Category: Uncategorized

  • Warm Reception?

    Warm Reception?

    Photo: Ina

    How heated tobacco might change the US

    By Cheryl K. Olson

    A new kind of nicotine alternative is sidling back onto the U.S. market. Modern heated-tobacco products (HTPs) were gone before most Americans knew they even existed. After a limited test, a patent dispute took them off U.S. shelves in 2021.

    The gradual return of HTPs has just begun, with a single brand. Within a few years, Americans will likely have access to multiple options now sold in other nations. 

    Conversations with a close family friend, a former pack-a-day smoker, piqued my interest in the potential of heated tobacco. While working for the European Union from Spain, he had sought out and rejected cigarette alternatives, from vapes to nicotine gum. For him, heated tobacco was a “radically different” revelation.

    “It soothed my needs. It felt right and reassuring,” he told me. “From the moment I bought my IQOS, in 2017, I never smoked a cigarette again.”

    Here’s a quick introduction to heated tobacco and its potential to attract and benefit Americans who smoke.

    What HTPs Are and Aren’t

    I asked Corey Henry, director of U.S. communications at Philip Morris International, to help me understand this product category. Basically, an HTP involves electronically heating a stick or capsule of tobacco to beneath the point of combustion, so it releases an aerosol but doesn’t burn. The design of the heating element varies.

    The primary difference between an HTP and an e-cigarette? “A heated-tobacco product has to have some tobacco presence, whether it’s a leaf or paste,” says Henry.

    HTP ancestors included Premier and Eclipse from R.J. Reynolds. These products were not electronic. The heat came from lighting a carbon tip (which glowed like a piece of charcoal on a barbecue); it was distributed through a rod. This approach did reduce some toxicants. PMI introduced the first electronic HTPs, including Accord in the U.S. and Heatbar in Germany.

    According to the Financial Times, HTPs have enjoyed steady worldwide growth, exceeding that of vaping. The global HTP retail market value is estimated to reach $38.9 billion this year. The largest markets thus far include Japan, Italy and South Korea. In addition to IQOS, major brands include BAT’s Glo and Japan Tobacco’s Ploom. 

    American Evolution

    The U.S. Food and Drug Administration first authorized the marketing of an IQOS “heat-not-burn” system in 2019. This included a holder and charger device plus several types of heated-tobacco units, called Heatsticks. That year, IQOS was gradually introduced in several Southeastern U.S. test markets by Philip Morris USA/Altria. Due to a dispute with R.J. Reynolds over technology patent infringement, IQOS left the U.S. market after just two years.

    In early 2024, PMI took over from Altria the exclusive U.S. commercialization rights to the IQOS tobacco-heating system. After some delay, the IQOS3 model (authorized by the FDA in 2021) will test-launch in Austin, Texas, this fall. Henry noted that internationally, IQOS launches usually start in one or two cities. “You can make assumptions going in, but then you’ve got to test those assumptions and adjust, adapt.”

    The national rollout of IQOS awaits the FDA’s OK of the latest evolution of IQOS, called Iluma. Applications were submitted to the FDA in October 2023; marketing authorization is anticipated in the second half of 2025. Iluma features various upgrades, including a slightly different heating technology and distinctive tobacco sticks. IQOS Iluma is available internationally in over two dozen markets.

    “There’s a great level of interest to see how IQOS does in the U.S., so they want to see it launch and expand rapidly,” says Henry. “What we say is patience. There’s 28 million smokers, there’s 50 states—it’s basically like the European Union.”

    U.S. HTP competitors are on the horizon. For example, a BAT submission for Glo has been under FDA review since 2021, along with a modified-risk tobacco product application submitted in 2023. Altria has partnered with JT Group to submit a PMTA to the FDA with the goal of bringing Ploom to the U.S. 

    The FDA’s list of authorized e-cigarettes includes a Logic Vapeleaf product that vaporizes capsules that contain tobacco. This is technically a heated-tobacco product. The product appears to be no longer marketed.

    Attractions and Risks

    One reason for a slow U.S. rollout is the low level of familiarity with heated tobacco. People need to get clear on the basics: It generates an aerosol; it doesn’t burn tobacco.

    “There’s always an initial period of awareness and education that you have to do with adults who smoke, to help them understand what it is and what it isn’t,” says Henry. “When people hear the concept, the reaction is, ‘So … it’s like vaping?’”

    We don’t even know how much awareness or confusion may exist. A large government survey fielded in May 2019 asked whether adults had heard of or tried heated-tobacco products (or heat-not-burn). Overall, 8.6 percent said they had heard of heated tobacco, and one-half of 1 percent had tried it. Here’s the catch: The brands mentioned in the survey questions were IQOS, Glo and Eclipse. Respondents who claimed knowledge of heated tobacco were likely thinking of the outdated Eclipse.

    Responses to the 2023 National Youth Tobacco Survey are another example. One percent of respondents (representing 370,000 teens) claimed to have used an HTP. Given that the category was not sold anywhere in the U.S. at the time, this is impossible; it can only be a misunderstanding. The next few youth surveys in the U.S. will require cautious interpretation of this topic.

    What makes us think people who smoke will switch to HTPs? Randomized controlled studies have shown that vaping works to help people stop smoking, even those without plans to quit. For HTPs, we’re not there yet. That kind of evidence would raise the comfort level of health professionals and public health advocates. An Italian trial found good results for HTPs, comparable to e-cigarettes, for smoking cessation.

    Japan makes a good test of HTPs’ potential; sales of e-cigarettes are restricted, and oral products are culturally unappealing. Reduced-risk products are reportedly close to 40 percent of total tobacco industry volume in Japan, with cigarette sales nearly halved since 2015. The latest estimates suggest nearly 12 percent of adults use HTPs. It’s less clear yet how many switch completely from cigarettes to HTPs.

    According to Henry, PMI’s research finds that internationally, about 72 percent of smokers who switch to IQOS do so fully. He anticipates similar results in the U.S.

    Do people have lower exposure to some toxicants and carcinogens when they use HTPs instead of cigarettes? A Cochrane review of randomized controlled trials found moderate-certainty evidence for that. Also, the FDA authorized IQOS 2.4 and 3.0 versions to be marketed with reduced-exposure messaging. Specifically, “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

    ‘Easier to Navigate’

    HTPs are designed to mimic the physical sensations of smoking. “We think that bridge is a little easier to navigate with heated tobacco because there’s a level of familiarity,” says Henry. For example, “Your experience with an IQOS heat stick is six minutes or 14 puffs, about the same time that a smoker will smoke a cigarette.”

