Vapor Voice

Category: This Issue

  • Executive Experience

    Executive Experience

    Eve Wang, vice president of the world’s largest atomization company, shares her vision for vaping.

    By Timothy S. Donahue

    The largest atomization company in the world is Shenzhen Smoore Technology Co. Based in Shenzhen, China, the company has maintained its position as the global leader in the atomization technology market since the beginning years of the vaping industry.

    Smoore has seen significant growth since its establishment in 2009 and operates three atomization businesses: nicotine delivery (including vaping and heat-not-burn), medicinal applications and healthcare.

    Within the nicotine-delivery business, Smoore’s technology brand, FEELM, holds a prominent position as one of the industry’s leading closed-system vaping solution providers. This diverse business structure allows Smoore to deliver innovative solutions across multiple industries to meet several varied consumer needs.

    Earlier this year, the international ESG rating agency Sustainalytics awarded Smoore International Holdings, parent of the FEELM and Vaporesso brands, the top position among global electronic atomization companies. Smoore consistently ranks first among global electronic atomization companies in the ESG ratings published by MSCI, the world’s largest index company.

    Vapor Voice invited Eve Wang, vice president of Smoore, to share her vision for the vaping industry and her insights into how Smoore will move forward as atomization technology continues to improve and develop into various marketplaces beyond the vaping industry.

    Vapor Voice:As an atomization technology solution provider, how important are Smoore’s investments in R&D?

    Eve Wang: Centered on Smoore’s mission of atomization makes life better, we have a long-term approach to everything we do and believe that continuous technological innovation is the only approach to develop the atomization industry. Last year, Smoore invested £160 million ($199.5 million) in R&D, which accounted for 11.3 percent of the total revenue in 2022. This investment has resulted in 2,254 new patent applications worldwide, including 1,125 invention patents.

    Our commitment to continuous technological advancement is best shown by the fact that we employ 1,500 R&D personnel, which accounts for more than 40 percent of our entire nonproduction workforce.

    As a young and developing industry, constant R&D in both technology and manufacturing is vital to drive growth and ensure the highest quality standards. Our professional testing facilities feature more than 700 different types of testing equipment, valued at over £23 million, and we have many partnerships with leading research institutes and analysis laboratories to complement our already comprehensive testing capabilities. We have developed the world’s first fully automation pods production line, and our ceramic coil disposable automation line is not only the world’s fastest but also allows our products manufactured by FEELM to achieve a first pass yield of over 99.5 percent.

    Looking toward the future, Smoore is exploring how to apply vape atomization technology within the healthcare sector, and our dedication to cutting-edge research and development, regulatory compliance and superior consumer experience supports our commitment to the longevity and sustainable growth of our business.

    Is Smoore seeking to invest beyond the vaping industry?

    We keep exploring the boundaries of innovation and the application of atomization technology in new application scenarios, such as medicinal and healthcare sectors. For example, last year in China we registered a ventilator in combination with an atomization drug delivery device and successfully obtained the production license for this technology.

    We have also set up a team in the United States which has developed two drug delivery devices targeting asthma and chronic obstructive pulmonary disease and started the development of relevant medicinal preparations.

    How do you see the vapor industry developing, and what will be the biggest growth areas in terms of technology and geography?

    According to a report by Frost and Sullivan, the global retail market for e-vaporization is expected to reach $122.2 billion by 2027. It is expected that in the long run, companies that prioritize regulatory compliance and harm reduction while also focusing on consumer experience will emerge as the ultimate winners.

    However, as an emerging industry aimed at assisting smokers toward a smoke-free society, e-cigarettes are still in their infancy and face a range of challenges which makes it crucial for all stakeholders in the industry to collectively provide the best possible harm reduction solutions for current adult smokers.

    Therefore, we have developed and launched a new 2 mL e-liquid compliant disposable solution to provide 800 puffs with the innovative technology FEELM Max, where conventional products typically provide around 600 puffs.

    How is the FEELM Max technology different from that used in conventional products?

    As the world’s first ceramic coil disposable solution, FEELM Max benefits from a cotton-free design that, with a compliant e-liquid volume of 2 mL, can provide 800 puffs whilst current solutions offer 600 puffs. This is a significant step toward setting a new industry compliant benchmark for 2 mL.

    In addition to more puffs, this innovative heating technology is designed to bring cleanness and silkiness, ensuring a satisfying experience for consumers. Our constant power technology provides a vapor and taste consistency, and together with a transparent e-liquid tank design offers an enhanced consumer experience.

    The ceramic coil is like an electric car, symbolizing a more advanced technology. Several major brands have already adopted our new technology, recognizing that differentiation is key in a competitive market. We are committed to providing superior vaping experiences that meet the evolving needs of consumers around the world.

    What is the largest market for Smoore and its subsidiary’s products?

    In 2022, Smoore’s global enterprise customer business revenue was £1.22 billion, with the U.S. market ranking first, accounting for 35.4 percent. The revenue share of Europe and other markets increased from 24.1 percent in 2021 to 43.6 percent in 2022, up by 19.5 percentage points. Smoore will continue to provide technology solutions and products worldwide, all tailored to fully comply with all local regulations.

    What are Smoore’s concerns about the growth of noncompliant products in the marketplace?

    We believe that effective regulation is vital for sustainable growth and that proportionate regulation can support the industry’s evolution.

    However, the presence of noncompliant or counterfeit products entering the U.K. market is a significant concern for us. These products not only pose potential health risks to consumers but also bring negative effects on the long-term development of the vaping industry. These illicit products can discourage innovation and deter potential investments in research and development, hindering the industry’s ability to evolve and improve.

    Like any industry, there are always those who operate illicitly. However, it is vital that the responsible majority within our sector, together with government, regulators, enforcement bodies, trade associations and partners, collaborate on initiatives and share intelligence to eradicate illegal and noncompliant vapes. This collective effort is necessary to ensure that the sector’s reputation is not only maintained but also improved.

    We believe in maintaining the very highest product standards whilst also being fully compliant in all local markets in which we operate. That’s why we have developed and launched the 800-puff compliant disposable vape: FEELM Max. FEELM Max represents a commitment to both technological innovation and regulatory compliance, moving the vaping industry forward in a responsible and sustainable way.

    Eve Wang, VP of Smoore

    Many vapor products that have been authorized for marketing in the U.S. were developed by Smoore. What is the secret behind Smoore’s high share of Food and Drug Administration marketing orders?

    Smoore is always committed to full regulatory compliance and product quality. In 2022, out of over 6.7 million e-cigarette product listing applications, the FDA only approved eight from JTI, nine from R.J. Reynolds Tobacco and six from Njoy. Smoore, as the atomization technology manufacturer, has aided the most clients in the ENDS [electronic nicotine-delivery system] category to pass the PMTA [premarket tobacco product application] process.

    Last September, Smoore had the distinction of being invited to an industry meeting convened by the commissioner and director of the Center for Tobacco Products. We actively engaged in explorations and discussions regarding the future of a more compliant and sustainable vaping industry.

    Smoore’s achievements stem from the long-term focus on the improvement of atomization technology and the commitment to innovation, compliance and product safety; we always deliver user-centric and user-friendly technologies and products to clients, consumers and industry.

    As the FDA commented when approving one of the closed-system pod vaping products: “It met the standard because, in several key considerations, chemical testing is sufficient to determine that the levels of harmful and potentially harmful constituents in the aerosol of these products are lower than those in the smoke from combusted cigarettes.”

    What is Smoore/FEELM’s strategy for the disposable market?

    The disposable vape has been a widely accepted product in the e-cigarette market. Even as far back as 2018, when closed-system vapes dominated the industry with a 72 percent market share, it was predicted that disposables would account for more than 70 percent of the closed-system market over the next five years.

    However, such rapid growth inevitably leads to challenges, and the market has seen a proliferation of noncompliant products and counterfeits, coupled with problems such as the illegal overfilling of e-liquids and the quality issues from the black market, as reported by the BBC. These issues have sounded alarm bells across society, calling for superior, compliant and healthier solutions.

    How will Smoore confront the challenges associated with disposable products, such as environmental concerns?

    As the first Chinese e-cigarette company to be included in the Dow Jones Sustainability Index, Smoore aims to minimize any environmental impact from our operations and products as much as possible.

    In May 2022, we officially launched our carbon neutrality plan, setting a net-zero target by 2050. We will continue to increase the use of renewable energy in our operations, aiming for 50 percent energy consumption from renewable sources by 2030.

    Whenever I come across a discarded disposable vape on the ground, I will pick it up and bring it back to the company, where my colleagues can professionally process and recycle it. But more needs to be done to encourage active participation by consumers in recycling their vapes. Therefore, we have launched the industry’s first end-to-end whole-chain recycling scheme, including manufacturers, brands, retailers, the Royal Mail and waste management specialists, Waste Experts.

    Working closely with our clients, we have created a household collection service whereby consumers who return 10 or more old disposable vapes for recycling will receive a free disposable product incorporating our latest technology as a reward.

    What do you consider to be Smoore’s greatest industry innovations?

    The cotton coil is widely adopted within the vaping industry, and there are many challenges that affect the consumer experience.

    Smoore drew inspiration from traditional Chinese ceramic making to develop the ceramic technology. We discovered that, compared to the cotton coil, the ceramic coil has advantages such as high thermal efficiency, leakage prevention and the ability for planned automated production as well as delivering strong taste consistency.

    Therefore, in 2014, Smoore initiated research into ceramic heating technology, and in 2016, Smoore’s ceramic coil technology brand FEELM was officially launched in the market, aiming to “feel the moment of vaping” and representing our long-term commitment to vaping sensory and technology. Today, FEELM has already become a very well-recognized tech brand by the industry, especially for ceramic coil technology. Since 2018, we have shipped over 3.5 billion pod products worldwide, and we cover more than 50 different countries and regions.

    We remain devoted to our mission of improving public health through the advancement of atomization technology.

    What are the greatest challenges facing the global e-cigarette industry, and how is Smoore helping solve those challenges?

    Smoore recently commissioned a survey, which was conducted by One Poll, among 2,000 adult smokers. The results revealed that 42 percent of respondents had little or no trust in e-cigarettes. Meanwhile, nearly two-thirds (62 percent) believed that e-cigarettes were more harmful or at least as harmful as traditional cigarettes whereas evidence from the Office for Health Improvement and Disparities highlights that e-cigarettes are at least 95 percent less harmful than smoking.

    That’s why we have established an independent panel of experts in science, smoking cessation and compliance to look at creating a new rating system that will allow adult smokers and vapers to make informed decisions about their choice of vapes based on their harm reduction profile.

    We are committed to innovating alternatives to traditional smoking, to reducing harm and to benefit public health. We strongly believe in the potential of e-cigarettes to provide a viable and less harmful alternative for smokers who struggle to quit.

    Smoore hopes to fulfill our mission: Atomization makes life better—better for our clients and consumers. We aim to achieve this by providing better technological solutions and products in the future in novel tobacco, medicinal and healthcare fields.

  • Understanding Synthetic

    Understanding Synthetic

    Credit: Nitiphol

    A nicotine industry veteran answers some common questions concerning the rise of synthetic nicotine.

    By Chris Howard

    Since President Biden signed the fiscal year 2022 Consolidated Appropriations Act into law on March 15, 2022, questions surrounding the U.S. Food and Drug Administration’s Center for Tobacco Products’ (CTP) handling of enforcement with respect to products containing nontobacco-derived (NTN), or synthetic nicotine, have been pervasive. While the CTP has indicated that it is not engaging in enforcement discretion to address the exceptionally short compliance timeline Congress provided in the bill, the center’s actions and public statements provide insight into its enforcement priorities and how the industry can assess the position the center takes. In this article, I will answer some frequently asked questions formulated from an extensive review of public statements and enforcement actions.

    What does the Consolidated Appropriations Act have to do with tobacco products containing synthetic nicotine?

