Author: Timothy Donahue

  • U.S. Urged to Bolster Post-Employment Rules

    U.S. Urged to Bolster Post-Employment Rules

    Image: bluraz

    Public policy experts are calling for stronger federal post-employment regulations as U.S. regulators, including those overseeing the tobacco business, are increasingly losing talent to the private sector.   

    A recent article in The Examination details how, over the past 15 years, nearly two dozen lawyers have left the U.S. Food and Drug Administration and its Center for Tobacco Products to advise, litigate for or work with the tobacco and vaping industry.

    “It seems like every time we get sued in the tobacco industry, a former FDA lawyer is leading the lawsuit,” Commissioner Robert Califf told an FDA oversight organization last year.

    After gaining  FDA experience, lawyers can significantly increase their salaries by moving to a major law firm or corporation. While a lawyer’s salary in the FDA’s chief counsel’s office, for example, starts at around $83,000, a first-year lawyer at a firm made on average $200,000 a year in 2023, according to the National Association for Law Placement.

    Daniel Aaron, a former FDA attorney, says lawyers who’ve left the agency to work on behalf of the tobacco industry not only increase their renumeration but can also have a powerful impact on what lands on store shelves.

    “It’s a huge advantage to getting your product to market.” said Aaron, now a University of Utah law professor. “Ex-FDA lawyers know what the agency is worried about, and how a client can maximize its options. They know not just what the law is, but they know how the FDA will enforce the law.”

    Federal post-employment rules also bar former employees from communicating with or lobbying a federal employee for two years on behalf of a client or employer under certain circumstances. That said, employees are allowed to work “behind the scenes” advising clients, according to the FDA’s post-employment guidelines. 

    Genevieve Kanter, a professor at the University of Southern California who co-published a study in 2023 on the revolving door in health care regulation, believes the rules should be strengthened if society is truly interested in preserving independent government.

    Kanter’s study focused specifically on conflicts of interest of employees at the highest level of the U.S. Department of Health and Human Services; It found that 38 percent percent of the political appointees from the FDA went into private industry, the fourth highest out of roughly two dozen offices and divisions.

    Eric Lindblom, director of the Center for Tobacco Products’ Office of Policy from 2011 to 2016, proposed blocking former staff from working for the tobacco industry for at least one or two years, in all cases, after leaving the policy office. “I thought it was really important that we had that independence,” said Lindblom, now a senior scholar at Georgetown University’s O’Neill Institute.

    The proposal went nowhere.

    The Examination is a publication supported by Bloomberg Philanthropies.

  • FDA Warns Companies For Selling ‘Smart’ Vapes

    FDA Warns Companies For Selling ‘Smart’ Vapes

    The U.S. Food and Drug Administration issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices.

    The products mentioned in the warning letters are promoted as having various designs and functions that might attract young people, according to an agency press release. These include features like playing games, connecting to smartphones, receiving text or call notifications, playing music, and customizing products with personalized wallpaper.

    “These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, director of FDA’s Center for Tobacco Products. “They’re illegal to sell and a flagrant attempt to target kids.”

    The agency states that the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because they help conceal the nature of the products as tobacco products from parents, teachers, or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market, such as smartphones and gaming devices.

    “The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug, and Cosmetic Act,” the release states.

    In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure, and/or civil money penalty.

    “FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”

  • France to Ban ‘Dangerous’ Nicotine Pouches 

    France to Ban ‘Dangerous’ Nicotine Pouches 

    French Health Minister Geneviève Darrieussecq said in an interview with the newspaper Le Parisien published on Wednesday that nicotine pouches “are dangerous products because they contain high doses of nicotine.” She added that a ban will be announced in the coming weeks.

    In Germany, while tobacco-free nicotine pouches are officially banned, they remain accessible and popular among young people, according to experts from the Tobacco Outpatient Clinic at Ludwig Maximilian University in Munich.

    “I am very concerned because poisoning centers are receiving more and more calls from young people with acute nicotine symptoms related to the use of pouches,” said the French minister.

    These include vomiting, shaking spasms, low blood pressure and impaired consciousness, she said.

    The minister warned that “the marketing of this product is directly aimed at young people. ” She added that young people need to be protected.

    Michael Landl, director of the World Vapers’ Alliance (WVA), criticized the move as being detrimental to public health.

    “By banning nicotine pouches, Minister Darrieussecq is closing off an effective, far less harmful path for millions who struggle to quit smoking. Pouches have proven to help smokers transition away from cigarettes in other countries and are considerably safer,” he said. “Rather than offering options, France risks pushing people toward smoking or the black market.”

    The French health minister plans to ban similar products, such as chewing gum or balls, in addition to the pouches.

  • Denver City Council Going for Flavor Ban … Again

    Denver City Council Going for Flavor Ban … Again

    A trio of Denver City Council members is proposing a ban on the sale of all flavored tobacco products in the Colorado capitol.

    The effort comes three years after then-Mayor Michael Hancock vetoed a similar ban, following months of debate and intense lobbying on both sides of the issue, including from tobacco industry interests. A different lineup of council members crafted that measure.

