Category: GTNF

  • Fireside Chat: Robert Pye, Luis Sanches and Chris Greer

    Fireside Chat: Robert Pye, Luis Sanches and Chris Greer

    The Fireside Chat with Robert Pye, CEO of Filtrona, Luis Sanches, chief strategy officer at Greenbutts, and Chris Greer, president and CEO of TMA, offered insights into the environmental, social and governance (ESG) framework.

    The chat started with a discussion of each company and what it does within the larger industry—Filtrona and Greenbutts are both in the filters aspect of the industry in different manners. Filtrona is a traditional and specialty filter supplier while Greenbutts is a material science company that has been working to introduce a more sustainable alternative to traditional cellulose acetate filters. While Filtrona has been in the industry for 80 years, Greenbutts is relatively new at 13—“a startup of sorts,” in the words of Greer.

    Greer noted that Filtrona has many locations in Asia, with the headquarters being in Singapore, and brought up the idea of the 21st century being “the Asian century.”

    “What attracted you to Singapore, first, and for your part of the industry, what are some key takeaways that you can give us about Asia and the marketplace and where that fits in, in the change and transformation part of things?” Greer asked Pye.

    “I think Asia is, as you mentioned, a very dynamic place,” Pye said. “Our global head office is based in Singapore. We’re happily ensconced there because, I think if you think about our 2,000 employees, probably in Asia, we have maybe 1,500 of those 2,000 employees based in Asia. So it just makes sense to be in Singapore. And also our largest part of revenue and profits are based in Asia as well.

    “So it just made sense for us to really base ourselves in Asia and really base our footprint around Asia. And the reason for being based around Asia is really that we see this being the most dynamic part of the industry for our industry as well. We see a lot of companies coming to Asia. Indonesia has had probably a lot of expansion over the last few years. That market’s still very interesting. Of course, I mentioned the China market, but India’s still interesting. And then you’ve got all the Southeast Asian countries, and they’re all very different, right? Whether they’re regulations or whether they’re cultural aspects or even tobacco-related industries within that country.”

    Pye also expressed that Asia is willing to advance “whether it’s technology or whether it’s a market or whether it’s embracing something new.” He said countries “probably less developed than some other Western countries usually tend to leapfrog in a lot of areas of technology.”

    Turning to Sanches, Greer said, “You’re in material science, you’re blazing your trail. What’s the biggest change that you’ve had to make in your thinking?” Sanches joined Greenbutts from BAT, a large company with lots of resources.

    “It’s an interesting consideration,” Sanches said. “Because I think for a gearbox perspective, every company, regardless of its size, it needs the core to be properly functioned. For instance, you need to define your goals. … And regardless if you’re in startup, the organization needs to have this very well defined. Then you set up a strategy, and the strategy has to be the way you want to deliver those goals. And then you move to metrics, and then you move to engagement, primarily to whom you need to partner with and which organizations you need to be very close [with], the shareholders you need to bring to your organization, the stakeholders that get affected or being affected by you.

    “So I think, in a sense, we share the same values. I think we share the same structure. … I think the biggest differences will be the size of the pocket for sure. Being part of a startup, funds and resources are not always there. So it’s more limited in terms of resources and talent footprint that Robert just mentioned. I think the other aspect is big organizations; they have very good governances. They sometimes, and most of them, they’re very bureaucratic. And the politics inside organizations drive you crazy and slow you down in every decision you need to make,” Sanches said. He noted that a big advantage to being a startup is flexibility.

    Greer noted that ESG sometimes gets a “bad rap” as a buzzword and, in the spirit of changing the conversation, asked Pye and Sanches to talk about the real work behind ESG. “We see it in our business as being very important,” said Pye. “We want to be part of the solution. We see it makes great business sense, and we also see it makes great moral sense. You have a morality to it that you can flag and engage with your employees and your customers.”

    “We are the largest producer of sustainable filters globally,” Pye continued. “I can sit on the stage and say that quite confidently. We work with all of the major suppliers in that area. We work with all the latest think tanks in that area, such as Greenbutts. But we also work with all the large customers and some small customers as well.

    “We are a zero waste to landfill business. Any waste we generate, we use it to generate steam for our products.” Pye also noted that one of Filtrona’s sites has zero emissions and that the company uses solar panels on many of its sites as well.

    Sanches added to that, noting that he made it clear in his early days with Greenbutts that the company could not “be seen as disruptors because disruption implies chaos” and the tobacco industry is a very efficient machine, so the company should focus on helping the industry transform itself without disrupting it.

    “When we establish this as a premise in our ways of working, we say we need to ensure that the entire value chain is covered. We’re going to do the pre-work, ensure that we have all the sources of the material that you utilize well set up in a proper geography. The converters which convert fibers into substrate are well set up as well in a global scale. … Therefore, when the tobacco industry decides to adopt this or the biodegradable filters as their future solution today, we are all set up. So, not chaotic, not disruptive, but in a very gentle and very smooth way that we can introduce this.”

    According to Sanches, Greenbutts aims to have the value chain covered so that companies can focus on other aspects. “We can help them in delivering their ESG targets,” he said.

    The fireside chat highlighted what ESG looks like with tangible products and outcomes and pivoted the conversation away from targets toward real results.  

     

     

  • Panel: Putting Consumers First

    Panel: Putting Consumers First

    Toward the end of the Putting Consumers First panel held during September’s Global Tobacco and Nicotine Forum in Seoul, South Korea, Matt Drodge, research director at Walnut Unlimited, made the point that while nicotine consumers were all different, they all wanted to be able to make informed decisions about whether to continue smoking combustible cigarettes or when and how to make the transition to new nicotine products.

    Of course, nicotine users can make such transitions only in countries where regulations allow them to do so, and the moderator of the panel, Nancy Loucas, public health policy expert and executive coordinator of the Coalition of Asia Pacific Harm Reduction Advocates (CAPHRA), made the point that the panelists represented countries forming a continuum of nicotine regulation.

    Panelist Samrat Chowdhery, former president of the International Network of Nicotine Consumer Organisations, told participants that he felt unhappy about representing India, a country that had put consumers last by effectively banning vapes. Chowdhery said this is a pity because India does not have a strong or widely used public health network, so prevention, including through the use of safer alternatives, is vital, as it is in other parts of the developing world where 80 percent of tobacco users live.

    Fiona Patten, leader of the Reason Party and former member of the Legislative Council of Victoria, who was unable to attend the GTNF in person and instead recorded a video message, apologized for representing Australia, a country that she said is leading the way on what not to do around tobacco harm reduction. Patten said that Australia’s “so-called medical model” of regulation is so onerous that 99 percent of Australians who are looking for a safer way to consume nicotine are being forced onto the black market.

    Alex Clark, CEO of the Consumer Advocates for Smoke-Free Alternatives Association, who also did not attend the event, but appeared via a live link, said the premarket tobacco product application (PMTA) system in the U.S. appears to consumers to be acting as a very tight bottleneck on the products they have access to; no flavored products have been authorized through the system, only variations of tobacco. Beyond the PMTA system, there was also concern that a methodical state-by-state, municipality-by-municipality effort to severely restrict the availability of lower risk products would continue. Clark said that while he hopes that in the future people will be able to find products they can trust, he questioned why there has to be a delay. What is needed now is to disseminate the idea that nicotine users are not just data on a spreadsheet and to get that message out, elevating it up the chain to the regulator.

    Clarisse Yvette Virgino, a Philippines-based member of the CAPHRA, had a more positive tale to tell because a “wild journey” that had seemingly been headed toward prohibition had ended with regulation. The regulations were somewhat burdensome, however. Retailers had a lot of rules to comply with, and there was a problem when it came to consumer choice because manufacturers had withdrawn certain products, such as juices, rather than go through the process of complying with what were stringent requirements.

  • Panel: Reinforcing Scientific Research

    Panel: Reinforcing Scientific Research

    During the Reinforcing Scientific Research panel held as part of September’s Global Tobacco and Nicotine Forum in Seoul, South Korea, New Zealand-based Marewa Glover, director of the Center of Research Excellence on Indigenous Sovereignty and Smoking, made the point that the forum had heard many times how there is a need for tobacco and nicotine policies to be grounded in science and, therefore, evidence-based. There is, in fact, no disagreement on this point between tobacco control officials and tobacco harm reduction (THR) advocates, she said. However, care needs to be exercised because a form of evidence has been appropriated by some opposed to THR, and they are driving a broad social change agenda aimed at instituting a utopia where, for instance, no one would ever use drugs. They used scientific platforms loaded with people who shared their views to spread their ideology. They redefined the meanings of words so that unproven assertions became facts and facts became lies. To combat such views, she added, it is necessary for THR advocates to produce demonstrably robust research as part of a project that includes a communication strategy identifying stakeholders and how the information is to be gotten to them.

    Glover had been asked three questions by moderator, Mark Littlewood, director general of the Institute of Economic Affairs: What needed to be done to reinforce scientific research into tobacco and nicotine?; who should form the audience for the research findings?; and how should the findings of junk science be challenged?—questions he also posed to the rest of the panel.

    Kai-Jen Chuang, professor in the Department of Public Health at Taipei Medical University, explained that THR is not taught as part of medical degrees in Taiwan and therefore is not a well-recognized term, even though harm reduction principles are engaged in other areas. In fact, vapes were banned in Taiwan on March 22 this year. What is taught is health promotion and, more latterly as part of social-work courses, disaster reduction. He pointed out, nevertheless, that health promotion, disaster reduction and THR have similar goals, so those from outside Taiwan wishing to engage at conferences with public health officials over THR principles should present their papers, translated into Chinese, as health promotion studies. Nevertheless, he warned that it would be difficult, because of their training, to convince public health people of all stripes of the efficacy of using new technology to reduce the harm caused by smoking. The starting point for getting across messages about THR, he added, should be scholars with open minds, and from there, the focus could move to journalists and politicians.

    Riccardo Polosa, professor of internal medicine at the University of Catania and founder of the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), said there is a need to reinforce quality science that has good repeatability. Repeatability, he added, is currently in crisis and not just in respect of tobacco control science, so the CoEHAR has established a comprehensive repeatability program pertaining to research into toxicity and biology in respect of combustion-free, nicotine-containing products. The program involves setting up and researching in seven laboratories with the same equipment and the same procedures to come up with super strong findings. Another thing that is needed, Polosa said, is to shift the focus from risk to harm. Relative risk has been studied for a decade now, and it is an easy win if combustible products are compared with combustible-free products. So now is the time to look at the absolute risk and show that it is low and that the level of harm is super low. This would provide a better position from which to convince governments, regulators and the public. Polosa had some good news on junk science, which he said is easy to debunk because it is junk, though this takes energy and time and requires a willingness to do it. A global network of scientists is actively rebutting junk science articles, though the challenge now is to speed up this process of rebuttal.

