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  • Fireside Chat: Talking About COP10

    Fireside Chat: Talking About COP10

    The upcoming 10th meeting of the Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC), which will take place this November in Panama, was the theme of a “fireside chat” moderated by Chris Kodderman, director of Kodderman Public Affairs.

    The disinformation that is making physicians skeptical about reduced-risk products and the misinterpretation of the FCTC’s Article 5.3 are the two biggest impediments to tobacco harm reduction (THR), said global health advocate Derek Yach, who was significantly involved in shaping the FCTC treaty. In his prework on the FCTC, Yach related, he invited tobacco companies to hear directly from them how the complex health problems relating to tobacco could be solved. “We never built on that, and then the shutters came down.”

    Flora Okereke, head of global regulatory insights and foresights at BAT, said the opportunity in COP10 lay in the fact that both the industry and public health have the same goal: getting people off cigarettes. In addition, she reminded her audience that the treaty mentions THR, which seems to suggest that it’s possible for countries to explore alternative ways of reducing smoking apart from handling the demand and supply side. “That provision has never been talked about in COP,” said Okereke. “We now have an array of reduced-risk products, consumers who have indicated that they can live with these products, and countries with experiences that are proof that adopting this THR approach as a policy has led to a decline in smoking rates.”

    Recent WHO documents, reports and statements suggest that the global health body is skeptical about the role of smoke-free alternatives in smoking cessation and concerned about underage access—a sentiment that will likely be echoed by the convention secretariat at COP10, Okereke said. “However, the treaty makes it clear that the power for decision-making is within the parties, insisting that decisions are made by consensus. If parties wanted to share their positive experience with THR, this is an opportunity for them to start requesting an independent team to evaluate the role of these products. All they would have to do is use their mandate effectively and withhold their consensus.”

    Yach pointed out that by developing guidelines on Article 5.3, the secretariat went beyond their legal briefs. “All of the guidelines that include words such as ‘banning,’ ‘demonizing,’ [and] ‘excluding’ in my view are against international law,” said Yach. “We have allowed these guidelines to slip away as if they are facts, but they’re not, and they need to be challenged legally. The member states are the best to do this.”

    At COP10, Yach recommended, countries with positive experiences with THR should share the positive changes that their policies have brought about. He also called for the industry to come together in a consortium to take concerted action. “It is long overdue that tobacco companies, despite competition, recognize that there are some areas where they must come together and present a united front that, I believe, would build confidence in their long-term intent.”

    For this approach, Yach singled out two areas: “A commitment made between the industry to prevent youth access would be very powerful.” In addition, he said, referring to an example where pharma giant Merck collaborated with the WHO to eliminate river blindness disease in West Africa and committed to making the drug forever, the tobacco industry should harness the use of nicotine pouches and snus. “This way, they could eliminate oral cancer in South Asia,” said Yach. “If they were to make that bold statement that they want to do this with the WHO, member states and all other private and nongovernmental organizations together, this would be a surprising and bold move that would get people to take note, particularly the people in these countries who are dying at the rate of 350,000 per year.”

  • Keynote: Ming Deng

    Keynote: Ming Deng

    Douglas Meng Deng, head of Next-Generation Products (NGPs) Industry Study at Yunnan University, provided an Asian view of regulation and innovation in NGPs. Evidence from bibliometrics, he pointed out, had shown that the number of articles and the frequency of citations on tobacco harm reduction (THR) have been steadily increasing. There has been dualization and dichotomy of studies of the role of NGPs in THR. Studies are either carried out by academic institutions or by the tobacco industry, and there is hardly any cooperation among multinational tobacco companies.

    In his research of NGP regulation in Asia, Deng focused on the five countries with the largest populations and the largest number of smokers. In Japan, Deng explained, e-cigarettes containing nicotine were regarded as drugs, requiring a prescription from a doctor, which resembles a ban. By contrast, nicotine-free e-cigarettes are a niche product that can be commercialized without any flavor restrictions. In terms of tobacco taxation, heated-tobacco products (HTPs) are favored. The country has seen a decline in cigarette sales along with a surge in HTP combustible sales. Studies published in BMJ have stated a decrease in hospitalizations for chronic obstructive pulmonary disease and ischemic heart disease following the introduction of HTPs in Japan.