    “We think this is important because it’s a public health issue impacting our community,” Councilman Darrell Watson said on Monday after a committee hearing that previewed the proposal. He had helped lay out the specifics of the proposed ban, which — like its predecessor — would outlaw the sale of flavored vaping cartridges and a wide swath of other flavored products, including menthol cigarettes.

    Watson’s co-sponsors are Councilwomen Shontel Lewis and Serena Gonzales-Gutierrez. None of the three served on the council in 2021 when Hancock vetoed the previous bill. The council later came one vote short of mustering the nine necessary to overturn the veto, according to media.

    Unlike his predecessor, Mayor Mike Johnston, who took office in mid-2023, has already committed to signing a flavored tobacco ban law if it makes it to his desk.

    Monday’s meeting was only a briefing. The ban still needs to be approved by the council before it can be considered for a final vote. The next step for the planned proposal—a hearing before the council’s Safety, Housing, Education, and Homelessness committee—could come as soon as next week.

  • Consumer Groups Demand Seats at COP11

    Consumer Groups Demand Seats at COP11

    Photo: v-a-butenkov

    The Coalition of Asia Pacific Harm Reduction Advocates (CAPHRA) is calling on the World Health Organization to open the upcoming Framework Convention on Tobacco Control (FCTC) Conference of the Parties (COP11) to consumer advocacy groups, in line with human rights principles and evidence-based policymaking.

    “The WHO FCTC process must adopt a human rights approach that considers the implications across the entire life cycle of tobacco products, from growing to consumption,” said Nancy Loucas, executive coordinator of the CAPHRA. “This requires meaningful engagement of all stakeholders, including consumers, to strengthen policy formulation and implementation.”

    The CAPHRA points to a WHO Western Pacific Regional Office’s report highlighting that “a key element to creating a successful tobacco control social movement is the meaningful engagement and involvement of civil society.” The report notes civil society’s crucial role in “initiating, leading and sustaining tobacco control efforts to improve public health.”

    “Consumer groups are not constrained by bureaucracy and can hold both industry and government accountable,” Loucas added. “Our exclusion from COP11 flies in the face of the WHO’s stated principles on civil society engagement.”

    The CAPHRA is urging the FCTC Secretariat to formally invite consumer advocacy groups as observers to COP11, to create dedicated sessions for civil society input during COP11 proceedings and to establish an ongoing mechanism for consumer group consultation between COPs.

    The organization emphasizes that evidence clearly shows tobacco harm reduction strategies like vaping have helped millions quit smoking. Consumer voices are critical to ensure policies reflect real-world impacts.

    “The WHO cannot claim to take a human rights approach while silencing the very people their policies affect,” said Loucas. “It’s time to practice what they preach on civil society engagement and let consumers into COP11.”

  • Vapor Voice Exclusive: Rotting Your Boots

    Vapor Voice Exclusive: Rotting Your Boots

    Credit: Hutpaza

    Vaping opinions may vary depending on a person’s experience and knowledge.

    By George Gay

    On Aug. 24, The Guardian, the daily newspaper to which I subscribe, ran an opinion piece about nicotine pouches and vaping devices in its Journal section, which carries its leaders, opinions, letters, birthdays and obituaries. I much enjoy reading this section, in which the letters are often informative and the birthdays throw up some oddities.

    The famous people listed as having birthdays on the day of the paper are always briefly described in relation to the jobs or activities in which they are involved or, in some cases, the jobs or activities in which they were once involved. For instance, politicians who are no longer active in politics might be referred to as former Members of Parliament, but the “former” label is not usually applied to sportspeople, and this can lead to some amusing results.

    A person celebrating their 60th birthday, for instance, might be described simply as a javelin thrower, but the most impressive birthday announcement I have seen was in an April 2022 paper in which a 91-year-old man was described as a rugby player. Respect.

    The Journal always bears as part of its masthead the assertion that “comment is free … but facts are sacred,” a lofty statement that seems not always to be lived up to, especially when the subject is tobacco or nicotine, subjects about which the paper is po-faced in the extreme and often ill-informed.

    The opinion piece on Aug. 24 told how the writer, a vaper, faced with a six-hour rail journey during which she would not be able to vape, decided to buy some nicotine pouches in the hope that they would make the trip more palatable, even though she had not previously indulged in such products.

    On boarding her train, she placed a pouch in her mouth, but, after 15 minutes, had thrown the entire pack, and presumably the pouch she had experimented with, in the bin. Apparently, she spent the rest of her journey, five hours and 45 minutes, feeling nauseous but not throwing up on the table in front of her. Respect.

    This outcome was somewhat surprising since she also wrote that she had lived for some time in Sweden, where she had come across snus but not used it because she had been warned by friends that first-time users usually were made to feel ill. At this point, I thought the opinion might examine the need for nicotine pouch packs to provide information about how best to start using this product, perhaps suggesting only very limited exposure in the beginning.

    In fact, as I understand it, some products do carry such information in countries where the consumption of oral products is not already established and where the provision of such labeling is permitted.