    The act provided the CTP jurisdiction over NTN products beginning April 14, 2022. It also established a period for compliance with the Federal Food, Drug and Cosmetic Act’s premarket review requirements for NTN on or introduced to the market by April 14, 2022.

    The legislation provided that for a manufacturer to continue marketing NTN products after May 14, 2022, they must submit a premarket tobacco product application (PMTA) for such products by that date. In the event a manufacturer complied with this requirement, they were permitted to continue to market such a product through July 13, 2022 (provided the FDA didn’t previously deny the PMTA, refuse to file the PMTA or withdraw a marketing order for a previous version of the product at issue that utilized tobacco-derived nicotine). Just like tobacco-derived products that remain the subject of pending PMTAs beyond Sept. 9, 2021, NTN products that are the subject of pending PMTAs after July 13, 2022, technically must have received market orders to be legally marketed today.

    Are tobacco products containing synthetic nicotine illegal?

    Just like tobacco products containing tobacco-derived nicotine that are subject to pending PMTAs, all current tobacco products containing synthetic nicotine on the market in the United States are illegal. It is important to note, however, that this doesn’t mean that CTP intends to expend its limited enforcement resources to remove all such products from the market. Rather, the center has expressed its intent to move forward in accordance with a discrete set of priorities outlined more particularly below.

    Does the FDA intend to treat enforcement of tobacco products containing synthetic nicotine differently than enforcement of tobacco products containing tobacco-derived nicotine?

    No. CTP leadership has made it clear that it will apply its enforcement priorities identically with respect to both categories of products.

    The CTP has been explicit that both tobacco products containing nicotine derived from tobacco (marketed after Sept. 9, 2021) and tobacco products containing nontobacco-derived nicotine (marketed after July 13, 2022) without premarket authorization (marketing orders) are considered by the FDA to be noncompliant and that manufacturers of both categories of products are subject to the same public health standards. The CTP’s position is set forth clearly in the below public statements:

    Tobacco Products Containing Nicotine Derived from Tobacco

    On Sept. 9, 2021, the FDA issued a statement entitled “FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90 Percent of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted,” which you can review at the following link: https://www.fda.gov/news-events/press-announcements/fda-makes-significant-progress-science-based-public-health-application-review-taking-action-over-90. In this release, former Acting Commissioner Janet Woodcock and former CTP Director Mitch Zeller indicated: “All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion” (emphasis added).

    Tobacco Products Containing Nontobacco-Derived Nicotine

    On Oct. 14, 2022, the FDA issued a statement entitled “FDA Completes Initial Review of 95 Percent of Nontobacco Nicotine Product Applications; Agency Has Issued Over 60 Warning Letters to Manufacturers, Including for Products with a Submitted Application and Negative Action,” which you will find at https://www.fda.gov/tobacco-products/ctp-newsroom/fda-completes-initial-review-95-non-tobacco-nicotine-product-applications-agency-has-issued-over-60. Upon review, you will note that the FDA is speaking about tobacco products containing nontobacco-derived nicotine. As we discussed, the FDA used nearly the exact same language employed by Woodcock and Zeller in September 2021 to describe the agency’s views with respect to tobacco products containing nicotine derived from tobacco. In particular, the FDA states, “To date, the FDA has not authorized any NTN products. Therefore, all NTN products on the market are marketed unlawfully and risk FDA enforcement action” (emphasis added).

    In a Feb. 3, 2023, email to the executive director of the National Association for Tobacco Outlets from a director in the CTP’s Office of Compliance and Enforcement, FDA leadership provides even more clarity:

    “FDA is fully committed to implementing the new federal law clarifying its authority to regulate tobacco products containing NTN, including synthetic nicotine. Manufacturers of these products are now held to the same public health standards, including premarket review, as tobacco-derived nicotine (TDN) products. Irrespective of whether the product contains TDN or NTN, it is illegal to sell or distribute tobacco products that the FDA has not authorized. On Aug. 8, 2016, all deemed tobacco products, including e-cigarettes, became subject to FDA’s tobacco authorities.

    “As a matter of enforcement discretion at the time, the agency stated that it intended to defer enforcement for a period of time of the premarket authorization requirement for certain deemed new products on the market as of Aug. 8, 2016. However, in light of later data on youth use and other information, FDA revised this policy in its 2020 enforcement priorities guidance. That guidance described how the agency intended to prioritize its limited enforcement resources regarding certain ENDS [electronic nicotine-delivery system] products. It also noted that all deemed new tobacco products on the market without authorization are illegally marketed and that the agency ‘retains discretion to pursue enforcement action at any time’ against such products.   

    “The same principle applies to NTN products; specifically, all illegally marketed NTN products are subject to enforcement ….”

    Director Brian King has made similar statements in several open forums indicating that tobacco products without market authorization (regardless of whether they contain nicotine derived from tobacco or nontobacco-derived nicotine) are noncompliant. Based upon these ubiquitous public statements, it appears the FDA will continue to prioritize enforcement against manufacturers with products (a) not covered by timely filed pending PMTAs or (b) that are the subject of marketing denial orders—with an emphasis on products that are particularly attractive to youth.

    What is the significance of the Aug. 8, 2016, effective date of the deeming regulation with respect to tobacco products containing synthetic nicotine?

    The FDA did not have authority to regulate tobacco products containing synthetic nicotine upon the effective date of the deeming rule. Rather, the FDA obtained authority to regulate such products following the effective date of the Consolidated Appropriations Act. The relevant timelines established by the act did not include a period for continued marketing of unauthorized new products containing synthetic nicotine beyond July 13, 2022. As such, all tobacco products containing synthetic nicotine on the market without premarket authorization are illegal and subject to FDA enforcement.

    What are CTP’s priorities when enforcement against tobacco products containing synthetic nicotine without market orders?

    Regardless of whether a product without market authorization contains synthetic or tobacco-derived nicotine, the FDA has indicated its intention to prioritize its enforcement efforts with respect to certain deemed tobacco products (1) not covered by timely filed PMTAs, (2) that have been the subject of marketing denial orders or those covered by PMTAs subject to negative determinations, including those rejected on procedural grounds (i.e., refuse-to-accept letters or refuse-to-file letters), and (3) that raise youth use concerns.

    As we are all aware, even though the continued compliance policy for certain deemed new tobacco products ended on Sept. 9, 2021, and those products were subject to immediate enforcement action, the CTP has not, as of the date of the publication of this article, brought enforcement action against any of those products covered by still pending PMTAs. Based on the center’s handling of these products combined with the CTP’s recent public statements, it seems likely that the CTP will exercise a similar approach to NTN products covered by PMTAs that remain pending after July 13, 2022. Moreover, the CTP is likely to refrain from taking enforcement action against such products while it reviews the pending applications.

    Chris Howard is the executive vice president of external affairs and new product compliance for Swisher International.

  • My Journey in Nicotine

    My Journey in Nicotine

    Kim Hesse shares her insight into the ignition of the ENDS industry and the attempts of regulators to manage it. 

    By Kim Hesse

    After years of working in the U.S. medical industry, life threw me for a loop and took me to Germany in late 2007. After going through a six-month language course, I learned enough Deutsch to get by in my new country and felt ready to enter the workforce. Fortunately for me, I had a friend in the employment office who secured me an interview with a company that needed someone who could speak fluent English. Ironically, this required me to stammer through a three-hour interview in German. I only understood about 10 percent of that conversation, but still got the job.

    In January 2008, I began my journey in the tobacco industry working at Eurofins Dr. Specht Laboratorien in Hamburg-Harburg, Germany. There I was trained, at a very high level, in the analysis of pesticides in tobacco. I learned about the various instruments in the laboratory and why some are used over others.

    For instance, a gas chromatography-mass spectrometry instrument can detect and analyze compounds that a liquid chromatography instrument might miss. Before working at Eurofins, I knew zilch about instrumentation, chemistry or tobacco. Today, I can rattle off many reasons why you might choose to use a GC over an LC, including the polarity and volatility of the item being analyzed.

    I spent four years becoming proficient in German and learning about the tobacco industry while performing customer service duties, which acquainted me with a variety of industry people. Since my brain ticks in a business manner, I began assessing the client base and pondering ways to reach out to gain more.

    One day, I took a phone call from a company called Contraf-Nicotex Tobacco. They were interested in having their products tested for nicotine concentrations and heavy metals. This was the first time the lab had received such an inquiry. A few weeks later, I received a similar call from a company called Red Kiwi. These two companies were my introduction to what is now called the electronic nicotine-delivery system (ENDS) industry.

    While Eurofins Dr. Specht chose to stay focused on their core business of testing for pesticides, my interest in this blossoming segment of the tobacco industry grew. I began researching these companies and grew excited about the potential of these emerging technologies.

    My desire to expand the business for Eurofins did not wane, and I eventually convinced my boss to exhibit at TabExpo Prague in 2011. For me, this was the first of many trade shows in the tobacco industry. While TabExpo was a good experience for me, it may not have been such a great one for my boss. While at that show, a man came to our booth and asked why I was living in Germany and if I would ever consider moving back to the U.S.

    Credit: Pudiq

    Going home

    Little did he know I had a family issue that had me wanting to return. Through him, I met Richard Higby, former president and managing director of Arista Laboratories and Microbac Laboratories, who recruited me to help build business for the newly formed smoke lab at Microbac Laboratories.

    Once back in the States, I was told about the new regulations affecting the tobacco industry there. I was surprised by the sweeping changes facing the industry as I never thought regulations like this would come into effect nor did I think they would be so stringent. I was amazed at the speed with which third-party laboratories had to develop and validate new testing methods for up to 93 compounds.

    Additionally, I was astonished by the absence of clear instructions that could effectively guide the process of keeping a product on the market. I began a deep dive into the abyss of the internet to learn what regulators expected and why. This task was overwhelming, and the Food and Drug Administration websites were hard to navigate. At times, it was like trying to find a needle in a haystack.

    My colleagues and clients were all scrambling to become educated. Clients needed assistance from many angles, and I assisted on the laboratory front and connected clients with potential partners. Clients found themselves in need of comprehensive guidance, not only for determining the appropriate testing procedures but also for seeking expert advice on navigating the intricate web of regulatory compliance and understanding the legal considerations associated with their testing practices. This multifaceted support was and still is crucial in enabling clients to meet regulatory standards and mitigate potential legal risks effectively.

    Finally, in January 2011, the FDA Center for Tobacco Products issued guidance on demonstrating substantial equivalence for tobacco products. This sent tobacco companies scrambling to find laboratories to complete the needed work for their submissions on deadline.

    During this time, I was at Microbac Laboratories, where smoke analysis was a brand new addition to its scope of work. This was an exciting time to be in the tobacco industry because of the new regulations and the opportunity to learn and help clients navigate their new environment. Combustible cigarettes were still the focus from 2011 to 2014, but slowly the ENDS industry began making noise.

    Credit: Sezerozger

    Global outlook

    In 2014, I was recruited again and went to work at Global Laboratory Services (GLS). There I was tasked with growing the smoke side of the business. I got my copy of Tobacco Reporter (sister publication to Vapor Voice) and scoured it for advertisers. I saw a large number of e-liquid companies advertising and began reaching out to them.

    Then I started looking at the trade shows and saw how many were turning more toward ENDS products. While at GLS, I helped the lab grow from a predominantly pesticide analysis laboratory into a lab offering a significant diversification of analysis, including e-liquid and ENDS testing.

    During the beginning years of testing ENDS products, most laboratories worked on method development and validation on their own. For anyone who doesn’t understand that process, it’s kind of like baking a cake without having a recipe. You try to put in a little bit of flour, baking soda or powder, eggs and other ingredients. However, you are not sure exactly which ingredients to use or the correct amounts. So you try and try again until you get it right. This is method development. But then you have to prove you can do this same thing and produce the cake exactly as it was the first time you got it—that is method validation.

    Most testing performed in those early years focused on propylene glycol, vegetable glycerin and nicotine concentrations. As we saw increasing interest in the testing of e-liquid and ENDS, third-party labs began developing more methods to meet the expanding scope of testing demands. Eventually, the demand for sound science and broader scopes of testing began being heard, and Coresta (the Cooperation Centre for Scientific Research Relative to Tobacco) became involved.