    Due to this familiarity, my friend in Spain found switching to heated tobacco a quick and smooth adjustment. “With a coffee, when talking with someone, the routine in which I use IQOS is identical to my routine when I smoked,” he said. He learned to keep an extra charger at his office and in his car.

    “The charger you hold in your hand has a very nice feel,” he said. “It’s light, it fits anywhere. So I didn’t miss having a cigarette in my hand,” he said. He also praised the absence of stale smoke smell in his home, car and clothing.

    What else might attract Americans to heated tobacco? One U.K. survey of nicotine users found that common reasons for trying HTPs included curiosity; lack of smell, smoke and ashes; greater social acceptability; wanting to cut down or quit cigarette use; and enjoying the flavors or taste.

    A Harm Reduction Journal study of the U.S. IQOS experience found that people who switched to the initial version were somewhat more educated and higher-income than the average smoking adult. That’s not unusual for early adopters of a new technology. It will be interesting to see how use patterns evolve as people get familiar with the device and see others switch to it. 

    A Role to Play

    Some health advocacy groups have criticized PMI’s claims, suggesting that benefits of IQOS had been overstated. I’ve often wondered how my public health colleagues would view vaping if it had been framed differently at the start. Vaping burst into wide awareness as the subject of a youth-use moral panic. That first impression is hard to overcome. I applaud a careful, gradual, unflashy U.S. reintroduction for HTPs.

    As one industry observer pointed out to me, the few e-cigarettes now authorized for sale by the FDA represent older technologies. New HTP technologies entering the market may benefit from that contrast. Another unknown affecting the fate of HTPs is whether sticks will be taxed like cigarettes or at a lower rate that encourages switching.  

    Now that nondeadly alternatives to smoking exist, it’s critical to speed up switching for those who can’t or don’t want to quit. More options are most welcome. 

    “There really isn’t a silver-bullet solution for smoke-free product alternatives,” says Henry. “It’s important that we distinguish heated tobacco from e-vapor, but in a way that isn’t disparaging. They each have a role to play.”

  • Unfinished Business

    Unfinished Business

    Photos courtesy of FOREST

    Despite changing attitudes, FOREST still has an important role to play, says Director Simon Clark.

    By George Gay

    Simon Clark readily admits that some people, even some people operating within the tobacco/nicotine industry, see the Freedom Organisation for the Right to Enjoy Smoking Tobacco (FOREST), of which he is the director, as something of a dinosaur. Indeed, he feels it is part of his job to counter this idea by letting it be known that FOREST is fighting for timeless principles—those of freedom of choice and personal responsibility.

    Not only are these principles timeless, in fact; they are universal in the sense that they apply to all consumer products, not only tobacco in its smoked form, as the name of the organization suggests. For the past 45 years, while not promoting the consumption or use of any product, FOREST has defended the rights of adult consumers, properly informed, to enjoy, without being harassed by excessive regulation, any product that may be sold legally in the U.K.

    But what is of course most impressive is that FOREST, almost uniquely, has been willing to stand up publicly for the rights of cigarette smokers, who, though still amounting to more than 6 million people, have been treated like outcasts by much of polite society—like people of the wrong class, people considered to be without agency, without the mental capacity to make the “right” choices for themselves.

    And, regrettably, it is not only the public health community that has tried to “denormalize” cigarette smokers in this way. In recent years, so too have large swathes of the tobacco/nicotine industry—those who would sell cigarette smokers alternative lower-risk nicotine products, some of them while still selling cigarettes. Many of these companies and organizations have acquiesced in the face of claims that smoking is a “problem” that must be solved rather than a legal activity that provides enjoyment, in various ways, to those who indulge in it.

    The Slippery Slope

    Clark, a nonsmoker, should not be seen as a dinosaur, however, because he and FOREST have long supported the idea of offering cigarette smokers alternative lower-risk products, but the emphasis is on “offering.” He views with dismay verging on disdain the way that some in the tobacco/nicotine industry are willing to throw cigarette smokers under the bus by supporting government efforts to eradicate cigarette smoking and, indeed, tobacco consumption in all forms. And he has a point. Shortly after I met up with Clark in London in July, an email dropped into my inbox with news from the U.K. Vaping Industry Association, toward the end of which was this sentence: “Furthermore, the vaping industry is all about [my emphasis] achieving a smoke-free Britain, and we look forward to working with the new government’s initiatives that support this, as long as it doesn’t damage the vast potential of vaping as our best hope for getting there.’”

    Hmm, you really must be careful what you wish for, and Clark has a salutary message for tobacco/nicotine companies and organizations that align closely with public health, including Philip Morris International, which, while selling combustible cigarettes, are calling for their eradication. He is convinced that once those public health organizations that are now trying to eradicate tobacco smoking do so to their satisfaction, they will go after nicotine consumption using the successful playbook they have honed in respect of cigarette smoking. And, in part, those offering the main forms of alternative products are laying the groundwork for their own demise. By trying to promote their products as therapeutic devices whose only purpose is to provide a way for smokers to quit combustible cigarettes, they are setting a time limit on these products’ useful lifespans. And by supporting the government’s efforts to meet its 2030 target (in England—other nations within the U.K. have their own targets) of ending tobacco smoking, they are further limiting those lifespans.

    Perhaps it might be as well if those attempting to wipe out cigarette smoking revisit their dinosaur imagery. When the dinosaurs were wiped out in the great extinction event of more than 60 million years ago, about three-quarters of all animal species went with them—for the same reasons. Surely, the time has come when it is necessary for those promoting vaping and other tobacco-smoking alternatives to say that they are so confident about the safety of their products that they see no reason why nonsmokers should not consume them.

    Looking Ahead

    I met up with Clark because I was interested to know if, in this, FOREST’s 45th anniversary year, he believed that the organization would be around to celebrate 50 years. “I’m more hopeful now than I was a few years ago that we will get to our 50th,” he said. “I wouldn’t keep FOREST going just for the sheer hell of it. I genuinely think we still have a part to play in the political process.”

