Category: GTNF

Science, technology and innovation

Photo: Chris Ferenzi
Continuous innovation is crucial to the tobacco industry’s transformation process. A substantial part of it is driven by freshly recruited talents from fields not linked to the sector in the past, such as consumer electronics. Despite their far-reaching consequences, the massive changes in the tobacco industry over the last decade have gone largely unnoticed on the outside, causing outdated stereotypes to persist and making talent acquisition challenging.
To be successful, employers must understand what great talents want today, said Steve Marley, founder and CEO of Ashwood International. “They seek inspirational leadership, flexibility and autonomy; there must be a sense of value and purpose in their job, and they want an inclusive workplace. To attract the best, companies need to make a stance—they must embed environmental, social and governance (ESG) goals in their talent acquisition strategy, build a progressive value proposition and broaden their talent reach.” Today, employees are no longer human resources, but stakeholders, Marley added. “The sooner a company realizes that, the more attractive it will be.”
Carlista Moore Conde, group head of new sciences at BAT, echoed Marley’s points. Coming from a background in consumer goods, she said she joined BAT because she was attracted to its purpose—helping adult smokers quit combustible cigarettes. Her uncle had died in his mid-sixties from a tobacco-related disease. “To manage consumer satisfaction risk, disruptive science and innovation is required,” she said. “In product development, nicotine companies need to ask themselves the same questions as other fast-moving consumer goods companies and can perhaps learn from them—their products do not only have to taste good but need to give emotional and social benefits as well.”
In recruiting, innovation in the tobacco industry has made a huge difference, said Philip Evans, senior advisor at the Boston Consulting Group (BCG). BCG has investigated the issues of trust and reputation that continue to haunt the tobacco sector. “The trustworthiness of a company goes up and down with the industry,” explained Evans. “Trust is slow to build and quick to destroy. For companies, it is important to carry a sense of purpose at every opportunity. The issue of trustworthiness in different countries is co-related and needs to be worked at.”
Deepak Mishra, president of the Americas region at Philip Morris International, emphasized the shift toward consumer centricity in R&D, which didn’t exist in the industry 10 or 15 years ago. “We need to understand the needs of consumers. Creating a matching portfolio that gets adult smokers to switch to less hazardous products is critical.” He named misinformation, a hindrance through flawed science, as continuous external impediment. “It is getting better every year, but education of the consumer remains important,” he said.
As important issues for the future, panelists singled out partnering across the industry and a clear model of innovation. Players seeking to merely follow the leading companies in their process of transformation should recognize that no company can ride on the tails of another company—every player is responsible for its own transformation.
October 16, 2022
Brad Rodu

Photo: Chris Ferenzi
Brad Rodu, a U.S.-based professor working at the University of Louisville Department of Medicine’s James Graham Brown Cancer Center, delivered a short, sharp shock to attendees at the recent GTNF.
His presentation was short, under 10 minutes in length, and therefore, by necessity, sharply focused on what was a shocking message, though one that, in different forms, GTNF participants have become all too used to hearing.
“The mission of a tobacco-free society drives the tobacco control industry, and it is driving bad tobacco science, which is not being addressed either pre-publication by peer reviewers, or post-publication, in any systematic way,” Rodu said at the end of his presentation. “And these … studies, if they are left alone, if they’re not challenged, they are going to deter smokers from switching [from combustible cigarettes to less risky tobacco and nicotine products]. We’ve already seen that, and we’ve had presentations about that. And I believe they will support harsh and unfair regulation.”
That needs some context, which Rodu provided at the start of his presentation when he told his audience that the U.S. federal government’s mission, the focus of its tobacco program, was aimed at creating a tobacco-free society. Under this program, hundreds of millions of dollars were being transferred from the Food and Drug Administration to the National Institutes of Health, and from there to universities around the U.S. for funding research on tobacco products.
The issue here is not that this research is being carried out but the way in which it is being carried out. Rodu said that a lot of the research was beset with problems, and he put up a slide showing a list of studies that he and his team had looked at critically and had commented on formally: reviews that could be found on the websites of the journals that had published the original research or on the websites of other journals. The list of studies was formidable, so he mentioned just a few. His team had looked, for instance, at the finding that the U.S.’ smoking population had been “softening” and that harm reduction was therefore unnecessary, a finding—a suggestion—that would have left many in the audience agape. They had looked, too, at the finding that vaping by teenagers was causing them to smoke, that tobacco product use of any sort was increasing mortality, that vaping by teenagers was related to Covid and that vaping by adults was causing heart attacks …. The last-mentioned finding Rodu described as the most famous one because his team had had that paper retracted.
Rodu then highlighted recent studies that basically claimed to have found that vaping is associated with myocardial infarctions or heart attacks, chronic obstructive pulmonary disease, asthma, emphysema, other pulmonary disorders, strokes and other medical conditions. In reporting these diseases, the researchers had claimed to have statistically accounted for smoking. But Rodu said these claims were completely unreliable, and he described why.
Rodu and his team found that none of the studies had information about the ages when participants had started smoking, started vaping or when they were first diagnosed with these diseases. When Rodu’s team analyzed the FDA Population Assessment of Tobacco and Health data, which contained this information, they found that all but a tiny percentage of diseases were diagnosed after participants started smoking but before they started vaping. And the small number of people who were diagnosed with diseases about the time they started vaping had all been smokers, making it highly unlikely that those diseases had been caused by vaping.
Rodu said the bottom line was that studies that did not take into account the ages of people when they started to vape and smoke, and when these vapers and smokers became ill, were unreliable.
October 16, 2022
The Investor’s Perspective