    Picking up on an earlier comment about uncertainty, Konstantinos Farsalinos, research fellow at the Onassis Cardiac Surgery Center, made the point that uncertainty is inherent in science and essential to human progress. There is nothing wrong with uncertainty provided that it is not used to maintain the status quo, especially where the status quo has failed miserably. It is important, also, that uncertainties are not used as the basis for decision-making, which needs to be based on current knowledge. But one problem being faced today is that current knowledge is not being used to make decisions [about THR]; rather, decisions are being made on the back of the abuse of uncertainties [that the long-term use of THR strategies are unknowable at this stage]. Revisiting the 1986 Ottawa Charter for Health Promotion by the World Health Organization, Farsalinos said, it is obvious that it was basically talking about harm reduction in our everyday lives. Everything, even medicine itself, was a harm reduction science because it was not possible, probably, to cure any disease besides certain infections. We were treating diseases and reducing the adverse effects and consequences of diseases. This was all known. What is needed now is the reinforcement of the applicability of scientific data, of which there is a lot, on decision-making, something that has not happened in many parts of the world. Finally, Farsalinos said that he has had bad experiences in rebutting junk science even though he has been successful. Basically, he had run into a wall behind which people had decided what they believed and were casting around for the data to support their predetermined views. With science, you have to do the opposite of that, he said.

  • Keynote: Julian Cheung

    Keynote: Julian Cheung

    The 2023 GTNF conference theme of “Change the Conversation. Change the Outcome.” was reiterated by keynote speaker Julian Cheung, anti-illicit trade operations director for Japan Tobacco International’s Asia-Pacific region. Cheung spoke on changing the conversations about illegal trade.

    Before working with JTI, Cheung worked for the Independent Commission Against Corruption in Hong Kong, bringing much experience to the subject of anti-illicit trade.

    She noted that there are many aspects to anti-illicit trade operations, including investigations, collecting evidence and looking at the forensics of samples. JTI works closely with law enforcement agencies to stop illicit trade, according to Cheung.

    Behind the contraband, Cheung said, is often organized crime, which takes advantage of shifts in supply and demand and sees tobacco as a “high-profit, low-risk” market.

    The illicit tobacco trade “impacts us all,” she said. Many jurisdictions have attempted to limit tobacco product usage and illicit trade through increased excise taxes, which has only led to more illicit trade—back to supply and demand; the demand is high, and if organized crime can offer supply at lower prices, they will profit rather than the licit industry. Online commerce, too, has made it easier for illicit products to flood the market. Consumers do not have an easy way to determine whether the products they order online are illicit or legal, regulated products. Online sales increased during the Covid-19 pandemic as many “nonessential” businesses closed either temporarily or permanently.

    Cheung expressed a need for greater cooperation between governments, industry and law enforcement agencies at national and international levels to help combat illicit trade. The tobacco industry has a role to play, she said. Policies should be better balanced with deterrents that disrupt the financial gain of criminal networks.

    “Let’s switch the narrative on illegal trade and act together,” Cheung said. “Through innovative strategies, cooperations and a focus on disrupting the financial foundation of these criminal networks, we can curtail the illegal trade and safeguard our communities and economies.”

  • Keynote: Brian King

    Keynote: Brian King

    When Brian King speaks, people come to listen. The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) director’s keynote address was easily the best attended session of GTNF 2023. King’s speech served as an overview of the current state of the CTP and an outline of the center’s main priorities over the next few years.

    King said that the CTP has made considerable progress in reducing combustible cigarette smoking in the United States, which he contends as one of the most remarkable public health achievements of the past century. He hopes that those declines continue, given that “we do know” that combustible smoking is responsible for the overwhelming burden of death from using combustible tobacco.

    Tobacco use continues to cost the U.S. government a considerable amount of money—to the tune of $600 billion per year from both direct healthcare costs and lost productivity, according to King. He said there are important human health benefits as well as financial benefits for regulators to continue to focus on reducing combustible use in the United States. As a part of this focus, he said, the CTP is continuing to make inroads when it comes to premarket tobacco production application review.

    “We have a new director of our Office of Science who has jumped in headfirst to continue to fiercely lead our 550-plus scientists on application review …. We have processed 99 percent of those and continue to finalize the remaining 1 percent. I’m hopeful that in the coming months and years, we will get back to what was intended to be a premarket approval process,” said King. “In the meantime, we have authorized 23 e-cigarettes, all tobacco flavored. So, it is possible. We have had successful authorizations. But again, I can’t reinforce enough the importance of providing that sound and robust science to inform on potential authorization.

    “And it is possible, as you can see. There will be more authorizations in the future, but it’s important that we have that science to support those decisions. As I noted earlier, we also continue to fold in the nontobacco nicotine work into our broader portfolio around regulation. We did receive a million applications, which I don’t think anyone anticipated. I will say that we are making great numbers. We are 99.9 percent through with the review of those. I will say that 100 percent is very imminent.”

    King said that when it comes to products that are illegally on the market (having received a marketing authorization and are not currently under review by the CTP), the CTP is mindful of the importance in exercising all authorities that it has to ensure that people are complying with the law. He said that the FDA has given retailers the information they need to comply with the law through a list of authorized products (the 23 products that have been authorized for sale). The CTP also continues to ramp up efforts in terms of training, education and outreach across the supply chain, particularly to retailers.

    “We also continue to do surveillance inspection investigations. This is something that occurs on a daily basis. We have arrangements with all 50 states and territories to continue to do investigations. We have issued many warning letters for flavored disposable e-cigarettes, which we know are particularly popular for youth,” said King. “There’s been a variety of blitzes that have occurred monthly throughout the summer. I will say there are more to come. We are going to continue to conduct those blitzes and making sure that we are routinely monitoring, particularly with a focus on those products that we know have high youth appeal.

    “On balance, we are also continuing to do work around issuing import alerts. I was a little tickled by all the attention that the import alert on Elf Bar got. That’s nothing new, folks. We’ve been doing that for many years. It was suggested it was something seismographic, but we’ve been doing import alerts for quite some time. And we do use those as, again, another tool in our toolkit to make sure that we are addressing not only the products that are already in the country but preventing illegal products from entering the country.”

    As of Sept. 31, the FDA has issued over 1,200 warning letters for online investigations. For manufacturers, the CTP has sent more than 800 warning letters, with more than 750 letters for e-cigarettes. Beginning earlier this year, the FDA also issued the first civil money penalties against manufacturers for violations for illegal e-cigarette sales. He said civil money penalties will remain a part of the CTP’s tools to combat illicit sales.

    “We also issued the first six injunctions in coordination with the Department of Justice. I got a lot of flak for that as well about enlisting the Department of Justice. And I will remind folks that the FDA doesn’t have an independent litigation authority. If folks do not comply with the law, we will escalate further, as has been evidenced by these actions, which again are going to be part of our broader portfolio moving forward,” said King. “Everyone is going to be held accountable across the supply chain. We do want to make sure that we address the bad actors in a meaningful way. We also continue to pursue no tobacco sale orders among retailers as well. This has traditionally been issued for underage sales. But again, we’re committed to using the full scope of our authorities granted through Congress.”

    King added that education is also a priority for the CTP. The center is ramping up efforts to address misinformation in the continuum of risk for nicotine products. He mentioned that he recently wrote a commentary where he highlighted the importance of opportunities and considerations for addressing misperceptions in nicotine. “There is science that exists in that there are misperceptions around the continuum of risk and also nicotine. And so, we do have opportunities that are present, but we have to follow the data-driven pandemic-based approach,” he explained. “That said, I’m putting my money where my mouth is …. We’re working with the National Institutes of Health for a funding opportunity to get more data on public health communication messaging about the continuum of risk.

    “And as noted in that funding announcement, we’re looking for data both for the target population, which is called smokers, but also unintended populations, particularly youth. This is several million dollars on an annual basis, and we look forward to that kickstarting and getting data to inform our work.”

    King said the CTP will also continue to gather input from the industry and the public. The CTP is creating a new office within the Office of the Center Director and is looking to hire a new director for Policy and Partnerships. “That posting is public,” he said. “And I’m looking forward to seeing those who have applied and getting someone in that seat to meaningfully oversee the product regulation portfolio across the center, particularly as we get that strategic plan in place.”

    During the closing of his address, King said that he continues to be big on communication and stakeholder engagement. He expects to provide the industry with more opportunities for communication with the CTP. “I know that you’ll see in the future an evolution of our messaging. Both through our press releases, our social media and our [overall] messaging to make sure that we are clearer, simpler and more digestible,” he said. “I’ve been a bureaucrat for many years, but that doesn’t mean that I can’t communicate effectively with the general public. I think we can do better. I know we can do better.”

  • JTI Calls for Greater Cooperation Against Illicit Trade

    JTI Calls for Greater Cooperation Against Illicit Trade

    JTI called for greater international cooperation between government agencies, industry and law enforcement in tackling the illicit trade in cigarettes.

    Speaking at the Global Tobacco and Nicotine Forum (GTNF) in Seoul, Sept. 19-21, Julian Cheung, the anti-illicit trade operations director for JTI’s Asia-Pacific region, warned that criminal groups involved in the illegal tobacco trade, siphon much-needed tax revenue from state budgets. “They don’t comply with laws and regulations and, therefore, taxpayers, governments and legitimate businesses are all paying a hefty price,” she noted.

    “Billions of dollars in revenue are lost to this criminal activity,” said Chueng. In 2019, the World Bank estimated the cost of the illicit tobacco trade to governments at between $40 billion and $50 billion annually.

    “Let’s shift the narrative surrounding illegal trade and act together,” said Chueng in her presentation. “Through innovative strategies, cooperation and a focus on disrupting the financial foundations of these criminal networks, we can curtail the illegal tobacco trade, and safeguard our communities and economies.”

    Chueng’s call for action fit well with the GTNF’s theme, “Change the Conversation. Change the Outcome.” The conference brought together hundreds of stakeholders from across the industry, including businesses, research consulting groups, scientists, public policy and regulatory experts and educators, to discuss industry trends and challenges and share best practice thinking.