    But he is cautious, saying he takes one year at a time, partly because he doesn’t take FOREST’s funding for granted. Philip Morris, never a major source of funding, made its last donation to FOREST in 1997, two years before Clark became FOREST’s director, while BAT, the first company to support the organization, pulled its funding three years or four years ago. That leaves Imperial and Japan Tobacco, the two major tobacco companies on the U.K market.

    Perhaps the split with BAT was inevitable. While Clark says he understands the political and business reasons behind the shift in focus toward lower-risk products, I think the company’s latest claim to be creating a better tomorrow by building a smokeless world would be a little paternalistic and get stuck in the craw of this lifelong libertarian. The trouble here is that by claiming to be able to create a better tomorrow, BAT seems to be saying that everybody must sign up to the same idea of what constitutes a better tomorrow, riding roughshod over Clark and FOREST’s cherished principle of freedom of choice.

    This is not to say that Clark is trying to bite the hand that feeds FOREST or that used to feed it. This is part of what he had to say at a gala dinner marking FOREST’s 40th anniversary, sentiments that he stands by today. “Finally, I’d like to thank the tobacco companies who have supported FOREST for 40 years. We don’t take the companies’ support for granted, and we know that society’s relationship with smoking has changed and will continue to change, and we also know that the companies are changing and moving toward safer nicotine products, as indeed they should.

    “FOREST’s focus is also evolving to embrace and support risk reduction products, but as long as there are adults who choose to smoke, enjoy smoking and don’t want to quit, we will never abandon them because it’s our belief that choice and personal responsibility are paramount.”

    Work Remains

    FOREST is not making a big thing of its 45th anniversary because it believes there is so much going on regarding tobacco smoking regulations that a celebration would have been self-indulgent. Even at its annual lunch, held at the Boisdale restaurant in London in May, which would have provided a suitable vehicle for a celebration, Clark demurred, instead using the occasion to carry forward its campaign to Beat the Ban—the generational ban on selling tobacco products, which, at that time, was making its way through parliament with cross-party support.

    As it turned out, an election was called, and the tobacco and vapes bill that included the ban was abandoned. But that, of course, is not the end of the matter. The new government has committed to resurrecting the bill, though what form it will take is not clear.

    And there is more to come. All tobacco issues in England are likely to be geared around 2030, when smoking is due to have been eradicated from the country—or, rather, in line with the strange way of such matters, is due to be reduced to about 5 percent from the current 13 percent. Clark expects that efforts will be made to reduce the number of outlets allowed to sell cigarettes, and he predicts that pressure will be applied to ban smoking in more outdoor areas, including beaches, which is ironic given that for many people, beaches have become no-go areas due to the illegal but wholesale dumping of untreated sewage into our seas and waterways. He also believes that the generational tobacco sales ban will collapse under the weight of its own absurdities but rather than be abandoned will form the basis for public health, having itself upset the generational balance and harmony, to call for the generational playing field to be leveled up by banning the sale of cigarettes to everybody. Politically, this sort of strategy is called “Building on failure.”

    Education Instead of Coercion

    To be clear, though, Clark has no problem with falling smoking rates; as he says, societies change, but he is concerned that the apparently arbitrary 2030 target date is going to be the springboard for more draconian regulations as the government sees that it has no chance of meeting it. He believes the government’s role should extend no further than educating people about the dangers of certain activities, including smoking, though he emphasizes that education should not include propaganda and fearmongering. Once governments start to exaggerate health risks, they lose their audience, he says. And he has no truck with the use of punitive rates of taxation, which amount to attempts at social engineering and in part lead to the government’s losing control of the market to illicit operators at the expense of the retail sector.

    One of Clark’s big concerns is that governments are, in this way, increasingly interfering in all manner of people’s lifestyle choices by attacking those choices rather than their likely causes. Noting that smokers are more prevalent in deprived areas, governments have chosen to double down on anti-tobacco activities in those areas rather than taking the more difficult route of attacking the cause of the deprivation.

    While such things make him angry, so that at times he can come across as quite cross, he also tends to see the funny side of things. With a twinkle in his eye, he told me it was interesting how many senior politicians whose periods in power were going pear-shaped would choose an easy target, such as smoking, to bolster their flagging legacies. Theresa May, as prime minister, had hit on the 2030 target date, seemingly without much evidence to support the relevance of that year, and Rishi Sunak, as prime minister, had lifted the generational tobacco sales ban from an opposition idea.

    Finally, it would be amiss not to mention the word enjoyment, which is very much part of the FOREST name and credo but can get overlooked because the organization is continually fighting fires. Clark said that one of the things he was most proud of during his time as director of FOREST was his commissioning eight years ago of a study by the Centre for Substance Use Research in Glasgow, Scotland, into the attitudes of about 600 confirmed smokers: people who smoked and didn’t want to quit. “The pleasure of smoking: The views of confirmed smokers” found that more than 90 percent of respondents smoked because they enjoyed it and derived pleasure from smoking. Just over half said they were probably addicted to smoking but didn’t care because the pleasure outweighed the addiction.

    The results of the study did not receive a great deal of media attention, probably because it goes against the received idea that smoking is a disgusting habit that most smokers wish they had never started and would not start given their time again. But one of the things that I take away from the study is Clark’s courage in commissioning it in the face of such received ideas. And partly because of his courage in standing up for what many think is a lost cause, smokers can be thankful that this “dinosaur” hopes he will be in charge as FOREST approaches its 50th anniversary. “I still enjoy my job,” he said. “I still think I have something to offer. I still get a kick out of it. And I still think we have a role to play.”

  • And the Winners are …

    And the Winners are …

    Announcing the 2024 recipients of the Golden Leaf Awards

    TR Staff Report

    Tobacco Reporter presented its 2024 Golden Leaf Awards Sept. 25 during a festive ceremony at the Agora Riviera Restaurant in Kavouri, near the site of this year’s Global Tobacco and Nicotine Forum in Athens. Sponsored exclusively by paper and packaging solution provider BMJ of Indonesia, the Golden Leaf Awards recognize excellence in the nicotine sector in the midst of our industry’s unprecedented transition.  

    Photos: Timothy Donahue

    ARAC received a Golden Leaf Award for its outstanding service to the industry. Renowned for its expertise in social and behavioral sciences, the company specializes in data-driven research and analysis, providing customized solutions to manufacturers, public health advocates, regulatory agencies and industry consultants globally.