Photo: Chris Ferenzi
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 be able easily 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 product 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.–George Gay
October 16, 2022
Philip Evans

Photo: Chris Ferenzi
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 noted 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.
October 16, 2022
Innovating for Tomorrow

Photo: Chris Ferenzi
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 Global Tobacco and Nicotine Forum (GTNF) in Washington, D.C.
Ming Deng, head of 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 with 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 the 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.”

October 16, 2022
Gal Cohen
In his keynote, Gal Cohen, head of scientific affairs at North Carolina-based Rose Research Center (RRC), which specializes in tobacco dependence research, including research on smokers, addiction, smoking cessation, tobacco harm reduction and the use of other tobacco products, discussed the opportunities offered by e-research versus traditional in-lab clinical studies for clinical trials in the field of vaping as the technology for virtual trials is maturing.
One of the crucial issues in a clinical trial is recruitment. In a typical trial setting, Cohen concluded from a comparison of 100 recently completed e-cigarette randomized controlled trials, many studies are underpowered and thus limited in scope as the intended number of subjects is often not recruited. Eighty percent of clinical trials finish late, and 20 percent are delayed for more than six months. Cohen said that it was not unusual for recruitment to take up to four years. Costs for clinical procedures, administrative staff, site monitoring, recruitment and retention as well as a laboratory were named as the top cost drivers.
The virtualization of trials, on the other hand, offers an opportunity to reduce recruitment time and facilitate larger trials, improve data quality and trial execution. Several developments facilitate this trend, among them smart phones and improved connectivity. In the U.S., for example, there is one cell phone per individual; in Russia there are close to two per individual. Meanwhile, connected sensors can use modalities such as breath or heart rate to track biomarkers like exhaled carbon monoxide. GPS shows where a current use pattern takes place and allows for detailed analyses. Despite the obvious advantages of e-trials, though, there are still instances where you want to bring the subject into a lab, Cohen said. Abstinence or quitting, for example, are best studied in a controlled setting.
The RRC recently introduced eResearch, the first mobile clinical research platform for volunteers who want to advance research in nicotine, smoking cessation and harm reduction. Implementation takes place via a cloud-based platform, and participants have access through an app on their phones. On the other side, there is an administrator who is running the study and monitoring it. The system includes a secure database and offers the opportunity to bring in data from other apps and devices.
The phases of a clinical study are also represented in the virtual study. The setup is designed for easy use and features a web administration portal, customizable study design, volunteer profile management and role-based access and permissions. Recruitment, screening and verification of eligibility involve scanning a driver’s license, taking a picture and validating that a volunteer is the right participant, and a medical eligibility screening. Clinical study process management includes connectivity with PayPal or other payment portals so that participants can get immediate monetary rewards if they achieve certain goals. The platform is globally scalable. For the last phase, data management, there is a dashboard with data export and visualization, which is updated in real time.
The advantages of virtual trials, Cohen summarized, include scalable recruitment, ease of compliance for participants, ease of administration, real-world use patterns and connected diagnostics, devices and apps on top of a compliant quality system.
October 16, 2022
Global Regulatory Issues

Photo: Chris Ferenzi
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 denicotization,” 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 [LIMCs], 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 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.