    The Coresta E-Cigarette Task Force (now called E-Vapour Sub-Group) began in 2013. This group has worked together for years now and has provided published methods, guides and reports, all with the intent of improving the science surrounding the testing of ENDS products.

    While the scientists were busy ensuring methodology was sound, the ENDS industry was busy expanding and innovating. One of the first organizations focusing on vapor products, the Consumer Advocates for Smoke-Free Alternatives Association began in 2009. I remember meeting Julie Woessner at a meeting of the Smoke-Free Alternatives Trade Association (SFATA) in Chicago.

    It was the first time I really learned about the organization and was impressed by Woessner’s passion. In addition to consumer advocacy groups, we saw the introduction of trade organizations like the American E-Liquid Manufacturing Standards Association (AEMSA), which began in 2012. Lou Ritter, on behalf of the AEMSA and Cynthia Cabrera from the SFATA were showing up and talking at many events to help educate regulators and the industry. I spent time with both Ritter and Cabrera at many events and eventually sat on the board of directors of the SFATA in 2015.

    Credit: Adobe

    Trading places

    Alongside the trade and consumer organizations growth, we all had front row seats to an amazing number of trade shows. The first ones began popping up around 2011. I had the pleasure of being at possibly one of the largest ENDS-specific trade shows I have ever attended. It was ECC 2015 at the Fairplex in Pomona, California. The line to get in was at least a mile long, and we all stood outside in the heat.

    Luckily for me, Norm Bour spotted me and helped get me in a little faster. Nearly every inch of the 543 acres was covered with exhibitors. New players with fun names—SpaceJam, VaporShark, Cosmic Fog—came to play with massive displays, loud music and some flashy cars. Little did people know that a small booth on the outside of buildings in a relatively nondescript white tent contained one company that would alter the industry.

    After hours of walking and talking, I saw a smaller tent outside with a comfortable-looking white sofa. My feet needed a rest, and the booth was not busy, so I stopped. There I met Gal Cohen and Adam Bowen for the first time. I tried their product, Juul, and was immediately impressed. To me, this product mimicked the experience of a combustible cigarette extremely well. I told them I felt their product would be a game changer because I believed it could help smokers quit.

    ECC was just one of many vape trade shows during that period—so many that one could literally go to a vapor trade show nearly every week. The industry was booming, full of young entrepreneurs daring to create innovative products. We saw the inception of cloud chasers: people experimenting with their devices to create the largest clouds of vapor.

    There’d be one group eagerly trading tips on enhancing mods, another learning how to blow vape rings and a third creating such a thick cloud that you couldn’t see through them. The indoor areas at ECC were enveloped in a thick haze of vapor, carrying intense fragrances of artificial fruit, vanilla and sweets. After spending several hours in this environment, I developed a headache and had to retreat to the outdoor booths, where the heat was equally unbearable.

    Unfortunately, as the industry was rocking and rolling, it started gaining more attention from the media and additional focus from regulators. By 2009, the FDA already had its eye on the vapor industry. In May 2016, the FDA deeming regulations were issued. This was the beginning of changes to come.

    During this time, I visited multiple vapor companies, many of which only produced e-liquids. When talking to those companies, I often asked what their plans were if the FDA began regulating and requiring routine testing. Many of these energetic entrepreneurs said they planned to make their money and exit the industry. Others planned to follow the regulations but faced an increasingly uphill and difficult course due to the slew of regulatory challenges.

    Those ranged from navigating through login to the FDA portal, discovering some information was missing or was constantly moving, changes in the process occurring frequently and sometimes even after deadlines and filings were complete. One of the most frustrating early events happened during what was supposed to be a seemingly small, relatively simple task that turned out to shut down the FDA’s portal for multiple days … registering and submitting ingredient listings.

    After that major bump in the road, companies faced challenge after challenge. Today, those companies that still exist must decide whether to enter the long, painful premarket tobacco product application (PMTA) pathway or to simply sell their products abroad where regulations are more clear, concise and defined. For those who choose to stay in the precarious U.S. game, a strategy to speed and strengthen their existing PMTA and the wise allocation of resources are imperative. Those who complete the obstacle course to market authorization will see big payoffs in dollars and saved lives.

    Looking back, I am amazed at how far the manufacturers have come with their quality control systems, which for some were initially nonexistent. The marketers have also grown, and focus has been more conscientious not to appeal to youth. The laboratories participating in the CORESTA studies have grown and made great strides in methodology.

    It was fascinating to watch the growth of ENDS technologies from initial rumblings to exploding into the massive industry this has become. For some, this industry has enabled them to live the American dream of doing hard work to get ahead.

    We saw small shop owners become millionaires, innovators create products that could help people transition off combustible cigarettes, laboratories and organizations grow and thrive, and the American economy prosper. And the ride is not over yet …. I am excited to see what the next 15 years will bring.

  • Challenging Times

    Challenging Times

    As tobacco harm reduction continues growing in influence, it is also facing many obstacles.

    By Stefanie Rossel

    Regulatory policies, industry standards and medicinal licensing were among the themes tackled during the May 23–24 ENDS Europe Conference in Amsterdam.

    Many countries, including New Zealand and England, aim to be “smoke-free” by 2040, a term generally defined as less than 5 percent of the population lighting up. However, according to speakers at the event, most of these countries are unlikely to achieve their goals due to prohibitionist policies, such as incremental increases in purchase age, reductions in tobacco sales outlets or ultra-low-nicotine requirements.

    The country most likely to achieve smoke-free status is Sweden, according to the conference participants. By helping smokers switch to less harmful alternatives, such as snus, it is living proof that tobacco harm reduction (THR) is a more effective strategy than prohibition to reduce tobacco-related illnesses.

    Noting that millions of smokers don’t want to quit, Christopher Snowdon, head of lifestyle economics at the Institute of Economic Affairs in the U.K., presented an alternative, pragmatic and realistic smoke-free plan that includes a wide range of reduced-risk products (RRPs), such as snus, nicotine pouches, e-cigarettes and heated-tobacco products (HTPs), and focuses on educating consumers and fostering innovation. To put an end to misinformation about RRPs, Snowdon proposed the introduction of public information campaigns and cigarette pack inserts informing consumers in a band-neutral manner about the benefits of switching to less risky products.

    He also asked for better regulation, including advertising, tank and bottle sizes and nicotine limits. For HTPs and nicotine pouches, Snowdon proposed proportional tax and regulation and independent research. He warned policymakers against overregulation, naming e-cigarette taxes, flavor bans or indoor vaping bans as examples. Anything that makes vaping, HTPs, snus or nicotine pouches less appealing will make smoking relatively more appealing, he cautioned.

    More Challenges Ahead

    Regulations, however, continue to mount. Ciprian Boboi, founder and board member of the Independent European Vape Alliance, provided an overview of upcoming EU laws that will affect the nicotine sector. The Battery Regulation, which will be adopted in June or July this year, stipulates that the batteries in portable devices must be removable and replaceable by the user. For disposable vapes, the new rules mean a de facto ban from January 2027. The Tobacco Products Directive (TPD), which is in revision until 2025/2026 and projected to be implemented by 2027/2028, may encourage the spread of flavor bans (which are already in force in five member states), plain packaging and advertising bans.

    The Tobacco Excise Duty Directive (TED), to be implemented by 2025, is expected to include vaping. The Packaging and Packaging Waste Regulation requires all packaging to be recyclable by 2030. Plastic must contain a minimum percentage of recycled material. Provisions are likely to apply to packaging used by the vaping industry, including e-liquid bottles.

    The upcoming TED, which aims to harmonize taxation of combustible cigarettes among member states based on the purchasing power parity index, was also the subject of a panel discussion. According to leaked information, the revised TED will tax e-liquids with a nicotine content of below 15 mg/mL (including zero nicotine liquids) at 20 percent, or €0.10 ($0.11)/mL, and those above 15 mg/mL at 40 percent, or €0.30/mL. HTPs will be taxed at 55 percent, or €91 per 1,000 sticks, nicotine pouches at 50 percent, or €120/kg, and other nicotine products at 50 percent, the latter two gradually over four years.

    Panelists questioned the objective of the directive, arguing that if it was about health or nicotine, it was illogical to also tax non-nicotine liquids. By failing to follow the risk continuum, tax differentials would merely protect the cigarette trade and worsen the public’s already poor understanding of THR, according to panelists.

    The global novel nicotine market is currently worth an estimated $56 billion, according to Marija Obradovic, head legal analyst at ECigIntelligence. Vape products are the predominant category in North America whereas HTPs are leading in Europe, the Middle East and Africa region and the Asia-Pacific region.

    Nicotine pouches are steadily growing but face a fragmented regulatory framework in the EU. In several countries, among them Estonia, the Czech Republic and Sweden, they are regulated, with some states imposing packaging restrictions and requiring health warnings. In Bulgaria and Austria, there is a tax on modern oral nicotine products. For HTPs, a flavor ban will enter into force this October. Obradovic said the regulation will likely lead to more illicit markets, especially in eastern European countries bordering non-EU countries where flavors are not banned. Meanwhile, the number of herbal consumables for HTPs with or without nicotine, a totally unregulated market, has been growing.

    Regulatory Approaches

    When it comes to regulatory policies for RRPs, there are three approaches, as independent consultant Patricia Kovacevic explained. Regulatory science-based policies rely primarily on premarket notification with some elements of product science or standards. The EU TPD notification scheme is an example of this approach. Advantages of this stance include faster and more accessible market entry and a more diverse range of manufacturers, importers and products. Due to distinctions among national legislation, however, consistent success of electronic nicotine-delivery systems (ENDS) as a consumer product is impeded, and the approach does not include an element of scientific communication of the risk continuum. As flavor bans show, it is not always science-based.

    By contrast, regulatory policies based on product science authorize market entry upon scientific review, including a comparative risk profile of products. The unit-by-unit review prevails in the U.S. under the Tobacco Control Act. While the approach is protective of the individual and, to some extent, public health, and robust science will eventually lead to a favorable outcome, it is a time-consuming, prohibitively complex, expensive and anticompetitive process that results in a limited number of products concentrated with a few large players, likely resulting in deceleration in harm reduction, according to Kovacevic.

    The third approach—no effective premarket requirements—is followed by a dwindling number of countries. It allows easy market access but is not protective of public health. There are no standards and no oversight of product ingredients or functionalities. A regulatory approach that best serves THR, Kovacevic summarized, would include proportional and science-based product design, ingredients and manufacturing standards, reasonable liberties to communicate with adult consumers and would consider distribution, retail and age verification.

    Regarding the future of global ENDS regulation, this November will see the 10th conference of the parties (COP10) to the World Health Organization Framework Convention on Tobacco Control (FCTC), to be staged in Panama. Jeannie Cameron, CEO of JCIC International, told the audience about the mechanisms behind the gathering’s decision-making, which takes place by consensus, not vote, and what to expect from the meeting. As the COP10 Bureau, the body that will be writing the agenda, consists of representatives of six countries, most of which have banned vaping, a pro-THR approach is unlikely.

    Key issues on the FCTC agenda will likely include bringing novel nicotine products into the FCTC remit, a redefinition of smoke that includes aerosols, restriction of nicotine delivery and bans on nicotine salts in vaping products. COP10 will also discuss nicotine addiction, environmental issues and illicit trade.

    As only governments have a say at the meeting, they will have to determine their views beforehand. Cameron recommended that to prepare for Panama, business and consumer advocates should contact small business and health committee members of Parliament, respectively, while political advocates should coordinate with like-minded countries.

    Making Adjustments

    In a presentation, Marina Murphy, director of scientific and medical affairs at ANDS, demonstrated that nicotine is not the evil substance anti-THR advocates make it out to be.

