Tag: science

  • 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.

  • U.S. CDC Makes Confusing Statements in Latest Report

    U.S. CDC Makes Confusing Statements in Latest Report

    Credit: JHVE Photo

    Monthly e-cigarette sales skyrocketed during the first two years of the COVID-19 pandemic, according to a new study published Thursday by the U.S. Centers for Disease Control and Prevention.

    “In the United States, the prevalence of e-cigarette use is markedly higher among youths and young adults than it is among adults overall. In 2021, 4.5% of all adults aged ≥18 years (an estimated 11.1 million) and 11.0% of young adults aged 18–24 years (an estimated 3.1 million) currently (≥1 day during the previous 30 days) used e-cigarettes; during 2022, 14.1% of high school students (an estimated 2.14 million) currently used e-cigarettes,” the CDC’s weekly Morbidity and Mortality Weekly Report (MMWR).

    However, in 2020, the U.S. Census Bureau counted 331.4 million people living in the United States; more than three-quarters (77.9 percent) or 258.3 million were adults aged 18 years or older and 30 million (of the 258.3 million) were aged 18-24. The Annie E. Casey Foundation confirms the CDC data. In 2019, 15.3 million students enrolled in high school (9th to 12th grade). Many U.S. high school students turn 18 before graduating high school, as well.

    Major media outlets such as ABC News are now reporting that “the CDC noted in its report that e-cigarette use is more common among young people than adults overall” even though the statement is misleading at best.

    The agency also states that e-cigarette sales boomed in 2020. Between January 2020 and December 2022, monthly unit sales increased by 46.6 percent, from 15.5 million units to 22.7 million units, the study found. Studies have also shown that combustible cigarette sales plummeted during the same time period.

    Researchers found the surge in vape sales was mostly driven by disposable e-cigarettes in flavors, including fruit and candy, which are popular among youth and young adult users, and several studies have found they are also preferred by adults who have quit combustible cigarettes..

    Additionally, while the share of pre-filled e-cigarette cartridges decreased from 75.2 percent to 48 percent of total sales, the share of disposable e-cigarette units increased from 24.7 percent to 51.8 percent of total sales.

    The study found this may be due to an announcement the U.S. Food and Drug Administration made in January 2020 that prioritized enforcement against prefilled cartridges in flavors other than tobacco and menthol.

    Disposable vaping products were the first e-cigarettes to be distributed broadly across the U.S. After winning a landmark lawsuit against the FDA in 2010, the Njoy King became the bestselling e-cigarette on the market after just a few years.

    By 2017, pod systems became more popular as battery technology improved. It was easy to switch between flavors, and the rechargeable battery lowered the cost of products for consumers compared to disposable devices.

    Open systems were popular too, but pods were easier and cleaner without the chance of spilling e-liquid everywhere. The versatility of pod systems helped vaping become more mainstream.

    Then in January of 2020, the FDA created an unnecessary problem. The regulatory agency stepped in under the guise of a youth vaping “epidemic” and banned the sale of all flavored (except tobacco and menthol) pod-style vaping products.

    Today, disposable vapes are the best-selling e-cigarettes, and millions are disposed of improperly every year, according to industry data.

  • Vape Korea Expo Set to Return for Second Year

    Vape Korea Expo Set to Return for Second Year

    Credit: Kampon

    In 2022, Vape Korea Expo was the first and largest e-cigarette exhibition in Korea. The event drew the attention of e-cigarette consumers worldwide. The Korean e-cigarette market has been growing faster than expected year over year, despite controversy and issues over the safety of vaping products and government regulation.

    The event is scheduled to take place from July 21st to 23rd at KINTEX, one of Korea’s major exhibition venues.

    Vape Korea Expo is returning for 2023 and expects to showcase the latest in vaping hardware, e-liquids, oils and accessories. The show combines B2C retail, commercial, and entertainment elements with a Trends Symposium and an E-Cigarette Art Exhibition, according to a press release.

    There will also be a number of networking events including B2B buyer meetings and VIP receptions during the show.

    “Vape Korea Expo provides a unique platform for Korean and international brands, manufacturers, distributors, retailers and e-cigarette consumers to meet and interact with each other,” the release states. “Korea Vape Show (KOVAS 2023) is gaining recognition as a paradise for vape enthusiasts, attracting the attention of the vape community centered around Northeast Asia.”