October 16, 2022
Christopher Russell
Flavors other than tobacco will not be allowed on the U.S. market. In order for that to happen, a manufacturer would need to show the U.S. Food and Drug Administration that flavors other than tobacco are appropriate for the protection of public health (APPH), and that may be more complicated than once thought. This was the opinion of Christopher Russell, director at Russell Burnett Research and Consultancy.
Presenting at the GTNF 2022 in Washington, D.C., Russell described the regulatory rationale and features of several types of research studies that can be conducted to compare the efficacy of flavored electronic nicotine-delivery system (ENDS) products versus tobacco-flavored ENDS products for facilitating switching and reducing cigarette consumption among adult smokers.
For a premarket tobacco product application, the FDA requires a range of valid scientific data and other research information to determine whether permitting the marketing of the new tobacco product qualifies as APPH. However, Russell explains, the Food, Drugs and Cosmetics (FD&C) Act, which guides the FDA’s authority, doesn’t clearly define APPH.
“Instead, to determine whether a new tobacco product meets the APPH standard, Section 910 of the FD&C Act requires FDA to, among other things, weigh the risks and benefits of the new tobacco product to the population as a whole, including users and nonusers of tobacco products, and taking into account both the likelihood that existing tobacco users will stop using such products if the new product is marketed and the likelihood that individuals who do not currently use tobacco products will start to use tobacco products if the new product is marketed,” Russell said.
To consider the marketing of a new tobacco product to be APPH, the FDA states that a PMTA must contain sufficient valid scientific information that demonstrates that the new tobacco product significantly reduces harm or the risk of tobacco-related diseases to individual tobacco users. Additionally, allowing adults access to ENDS and other noncombustible tobacco products cannot come at the expense of addicting a new generation of children and teenagers to nicotine.
“Though the FDA has sought to strike a balance in recent years between reducing youth appeal and access to ENDS on one hand while maintaining opportunities for addicted adult smokers to access ENDS on the other hand, the FDA’s current position expressed most recently in the issuance of marketing denial orders (MDOs) for flavored ENDS products is that the evidence available to FDA is clear in showing that the appeal and the likelihood of use of flavored ENDS by youth harms the public health to a level that is not outweighed by the health benefits of adult smokers switching to ENDS products,” said Russell. “In fact, flavored ENDS do not confer any incremental benefits over and above tobacco-flavored ENDS.”
The FDA has indicated that it may require a randomized controlled trial (RCT) and or a longitudinal cohort study (LCS) that demonstrates the benefit of an applicant’s flavored products help adult smokers more than they entice youth to start vaping. The FDA said it would also consider data that showed the same results through other research routes.
An RCT uses control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments, according to Russell. An LCS is a research study that follows large groups of people over a long time. The groups are alike in many ways but differ by a certain characteristic (for example, vapers who use flavors other than tobacco, those who vape tobacco and those who smoke combustible cigarettes).
“I think FDA is—without being explicit—they are strongly communicating that an RCT or a longitudinal cohort study would provide the strongest evidence of an added benefit of a flavored ENDS product and that any application for a flavored ENDS product that does not contain one of those two studies or both of those studies will leave FDA in a position where they cannot possibly be confident that the potential benefits of the flavored ENDS would outweigh or overcome the risks to youth or would exceed the benefits of a comparable tobacco-flavored product,” said Russell. “I cannot see any circumstance in which flavored ENDS products will receive marketing authorization without having provided FDA with reliable and robust evidence from at least one of these two study designs. RCT is the gold standard in interventional research, and longitudinal cohort studies [are] the gold standard in observational research.”
October 16, 2022
The Evolution of Sustainability

