Category: Also in TR

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  • Nicotine 2040

    Nicotine 2040

    Photo: Artinun

    The market for tobacco and nicotine is transforming—how could it look by 2040?

    By Clive Bates

    “Prediction is very difficult, especially if it’s about the future,” said the great Danish physicist Niels Bohr. The future is a burial ground for expert reputations, but that should never be a reason to shy away from predictions. Much of what we do today will shape the world in 2040, and our view of how the world should be in 2040 should shape what we do today. So let us consider the evolution of the market for tobacco and nicotine products out to 2040. There’s a lot to think about, so buckle up!

    First, three epochs. I see the evolution of the tobacco and nicotine policy as three overlapping epochs covering 1960 to 2040.

    (1) The tobacco control epoch stretched from 1960 to 2010. It was triggered by reports from the U.K. Royal College of Physicians and U.S. Surgeon General. It involved an all-out struggle between public health and the tobacco industry over the multiple harms of cigarette smoking, culminating in the World Health Organization Framework Convention on Tobacco Control, agreed in 2003.  

    (2) The tobacco harm reduction (THR) epoch started around 2000 with the increasing recognition that smokeless tobacco, especially Swedish snus, was much safer than cigarettes and could displace smoking. That epoch took hold in 2010 with the rise of vaping, then heated tobacco, and now nicotine pouches. The THR controversy is focused on reducing the harms associated with smoking and exploiting (or resisting) a massive public health opportunity (or risk). However, this is an interim phase.

    (3) The rethinking nicotine epoch is already underway and beginning to shape thinking about the future. We will need to confront the fundamental question: What is the place of nicotine in society? What does nicotine use mean if few people are smoking and there is not that much harm to reduce? This is already a live question; around half of American vapers aged 18–24 have not previously smoked, though some might have smoked had there been no vapes. We will undo the deep conflation between the relatively benign stimulant nicotine and the harms of smoke inhalation and place it alongside caffeine, alcohol and, increasingly, cannabinoids as legal recreational substances.

    Second, the persistence of the demand for nicotine. Many tobacco control activists have hoped that the relative decline in cigarette smoking would also eventually lead to a nicotine-free society. However, they misjudged the underlying behavioral drivers. The decline in smoking was driven by the harm to health and welfare, reinforced by policy-induced pain, such as taxes, smoking restrictions or “denormalization” designed to create a deterrent to uptake and motivation to quit. However, without the underlying harms, the deterrents are greatly weakened, and there is no justification for a punitive, coercive and stigmatizing policy. We are left to answer the question: Why is there a demand for nicotine? The demand derives from a simple proposition: For some people, nicotine use makes them feel or function better. Looking out to 2040, we should see the demand for nicotine as robust and resilient. The demand for any particular way of taking it is much more fluid or, as economists say, “elastic.” In fact, without the harms of smoking and related deterrents, demand might increase. That may seem unnerving, but should we care if the harms are low or negligible? As a 1991 Lancet editorial put it: “There is no compelling objection to the recreational and even addictive use of nicotine provided it is not shown to be physically, psychologically or socially harmful to the user or to others.”

    Third, technology and innovation. Can smoke-free nicotine products entirely replace smoking to meet all nicotine demand? Many smokers have tried the alternatives and chosen not to switch. There is more to smoking than nicotine self-administration, including the speed and peak of nicotine delivery, other psychoactive agents, sensory experiences such as “throat hit,” flavors and aromas, behavioral and ritual aspects, and perhaps deep brand loyalties that reach right into the individual’s identity. However, the pace of change in alternative technologies has been extremely rapid since the emergence of cigalike vapes at a noticeable scale about 15 years ago. Imagine the product landscape 15 years from now. That will include better versions of the product categories we have today: vapes, oral nicotine, heated tobacco and smokeless tobacco, but perhaps also sprays, inhalers and nasal products. Who knows? Competitive innovation meets consumer demand in novel and sometimes surprising ways. Many public health commentators, and perhaps tobacco industry die-hards, believe that these products will remain a niche alternative for only some smokers. Don’t count on it. Over time, that niche will expand through innovation until it dominates the market. That trend is inevitable and unstoppable.

    Fourth, regulation and markets. The twin forces of consumer demand and innovation will squeeze the cigarette market into contraction and lower profitability. The greatest danger is that the rise of smoke-free alternatives will be treated as a threat, not an opportunity, and be met with prohibitions or excessive regulation and taxation. Although such regulation will aim to reduce nicotine use by constraining supply, its effect will be to switch from lawful commercial supply to illicit, criminal and informal supply. This effect is already visible in supposedly strong regulatory jurisdictions like Australia and the United States, where authorized products from approved suppliers meet less than 10 percent of the vape market. Jurisdictions such as Brazil and India have imposed prohibitions, but all that means is that the regulator is missing in action along with any consumer protection. Prohibitions trigger the nasty triad of more smoking, more illicit vapes and more risky workarounds. Whatever the regulation, there will be supply. Banned products do not simply disappear. Whether the supply is lawful or illegal will become the nicotine and tobacco policy conflict of the coming decade. The market will remain lawful if (and only if) the policies adopted for smoke-free alternatives are risk-proportionate, focus on consumer protection and meet the adult demand for low-risk nicotine.

    “If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee!”