    There is evidence that nicotine, an alkaloid like caffeine, could have a neuroprotective effect, she noted. Murphy pointed out that in nicotine product regulation, lawmakers apply widely varying standards, with cigarettes being regulated based on what comes out and e-cigarettes being regulated on what comes in, for example. With the WHO promoting nicotine flux—the rate at which nicotine flows from the mouth end of an e-cigarette per puff second—as a new regulatory target, she said it is time for the industry to reframe nicotine.

    Righting misperceptions derived from flawed science can be helpful in this regard. Rosalia Emma, assistant professor at the Department of Clinical and Experimental Medicine at the University of Catania, reported on the Replica project at the Center of Excellence for Acceleration of Harm Reduction (COeHAR), in which researchers between 2019 and 2022 replicated the most relevant international studies and unequivocally demonstrated the reduced toxicity of e-cigarettes and HTPs. With Replica 2.0, a new phase of research has started this year, which repeats a study by Fetterman that suggested that flavorings in tobacco products induce endothelial cell dysfunction.

    In contrast to the Fetterman study, COeHAR’s preliminary results show no significant differences in cell viability between PG/VG and PG/VG with vanillin. Reviewing recent literature about emission characterization, Sebastien Soulet, an engineer at Ingesciences, concluded that the contested studies used devices with high power and low airflow. He said that the condition of use should be investigated by researchers as there was a lack of information in many commissions and committees, including those that put together the FCTC’s nineth report, or the SCHEER report.

    Compared to other age-restricted consumer products, such as combustible cigarettes or alcohol, vape products face a stronger regulatory, often prohibitionist stance, mainly because of the flavors involved—although these are also common in alcoholic beverages, according to speakers at the Amsterdam event. To make their products less prone to attack, panelists argued, the industry should behave more responsibly in the design and description of their products to prevent them from attracting youths. It should also develop a nomenclature to rule out violations, they suggested.

    Rather than raising taxes on vape products, regulators should step up enforcement against retailers selling to youth, according to speakers. No longer subject to EU requirements, the U.K. should also consider allowing larger tank sizes, they suggested. This would make vapor products less appealing to youth due to higher prices.

    The Flavor Issue

    The conference also tackled the issue of flavors. In her Tobacco Products Prevalence Study, Andrea Patton, behavioral epidemiologist and head of prevalence research at the Centre for Substance Use Research, modelled the impact of an ENDS flavor ban on U.S. youth and adult users, developing two scenarios. Under the first, the U.S. Food and Drug Administration would ban all flavors except tobacco; under the second, the agency would ban all flavors except tobacco and menthol.

    According to the study, the first scenario would result in a 31 percent reduction of vaping among current adult cigarette users while the second scenario would yield a 21 percent reduction. In both scenarios, participants stated that they would start using tobacco. Flavor, Patton concluded, was the main driver for quitting cigarettes. By contrast, only 5 percent of youths said that they vaped only because of flavors; the main reasons cited for vaping were anxiety, stress or depression. A flavor ban would thus not affect youth use as intended, according to Patton, who also stressed the importance for studies on youth use to look beyond the brand level.

    Citing research by Konstantinos Farsalinos, Michael Landl, director of the World Vapers’ Alliance, explained the importance of flavors. Most vapers, Farsalinos’ work showed, use flavors other than tobacco. Over time, they will get “flavor fatigue” and hence need a variety of flavors. Flavor bans, he argued, won’t work as they make vaping less attractive to smokers, imply a never-ending “war on drugs” mentality and drive consumers to the black market.

    In Estonia, where flavors have been banned since 2020, 58 percent of vapers still use flavors, he said—a real-life experience the Netherlands should have considered before enacting a similar ban. A flavor ban wouldn’t prevent youth uptake either, Landl argued, as most adolescents consumed nicotine for relief of psychological stress. To solve this problem, he asked politicians to improve the socioeconomic conditions and create better opportunities for disadvantaged adolescents.

    Richard Young, principal toxicologist at Bibra Toxicology Advice and Consulting, identified aspects that vape manufacturers need to consider when carrying out assessing their products under TPD rules. He recommended getting a toxicologist involved early in the process—doing more extensive toxicity assessments, comparing acceptable levels or thresholds of toxicological concern for each ingredient to appropriate consumer exposures and documenting hazard and risk assessment clearly.

    What THR Also Means

    Credit: Smithers

    Three speakers shared their personal experiences with THR. Tom Gleeson, trustee of the New Nicotine Alliance Ireland, related how he, a smoker of 35 years, successfully quit within two days 12 years ago by trying an early vape product. 

    Flora Okereke, head of global regulatory insights and foresights at BAT, said that to her, a better future is to use and enjoy nicotine with little or no health impact, which she described as an achievable goal. Okereke made clear that leaving cigarettes, the cash cow for the tobacco industry, to an uncertain future was a bold step for a cigarette manufacturer. She called on the industry to unite and send a unified message to policy regulators. The industry, Okereke said, needed to use COP10 as an opportunity to shape where the industry will be heading.

    Liam Humberstone, technical director at Totally Wicked, described his company’s strategy to deal with the waste created by disposable vapes. According to Nielsen, the U.K.’s single-use vape market was worth £1.12 billion ($1.38 billion) in May 2023, corresponding to 200 million pieces sold each year. In addition, there are an estimated 300 million illegal products.

    Totally Wicked promises consumers it will take back any device of any brand, even illegal vapes. Products are recycled through some of the country’s few authorized treatment facilities, as their batteries are hazardous waste that needs separating. He pointed out that reducing, reusing and recycling makes sense—a lithium-ion battery, for instance, can be recharged 150 times to 300 times—but is not yet widely practiced. Concrete steps and appropriate regulations are needed to improve the situation, he claimed.

    New Technologies

    One way to accelerate THR is to offer licensed e-cigarettes on prescription. According to Ian Fearon of WhatIF? Consulting, doctors could prescribe vapes instead of less effective nicotine-replacement therapies. The best places for the medical licensing pathway, according to Fearon, are the U.K. and the U.S. Pete Lomas, managing consultant of product realization at Broughton, explained in detail what it takes to develop an ENDS product for medicinal licensing.

    The ENDS Conference also highlighted innovative technologies. Stefanie Scheffler, scientist at the Fraunhofer Institute for Toxicology and Experimental Medicine, presented a novel device for standardized e-liquid testing. Capable of producing a defined and adjustable temperature, the prototype eliminates the influence of the vaping device on aerosol emissions and creates more safety for the user, independent from the e-cigarette used.

    Scientific Horizons Consulting launched a new puff-recording ENDS that allows researchers to assess real-world user behaviors in real time. According to the company’s principal scientist, Xiang Gao, a two-month observation study revealed that users had vastly varying, complex and nonlinear puff behavior patterns.

  • Best of Both Worlds

    Best of Both Worlds

    What makes the FAV different is both its new wicking technology and its state-of-the-art microchip technology.

    A new vaping product is slated to offer the cigarette-like flavor of combustibles with the ease of vaping.

    By Timothy S. Donahue

    It might be the most “wicked” thing to ever happen in the vapor industry. A new vaping device will enter the U.K. market this summer that brings together the taste and aroma of heat-not-burn products with the ease of use, mouthfeel and lowered risk offered by liquid-based vaping products. Developed by Avail Vapor founders James Xu and Donovan Phillips, the new FAV system hopes to be the ultimate transition device to trend combustible smokers toward less risky electronic nicotine-delivery system products.

    Xu and Phillips co-founded FAV Tech Hong Kong Limited with a leading Chinese hardware manufacturer to launch this new hybrid product, the FAV. What makes the FAV different is both its new wicking technology and its state-of-the-art microchip technology. Xu said the wicking is the first of its kind in the industry to use real tobacco leaf in the wick to help produce the tobacco flavoring in the atomized vapor. Xu uses proprietary patented technology to “sandwich” a layer of tobacco particulate in the cotton wicking used to absorb the e-liquid into the coil. The liquid is then atomized, and the heat releases the natural tobacco’s essence into the vapor as flavoring.

    National data shows that at least two-thirds of combustible smokers try to quit each year. During his time with Avail, Xu said that shopper survey data showed that of those two-thirds of users, only six percent converted completely to vapor. That left 94 percent that continue to use traditional tobacco cigarettes. There had to be a better way to transition combustible smokers.

    “It’s a scary experience for them to quit smoking because it’s a habit they form over many years. Any reason that they [combustible smokers] could find not to switch, such as it’s too complicated to use, it leaks or the flavor’s not there … They walk away from it or any other less harmful product,” explains Xu. “From the early days, we could see that there were certain ‘boxes’ that had to be checked to convert smokers. A convenient form factor, ease of use, but the one thing that was the most important was flavor.”

    This knowledge sent Xu and Phillips on their journey to develop the FAV. Heated-tobacco products offered the touch and feel of combustibles, but they were complicated to use, and many users rejected the flavor. E-cigarettes were easier to use, but none offered the combustible cigarette flavor profile that nearly mimicked traditional tobacco cigarettes. The industry often said that if such a device was ever marketed, it could be the missing piece to the puzzle of tobacco harm reduction.

    The chip embedded in FAV pods will not allow the device to be used without being activated at the store from which it’s purchased.

    “When the smoker is first attempting to quit, it needs to be a lateral move. Something that tastes like combustible cigarettes,” said Xu. “For the smoker, taste is very important.”

    Xu said the lightbulb moment happened when he was in China exploring factories with representatives of a global leaf supplier that explained how recon tobacco was created and used. Also known as homogenized tobacco recon (RTL), it was developed in the 1950s to save valuable raw material by combining remnants of virgin tobacco during production. RTL is a paper-like sheet approaching the thickness of tobacco laminae.

    “They explained how they make recon paper. And that’s when we began to wonder if we could use recon paper near the heating coil so it can release the aroma. We later started to research how we could incorporate pure leaf into the cotton wicking existing in e-cigarette coils,” Xu said. “We devoted the last 12 months to perfect the process. We use real tobacco particulate. We can make infinite combinations to mimic all the different cigarette blends by using different leaves. It’s an extremely difficult and unique process to blend tobacco with cotton. The tobacco is ‘sandwiched’ in between the cotton fiber.”

    The heat from the coil then releases the tobacco aroma into the vapor produced by the e-liquid passing through the cotton wicking and heating coil. The tobacco never burns, it just “heats” to release the flavor in the leaf blend mixed into the wicking. Xu said the concept is simple. To make it work, however, is quite the process.

    “This wasn’t something we could do ourselves. We needed the assistance of scientists to help us be able to identify what particle size and layering process would actually work,” Xu said. “This is a specialized, unique and proprietary process.”

    Technical response

    An exceptional quality of the FAV is that the e-liquid used in the device contains only 3 percent tobacco essence boosters. Typical disposable vaping products contain between 20 percent and 36 percent flavoring. Xu didn’t disclose what flavoring was used, only saying it had no added sugars and only “enhanced” the flavor produced by the tobacco in the FAV’s wicking. Xu said the added flavoring “mimics other aspects of a combustible cigarette’s flavoring.”

    Xu said that another innovation offered by the FAV is its microchip enhancement technology developed over many years with their Chinese partner. The chip embedded in FAV pods will not allow the device to be used without being activated at the store from which it’s purchased. This prevents any use unless the seller verifies the purchaser is of legal age to consume tobacco products. Xu acknowledges that there is little a manufacturer can do if devices are purchased by an adult, then given to an underage user (straw purchase). The technical enhancements, however, are aimed at combating underage nicotine consumption.

    “The device can’t be stolen from a store and then used. It also prevents counterfeit products from becoming available. Only legitimate FAV pods work with the FAV battery device. The cartridge (pod) comes in the factory setting but can be modified by the user. Some users may want the wattage a little higher to squeeze out that last little bit of e-liquid. They have that ability to do that but within certain limits,” Xu explains. “Because many app platforms don’t allow tobacco product apps, users will have to initially connect the device to their computer to alter any settings.”