  • Smoore Demonstrates its Commitment at GTNF

    Smoore Demonstrates its Commitment at GTNF

    Eve Wang (middle) receiving the Golden Leaf Award for Innovation for VAPORESSO COSS (Photos: Smoore)

    A Golden Leaf Award and keynote presentation highlight the company’s investments in cutting-edge vaping technology.  

    At the recent Global Tobacco & Nicotine Forum in Seoul, Smoore earned a Golden Leaf Award and proposed a framework to help the industry “innovate through challenges.”

    The atomization company was recognized for its Vaporesso COSS, which stands for “Convenient Operating and Smart Supplying,” according to Smoore.

    “One of the major pain points for vapers is the trade-off between e-liquid or battery endurance and convenience,” explained Smoore Vice President Eve Wang upon receiving the award. “Typically, the longer it lasts, the less convenient it becomes. That is why COSS was introduced. It keeps you powered up and well-supplied with its smart supplying system. Additionally, thanks to its coil-e-liquid separation design, it’s also leak-resistant, ensuring a fresh puff every time.”

    In thanking the GLA judges, Wang promised Smoore would keep pushing forward and innovating.

    The company’s commitment to innovation was also demonstrated in Wang’s keynote speech at GTNF.

    She started by giving an overview of development of vapor products over the past 20 years and summarizing the biggest current challenges—preventing underage vaping and minimizing the environmental impact of vaping products.

    According to Wang, vaping efficiency is a combination of atomization efficiency and power efficiency. “For atomization efficiency, there are several key factors to be considered, such as e-liquid supply, the physical and chemical process atomization, as well as the technology for aerosol generation and distribution,” she explained.

    “We have seen some promising results in these areas,” she said. “If we translate it into consumer benefits, atomization efficiency is fully utilizing e-liquid for good taste, more puffs and improvement in cost effectiveness. Power efficiency translates into increased energy density; therefore we are able to reduce the battery size as small as possible. It means less impact to the environment and a longer life cycle.”

    Wang then shared the contributions to vaping efficiency made by Smoore’s Feelm Max, Feelm Air and Power Alpha products.

    She concluded her speech by encouraging stakeholders to keep innovating and evolving the technology to improve harm reduction, cost-effectiveness and sustainability, along with providing a better user experience. Wang urged her audience to harness collaborations in innovation and social responsibility to achieve a balanced solution between regulation and user experience. Following her speech, Wang moderated a panel titled “Innovating Products for the Future.”

    Eve Wang (left) as moderator

    Later that day, Smoore Senior Strategy Director Rex Zhang joined a group of panelists to provide an update on research and innovation relating to next-generation products.

    Zhang detailed Smoore’s advancements in sustainability and vaping efficiency. The company, he said, had reduced the amount of lithium materials in its vaporizers and increased the lifespan of its products, thus reducing the environmental impact of disposables.

    Demonstrating Smoore’s commitment to preventing underage vaping, Zhang highlighted the Feelm Max’s smart child lock. Once an adult user puts down the vape and doesn’t use it for a while, the atomizer will automatically lock, he explained. If a child subsequently attempts to use it, the device will not produce vapor. To reactivate the device, an adult user must suck on the mouthpiece three times within two seconds.

    Zhang also spoke about the importance of regulatory compliance and the user experience. He expressed confidence that science would demonstrate the potential of electronic nicotine devices as tobacco harm reduction tools.

    Going forward, Smoore innovation efforts will focus heavily on vaping efficiency, Zhang explained. “It is our internal thinking—the engine driving us forward to achieve more,” he said. “Smoore’s mission ‘Atomization Makes Life Better,’ aligns very well with this objective to continue to work on the R&D; improving it for bettering people’s life.”

    Rex Zhang (third from right) as panelist
  • Focus on Harm Reduction

    Focus on Harm Reduction

    Photo: Andreas

    Experts share their insights relating to tobacco harm reduction during the May 25 In Focus webinar

    In the run-up to the 10th Conference of the Parties to the Framework Convention on Tobacco Control in Panama (COP10) this November, public health professionals, industry representatives and policy experts on April 25 shared their insights into issues relating to tobacco harm reduction (THR) and sustainability as part of the GTNF’s IN FOCUS online series. Following is a summary of the presentations and panel discussions.

    Contributed

    James Murphy

    James Murphy, director of research and science at BAT, opened by saying that tobacco harm reduction is simple in concept: the switching of people who wish to use nicotine from risky forms of combustible tobacco products to lower risk tobacco and nicotine products. He noted that THR was the reason he joined the industry as a scientist almost 20 years ago, and that motivation remains today as the principal driver for coming to work each morning. His focus is making THR the centerpiece for all of BAT’s scientific research efforts.

    Murphy outlined that the challenges to THR are many, but they are outweighed by the opportunities for reducing the health impact of the industry across the globe if stakeholders get it right. He sets out four key topic areas for his remarks: 1) the benefits of THR for reducing the impact of the industry on global public health; 2) the key challenges facing THR; 3) the need for a common view on the race to zero combustion; and 4) the importance of science.

    Murphy stated that adult smokers who wish to continue to use nicotine now have access to a range of reduced-risk products that are better for them and for those around them. In countries that have embraced the concept of THR, including Sweden, the U.K., Japan and the U.S., there have been significant declines in smoking rates as smokers have migrated to noncombustible products, such as heated-tobacco products, vapor products and oral nicotine and tobacco products. Real-world evidence continues to be collected that indicates improvements in quality of life and lower instances of smoking-related morbidity when noncombustible products displace cigarettes.

    Murphy gave an overview of upcoming opportunities for THR to be discussed globally, including the U.K. government’s upcoming publication of a new tobacco control plan, the COP10 meeting in Panama, the recommendations from the Reagan-Udall Foundation’s evaluation of the U.S. Food and Drug Administration’s Center for Tobacco Products, and proposals in 2024 from the EU around the third Tobacco Products Directive (TPD).

    He set out four key challenges on THR: 1) objective science remaining at the core of the debate, with agreed frameworks for all stakeholders on assessing the risk profile of noncombustibles; 2) ensuring each country offers consumer access to regulated noncombustibles; 3) regulations must be enforced to prevent unregulated black market products being sold to consumers; and 4) preventing youth access to nicotine products and balancing the debate with the benefits of adult smokers switching to lower risk products.

    Murphy then turned to the importance of the race to zero combustion, setting out the relative harm reductions (90 percent to 95 percent less) from heated-tobacco, vapor and oral products as compared to combustibles. Consumers using lower risk noncombustible tobacco and nicotine products experience substantially lower levels of toxins, comparable to levels observed in those who quit using tobacco products altogether.

    He focused on the need for the industry to codify what is meant by THR: a race to zero combustion, not zero nicotine use, and reducing cigarette prevalence to below 5 percent, the accepted threshold for effectively zero in a country. He highlighted Sweden, which, through the use of snus and oral tobacco products, will achieve its smoking target 16 years ahead of the EU and has the lowest smoking-related disease outcomes anywhere in the EU.

    He then turned to the importance of world-class science in providing a robust evidence base to substantiate the role of reduced-risk products (RRPs) in global THR. Regulators need it to form the basis of regulation; politicians need it so they can cut through the rhetoric; and consumers need it so they can feel confident in switching to lower risk products. He remarked that industry science is necessary as regulators require specific data on the manufactured products, as seen in the U.S. with premarket tobacco product application (PMTA) regulations or in the EU with the TPD.

    Murphy closed by lamenting the polarization of the global debate on THR and the lack of scientific conferences where all stakeholders—industry included—can debate scientific studies and come to common conclusions on THR science to drive progress forward. His final remarks highlighted that the race to zero combustion has only really begun and that common science conclusions must form the basis of what the industry does.

    Riccardo Polosa

    Riccardo Polosa, professor of internal medicine at the University of Catania and founder of the Center of Excellence for the Acceleration of Harm Reduction, began his remarks by stating that there is no doubt that the evidence in favor of e-cigarettes being effective in terms of smoking substitution is quite strong. He highlighted the systematic reviews, randomized control trials and population studies that show evidence that e-cigarettes are important tools in helping smokers quit.

    Turning to heated-tobacco products (HTPs), Polosa explained that it is true that HTPs are similar to e-cigarettes in that they deliver nicotine in an equivalent range and mimic the ritualistic aspects of cigarettes, and both have a potential for smoking substitution. Although there is population evidence to suggest that HTPs are effective in this, to date, there have been no real randomized controlled trials that have proved these assumptions.

    He set out that researchers at the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) had designed and conducted a study to directly compare e-cigarettes with HTPs, involving the first randomized controlled trial of HTPs, in order to compare the effectiveness, tolerability and acceptability of both HTPs and refillable e-cigarettes for the purposes of cigarette substitution. The design of the study was standard: a switching trial, involving the randomization of 220 smokers not intending to quit but interested in trying new technologies and tar-free products. These 220 random subjects were split across two different products: IQOS 2.4 for HTPs and Justfog Q16 for e-cigarettes.

    Polosa highlighted that the results showed clearly that the efficacy in terms of smoking substitution for HTPs is impressive, demonstrating how HTPs can help smokers to quit, with a continuous abstinence rate of 39 percent for HTPs versus 30.8 percent for e-cigarettes. He also showed that the number of dual users reduced over time, with the number of quitters increasing over time, and commented that this is a trajectory not normally seen in conventional smoking cessation trials.

    Looking at risk perception, Polosa stated that there was no difference between the two groups: People using e-cigarettes perceive conventional tobacco as fairly high risk whereas they do not perceive their smoke-free product to be as risky as tobacco or conventional cigarettes. He also highlighted that both groups showed a clear improvement in terms of exercise tolerance over time, with results apparent even in week 4 of the trial, very early after switching.

    He concluded by answering the question of whether HTPs are successful: yes.

    Delon Human

    The next speaker, Delon Human, president of Health Diplomats, started by quoting the definition of Article 1d of the World Health Organization Framework Convention on Tobacco Control (FCTC) and highlighted the phrase “harm reduction strategies” (HRS). He went on to set out that the overall goal of population health is to prevent disease and premature death, but it is important to remember that these are individuals with different needs and lifestyles. It is also important to include health professionals in any discussion on HRS to balance the needs of populations and individual health as well as the rights of individuals to access healthcare and to use nicotine products.

    He stated that he wanted to make three suggestions to accelerate THR.