    Fifth, young people and nicotine. By 2040, a more sophisticated discussion of youth nicotine use will emerge. If we accept that adult use of nicotine will persist indefinitely, then we should expect some young people to try it, and for some, it will make them feel or function better. To the extent that youth vaping displaces smoking, it provides net benefits to public health. No reasonable person, including me, wants young people to smoke, vape or use nicotine in any form. However, it is one thing to express an opinion on what is best for young people, but it is quite another to believe this can or should be achieved by various forms of prohibition imposed on adults. Four strategies will emerge to provide reasonable protections to young people. The first will be an imperative to keep the adult nicotine market lawfully supplied and thus inhibit the formation of large criminal supply networks that will also supply youth. The second will be age-secure retailing, drawing on technology and licensing. The third will be controls on marketing, including branding, packaging imagery and flavor descriptors. Finally, we need to be candid and not hysterical in communicating the risks of nicotine use. The global public health problem is not youth vaping but the millions of existing adults who have already been smoking for a decade or more.  

    Sixth, the tobacco control complex. The abstinence-only tobacco control field will face a bruising contest with reality. As the wide range of negative consequences of prohibitions are increasingly visible and articulated scientifically, major funders will become wary and back away. The research funding agencies will become more skeptical. The “realists” will grow in stature and begin to prevail over the “idealists” (see “Realists and Idealists,” Tobacco Reporter, June 2024). Pragmatism will drive out hubris, and grand regulatory schemes will fall into disrepute. The original goal of tobacco control has been to address the range of serious diseases and other harms caused by smoking. But that game is up. In comments to the New York Times almost 20 years ago, the then president of the Campaign for Tobacco-Free Kids, Matthew L. Myers, endorsed a world of nicotine use without significant harm: “The challenge to me is not to eliminate smoking but the death and disease from smoking,” Myers said. “That should be the end goal. If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee! I have to believe that if the marketplace incentives were such that over time, someone could devise a product that would give the same satisfaction as tobacco but didn’t kill them, people would flock to it.”

    Then you’d have coffee! Yes, precisely. But there is no gigantic “coffee control” movement. There is no multimillion-dollar Campaign for Caffeine-Free Kids. As Myers’ statement unintentionally suggests, the tobacco control movement is profoundly threatened by nicotine use without significant harm. Without harm, it has no purpose.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Playing with Numbers

    Playing with Numbers

    Photo: Hafiez Razali

    How research methods distort nicotine effects and risks

    By Cheryl K. Olson

    “The paper seems like a joke.” That’s what Harvard researcher Miguel Hernan said recently to the journal Science about a report linking e-cigarettes and strokes.

    The article was concocted by a dubious research group, founded to help young international medical school graduates get coveted authorship credits. Its analysis of U.S. government survey data claimed that respondents who vaped had a higher risk of stroke, at younger ages, than those who smoked. Its glaring flaws included inflating the number of survey takers by tens of thousands and failing to correct for the relative youth of vapers.

    Despite this, the 2022 paper’s findings found their way into media headlines and anti-vaping advertising. The Science article credits Gal Cohen and Floe Foxon with sounding the alarm on this appalling study.

    Subtler issues that affect research quality, and how research is perceived by the public, are harder to spot. Research methods may seem a dull or arcane topic. But a peek at how the research sausage is made reveals some simple yet surprising ways that the process can go wrong.

    Sometimes old habits or unquestioned assumptions are to blame. Just as typewriters affect how we text on our mobiles, legacy cigarette research methods and mindsets influence how we study noncombustible nicotine products.

    Hours of Vaping?

    Everyone understands cigarettes. When it comes to totting up use, cigarettes are easy. They come in standard units. You light, puff and extinguish. Not so for products such as vapes. How, then, do researchers compare smoking with these new nicotine-delivery systems?

    “There’s a lot of research showing that people who use e-cigarettes graze throughout the day,” says Arielle Selya, who conducts nicotine product research at Pinney Associates. “Unlike cigarettes, there’s no defined stopping and starting. They don’t have to finish a discrete unit; they just puff on and off.” Measuring this kind of variable, intermittent activity is a challenge.

    This problem is not unique to vaping. Studying nicotine pouch use, I found unexpectedly wide variations in what people did and what they thought was normal. Some tossed a pouch in the trash after 10 minutes or 15 minutes. Others kept one in their mouth for a couple of hours. A few sometimes reused a pouch they’d started earlier or cheeked pouches of two different flavors at once.

    As an example of what can go wrong, Selya pointed to a recent study of vaping and respiratory symptoms. To the authors’ credit, they tried to measure heaviness of e-cigarette use. The problem was the poor fit between their question and the behavior. They asked, “How many hours did you use electronic cigarettes per day?”

    “I’m not a vaper, but that seems like such a strange question,” says Selya. “Like asking how many hours do you spend drinking water?”

    Better approaches to measuring nicotine product use include writing down what you’re doing whenever a device pings you (ecological momentary assessment) or in a daily diary.

    Twisted Terminology

    Another holdover from cigarettes is the way tobacco is seen as the default flavor for all nicotine-containing products. “With e-cigarettes, you have to add a tobacco flavor,” notes Selya. “But researchers often say ‘flavored’ when they mean ‘non-tobacco flavored’–in some communications even the NYTS team does this–but tobacco itself is a flavor! This generates misunderstandings.”

    Nicotine research terminology can defy common sense. Consider the concept of “abuse liability.” In everyday English, abuse implies harm. When the U.S. Food and Drug Administration assesses new drugs, stricter regulation may be required if there’s abuse potential, defined as “intentional, nontherapeutic use” to “achieve a desired psychological or physical effect.” An effect like euphoria, hallucinations or distorted thoughts or perceptions. 