    ARAC’s comprehensive services include surveys, interviews, focus groups, label development, usability studies and clinical behavioral studies, all aimed at advancing tobacco harm reduction.

    The company has transformed from a consultancy to a fully staffed contract research firm. The expanded team brings unmatched expertise to every project, ensuring comprehensive and impactful results. ARAC’s internal team of psychologists, statisticians, behavioral scientists and business development specialists boast over a half-century of industry expertise.

    The in-house survey methodologist and medical monitoring team enhances its standardization and facility training with on-site clinical assessments and proper sample distribution.

    ARAC assists clients worldwide in product development and consumer research supporting innovation and next-generation products, with a focused expertise on the regulatory sciences for U.S. applications, including premarket tobacco product applications, modified-risk tobacco product applications and substantial equivalence procedures.

    Greentank was recognized for its Quantum Vape, a state-of-the-art heating chip that replaces traditional cotton wick and ceramic heating elements. The technology outperforms other leading atomization products on key safety metrics, including harmful and potentially harmful constituents (HPHCs) and metals. It also delivers superior flavor and a consistent consumer experience.

    The Quantum Vape represents a breakthrough in inhalation science with the potential to catapult the industry beyond the current generation of atomization technology. Whereas most developments in recent years have amounted to tweaks of substrates and print materials, Greentank’s is the first in years to explore an entirely new foundation.

    Among other benefits, the heating chip eliminates the risk of thermal cycling, therefore ensuring unprecedented levels of flavor consistency. Innovative assembly technologies ensure the heating chip emits no ceramic particle emissions and contains the lowest levels of HPHCs. While it’s not possible to claim complete absence, third-party testing and rigorous chemical analysis have found HPHCs to be at undetectable levels.

    With its Quantum Vape, Greentank aims to lead the market toward a safer and better future.

    Koerber took home the BMJ Most Committed to Quality Golden Leaf Award for its unwavering support of the nicotine business for nearly 80 years. Since its creation, the Hamburg-based company has consistently pushed the envelope with groundbreaking technologies, enabling the nicotine industry to produce ever more efficiently without compromising quality.

    Koerber’s filter machines continue to set the global standard while its legendary Protos cigarette-making machines lead the market worldwide. Over the years, the company has added, organically and through acquisitions, many competences, including in physical measuring, foreign matter detection and smoke analysis, along with primary machinery, recon equipment and flavors.

    As the nicotine business moves to its next chapter, Koerber is again at the forefront, developing equipment for the manufacture of cigarette alternatives such as tobacco-heating products.

    In creating the technology to manufacture tomorrow’s products, the company leverages not only the expertise developed in the traditional tobacco business but also the pioneering mindset that has kept it at the cutting edge of nicotine technology for more than three quarters of a century.

    Photo: Taco Tuinstra

    The Kutsaga Tobacco Research Board was recognized for its efforts to promote sustainable growth. Eager to capture more value from its tobacco business, Zimbabwe aims to build a $5 billion industry by 2025 by expanding cultivation and moving up the value chain. With seed sales of more than 1 million grams as of Aug. 1, according to The Herald, the nation is poised to set new production records in the upcoming growing season.

    To promote farmer viability and minimize the environmental impact of growth, Zimbabwe aims to increase production without laying claim to significantly more farmland. Kutsaga has contributed to those goals by developing seed varieties that are not only more productive but also more resilient, helping farmers cope with challenges such as pests and climate change.

    In addition, the research board has been helping growers become more productive by reducing post-harvest losses. Zimbabwean tobacco production is dominated by smallholders who use wood as a fuel for tobacco growing. To address deforestation, Kutsaga has been developing sustainable wood sources and more efficient curing methods.

    SindiTabaco received a Golden Leaf Award for its role in coordinating relief efforts after Brazil’s Rio Grande do Sul state in May suffered the worst floods in living memory. In all, the deluge impacted 1,929 rural properties in 75 municipalities. Candelaria was worst impacted, with 214 tobacco farmers suffering losses.

    As one of the world’s leading tobacco-growing areas, Rio Grande do Sul plays a key role in global leaf supply. To help flood victims, SindiTabaco and its member companies donated basic food items, cleaning supplies, hygiene kits and furniture. They also provided personal loans for reconstruction and offered mental support from psychologists. In addition, tobacco companies and associations made available power generators and water tanks as well as boats and vehicles to rescue stranded people and animals.

    The efforts helped many tobacco farmers and their dependents recover from disaster. According to a survey, 96 percent of the affected farmers intend to continue producing tobacco. SindiTabaco expects tobacco production from the impacted area to remain close to the projections estimated for the 2024–2025 growing season.

  • Penalties for U.S. Retailers Selling Illegal Vapes

    Penalties for U.S. Retailers Selling Illegal Vapes

    The U.S. Food and Drug Administration is seeking fines against two brick-and-mortar retailers and nine online retailers. The FDA previously issued warning letters to these retailers for their sale of unauthorized tobacco products; however, follow-up inspections revealed that the retailers had failed to correct the violations. Accordingly, the agency is now seeking a civil money penalty of $20,678 from each retailer.

    To date, the FDA has filed civil money penalty complaints against 70 manufacturers and 160 retailers for distribution and/or sale of unauthorized tobacco products. These actions reflect the FDA’s continued dedication to bringing enforcement actions against entities along the supply chain that violate the law relating to tobacco products.

    The FDA has currently authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer of all authorized e-cigarette products that retailers can easily consult to determine which products may be lawfully marketed and sold in the United States. Entities manufacturing, importing, selling or distributing e-cigarettes that lack the required premarket authorization risk enforcement actions.

  • Vapes Major Culprit in Aviation Battery Incidents

    Vapes Major Culprit in Aviation Battery Incidents

    Image generated with Adobe Firefly

    The rate of “battery thermal Runaway incidents”—instances of lithium-ion batteries overheating on passenger planes—hit a five-year peak last year, with e-cigarettes being the biggest culprit, according to a report from UL Standards & Engagement (ULSE), a nonprofit organization focused on safety standards.

    The data comes from ULSE’s Thermal Runaway Incident Program (TRIP), a voluntary lithium-ion battery incident reporting system. TRIP comprises 35 passenger and cargo airline participants. The program was designed with the aviation industry to better understand the extent of thermal runaway incidents caused by lithium-ion batteries onboard aircraft and how to prepare for, or ideally prevent, future incidents.