Photo: Crhis Ferenzi Photography
Panel Discussion: The Evolution of Sustainability
The “pace of change is accelerating” for environmental, social and governance (ESG) issues, which requires companies to invest in policies and actions that encourage responsible behavior. “ESG is a driver of choice,” a GTNF speaker said.
Due to the nature of its business, tobacco companies can make the greatest ESG gains by reducing the health impact of their products. Moving to a smoke-free future is the single best thing the industry can do in order to maintain its license to operate and create long-term sustainability. “We think that’s right for our consumers,” said a representative of a leading tobacco firm. “We believe it’s right for our employees. We believe it’s right for society broadly.”
Innovation creates value. Sustainability creates value. And those two things are not in conflict, according to one speaker. They are instead reinforcing ideas. Companies cannot innovate alone. They need to innovate alongside their consumer base. The speakers agreed that everyone needs to be involved in innovation with a shared goal of sustainability.
“We believe [one way] we can create positive change is to address the harm of our products. And so that gets more to our vision, which is moving beyond smoking,” a speaker noted, adding that some of the challenges in ESG are knowing what expectations are, especially from consumers and shareholders. “You take the time to understand what they expect, you identify where are the areas of your business where you can align those expectations into your business practices and then measure and communicate the progress that you’re making.”
ESG used to exist on an island. Today, it’s a core part of how leadership drives the long-term success of a business. The speakers noted that changes brought about through ESG initiatives will determine the long-term success of companies. A company must address its “most pressing issues” that stakeholders care about.
“We talk about transforming people’s lives so that together we can grow better. It’s frankly something that all our employees around the world can really get behind. But it’s not just the talk; it’s the walk, right?” a speaker asked. “It’s measuring what you have and setting real targets of what we want to achieve and reporting on those in a very public way. I think this industry is way too shy about talking about some of the positive achievements that it’s had and it’s made and continues to make around the globe.”
The best practice is to intertwine sustainability and business strategies—where the board and the executive team are acting as the coaches of the company’s sustainability goals. “It is about being standardized, being transparent, basing your numbers on actual science and facts, and being [able to implement these policies throughout] the full value chain,” one speaker explained. “One of the key takeaways is that perhaps ESG/sustainability efforts at some point were seen as optional. But the reality is that this is not the case now. It is no longer optional. And I think we’re all committed to trying to do the right thing.”
ESG can be driven by governmental regulation too. Those regulations can become game changers for companies, according to several speakers. For example, the European Union has launched the “European Standards for Sustainability Report.” The report essentially outlines what companies have done over the past 20 years to move toward a more sustainable future. The report also shows that ESG isn’t easy. It also offers a potential blueprint for companies struggling for innovative sustainability ideas.
“[The meaning of] ultimate sustainability is really sort of combatting climate change and decreasing emissions, saving water … minimizing pollution and waste, looking at diversity and quantity, having zero corruption, looking at almost everything from tax clarity to human rights and supply chains,” one speaker said. “It’s a lot of work and you don’t want to invest in that work if you’re not going to get the value to actually build a more successful, sustainable company.”
In the end, sustainability, ESG and tobacco harm reduction go hand in hand. One speaker explained it as a three-legged stool. When you think about the products themselves, you have to have products that are satisfactory to the adult tobacco consumer. It’s a product that’s going to be commercially successful. Consumers will enjoy it, and they will transition to authorized smoke-free products.
“We also know that there are consumers who want to entirely quit using tobacco products, and so we think supporting adult tobacco consumers who have made the decision to quit [and are] able to do so successfully is also an important element of harm reduction.”
“And then we absolutely have to make sure that underage use is not an issue,” one speaker explained. “We’ve heard the conversation about innovative reduced-risk products cannot be an offramp for the adult tobacco consumer and an on-ramp for youth, and so there has to continue to be a lot of attention to those three pillars of the stool to make sure that underage use [is limited], especially as we start thinking about new-to-market products.”
October 9, 2022
Jonathan Adler