    The No. 1 issue for Human is engagement. A whole-of-society and whole-of-government approach, involving multi-stakeholder action, is required, and more needs to be done with key stakeholders in the tobacco and nicotine industries, particularly regarding engagement with the WHO and governments. He continued by saying that Article 5.3 of the FCTC does not exclude engagement between industry and government; complex problems can only be solved with multi-stakeholder engagement, and engagement does not mean agreement. This engagement with industry is needed to facilitate the crucial exchange of knowledge and data.

    Turning to his second suggestion, Human made the point about the centrality of science in the debate. The “quit or die” approach is ineffective, irresponsible and disrespectful of patients and consumers. They need to hear the full story and have access to information and products that do not involve combustion, specifically reduced-risk alternatives if they cannot or will not quit.

    He highlighted that this transformation can be accelerated if global public health scientists were to embrace the opportunity to test the benefits of adult smokers switching to reduced-risk products. Human commented that, for too long, the argument has been that there is not enough evidence to validate THR in smoking cessation. HRS have been used successfully with HIV/AIDs, drug control and alcohol consumption, and they should be applied to tobacco control. He raised the speed of Covid vaccine testing, which gave a powerful validation of HRS.

    Human spoke to the opportunity presented by COP10 to prepare the ground for further research in HRS and the new evidence available from countries where governments have allowed properly regulated reduced-risk products. Where THR has been adopted, smoking rates have reduced.

    He gave examples: In Sweden, the smoking rate is the lowest in the EU at 5.6 percent whereas Germany has seen rates increase to up to 36 percent. He lamented that “smoke-free Sweden” should be a case study in successful THR, but little attention has been paid to the public health revolution there. In the U.K., the government’s “swap to stop” scheme has both incentivized and funded adult smokers to switch from combustibles to vaping, and more broadly, the country has seen a 4.3 percent decrease in smoking. In Japan, heat-not-burn (HnB) products launched in 2014 and have led to a significant decline in smoking rates: Between 2016 and 2019, the number of adult smokers fell by 10 percent. In the U.S., nicotine products go through a rigorous and scientific PMTA-testing process, which costs hundreds of millions of dollars to companies, and other countries could benefit from this knowledge to support their adult smokers to quit.

    He closed this section of his remarks by suggesting that each example merits a country case study to consider how each THR approach has reduced incidence of smoking-related diseases and premature deaths, and more engagement among the WHO, governments and the whole of industry would facilitate progress in THR.

    Lastly, Human turned to industry contributions to the debate, highlighting the critical role played by the GTNF in bringing stakeholders together. He highlighted several dimensions that merit industry having a seat at the table: 1) R&D capacity, with companies investing greatly in this, including specific knowledge on consumer behavior; 2) product innovation, with all stakeholders needing to incentivize innovation while ensuring consumer safety and high standards; and 3) responsible marketing practices, with the marketing to children of primary concern.

    In closing, Human stated that there are 100 million consumers worldwide who have switched from combustible cigarettes to noncombustible nicotine alternatives, and now is the time to accelerate, transform and modernize tobacco control by injecting HRS, ensuring that affordable, accessible and acceptable alternatives can make a contribution.

    Following his remarks, Human moderated a panel discussion titled “Using the FCTC to Accelerate Tobacco Harm Reduction” that included the following panelists: Grant Churchill, tutor in medicine at New College Oxford and associate professor in chemical pharmacology at the University of Oxford; Ehsan Latif, senior vice president of grants management and health and science strategy at the Foundation for a Smoke-Free World; Mihaela Raescu, professor in the faculty of dental medicine at Titu Maiorescu University in Bucharest; and Heino Stoever, social scientist and professor of social scientific addiction research at the Frankfurt University of Applied Sciences in Germany.

    Human referenced the positive work done around the work in the harm reduction space, specifically citing Sweden, the U.K. and Japan as world-leading in this field. He spoke of Sweden’s incredibly low smoking rates with only 5.6 percent of the population using combustible tobacco.

    He explained that the success seen in these countries needs to be examined in greater detail to highlight why vapes in the U.K., snus in Sweden and heated tobacco in Japan are increasing in popularity.

    Human then detailed how several of his patients have seen remarkable improvements in their taste, smell and respiration since switching from combustible tobacco to RRPs in only two weeks.

    Churchill tailored his contribution around the misconception of nicotine. He emphasized that tobacco, specifically combustible tobacco, needs to be separated from nicotine. He set out the molecular level of nicotine as a compound and explained that nicotine is not harmful in the concentration it exists within RRPs.

    Churchill outlined that tobacco is made up of 4,000 smaller compounds, many of which are harmful. Nicotine represents only one of those 4,000 compounds and is not nearly as damaging as most of the others found in tobacco. For that reason, the education and rebranding of nicotine is critical in establishing RRPs as safe alternatives to combustible tobacco.

    Latif spoke primarily from the regulatory perspective of the panel and led the conversation about the upcoming COP10 summit hosted in Panama later this year. He expressed his concern over a lack of action and not wanting legislators to make rash decisions. He called for all decisions to be led by facts and science, explaining that no RRP category should ever be prohibited as it will only lead to illicit trade and unregulated, untested products.

    Latif echoed the message from Churchill that combustible tobacco is causing the most harm within the industry and that legislators need to take action to reduce the number of smokers. He emphasized this by saying, “You can’t wait 10 [years] to 15 years and then count the bodies at the end … We need some action now.”

    Raescu explained the oral health benefits of switching from combustible tobacco to RRPs, describing how oral health improves drastically within nine months of making the switch. She mentioned that there is a decrease in bacterial plague concentration and quality, resulting in major oral health improvement.

    Raescu also called for improved education for doctors and other health practitioners regarding nicotine and tobacco. She set out her belief that, currently, a lot of misinformation and misunderstanding results in the wrong advice for patients, having a negative effect on their individual health. Nicotine as a compound must be better understood by medical practitioners in order for it to be correctly conveyed to legislators.

    Stoever started by giving a summary of the focus of his career on harm reduction in Germany. Using his experiences from Covid-19 and other emergencies, Stoever emphasized the importance of education and the lack of this in Germany: 60 percent of Germans think the dangers of vaping equate to those of tobacco. Stoever went on to set out that public health agencies in Germany are not providing adequate information on the benefits of reduced-risk products, and this gap has had to be filled by academics.

    He spoke to the changes observed during the pandemic, where people’s lifestyle patterns changed radically to include working from home: There was an increased observance of people smoking during virtual meetings, which demonstrated the effectiveness of normal structural prevention strategies and social controls on preventing smoking besides behavioral prevention.

    Mary Glindon

    The panel discussion was followed by a keynote presentation by Mary Glindon, Member of Parliament for North Tyneside in the U.K. and vice chair of the All-Party Parliamentary Group (APPG) for Vaping.

    Glindon set out her role at the APPG and the reasons for her interest in the topic of tobacco harm reduction. She spoke about her late husband’s transformation from smoking to vaping—his “pipe”—and the impact more widely that smoking has on her constituents in the northeast of England. Not only does she hear from those who have switched that their health has improved but also their finances, given the lower costs of vaping.

    She spoke of her support for the U.K.’s ambition to be smoke-free by 2030 and the work undertaken by the Office for Health Improvement and Disparities (previously Public Health England) since 2015 to support vaping as a key harm reduction strategy, with it being proven to be at least 95 percent less harmful. Going further, Glindon praised the U.K.’s approach—one that she described as world leading and evidence led—with e-cigarettes at the heart of its strategy. She also highlighted the independent review last year by Javed Khan into “making smoking obsolete,” which included support for vaping as one of his key recommendations.

    However, Glindon then spoke of the concerns Khan had also raised in his report that the U.K. will miss its 2030 target if it does not accelerate the rate of smoking decline by at least 40 percent.

    She gave a series of recommendations on what action the government should take to remedy this while being clear that the preference is that people should neither smoke nor vape, nor should nonsmokers take up vaping. She spoke of tobacco harm reduction through vaping in the U.K. being consumer led but that it had left more than 6 million people who had not yet made the switch. Ensuring access to the right information and tackling misinformation and misperceptions of the relative harms of e-cigarettes versus combustible tobacco is key and must be embedded in all approaches on tobacco harm reduction.

    Glindon also stated the need for effective communication strategies from governments, approved and trusted independent health messaging and the inclusion of the benefits of switching on vape packaging and on cigarette packaging too. She raised the need to ensure that medical professionals at local stop smoking services are sufficiently supported to speak authoritatively on reduced-risk products, with clinicians signposted to the latest clinical guidance and evidence on e-cigarettes.

    Covering the recent announcements by Minister for Public Health Neil O’Brien, Glindon called for the U.K. government to finally release its new tobacco control plan and the new tobacco and related products regulations, both of which are two years overdue. She called for responsible companies like those represented at the GTNF to call out the bad actors who are undermining progress on tobacco harm reduction and for the industry as a whole to prevent youth access, tackle illegal products and promote sustainability.

    Turning to the world stage, Glindon highlighted pressures from outside the U.K., including alternative policy directions from the EU and World Customs Organization on tariffs and taxes. Going further, she spoke to the upcoming COP10 conference in Panama later this year, calling it “the biggest threat to the U.K.’s world-beating harm reduction strategy” with its “singular mission focused on actively encouraging countries to ban vaping as part of its tobacco control approach, purposefully flouting the evidence of vaping’s success.” She called on the U.K. government to show leadership, to send ministers as part of the delegation to COP10 and to “actively take part in leading the conversation instead of only being a passive observer and financial contributor.”

    Glindon then expanded on her concerns around preventing youth access, tackling illegal and noncompliant products and ensuring that the issue of sustainability, particularly with disposable devices, is addressed. She also called for an update on the vaping evidence set out by Public Health England back in 2015, asking how to get to a certainty greater than 95 percent less harmful.

    In her closing remarks, Glindon spoke of the need to expand beyond a focus in the U.K. solely on vaping as a tool for tobacco harm reduction and called for the government to consider HnB and oral nicotine products to help reach the remaining 6.6 million smokers in the U.K. She emphasized the need for more research to be done, independent of commercial interests.

    Finally, Glindon made clear that the industry has to address the key issues it faces—rogue players, youth access and environmental concerns—otherwise it faces being regulated out of existence. Her final words were “Be good: work hard, tackle the problems, seize the future.”

    Derek Yach

    Global health advocate Derek Yach opened by stating how the world’s health is in a much worse state since coming out of the Covid-19 pandemic, particularly regarding noncommunicable diseases (cancers, cardiovascular diseases, diabetes and chronic lung illnesses) as well as mental health.