    “Passengers are often unaware that many devices they bring on board are powered by lithium-ion batteries, let alone the risks they carry, and it’s much harder to solve a problem that they do not know exists,” said David Wroth, director of technology and systems at ULSE and the leader of TRIP, in a statement. “Thermal runaway incidents on board aircraft are largely preventable but admittedly more difficult to contend with at 40,000 feet. TRIP provides a unique opportunity for the aviation industry to come together to find strategies to mitigate the risk of these incidents.” 

    As technology evolves and more products rely on rechargeable power, lithium-ion batteries are getting more powerful and in some cases larger, further complicating the thermal runaway threat. Damaged, substandard, or counterfeit batteries run the greatest risk of going into thermal runway, presenting serious consequences in flight.

    Key takeaways from the report include:

    • Incidents are at the highest point in five years of data collection, rising 28 percent from 2019-2023. There are an average of two thermal runaway incidents reported in the TRIP database each week. While on the rise, with approximately 180,000 flights in U.S. airspace per week, it is still highly unlikely to experience a thermal runaway incident.
    • The average passenger brings four rechargeable devices on board. Most common items include smartphones (82 percent), laptops (41 percent), wireless headphones (39 percent), and tablets (36 percent). E-cigarettes were responsible for the most incidents in 2023, with 35 percent of reported incidents attributed to vaping devices on passenger flights, followed by power banks, representing another 16 percent of incidents.
    • Most incidents happen on the aircraft with devices that are stored near the passenger’s seat. Almost nine out of 10 (87 percent) incidents are reported on the aircraft, with the remaining 13 percent occurring when baggage and personal items are on the move. On the aircraft, thermal runaway incidents occur in or around the passenger’s seat nearly 60 percent of the time.
    • The vast majority of incidents are addressed before reaching the fire or explosion stage of thermal runaway. Most (85 percent) incidents in 2023 were addressed when batteries showed warning signs such as overheating and smoking prior to entering full thermal runaway. While only 15 percent of incidents resulted in fire or explosion, the speed in which thermal runaway can develop means that the events in the majority could have been more serious had the issue not been addressed quickly.
    • Rechargeable devices are being packed in checked luggage. The devices that were most cited in thermal runaway incidents in 2023 were also the two most frequently put in checked luggage, according to passengers surveyed. More than a quarter (27 percent) of travelers reported checking portable chargers, and another 27 percent said they checked e-cigarettes. Devices that enter thermal runaway in checked baggage cannot be accessed by crew while in flight, and fires may not be detected as quickly in the cargo hold as they would be in the cabin.

    “Our research highlights several trouble spots that need to be addressed, from passengers missing warnings about lithium-ion batteries to packing rechargeable devices out of reach,” said Lesley Rohrbaugh, head of insights and policy analysis for ULSE. “But we also see clear opportunities to reduce the risk and that’s where we’re focused.” 

    Through additional passenger and cabin crew focus groups and interviews conducted by ULSE and data from TRIP, strategies to reduce these risks include passenger education, cabin crew training, and standards for aircraft baggage handling.

  • Zimbabwe Growers Start Planting Irrigated Tobacco

    Zimbabwe Growers Start Planting Irrigated Tobacco

    Photo: Taco Tuinstra

    Tobacco farmers in Zimbabwe started planting irrigated tobacco this week, with many expressing optimism about the upcoming growing season, reports The Herald.

    Zimbabwe law stipulates Sept. 1 as the earliest legislative date for transplanting tobacco from the seedbed to the field. The bulk of rain-fed tobacco crop will be planted from late October to early December.

    Most irrigated tobacco is grown by contracted growers who get their inputs on time. About 95 percent of the country’s crop is grown by contracted farmers.

    “We have high hopes this season following the weather forecast so farmers are in the fields,” said  Tobacco Farmers Union Trust President Victor Mariranyika.

     Zimbabwean growers earned $793.18 million from 231.47 million kg in tobacco sales during the most recent marketing season, compared with $896.38 million from 295.94 million kg the previous year.

    However, most farmers made more money than in the prior season, leaving them in a good position for the upcoming growing season.

  • Lifting the Veil

    Lifting the Veil

    A peek at the future of vaping technologies

    By Stefanie Rossel

    David Newns

    As sales of combustible cigarettes continue their downward spiral, reduced-risk products (RRPs) keep gaining ground. Euromonitor International estimated the retail value of the worldwide RRP market at $19.34 billion in 2023 and expects further growth.

    Plxsur, the world’s largest group of independent vaping companies, reckons that the 12 markets it operates in are together worth $20.8 billion and will grow to $59 billion by 2033. The company expects RRPs to overtake cigarettes over the next 10 years. “Looking at the U.K. alone, the number of cigarette users is currently at parity with RRP users at around 12 percent of the population, with the latter expected to become the dominant format this year,” says Plxsur’s chairperson and co-founder, David Newns.

    In terms of technology trends, a decade is a long time. In the past 10 years, vapers have moved from “cigalikes” to pods then to disposables and now back to reusables again. However, many current vape products still have shortcomings, particularly in areas such as user-friendliness, nicotine delivery and sustainability. Going forward, Newns sees two main considerations driving people to RRPs. “The first is cost-effectiveness, with reusables more cost effective than disposable vapes and certain cigarettes,” he says. “The second is user experience. Technology is constantly evolving, and the category continues to advance RRPs to replicate the delivery of nicotine in a cigarette in terms of speed of delivery and satisfaction.”

    Innovation in the category, Newns points out, will depend on two key factors: the delivery of nicotine in a reduced-risk format that satisfies users to a point that they don’t feel compelled to return to cigarettes and the behavioral aspect of smoking. “In order to ensure RRPs are attractive to smokers, the behavioral patterns must not differ dramatically,” observes Newns. This, he says, explains why nicotine patches or gum alone often aren’t successful in helping smokers quit. “Smokers are most successful at quitting when using vapes, either on their own or in combination with other products,” says Newns. “Given the ritualistic elements that vapes provide, which [are] similar to smoking, they are often seen as a natural next step for those looking to quit.”

    According to Newns, devices will likely also feature more connectivity functionality in the future.