Photo: Chris Ferenzi
There are numerous challenges to achieving the goal of tobacco harm reduction. Addressing these challenges might require thinking differently about how to approach the regulatory process and perhaps the extent to which the regulatory process needs to be changed, according to Jonathan Adler, the inaugural Johan Verheij Memorial Professor of Law and the founding director of the Coleman P. Burke Center for Environmental Law at the Case Western Reserve University School of Law, where he teaches courses in environmental, administrative and constitutional law.
Speaking at the GTNF 2022, Adler said that the U.S. Food and Drug Administration’s handling of premarket tobacco product applications (PMTAs) has been arbitrary. It’s been sloppy. It hasn’t followed its own guidances. “It’s pretty clear that the FDA was not prepared for this onslaught of applications, prepared for the volume, prepared for the type of analyses it would have to conduct,” he told attendees. “And [the agency] responded to that with a mixture of cutting corners and adopting shortcuts that would enable it to make decisions, typically negative decisions, so that it could process these applications.”
Companies aren’t happy with how the FDA has handled the PMTA process. Numerous companies have taken the agency to court, with mixed results. There are currently more than 30 court cases surrounding PMTA actions. Adler said that the FDA has responded inconsistently to these lawsuits. After denying Juul’s application, for example, the FDA decided to reconsider and review all the things it was supposed to review before issuing a marketing denial order. The agency took the same type of action with Turning Point Brands.
In other cases, however, the FDA has been willing to let the courts decide. The challenge in this approach is that the FDA is being strategic about which cases it fights in court and which cases it retreats on. “As someone that follows a lot of administrative litigation, it certainly looks as if FDA is retreating where the cases against its actions are the strongest and allowing cases to proceed where it thinks the challenges are weak,” said Adler. “[This is] either because issues haven’t been raised or because issues haven’t been printed in the strongest way possible or perhaps because the applications were weaker to begin with.
“As these precedents build, it will become easier and easier for FDA to defend against challenges to even the strongest arguments, so this is certainly part of the regulatory challenge …. We know—and this is all information that you’re all aware of—that the majority of people in the United States believe that ENDS [electronic nicotine-delivery systems] are as [dangerous] if not more dangerous than combustible cigarettes.”
There are other challenges too. Adler said the United States also has trust issues on both sides of the aisle. Many of the institutions and authorities that historically have been seen as trustworthy and would provide accurate information aren’t considered to be as reputable anymore.
“And certainly, the experience of Covid and the like has eroded that trust even more,” he said. “We need to think more broadly about how we might overcome this challenge. My own view is that we need to think more about the competitive process and how we discover how to communicate to consumers. And that word ‘discover’ is important. Because it’s not always clear what consumers want, why they want it and how you let them know that what you have might be what they want.”
In the case of nicotine products, due to FDA regulations, companies can’t compete in trying to convince smokers that their product will satisfy the desire for nicotine, or whatever else, in a less risky way. In Section 911 of the Tobacco Control Act, there are strict restrictions on what can be said about modified-risk tobacco products, including factually true statements. Adler said that’s a problem because if companies are able to compete on characteristics like health impact, it affects not only the behavior of those companies, but it also affects consumer understanding.
“This statute has also been interpreted, I would argue quite aggressively, by the FDA. The FDA’s position is that producers of electronic cigarettes can’t quote things that Brian King said here yesterday [the CTP director spoke at the GTNF on Sept. 28]. Can’t quote things the FDA has put in the Federal Register that are indisputably factually true. And if they say things like ‘This might help you quit smoking,’ well, then the FDA’s position is ‘forget [the modified-risk order] …. That makes you a drug device.’ And there’s a whole different approval process you have to go through for that.”
A constitutional law professor, Adler views Section 911 as a potential First Amendment issue. The U.S. Supreme Court, he said, has stated repeatedly that courts should be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. That includes attempts to deprive consumers of accurate information about their chosen product.
“We’re not talking about sensational claims about unproven medications or unproven treatments. We are talking about claims that the FDA itself acknowledges are true. [In a case involving the FDA and a compounding pharmacy that the agency wanted to prevent from advertising,] we rejected the notion that the government has an interest in preventing the dissemination of truthful, commercial information in order to prevent members of the public from making bad decisions with the information.
“And the circuit, in the context of nutritional supplements, has also said that it is clear that when the government chooses a policy of suppression over disclosure, at least where there was no showing that disclosure would not suffice to cure misleadingness, government disregards are far less restrictive means. It violates the relevant standards under the First Amendment.
“The FDA’s position is that no disclaimer, no disclosure can somehow cure the problem of telling people what the FDA itself has said about noncombustible products. It’s not clear to me—I mean that’s not only not rational, [but] it’s not clear to me why that’s constitutional.”
October 5, 2022