    The device can also program puff counts for users who may be using the device to wean themselves off nicotine entirely. Xu said that the first version of the FAV will have a very limited set of options for users. “It’s going to be very limited because we need regulatory approvals on some options. However, the sky is the limit with the chip,” he said. “But if you tell me you want to quit smoking or vaping, we can program that. Today, you can have 100 puffs, tomorrow, 99; the day after tomorrow, 98. Everything can be stored in the chip.”

    The FAV device has also performed better on toxicology testing than other heated-tobacco products. Xu said the FAV is equal to if not better than typical e-liquids as well because of the lack of flavoring and sugars in the e-liquid. There is little introduction of tobacco-specific nitrosamines (TSNAs) (which comprise one of the most important groups of carcinogens in tobacco products) or harmful and potentially harmful constituents (HPHCs) that are chemicals or chemical compounds in tobacco products or tobacco smoke that cause or could cause harm to smokers or nonsmokers.

    The device can also program puff counts for users who may be using the device to wean themselves off nicotine entirely.

    “There are minute TSNAs or HPHCs present. FAV tests better than heat-not-burn by a significant amount and surpasses most vapor product testing because our cartridges/e-liquid use little flavoring. Additionally, the amount of tobacco equivalent to a pack of cigarettes is 12.4 grams for [an estimated] 300 puffs,” explained Xu. “We use 0.05 grams of tobacco in our wicking. It’s only a small fraction of real tobacco compared to a pack of cigarettes that’s needed to give that authentic taste.”

    Xu said the FAV is expected to hit the European market this summer. The FAV is already TPD certified. The device has a 2 mL capacity with a 20 mg nicotine e-liquid mixed in a PG/VG base. It will come in three different tobacco flavors, and each flavor will have a menthol counterpart. Xu said he has submitted the FAV to Canadian authorities as well and expects to be able to enter that market sometime this year.

    Concerning the world’s largest vaping market, Xu said he does want to submit a premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration. He does, however, want to wait until the FDA gets the PMTA process in order and is clearer on what it expects from a vaping product to receive marketing approval. Xu said the FDA’s failure is costing the U.S. economy, limiting the technology of less risky tobacco products in the U.S. market and, most importantly, costing the lives of millions of smokers who want to quit but are unclear of the benefits of using less risky products.

    “We identified the European market for our initial product launch. The FDA has this ludicrous regulatory environment. Initially, we were thinking about releasing FAV in the U.S. and manufacturing it in the U.S. This would have brought jobs and the first vaping hardware production to the Unites States,” said Xu. “We just couldn’t make it work because of the U.S. regulatory landscape. Because of the uncertainty with FDA regulation, we had no other choice but to choose production outside the U.S.”

    There is one problem, however, that Xu hopes will never be solved: Focus group test panels seem to love the FAV. “The biggest problem we have right now is when we do a focus group test panel, and our testers are actual current combustible cigarette smokers, they don’t want to give me the FAV back,” he joked. “They just keep telling me, ‘This is exactly what we’ve being looking for.’ That’s a good problem; those individuals smoking combustible cigarettes don’t want to give it back. Maybe this is the unicorn device that makes the transition to less risky products easier.”

  • Better Late Than Never

    Better Late Than Never

    The major complaint against the proposed U.S. rules for vape manufacturing is that they took too long.

    By Maria Verven

    The U.S. Food and Drug Administration published a new set of proposed requirements for tobacco and vape product manufacturers in March 2023 with the goal of ensuring product consistency and ostensibly protecting public health. But vape industry experts say the new rules should have come out years ago. And for most vape manufacturers, it’s simply too late.

    The FDA held a public hearing on April 12, and stakeholders can still comment on the proposed rule until sometime this fall before the regulatory agency issues the final guidance. In the meantime, Vapor Voice spoke with several industry experts to gather their perspectives.

    Minimizing the risks

    The proposed requirements apply to all manufacturers of nicotine vaping products and tobacco products designed for consumer use, whether complete and sealed in packaging or simply their parts or components. Applied to the manufacture, design, packing and storage of these products, the rules are designed, among other things, to ensure product consistency and prevent contamination with foreign substances.

    “While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,” said Brian King, director of the FDA’s Center for Tobacco Products. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”

    Key aspects of the proposal affecting vape manufacturers cover product design and development controls, manufacturing specifications, potential contamination and the traceability of components, ingredients and materials. Any inconsistencies between e-liquid product labeling and the actual nicotine concentrations are also addressed in the proposed rule.

    Finally, the rule includes what corrective actions the FDA will take for products that fail to meet these specifications, such as issuing a recall for incorrectly produced products that have already been distributed.

    What took so long?

    The FDA’s proposed rule was at least 10 years in the making. Sometime in 2012, a group of 13 tobacco manufacturers submitted to the FDA a list of recommendations for good manufacturing practices—a system for ensuring that products are consistently produced and controlled. The following year, the FDA created a public docket to obtain input on the recommended regulations for good manufacturing practices that had been submitted by the tobacco companies.

    And in 2017, an expanded group of manufacturers submitted proposals following the FDA’s 2016 Deeming Rule, which brought vaping manufacturers and products under the FDA’s jurisdiction, according to Patricia Kovacevic, general counsel for Cryomass Technologies Inc. A nicotine/cannabis regulatory consultant, Kovacevic has over 20 years’ experience in legal and regulatory affairs.

    “Tobacco product manufacturing practices (TPMPs) are not unexpected or new to the industry,” Kovacevic said. “Most reputable manufacturers already have a quality management system in place and design their manufacturing facilities to comply with the general principles of current good manufacturing practices (CGMPs).

    “The 2023 proposed rule on TPMPs is consistent with the manner in which the FDA regulates the practices, design and construction of personal hygiene products,” she said. As early as 1969, the FDA established CGMPs for foods as well as dietary supplements, infant formula and the like, added Kovacevic.

    This is a positive step in the right direction, both for the industry and the FDA, agreed Azim Chowdhury, a partner with Keller and Heckman LLP. Chowdhury advises domestic and international corporations on regulatory compliance with the FDA, focusing on vapor, nicotine, tobacco product and cannabis/CBD regulation.

    “This proposed rule is long overdue,” Chowdhury said. “This proposed rule should have come out years ago following the industry-proposed TPMPs that were submitted back in 2012. The vapor industry in particular has been in dire need of this type of regulation, which can only benefit public health.”

    In essence, the principles are not substantially different from other FDA-regulated industries, Kovacevic said, adding that some manufacturers also comply with ISO quality standards, the world’s best-known quality management standards for companies of all types and sizes.

    “It’s important to understand that TPMPs do not impose a certain product or manufacturing facility design or even dynamic of reporting,” Kovacevic said. “TPMPs are not prescriptive. They allow great latitude to manufacturers; thus, they should not be a great burden to be implemented.”

    As with all CGMPs, the common components are documenting procedures for business operations and outcomes, ensuring that personnel are appropriately trained, work procedures are followed and a document trail is created. This allows manufacturers to design the day-to-day practices for maintaining their equipment and facilities to maximize product quality, cleanliness, consistency and employee safety.

    TPMPs and PMTAs

    While the general reaction to the FDA’s proposed rule is positive, frustrations remain that the FDA has already banned most vaping manufacturers through the premarket tobacco product application (PMTA) process. Large manufacturers (with 350-plus employees) will be subject to the TPMP rule as soon as it is finalized, according to Chowdhury. Smaller companies have four years after the effective date to meet the requirements.

    “However, the question is will the small vape industry even be around in four years?” Chowdhury said. “The way things are going with the PMTA process and FDA enforcement, it seems that only the larger players will survive to see the implementation of this rule.”

    “As it became evident from the vast number of PMTAs that were denied or refused to file, small manufacturers and even some of the large ones did not meet FDA’s expectations regarding premarket review of vaping products and are consequently out of business for now,” Kovacevic said.

    “The vaping industry has tried in vain for more than a decade to work with the FDA on sensible manufacturing standards only to be ignored while the agency recklessly vilified nicotine vaping,” said Gregory Conley, president of the American Vaping Association. “While the FDA’s proposed requirements are a step in the right direction, the larger issue of the PMTA process disproportionately affecting smaller manufacturers and limiting market diversity must be addressed.”

    “The FDA needs to strike a balance between ensuring public health and maintaining a diverse and competitive market,” he said. “Without PMTA reform, there won’t be many companies left to be impacted by this proposed rule. It’s highly likely that vaping product manufacturers that received marketing orders under the PMTA pathway already have rather robust quality systems. So, complying with TPMPs will not represent a meaningful burden to them.

    “These regulations do not appear to differ a great deal from what would already be contemplated in a PMTA. But if the FDA’s Center for Tobacco Products does not reform itself, the real-world impact of this rule will be small, as companies with PMTAs will have no issue meeting just about any standard the FDA issues,” he said, adding that he wouldn’t recommend any manufacturer put themselves on the FDA’s radar at this junction.

    Kovacevic agreed. “Compliance with TPMPs, when effective, should not require a massive effort for responsible manufacturers, who by now should have a robust quality management system,” she said.

    Monica Schick, CEO and regulatory consultant with North Guide Solutions, predicted that the new rules could impact the industry financially. Smaller companies that are holding onto their market share with the rise of illicit products might need to increase their price points to add quality processes and/or testing requirements, according to Schick.

    “My concern is are we bringing out the cart when we are sending the horse to slaughter? With illicit products still being marketed and sold and open systems getting continuously MDOed [marketing denial orders from the FDA], what will be left to hitch this cart to?” she asked. “I would like to see this as FDA’s attempt to work with the industry and possibly see some increase in the number of legal products on the market.”

    Feelm research lab

    What about foreign manufacturing?

    The FDA’s new regulations will also apply to Shenzhen and other foreign-based e-cigarette manufacturers, although just how they will exercise enforcement is in question as the FDA currently doesn’t conduct regular foreign tobacco product manufacturing site inspections.

    “Unlike domestic manufacturers, this rule does not require foreign manufacturers to register their establishments, submit a product list or be subject to regular biennial inspections,” Chowdhury said. “However, FDA’s unified agenda of upcoming rulemakings indicates the agency may soon propose another rule that extends the Tobacco Control Act’s registration and product listing requirement to foreign establishments,” he said.

    The TPMP rule also highlights the FDA’s existing authority under Section 801(a) of the Federal Food, Drug and Cosmetic Act to refuse the importation of tobacco products that are manufactured, processed or packed under unsanitary conditions, are adulterated or misbranded and/or are forbidden or restricted in sale in the country where they were produced or exported, Chowdhury explained.

    Chowdhury said he doesn’t believe the FDA has ever exercised its authority under this provision to deny entry of imported vapor products, such as open-system devices or nontobacco-flavored vapes that are prohibited from domestic sale in China, as this would require the agency to evaluate imported tobacco products not only with respect to the FDA’s own rules but also on the importing country’s applicable laws and regulations. That could prove to be highly inefficient and impractical.

    “Furthermore, provisions concerning unsanitary conditions and adulteration/misbranding suggests that the FDA’s overall intent may be to control the quality of tobacco products rather than the specific legal status of tobacco products in their country of manufacture,” he said. “That said, members of Congress, public health groups and even Big Tobacco have been pressuring FDA to find a way to prevent illegal and counterfeit disposable vapor products from continuing to enter the country.

    “The TPMP rule could be highlighting that FDA already has the ability to accomplish this.”

    Final ruling could take years

    A final rule could take at least a year or more. First, the FDA needs to address all the comments from industry stakeholders. And even after that, it’s likely the final rule will be similar if not outright identical to the proposed rule, predicted Kovacevic.

    Chowdhury expects that thousands of comments will be submitted over the next six months, which the FDA will need to review carefully before finalizing the rule. “All in all, this rule will likely take at least one [year] to two years to become final. While it won’t directly impact pending PMTAs, companies should be reviewing this rule carefully and bolstering their existing practices to ensure compliance,” he said. “We now know what FDA expects.”

    “It is disappointing, but not at all surprising, that the FDA would wait to propose these regulations until it had already committed itself to banning 99.99 percent of the vaping market,” Conley said. “Our recommendations for the FDA include reconsidering the PMTA process, as its current review standards will shutter most legally operating manufacturers.

