Jean Gonnell, a regulatory attorney with a significant focus cannabis and tobacco law, has joined Troutman Pepper’s Regulatory Investigations, Strategy and Enforcement (RISE) practice group. Resident in the firm’s Charlotte office, Gonnell joins from her private practice, Gonnell Law.
Gonnell began her legal career in Colorado, where she was at the forefront of cannabis legislation before the larger movement to legalize the drug. Over the course of her career, she has represented more than 100 clients in the cannabis industry, including approximately 15 percent of all licensed cannabis businesses in Colorado. With a deep commitment to her clients and dedication to the flourishing cannabis field, she continues to expand her practice and make a positive impact in the evolving landscape of cannabis law.
“Jean’s addition to the firm will deepen the expertise of the firm’s established tobacco and nicotine and cannabis law practices,” said John West, chair of the business litigation department, in a statement. “Her extensive experience will enhance the innovative solutions we provide for our existing cannabis-focused clients as well as expand the services we can offer to potential new clients in the space.”
“With the possibility of North Carolina passing a new medical marijuana regulatory regime, the timing of Jean joining our Charlotte office could not be better,” said Jason Evans, managing partner of the Charlotte office. “We welcome her and are confident that her guidance will help to expand our reach in providing service to clients.” Gonnell is the second partner to join the Charlotte office in recent months, following the arrival of white-collar partner Matt Orso in May.
Gonnell is licensed to practice in Arizona, Colorado and North Carolina.
“I’m thrilled to join Troutman Pepper due to its strong regulatory presence,” said Gonnell. “I chose the firm because it allows me to maintain top client service while also giving me the network to expand my practice to new fronts. I’m excited to continue working with my clients in Colorado while also expanding my client base here in North Carolina.”
Jason Carignan has joined Chemular, an FDA regulatory consultancy group, as its chief commercial officer.
Carignan will lead the company’s revenue generation initiatives, strategic partnerships, and intellectual property monetization strategies across its diverse portfolio of business units, according to a press release.
“Carignan brings a wealth of experience and expertise to Chemular, having held various leadership positions in the tobacco and nicotine industry. He most recently served as president of Phillips & King and the Total Product Expo (TPE), both part of the Kretek International Inc. family of companies,” the release states. “Prior to that, he served as president of DRYFT Sciences, overseeing the successful development of the DRYFT line of nicotine pouches before selling the company to British American Tobacco in late-2020.”
With an impressive track record of driving growth and creating strategic alliances, Carignan is well-positioned to play a pivotal role in expanding Chemular’s market presence and further establishing the company as a leader in FDA regulatory matters.
Kevin Burd, CEO of Chemular. said he is thrilled to welcome Carignan to the Chemular team. “His deep industry knowledge and proven leadership in revenue generation and partnership strategies will be instrumental in driving our growth and expanding our client base,” said Burd. “We believe Jason’s appointment will advance our mission of providing comprehensive regulatory solutions to our clients and partners.”
Carignan will work closely with Chemular’s executive team to develop and execute business development strategies, identify new revenue opportunities, and forge strategic partnerships that enhance the company’s market position, according to the release.
Carignan said he was excited to join the Chemular team.
“Chemular has established itself as a trusted and innovative partner for clients navigating the complex landscape of FDA regulations,” Carignan said. “I look forward to leveraging my experience and expertise to drive revenue growth, establish impactful partnerships, and contribute to Chemular’s continued success.”
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.
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.
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.
Kaival Brands Innovations Group appointed James P. Cassidy as a new member of its board of directors, according to a press release.
Cassidy joins the board of directors as part of Kaival Brands’ recently announced acquisition of an extensive vaporizer and inhalation technology patent portfolio from GoFire. Cassidy is an investor in, and serves as board advisor to, GoFire.
“We are excited to announce Jim Cassidy as our newest independent director,” said Eric Mosser, chief operating officer, president and a director of Kaival Brands. “Jim’s background as a private equity investor and advisor to growing companies not only in the tobacco space but within the consumer and healthcare spaces will be of tremendous value as we look to expand into new verticals and opportunities following our GoFire patent portfolio acquisition.”
Cassidy currently serves as the founder and CEO of Preposterous Holdings, a family-run private equity firm with offices in Asheville, North Carolina, USA, which he established in 2013. Cassidy has over 25 years of extensive experience and expertise as a private equity investor and advisor across several industries, including the key areas of tobacco, healthcare, consumer packaged goods and technology.
Prior to his current roles, from 2000 to 2007, Cassidy was partner in the Strata Group, a wealth management advisory group at Smith Barney. He started his career in 1983 at UST, a tobacco business holding company, working in various roles in the government relations department and as director of corporate services.
McKinney Regulatory Science Advisors stated today that it has appointed Ian Fearon as its new Chief Scientific Officer.