    Perhaps there might have been a discussion on whether there should be available beginners’ packs with pouches that offer only slow, low-level nicotine deliveries. Such a discussion could then have looked at the ethical issue of offering pouches that might be seen by some as being aimed at people who were not already tobacco or nicotine users.

    It might have been interesting to look, also, at whether, to overcome this issue, all nicotine pouch packs might offer a range of nicotine deliveries. After all, perhaps even long-term users might like to have a low-hit product now and again.

    But no, the writer, Imogen West-Knights, had other ideas. She apparently started thinking about “nicotine and addiction in general.” Although West-Knights did not define what she meant by “addiction,” she had already declared that she was “pathetically addicted” to nicotine and her vape, and later wrote in two instances of nicotine as being “mind-warpingly” addictive.

    She was interested in what she said was a moral quandary thrown up by the question of whether it was “… bad for people to have access to a mind-warpingly addictive substance if it has no health consequences?” In the end, she took a libertarian stance and declared that what others did was none of her business nor that of the government.

    To my way of thinking, she came to the correct conclusion, but she could have saved herself a lot of anguish in respect of nicotine if she had taken the trouble firstly to define addiction. In writing that nicotine had no negative health consequences, she was, in effect, declaring that nicotine was not addictive.

    To be addictive, a product or an activity must be indulged in compulsively, and that activity must have negative health consequences, otherwise, breathing unpolluted air, if such were available, would constitute an addiction.

    I wrote a letter to the newspaper pointing this out, but it didn’t cut any ice. Obviously, what was written came under the “comment is free” part of the declaration, not the “our opposition to tobacco and nicotine is sacred” part.

    I don’t blame West-Knights for her confusion because she had apparently looked up the U.K. National Health Service’s Quit Smoking webpage and found that it stated that “although nicotine is addictive, it is relatively harmless.”

    In other words, the NHS had squeezed nicotine into the addictive category simply by inserting the phrase “relatively harmless.” But, of course, such a fudge raises its own issues because it clearly drags into the addictive sphere all sorts of other products and activities. Indeed, the writer raised the cases of coffee and sugar.

    Which leads me onto another addictive product, water. If, as above, addiction is taken to be the compulsive consumption of a substance or involvement in an activity that causes harm to the consumer or participant, then, apparently, both cigarettes and water are addictive. This came to my notice when reading in The London Review of Books a review by Steven Shapin of a book by Christy Spackman, The Taste of Water: Sensory Perception and the Making of an Industrialized Beverage.

    Shapin made the point that there was a suspicion, if not yet solid evidence, that the toxic pollutants in water posed risks to human health that took in cancer, damage to the nervous system, liver and kidneys, and interference with fertility and development. Sound familiar?

    And there is another parallel. “It is thought that the monetary scale of American lawsuits against companies responsible for PFAS [perfluorinated and polyfluorinated alkyl substances] water pollution may eventually dwarf those involving asbestos and tobacco, considering that people are in a position to decide whether or not to smoke cigarettes, but everybody has to drink water,” Shapin wrote.

    He made the point too that there are potentially dangerous things in water that are difficult for the consumer to detect because they don’t taste, smell or look odd. He didn’t contrast water and tobacco in this instance, but it is the case that cigarette smoke doesn’t sneak up on you in this way because it has a particular smell and is highly visible.

    For the sake of my health, I think it might be time to try overcoming my long-term addiction to water. My grandfather, a beer aficionado of some note, warned me on many occasions that water rotted your boots. Respect.

  • Thoughtful Progress

    Thoughtful Progress

    GTNF 2024
    Credit: TS Donahue

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

    By Taco Tuinstra

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

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

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

    Credit: TS Donahue

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

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

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

    Brian King (Credit: TS Donahue)

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

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

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

    Elaine Round (Credit: TS Donahue)

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

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

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

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

    Joe Murrilo (Credit: TS Donahue)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  • Cognitive Dissonance

    Cognitive Dissonance

    Credit: Good Ideas

    Regulators often run a campaign of hypocrisy when confronting vaping.

    By George Gay

    “However, it is vital that we do not sit and wait for this data [on the long-term health impacts of using nicotine-containing products] and action is taken now to prevent any potential harms caused by vapes.”

    “However, it is crucial that any proposed regulations [on vaping] are based on robust evidence, ensuring they are effective as possible, and implemented without delay.”

    You could be forgiven for assuming that these two quotes have been taken from statements by people or organizations on different sides of the vaping debate because, on the one hand, it is said to be “vital” that action must predate the collection of data while, on the other hand, it is said to be “crucial” that the collection of data must predate action. But you would be wrong.

    The first is from the final paragraph of the Executive Summary of the August-published report from the British Medical Association (BMA: the trade union and professional body for doctors and medical students in the U.K.) titled Taking Your Breath Away: Why We Need Stronger Regulation of Vapes. The second is taken from the final paragraph of the full report.

    Would I be rude in suggesting that the BMA authors might be suffering from cognitive dissonance and that they should try healing themselves before handing out advice willy-nilly? After all, the authors, if not doctors themselves, are representatives of the U.K.’s doctors, people whose opinions those of us of the outer dark tend to accept without question in respect of matters of health.

