoveries into applied technologies. “The way vape products are manufactured is also constantly evolving; more effectively and definitely more environmentally friendly,” said Han.

    SMOORE had begun operations using the first fully automated pod production line in the world. Each new manufacturing (single) line can produce 7,200 standard vaporizers per hour, double the previous generation’s output. “We have been working with business partners to improve sustainable practices in all stages of product development, especially manufacturing with the common goal of reducing carbon footprint,” said Han.

    SMOORE is currently evaluating the underlying technology of atomization for its potential applications in other fields. “With one direction of our R&D focus on the atomization application in healthcare, I am proud that SMOORE has made progress on the research of atomized medication, along with partners from different sectors,” Han said. “The initial results are all positive. We are hoping in the near future, more and more people might be able to inhale medicines or even vaccines with atomization devices.”

    Looking ahead at the vaping industry overall, Han said that policymakers and NGOs must be inclusive. Regulation has been a heated topic recently in both the U.S. and China, and while institutional innovations to promote healthy industry development and more balanced regulations are needed, regulators must also embrace vaping as a strategy to improve public health while safeguarding against youth initiation, he said.

    “The global media must also be inclusive. We must value the media that report from an unbiased perspective, involving more people in the public dialogue on vaping, discussing the pros and cons and discovering the truth,” said Han. “I’d like to share an old Chinese saying here: ‘Though the road ahead is dangerous and difficult, we can only achieve our goals with constant efforts.’ We must press ahead with a sense of perseverance to expect a better future.”

  • Consumers

    Consumers

    Malcolm Griffiths

    For many people, the threats they face in day-to-day life are far more immediate than their long-term health. The mission of harm reduction should be to empower people to make their own choices about what products they consume and their own health decisions, even if those decisions don’t align with what public health experts would say is optimal. This was the general focus during a plenary panel discussion at the GTNF called Consumers: The Key Stakeholders.

    Most of the session centered consumers standing up and advocating for the industry, the global attacks on flavored e-liquids and growing threats from the World Health Organization (WHO), which remains suspicious of tobacco harm reduction. Panelists agreed that while some consumers prefer to remain on the sidelines, many others are willing to get organized and campaign for tobacco harm reduction and the vaping industry. “The consumer voice is very powerful,” a panelist said.

    A major concern for the vaping industry is the concerted campaign against flavors. Flavors, according to one panelist, are used to by the industry’s enemies to redirect the conversation toward children. “They’ll say vaping flavors attracts children, and then they get us to play in their playground,” he said. “It’s very different. You [consumers] have got to keep asserting that adults use flavors.”

    The WHO is a threat no matter what, the panel agreed. The global health body is now even talking about redefining smoke to include anything that’s heated and emits a vapor. “This means that any customizability of a product will be restricted and have limits on it, which basically means all the vape products will be the same,” explained one panelist. “These [recommendations] have to be resisted. The WHO doesn’t make laws, but it’s very influential, and these things can’t just be waved away.”

    The scientific studies the WHO uses to justify its negative view toward next-generation products as tools for harm reduction are “fantasy and cherry-picked” studies, according to another speaker. “The people who are against harm reduction will never sleep. They’re always working, and they’re highly funded,” a panelist said. “[Consumers] have to stay alert, and they have to stay organized because, at the end of the day, there are more consumers than there are activists against harm reduction, and we’ll vote. So, consumers really have a big role to play.”

    Consumers are the key stakeholders. However, when talking about consumers, regulators must acknowledge that not every smoker is the same, according to the panel. Many smokers don’t want to quit combustibles. “The important thing is to understand why and respect their choice,” a panelist said.

    One speaker said that the industry also needs more responsible vape reviewers on YouTube because the current ones “are absolutely appalling.” The speaker urged consumers to make their voices heard in politics. “You’ve got to have somehow to get ahold of your Parliamentarians or your politicians in your country and get them to campaign on your behalf because there are many, many consumers, but you haven’t got great voice in government, and that’s what you really need to try and get,” he said.