    When it comes to reduced-harm nicotine products, abuse potential becomes, weirdly, a plus. A backhanded compliment. If you want to attract someone away from cigarettes, features like rapid nicotine absorption, relaxation and relief of withdrawal encourage that transition.

    Abuse liability also illustrates another nicotine methodology vexation: there is no agreed-on way to measure it. One article looked at comments made by the FDA on manufacturers’ submissions for multiple types of nicotine products. Regulators considered a whole range of measures related to abuse liability, from product chemistry and pharmacokinetics to subjective factors. Of the latter, “liking” the product turned out to be the most reliable and sensitive abuse liability measure!

    Misleading Measures

    Again, cigarettes are simple and familiar. Novel nicotine products, by contrast, come in ever-evolving variations. U.S. government surveys, such as the Population Assessment of Tobacco and Health (PATH) and National Youth Tobacco Survey (NYTS), measure trends in who is using what products. The results are widely used and reported. However, for survey results to make sense, people must understand the questions.

    Discrepancies in results suggest that research participants often misunderstand nicotine products and/or the terms being used to describe them. For example, answers about vaping brands and device types often don’t match. In the NYTS, just two-thirds of teens who said they “usually” used a pod/cartridge brand of e-cigarette (such as Juul, Logic or Vuse) also said they “most often” used a pod/cartridge device. Almost one in five adults in the PATH study had these kinds of mismatched answers about their vaping behavior. 

    Some questions have even larger errors. “The NYTS asks whether your e-cigarette product contains nicotine salts,” says Selya. “And overall, about 50 percent said they don’t know.”

    This is also true for so-called “concept” flavors, she notes. “Not strawberry-banana, but something like cosmic fusion. When youth are asked about concept or ice flavors, they don’t know the characteristics of their product, or maybe don’t understand those words.”

    NYTS first asked youth about tobacco-free nicotine pouches in 2021. That year, just 1.9 percent of teens reported ever using one. Checking the details, I found a flaw: The questionnaire defined nicotine pouches as “flavored.” However, over a third of teen ever-users said the pouch product they used was unflavored. (Perhaps they confused pouches and snus?) 

    A further example: the 2023 NYTS found that 1 percent of youth—an estimated 370,000—had ever used a heated-tobacco product. At the time, that product category was not sold in the United States.

    As Ray Niaura of New York University told me, “That can’t be right. Literally, it’s impossible. So that means it’s measurement error.”

    This suggests young survey takers were befuddled. “Kids aren’t going to know,” says Niaura. “‘Heated tobacco: Yeah. I smoked a cigarette. It’s heated. I light it on fire.’”

    Yet the Centers for Disease Control and Prevention reported the result without comment or explanation.

    If a product is only used by a small percentage of people, these sorts of errors could create unreal changes in year-to-year trends. The reporting of those potentially misleading trends affect the perceptions of academics, regulators and the public. “With that amount of uncertainty and some of the low numbers, it’s hard to figure out what’s the signal versus the noise,” notes Selya.

    Questionable Choices

    Another seemingly simple but complicated issue: Who counts as a current product user? Youth surveys typically ask “have you used e-cigarettes at all, even a puff, in the last 30 days?” Surveys aimed at adults commonly ask, “Do you currently use e-cigarettes some days, every day or not at all?”

    If you assume capturing any youth e-cigarette use is important, then “even a puff” makes sense. But it also makes it difficult to separate teens who are briefly experimenting from teens at risk for problematic ongoing use.

    In studies that look at how using nicotine products affect some aspect of health, researchers choose what outcomes to measure. Their choices can suggest biases or suspicious holes in what’s reported.

    A recent study using PATH data tried to compare e-cigarette use and the age at which people developed asthma. “Why age of asthma onset rather than whether they developed asthma at all?” says Selya. “Often, I read a study and think, did you look at these other related outcomes? If so, why weren’t they published?” This issue of results that may exist but aren’t reported are known as the “file drawer problem.” Preregistering study plans would avoid this issue.

    Researchers, Meet Users

    Before I dove deeply into tobacco harm reduction, my research focused on the effects of violent video games on youth. Finding discrepancies between research reports and what teens told me, I realized that many of the field’s most-cited “experts” had never actually played or even observed the games they studied.

    Similarly, many nicotine researchers seem to have never held or used the noncombusted products they study. This leads to findings that don’t reflect real-world situations. One example is an article by Sebastien Soulet and Roberto Sussman on metal contents of e-cigarette aerosols. They found that researchers were overheating tank vaping devices, generating aerosols that would be “likely repellent to human users.”

    “I think there’s a big disconnect and abysmally low involvement of actual consumers, the people affected by policies,” says Selya. Partnering with people who actually know and use novel nicotine products would be a giant step toward improved research quality.  

    References

    Foxon F. (2023). Discordant device/brand reporting among adolescents who used e-cigarettes in the National Youth Tobacco Survey. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntad228

    Joelving F. (2024). Prescription for controversy. Science. https://www.science.org/content/article/questionable-firms-tempt-young-doctors-with-easy-publications

    Selya A, Ruggieri M, Polosa R. (2024). Measures of youth e-cigarette use: strengths, weaknesses and recommendations. Frontiers in Public Health. https://doi.org/10.3389/fpubh.2024.1412406

    Soulet S, Sussman RA. (2022). A critical review of recent literature on metal contents in e-cigarette aerosol. Toxics. https://www.mdpi.com/2305-6304/10/9/510

    Vansickel A et al. (2022). Human abuse liability assessment of tobacco and nicotine products: approaches for meeting current regulatory recommendations. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntab183

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
  • Shock Absorber

    Shock Absorber

    Photo: Alessandro De Leo | Dreamstime

    With an appropriate tax regime, fine-cut tobacco can provide a useful buffer between high-priced cigarettes and illicit products.