    And this level of trust, I think, is perfectly reasonable when it comes to face-to-face consultations involving doctors and individual patients. But once doctors become involved in wider concerns, I think it is necessary to take a more jaundiced view of what they have to say.

    Once doctors stop seeing people as individuals and view them only as groups marking points on a graph, they lose that which makes them special, as when they pay more attention to your “body mass index” than to your body. At a populations level, their pronouncements are little more than opinions based not on their medical knowledge but, as in the case of the rest of us, largely on ideologies and prejudices. They become part of the “tyranny of experts.”

    In other words, it is important to keep in mind that once doctors step outside the surgery, they can be just as irrational as you or me—or you at least; let’s keep me out of this. Indeed, some time ago, I was at an event where, at the end of the evening, a person who I knew to be a senior medical doctor was doing the rounds, pouring any remaining wine from the bottles on the tables into his glass and drinking it. The event had attracted a wide range of people, from those in their early 20s to those in their 80s, and even a few teenagers.

    Sitting at a table watching this person, I started to wonder about him. Was he, for instance, an alcoholic or somebody who usually drank in moderation but was on this occasion letting his hair down? Did he understand, care, or was he too far gone to think about the example he was setting to the younger people present?

    Surely, I thought, he must be aware that any level of alcohol consumption creates health risks. Was he a hypocrite who would have been offended if I had smoked or vaped in front of the young people; was he dimmer than his qualifications would have me believe; or was he as heavily into cognitive dissonance as he seemed to be into drinking?

    I often think of this occasion when I read of medical professionals making pronouncements on smoking and vaping (but rarely on drinking). And I thought of it again when I read the BMA report, which should have been called the “however” report. You might have noticed that the two report quotes with which I started this piece both opened with the word “however.”

    Basically, the report could be summed up as one that reluctantly admits the important role that vapes can play in helping smokers quit their habit but then de facto goes on to say, “however,” we don’t like these products and therefore we are calling for them to be debased by regulation to the point where they will not appeal to anybody and smokers will return to smoking. After all, you know where you are with smoking because people have been doing it for a long time.

    The word “however” appears 16 times in the BMA report, whose text takes up only 12 pages. How many times have we seen doctors and researchers put their names to such “however” reports? Reports that purportedly aim at striking a balance between the need to keep vapes appealing enough to smokers so that they are encouraged to give up smoking while not appealing to young people but that, “however,” always come down in support of protecting from themselves a few misbehaving students from well-off families at the expense of trying to help financially impoverished smokers?

    Reports that complain about how smoking is the major cause of premature death worldwide but wind up unable to support the use of the one product that has come along that could make a real dent in the toll caused by smoking because the authors are ideologically opposed to people enjoying using nicotine.

    The authors of such reports like to sex them up by talking of an “epidemic” of vaping that is in part harming “children.” You can imagine them wringing their hands in anguish at what is happening to these middle-class, mischievous students while ignoring the fact that hundreds of thousands of children from financially impoverished families live in poverty, meaning they are undernourished, with all the negative impacts on their life chances that that entails.

    On Dec. 22, just three days before the major feast of Christmas, The Guardian newspaper led with a story titled “Revealed: huge rise in hospital admissions with malnutrition” while on page six it ran with “‘Heartbreaking’: Teachers tell of children with bowed legs and no winter coat.” The latter story, by Jessica Murray, quoted a headteacher as saying some children at her school had bowed legs because they were so deficient in vitamins.

    “We’ve had children so malnourished they’ve had heart murmurs,” the headteacher said. “It’s heartbreaking. It’s not how it should be. It’s the worst I’ve ever seen it. We’ve got two-year-olds coming in and trying to eat sand because they’re so hungry.”

    As the lead story pointed out, such deficiencies can interfere with brain and bone development and cause health problems in later life. But, despite this, there has been little follow-up of these issues since then, with space being given over rather to numerous negative stories about vaping. 

    The BMA reports on health problems visited on children by vaping but set against the damage caused by malnutrition (or any number of other causes, such as ketamine addiction), these problems are minuscule. “The NHS revealed that in 2023, 50 children were admitted to hospital with vaping-related disorders,” the report states “The U.K. has a population of more than 12 million children defined as those 0 years old to 17 years old, so 50 represents 0.0004 percent].

    “This is up from just 11 children three years previously, demonstrating the significant growth in prevalence of vaping in this age group. Vaping-related disorders can range from lung damage to worsening asthma symptoms, which include wheezing, coughing and chest tightness.”

    These numbers are tiny, and, in any case, I wonder if even they can be put down to vaping in the way that malnutrition can be put down to vitamin deficiencies. After all, we are not told how many of the children said to be suffering from the effects of vaping live in our highly polluted cities and/or in the many houses afflicted with damp and mold that are inhabited by impoverished families, but perhaps the doctors assumed that vaping children would live in comfortable houses in leafy suburbs.

    In any case, I don’t wish to sound cynical, but aren’t children suffering from asthma rather asking for trouble if they vape? After all, children who are intolerant or allergic to certain foods are taught to avoid them. We don’t seek to regulate such foods so they become unpalatable to children and adults alike.