Fearon will play a pivotal role in enhancing the regulatory science consulting firm’s capabilities and expanding its range of services to clients, according to a press release.
“Fearon brings over 15 years of invaluable experience in the field of Tobacco Harm Reduction, with a specific focus on clinical and behavioral studies of these products,” the release states. “His deep understanding of regulatory submissions in the United States and Europe will enable McKinney Regulatory Science Advisors to provide unparalleled support and guidance to clients navigating the complex regulatory landscape.”
Prior to joining McKinney, Fearon held key leadership positions at several industry organizations such as senior director of Clinical and Regulatory Affairs EMEA at Juul Labs, where he helped advance the scientific understanding of tobacco and nicotine products and supported the company’s premarket tobacco product application (PMTA) submission to the U.S. Food and Drug Administration.
Fearon also served as the director of Tobacco Research at Celerion, where he contributed to the development of clinical evidence to support regulatory filings, and as principal scientist and head of Clinical Research at British American Tobacco.
Fearon has published more than 60 papers, including more than 20 on tobacco/nicotine product assessment, which generated more than 3,200 citations, according to the release.
“We are thrilled to welcome Ian as our Chief Scientific Officer,” said company CEO Willie McKinney. “His extensive experience and deep knowledge of tobacco and nicotine science and worldwide regulations make him an invaluable asset to our team. With Ian’s guidance, we will continue to provide exceptional scientific and regulatory consulting services to our clients, facilitating their success in bringing innovative consumer products to market.”
As the Chief Scientific Officer at McKinney Regulatory Science Advisors, Fearon will oversee the company’s scientific operations, lead strategic initiatives, and drive innovation in the regulatory science domain, according to the release.
The tobacco and nicotine product regulatory arm of the U.S. Food and Drug Administration has hired a senior advisor for health equity for the first time. The Center for Tobacco Products (CTP) announced Charlene Le Fauve will fill the role.
“Beginning today, she will join CTP’s Senior Leadership Team within the Office of the Center Director,” a release states. “Dr. Le Fauve is a behavioral scientist and addiction researcher with 25 years of federal work experience related to health equity and health disparities research. She has dedicated her career to advancing health equity and the health of underserved and underrepresented populations through research and research workforce development.”
Most recently, Le Fauve served as the senior advisor to the Chief Officer for Scientific Workforce Diversity at the National Institutes of Health (NIH). In this role, she educated national audiences about NIH’s role in scientific workforce diversity and health equity research, according to the release.
Prior to her NIH role, Le Fauve held various leadership roles, such as the deputy director of Disparities Research and Global Mental Health at the National Institutes of Mental Health and the senior policy coordinator and lead for the Center for Medicare and Medicaid Services Team at the Department of Health and Human Services.
“Diversity, Equity, Inclusion, and Accessibility (DEIA) are core values of CTP, and efforts are underway to ensure that the full scope of the Center’s work is reflective of these principles. In this new position, which is the first of its kind for any Center at FDA, Dr. Le Fauve will work with all of CTP’s Offices to ensure health equity is integrated into the Center’s programmatic plans and priorities,” the release states, “She also will serve as CTP’s primary representative in a variety of activities that promote and facilitate the reduction of tobacco-related health disparities, including during external meetings, conferences, and presentations.”
Pinney Associates has announced a new leadership team.
Joe Gitchell recently assumed the role of CEO, Lucy Owen is its new president, Judy Ashworth has been promoted to senior vice president, and Robyn Gougelet has been promoted to vice president, health policy and regulatory strategy.
In their new roles, they provide strategic advice and tactical support to help clients reduce regulatory risk and achieve regulatory approval across our four practice areas. Pinney Associates helps clients switch prescription medications to over-the-counter status, supports the clinical and regulatory development of central nervous system-active medications, advises on the development and commercialization of dietary ingredients and supplements, and advances research and policies to minimize the death and disease caused by smoking cigarettes.
Owen guides clients through the complex and dynamic Rx-to-OTC switch regulatory process and specializes in developing and executing science-based regulatory strategies. Ashworth guides the clinical development of CNS-active drugs in a challenging and rapidly evolving regulatory environment.
Gougelet advises clients on public health legislative and regulatory policy efforts, as well as regulatory submissions to the U.S. Food and Drug Administration.
“We are thrilled to have promoted these talented individuals to our leadership team,” said John Pinney, founder and chair of Pinney Associates, in a statement. “Each of them brings unique skills and experiences that will help us continue to deliver exceptional value to our clients and better public health.”
“For over thirty years, Pinney Associates has worked hand-in-hand with our clients to overcome their regulatory and policy challenges by identifying root causes and developing innovative solutions based on medical and behavioral science and public health. We look forward to future collaborations with clients to increase access to products that advance individual and public health,” said CEO Joe Gitchell.
Pinney Associates is a science-based health consulting firm with resources and experience in scientific, medical, public health, regulatory and commercial aspects of prescription and consumer healthcare products.