    China implemented a comprehensive regulatory framework for NGPs called “1+2+N” in October 2022. It allows tobacco-flavored products only. Manufacturers, brand owners and retailers are obliged to obtain licenses. Electronic nicotine-delivery systems are subject to premarket review and approval, and HTPs are regulated as cigarettes. “E-cigarette penetration in China was never above 2 percent, and it has been decreasing further since the regulation was introduced,” Deng said. “The portfolio performance of listed vape companies has fluctuated drastically.”

    Indonesia permits HTPs and e-cigarettes, allows online sales and regards national standards as an endorsement rather than mandatory. Multinationals’ HTPs have gained significant traction, Deng stated, showing that the country could potentially become a hub for NGPs in Asia.

    By contrast, India has chosen to ban e-cigarettes and HTPs completely with its 2019 E-Cigarette Act. Offenders face penalties including a one-year jail term or a fine of inr100,000 ($1,202) or both. “The ban has led to a flourishing illicit market,” Deng said. “Insufficient controls together with weak age verification will probably raise the question about the effect of both tobacco control and THR in the country.”

    Properties of NGPs, which the World Health Organization’s Framework Convention on Tobacco Control (FCTC) began discussing at its fourth Conference of the Parties (COP4), are still vague within the FCTC context, an ambiguity potentially leading to regulatory loopholes among member states.

    Deng highlighted two innovations in the field of HTPs. South Korean KT&G’s Lil Aible integrates an artificial intelligence of things application in its heated-tobacco units while combining features of both vape products and HTPs. “The convergence of the two technologies may represent a future trend.”

    NSC of China offers a product with an oxygen-free environment in which sticks are being heated, potentially offering a superior smoking experience, Deng explained. “Both developments underscore a fundamental principle in NGPs: understanding customer needs.”

    Deng recommended that the next Conference of the Parties (COP10) to the FCTC, which will take place in Panama this November, clarify the harm reduction properties of NGPs. The FCTC itself, he said, should also undertake rigorous, evidence-driven research and faster communication with the industry.

    For state-level regulators, Deng proposed introducing the regulator’s sandbox into NGP regulation and shifting from the “wait and improve” approach to “test and innovate.” “Regulatory sandboxes, commonly used in the financial sector, allow NGPs to be regulated at a close loop and encourage enterprises to innovate at the same time,” Deng said. “Regulators may monitor testing in real time while enterprises can get regulatory feedback simultaneously and adjust R&D accordingly.”

    Deng called for the industry to engage in evidence-based and science-based studies and actively pursue publication. Multinationals, he argued, should cultivate the market through patent openness. “The industry is ready to enter the next curve of entrepreneurship, but it should keep in mind to innovate toward THR, not for youth, and facing ESG. Entrepreneurship and rapid commercialization of NGPs in Asia [are] the tobacco industry’s future, provided it can seamlessly integrate into the global tobacco value chain.”

    He urged stakeholders to recognize that the diversity and multitude of cultures and languages in Asia demands a nuanced approach. “The multinationals should leverage the expertise of local Asian talents to solve issues specific to the region.”

  • Bonus Content: Brent Taylor

    Bonus Content: Brent Taylor

    Brent Taylor, managing director of consumer marketplace insights and innovation at Altria Client Services, emphasized that his company wanted to make sure that the adult consumer’s voice is heard and embedded in all of Altria’s decision-making regarding regulation, innovation and science discussions for tobacco harm reduction (THR). The latter, he pointed out, rests on three pillars: youth smoking prevention, cessation support and switching adult smokers to reduced-risk products. The U.S. currently has 42 million adult tobacco users, of whom 28 million smoke combustible cigarettes, 6 million consume smokeless tobacco, 8 million smoke cigars, and 14 million use e-cigarettes.

    According to an Altria survey, over 50 percent of adult smokers are interested in switching to a less hazardous alternative. To understand the barriers that keep many of them from changing, Taylor, a former smoker himself who had successfully switched to smoke-free products six years ago, in 2021 set up Project 2021, a deep ethnographic research study that followed 21 consumers for 21 days on their journey away from cigarettes. Participants were asked to catalogue their behavior via video diaries daily, and study investigators had check-ins with them routinely to understand how this journey was going for them. After three months and six months, respectively, there were follow-up interviews to examine the long-term impact that short experience had on consumers.