    “We also want the FDA to focus on how to support smaller manufacturers that are committed to producing high-quality, compliant products. The millions of Americans who rely on vaping to stay off cigarettes could benefit from the FDA’s proposal but only if the agency stops thumbing its nose at its critics and starts to regulate the category in good faith.”

    The original “Vaping Vamp,” Maria Verven owns Verve Communications Inc., a public relations and marketing firm specializing in the vapor industry.

  • More to NJOY

    More to NJOY

    As Altria sheds the burden of Juul, its leaders are hoping investors ‘Njoy’ the company’s new outlook.

    By Timothy S. Donahue

    It would have been hard to imagine less than five years ago. In September of 2018, Juul had a U.S. vapor market share of 72 percent. By mid-March of this year, Juul’s market share had plummeted to 25.6 percent and continues to drop. Meanwhile, R.J. Reynolds Vapor Co.’s Vuse products have grown from single digits to a more than 47 percent market share during the same period.

    Altria, Juul Labs’ largest minority shareholder, had to do something. Juul’s baggage of lawsuits for youth marketing and ongoing battle with the U.S. Food and Drug Administration over marketing denial orders just became too much to bear. After devaluing its $13 billion investment in Juul Labs to less than $250 million earlier this year, Altria stated that it would exchange its entire minority investment in Juul Labs for a nonexclusive global license for some of Juul’s heated-tobacco intellectual property to potentially boost its IQOS heated-tobacco products. It then did something that surprised no one in the industry.

    The next day, Altria Group announced it had entered into an agreement to acquire Njoy Holdings for approximately $2.75 billion in cash. Altria said it had multiple sources of funding for the deal, including cash from a $2.7 billion agreement with Philip Morris International last year for IQOS. In less than a week, Altria went from vaping product purgatory to owning the best vaping product on the market with a U.S. marketing order, the Njoy Ace. In total, Njoy Holdings has received six of the 23 marketing orders granted by the FDA as of this writing for the entire vaping product category, including pods, disposables and open systems.

    The other major factor in purchasing Njoy is the product didn’t come with the stigma tied to youth vaping, according to Altria CEO Billy Gifford. Speaking during an investor call, Gifford said that his company evaluated Njoy’s marketing practices and national survey data regarding underage use of Njoy tobacco products.

    “We believe Njoy has taken a responsible approach to marketing its products. According to the 2022 National Youth Tobacco Survey, Njoy-branded products are not included among the top usual brands among middle school and high school e-cigarette users. Additionally, Njoy is developing access restriction technology for its devices to further address underage use,” explains Gifford. “Our consumer research indicates that once consumers try Njoy Ace, it is a competitive product for both smokers and vapers. After trying the authorized nonmenthol Ace variant, 19 percent of surveyed smokers and 27 percent of surveyed vapers indicated that they would definitely buy the product.

    “The Ace results were on par with the post-trial findings for Vuse Alto nonmenthol and better than those for Juul nonmenthol. We observed similar post-trial results for the Ace menthol variants when compared to Vuse Alto and Juul menthol products. This encouraging research supports our belief that Ace is a compelling proposition.”

    The FDA said that it authorized Njoy’s products because they were found to meet the appropriate for the protection of public health standard as, among several key considerations, chemical testing was sufficient to determine that overall harmful and potentially harmful constituent (HPHC) levels in the aerosol of these products is lower than in combusted cigarette smoke.

    Further, data provided by Njoy demonstrated that participants who had used only the authorized Njoy Ace products had lower levels of exposure to HPHCs compared to the dual users of the new products and combusted cigarettes. Therefore, these products have the potential to benefit adult smokers who switch completely or significantly reduce their cigarette consumption.

    Additionally, the FDA considered the risks and benefits to the population as a whole, including users and nonusers of tobacco products and, importantly, youth. This included review of available data on the likelihood of use of the product by young people. For the authorized products, the FDA determined that the potential benefit to adult smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth, provided that the company follows postmarketing requirements to reduce youth access and youth exposure to their marketing.

    Open access

    Altria has the ability to take Njoy products to the top. Gifford said that a large number of tobacco consumers are not currently aware of nor have access to the Ace vaping system. Njoy’s Ace, the most technologically advanced FDA-authorized vaping product, is currently available only in an estimated 33,000 stores. Altria services more than 200,000 U.S. stores. Njoy’s sales force is fewer than 50 people. Altria has 1,600.  

    “As a result, total U.S. retail share for Ace pods in 2022 was only 3 percent. Yet, we know that Ace has performed better in stores where it’s visibly merchandised and has consistent distribution. In the top 5 chain accounts where Ace competes with Vuse Alto and Juul, the weighted average share for Ace is approximately 11 percent,” Gifford said. “We believe we can responsibly accelerate U.S. smoker and competitive vaper adoption of Ace in ways that Njoy could not as a standalone company.”

    During the session, Bonnie Herzog, managing director with Goldman Sachs, questioned whether Altria would need to reposition the Njoy brand or change its strategy considering the brand’s relatively small share of the market. After all, several devices have done very well in the market and then disappeared or lost their position. Chris Growe, with Stifel Financial Corp., wanted to know what made the Ace device so unique. Could the Ace device develop another level of brand loyalty it had yet to reach? Gifford said Altria has an extensive relationship with retailers that its “sales force has built over decades.” It’s all about consumers having better access.

    “You’re going to see loyalty in these new spaces that we experience in the tobacco category. When you see the consumer, they’re trying various products. They’re looking for products that satisfy their unmet needs and desires, and once they find a satisfying product, it’s up to us to build a brand around that. I think when you look at Njoy, and I’d reference you back to the consumer research, it was both smokers looking to transition and how they rank the products in the marketplace as well as existing vapers, people that have already converted, and their preference there,” Gifford told the investment advisers.

    “I think you see that we believe this is a strong asset because not only does it bring certainty around the authorization but the consumer is telling us they have preference for this product over some of the other products in the marketplace. That’s the way we think about it and are extremely excited to, again, have that base IP, have a product ready in the marketplace, but then be able to develop on it as we move forward,” Gifford said.

    Gifford told Priya Ohri-Gupta, with Barclays, that prior to closing the deal, Altria would offer none of its services to Njoy but that after closing, Njoy would experience all of the assets Altria has at its disposal. “Our sales force, our regulatory team, our government affairs team, all of that would be available subsequent to close,” said Gifford.

    Gifford said that in the next few years the company expects the FDA will complete marketing determinations on the remaining premarket tobacco product applications, including those filed for synthetic products. He said he also hopes the agency will implement the suggestions from the Reagan-Udall Foundation report.

    Altria expects the vaping market to remain “in flux” until the FDA goes through the enforcement process and removes unauthorized products from the market. Over the next 10 years, U.S. volumes will grow at a single-digit compounded annual growth rate, Gifford predicted.

    After the Njoy acquisition is finalized, Altria will have a compelling portfolio of products and technology across the three largest smoke-free categories, according to Gifford. In the vaping segment, the company will fully own the only FDA-authorized, pod-based product on the market. In oral tobacco, it owns the largest brand, Copenhagen, and holds 100 percent of the global rights to On!, one of the fastest-growing nicotine pouch brands in the U.S. last year.

    “We have differentiated new products in development. And in heated tobacco, we have the majority-owned joint venture with JT Group for the U.S. commercialization of the next-generation Ploom device and Marlboro heated-tobacco sticks,” said Gifford. “We [also] have full ownership of an exciting heated-tobacco capsule technology, which we will discuss further at our Investor Day.”

    Gifford also explained that the Juul IP rights deal is centered on the Ploom device and the capsule technology. He told Herzog that Altria viewed the technology as “very interesting,” and it allows Altria to put it “in the toolkit” of its product developers. That would give Altria the ability to market the new product anywhere around the world. “Our focus, of course, would be the U.S. because that’s the biggest opportunity we see in products,” said Gifford.

    When asked when new heated-tobacco products using the newly acquired IP would make it to the U.S. market, Gifford’s answer became lost in translation. Deciphering the double talk quickly, Herzog ended the conversation by clarifying Gifford’s answer, saying, “OK. So, in a few years. Appreciate it. Thank you.” Gifford did not disagree with Herzog’s assessment.

  • Vaping in Ireland

    Vaping in Ireland

    Vaping is beginning to take hold in Ireland’s smaller cities, but combustibles are still king in Dublin.

    By Timothy S. Donahue

    Going on a trip to Ireland, I had expectations. I thought the vaping community would be small and just learning about new products coming to market. No. That wasn’t how it was at all. In Ireland, and I imagine it’s the exact same thing one could witness across the entire European Union, people understand that vaping is better than smoking combustibles. Many former cigarette smokers, an estimated 200,000, have already made the switch.

    According to a 2021 survey from Eurobarometer, Ireland has the highest rate of people who use e-cigarettes in the European Union at, 7 percent, while the EU average is 2 percent. There seemed to be a lot of vapers across Ireland. Media reports suggest that Ireland has a youth vaping problem. When a vape shop owner in Dublin was asked about this, he said that the people who vape are mostly former smokers, but there are youth who would have started smoking combustible cigarettes that instead started vaping.

    This was evident in Killarney, a town of 15,000 in southwest Ireland. It also has about 1.7 million tourists per year. College kids were vaping here. They were also smoking combustible marijuana. They were also drinking at noon on Tuesdays and Wednesdays and so on. It’s Ireland. Drinking is sort of a thing. I asked a few students if they would be smoking combustible cigarettes if vaping didn’t exist. The answer was an overwhelming yes. It’s university; nicotine use is a thing too. Just two years ago, everyone smoked combustibles. 

    Not anymore. Vaping is the way today. Many said they even have their parents, who were two-pack-a-day to three-pack-a-day smokers, vaping now. The older folks like the simplicity of the pods. The younger group likes the flavor varieties in disposables. Walking the streets of downtown, you could witness vapers from a variety of age groups and economic backgrounds. Flavors are also extremely popular.

    “The older folks want the tobacco taste first,” a college student said. “Now, they vape a while, and they don’t want that taste; my mom loves the watermelon now. She’s stopped smoking cigarettes completely and now just vapes. She used to smoke two packs a day.” Watermelon is the favorite flavor in Ireland, followed by Blue Ice, a straw poll of shops in Killarney and Dublin has confirmed.

    Ireland had no age restrictions on the purchase of vaping products until recently. In November of 2022, the country’s minister for health, Stephen Donnelly, and the minister for public health, Frank Feighan, received government approval to introduce additional restrictions on the sale and advertising of nicotine inhaling products, such as e-cigarettes.

    Under the new proposals, the sale of e-cigarettes and related vaping products became prohibited from self-service vending machines, from temporary or mobile premises and at places or events for children. In addition, advertisements for e-cigarettes are now prohibited on public transport, in cinemas and near schools.

    At the time the proposal was announced, Feighan said the legislation was necessary because tobacco smoking continues to kill approximately 4,500 people in the island country each year. “We recognize that nicotine inhaling products are used by some adult smokers to assist them to quit tobacco smoking,” he said. “However, we are clear that these products are of no benefit to our children and young people or to nonsmokers, and that is why we are taking this action.”

    All Irish and EU vaping devices and e-liquids are regulated by the Tobacco Products Directive 2. The Tobacco Products Directive regulates nicotine strengths, bottle sizes and ensures that communications about products are factual and clear. The ingredients that make up all Irish regulated vaping products must be provided to the Health Service Executive, with detailed information, including chemical studies and risk assessments.

    These regulations act as an important barrier to any products that do not adhere to EU standards entering the Irish market and can be contrasted sharply with the absence of similar regulations in the U.S. and elsewhere, according to Vape Business Ireland (VBI), the largest vapor industry trade association in Ireland.

    Credit: TS Donahue

    VBI is advocating the Irish government to consider more evidence-based policymaking decisions, which in turn will allow for more evidence-based regulation of vaping products in Ireland. The trade group wants the government to “deliver effective, evidence-based and balanced regulation of vaping products,” according to its leadership.