    He used his own experience in the field of noncommunicable diseases to explain how different approaches must be taken, highlighting his concerns that what worked 20 years ago will no longer work in today’s climate and that modern science and health have to receive political and private sector support.

    He then introduced tobacco harm reduction as a critical category that can help to reduce the growing concerns in this area. Yach spoke to the point that governments around the world are being inactive to, or even dismissive of, the clear and obvious benefits of RRPs. This is risking the health and lives of many of its own citizens.

    Yach gave his own recommendations on how governments should address the 1.1 billion global combustible tobacco smokers still in existence today, referencing the positive work being conducted in the U.K., specifically mentioning the recent review by Javed Khan and the U.K. government’s recently introduced “swap to stop” scheme, which will offer 1 million vape starter kits to current smokers.

    He made a call for the WHO and other governing bodies to appoint a commission that could 1) further develop the science and evidence now available; 2) review the progress of the U.K. and FDA in authorizing this positive change; and 3) take stock of the current situation and set it out in front of COP10 in Panama in November.

    He then outlined the importance of the role of physicians and the need for them to be properly educated to understand the difference between tobacco and nicotine and between cigarettes and e-cigarettes. Without this education, medical professionals are unable to prescribe other, less harmful solutions to their patients.

    Next, Yach spoke of the importance of COP10, urging delegates to showcase positive examples of how RRPs are used around the world to radically reduce the number of combustible tobacco smokers. Sweden, the U.K., South Korea and Japan were all offered as examples of how RRPs have been deployed correctly to help users make the switch away from cigarettes.

    Finally, Yach held a mirror to the tobacco industry, commenting that it, too, was in need of further analysis of its own practices. He explained that in many low-income and middle-income nations, RRPs are legally available; however, the industry has not launched or given easy access to the range of harm reduction products available.

    To this point, the major focus on RRPs has been in high-income countries, and there needs to be an acceleration of getting these products to all countries around the world.

    Yach concluded his remarks by reflecting on his opening comments: Tobacco harm reduction is about stopping the growing trend of noncommunicable diseases and saving lives.

    Yach then went on to lead a discussion panel titled “Drawing on Behavioral and Consumer Insights to Encourage Harm Reduction,” which included the following panelists: Jessica Zdinak, social and behavioral scientist and owner at Applied Research and Analysis Consulting; Mohamadi Sarkar, scientific strategy and analysis and regulatory affairs at Altria Client Services; and Cother Hajat, public health physician and epidemiologist at Independent Respondent.

    Yach identified several smokers across the world attempting to quit smoking and asked panelists to consider what approaches should be adopted to help them do so. In many of the deprived communities of the world, Yach mentioned that availability of tobacco harm reduction products is an issue in order to get people to quit and tasked the panel to come up with solutions to remedy that.

    Yach lamented the disinformation surrounding the e-cigarette or vaping product use-associated lung injury crisis that appeared in many academic research papers, which can still be found on the internet despite retractions being made by a research journal. He suggested that inspiration could be found from Twitter to ensure that such articles can be traced in order to issue a warning and correction relating to the disinformation.

    Sarkar focused on the personal dimension that needs to be adopted by each of the 1 billion smokers around the world who need to stop smoking and shared his memories of treating smokers with diseases, such as myocardial infarction, when he was a clinician, but who ultimately did not quit.

    Sarkar’s main concern is that disinformation has become a significant barrier to smokers quitting, with 80 percent of Americans in 2021 believing, wrongly, that e-cigarettes are as harmful as, if not more harmful than, combustible cigarettes. He also lamented that 80 percent of doctors surveyed believed that nicotine causes cancer.

    Zdinak criticized the public health profession generally for omitting the basics of psychology and physiology in their appraisal of harm reduction efforts. She asserted that smokers’ basic needs must be met to successfully get consumers to switch to alternative products that are less harmful.

    She went on to say that health communication messages should capture what people are thinking and feeling. In doing so, Zdinak referred to Maslow’s hierarchy of needs and where smoking cessation sits within smokers’ priorities and said that community groups may be necessary to create a higher order for them to consider quitting.

    Hajat stated that the voices of smokers are often missing from research reports and reinforced the need to change that. She praised the U.K. Department of Health for embracing tobacco harm reduction products as vital weapons in its arsenal to improve the health of the nation and welcomed recent proposals to use pack inserts in combustible cigarettes.

    She also welcomed the incentives for pregnant women, who make up 10 percent of the smoking population, and for people on low incomes to receive starter kits to accelerate smoking cessation and meet the government’s 2030 target to become smoke-free.

    Jeremy Lim

    The panel discussion was followed by a keynote presentation from Jeremy Lim, CEO and co-founder of AMiLi. Lim opened by reflecting on the themes developed throughout today’s conference. He started by reaffirming the words of Yach, echoing his sentiment about the polarization of tobacco control and a lack of understanding of the differences between combustible tobacco and other nicotine products. He made clear that this is essential for countries in the developing world, which are chronically short of doctors, making misinformation even more problematic.

    He supported the concept of introducing a WHO commission that specifically analyzes the positive progress made in countries like Sweden, the U.K. and Japan, which could result in a homogenized view of tobacco harm reduction, eradicating the misunderstanding about tobacco and reduced-risk products.

    Lim then reemphasized what Sarkar had set out, explaining that much of the focus and attention is around theoretical concerns, such as youth access and environmental impact, but not enough spotlight is given to the individual smokers themselves who suffer the greatest impact from their addiction. He spoke of a systemic bias against smokers, citing the perception that smoking is a self-inflicted issue where subtle blame is given to the individuals who smoke. Smoking is not seen as a mental health or social health issue—it is seen as a choice.

    Offering his own thoughts on the role society plays in helping or hindering the progress of tobacco harm reduction, Lim used the analogy of a person pushing a large cylinder up a steep hill. The gradient of that hill is determined by society—the more society hampers harm reduction, the harder it will be for people to quit; vice versa, the more society embraces the concept, the more support each smoker is given to quit.

    Lim outlined his concern over the rising cases of youth access to vaping products, calling for a joint effort from everyone involved in the industry to remove these “bad players.”

    He concluded his remarks by urging the industry to put its ideological and political preferences aside and to focus on science and on individual smokers instead.

  • Pondering Prohibition

    Pondering Prohibition

    Photos: Chris Frenzi

    The pitfalls of banning tobacco and nicotine

    TR Staff Report

    Mention prohibition and most people will think of the United States’ ill-fated attempt to eradicate the health and social problems associated with alcohol consumption by banning the manufacture, transportation and sale of intoxicating beverages in the 1920s. Rather than achieving the desired effects, the experiment fueled a wave of illegal manufacturing and smuggling while spawning some of America’s most notorious crime syndicates. In 1933, the federal government acknowledged defeat and repealed the law.

    Given prohibition’s poor track record, it’s tempting to conclude that the measure has been consigned to the dustbin of history. Surely, modern policymakers would steer clear of such a crude and ineffective tool? But as became clear during a panel discussion at the recent Global Tobacco and Nicotine Forum (GTNF), prohibition has been making a bit of comeback lately, even if its contemporary proponents are careful to avoid the term. As moderator Flora Okereke of BAT pointed out, 15 years ago, the concept existed only at the fringes of tobacco control. “Today it is mainstream,” she said. “At some point in the not-too-distant future, tobacco and even nicotine could be outlawed.”

    Okereke’s panel included experts with a variety of professional backgrounds: Christopher Snowdon, head of lifestyle economics at the Institute of Economic Affairs; Abrie du Plessis, trade law consultant; Kgosi Letlape, president of the Health Professions Council of South Africa and president of the Association of Medical Councils of Africa; Simon Clark, director of the smokers’ rights group Forest; and Riccardo Polosa, full professor of internal medicine at the University of Catania and director of the Center of Excellence for the Acceleration of Harm Reduction.

    During a skillfully guided, hour-long debate at the Hay-Adams hotel in Washington, D.C., they examined the drivers and consequences of the new prohibition movement and offered suggestions on how tobacco regulation might more sustainably evolve to embrace harm reduction instead of prohibition.

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    Snowdon started by noting that, despite the negative U.S. experience with alcohol, prohibition has always been the natural conclusion of the anti-smoking campaign. “Prohibition somewhere is probably more imminent than some people think,” he said, pointing to New Zealand’s recently announced policy of gradually raising the age at which consumers can buy tobacco until it covers the entire population and the United States’ plan to require tobacco companies to reduce the nicotine in their products to a level at which nobody would want to smoke. “Both are variations of prohibition,” said Snowdon, but neither country is calling it that, instead using euphemisms such as “tobacco-free generation” and “endgame.”

    The panelists identified several reasons for prohibition’s revival, including pressure from advocacy groups, continued hostility to the tobacco industry and health ministers eager for approval from their colleagues and the World Health Organization.

    Other unfortunate examples of recent tobacco prohibitions include that in Bhutan (recently lifted in the wake of thriving illicit trade and concerns about cigarette smugglers spreading Covid), the ban implemented by the Islamic State terrorist group when it controlled swaths of Iraq and Syria, and the quickly reversed South African prohibition temporarily instituted during the Covid-19 lockdown.

    Clark observed that the threat of prohibition has never gone away. The temperance lobby from the start of the 20th century, he said, has simply reappeared under the guise of public health and devised a new strategy—creeping prohibition. As examples, Clark cited public smoking bans, which in some jurisdictions have expanded to include outdoor areas and even social housing, preventing people from smoking in their own homes. Britain’s ban on menthol cigarettes, he observed, has outlawed a product category that accounted for 20 percent of the domestic market.

    Meanwhile, England, Scotland, Wales and Ireland have all set dates by which they want their countries to be “smoke-free,” by which they mean less than 5 percent of adults smoking. According to Clark, those targets can be achieved only by further and excessive regulation. He was particularly disturbed by Philip Morris’ call on the U.K. government to ban the sale of cigarettes by 2030—a step that could very well backfire, according to Clark. “The day will surely come when alternative nicotine products, including e-cigarettes, will also be targeted for prohibition—as indeed they already are in some parts of the world,” he said.

    In recent years, prohibition has also been deployed under the guise of Covid prevention. Snowdon pointed out that, in 2020, one in five people lived in a country where you could not buy tobacco or e-cigarettes—mainly as a result of India’s temporary sales ban. But the most striking recent illustration of the risks associated with prohibition comes from South Africa.