    After six months, 16 of the 21 participants had switched completely to smoke-free alternatives. The balance significantly reduced cigarette consumption—down, for example, from one pack per day to one or two cigarettes. “It’s all about the mindset,” Taylor said. “Consumers will only be able to make this change if they want to make this change.” The survey also showed that external factors can influence smokers on this journey—having had a bad day, for instance, would make them go back to using a cigarette. Becoming smoke-free was liberating and opened new opportunities for participants, allowing them to move into a smoke-free apartment or date nonsmokers, for example.

    The study made clear that a support system was required in the journey to becoming a nonsmoker and that the experience was emotional and complicated, with many ups and downs through their daily life, all of which affected their success. “There’s no single way that each of these consumers approach this journey,” Taylor explained. “To accelerate THR, we need to recognize that smokers are not a monolith but represent a vast cross section of adults, different races and incomes, different genders. We need to make sure that we identify which types of clusters exists among that population so that we can design messaging and products that really cater to these different types of people.”

    Altria also looked at usage moments of cigarettes. “Smokers use cigarettes either to detach from the world to take a break or to engage with other people,” Tayor said. “If you layer these two areas, there are barriers and motivators for switching across each. We need to think of a portfolio of products to address the needs of consumers throughout the day. The tobacco space is starting to behave like the beverage category, with a proliferation of options for consumers. They might choose a different product first thing in the morning versus throughout their workday versus in the evening.”

    To help them transition to reduced-risk alternatives, he added, smokers are very much in favor of THR over prohibitionist methods. They also want options in the marketplace and choose different products, also throughout the day. Misperceptions of nicotine, however, are widely spread, with 80 percent of adult smokers believing that nicotine is a carcinogen. “The key is to always start with the consumer and build empathy with adults who smoke. The highest form of knowledge is empathy. It allows us to step into the shoes of others so we can create real change.”

  • Panel: Youth Use

    Panel: Youth Use

    Youth use is everyone’s responsibility. It’s also the name of the GTNF panel that focused on how to balance preventing youth use with helping combustible cigarette smokers move toward less risky nicotine products. The panel’s moderator, Stacy Ehrlich, partner at Kleinfeld Kaplan and Becker, encouraged panelists to debate whether abstinence is a realistic or appropriate goal when attempting to combat youth use.

    “Hopefully, speakers will address that and whether and how to communicate with youth and children about relative risks and progress. I think an interesting question is: Are youth an unintended population for these communications?” said Ehrlich, referring to the U.S. Food and Drug Administration’s acknowledgment that e-cigarettes are less harmful than combustible cigarettes. “Should we be communicating with underage individuals about consumer risk?”

    All the panelists were given the opportunity to make a short presentation. Jasjit Ahluwalia, professor of behavioral and social sciences and professor of medicine at the Center for Alcohol and Addiction Studies at the Brown University School of Public Health and Alpert School of Medicine, said that tobacco addiction is a pediatric disease and noted that many diseases resulting from tobacco use were effectively human caused, such as chronic obstructive pulmonary disease, as 95 percent of cases were the result of tobacco use.

    He also stated that youth use of tobacco and nicotine was unethical as young people are uninformed consumers. However, he noted that communicating risk to this group was complicated. He said that tobacco prevention campaigns are key.

    “This is something that we know [is] important to effectively educate youth,” said Ahluwalia. “I’m mindful of the importance of the issue of spillover … this is, again, a careful area where I think it’s important that we’re mindful of what the impact is on the intended population and mitigating risk for the unintended population, which in this case, I believe is adult smokers that you want to make sure that they’re not scared away from using an e-cigarette that could potentially be beneficial for them to transition completely from combustibles.”

    Ahluwalia also highlighted the vast amount of misinformation that had been communicated through anti-vaping/smoking campaigns, noting the role of the media in misrepresenting the science behind vaping products. He stated that the industry needed to focus on innovating safer and better products. He also called for the FDA to approve new smoking cessation medications. Lastly, Ahluwalia stated that a goal of zero youth use was unrealistic and unreasonable.