    There were at least four vape shops in Killarney. None of the owners would speak to me on the record because they said they aren’t “trying to call attention to themselves.” The truth is probably more along the lines of the massive distrust of the media that Ireland has. Owners probably believed I didn’t just want to know about vaping in Ireland and what types of products were popular and that I instead had more dubious plans for this article.

    One shop attendant, Karen, said that most of her customers are college-aged; however, many of them were buying combustibles from her store until vaping became more popular in the country around 2020. She thinks youth are going to experiment with things like drinking, drugs and nicotine and that if there are safer ways to consume these products, government regulations shouldn’t hinder their availability.

    According to the Global State of Tobacco Harm Reduction (GSTHR), the overall smoking prevalence in Ireland has decreased since 2006. More than 23 percent of the adult population in Ireland are current smokers, down from 29 percent in 2006. This means there are now approximately 893,778 smokers in the country. An estimated 26 percent of men still smoke combustibles, and for women, the figure is an estimated 21 percent.

    In Ireland, there are 265,500 vapers in the country, giving an adult vaping prevalence of 6.7 percent, according to the GSTHR. There is a requirement to ensure that vape packaging contains a health warning and vaping devices can be purchased without a prescription. There are no legal restrictions on their use in public places. Heated-tobacco products cannot be marketed, and the situation is “quite complicated” for snus. While it is illegal to import snus for trade or to buy the product online, it is possible to import it for personal use.

    In Dublin, it seemed that combustibles were still king. A short walk around the city, and there are cigarette smokers everywhere. There were also cigarette butts littering the streets everywhere we walked. Places like Temple Bar, an insanely popular tourist neighborhood littered with drinking establishments where few true Dubliners visit anymore, hundreds of people were smoking cigarettes and marijuana openly, and vapers could be seen mixed in the crowd but in much lower numbers.

    There are an estimated 50-plus vape shops in Dublin; however, it seemed like a lot more. Still, no vape shop owner or employee would speak with me on the record. Vaping products could also be found at many discount shops that sold everything from shampoo to clothing throughout Ireland.

    There was even a vape shop in the small fishing village of Howth, a suburb of Dublin. While we only went to see Dublin and various places around County Kerry where Killarney is situated, it wasn’t hard to find vaping products anywhere we visited. One cab driver told me that he was sure everyone in Killarney drank and used nicotine in some form or another and that vaping is definitely more popular than combustible cigarettes in the small town.

    Overall, the rising popularity of vaping in Ireland can’t be denied. The harm reduction benefits of vaping are widely known, and even many cigarette smokers told Vapor Voice they wanted to quit combustibles and have or would try vaping products to try to end their compulsion to smoke cigarettes. It’s quite the contrast to the United States, where many doctors still believe nicotine causes cancer and are skeptical of the harm reduction benefits of vaping.

  • Mixed Messages

    Mixed Messages

    Credit: Onticello

    The head of the FDA’s Center for Tobacco Products sent mixed messages during a recent public event.

    By VV staff

    When the American Vapor Manufacturers (AVM) Association announced it had secured a Q&A session with the Brian King, the industry was taken by surprise. It was the first time King, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), would speak with vaping industry advocates publicly and answer questions from the audience. Surprisingly, King was quite candid. He did shy away from certain questions, however, and some of his responses were questionable.

    Brian King

    Youth e-cigarette use was first declared a national epidemic in December 2018 by then U.S. Surgeon General Jerome Adams. King said the “FDA has not used that terminology” (epidemic) in its “most recent estimates” of youth use. However, during a hearing of the House Oversight Subcommittee on Economic and Consumer Policy in 2021, then acting FDA Commissioner Janet Woodcock was asked if Juul Labs was “the e-cigarette company most responsible for creating this epidemic.”

    She answered that it does “appear” to be the case. The title of the FDA’s own press release was “An Epidemic Continues: Youth Vaping in America.” A 2018 FDA focus group study conducted by the agency reported that “‘epidemic’ ads [had a] perceived effectiveness score of 4.17 out 5.0.” King defended the agency’s youth-oriented anti-vaping ads, which he said were “rigorously evaluated” before and after they aired and were effective at reaching teenagers. King ignored that the ads continue to use the FDA’s approved youth vaping “epidemic” terminology.

    “So, I believe you’re thinking about the CDC [U.S. Centers for Disease Control and Prevention]. And FDA has not used that terminology to view the most recent estimates of youth use. I will say that I’m an epidemiologist by training, so I’m fully cognizant of the definition of an epidemic, which is unprecedented increases over what you’d expect at baseline,” said King. “That said, I think, no, that science has shown a decline in the number of youth users. And that’s a good thing. Over the past couple of years, we have seen [a] decline since the peak in 2019. It’s still too high.

    “Since I’ve started, I have not [used the term]. I’m not aware of any of my staff. But as far as I’m aware, we have not used the term. It’s ultimately up to respected individuals. There’s certainly disagreements among epidemiologists. Like there is in any discipline, you’re going to find people disagree.”

    It should be noted that King’s disdain for vaping is well-documented. King is credited with creating the term “e-cigarette or vaping product use-associated lung injury,” or EVALI. The term was used by the CDC for the lung injuries caused by the 2019 spread of illicit THC cartridges tainted with vitamin E acetate during King’s tenure at the CDC. The name suggested that nicotine vaping products (e-cigarettes) were responsible for at least 70 deaths attributed to black market THC products. No nicotine vaping device has ever been associated with an EVALI death or any death; however, King and the CDC have never tried to correct the misinformation.

    The event was moderated by AVM Vice President Allison Boughner and its director of legislative and external affairs, Gregory Conley. When the moderators asked King if the FDA had ever identified a single nicotine vaping product, not an illicit THC cartridge (referencing EVALI deaths), that could be more hazardous than combustible smoking, King dodged the question.

    “I would say that at present, we evaluate the merits of evidence that has been submitted to this agency. In terms of applications and science on their products, at present, we have authorized 23 e-cigarette products or devices that we have found and that benefits outweigh the risks,” he explained. “And we’ll continue to do that. The onus is on the applicants to submit that information. And we’re fully open to evaluating that information and then making an informed scientific decision.”

    Being more direct, moderators asked King if vaping products are far less hazardous than smoking cigarettes and if that is something consumers should know. “I would agree with the statement that if an adult smoker were to transition completely from a cigarette to an e-cigarette, that would be a benefit to their health, yes,” King responded. Moderators then questioned whether it was ethical to mislead the public, letting people believe that vaping isn’t safer than smoking cigarettes.

    “Although we know that in general, e-cigarettes have lower risks than a conventional cigarette, there’s a broad class, and there’s a lot of different factors that can influence the extent of risk. And so it’s not just a simple statement that every single e-cigarette is going to be lower risk,” King said. “There are different factors that we have to consider, particularly when it comes to risks to vulnerable populations like kids.”

    Fighting misinformation

    Credit: Vadim Pastuh

    King acknowledged that vaping has been effective at helping smokers quit smoking. He added that the FDA and CTP don’t want people using combustible cigarettes. Combustible products introduce 7,000 chemicals and 70 carcinogens into users. However, the misinformation surrounding vaping products is massive. King acknowledged that he is “fully cognizant” of the misperceptions.

    “I am wholly open to enhanced efforts by the Center for Tobacco Products to message not only on the continuum of risk but also misperceptions related to nicotine,” he said. “But again, the devil is going to be in the details there in terms of making sure that we have scientifically defensible messages and that we’re delivering it to the target population, which is adult smokers, and not inadvertently delivering it to the unintended populations where there’s consequences, including youth.”

    The FDA’s fight against misinformation is confusing at best. For the last several years, former CTP Director Mitch Zeller and several CTP employees have repeatedly stated in public that correcting misperceptions surrounding vaping and nicotine are part of the CTP’s agenda. King seemed to imply that little had been done so far in accomplishing that goal. He said that little had been done, and that was due to competing priorities at the CTP.

    “When you have a finite number of resources and people, you have to prioritize what you do to have the greatest impact. And so, I will say that for my part, coming into this position, there’s four key tenants that I am adhering to, and that’s strong science, stakeholder relations, communications and health equity,” King said. “And so, obviously, the stakeholder relations and communications are pivotal to this. In terms of my prioritization, I think it’s important that we engage with people, hear them out, but also use science to inform our communication strategies moving forward. It’s not that we haven’t done this work before but it’s just where prioritization is moving forward. And I can tell you that we’re working on it.”

    Concerning misperceptions and the FDA’s message in the public arena, moderators questioned King on the FDA’s advertising. FDA ads have portrayed vapers as being possessed by demons or shapeshifting metal dragons, and vaping will cause huge parasites to crawl through your skin. None of these things have ever been reported as being true. King said that the agency does a “rigorous evaluation” both before and after the implementation of any of its campaigns, and all of the FDA’s youth-centric campaigns have very targeted strategies to reach that target population.

    “We cognitively test them and do science in the beginning, and then we evaluate them on the back end. And that science has shown demonstrably that there is a beneficial impact. That said, I think that we’ve got opportunity for better public engagement on our campaigns,” he said, which didn’t really provide a clear answer to the question. “That is a critical component of our work. We don’t function in silos, and we want the opportunity to engage, but we’ve got to give people that opportunity. And if they’ve got data, if they’ve got evidence to demonstrate that a certain message or a certain target audience is going to be problematic in terms of the campaign, we welcome it.”

    Illicitly speaking

    confusedBans on consumer goods haven’t worked well historically. Prohibition of alcohol and marijuana led to massive black markets for those products. U.S. states that have enacted tobacco flavor bans, such as Massachusetts, have seen a huge increase in black markets. King said this depends on how an illicit source is defined. He added that any vaping or other tobacco product on the market that does not have FDA authorization is considered illegal, and anyone selling those products is operating in the black market.

    “In terms of our enforcement and compliance strategy, we’re committed to taking action to address those that are violating it. And that can take a broad spectrum of action, whether it’ll be warning letters all the way up to civil money penalties as well as injunctions,” he said. “But we have an obligation to enforce the law. And that’s what we will do. That is what Congress has told us to do. And so we’re committed to continuing to do that. But in addition, we’re also working to make sure we get efficiencies and ramp up our efforts around reviewing applications.”

    When questioned whether he had concerns about the black market continuing to grow, King said the CTP is committed to continuing to review premarket tobacco product applications as quickly as possible to guarantee a clear pathway to a marketing order. He’s also equally committed to making sure that the regulatory agency enforces the law. He says he’s committed to continue to implement the law.

    “This is what Congress has told us to do. We have specific authorities that we are responsible for, and in my job as the director [of the CTP], I have to make sure that we exercise those authorities, and toward that end, I don’t think we’re perfect,” said King. “I think we’ve got opportunity for improvement. I think that there’s always [an] opportunity for improvement. We acknowledge that. I think we can do some things better, and from our part, I’m happy to continue to move us into the next chapter of the center to make sure that we’re engaging people in a meaningful way.”

    On the enforcement front, King was asked why only small businesses bore the brunt of FDA action. King said that the CTP does not have a policy against small business and that its enforcement compliance actions have been taken against small and large businesses. However, one participant explained, many small businesses don’t have the finances to hire lawyers to petition the courts to fight the FDA. They also question whether the FDA would ever approve open-system products, which are mostly sold by independent vape shops.

    “We’re committed to enforcing the law. I will say that some of the recent actions in terms of the civil money penalties and also the injunctions were a result of companies that did not obey the law after repeated warnings. And there are many small businesses that are obeying the law and have submitted their applications and have gone through the process,” said King. And so it’s certainly possible. I will say that for our part, we’re committed to continuing to explore opportunities where we can better provide information to applicants to make sure that the process is as flexible and straightforward as possible.”

    A bad taste

    During the open question session, one participant questioned whether the FDA would ever approve a flavor other than tobacco. The business owner wanted to know if the FDA intended to have an outright ban on flavored products or any open system with potential for flavored e-juice options. King said the CTP does not have an outright ban on flavored products, but the onus is on the applicants to submit the evidence to demonstrate that the benefits among adult smokers outweigh the risks to youth.