    Registering in advance on the KOVAS 2023 website, www.koreavape.show, before 6:00 PM on July 20th, admission. For more detailed information and inquiries, please contact the Korea Vape Show (KOVAS 2023) office is free.

  • Second Circuit Appeals Court Rules in Favor of FDA

    Second Circuit Appeals Court Rules in Favor of FDA

    Credit: Brian Kinney

    A federal appeals court has ruled that the U.S. Food and Drug Administration didn’t change its position on admissible evidence and the agency’s failure to consider a marketing plan didn’t impact the outcome.

    The FDA acted reasonably in denying vapor maker Magellan Technology Inc.’s request for a marketing order for its flavored vaping products, the U.S. Court of Appeals for the Second Circuit ruled Friday.

    The court upheld the FDA’s finding that Magellan failed to show the product would provide a benefit to adult users that would outweigh the risks to youth.

    The agency found Magellan’s evidence—four non-clinical studies—was insufficient to establish that the flavored pods would be more effective than tobacco-flavored electronic nicotine delivery systems (ENDS) in helping smokers switch to e-cigarettes to stop smoking altogether, according to Bloomberglaw.

    The manufacturer of Hyde and Juno brand e-cigarettes sued the FDA and the U.S. Department of Health and Human Services claiming the agencies violated the Administrative Procedure Act.

    New York-based Magellan Technology accused the agencies of refusing to review the company’s premarket tobacco product applications (PMTAs) for 12 products, a process which cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications.

    “Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

    Texas-based retailer Vapor Train 2 LLC is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order the FDA issued to Magellan, according to the lawsuit filed Thursday.

    “FDA acted arbitrarily, capriciously, and otherwise not in accordance with applicable law in issuing the [refuse-to-accept] order,” the lawsuit states. “The agency invoked regulations governing [premarket tobacco product applications] acceptance that do not apply to Magellan’s [applications] and failed to consider timely amendments containing required content that Magellan properly submitted.”

    The companies are expected to appeal the ruling. Magellan could now seek an en banc review of the case (a rehearing by the full Second Circuit) or could appeal to the Supreme Court of the United States. 

  • Criminal Reform Groups Push Back on Flavor Ban

    Criminal Reform Groups Push Back on Flavor Ban

    Image: Tobacco Reporter archive

    A coalition of more than 50 criminal justice reform groups sent a letter to U.S. President Joe Biden warning that the U.S. Food and Drug Administration’s proposed ban on flavored tobacco products will lead to overpolicing in communities of color, according to The Hill.

    Prohibition-style policies, like the one proposed, “have serious racial justice implications,” wrote the organizations, which include Blacks in Law Enforcement, the National Association of Criminal Defense Lawyers, the National Latino Officers Association and the Sentencing Project.

    “Banning the legal sale of menthol cigarettes through licensed businesses will lead—and, in fact, has already led in some states—to illegal, unlicensed distribution in communities of color while triggering criminal laws in all 50 states, increasing the incidence of negative interactions with police and ultimately increasing incarceration rates,” the letter said. “There are far better solutions for reducing menthol cigarette use than criminalizing these products and turning this issue over to the police.”

    The aim of the flavor ban is not only to make smoking less attractive but also to advance health equity, according to Health and Human Services Secretary Xavier Becerra

    “FDA has the power to provide smokers with less harmful options and information to help accelerate reductions in smoking,” the coalition wrote in its letter. “Rushing forward with a total ban without these alternatives in place contradicts everything we know—and everything the administration has been saying in other spheres—about why harm reduction works and criminalization doesn’t.” The coalition urged the FDA to reconsider the ban and find solutions opposed to criminalization.

  • Lawmakers Continue to Urge FDA to Finish PMTA Reviews

    Lawmakers Continue to Urge FDA to Finish PMTA Reviews

    Credit: Adobe

    U.S. lawmakers are urging the Food and Drug Administration to wrap up its review of pending e-cigarette premarket tobacco product applications, reports Law360.

    In a letter to FDA Commissioner Robert Califf, 50 members of Congress requested the agency finalize its review of pending applications for e-cigarette products; deny applications for all nontobacco-flavored e-cigarette products, including menthol; and utilize the enforcement tools that have been given to the agency to remove all synthetic nicotine products from the market, including those with pending applications.