    Brian King, director of the FDA Center for Tobacco Products, explained that youth prevention continued to be a critical part of the FDA’s portfolio since nine out of 10 adult smokers started smoking below the age of 18. He noted that the youth were using a variety of different products, with the use of e-cigarettes being particularly prominent.

    “Youth prevention is a key component of FDA’s portfolio … we do see kids using a variety of different products. But right now, the focus is primarily on e-cigarettes,” explained King. “We’ve seen an evolution within even that product class as well, which I think is important for us to consider as we talk about what the inherent risks of these products are, particularly when it comes to dependency. That said, although we’ve seen declines in e-cigarette use, which again, we’ve noticed, is a good thing, among the kids who are currently using e-cigarettes, we’re seeing increased signs of dependency.”

    King said the FDA is held by the standard of being “appropriate for the protection of public health.” This is not like the other centers at the FDA, such as the Center for Drug Evaluation and Research (CDER), which has a “safe and effective standard.” In therapeutics, the CDER wants products to be safe for people to use but also effective at treating the ailment.

    “When it comes to tobacco products, the U.S. Congress has given us appropriate for the protection of public health, where we have to weigh the benefits and the risks. That said, the risks are typically focused on youth initiation. And we have made decisions based on that,” King told attendees. “The primary reason you’re seeing a variety of negative actions that have been taken on e-cigarettes is because of the prominent youth use of these products. It certainly is possible to mitigate that risk. For example, we know that youth have very little [interest in] tobacco-flavored e-cigarettes, which are the products that have been authorized to date because that benefit of adults has been able to outweigh the risk of kids.”

    Colin Mendelsohn, general practitioner and founding chair of the Australian Tobacco Harm Reduction Association, said that current vaping policy is largely driven by fears over youth vaping. The scientific evidence of vaping is being overlooked. He stated that children should not vape or smoke; however, he acknowledged, it is inevitable that some will. Mendelsohn argued that most youth vaping was experimental, with frequent vaping being rare.

    “I think policy around e-cigarettes is largely driven by youth [and] flavor. And I think it should be driven by the evidence, not by emotion and moral values,” he said. “What I’m going to talk about is actual evidence, or at least the best evidence we have today. Kids shouldn’t vape or smoke. They shouldn’t be using alcohol or useless drugs. Of course, they do lots of things they shouldn’t do.”

    Mendelsohn said his research showed that only 3 percent of children who had vaped were frequent vapers, with half of those also being smokers. This evidence, he said, showed that vaping was not a gateway to smoking. He said that the opposite was true, and vaping was diverting kids away from smoking combustible cigarettes.

    “I think we all agree that vaping is not a significant gateway to smoking,” said Mendelsohn. “If there were a significant gateway, we would expect to see smoking rates going up. And of course, they’re going in the opposite direction. In the U.S., when vapes became popular, smoking rates continued to decline. In fact, they declined faster than they ever had compared to the historical period before 2013 since vaping became available.”

    Stefanie Miller, vice president of external engagement at Juul Labs, said one of the reasons why she wanted to join Juul Labs is that she gets to say that Juul has a problem with youth use. “We don’t need to skirt around that. So I’m going to talk to you about what this company has done to successfully deal with youth using the product,” she said. “We took what we consider a three-pillar approach … it has been a productive initiative that we’ve taken …. It’s limiting underage appeal, restricting underage access and enforcing against third parties, enforcing against illicit products.”

    Miller said Juul Labs is also using technology and innovation to help in the company’s fight against youth use. However, Juul Labs is also looking at how initiatives that are put in place to prevent youth use impact adults making the switch from combustible cigarettes. “We’re also considering what these interventions would do to make it potentially more difficult for an adult smoker to have access to a less harmful product, which is not the goal of our company,” said Miller. “We’re trying to walk this really careful line, both from the innovation but also the point-of-sale intervention along these three lines.”

    Many of the questions coming from the audience were directed at King concerning the FDA premarket tobacco product authorization process. For example, Fadi Maayta, the CEO and co-founder of Alternative Nicotine Delivery Solutions (ANDS), a Dubai-based vaping product manufacturer, asked King to explain why the agency does not do more to incentivize law-abiding players. The FDA’s current penalty framework, he argued, penalizes good and bad players alike.