    Enhancing Nicotine Delivery

    Michael Wang

    Optimizing nicotine delivery has been front and center in recent innovations. The German startup Splash, for example, has developed a product that generates a foam instead of vapor (see “Bubbles of Bliss,” Tobacco Reporter, December 2023) while U.K.-based Qnovia has designed an inhaler that works without heating (see “High Tech Quitting,” Tobacco Reporter, March 2023).

    Ispire Technology Co-CEO Michael Wang expects constant introductions of novel and unique entries into the nicotine-delivery space going forward. “However, the key factor to consider is efficacy—the actual effectiveness of nicotine delivery, its impact on the body and its absorbency,” he says. “Methods like Splash, which deliver nicotine through a foam in the mouth, or pouches like Zyn result in a different neurological uptake of nicotine. These methods take longer to be absorbed into the bloodstream, delaying the time it takes to reach peak effect. Research supports [the idea] that aerosolization is the most efficient and optimized way to deliver nicotine into the bloodstream for immediate absorption. This efficiency is largely due to particle size and how it is distributed in the body. Aerosolized nicotine, delivered to the lungs, ensures rapid absorption and immediate effect, unlike oral or sublingual methods, which take longer to act.”

    Both Wang and Newns anticipate the development of better heating systems that eliminate the metal emissions associated with nichrome wire-based heating systems. “The performance and safety of the core vaporizer technology are critical concerns,” says Wang. “Many devices rely on ceramic heating elements, which, while cost-effective and easy to manufacture, present risks. If the manufacturers do not hold themselves to the highest standard in their manufacturing process, then over time and with repeated heating cycles, ceramics can become brittle and potentially release harmful particles into the vapor. This underscores the need for the industry to move away from ceramics and adopt safer alternatives.”

    Wang views the introduction of heating chip technology, as recently launched by Greentank (see “Heated Breakthrough,” Tobacco Reporter, June 2024), as a significant step forward as it performs better on key safety metrics, including the reduction of harmful and potentially harmful constituents. “By using biocompatible materials and moving away from ceramics and heavy metal-producing heating elements, we can improve the safety and performance of vape devices. These innovations aim to minimize health risks and enhance user experience by providing cleaner and more efficient vaporization.”

    Precision dosing and dosing control, Wang stresses, are essential yet often inadequately addressed aspects of vaping technology. “Accurate nicotine delivery is crucial for both consumer satisfaction and regulatory compliance,” he says. “There is a growing demand for solutions that help users manage and reduce their nicotine intake effectively.”

    Age-Gating is Key

    Progress will be driven not only by hardware developments but also by the characteristics of nicotine. “Certain clean technologies such as synthetic nicotine could further reduce risk and improve delivery,” says Newns. “We are already seeing this rolled out in markets across the world. We believe that such development can only be a positive thing if the developments are carried out from a scientific point of view. That is, keeping in mind the nicotine user’s journey from cigarettes to safer alternatives, complying with regulation and placing responsibility to the customer and environment front of mind.”

    Wang expects novel nicotine particulates to enhance the speed and efficiency of nicotine delivery, building on the foundation laid by innovations like nicotine salts. “Nicotine salts improved the speed of delivery and provided a stronger throat hit, closely mimicking the experience of smoking combustible cigarettes,” he says. “This similarity, along with the availability of various flavors, greatly contributed to the success and adoption of reduced-risk products.”

    According to Wang, the success of flavors in helping smokers transition to e-cigarettes underscores the importance of continuing to develop advanced nicotine-delivery systems that provide a satisfying and effective alternative to traditional tobacco products.

    Preventing underage access to nicotine products will remain an important objective for manufacturers. To ensure its products never get into the hands of minors, Puff Store rolled out MyChekr, a technology that uses artificial intelligence to estimate the ages of would-be buyers (see “Beyond Face Value,” Tobacco Reporter, December 2023). The system is being adopted by a growing number of companies.

    Ispire Technologies offers an age-verification system that uses a combination of Bluetooth and blockchain technology. “This system employs biometric verification, ensuring that only authorized users can access the devices, thus preventing underage usage effectively,” says Wang. “The integration of blockchain technology sets our solution apart from the competition by offering an unparalleled level of security and transparency. Blockchain’s immutable nature ensures that all age-verification data is securely stored and cannot be tampered with, providing a trustworthy system for both consumers and regulators. The use of Bluetooth enables a seamless and efficient user experience, making our age-gating technology not only secure but also highly accessible and convenient for users.”

    Transitioning to Reusables

    Meanwhile, disposable e-cigarettes face an uncertain future due to environmental concerns, with some markets banning the entire category and others considering restrictions. “Although the U.S. may not see immediate FDA [Food and Drug Administration] mandates on disposables, the long-term trend will likely favor pod systems and reusable products, significantly reducing e-waste and aligning with environmental sustainability goals,” says Wang. “We are confident that disposable vapes will either disappear altogether or become a smaller player in the market over time. While disposables are incredibly convenient, their environmental impact is prompting a shift toward more sustainable options. Moving forward, we anticipate a greater emphasis on devices with removable batteries and the adoption of pod systems to reduce waste.”

    Newns believes that vaping companies have a responsibility to ensure that new regulatory restrictions, such as a ban of disposable vapes, do not prevent adult smokers from transitioning to safer alternatives. “We also know that disposable vapes, given the products’ convenience and price point, are vital for many adult smokers in the initial phase of the switch from cigarettes,” he says. “We hope to see regulation as a driving force for new technology and innovation to allow safer products to be developed with better inhalation techniques and quality.”

    With this in mind, he says, Plxsur remains focused on supporting customers to migrate from disposables to pod-based systems. “We have worked closely with our partner companies to put commercial strategies in place to achieve this,” says Newns. “For example, in Q4 last year, Puff, the number one vaping company in Italy and part of Plxsur, successfully migrated many of its customers to pod and open devices, with these alternative products now outperforming disposable devices by volume for the company. As we remain focused on our responsibility to reduce our environmental impact, we continue to see such efforts on migration across the group.”

  • Universal Announces New Leadership

    Universal Announces New Leadership

    Preston D. Wigner will succeed George C. Freeman III as chairman, president and CEO of Universal Corp. on Oct. 1, 2024.

    Wigner joined Universal in 2003. After serving as the company’s vice president, general counsel and secretary for nearly 20 years he was appointed senior vice president of Universal in December 2023. Prior to joining Universal, Wigner served as an associate with the law firms Williams Mullen and Hunton Andrews Kurth.