    Why is there so much emphasis on children vaping but so little on their going hungry? There are a number of reasons, but, in my opinion, the main one has to do with the fact that coming down on vapers and smokers allows those involved to do some virtue signaling at little or no cost whereas making sure that children are properly fed needs an effort by those responsible that comes with a price tag that most are not willing to pay.

    In fact, the BMA’s report came out at a rather bad time in respect of its attitude to at least some children. The day after publication, The Guardian newspaper ran a story under the heading “BMA accused of witch hunt after transgender care leak.”

    The piece, by health policy editor Denis Campbell, described how the BMA had been heavily criticized by key medical figures since it voted on July 17 for, in effect, rejecting a report by Hilary Cass on transgender care, which put it in the position of being the only medical organization in the U.K. not to accept, and to find fault with, her findings, findings that were accepted by the previous right-of-center government and its left-of-center successor.

    Campbell wrote that the Academy of Medical Royal Colleges, which represents all U.K. doctors professionally, had criticized the BMA’s refusal to accept “the validity of the evidence and consequently the findings of the independent Cass review of gender identity services for children and young people.”

    And ignoring the rule that when in a hole, the best idea is to stop digging, the BMA allegedly undertook a “witch hunt” to try to identify which senior figure leaked that it was set to oppose the Cass review. According to Campbell, critics described the BMA’s action in this regard as “disgraceful” and “Orwellian.”

    None of this will make the slightest difference, of course. Nor will the fact that, in my opinion, the BMA report is largely a rehash of stuff that has gone before many times over because the likelihood is that the government, like the general media, will merely read and relay the recommendations, not the thinking or lack of thinking behind them. They will probably not notice that though the report’s 99 references suggest a scientific accountability, in places it reads more like an essay in that it throws out unreferenced and vague statements such as “there are concerns that,” “there is no doubt,” “many health organizations” and “can also influence belief.”

    Some of what is said seems not to be supported by evidence and amounts to little more than urban myths while some is based on the lazy idea that what happens in the future will be the same as or similar to what happened in the past unless an intervention is made.

    And how does the BMA come up with a sentence such as this: “Novel products such as nicotine pouches are a growing class of noncombustible nicotine product that pose similar public health risks as [those posed by] vapes yet are not sufficiently regulated.” One would have hoped that doctors or their representatives would have figured out that the risks must be different. One activity involves inhalation while the other does not.

    The BMA report, like many such reports in the past, comes with a helping of emotional blackmail. The word “children” is used 55 times, and the phrase “young people” is used 23 times, but while these are not used as synonyms (on 16 occasions on which each of these terms are used, they are used in combination as “children and young people”), we are not told what the difference is between them, so we can assume only that “young people” refers to those people who are 18 years of age or older but who are not middle-aged or old. The word “youth” is used 15 times and the word “adolescent” four times.

    We are also treated to “people under 18” (the usual definition of a child in the U.K., though the National Health Service sometimes refers to children as those under 16), “children 11–17,” “young fashionable models” and even the impersonal “younger market.”

    And what of the “growing epidemic” mentioned in the first sentence of the Executive Summary? Well, this is what is said in the rest of the first paragraph: “Vape use by adults has risen significantly over recent years, but more worryingly, by children and young people. 7.6 percent of 11[-year-olds to] 17-year-olds are now vaping, either regularly or occasionally, compared to 1.3 percent in 2014.”

    I’m reluctant to go to bat against the BMA on the question of an “epidemic,” but what the hey? If the “epidemic” is supposed to refer to children as well as to adults (it’s unclear), under 8 percent seems a little short of a “widespread” outbreak, which is how my dictionary in part defines an epidemic. And this is especially so when you start to pull apart that 7.6 percent figure, which is from Action on Smoking and Health (ASH).

    It is made up of 4.6 percent of “regular” vapers, who, inexplicably, in my view,* are defined as those vaping more than once a week, and 3.1 percent of occasional vapers, defined as those who vape “less than once a week,” which means, I assume, they could vape only once a month, once a year or once a millennium. (*Imagine the reaction of your doctor when, on asking you whether you had regular bowel movements, you said, “Oh yes, more than once a week!”) 

    The truth of the matter is that, as part of this “epidemic,” “ever vaping” (a category it is safe to assume includes even those children who once looked sideways at a vape) fell between 2023 and 2024 in respect of all age groups examined. Of course, this is true only if the figures are correct. I guess the ASH figures are based on “self-reporting,” and it often puzzles me how those collecting data will accept the word of people, some of whom are breaking rules.

    The report seems to me to be poorly written. Take this sentence from the Executive Summary: “The availability of disposable vapes is clearly linked to the sharp rise in child use.” It seems that the BMA is mixing up cause and effect. According to it, the rise in the use of disposable vapes by children has caused the availability of disposable vapes. Well, not caused, because it clearly cannot state that, so it uses the word “linked,” which it hopes will do the same job as “cause” in the minds of the readers. Like I can say my bed is linked to my sleeping, and my knife and fork are linked to my eating.