    King said he understood Maayta’s frustration. There are numerous good players in the vaping industry that don’t have the issues of youth uptake, he acknowledged. The reality, however, is that the U.S. Congress wrote the Tobacco Control Act and prescribed very specific processes that the agency is required to do by law, said King.

    “That said, the intent is not to penalize everyone … but we do have to follow the law in terms of implementing the regulations that have been required by us. And that includes a premarket tobacco product process and a rigorous scientific assessment …. We also have to enforce the law, and we are a free market paradigm. So there’s no safe harbor. If you don’t have authorization, your product is subject to enforcement compliance,” explained King. “That said, are there opportunities to streamline those processes? Absolutely. And that’s what we’re looking at. There are efficiencies that I think we can gain by looking at our processes to make it more streamlined moving forward.”

  • Panel: Innovating Products for the Future

    Panel: Innovating Products for the Future

    Discussing the future of innovation in nicotine products is complicated. The industry is innovating at lightning speed, especially in batteries and atomization. However, manufacturers don’t often want to discuss innovations in progress because competition in the next-generation nicotine-delivery segment is fierce. It’s not uncommon for a company to launch a new innovative design only to see its IP stolen and used in counterfeit products.

    During the panel “Innovating Products for the Future,” moderator Eve Wang, executive director of Smoore International and vice president of Shenzhen Smoore Technology Co., questioned five industry experts about how they imagine the future of the vaping industry. The participants agreed that innovation would continue boosting the harm reduction potential of next-generation nicotine-delivery products. Surprisingly, they all willingly shared interesting insights into new product innovation.

    Tao Cui, director of innovation, strategy and compliance at Innokin Technology, said that future vaping products will likely be more individualized, more efficient and more intelligent. He also said that products will continue to become less harmful. He said the heating element is especially an area that will see more innovation.

    “In a perfect scenario, you can control the temperature as low as possible and also precisely control it. And, if you have a much, much less harmful substance, we combine both together, then we have a less harmful product,” he said. “In the future, I would say the products will be more individualized because no one product fits 1 billion people. In the future, your product may adapt to your habits. The product may know if you need more [puffs] in the morning, in the afternoon, today or tomorrow.”

    Cui outlined some potential solutions for sustainability-related issues, including the use of research and development. He proposed that countries that have successfully controlled youth usage could offer insight; they could accomplish this by better regulating flavor names and packaging.

    James Kuang, chief scientist and head of the Life Science Institute at ICCPP, parent to Voopoo vaping products, stated that the innovation of products is needed to balance user experience, harm reduction and environmental protection. “Yes, we should develop some [better batteries] and [e-liquid bases] for that. “We talk about the effective battery …. Can we do something for our environment by developing different [e-liquids]? I say if we can develop some new type of [e-liquid base] … for example, can we use some nature-sourced alcohol? …. Another solution, I think, is a water-based solution. In my opinion, a water-based [solution] may be the best product for the future.”

    Fadi Maayta, president and co-founder of Alternative Nicotine Delivery Solutions (ANDS), stated that the next stage of innovation should be aimed at protecting consumers—especially nonsmokers and ex-smokers—and youth. He noted that it was the responsibility of the industry to ensure it was on the right path to responsible growth. He said that artificial intelligence (AI) could play for both the industry and regulators by helping to better analyze data concerning consumers and product use.

    “I know many companies that invested in applications to link [AI] to the device to tell the consumer how many puffs they took, what’s the health risk. All these apps failed. I don’t see consumers really using it, to be realistic,” said Maayta. “It will help consumers to get more data. It will help companies and factories [know where] to locate and know how to get the right product for the consumers through using that engine but also externally for the regulators and policymakers to get data about these products. It might help in tracking as well, track and trace for the product.”

    When it comes to eco-friendly products, Maayta claimed that a rational vision of environmental sustainability involves four distinct pillars. The first pillar is the product. Manufacturers should use the right elements … cardboard, biodegradable silicon and biodegradable plastics. The second pillar is showing that your claims of eco-friendliness are provable—that they can be substantiated.

    “If you want to claim that your product is recoverable and recyclable, and your product can be recycled to 99 percent, whatever—you [had] better be careful. You are in a very controversial industry, and every word will be tracked,” he said. “You better [be able] to substantiate every word, every percentage, everything you say about the recyclability and the probability of the product.”