    According to Universal, Wigner’s appointment is the culmination of a succession planning process conducted by the board of directors and assisted over the past two years by a global leadership advisory firm. Freeman will serve as vice chair of the company through Dec. 31, 2024, and then as a senior advisor through the company’s fiscal year-end on March 31, 2025.

    “George has played a critical role in shaping Universal into the company it is today, and we are grateful for his tremendous leadership,” said Thomas H. Johnson, lead independent director of Universal’s board, in a statement.

    “During the last several years, George and the senior leadership team have consistently delivered value to Universal’s shareholders by driving strong tobacco results and establishing our Universal Ingredients business. With the positive momentum from our most recent fiscal year and the strong beginning to our current fiscal year, now is the right time to implement this leadership succession.

    “We are delighted to name Preston as our next chairman, president and CEO. Preston has been a valued member of Universal’s senior leadership team for many years. With significant tobacco industry experience, active involvement in our ingredients business strategy from its inception, and deep familiarity with our global organization, Preston has the right mix of skills and expertise to drive Universal forward.”

    I am energized by the opportunity to lead our incredible organization and advance our growth strategy by optimizing our leading tobacco business and expanding our ingredients business.

    “It is a privilege to be named chairman, president and CEO of Universal at this exciting time in the company’s 100-plus year history,” said Wigner. “I am energized by the opportunity to lead our incredible organization and advance our growth strategy by optimizing our leading tobacco business and expanding our ingredients business.

    “Our future success will build on the foundational work we have accomplished under George’s leadership as well as our continued efforts to develop and pursue innovative strategies, set new standards of social and environmental performance, and motivate and inspire our global workforce. I am grateful to George for his mentorship and friendship, and I look forward to continuing to work with him through the remainder of our fiscal year.”

    “It has been an honor to lead Universal in building and growing our portfolio of agriproducts and extending our sustainable supply chain operations to now support more than 200,000 farmers over five continents,” said Freeman. “We have made incredible advances in the 27 years I have been with Universal, and I thank our talented employees around the world who work tirelessly for all our stakeholders. As I prepare to leave the board, I would also like to thank each director for their support and guidance as we have worked to position the company for success. I have worked closely with Preston, and my decision to retire is made with the utmost confidence in his ability to advance Universal’s strategy with the support of the board and management team and deliver long-term value for our shareholders. I look forward to supporting a smooth transition.”

  • A Cold Chill

    A Cold Chill

    While FDA menthol market authorizations are rightly seen as a victory, they may be pyrrhic.

    By Rich Hill

    The flavored electronic nicotine-delivery systems (ENDS) road has been a bumpy ride. Going back to pre-deeming days, flavored ENDS were ubiquitous, as were unquantified, anecdotal reports of their cigarette-smoking cessation efficacy. Following the accelerated premarket tobacco product application (PMTA) submission timeline, as everyone knows, the Center for Tobacco Products’ (CTP) decisions decimated flavored ENDS. Likewise, even the most sophisticated companies were receiving marketing denial orders (MDOs) for menthol ENDS. Throughout this bloodbath, the CTP oft repeated that flavored products need to demonstrate a cessation benefit to adult smokers weighed against the risk of youth initiation. Until recently, this had not played out.

    Njoy’s marketing granted orders (MGOs) for menthol Ace and Daily products was a watershed moment demonstrating that an ENDS product with a flavor other than tobacco could be granted marketing authorization status. However, the authorization does leave some questions unanswered.

    CTP’s Menthol Positioning

    In 2022, the CTP staked out its position on menthol in the cigarette context with the product standard prohibiting menthol in cigarettes. The center asserted that menthol reduces irritation and harshness of smoking, increases appeal and makes cigarettes easier to use—especially for youth, increases nicotine’s sensory effects in the brain and makes it more difficult to quit smoking. While the first points on irritation and harshness are unique to cigarettes, the CTP’s other points arguably apply to menthol and nicotine more generally—a dour omen for ENDS and other products.Given this position, particularly on youth initiation, it came as little surprise that several menthol ENDS products received MDOs over the past several years.

    An About Face?

    The Njoy Ace and Daily menthol product MGOs were a surprise considering the CTP’s menthol position and flavored vapor product denials. What was different about Njoy’s applications that tipped the scales?

    Beyond Njoy’s successful showing of product characterization, toxicology and abuse liability data, according to the Njoy Ace Technical Project Lead Review (TPLR), behavioral studies and marketing restrictions appear to have made the difference. Alongside other behavioral studies, Njoy simply did what the CTP required and conducted a longitudinal study comparing cigarette smoking cessation efficacy between tobacco and menthol ENDS products. Per the TPLR, “[t]he applicant’s findings and additional analyses conducted by statistics demonstrate a statistically significant added benefit of using menthol-flavored Njoy Ace compared to classic tobacco flavor … in achieving past-30-day [combustible cigarette] smoking cessation ….” Among other data in the TPLR, Table 3 reports that in the Intention to Treat Analysis, initial flavor at baseline analysis resulted in 26.6 percent past-30-day abstention rates for menthol versus 19.3 percent for tobacco at 6 months. When analyzed by flavor at time of switching, past-30-day cessation rates of 27.1 percent for menthol versus 19.3 percent for tobacco at 6 months were reported.

    Along with the adult cessation data, Njoy agreed to a long list of marketing restrictions—beyond what is observed in other applications. The restrictions included limitations on advertising means including no radio, television, outdoor, print, search engine advertising, social media promotions, product placements, engagements or activations or influencers, sponsors, etc., among others. Talent portrayals would be limited to models over 45 years of age. Njoy identified a range of sales restrictions as well.

    Ultimately, after assessing the youth data and risks, the TPLR executive summary states, “[t]he PMTAs contain sufficient evidence to show that the new products have the potential to benefit adults who smoke combustible cigarettes and who switch completely or significantly reduce their combustible cigarettes  use …. The applicant also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization. The Office of Health Communication and Education has determined that these restrictions may help further limit youth exposure to the new product, the products’ labeling, advertising, marketing, and/or promotion, and the potential for youth initiation.”

    Questions Remain from the Njoy Decision

    The MGO, however, raises two interesting questions. First, how much adult benefit is enough to overcome youth uptake? And second, what impact do marketing restrictions have on marketing authorization decisions?

    The Math on Youth Use vs. Adult Cessation – How Much Differential is Enough?