    This linking business seems to be linked to an ASH graph that appears under the title “Rapid rise in youth vaping 2021–2023 associated with [not linked to, but associated with] growth in use of disposables.” But the graph seems to show nothing of the sort. Rather, as a subheading indicates, it graphs the “Proportion of vapers of all ages who mainly use disposable vapes, by age.” And the BMA does not mention that between 2023 and 2024, the proportion of 11-year-old to 17-year-old vapers who mainly used disposable vapes fell from 69 percent to 54 percent.

    This might come as a surprise, but I am on the same page as the BMA when it comes to one issue: the need, from an environmental perspective, to ban disposable vapes. Companies and consumers have proved time and time again that they are unwilling or unable to dispose of these and other consumer products and their packagings in a manner that does the minimum damage to the environment. They, like much of the rest of the population, seem to be so dim that they cannot absorb the simple but vital environmental message so eloquently expressed about another matter in the film Moonstruck: Don’t shit where you eat.

    Where I diverge from the BMA’s stance is at the point at which it is not willing to accept those products that have been designed by parts of the vaping industry to address these environmental concerns while still offering the positive usage characteristics of disposables.

    In fact, the report’s first recommendation is that the U.K. government bans “the manufacture for commercial sale and the commercial sale of all disposable vapes ….” I’m not sure how far the BMA imagines the U.K. government’s writ runs in such matters, but I would assume that at least a number of China-based manufacturers would be somewhat bemused by such an idea.

    But the BMA, while it is ready with its vaping advice, seems to be rather lost when it comes to the world of vaping. It bemoans the fact that the “nicotine contained in one disposable vape can be equal to [that in] two packs of cigarettes.”

    What is the problem here? It is not the quantity of nicotine in a device that counts but the amount of nicotine delivered to the user, and the amount of nicotine delivered is controlled by the vaper. And surely, if the BMA were really concerned about the environmental consequences of disposables, it would welcome bigger nicotine reservoirs.

    Bizarrely, the BMA also talks of vapes not containing tar. Well, no, but then neither do cigarettes; the tar is a product of the combustion process after a cigarette’s tobacco is set alight. And there is no tobacco in a vape and no combustion process.

    And finally, the BMA notes that “[a]s more young people are using disposable vapes and using them more frequently, there are concerns that they are at significant risk of addiction to nicotine.” Here the risk is probably being exaggerated. According to ASH figures, more 11-year-olds to 17-year-olds (9.5 percent) try vaping only once or twice than go on to become either regular or occasional users (7.6 percent), and 1.3 percent are classed as having been vapers but having quit.

    The question should at least be asked about how this 1.3 percent threw off this appalling addiction. Perhaps they returned to smoking, or did they just get bored with vaping? Young people get bored with things quite easily. That’s the main difference between old people and young folk. The former hang onto the past with a vice-like grip because they cannot compete in the present while the latter want to move on; they are hungry for the future. You can see this reflected in the charts of ASH and the dark forebodings of the BMA that are issued even as the young are moving on, beyond last year’s concerns.

    The report’s second recommendation and the one that has attracted most criticism calls for a ban on all nontobacco vape flavors. The BMA is clearly against vaping, and here at least the organization nails its colors to the mast but not without hitting its thumb in the process.

    Look at this sentence from the report, bearing in mind that the report is supposed to be a serious attempt at influencing government policy and presumably was read by any number of people before being loosed on the world: “However, like children, fruit flavors are the most popular with adults.” Hmm.

    Recommendation three, if implemented, would degrade the aesthetics of vaping devices and their packaging, which would make them less appealing to smokers, a move that would be simply vindictive since the BMA also wants, according to recommendation four, for these products to be kept out of sight at retailers.

    And just in case there were any doubt that the BMA is against vaping full stop, part of recommendation five calls for a government-funded and government-delivered “education campaign”—read propaganda—to warn the public “on the dangers of vapes to reduce appeal.” Again, an awful phrase, but we can figure out what is meant.

    Recommendation five includes some sensible ideas about policing the retail environment, but these are measures that the industry, at least in the form of the U.K. Vaping Industry Association, has been calling for for years. In fact, the recommendations do not go as far as the UKVIA has suggested, though there are signs that the government might be starting to favor the suggestion about licensing retailers that sell vapes.

    This is sensible. Most of the problems that vaping throws up have been caused by 14-years-and-counting of austerity under which the authorities responsible for overseeing retailing have been starved of funds so that checking the import, compliance and retail sale of these products has been nowhere near as vigorous as it should have been.

    But somehow, it is the smoker and the vaper who must be punished for these failures. Children are being naughty in using these products, manufacturers are putting noncompliant products on the market, retailers are selling vapes illegally, the authorities are failing in their duty to stop this abuse, but it is the people who are not doing anything wrong, the smokers and vapers, who are to be made to suffer.

    Recommendation six merely expands the report’s ideas, if you can call them that, to other nicotine products but not to traditional tobacco products.

    I think that one of the problems identified above is that the opinions of doctors should not be given too much credence when they are based on issues that go beyond their individual patients. We know that a lot of medical doctors still believe erroneously that nicotine causes cancer.