Matthew L. Myers is stepping down as the president of the Campaign for Tobacco-Free Kids (CTFK) effective July 1. The board of directors has appointed Yolonda C. Richardson, currently the organization’s executive vice president for global programs, as the new president and CEO.
“I want to thank Matt for the extraordinary leadership he has provided to the Campaign for Tobacco-Free Kids and throughout his long career fighting the tobacco industry,” said Bill Novelli, chair of Tobacco-Free Kids’ board of directors and president of the organization from 1996 to 1999, in a statement. “Matt and his team at Tobacco-Free Kids have contributed enormously to driving down smoking rates to record lows among both youth and adults in the U.S. and to reversing the tide of the global tobacco epidemic.
“It has been the privilege of a lifetime to serve as president of the Campaign for Tobacco-Free Kids, and I am incredibly proud of what our team and our many partners have accomplished,” said Myers. “Through smart, tenacious advocacy and a commitment to health and social justice, we have helped bring about transformative change in the U.S. and around the world. No one is more qualified than Yolonda Richardson to take this organization to new heights and achieve even greater progress in saving lives not only from tobacco, but also from other critical public health issues.”
No one is more qualified than Yolonda Richardson to take this organization to new heights and achieve even greater progress in saving lives.”
“I am deeply honored to be named president of the Campaign for Tobacco-Free Kids and to continue the work started by Matt Myers and Bill Novelli 27 years ago. There is much to do, but there is also immense opportunity to make large-scale impact,” Richardson said.
The CTFK was created in 1996 with primary funding from the Robert Wood Johnson Foundation. Since 2006, it has been a partner in the Bloomberg Initiative to Reduce Tobacco Use.
Mitch Zeller, former director of the FDA’s Center for Tobacco
Products
Mitch Zeller, the much-maligned former head of the U.S. Food and Drug Administration’s tobacco center has joined the advisory board of a company developing a first-of-its-kind smoking cessation inhalation product.
Zeller said Qnovia’s nicotine inhalation product, RespiRX, has the potential to be a “game changer” in lowering the use of combustible cigarettes.
The former director of the Center for Tobacco Products (CTP) from March 2013 until his retirement in April 2022, Zeller is now providing policy and regulatory strategy consulting to Qnovia, Inc.
The company is currently preparing an application to the FDA’s Center for Drug Evaluation and Research (CDER) for a cessation therapy which, if approved, will be the first inhaled prescription therapy to help tobacco smokers quit.
Zeller’s addition to the company’s advisory board comes as the FDA aims to finalize proposed bans on menthol cigarettes and flavored cigars by August. The FDA also plans to propose a rule limiting nicotine levels in cigarettes and some other tobacco products.
Zeller said access to Qnovia’s product can be one essential tool along with an administration-wide effort to provide support to those with nicotine addictions once those product standards take effect.
“Some people will be able to quit cold turkey, but a whole bunch won’t, and they will be seeking nicotine elsewhere,” Zeller said in an interview, told Bloomberg Law.
“The last thing that we want smokers to do if any of those policies go into effect is to simply switch to another tobacco product,” he added.
Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, according to Qnovia CEO Brian Quigley. Instead of using heat to create vapor, the RespiRx device uses an orientation-agnostic vibrating mesh nebulizer. The aerosolizing engine is nothing like a traditional e-cigarette that heats a coil to atomize nicotine based in PG and/or VG.
RespiRx is activated when a user inhales on the device. To aerosolize the nicotine, it sends an electrical current that causes the perforated piezo mesh to vibrate more than 100,000 times a second. “It’s that vibrating action of the mesh that then forces the liquid to the holes, creating an aerosol that appears vapor-like, allowing it to be inhaled,” says Quigley. That, he says, is fundamentally different from a traditional e-cigarette product, where the heating process can create undesired thermal byproducts.
RespiRx uses proprietary software to deliver a precise dose of nicotine. Every time it’s activated, the device fires for three seconds and delivers a targeted dose of the drug. The base is reusable and serves as the housing for the battery and software. The RespiRx nebulizer sits within the pod that houses the nicotine drug product.
“The nebulizing unit (cartridge) gets replaced by the patient every one to two days. That interface means that the patient doesn’t have to clean the nebulizer,” explains Quigley. “The biggest challenge with other vibrating mesh products is that they require cleaning if used over an extended period. We’re mitigating that through the design of the interface. There is no cleaning required. We do believe that this will result in RespiRx having a very long use life.”
Late last year, Qnovia raised $17 million to continue the development of its RespiRx nicotine replacement product.
In June of 2020, the company appointed Quigley, a 16-year veteran of Altria Group, as its Chief Operating Officer. At Altria, Quigley served as CEO of its smokeless tobacco business from 2012 to 2018, a $2.3 billion business with over 800 employees,