    After the World Health Organization declared Covid-19 a public health emergency in March 2020, South Africa quickly banned sales of alcohol, tobacco and e-cigarettes to help slow the spread of the virus. According to du Plessis, the minister in charge acted rationally based on the information available at the time. She feared that smokers sharing cigarettes would accelerate transfer of the disease and that smoking would exacerbate the symptoms of Covid, resulting in an overload of hospitals. Unfortunately, when evidence for her assumptions failed to emerge and the cigarette market moved underground, she failed to adjust her strategy.

    The University of Cape Town Research Unit on the Economics of Excisable Products found that within a short period after the start of the ban, 100 percent of South African tobacco users were able to find tobacco in the illicit market, albeit at heavily inflated prices. This meant that none of the outcomes the minister sought were possible anymore; the measure could not serve as a break on Covid transmissions because, unlike the treasury, the virus does not distinguish between licit and illicit cigarettes.

    The tobacco industry challenged the ban and the case went all the way to the Supreme Court, which ruled the measure was unconstitutional. Because the illicit market had completely replaced the licit market, the ban had no impact, the judges noted, so denying legal operators the right to sell tobacco was senseless.

    South Africa lifted its tobacco ban on Aug. 17, 2020, but its negative impact endures. To maintain their market share, illicit traders started selling their products below the minimum collectable tax level after prohibition ended. Today, one in four cigarettes in South Africa are sold below the excise and VAT level combined while the share of the illicit market remains higher than that of the licit market.

    Despite such experiences, one GTNF panelist saw a role for prohibition under certain conditions. Polosa said he would favor a ban on traditional cigarettes providing there are alternatives in the form of combustion-free products. In a market still dominated by combustibles, however, he said such a move would be ill advised.

    Clark said that tobacco harm reduction is best achieved by extending consumer choice and allowing companies to produce and market reduced-risk products (RRPs). “The onus is not only on government to adopt light-touch regulation policy on vaping and smokeless products; the industry can also help by developing better RRPs that appeal more to smokers,” he said, adding that many smokers don’t want to switch because they don’t like the currently available RRPs as much as they like smoking. “So instead of calling for a ban on cigarettes as Philip Morris has done in the U.K., the industry should fight prohibition and focus on improving e-cigarettes and other RRPs,” Clark said.

    Letlape stressed that the key to tobacco harm reduction is education, empowerment and appropriate regulation based on science and evidence. “Prohibition should be prohibited,” he said, noting that the main party harmed by smoking is the smoker himself. Part of the challenge, according to Letlape, is that the “tobacco wars” of the past century have not been dealt with. Health advocates battered by that conflict hold on to a grudge and pass it on to new generations based on lack of information, he observed. “How do we break the chain? By saying, ‘we don’t have to reconcile—we don’t have to love each other—but we must sit around the table and talk about these issues.’ Anywhere you want to reduce harm, you got to get all parties around the table.”

    Asked what role prohibition might play during next year’s Conference of the Parties to the Framework Convention for Tobacco Control (FCTC), du Plessis reminded his audience that, while currently dormant, the concept of prohibition is present in the FCTC preparatory documents. When the FCTC was negotiated, the smoking rate was so high that the parties considered a ban inappropriate. Yet if prevalence is reduced to a certain level, the FCTC may very well again look at the feasibility of prohibition. Pursuing an endgame, however, requires getting the illicit market under control, according to du Plessis, because the FCTC measures were designed for a controlled environment. “You can’t do tobacco control unless you control tobacco,” he said.

    Okereke then invited the panelists to speculate on which countries would attempt to ban tobacco next. Snowdon expected it to be a place with an authoritarian leader—“any of the countries with names ending in ‘stan,’” he ventured—or perhaps North Korea “if President Kim Jong-un gives up smoking and becomes a classic ex-smoker.” Other candidates were countries with histories of temperance movements and already low smoking rates: the Scandinavian nations, Australia and New Zealand, along with, remarkably, the country with arguably the most traumatic prohibition experience, the United States, if it moves forward with its nicotine-reduction plan.

    In a post-panel interview, Okereke identified three lessons from the history of prohibition: First, she said, policymaking must be context specific. “There is no one-size-fits-all approach to tobacco control policies,” she said. “What is right in the Pacific will not necessarily be right in South Africa or Singapore or Malaysia. And if the preconditions are wrong for a policy—such as high levels of illicit trade—there can be serious and irreversible consequences for society.”

    Second, policymaking must be evidence-based and science-based. “Policy experimentation is prone to failure, can violate international law and can create unintended consequences that can create costs for society that vastly outweigh the benefits of a proposed policy,” said Okereke, adding that policies should be based on what has worked historically, subject to impact and cost-benefit analysis, and must take into account science about the behaviors of people and the relative risks of products. “Believe it or not, these first two points hew very closely to what the WHO itself has said about extreme tobacco control policies,” said Okereke. “They must be context specific, and they must be based on evidence.”

    Finally, Okereke noted, the world has a better chance of changing through choice. “We should strive for promotion and not prohibition,” she said. “We will more quickly and effectively move consumers away from more harmful forms of tobacco by providing appealing, affordable and well-regulated access to reduced-harm products versus pouring our energy and resources into prohibition and at the same time criminalizing a whole segment of society that uses nicotine and tobacco.”

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  • Accessing Innovation

    Accessing Innovation

    Photos: Chris Frenzi Photography

    The GTNF 2022 once again delivered on its promise to promote respectful debate among stakeholders in the nicotine business. From Sept. 27 to Sept. 29, participants gathered at the Four Seasons hotel in Washington, D.C., to discuss the challenges and opportunities facing their business, with an emphasis on innovation—and the importance of making the fruits of that innovation accessible to consumers worldwide.

    This year’s GTNF was noteworthy for the diverse lineup of participants. More than half of the forum’s participants were not employed by the tobacco industry, and at least 41 percent of speakers addressed the conference for the first time.

    Below is a sampling from the conference.

    Adam Afriyie: The U.K. Example

    Adam Afriyie, Member of Parliament for Windsor and vice chair of the All-Parliamentary Group on Vaping, examined the successful U.K. approach to tobacco harm reduction and the lessons it might hold for other countries.

    This was an appropriate time to do so, he insisted, with life returning to a semblance of order following the Covid-19 pandemic and regulators around the world poised to make decisions—“life-and-death decisions”—about alternatives to smoking.

    Despite progress, smoking still kills 75,000 people in England yearly. Britain’s National Health Service spends about £2.5 billion ($2.82 billion) annually treating smoking-related illnesses. Every year, tobacco use results in economic losses of £17 billion through ill health, absence and low productivity.

    Afriyie distinguished four elements in the U.K. approach, which started with Britain setting a target to make smoking obsolete by 2030.

    Second, the government and the health establishment accepted the evidence that vaping and other smoking cessation products, such as patches, pouches and snus, are all part of the legitimate arsenal of weapons against smoking—a conclusion that was reinforced by the Department of Health’s conclusion that vaping is at least 95 percent less risky than smoking. “What matters is the relative harm,” said Afriyie. Rather than relying on conjecture, emotion or the fear of Big Tobacco, the government relied on data, he noted.

    Third, the government regulated vaping as a consumer product, setting minimum standards for quality and safety, such as a requirement to sell e-liquids in child-resistant packs. This framework, said Afriyie, allows adults to make informed decisions while protecting children from marketing and harm. All new products must be registered with the Medicines and Healthcare products Regulatory Agency. While vapes are not considered medical products in Britain, this prerequisite installs a discipline among manufacturers to be cognizant of the evidence base behind their offerings, said Afriyie.

    Finally, the government commissioned an independent review of the progress toward its smoke-free objective. Published in June, the Javid Kahn report concluded that Britain would miss its target if it continued on the current trajectory. To get the project back on track, Kahn suggested that vaping must be front and center of the drive to eradicate smoking. In light of widespread misperceptions about vaping—50 percent of general practitioners are unaware that vaping is less harmful than smoking—the report also recommended opening a conduit for the industry to communicate directly to smokers the benefits of switching from cigarettes to vapes.

    While Afriyie was inspired by the level of technical innovations in nicotine-delivery products, he was less encouraged by the equally important innovation or evolution of regulatory frameworks internationally. For example, while heat-not-burn products have been thriving in Japan, vapes are nearly impossible to access in that country because they are treated as medical products rather than consumer products.

    The World Health Organization, too, should adopt the U.K. approach, according to Afriyie. Unfortunately, the global health body’s direction of travel, he said, appears to be made in “smoke-filled” rooms lacking transparency. Rather than basing its policies on science, said Afriyie, the WHO’s stance on tobacco harm reduction products appears to be subject to influences that are not directly to do with public health.

    Concluding his presentation, Afriyie addressed each of the stakeholders in the tobacco harm reduction debate. “My message to smokers is please stop. And if you can’t stop, choose a vaping device or a heat-not-burn product—but move on. My message to investors: Britain is open for business.” His comment drew good-natured laughter, but Afriyie was only half joking, reminding his audience that when it comes to smoking cessation products, Britain is a gateway to the world. “The U.K. regulatory imprimatur on your documentation is a sign of quality and an aid to marketing and acceptance around the globe,” he said.

    “My message to industry: Be good. Conduct open, honest research,” said Afriyie. “If the answers aren’t exactly what you want, don’t hide the results. Every bit of extra information and knowledge that we gain through research is useful.” To regulators, Afriyie stressed the importance of following the science. “Follow the U.K.,” he said. “Do not let the perfect be the enemy of the good.”

    Philip Evans: An Outside Perspective on Innovation

    Philip Evans, senior advisor at the Boston Consulting Group, provided an outside perspective on the challenges and opportunities of transformation through innovation.

    Evans started by reflecting on the successes and failures of other sectors that, like the tobacco industry today, had faced existential crises. He cited Netflix CEO Reed Hastings’ decision to walk away from the business of distributing DVDs in favor of streaming video, thereby transforming the company and creating staggering amounts of economic value—and contrasted that with BP’s fruitless attempt to rebrand as “Beyond Petroleum.”

    What can such experiences teach the tobacco industry about transformation through innovation? Evans identified five lessons.

    First, transformation requires a crisis—the more acute, the better. Transformation takes place regularly in the military—always after defeat, when generals are forced to fundamentally rethink their strategies. And one reason the fast-moving tech industry is so innovative is that when a crisis hits, it tends to hit quickly, which means it cannot be evaded.