    By Stefanie Rossel

    Across Europe, three countries offer showcase examples of unintended consequences created by ill-designed tax policies. The fiscal frameworks in France, the United Kingdom and the Netherlands prevent fine-cut tobacco (FCT) from fulfilling its buffer function in the nicotine ecosystem, leading to high levels of illicit trade. When taxed at comparatively low rates, FCT products can serve as a “shock absorber” between higher taxed factory-made cigarettes and illicit smokes. If the tax rates and retail prices of combustible cigarettes and FCT become too similar, fine roll-your-own (RYO) and make-your-own (MYO) products may lose their appeal to smokers with lower disposable incomes.

    In the European Union, home to some of the world’s leading RYO and MYO markets, France presents a prime example. “The market is riddled with illicit trade, as the taxation levels prevent FCT to fulfill its buffer function,” says Peter van der Mark, secretary general of the European Smoking Tobacco Association (ESTA). “Since 2020, volumes of FCT have consistently declined, by 8 percent in 2021, 13.7 percent in 2022 and 10.2 percent in 2023.” This decline is slightly more pronounced than that in other tobacco segments.

    On the bright side, according to van der Mark, French authorities appear to have belatedly recognized the negative impacts of their policies. Last month, the responsible minister acknowledged that beyond a certain point, raising taxes becomes counterproductive and boosts contraband, which benefits neither public health nor public finances. “We can only regret that it took one-third of the market to be illegal to come to that conclusion,” laments van der Mark.

    The U.K. faces a similar situation. According to van der Mark, that country’s government has nearly aligned the tax rates on FCT with those on cigarettes—and without consulting the industry. As a result, legal volumes have been declining substantially, benefiting smugglers and illicit traders. According to van der Mark, this is not only impacting manufacturers, distributors and retailers but also the finance ministry (and therefore U.K. citizens), which last year saw its tobacco tax receipts drop by nearly 15 percent compared to 2022—a loss of approximately £1.5 billion ($1.91 billion).

    Germany, the largest EU market for hand-rolling products, also hiked FCT taxes but managed to avoid the negative effects experienced by Britain and France, thanks to its incremental approach. “The ad valorem component on FCT increased progressively and moderately whilst step increases of the specific or minimum were always kept below 10 percent,” explains van der Mark.

    “In general, we consider the German tax model to be well crafted as it allows for predictability and ensures the market functions smoothly whilst allowing the government to pursue its treasury and health objectives,” says van der Mark.

    “Volume-wise, of course we note a decline in comparison with 2020 [consumption], which was exceptionally high due to the Covid-19 outbreak. In 2023, volume declined by 5 percent compared to 2022, confirming a declining trend in general.”

    This year, however, Germany’s market has benefitted from rising FCT taxes in the Netherlands. According to van der Mark, a 50 gram pouch now costs approximately €25 ($27.02) there, encouraging Dutch smokers to source their tobacco elsewhere, including in neighboring Germany.

    Across Europe, the general trend is toward less tobacco consumption, and FCT is no exception. “Inflation had a massive impact on consumer ability to buy tobacco products in 2022–2023,” says van der Mark. “Consumers down-traded or moved to FCT or illicit cigarettes. Although inflation has decreased, it remains very unequal from one country to another. Where inflation remains high, we expect sales of FCT to slightly increase, demonstrating once again the buffer function this product category can fulfill, provided it is taxed approximately.”

    “We consider the German tax model to be well crafted as it allows for predictability whilst allowing the government to pursue its treasury and health objectives.”

    STG Buys Mac Baren

    As the market contracts, the fine-cut industry has been consolidating. In June, Scandinavian Tobacco Group acquired family-owned Mac Baren Tobacco from Halberg for DKK535 million ($76.87 million). Founded in 1826, Mac Baren’s portfolio includes pipe tobacco brands such as Mac Baren, Amphora and Holger Danske as well as fine-cut tobacco brands such as Amsterdamer, Choice and Opal. The company also produces and sells nicotine pouches with the brands Ace and Gritt.

    Mac Baren sells its products in 74 countries and generates most of its net sales in the U.S., Denmark and Germany. Other key markets include the U.K., France, Spain and Italy. Headquartered in Svendborg, Denmark, the company has production facilities in Denmark and the United States (in Richmond, Virginia), and employs approximately 200 people full time.

    Both Mac Baren and STG are members of ESTA. “The reduction of family-owned companies in our sector is always regrettable, but at the same time, we are pleased to see that its traditional know-how will remain in the very capable hands of STG, a company that is committed to high-quality traditional smoking tobaccos,” says van der Mark.

    The FCT sector has consolidated at regular intervals, with the last wave being triggered by the EU Tobacco Products Directive (TPD) in 2014. At this time, van der Mark sees no indications of a new consolidation wave, however.

    New Regulations on the Horizon

    Whether the pending TPD revision will change that situation is up for discussion. The European Commission’s evaluation report, expected toward the end of 2024, should provide some insights into the future regulatory environment. According to van der Mark, a 2021 report on the TPD application identified topics likely to be discussed further in the future.

    “This includes the field of ingredient regulation, where we have seen several member states taking cavalier initiatives and establishing outright bans of certain ingredients,” he says. “In general, we fear that the notion of ‘flavors’ has been largely misunderstood and will be subject to debates that will most likely be based on assumptions more than on actual scientific underpinning. Labeling and packaging, where the commission is no longer hiding its preference for plain packaging, will also be an issue, and, of course, the regulation of novel tobacco products.”