    And in a letter to The Guardian at the beginning of September in response to a government proposal to ban smoking in beer gardens, James Scott wrote, in part, “Tobacco is unique among the substances that humans use: When used exactly as intended by the manufacturer, it will harm and eventually kill its consumers. It is categorically different from alcohol and other drugs humans use and needs to be treated as such.”

    This completely ignores recent findings that drinking alcohol also harms and eventually kills its consumers when used exactly as intended. Writing in The Guardian on Aug. 21, Devi Shridhar, chair of global public health at the University of Edinburgh, pointed out that the World Health Organization had stated in January 2023 that there was no safe level of drinking. “The agency highlighted that alcohol causes at least seven types of cancer and that ethanol (alcohol) directly causes cancer when our cells break it down,” Sridhar wrote.

    But of course, it goes so much further than the direct harm caused by consumption. Smokers, unlike drinkers, do not go home and assault their partners just because they have been smoking. They do not start fights in the street just because they have been smoking, and they do not cause vehicle “accidents” just because they have been smoking.

    The problem is that you must have a wide view of society to see things clearly, in the round. On the same day that Scott’s letter was published about the proposed ban on smoking in beer gardens, there was a letter from Robert Lee, the contents of which anybody who has been involved in magistrate court proceedings would recognize as being right on the money.

    “The government’s almost evangelical crackdown on smoking contrasts sharply with its attitude to alcohol, which is responsible for more problems,” Lee wrote. “I sat as a magistrate for many years, and a huge proportion of offenses were directly or indirectly linked to alcohol. But I never heard a defense lawyer plead in mitigation that their client had smoked too many cigarettes.”

    And I cannot imagine that excessive vaping will ever be cited as mitigation in such proceedings. There is only one reason why smoking tobacco and vaping nicotine are under constant attack by all and sundry while drinking ethanol is not, and that is because the U.K. runs on hypocrisy. Let them eat sand.

  • Tools to Quit

    Tools to Quit

    Credit: Qnovia

    The RespiRx, the first inhalable nicotine-replacement therapy, gains IND clearance.

    By VV staff

    A Virginia-based pharmaceutical company is developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform. Qnovia announced that its RespiRxNicotine Inhaler (QN-01) received clearance for its Investigational New Drug (IND) application by the U.S. Food and Drug Administration.

    The company will initiate a Phase 1, randomized, crossover, open-label trial in the U.S. to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes, according to Brian Quigley, CEO of Qnovia.

    “The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company. Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine-replacement therapies [NRTs],” said Quigley. “The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison.

    “We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission to the MHRA [Medicines and Healthcare products Regulatory Agency] in 2026.”

    Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to Mitch Zeller, the former director of the FDA’s Center for Tobacco Products, who is now serving as Qnovia’s policy and regulatory strategy advisor.

    “There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Zeller. “There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit.”

    Qnovia’s goal is for RespiRx to be the first inhaled prescription smoking cessation therapy product, Quigley told Vapor Voice last year (“Licensed to Thrive,” Issue 1, 2023, page ?). 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 by-products.

    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.

    Credit: Qnovia

    “The nebulizing unit (cartridge) gets replaced by the patient every one [day] 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.”

    Mario Danek, Qnovia’s founder and chief technical officer, agrees that eliminating the cleaning requirement was a priority. “The idea was to create a technology that emulates the form factor of a successful high-adoption consumer product but that is imbued with technologies that would pass CDER’s [Center for Drug Evaluation and Research] stringent standard for safety—combined with Qnovia’s purposeful design features, it should bring patient adherence and quit rates to new highs, which historically have been found lacking in NRT,” he said. “Additionally, from a drug delivery platform perspective, those CDER-aligned device safety requirements are just as imperative to Qnovia’s API expansion strategy into other indication areas.”

    RespiRx is a “step-down” therapy, like many NRT products. However, instead of buying different pods with varying levels of nicotine, Qnovia’s device has a dosage-monitoring system programmed into the device. Uniquely, the use regimen is determined based on how much a smoker is smoking, said Quigley. For example, a one-pack-a-day smoker would start with 20 doses per day. The two-pack-a-day smoker would start with 40 doses per day.

    “Then the device will, over the 12 weeks, gradually reduce the available number of doses to that patient. It is a much more manageable step-down over the 12 weeks, unlike currently available cessation methods. And the device itself will prevent the patient from using more than they’re supposed to use,” said Quigley. “Patients would also have the on-device LCD screen interface to help them understand how to use their doses. That, too, is another benefit of our product versus the existing smoking cessation therapies.”

    Danek said the company is proud to lead the charge in encouraging the innovation and development of safe and effective pharmacotherapies to help the millions of smokers who are trying to quit smoking.

    “We believe our proprietary drug delivery platform has the potential to be a highly differentiated treatment option not only for treatment of nicotine dependence but for a wide variety of treatments that would benefit from inhaled drug delivery,” said Danek.

  • Myriad Issues

    Myriad Issues

    Credit: Phaisarnwong2517

    Industry experts explain why vaping regulations vary throughout Southeast Asia.