    The third pillar is that if you market an eco-friendly product, you need to have a program to support recycling. The collection of these products is important. “Make it simple … because consumers need simplicity,” he said. “You used to have a cigarette and a lighter. That’s it. You are giving them an electronic device. They don’t want to have a headache there.”

    The fourth element is regulation. Maayta said regulators should be involved in investing in approving sustainable products and possibly incentivizing recycling programs. He criticized manufacturers that aggressively market products that appeal to youth. He criticized regulators for not doing more to remove the “bad players” from the market because it’s leading to good manufacturers being replaced by the black market.

    Cherry Pan, managing director of consumer and marketplace insights at Altria, said that as the industry moves toward more “eco-friendly” products, the term needs to be better defined. Pan said that the environment should be a concern for all manufacturers. She also suggested that manufacturers could play a more innovative role in the design of eco-friendly products.

    “First, how to define eco-friendly … that means you’re 100 percent recycled or 50 percent recycled or 30 percent? …. Or does it mean that we use vaping products that are less harmful than cigarettes? This also means it’s eco-friendly,” Pan explained. “We will make about 150 to 200 new products every year [not necessarily that make it to market] with our army engineers. We have about 150 engineers. So we also must make products which we [consider] eco-friendly because we can recycle it, maybe 70 [percent] to 80 percent. We use some degradable materials. The percentage we use is higher [than many other products]. We want to make removable batteries.”

    Ryan Selby, CEO of Generative AI Solutions and executive chairman at The Modern Nicotine Co., said that innovation will not bring about a one-size-fits-all solution for consumers. It’s going to take a comprehensive approach to create choices for consumers through innovation. However, he doesn’t know what the next best thing is.

    “I do think we need to keep our eyes on the future and look at there’s some big changes coming down in terms of the virtual and augmented reality experiences,” Selby said. “In the oral space, looking at opportunities for creating more personal nicotine experiences that have a lower [third-party] impact as well as lower the impact on the environment.”

    Selby also said that AI could be beneficial in providing consumer insight and in helping find innovative ways to restrict youth access. He said AI can aid the nicotine industry by helping to reduce harm by analyzing data. Regulators may even be better able to understand the consumer experience.

    “I think this is a tremendous opportunity for AI in this space to help feed in massive amounts of data set and tease out some of these interactions between devices … looking at opportunities for combining substances and devices in a way that can reduce the harms associated with [use],” said Selby. “I think there is tremendous promise with large data sets and the ability of AI to tease out some hidden secrets in there that can help us to continue moving in the right direction.”

  • GTNF 2023 Sessions

    GTNF 2023 Sessions

    Arizona Advances Landmark Vape Bill

    The Arizona Senate passed House Bill 4001 on May 26 with an overwhelming bipartisan vote of 24-2, establishing the state’s first formal regulatory framework for

  • Bonus Content: Rob Burton

    Bonus Content: Rob Burton

    In a video recording posted as part of the Bonus Content of the September Global Tobacco and Nicotine Forum in Seoul, South Korea, Robert Burton, group scientific and regulatory director of the Plxsur Group, made the case for the vaping industry to comply with the highest standards of integrity—even going beyond the requirements of regulations where necessary.

    “As the world’s largest group of independent vaping companies, we at Plxsur take our responsibilities very seriously and to that end we have developed a set of standards that we feel are appropriate, not just for ourselves, but for the industry as a whole,” Burton said.

    “Our first standard is in relation to compliance. We believe that all products should be manufactured to the highest possible standards. This includes the ingredients that go into them, the packaging, and the final product in terms of how it is merchandised, distributed and consumed.

    “Our second standard is youth access prevention. Nobody under the age of 18 should get access to these products. We should only be targeting adult smokers and adult vapers. To that end, online age verification systems should be standard. In-store education of shopkeepers, people selling these products, should also be standard, and systems in place in those stores to prevent access … [by] youth, such as age verification, facial recognition systems, which are now standard in many of our stores.

    “Our third standard is recycling, and obviously this is a very hot topic at the moment, particularly relating to disposables, the single use of plastics and the battery-use regulations that are coming into many countries. We believe it is the responsibility of not just the manufacturers but of the retailers of these products to encourage consumers to recycle and to proactively encourage facilitation of that recycling with collection sites and partnerships with recycling companies.