    Second, while companies can try to overcome their problems through mergers and acquisitions, this will not necessarily achieve the type of transformation that the tobacco industry is interested in. Evans cited the example of the American Can Co., a low-margin commodity business that transformed itself into a life insurance company by buying other businesses. “Over time, the only thing that transformed was the business card of the chief executive,” said Evans, adding that “a bunch of investment bankers probably got very rich in the process.”

    The third lesson in transformation, according to Evans, is that it almost invariably takes new leaders to set a new direction—and those leaders need a single-minded, long-term vision along with the security and legitimacy to withstand short-term reversals, which is the fourth lesson. Evans notes that successful transformers were often led by a sole proprietor. Bill Gates was able to overcome the threat posed by the internet to Microsoft’s software-based business model in part because he was a uniquely powerful controller and owner of the company.

    As the fifth lesson, Evans stressed the importance of a clearly articulated strategy and purpose. “Companies that lose their way cannot recruit good people,” he said. Talented candidates are attracted by the promise of growth and vitality, especially through innovation.

    Evans then set out to dispel the myth that big companies are unable to innovate. “It’s untrue,” he said. To illustrate his point, he showed a chart plotting the number of patent filings against the population levels in America’s biggest cities. The cities with the most people clearly filed the most patents. “Innovativeness is a function of the breadth and comprehensiveness of the other ideas to which an individual is exposed,” explained Evans. “That exposure is much greater in a large network than it is in a small one. If appropriately structured, there can be positive economies of scale to innovation; big is indeed beautiful.”

    The other secret of cities’ success in innovation is their lack of hierarchies. According to Evans, it’s the hierarchy rather than the scale that squelches the ability of many large organizations to innovate. If a large organization wants to be successful in innovation, it should replicate the hierarchy-free social structure of cities.

    To illustrate his point, Evans showed charts revealing patterns of collaboration within Google, Apple and Amazon—companies that are large and innovative. While each of these companies operates in a different part of the innovation cycle, the charts revealed patterns of considerable collaboration.

    Openness is key, according to Evans. Google, for example, is deeply networked in academia and does not assert intellectual property in the traditional sense.

    This lesson was learned the hard way by the pharmaceutical industry toward the end of the 20th century. In the late 1980s, there was little collaboration among pharmaceutical companies, with each player jealously guarding its intellectual property. When large molecule biotechnology emerged in the early 1990s, many traditional pharmaceutical companies stuck to old models of who owns what—and therefore got marginalized.

    In the ensuing decades, they were forced to buy their way back into the business by acquiring some of these biotech companies. According to Evans, the pharmaceutical companies have since learned their lesson. But the point, he noted, is profound: Innovation requires openness and sharing. “It is incompatible with a lot of the traditional ideas about exclusivity, secrecy and ownership,” he noted.

    Brian King: Leading an Agency Under Scrutiny

    There are plenty of reservations about the way in which the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has handled its responsibilities. During a brief speech at the GTNF 2022 in Washington, D.C., the new director of the CTP, Brian King, did little to quell those concerns. He did, however, acknowledge the continuum of risk. “We do have certain products that are lower risk than combustible cigarettes, and that’s an important component of the dialogue,” said King.

    King told attendees that there is an opportunity for the CTP to assess the risk of youth vaping initiation and counterbalance that with the opportunity for adults who use e-cigarettes to quit combustible cigarettes.

    “I think that [the] public health standard is pretty critical to the work we do, and it’s definitely a guiding light in terms of my determinations and decision-making,” he said. “Ultimately, it comes down to the science … it’s very critical, to me, to ensure that we use that as our guiding light. And, of course, the onus is on the applicants to ensure that they are providing the most robust signs possible to inform decision-making.”

    The FDA has long been criticized for its handling of the premarket tobacco product application (PMTA) process and is currently defending multiple lawsuits from vapor companies challenging its marketing denial orders (MDOs), including two from Juul Labs, which recently filed a lawsuit over the regulatory agency’s refusal to disclose documents supporting its MDO.

    Juul claims the agency overlooked more than 6,000 pages of the data it submitted on the aerosols that users inhale, according to Joe Murillo, chief regulatory officer at Juul Labs, who also spoke at the conference.

    King said that a sizeable portion of youth are still vaping flavored and disposable products. However, he also said that the potential benefits for adult smokers are “mutually exclusive” from youth uptake concerns. “I don’t think that they necessarily have to be separate; they can certainly be explored concurrently,” he said. “But again, we need to ensure that we’re considering the science from both ends when making our decisions.”

    King said the agency is “continuing to make progress” on the estimated 1 million PMTAs for nontobacco nicotine products as well. He said over 90 percent of the applications have been completed. “We have 350 acceptances so far, and there’s about 800,000 that have received an RTA [a refuse-to-accept letter], and I’m hopeful that within the next few weeks we should be able to get through all 100 percent of those 1 million.”

    Being accepted for review is only the first step in the PMTA process. There are six stages, or rounds, to the PMTA process. After acceptance is filing, then a substantive review before an action is taken. King called the first step an important one. “[It’s] an important step, and I’m committed to ensuring that we keep things moving as expeditiously as possible,” King said.

    King recently told the AP that he believes “there’s a lot of really important science and innovations” that have occurred in the vaping industry in recent years, adding that the most notable is nicotine salts in e-liquids. “We know that when you smoke a tobacco product, it’s a very efficient way to deliver nicotine across the blood-brain barrier. So it’s been very difficult to rival that efficiency in another product,” said King in the interview. “But in the case of nicotine salts, you have the potential to more efficiently deliver nicotine, which could hold some public health promise in terms of giving smokers enough nicotine that they would transition [off cigarettes] completely.”

    King also discussed the FDA’s ability to force companies to comply with its MDOs. So far, very few companies that have been told to remove their products from the market have complied. King said the agency has multiple enforcement options to bring both manufacturers and retailers to heel.

    “We have several tools available to us, including advisory actions,” he said. “We also have regulatory enforcement actions, including voluntary recalls as well as various other requested recalls. We can also take administrative action, civil money penalties (in terms of manufacturers, that penalty cannot exceed $15,000 for any single violation or $1 million for any number of violations related to a single action),” explained King. “When it comes to judicial action, we can do seizure, injunction and also criminal prosecution. I will say that when it comes to enforcement and compliance, nothing is off the table.”

    King also updated attendees on the FDA’s external review of the CTP’s procedures, which is being conducted by the Reagan-Udall Foundation. Lauren Silvis, a former FDA chief of staff, was named as chair of the panel that has been asked to “evaluate regulatory processes and agency operations related to tobacco to help the center address new challenges as it works to reduce death and disease from tobacco and achieve its public health mission.”

    “Within only a few weeks of assuming this role, we were told that there would be an external evaluation,” said King. “I actually wholly welcome it. I think it’s a good opportunity, particularly with new leadership, to identify areas where we’re doing things very well but also identify areas where we can enhance our efficiency and effectiveness. I have had meetings with [Silvis] and her team, and I’m confident that we’re going to get very useful information.

    “It’s an ambitious timeline, 60 business days, so it’s going to work out to about 90 days total. It should finish probably by the end of the year, mid-December, and I’m looking forward to the opportunity to hear the recommendations. And I do have a very open mind on this. I’m always for improvement.”

    King expects there will also be opportunities for external engagement, including listening sessions. He could not provide specifics during the speech but said he welcomes feedback from others in terms of informing the CTP’s processes.

    “It’s not a one-size-fits-all, but I do think that we have some great opportunities here,” he said. “I’m fully committed to listening to the evaluator’s input and ensuring that we use it in a very useful way … then we’ll take it from there … I’m sure many of you have heard publicly, my calendar is rapidly filling up, and we are meeting with many—I know I’ve met with several of you in the room already, and I value those opportunities to meet with folks from across the spectrum, whether it be industry or public health … to hear people’s insights, what your priorities are.

    “And those have been very productive and helpful to me. I do listen. I think it’s a very useful opportunity to me in terms of hearing specifically what the recommendations are from industry and what are areas where you feel it would be useful for FDA to engage in to make your life easier in terms of submissions and applications and [what] processes are overly complicated and could be improved,” said King. “I’m fully committed to ensuring that happens.”

    Panel Discussion: The Investment Climate

    The 2009 Family Smoking Prevention and Tobacco Control Act charged the U.S. Food and Drug Administration with regulating tobacco products for the protection of public health, so, from one point of view, it was dismaying to hear a panelist on the investor panel of the recent GTNF describe how, under the tutelage of the FDA, the U.S. tobacco and nicotine market had become a resilient one for combustible cigarettes.

    Of course, this being an investors panel, the panelist’s comment was less about the FDA and more about Altria, whose short-term fortunes are tied to a large extent to the resilience of the combustible segment and whose reduced-risk strategy was said by another panelist to be unclear. Altria’s appeal as an investment opportunity was contrasted with that of another U.S.-listed company, Philip Morris International, which has had success in moving its sales from higher risk to lower risk products.

    The panelists discussed the proposed acquisition of Swedish Match by PMI, which, if it goes ahead, would allow PMI to use SM as a vehicle for marketing in the U.S. the heated-tobacco device IQOS, which has marketing approval and is the subject of an FDA modified-risk order but which is currently banned from being imported following a patents dispute, a ban that is being challenged in the courts. According to one panelist, Altria has an agreement with PMI to market IQOS in the U.S. until April 2024, but there is apparently a question mark over whether the agreement provides for Altria to extend the agreement for another five years.

    This raises the question of how an Altria shorn of its right to market IQOS would fare. Well, apparently, Altria is said to be due to unveil a heated-tobacco product toward the end of this year, but with FDA approval necessary, it would take some time for the company to start commercializing a new product. One interesting comment made the point that while PMI was years ahead of Altria in the heated-tobacco product field, the two companies used to be one.

    There seemed to be an assumption at times that PMI would easily be able to muscle in on the U.S. market, but not everybody was having that. One panelist made the point that Altria and other U.S. companies were likely to prove highly competitive, and another added that IQOS might not be welcomed with open arms by U.S. consumers who had access to a range of reduced-risk products, including e-cigarettes, which had out-competed IQOS on some other markets. But on the other side of this coin, PMI was said to be starting to widen the focus of its reduced-risk strategy in respect of product categories.

    It would seem that a week is a long time in the investment arena. During the panel discussion, Altria was seen as being in a difficult position when it comes to vaping. Its investment in Juul Labs involved a no-competition clause, and Juul has suffered a setback in the form of an FDA marketing denial order (MDO). The panelists indicated that the MDO was being contested, however, and that it would be open to Altria to make an outright bid for Juul. Less than a week after the panel met, however, Altria announced that it had exercised its option to permanently terminate its noncompetition obligations to Juul.