    By Norm Bour

    After living in Southeast Asia for the past year, I don’t have much more clarity about the vaping laws here than when I arrived. There is no commonality and no correlation between countries. And in many cases, there is no common sense either.

    In the U.S., England and other large countries, there is usually just one regulatory agency in control, the proverbial Goliath to be fought by the Davids out there. The U.S. Food and Drug Administration has been the American tormentor for the dozen years I have been in the vaping industry, and even though some states—and in some cases cities—have instituted their own guidelines (thank you, San Francisco, for your 2018 flavor ban), at least the “enemy” is understood.

    To get a better feel of what I might be missing, I contacted highly regarded and well-known Ecigintelligence and its parent company, Tamarind, which has offices in Barcelona, London and New York. They were kind enough to get thoughts from several of their team members.

    Legal analyst Sergi Riudalbas Clemente identified Malaysia and Indonesia as being the furthest along regarding specific regulations for vaping in their countries.

    “Malaysia and Indonesia have wanted to regulate these products for a long time, and they have finally decided to do so. This entails a comprehensive regulatory framework, in contrast to what other Asian countries have decided to do, which is to ban these products,” said Clemente, and I agree with those directions since they are attempting to control rather than ban the products, as they do in Thailand, one of the most draconian markets.

    One of the biggest problems Clemente identified is that “harm reduction is never acknowledged, thus vaping is treated equally to tobacco products,” which is a misstep.

    Freddie Dawson, who has also spent a decade in the industry, serves as managing editor at Tamarind Intelligence. According to him, one of the biggest culprits pushing the anti-vape message is the World Health Organization, which has historically focused on scare tactics like “accidental poisoning, youth corruption and unexpected consequences and side effects.”

    Of the four Asian countries I have lived in since last year, just one, Malaysia, seems to take a commonsense and open-minded look at the vape scene. Dawson sees Malaysia following that same direction on the one “good” hand but Thailand staying the course on the other “bad” hand.

    Another Tamarind employee, legal analyst Fernanda Tucunduva, cited a scary statistic from Vietnam. “Data from the authorities show that the use rate of e-cigarettes by young people (13–15) increased from 3.5 percent to 8 percent in one year,” Tucunduva said. “This is a big jump and seems to reflect a shifting preference among younger populations toward vaping and other nicotine alternatives.”

    According to Statista, in Southeast Asia, the revenue generated in the e-cigarette market is projected to reach $700 million in 2024. The market is anticipated to experience a compound annual growth rate of 1.85 percent between 2024 and 2029. Compared globally, the United States leads in revenue generation, with an estimated $8.83 billion in 2024. Considering the total population figures, the per-person revenue in Southeast Asia is expected to be $1.25 in 2024. In Singapore, the strict regulations on e-cigarettes have led to a decrease in popularity and limited market growth.

    As much as disposables have been a double-edged sword—convenient on the one hand, easily concealable on the other—it’s hard not to point at them as a catalyst to underage vaping. With such low price points and various options, there is something to suit anyone’s tastes.

    Overall, in Asia, as well as the rest of the world, two enormous problems are limiting the vape market: education and the enforceability of the laws. Eva Antal, the group’s director of market analysis, shared her thoughts about the youth market in Vietnam and addressed the youths’tendencies to follow the crowd.

    “It is true that younger age groups are more likely to experiment and that disposables are very easy to use, but it’s very hard to prove if that person would have started smoking if vapes were not around, and sad as that is, it is extraordinarily accurate,” she said. “Cigarettes have appealed to the youth market as long as kids looked for ways to rebel against their parents, authorities and society as a whole.

    “Decades ago, before cigarettes were identified as being the cancer-causing vehicles they are, most parents discouraged their kids from doing it, but since they probably did it themselves, they didn’t want to appear hypocritical.”

    In developing nations, cigarettes are too prevalent and familiar, and seeing construction workers and vendors smoking in the streets is an everyday situation. When I wrote in an earlier article about Vietnamese cigarettes being crazy cheap at a price of $1.33 (second only to Nigeria), I was reminded that that price was a significant percentage of their gross income.

    Dawson reiterates the enforceability issue as significant in Asia and elsewhere. Vapers more often do not make their own vaping devices; they buy them somewhere.

    He writes, “In the American market, 99 percent of the products currently being sold are technically illegal as they do not have a PMTA [premarket tobacco product application] market authorization.” Whether we are critical of the entire PMTA process or just its convoluted nature, these two wrongs do not make a right.

    “In Australia, Uber drivers were, until recently at least, openly advertising the sale of e-cigarettes despite there being a prohibition in place,” stated Dawson.

    Malaysia may be at the forefront of regulation in Southeast Asia with its Generational Endgame provision, which was part of the Control of Smoking Products for Public Health Act 2024.

    It appears that industry pressure from various places has kept this regulation off the table. It would have prohibited the sale of vaping and tobacco products to anyone born after Jan. 1, 2007, and two different Tamarind persons indicated that there seem to be political and financial motives to keep things at the status quo.

    Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.