    At the end of the session, an audience member asked the panel if it could see a situation where consumers would sue regulators over counterproductive rules, such as flavor bans. “I have mentioned the fact that it would be interesting if someone could do a test case, but I don’t know whether that someone could come from the consumer side and sue [over regulatory action],” the panelist said. “It’s also expensive, and someone will end up having to pay if you lose.”

  • From Local to Global

    From Local to Global

    Photo: Malcolm Griffiths

    African countries tend to formulate health policies based on advice from the World Health Organization, a strategy that is problematic when it comes to tobacco harm reduction (THR) aspects of tobacco control, participants at the 2021 Global Tobacco and Nicotine Forum (GTNF) were told. The nub of the problem is that tobacco control advice is filtered through the WHO’s Framework Convention on Tobacco Control (FCTC), which was written toward the end of the last century in an attempt to deal with the ill effects of combustible tobacco. Consequently, since no attempt has been made to write a new framework relevant for the innovative noncombustible products developed this century, the WHO has no adequate framework with which to help governments regulate these new products appropriately.

    These points were made during the plenary panel “From Local to Global: Regulatory Policy Trends.”

    Of course, there is something odd here because the direction of policy travel—or, at least, the policy-advice travel—is in the opposite direction to that suggested in the session’s title: It goes from global to national. But that should not be interpreted as the reason for its failings. Things can fall apart just as easily when traveling in the other direction.

    In the U.S., states and other jurisdictions have imposed restrictions on reduced-risk products that have caused increases in smoking, which they were designed to reduce, and increases in sales of illicit products. But at least there is something of a bright side here if you believe that government policymaking is evidence based. In not working, these restrictions provide evidence to use against suggestions that they should be applied more widely, even at a national level.

    I’m not sure that I’m convinced in this matter, but then I come from the land where a lot of people still cleave to the idea that Brexit was a good move: the idea that by becoming more insular we would become more global.

    There is no doubt, however, that the interactions between the local and the global are complex. One presentation made the point that a main principle in respect of environmental issues was that there was a need to think globally while acting locally, something that was applicable in respect of tobacco harm reduction. The FCTC had a floor but no ceiling, so it was up to individual countries to adapt the convention’s articles to suit national, regional and local circumstances. While countries had circumstances that differed one to the other, there existed, too, internal differences. The U.K. had seen a significant reduction in the consumption of combustible tobacco products but not among its marginalized communities. And in Brazil, while tobacco smoking had fallen significantly in urban areas, this phenomenon had not been reflected in the countryside.

    One question that arises from this is, how local do you go? If you return to the title of the session, it is obvious that there is a glaring omission: smokers. OK, you might argue rightly that smokers aren’t involved in policymaking; we’re not debating in ancient Athens, but surely, they should get a look in—even a walk-on, nonspeaking part? No. The session was told it was obvious from the documents released ahead of the FCTC’s Conference of the Parties (COP9) in November that smokers, who were not at the center when the FCTC was developed, were not meant to be at the center of the upcoming debates. It seemed as though it was easier to ignore them, and this raised a social justice issue.

    Many of the presentations at the session tended toward simply describing the counterproductive nature of much tobacco and nicotine regulation, especially, but by no means exclusively, in Canada and the U.S.—counterproductive, that is, given the original objective was to drain the harm caused by the consumption of combustible tobacco products. Such regulation was focused largely on flavors and nicotine and justified often on the need to protect young people, even though there was little credible justification for such actions.

    Things are different in China, where, it was said, optimists in the electronic cigarette business broadly welcomed a move by the Ministry of Industry and Information Technology to bring these products into line with regulations governing combustible cigarettes. It was hoped that such regulation, designed in part to protect consumers, would bring clarity to the operation of an industry that had so far been largely unregulated while growing rapidly and imposing its own standards in such areas as youth protection and recycling.

    We live in interesting times, and the most interesting regulatory issue on the horizon has to be that concerning synthetic nicotine.