    “Our fourth standard is responsible marketing. We believe, as with our child-protection standards, that these products should not be marketed to youth. They should be marketed to adult smokers and vapers, and that includes the way that these are packaged—so no cartoon characters, no descriptors that imply these are sweets, confectionery. And also, that should be encouraged through the retailers as well to make sure these products are not in obvious areas where youth can have access to … [them] visually; or even access to them from a purchasing point of view.

    “The final standard, standard five, relates to child protection. And this relates to protecting children from access to these products; so accidental vaping or swallowing ingredients that could potentially cause harm. Specifically, we believe that all manufacturers should look at methods to protect their devices from access … [by] children. That includes pod activation systems, child locks on the devices themselves, and also various types of packaging that prevent access .. [by] children. There is no justifiable reason why any vape system should find its way into a child’s hands.

    “One thing that we need to remember is that this industry is still new, it’s still emerging, it’s still disruptive. Regulation is still playing catch-up. And just because that regulation either doesn’t exist or is being abused doesn’t mean that we as an industry should not set the highest possible standards. We at Plxsur are doing that not just for ourselves, we believe that this is a benchmark for the whole of the industry to follow.”

  • Bonus Content: Christopher Russell

    Bonus Content: Christopher Russell

    In a 45-minute video recording posted as part of the bonus content of the September Global Tobacco and Nicotine Forum in Seoul, South Korea, Christopher Russell, director of Russell Burnett Research and Consultancy of Glasgow, U.K., described a type of study that manufacturers of new tobacco products can conduct to demonstrate the cigarette-switching and smoking reduction potential of their products.

    Russell started by outlining the risks associated with smoking and the importance of reducing smoking prevalence and smoking-related harms.

    Then, in a presentation largely looking at the U.S. and the Health Risk Investigations section of the Food and Drug Administration’s system of premarket tobacco product applications (PMTAs), which require the submission of substantive amounts of data and information, he focused on the requirement to demonstrate the impact of a new tobacco product on tobacco use behavior among current tobacco users.

    The FDA, he said, had recommended that an applicant manufacturer conduct an Actual Use Study (AUS) but had not provided any formal guidance on how to design and conduct such a study in respect of a new tobacco product. Russell therefore spent some time describing how pharmaceutical manufacturers carried out AUSes in support of applications to change the marketing status of a drug from prescription to nonprescription and followed that up by describing how a PMTA applicant might take some of the key principles and design elements from such a drug-switch AUS and apply it to an AUS for a new tobacco product aimed at assisting adult smokers completely to switch or substantially to reduce their cigarette smoking when using a new product in everyday settings. He described four core principles that underpin how an AUS should be designed and conducted and on the objectives that new tobacco product AUSes had focused to date.

    Russell referenced a number of studies conducted primarily by the major tobacco manufacturers, Philip Morris International, Altria and Reynolds American. And he briefly described the design and key results of two of these studies, one involving a heated-tobacco product and another involving a nicotine pouch.

    In summary, Russell said the AUSes that had been completed to date showed they could provide near to real-world evidence that new tobacco products can serve as complete or substantial substitutes for combustible cigarettes for many adult smokers, so demonstrating the utility of this behavioral study design for providing the FDA with reliable and robust real-world information about the likelihood that if a new tobacco product were to be authorized for marketing, it would be used by adult smokers and that those adult smokers using the product in question would ultimately, in the short term to medium term, completely switch to using the product or, if not completely switch, substantially reduce the number of cigarettes they smoke while continuing to use the product, hopefully on a path to complete abstinence from cigarettes.

    Finally, Russell outlined a number of factors that manufacturers should have in mind when considering undertaking AUSes, including the company’s internal and external expertise capacity; the time required to design and conduct a study; the timing relative to the proposed PMTA; scientific engagement with the FDA’s Center for Tobacco Products; the possible availability of a robust, reliable alternative; the cost of the study and the cost of a lost opportunity.

  • Panel: Pathways to Sustainability

    Panel: Pathways to Sustainability

    The panel discussion “Pathways to Sustainability” explored how different companies approach the topic and navigate the path to a sustainable future.