    “So, there is no de facto policy within this center that would prevent the authorization of a flavored e-cigarette. But I will say that with continued high rates of youth use, the onus is high to make sure … to demonstrate that benefit to adult smokers,” King said. “But it’s not impossible. We’ve seen the authorization of several products already, all tobacco flavored, but we are certainly open to applications on flavored products.

    “And if the science demonstrated that there was a net benefit compared to the risk, we would authorize it. And so that’s my take-home here [that] there’s no blanket policy against flavored, but we’ve got to follow the science, and at present, we have not got sufficiently strong evidence that demonstrates that the flavors are needed for the adult smoker to quit.”

    King was also asked about memos submitted to the U.S. Court of Appeals for the 3rd Circuit but an attorney for Logic Technology showed that King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists. King said that that was an “erroneous description” of what occurred. It was not an overrule.

    “In this case, there was [an] initial assessment of that science, and then there was further scientific discussion. And I am a scientist by training. I have been for many, many years. And we sat down and discussed the merits of the available science that was presented,” explained King. “And after the discussion of that science and those merits, the determination was made that the applicant did not meet the standard.”

    A recent report published in the journal Addiction examined e-cigarette use in England among young adults between 2007 and 2018. That study concluded that 18-year-olds to 24-year-olds who use e-cigarettes did not use vaping as a gateway to smoke combustible cigarettes. King was asked about the study and whether he believed a “gateway effect” existed despite evidence that one did not. King responded that there’s still a strong body of evidence that suggests that the gateway does exist, but it’s dependent on a variety of different factors.

    “[It’s] certainly not conclusive evidence, but there’s moderate evidence to demonstrate that [a gateway exists]. But you also have to look at the net impact of the science. And so I’ve said publicly many times that you do have some gateway effects. We’ve seen that through the past study and others, but that doesn’t mean that every single kid who’s using an e-cigarette is going to go on to smoke,” King explained. “There’s a variety of factors that impact that. So I caution folks against definitive statements like that, that every person is going to transition who uses the product. It’s certainly happening. But when you look at the net effect, we’ve definitely seen a decline in overall e-cigarette use.”

    In the end, King said that the one thing people should realize is that he’s the type of person who speaks plainly and honestly. He doesn’t have the stereotypical characteristics of a civil servant. “If there’s anything that folks know about me, it’s I aim to be the most nonbureaucratic bureaucrat that you’ve ever met, and that involves just straight-shooting. And so, if we can do better, I want to know about it, and we can definitely enhance the communication on that front,” explains King. “So, I would say more to come, but the science is going to drive it. And we’re at the initial stages in informing what effective messages are most critical to reach the target audience without unintended consequences.”

  • Quitting is Easy

    Quitting is Easy

    Credit: Ivelin Radkov

    It seems to be very difficult for many politicians and think-tankers to change their minds.

    By George Gay

    Ever since they were mentioned in a Guardian newspaper leader in the U.K. in February, I have been fascinated by sea squirts. These tiny creatures start off as eggs and then develop into tadpole-like entities that swim around seeking a suitable rock or piece of coral on which to make their homes for life. But this is the good bit: Once they have attached themselves to their homes-for-life, they no longer need to swim or seek out suitable habitats, so they devour their own brains.

    The rest of their lives is spent blissfully drawing in sea water through one orifice, removing the nutrients they need and then squirting out what they do not want through another orifice—all without having to contemplate tricky meaning-of-life questions.

    Do these little creatures remind you of anything or anybody? To me, their way of life mirrors that of many politicians and employees of ideologically rigid “think tanks.” I mean, once these people have swum away from home, school or university and attached themselves to their political party or ideology of choice, they no longer need their brains, just a couple of orifices, one of which takes in information that is scanned for the nutrients that will feed their political or ideological prejudices and the other to squirt out the indigestible, inconvenient facts.

    You might laugh at this, or you might find it outrageous, but it would explain something that to me is otherwise inexplicable: the fact that it seems to be enormously difficult for many politicians, think-tankers and people in thrall to the aforementioned to change their minds.

    It is not unusual to hear a person who has always voted for a particular political party to say, while acknowledging that their party has been in power for years and proved itself to be incompetent, corrupted and lacking ideas, that they will continue to vote for it because “imagine what another party would have done if it had been in power during the same period,” something that, obviously, cannot be known. This is your individual as a sea squirt, operating to her full potential with two orifices while comfortably attached to her easy chair.

    In a similar vein, there is no end of people willing to tell you that tobacco smoking is the worst thing that anybody could do, but who will then add that, nevertheless, “can you imagine the awful things that vaping could usher in in the long term.” These two-orifice people look for nothing new, listen to nothing new and say nothing new.

    This resistance to doing things in new ways, even putting one foot in front of the other, was highlighted by John D. Barrow in The Book of Nothing when he quoted Francis Cornford. “Every public action, which is not customary, either is wrong, or, if it is right, is a dangerous precedent. It follows that nothing should ever be done for the first time.” Crazy as it might seem, this is where we are with vaping. Traditional tobacco products are customary, so they are OK, but vaping devices could set a dangerous precedent.

    It must have been the case that sea squirts or their relatives were in charge at Suring School in Wisconsin, USA, recently. According to a Vaping360 story relayed by Tobacco Reporter, Wisconsin legislators have had to propose a bill that would make certain invasive searches of students illegal.

    “The proposed law follows searches of students aged 14 to 17 last year in Suring, Wisconsin, in which the students were made to strip down to underwear in order for the superintendent to search for vapor devices,” the story reported. “The students were not told that they could decline the search, and parents were not informed until after the searches were completed.”

    At first, I found this story difficult to believe because it requires your accepting that somebody, or some people, thought that one way of protecting students, who might or might not have been carrying vapes, would be to humiliate them. They apparently thought that theirs was a proportionate response to student vaping.

    The students were 14 to 17, at a time of their lives that many find difficult to navigate, when they should be able to rely on the adults running their school to set an example of rational, humane behavior. Instead, they seem to have been confronted by adults obsessed with enforcing petty rules even to the extent of carrying out strip searches, which most people probably associate with prisons.

    I would suggest that even if those students vape for 50 years, it will do them less damage than the memory of being strip searched. I salute the legislators who are seeking to stop such incidents occurring again.

    An issue that seems to me to arise from the above story and one from Sheridan, Wyoming, USA, is that a lot of adults need to grow up. Their ideas on rules and discipline seem to be aligned with those of your average 13-year-old, which often tend to be inflexible. According to a Sheridan Media story relayed in TR, the city council in Sheridan was due to consider an ordinance pertaining to vaping and tobacco use by minors in the city.

    “Under the proposed ordinance, any minor [I assume, anyone under the age of 21] found possessing tobacco or electronic cigarettes (vaping devices) would be subject to a tiered system of fines through municipal court,” the story reported.

    Credit: Olly

    It’s none of my business, I suppose, because I don’t live in Wyoming, but, nevertheless, perhaps I could respectfully suggest that there should be some consultation on this. Perhaps the authorities might do well to draw on the expertise of people informed about comparative risks and gun laws in Wyoming, where I gather from the internet that just about anybody in the state who is above the age of 18 may carry a gun.

    As elsewhere, in clamping down on vaping devices, the authorities in Wyoming seem to be more concerned about things that people can protect themselves from, such as vaping, than about things that it is difficult if not impossible to protect themselves from, like being shot. At the outbreak of the Covid-19 pandemic, the World Health Organization seemed more intent on putting on an anti-tobacco/anti-nicotine conference than protecting us from a deadly virus that, unlike tobacco smoke, could and did sweep unseen across borders.

    By the way, the Centers for Disease Control and Prevention (CDC) rank Wyoming as having a firearm mortality rate of 25.9 per 100,000 people, which places it third highest, below Mississippi (28.6) and Louisiana (26.3). And, as another aside, this raises an interesting question about whether the CDC believes that gun ownership is a disease, but that is not for discussion here.

    Although, having said that, language does matter, according to Johanna Cohen, Bloomberg professor of disease prevention and director of the John Hopkins School of Public Health’s Institute for Global Tobacco Control. Cohen stars in a video that seems to be an advertisement for language purity by scientists and academics working in the field of opposing new-generation products (NGPs).

    It is a rather confusing video to my way of thinking because, while the voice-over makes the point that language evolves, Cohen seems not to be a Darwinist. She seems to lean toward genetically modified language, where such modifications are controlled by people such as her to avoid language developing adjectival diseases helpful to the tobacco industry.

    This all becomes rather silly in fact. At one point in the video, according to a piece by Alex Norcia writing in Filter magazine [I quote Norcia because, though I watched the video, I did not transcribe it], Cohen says that “words like ‘novel’ and ‘emerging’ are really misrepresentative by nature as a product is only new for so long.”

    I mean, come on, I know that a lot of people who like to go on about tobacco cannot resist dredging up the past, but what is she trying to do here, reignite the 1920s debate between Albert Einstein and Henri-Louis Bergson on the nature of time? As a bit of a diversion, is she seeking the illusive equation that will define for us the “now” moment? Cohen seems to want to set up an Academie Anglais when the object of the NGPs exercise should simply be to make it as easy as possible for those people who want to do so to switch from traditional combustible cigarettes to these less risky products.

    As always, if you want to make sense of something, it is best to seek out the experts, and by that, I don’t mean the scientists and academics. I mean the people who smoke and who use NGPs. At the bottom of a TR news report on the Filter piece, a viewer of the video was quoted as saying, “WE use these devices. WE define the terms. You need to stop talking and start listening.” Sixteen words that say it all.

    But Cohen is right in one way: Language is important, and those who support tobacco harm reduction (THR) should not be lulled into picking up and repeating whatever ideas the anti-tobacco/anti-nicotine activists put out. And there is a tendency to do this, especially within the tobacco industry, which is forever issuing mea culpas in an effort to curry favor with its enemies. One obvious example of this is the way in which just about everybody applies the word “addiction” to smokers and vapers without bothering to define what exactly is meant by addiction, something that I try to point up in another piece in this magazine.

    Another example can be seen in the otherwise useful World Vapers’ Alliance Policy Primer featuring case studies of the most successful countries that have embraced alternative products as a means of combating traditional smoking. It is unfortunate, in my view, that the primer at one point had this to say: “Quitting smoking is one of the hardest things to do, and smokers need all the support they can get instead of being stigmatized.”

    I find it hard to believe that anyone whose aim is to get people to switch from smoking to vaping would make this point, which I don’t think is even correct. For one thing, the hardest thing to do would vary from person to person, but it is easy to imagine that, for some people, obtaining a doctorate in quantum physics, playing Hamlet well, knitting a jumper with two arms in the right place, playing Wagner or listening to The Ring Cycle right through … might all come higher up the scale of difficulty than giving up smoking.

    I gave up smoking without recourse to any replacement or alternative products, and many of my peers did so, too, and I don’t for a minute believe that we were a particularly strong-willed bunch. Indeed, the figures showed that countless numbers of people did so at the same time.

    And even if this were not the case, I would find it difficult to understand under what circumstances any sensible person would try to encourage another person to do something by telling them it was difficult. It is time to take advantage of some corporate speak. For years now, no company worth its salt has faced problems; it has instead faced challenges. Note, the obstacle hasn’t changed, just the way of looking at it.

    The worker faced with a problem is entitled to hold her chin and shake her head. The worker faced with a challenge is set up to measure the height of the obstacle and the length of the run-up needed to clear it.

    We of the THR persuasion should not perpetuate the myth that quitting tobacco is difficult. We are not sea squirts attached to the anti-tobacco/anti-nicotine rock and being force-fed its solutions. It is not in our interests to perpetuate such myths, though it could be seen as being in the interests of those in the anti-tobacco camp. After all, if smokers came to know that it was not difficult to quit, they might do so and put those employed to be anti-tobacco out of work.