    With a new commission poised to take office in November, van der Mark expects more emphasis on novel nicotine products and less impact on the FCT segment. “For fine-cut tobacco, the whole legislation has already been there since TPD2,” he says.

    “We are more concerned about the ingredients regulation. We believe that the ingredients which are in tobacco products, representing between 1 percent and 3 percent of the total weight, are nonconsequential, but the commission is continuously looking at the ingredients as if they would make the product even more problematic from a health perspective. We think that the commission simply has the wrong end of the stick.”

    Whether the EU’s approach toward tobacco products will change with the new crop of lawmakers remains to be seen. “At this stage, it is not sure whether the ‘shift to the right’ will affect the functioning of the EU Parliament and its ‘great coalition’ made of the Socialists and Democrats, Renew and center-right European People’s Party groups,” says van der Mark.

    “An interesting statistic, however, is that about 60 percent of the elected members of the European Parliament are coming from parties that are not governing in their national jurisdictions. This means that we could see a European Parliament ‘free’ from the guidance of the national government, at least to a certain extent.”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Something to Smile About

    Something to Smile About

    The CoEHAR is studying the impact of reduced-risk products on oral health.

    Photo: Andrei

    By Stefanie Rossel

    Polosa and his team anticipate observing better gingival/gum conditions, improved tooth color and reduced dental plaque accumulation in smokers who stop smoking after switching to alternative tar-free nicotine products. | Photo: Chris Frenzi

    In the context of smoking-related issues, oral health has long been neglected. According to Riccardo Polosa, founder of the Center of Excellence for the acceleration of Harm Reduction (CoEHAR) in Italy, this can be explained by several factors. “Smoking is primarily linked to fatal systemic conditions such as cancer, heart disease and respiratory problems, which tend to overshadow its effects on oral health,” he says.

    In addition, until recently, dentists were less aware of the detrimental impact of smoking on oral health, particularly in managing gum disease, tooth loss and dental implant procedures. What’s more, because oral health is influenced by multiple factors, including diet, oral hygiene practices and genetic predispositions, it is difficult to isolate smoking as a culprit.

    “Dentists have historically been hesitant to invest their professional efforts in helping clients quit smoking,” Polosa says. “However, there is now an increasing recognition among dental professionals of the significant benefits of smoking cessation in improving treatment outcomes, and more and more dentists are increasingly promoting smoking cessation strategies and advocating for the use of tar-free nicotine products.”

    To investigate changes in oral health parameters and dental aesthetics in smokers who switch to tar-free nicotine products, the CoEHAR earlier this year launched the SMILE study with funding from the Foundation for a Smoke-Free World (FSFW), which recently rebranded as Global Action to End Smoking. Polosa says the study is the first and only of its kind, as it aims to measure risk reduction, harm reversal and smoking cessation combined, which sets it apart from other trials that focus solely on cessation.

    Geographically Diverse Approach

    The international, randomized controlled trial involves 474 participants in four countries—153 in Catania (Italy), 45 in Warsaw (Poland), 168 in Chisinau (Moldova) and 108 in Bandung (Indonesia). The decision to focus on these countries was based on strategic and practical considerations, Polosa explains. “Mandated by the FSFW’s mission, the selection of low[-income] and middle-income countries was crucial to facilitate the dissemination of high-quality tobacco harm reduction [THR] science through collaborative partnerships and knowledge exchange,” he says. “Additionally, factors such as low operational costs and strong interest in participating in the study were significant in their inclusion. Italy was specifically chosen to take a leadership role in training and coordination within the study.”

    All four countries have high smoking rates, providing a substantial pool of participants for studying smoking cessation and switching behaviors. “The selection of these countries enables the SMILE study to capture a broad spectrum of socioeconomic, healthcare and cultural factors that influence smoking behavior and the adoption of THR,” says Polosa. Each country represents a distinct healthcare system, ranging from well-established systems in Italy and Poland to less developed systems in Moldova and Indonesia. This diversity enhances the study’s relevance and generalizability on a global scale.”

    Indonesia presents a unique case due to its widespread use of clove cigarettes, which account for nearly 90 percent of the Indonesian cigarette market. “Studying THR in a context where very popular traditional tobacco products dominate can offer valuable insights into cultural attitudes toward smoking cessation and alternative nicotine-delivery systems,” says Polosa. “Smoke from clove cigarettes contains high particulate matter and toxicants, making them as harmful as conventional tobacco cigarettes. Therefore, THR is strongly needed in Indonesia, with advocacy and education being key to successful implementation.”

    Dentists increasingly recognize the significant benefits of smoking cessation in improving treatment outcomes. | Photo: RomanR

    State-of-the-Art Technologies

    For their study, the SMILE researchers recruited cigarette smokers interested in switching to alternative products. The participants were randomly allocated to receive either standard care, including cessation counseling (i.e., “very brief advice”), or the nicotine product of their choice plus very brief advice. The trial also includes a reference group of individuals who had never smoked. The researchers then recorded participants’ cigarette consumption and tar-free nicotine product at every visit. Additionally, participants were asked to return all empty, partly used and unused consumables. Throughout the study, the researchers monitored smoking and tar-free nicotine product use via a tracker app.