    The lawmakers’ call comes after the FDA failed to meet a court-ordered deadline of Sept. 9, 2021, to complete its review of all pending e-cigarette applications submitted to the agency. In its most recent filings with the court, the FDA has indicated that it will not be able to finalize its review of products with the largest market share until December 2023.

    “FDA’s repeated delays in removing flavored e-cigarettes from the market is putting children’s health at risk,” said Colorado Representative Diana DeGette in a statement. “FDA needs to step up its enforcement of these harmful products and get them off our store shelves now. Every day that these products remain on the market, the more harm they cause to young people’s health.”

    While the FDA has completed its review of many e-cigarette products, it has not yet completed its review of thousands of pending applications—including those for popular products manufactured by Juul Labs, Reynolds Vapor Co. and Smok.

    The lawmakers urged the agency to complete its review of all its pending applications no later than Dec. 31, 2023.

  • Misconceptions About E-Cigarettes Persist: Study

    Misconceptions About E-Cigarettes Persist: Study

    Photo: pavelkant

    About half of cigarette smokers and young adult nonsmokers think that nicotine-based electronic cigarettes have the same amount or even more harmful chemicals than regular tobacco-based cigarettes, according to a Rutgers study.

    Published in Addiction, the study measured perceived levels of harmful chemicals in e-cigarettes compared with cigarettes using national samples of more than 1,000 adults ages 18 and older who smoke cigarettes and 1,000-plus adults ages 18 to 29 who are nonsmokers. The study also measured associations with e-cigarette/cigarette relative harm perceptions, e-cigarette use and interest. About 20 percent of all participants believed e-cigarettes contain fewer harmful chemicals than cigarettes while about 30 percent responded that they did not know how the levels compared.

    “Our results were interesting to see given that previous review reports suggest e-cigarettes expose users to fewer types and lower levels of harmful and potentially harmful chemicals than cigarettes,” said Olivia Wackowski of Rutgers Center for Tobacco Studies, an associate professor at the Rutgers School of Public Health and lead researcher of the study, in a statement. “It was also interesting to find that only about half of adult smokers who thought e-cigarettes have fewer harmful chemicals also thought e-cigarettes are less harmful to health.”

    E-cigarette harm perception relative to typical cigarettes is a common question included on major national health and tobacco surveys in the United States. However, surveys of e-cigarettes typically haven’t included a question about the perceived exposure to or level of harmful chemicals in e-cigarettes relative to cigarettes.

    According to the study researchers, measuring perceptions of e-cigarette and cigarette chemical exposure is important because e-cigarette communications often directly refer to chemicals in some way, which may impact perceptions about chemicals and harms from using e-cigarettes compared to cigarettes.

  • Innovator to Harness Artificial Intelligence for Tobacco

    Innovator to Harness Artificial Intelligence for Tobacco

    Ryan Selby | Photo: Poda Holdings

    Generative AI Solutions Corp. intends to build a large language model (LLM) dedicated to harnessing the power of artificial intelligence for the tobacco industry. For this purpose, it has incorporated a new subsidiary called GenAI Tobacco. The company intends to launch the LLM tobacco product under the brand name Tobacco Titan.

    Tobacco Titan aims to provide AI-powered information about products, marketing and regulations, along with health and safety insights. The product could also make customized recommendations, such as new flavors, brands or smoking accessories that align with the adult user’s tastes and preferences.

    “I have seen the need for innovation and data collection firsthand in the tobacco industry,” said GenAI Chairman and CEO Ryan Selby, who previously was co-founder and CEO of Poda Holdings, in a statement.

    “Through my various contacts at some of the largest tobacco companies in the world, along with various other industry leaders, I believe we can build Tobacco Titan into an extremely valuable global enterprise system, providing utility to individuals and businesses alike.

    “Our goal is to partner with certain companies in the tobacco industry that have access to various proprietary datasets which will give Tobacco Titan a competitive advantage based on the uniqueness of the data that is not generally available on the internet. We plan on working with our partners Metachain Technologies. to facilitate the development of Tobacco Titan and will finalize our arrangement with them in the coming weeks.”