    Christopher Fleury, senior vice president of regulatory affairs research at Ipsos, who moderated the panel, started off with a simple statement: “Promoting sustainability is a priority for businesses, but it is not easy.” This idea of sustainability being a complex goal remained a theme throughout the discussion.

    Each panelist brought a different perspective to the conversation. Ana Krasojevic, sustainability strategy and reporting director at Japan Tobacco International, offered corporate sustainability insight, noting that to achieve sustainability in any aspect requires full commitment.

    Sudhanshu Patwardhan, HealthTech entrepreneur and director of the Center for Health Research and Education, brought in the consumer perspective, having worked with many consumers in a medical capacity. He noted that sustainability brings with it a broader discussion of society at large and the environment.

    Diane Raverdy-Lambert, chief scientist and director of regulatory affairs at SWM, discussed the papers side of sustainability and how SWM looks at the entire life cycle of papers when creating their products. She also reiterated that “data is data” and “science should be irrefutable.”

    Michiel Reerink, international affairs director at Alliance One International (AOI) and managing director at AOI GmbH, addressed the agricultural side of sustainability, discussing how AOI works with farmers in Malawi to ensure they are using sustainable wood sources and are able to generate additional sources of income by growing crops like groundnuts. Sustainability is about the farmer relationship, he said, noting that it is not an isolated action but requires the whole supply chain to be involved.

    As the conversation progressed, Krasojevic noted three key aspects in thinking about sustainability and how to implement sustainable practices: taking decisions in a balanced way; taking a multi-stakeholder view; and looking at how the company impacts the external world and how the external world impacts the company. In her view, sustainability is embedded in “each and every business function” and is “circular.”

    The panel also discussed how sustainability has changed, noting that younger talent has strong expectations regarding sustainable practices and that it’s important to have standardized frameworks, like those of the United Nations’ Sustainable Development Goals (SDGs), that allow everyone to “speak the same language.” Standardization allows for something concrete rather than an “abstract story.”

    Much was said about the SDGs, with an emphasis on industry and consumers taking part in discussions and engagement. Patwardhan expressed that more of the SDGs should be discussed and engaged with by industry. The question was also posed as to whether the voices of the customer, the citizen and the smoker are saying the same thing. Ultimately, the panel seemed to agree that communication is important in achieving sustainability. Reerink noted that in many countries, companies are not allowed to communicate the sustainability of their products to consumers. Communication with consumers is extremely important, however, and misinformation regarding nicotine and tobacco products needs to be addressed, he noted.

    Sustainability is the new norm, according to the panel, and it drives innovation and a sense of purpose for companies. The ongoing question is how does the industry transform itself to be more responsible to the consumers and broader society? “Let’s not be reactive to everything that’s thrown at us,” Patwardhan said, referring to the industry at large. “If we are reactive, only we are to blame for the eventual outcomes. If we are proactive, there are benefits to be for the broader society.”

  • Keynote: Eve Wang

    Keynote: Eve Wang

    Eve Wang, executive director of Smoore International and vice president of Smoore Technology, gave a keynote speech on balancing innovation and social responsibility.

    Wang began by discussing the vapor industry as a whole, noting that the industry is young at only 20 years old. Smoore, she said, has been an industry player for 17 years.

    “We are at a very critical path for the vapor industry,” she said. The vapor industry has grown rapidly over the past 20 years. The first decade saw rapid growth while the following 10 years were characterized by diversification and sophistication along with greater regulation. Products became more compact and portable, usability improved, and open systems evolved into pod mods.

    Wang cited Frost and Sullivan data from March of this year, which showed that as of last year, the vapor industry was worth $52 billion, nearly double what it was in 2018. “There is no doubt the market is fast growing with huge potential,” said Wang. 

    With growth comes media attention, as Wang noted, highlighting headlines that called for bans and restrictions, overwhelmingly regarding disposables. Smoore, Wang explained, is tackling the issue by improving atomization efficiency and power efficiency. Atomization efficiency involves improving the utilization of e-liquid while power efficiency means increasing energy density and reducing battery size.

    “Do we have answers to all the challenges?” she asked. “I’m afraid it’s too early to tell.” She urged the industry to keep innovating and for every player to take their responsibility seriously.

    “As long as the conversation goes on, we are confident that together we can make the best outcome.”