    “The SMILE tracker app is an integral component of the SMILE study, designed to monitor participants’ behaviors and lifestyle choices. Through daily prompts, the app assists in tracking cigarette consumption, the use of nicotine products, and regular oral hygiene practices such as brushing, flossing and mouthwash use. Although personal oral hygiene practices were carefully tracked, there was no emphasis on oral hygiene education or management of dietary patterns,” says Polosa.

    “A standardized approach was implemented to mitigate the effect of these potential confounders on both primary and secondary study endpoints,” he continues. “Participants were explicitly advised to continue their established oral hygiene practices for the entire duration of the study. Furthermore, adherence to specific restriction criteria before each scheduled study visit was emphasized to prevent any confounding of the collected data.”

    To prevent confounding factors, oral hygienists removed plaque, calculus and stain from the study participants’ teeth 14 days prior to baseline measurements. “This critical element is absent in most clinical trials,” says Polosa.

    Chronic periodontal disease is common in smokers that is unlikely to improve with cessation alone, according to Polosa. “Therefore, participants with periodontitis have been excluded, and only participants with mild to moderate gingivitis have been recruited, as they are more likely to maximize the impact of the intervention.”

    The researchers use state-of-the-art technologies, such as spectrophotometers and quantitative light-induced fluorescence scanners, to quantify tooth discoloration and the amount of dental plaque.

    “These study endpoints measure important patient factors that may drive behavior change,” says Polosa. “This is particularly persuasive for young adults, for whom a cardiovascular-cancer-respiratory risk-based narrative is either ineffective or counterproductive and for whom concern about bad breath and poor dental aesthetics due to enamel discoloration and ‘tar’ stains may be a much more significant reason to stop smoking.”

    The Importance of Aesthetics

    The SMILE study allows volunteers to choose their own type of tar-free nicotine product, says Polosa. “This personalized choice is likely to enhance adherence, retention, and optimize compliance, thus maximizing cessation of tobacco cigarettes,” he explains. “This unique approach also generates results that are not product-specific and therefore more generalizable and realistic for implementing such a strategy in the real world.”

    According to Polosa, the researchers enroll only those who would not otherwise commit to a smoking cessation counseling program but are prepared to choose from smoking alternatives such as e-cigarettes and tobacco-heating products. The study has been designed to allow participants to tailor their own “nicotine experience” by selecting the tar-free nicotine product that aligns most with their preferences, thereby maximizing the transition away from tobacco smoking and reducing the likelihood of relapse.

    The study is not designed to coerce participants to avoid tobacco smoking completely, he says. Dual use is not prevented; therefore, the sample size has been oversampled to ensure that enough exclusive users of tar-free nicotine products by the end of the study are included.

    “The SMILE study also provides a unique opportunity to evaluate the impact on oral health and dental aesthetics among individuals who simultaneously smoke conventional cigarettes and use tar-free nicotine products,” says Polosa. “Different dual-use patterns exist—e.g., strong switchers versus light switchers—and are likely to have varying impacts on overall oral health. We expect to observe progressive changes with different patterns of dual use.”

    Perhaps the most interesting aspect of the SMILE study is its inclusion of aesthetics. Polosa says that stained teeth and tobacco odors are a growing concern, especially among young smokers, who demand not only healthy mouths but good-looking smiles.

    “Everyone wants to have a perfect dentition, as it helps in interpersonal contacts and raises value in the job market,” he says. “In our social media-driven age, vanity plays a significant role in influencing behavior. The desire for an attractive appearance, including a bright smile, is often a powerful motivator, especially among younger demographics who are highly engaged with social media platforms.”

    Evidence from literature demonstrates that using images of damaged and tar-riddled lungs does not act as an effective deterrent to smoking, he says. “This is partly because people do not respond well to negative messaging and because they do not identify such images with their own bodies. The focus on aesthetics—rather than vanity—is important because we are conveying a positive outcome message for smoking cessation, leveraging the explosion in social media posts of happy, healthy people with bright smiles.”

    Appealing to individuals’ desire to present themselves well and feel confident not only acknowledges the importance of aesthetics but also offers practical solutions for oral healthcare practitioners, such as aesthetic-enhancing alternative nicotine products for those who may struggle to quit smoking, according to Polosa. “The goal here is to harness today’s emphasis on appearance to encourage healthier behavior,” he says. “I predict that the argument for better aesthetics and oral health will become a more prominent and effective tool in smoking cessation efforts.”

    The study’s results are expected in 2025. Polosa and his team anticipate observing better gingival/gum conditions, improved tooth color and reduced dental plaque accumulation in smokers who stop smoking after switching to alternative tar-free nicotine products.

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • The Case for Nicotine

    The Case for Nicotine

    Image: Maridav

    Many policymakers see nicotine as part of the problem; THR proponents see it as part of the solution. Understanding why such deeply opposing views are held also provides a view of the way ahead.

    By Barnaby Page

    Advocates of tobacco harm reduction (THR) and the industry making THR products are accustomed to fighting battles on multiple fronts—simultaneously contending with the threat of flavor bans, new taxes and misrepresentations of science, for example. But perhaps the most essential battle of all is the one against the demonization of nicotine; it’s possible to imagine vaping continuing to exist without nontobacco flavors, for example (even if it might be a less appealing kind of vaping), and it’s possible to imagine consumers continuing to buy THR products even if taxes hike their price, but it’s not really possible to imagine THR without nicotine.

    This means that, while its opponents are not wrong to say that that nicotine is to an extent an initiator and certainly a perpetuator of smoking, it’s also a “friend” as much as an “enemy” in the quest to reduce smoking rates and smoking-related harm. Persuading others, including lawmakers, the medical profession and the public health establishment, to see it this way is a key and decidedly nontrivial task for the THR movement, one that could have profound effects on future policy and regulation concerning THR products and therefore their uptake.