    Surprisingly, perhaps, threats raised by the potential cigarette menthol ban and the imposition of a very low-nicotine cigarette standard in the U.S. were not yet seen as particular drags on tobacco businesses’ appeal to investors since, partly because of likely legal challenges, they were seen as being some way off.

    On a wider front, while PMI was seen as a growth company, it was said to be facing headwinds created by the strength of the dollar and its exit from Russia. Or not. One panelist said that only Imperial Brands had exited Russia completely and that he would be surprised if the other major companies, which had invested heavily in the country, had exited Russia without providing for a way back.

    On a more general level, the investment case for tobacco was seen as strong, partly because most companies—the exception seems to be PMI—are undervalued but also because they offer strong and secure cash flows and high yields. This situation was said not to have changed but to be more appreciated now than it was two or three years ago, particularly in the face of a recession. And while the appeal of tobacco stocks would be negatively impacted by the current increases in interest rates, on the positive side, most tobacco company debt was at fixed rates. Still, environmental, social and governance issues comprised an overhang in respect of getting investors interested in tobacco stock.

    The discussions were heavily skewed toward the U.S. market and U.S. companies to the extent that the chairman apologized for ignoring the world outside the U.S. and Europe. The upcoming EU directives on excise taxes and tobacco products were mentioned, the former in a fairly good light given that it seemed that harmonized taxes would not be set at the same level across product categories but at a lower level on less risky products. Such a rational policy seems at odds with the Tobacco Products Directive, which seems set to retain the irrational ban on snus.

    BAT and Imperial Brands were said to be undervalued by investors. BAT’s multi-category reduced-risk portfolio was held up as the way ahead, and its success with Vuse was highlighted a couple of times. Mention was made of a new management at Imperial that was said to be getting to grips with the business, focusing on the areas where it could perform well, resetting its new-generation products business and creating an opportunity for some geographical divestments.

    Panel Discussion: Global Regulatory Issues

    It’s been almost 60 years since a U.S. Surgeon General first stated the dangers of cigarette smoking and 50 years since scientists found out that the inhalation of smoke rather than nicotine is the major cause of smokers’ health problems. With goals in tobacco harm reduction (THR) long set, regulators should be able to solve the problem and shape rational regulation, argued moderator David Sweanor, adjunct professor of law at the University of Ottawa. “In all cases, it’s only small steps forward. What would happen if we saw this as a matter of urgency and, for instance, allow more products at a time?”

    Gizelle Baker, vice president of global scientific engagement at Philip Morris International, stressed the role of science as a basis for policymaking. “Science isn’t perfect, but it has evolved,” she said. “We need to look at the data we need in the future to correct our idea and come to conclusions that can drive policy. Because the only way to shape policy is to use science, data and facts.” Knowledge about long-term effects or which part of the population in certain countries will use a reduced-risk product (RRP) can only be gained if the products are put on the market, she stated.

    Konstantinos Farsalinos, research fellow at Onassis Cardiac Surgery Center, noted that there are no missing data, only missing common sense. “We will never be fully informed about anything,” he said. “At one point, we have to make a decision.” The bar of proof for THR has been set extremely high, Farsalinos noted. In some markets, this forces smaller companies to leave the market to big companies that can afford the approval process. “We live in a high-risk society—let’s consider THR like any other harm reduction strategies,” he said.

    Marewa Glover, director of the Center of Research Excellence on Indigenous Sovereignty and Smoking, spoke about New Zealand’s Smoke-Free Aotearoa 2025 Action Plan, which is currently under review and includes a smoking ban for all those born after 2008, a drastic reduction of legal retail outlets for RRPs and the reduction of nicotine content in combustible cigarettes to nonaddictive levels. Glover said the draft bill lacks not only common sense but also compassion. “The regulatory intent is to not allow vaping to become normalized but denicotinization,” she said. “As a smoker, you should switch to vaping temporarily and then quit completely. Anyone who quits vaping should never go back.” She predicted a domino effect on other countries and urged regulators not to follow the example of New Zealand.

    The objective of THR, said Sharon Goodall, group head of regulatory science at BAT, is very clear: to reduce the number of smoking-related deaths. The sentiment of positivity that comes with this prospect should be maintained in the industry’s talks with regulators who are willing to change their approach toward THR. “We must not get distracted. We must react to individual events but remain focused on the long-term outcome. There are insufficiencies in the system, markets without open dialogue, therefore we must continue to work with regulators.”

    Focusing on the role of market structure and competition in the U.S., David Levy, professor of oncology at Georgetown University, pointed out that before 2005, the cigarette industry was static and homogeneous and, for tobacco control, the epitomized enemy. After 2005, the market fragmented, with consumers using multiple products. After 2012, e-cigarettes quickly gained market share.

    Tobacco companies responded by producing their own e-cigarettes. They played a role but didn’t control the market. Vaping became a highly competitive market. Recently, it has been joined by heated-tobacco products, which, Levy said, could play an important role as they solved problems e-cigarettes couldn’t solve. “Companies have to be serious in THR because it’s decisive for their businesses,” he said. “New Zealand and the U.K. have done well in THR. In low[-income] and middle-income countries [LMICs], such as India or Pakistan, oral nicotine could replace the highly harmful chewing tobaccos. However, restrictive policies, such as a ban of RRPs, will drive smokers back to cigarettes.” Levy saw clues for a closer cooperation between the industry and public health.

    Fadi Maayta, president and co-founder of Alternative Nicotine Delivery Solutions, provided a snapshot of the situation in LMICs by portraying the Middle East and North Africa (MENA) region, which he called a forgotten region in the picture of THR.

    Of the 547 million who live in the region, there are 140 million adult smokers. In some countries like Jordan, there is a smoking incidence of more than 60 percent, and cigarette sales are growing across the region. Governments are employing the typical measures to curb consumption, such as tax hikes and increases in customs. Saudi Arabia was the region’s only country to introduce plain packaging, which resulted in a burgeoning illicit cigarette market.

    Eight out of the 22 MENA markets have regulated vape products whereas the remaining 14 have banned them altogether. In these markets, however, vape products are still around—and unregulated. But even in regulated markets, 80 percent to 90 percent of the markets are illicit products because the government followed an aggressive path when regulating the products, introducing a fiscal and regulatory framework that is stricter than that for cigarettes.

    “Throughout the region, misinformation is polluting the whole idea of THR,” said Maayta. “Regulators rely on articles about the harm of e-cigarettes, instead [of] on robust science, and still believe that nicotine causes cancer.” An opportunity, he said, could be to cooperate with global THR associations.

    Plenary Panel: Innovating for Tomorrow

    When creating a smoke-free world, innovation must take place not only in terms of products but also in terms of regulation, communication and sustainability. That was one of the messages of the “Innovating for Tomorrow” panel discussion during the recent GTNF in Washington, D.C.

    Ming Deng, head of the Next-Generation Products (NGPs) Industry Study at Yunnan University, spoke about his desire to make NGPs smart and mobile. At present, he said, the electronic functions that differentiate an NGP from a combustible cigarette just serve as a marketing tool. However, the Artificial Intelligence of Things (AIoT)—the combination of artificial intelligence and the Internet of Things—offers considerable opportunity to improve human-machine interactions and enhance data management and analytics, among other benefits. “With AIoT, producers could trace consumers’ needs and innovate products accordingly,” said Deng.

    For Meisen Liu, R&D director at Shenzhen Zinwi Bio-Tech, lower temperature atomization is one of the most important objectives in current research as it is safer for human health. A higher atomization temperature causes atomizing agents to decompose into harmful aldehydes whereas atomizing agents with a low boiling point decrease the atomizing temperature and reduce the emission of harmful substances. Liu also described how nicotine salts derived from different acids had different properties regarding sensory stimulation or taste. His company, he said, had created a new type of nicotine salt that allows for enhanced stimulation in markets where the amount of nicotine in e-liquids is restricted.

    Kevin Peng, advanced technology scientist at ALD Group, spoke about technologies to reduce the carbon footprint of vape product manufacturing and consumption. Earlier this year, his company launched a “green cigarette,” a disposable vape product featuring 6 percent lower carbon emissions than combustible cigarettes. The company also developed a super-slim pod for reusable vaping devices made from a material that has only one-third of the carbon emission of ALD’s older materials. This way, he said, his company had achieved a 50 percent emission reduction compared to other pod products.

    ALD also conducted an emission assessment for its organization and products. “ESG [environmental, social and governance] is a much more difficult thing than we thought,” Peng stated. “We found that most suppliers are not very responsive in terms of such requirements.” He called for a unified industry ESG standard for suppliers, which would make it easier to reduce emissions.

    To help accelerate its transformation, BAT established Btomorrow Ventures two-and-a-half years ago. Lisa Smith, the subsidiary’s managing director, related how Btomorrow had set up a number of innovative ecosystems. “It’s a highly competitive market,” she said. “It’s difficult to find the best innovators out there.” Her company’s role is to be the “handshake” to the outside world to show that BAT is an appropriate partner for innovators. Among the many tasks in BAT’s transformation are to quickly promote the ESG agenda and move beyond nicotine. In order to achieve the latter, she said, the company had to build science and credibility.

    ICCPP, a provider of solutions for e-cigarettes and heated-tobacco products, believes that the key to innovation in vaporization might be the ceramic coil. The company, which focuses on research and manufacture of electronic atomizing technologies and is the parent company of the Voopoo vaping brand, introduced the world’s first nano-microcrystalline ceramic core in 2021. According to William Yu, vice president of global ODM business at ICCPP, the core is based on environmentally friendly mineral materials that result in an increased nicotine delivery and stable flavors. In combination with a powder-free technology and a porous structure, the core enables a significant increase in atomization, according to Yu. The company also develops environmentally friendly products, such as a disposable cigarette made from special recyclable paper.

    Continuing to innovate is essential as the industry is at a crossroads, said George Cassels-Smith, CEO of Tobacco Technology Inc. (TTI). After the Food and Drug Administration, through its onerous market authorization processes, had “frozen” the U.S. market for next-generation products, TTI opened a new manufacturing site in Italy, which according to Cassels-Smith is more open to innovation. “It’s vital to involve science, which is one of the pillars of what is a quick-moving new technology,” he said. “It needs expertise to focus on this direction because, ultimately, we must find superior products to combustible cigarettes.”

    Additional GTNF 2022 session summaries >>