    The TPLR reports youth Njoy use data from both applicant data and national surveys and concludes that “[w]hile ENDS with nontobacco flavors and high nicotine delivery may help adults who smoke switch from CC to ENDS, these same characteristics may facilitate initiation and continued nicotine use by youth.” The cost-benefit analysis is troubling because CTP provides no real quantitative measure comparing youth use rates to adult cessation rates. Rather than a numerical comparison, the analysis seems to rely upon the totality of the evidence. As the TPLR states, “the totality of evidence provided by the applicant suggests that the menthol-flavored [product] … is associated with significantly higher smoking cessation rates than tobacco-flavored Njoy Ace products, and epidemiology concluded that the new products are highly beneficial to adults who smoke CC.” The close of the TPLR user population synthesis states that menthol-flavored new products pose a risk to youth but went on to assert that the data “demonstrate added benefit of using menthol-flavored compared to classic tobacco-flavored … Njoy Ace in achieving past-30-day smoking cessation—a showing required to outweigh the risks associated with flavored ENDS among youth.”

    For some time, many in industry have wondered how much cessation difference between tobacco and flavored ENDS would be enough to outweigh risk to youth. While the balancing test is not numerically quantified, this marketing decision does provide some level by which to assess menthol products.

    Are Marketing Plans Back on the Table?

    In the White Lion Investments dba Triton Distribution v. FDA5th Circuit Court of Appeals decision from January 2024, the majority opinion found that the FDA ignored marketing plans in the Triton PMTAs: “[w]orse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the 1 million plans.”

    Njoy’s marketing plan, however, seems to have an effect on the outcome. Reviewers remarked that the Njoy plan was “robust and is expected to limit youth exposure” to marketing materials. Interestingly, the TPLR states that the marketing plan was “not considered in the APPH assessment,” but then goes on to refer to the plan positively, stating, “the applicant’s approach to marketing may help further limit youth exposure to the new products.”In Njoy’s case, the marketing plans may not have moved the APPH needle but were considered as a net positive in youth prevention.

    Are marketing plans important to your application? Beyond being a required part of the PMTA submission, it appears that in this case, the restrictions at least supplemented the adult benefit data to good effect.

    Will Menthol MGOs Have an Impact in This Market?

    While the menthol market authorizations are rightly seen as a victory, such a victory may be a pyrrhic one.

    The presence and consumer acceptance of flavored disposable ENDS products looms over this seminal marketing authorization. The fact is that many menthol-flavored ENDS products with pending PMTAs remain on the market. Even in the face of the availability of menthol ENDS, flavored disposable ENDS sales have skyrocketed.

    The Centers for Disease Control and Prevention published a Morbidity and Mortality Weekly Report (MMWR) in 2023 assessing e-cigarette unit sales across the various categories of products and flavors using scan data from brick-and-mortar retailers only. The MMWR reported that “the percentage of disposable e-cigarette sales more than doubled, from 24.7 percent in January 2020 to 51.8 percent in December 2022.” The predominant disposable flavors reported were “flavors other than tobacco, menthol or mint” (71.4 percent in 2020 and 79.6 percent in 2022). At the same time, menthol ENDS sales overall did not significantly change, while tobacco and mint flavors declined. With half of the market occupied by flavors that consumers clearly want, the growth space for a couple of menthol products seems limited.

    VV Archives

    While the FDA continues to publicize enforcement efforts, the flavored disposable ENDS trend will not abate anytime soon. Given that flavored disposables are crushing the category, it seems unlikely that the MGOs for Njoy’s menthol products will play a significant role in shifting market share in the near term.

    Where Does This Leave Us?

    Foremost, good on Njoy for cracking the code—most observers have been very skeptical that an ENDS product with any flavor would ever be granted marketing authorization. Ultimately, Njoy demonstrated what the industry knows to be true from ENDS consumers—flavors, including menthol, are a net positive for adults who smoke to transition away from higher-risk combustible cigarettes. However, questions remain about how the risk-benefit test will be applied—how that math actually works and who, other than the largest companies, can afford to produce such evidence.

    Rich Hill is senior director and new product compliance counsel at E-Alternative Solutions.

  • Asia Pacific Urged to Permit Oral Nicotine

    Asia Pacific Urged to Permit Oral Nicotine

    Photo: Tobacco Reporter archive

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) is urging governments across the Asia Pacific region to follow New Zealand’s lead and allow the sale of oral nicotine products as part of a comprehensive tobacco harm reduction strategy.

    New Zealand’s government recently agreed in principle to permit the sale of reduced-harm smokeless tobacco and oral nicotine products, such as Swedish snus and nicotine pouches. This progressive policy aligns with mounting evidence that these products can play a crucial role in reducing smoking rates and improving public health outcomes.

    “New Zealand’s approach demonstrates how embracing tobacco harm reduction can accelerate progress towards smoke-free goals,” said Nancy Loucas, executive coordinator of CAPHRA. “Their smoking rates have plummeted to historic lows, proving that pragmatic policies focused on harm reduction work.

    “Recent data from New Zealand shows daily smoking rates have dropped to just 6.8 percent, down from 16.4 percent in 2011/2012. This remarkable decline coincides with the country’s adoption of progressive vaping regulations and openness to other reduced-risk nicotine products.”

     According to Loucas, scientific evidence increasingly supports the harm reduction potential of oral nicotine products. She cited a study published in the Harm Reduction Journal, which found that snus use in Sweden has led to “substantially lower rates of smoking-related disease” compared to other European countries. Loucas also referenced research from the U.K.’s Royal College of Physicians, which concluded that nicotine products are “unlikely to exceed 5% of the harm from smoking tobacco.”

    “Asia Pacific nations have an opportunity to dramatically improve public health by allowing and properly regulating these products,” Loucas said. “Continuing to ban safer alternatives while deadly cigarettes remain widely available is counterproductive and harmful to public health.

    “CAPHRA emphasizes that regulations should ensure product quality and safety while making these alternatives accessible to adult smokers looking to quit. The organization calls for a balanced approach that protects youth while helping millions of current smokers transition away from combustible tobacco.  

    “We urge policymakers across the region to objectively review the evidence and engage with consumers and experts in tobacco harm reduction,” said Loucas. “It’s time to move beyond outdated ‘quit or die’ approaches and embrace the full range of tools available to end the smoking epidemic.”