    Smoking and Addiction

    Opposition to nicotine probably derives, at heart, from two somewhat different but related factors: cigarettes and addiction. First, it’s easy to forget—but essential to remember—that until around a decade ago, nicotine effectively meant cigarettes for most people in most countries. Sure, there were other delivery mechanisms (e-cigarettes were already starting to make their presence known; oral products of different kinds had traction in some places; a few people even smoked cigars or pipes), but the cigarette was dominant … and so for the average person, who in a specialist field like this also includes the average policymaker, nicotine was inextricably tied to smoking, which in turn was inextricably tied to combustible cigarettes.

    As a result, it’s not surprising that many people find it difficult to separate the effects of nicotine from the effects of cigarette smoking in their head. (Even some people who ought to know better seem to find it tough.) Meanwhile, public health messaging had for decades reinforced the same point—Superman’s foe, the evil Nick O’Teen, is a classic example.

    Plus, and this brings us to the second point, nicotine was not only that generally sinister thing, a “chemical,” but it was one you could become addicted to. Again, it’s understandable that people who weren’t specialists in addiction science wouldn’t realize that the concept itself was a much-debated thing, and people who had grown up in a War on Drugs era when “drug addicts” were seen as an undifferentiated group of miserable, ruined junkies naturally saw addiction itself—regardless of the addictive substance concerned—as a terrible condition.

    Again, of course, there are those who ought to know better who use the concept to spread distrust; it amused me a few years ago when the then U.S. surgeon general, Jerome Adams, said that nicotine was “as addictive as heroin.” Leaving aside the whole issue of how you assess comparative addictiveness, the logical corollary here was that heroin is no more addictive than nicotine, but I doubt he would have wanted to spread that as a public health message.

    THR advocates need to recognize that the perception is just as potent as the reality.

    The Power of Perception

    In any case, some definitions of addiction or dependency now stipulate that it must be harmful, and it’s highly questionable whether nicotine—once separated from cigarette smoking—falls into that category. So there’s even a case to be made that nicotine addiction doesn’t exist as a problem in the first place. But the bottom line is that it is widely perceived to be harmful and addictive.

    And that is a huge obstacle for THR to overcome. Nicotine is absolutely central to the THR proposition. Indeed, it is founded on the distinction between nicotine and smoking, as famously expressed by Michael Russell when he observed that people smoke for the nicotine but die from the byproducts of smoking. It is the ability to make this distinction that leads to the concept of the continuum of risk—the idea that though different product categories (cigarettes, oral, vapor, heated tobacco, nicotine-replacement therapy [NRT] and so on) may all deliver nicotine, they do so with different risks, with some categories (for example, NRT, pouch and vape) at the bottom of the range while others (all of them involving combustion) are at the maximum.

    This concept is hardly news to anyone involved in THR or indeed anyone in the tobacco industry. But it’s worth repeating that it may not only be an unfamiliar idea but an apparently contradictory one to people outside those worlds if they believe that risk is inherent to nicotine use. Before any progress can be made on improving policy and regulation, this is a misconception that needs to be corrected, and for the reasons that I’ve discussed, it can be quite a deep-seated one. Of course it’s illogical—it’s like concluding that because it is very dangerous to drive on icy roads at high speed, it must be equally dangerous to drive on any road at any speed—but being illogical doesn’t mean it’s not thoroughly believed in by many people.

    The continuum of risk also means that where public health is concerned, logical regulation would focus on the delivery mechanisms (the icy road and the 90 mph) rather than the nicotine (the existence of cars). Except insofar as it may encourage use of more-risky delivery mechanisms, it doesn’t make sense for nicotine itself to be a prime concern. The on-off debate about very low-nicotine cigarettes (VLNCs) is a vivid illustration of this; there are surely questions to be asked about a policy that retains the dangerous thing (combustion) and concentrates on eliminating the far less dangerous thing (nicotine). To be fair, the research on how consumers might use VLNCs in real life is not yet conclusive, and it is possible they would have a deterrent effect beneficial to public health. But it’s difficult to escape the impression that the image of the evil Nick O’Teen is lurking in the background here as well.

    A survey on U.S. vape stores published in 2023 by ECigIntelligence, one of a regular series, found that misconceptions about vaping—which often means misconceptions about nicotine—are a persistent problem.

    What Regulation Might Look Like

    Of course, we can’t realistically expect that lawmakers are going to leave nicotine entirely alone. So if we were going to regulate nicotine the substance—as opposed to characteristics of the delivery mechanisms, and nonproduct issues such as minimum purchase age, advertising and public usage—what areas could be looked at?

    We could regulate nicotine content, which we could measure in two ways: either absolutely—the total amount in a cigarette stick or a vape pod, for example—or comparatively, by measuring concentration. The latter makes more sense for product categories where there is notable variation in product size (for example, e-liquid bottles).

    We could also look at regulating the nicotine yield, which is the amount of nicotine actually emitted from the product and thus available for consumption by the user; although clearly dependent on the nicotine content level to some extent, this is a more meaningful number in terms of effects. (A hypothetical product with very high content yet very low yield would contain an awful lot of nicotine that might just as well not have existed—it would be irrelevant in any calculation of risk or health impact.)

    We could also look at nicotine flux, the rate of nicotine emission—a crucial difference between combustible cigarettes and vapes, for example, and one that strongly affects the actual experience of use. And finally, just to be complete, of course we would want to regulate safety where nicotine is sold in very high concentrations such that accidental consumption of a relatively small amount could have seriously deleterious effects. The perception of risk here is, again, quite possibly exaggerated, but measures like childproofing do nothing to undermine the value of THR, they may prevent some accidents, and many countries have implemented them. This aspect, at least, is a no-brainer ….

    But (apart from the childproof caps) does regulating nicotine itself actually solve any problems that aren’t addressed by, for instance, regulating underage purchase—especially if we don’t consider dependency in itself, among adults, to be a problem?

    The THR movement will have to work relentlessly to keep the focus on risk profiles of delivery mechanisms, not on nicotine.

    The Gateway Effect

    The biggest contender for “problem to be solved” could, of course, be the so-called “gateway effect”—the idea that even when less risky forms of nicotine consumption are available, enjoyment of and/or dependency on them (take your pick) could lead the user toward more-risky forms.

    A logical riposte would be that though doubtless there are individual cases of such a gateway being passed through (as there are individual cases of almost anything you care to imagine), there is no convincing evidence of it happening on a large scale—and in any case, other measures could deter it. If we want to prevent people progressing from vapes to combustibles, the THR argument would go, surely it’s sensible to make vapes more attractive and combustibles less (whether that’s through differential taxation, marketing restrictions, flavor restrictions or other measures). Going in the other direction—for example, reducing nicotine levels in THR products (which are often less effective than combustibles at delivering nicotine to the body anyway)—would likely just have the effect of making THR less attractive to existing smokers and discourage them from switching.

    Nevertheless, the gateway effect is a widespread concern that ties in at an emotional level with the idea of nicotine as an irresistibly addictive substance leading users further and further into its grip. And once again, THR advocates need to recognize that, as is so often in this field, the perception is just as potent as the reality—often more so. Addressing that will be a long and tough task, but the agenda for THR should be clear.

    The THR movement will have to work relentlessly to keep the focus on risk profiles of delivery mechanisms, not on nicotine itself. It will have to encourage policy based on proven risk, not on nicotine-specific characteristics such as concentration that in themselves don’t obviously connect to risk. It will have to put forward convincingly the idea that THR products need to be at least as attractive to the consumer as combustible products if their public health potential is to be realized—this means, in effect, undertaking the very difficult task of persuading policymakers that we should encourage nicotine consumption via THR.

    And, to achieve all this, it will have to educate not just policymakers but also health professionals, the media and the public. This includes actively countering misinformation, but simply saying people are wrong is clearly not going to be persuasive in itself, and it’s those THR advocates who engage directly and deeply with the “nicotine skeptics” who will end up making the biggest difference.

    For not only can nicotine be part of the solution rather than part of the problem, ignoring this is also a risk in itself. We shouldn’t lose the focus on reducing smoking by becoming distracted into reducing nicotine consumption.

    Barnaby Page is the editorial director of Tamarind Intelligence, the publisher of ECigIntelligence, TobaccoIntelligence and CannIntelligence. As a journalist, he has been covering the worldwide reduced-risk nicotine sector since 2014, with a particular focus on public health and regulatory issues.In his current role, he manages Tamarind’s editorial and reporting teams, producing a wide range of nicotine-related content. He previously spent 30 years as a reporter and editor for newspapers, magazines and online services, specializing in technology and business. He is based near London, England.
  • The Heart of HTMS

    The Heart of HTMS

    woodthorpe
    Ron Woodthorpe

    Celebrating the life and legacy of Ronald Woodthorpe

    By Marissa Dean

    Ronald Woodthorpe passed away on March 26, 2024, at age 86 after a three-year fight with dementia. He is missed by his surviving family and friends, but his legacy remains at the heart of Hampshire Tobacco Machinery Services (HTMS).

    Born in London in 1938, Woodthorpe was always a hard worker, training as a toolmaker after finishing secondary school. He took a job with Robert Legg in 1964 as a toolmaker—the company manufactured tobacco machinery and domestic appliances at the time. The next year, Robert Legg was acquired by American Machine Foundry Co. and renamed AMF-Legg, specializing in machinery for preliminary leaf processing and the processing and manufacture of cigarette and pipe tobacco. During this time, Woodthorpe developed a love for the industry that would span decades.

    In 1974, Woodthorpe was approached by John Payne, a director from AMF-Legg, with the idea to start a new business reengineering and upgrading machines for the tobacco industry. Thus, John Payne Engineering was born, and Woodthorpe was named technical director. The company quickly grew, supporting larger manufacturers like Imperial and BAT. Woodthorpe was involved with developing an upgraded, faster hinge-lid packer based on the Molins HLP 2 during his time at the company, and he inspired a technology transfer with Bulgartabac in the 1970s.

    John Payne Engineering was eventually sold in 1986 to Evered Holdings and later became part of GBE International. This didn’t sit well with Woodthorpe, who decided to start his own business: HTMS.

    HTMS began as a supply company in 1987, supplying spare parts for Molins and Sasib/AMF machinery from a small office and store in Southampton. Woodthorpe’s contacts in the industry supported him, and the business developed well. In 1988, Woodthorpe’s daughter, Gillian, was hired to assist with business administration. Two engineers were then hired to facilitate workshop activity.

    Three years later, the company moved to a larger office with stores beneath and a separate workshop facility. There, they began rebuilding Sasib/AMF soft packing machinery lines. Within the next five years, Woodthorpe’s daughter-in-law, Sara Fielder, and his youngest son, Peter, joined the company. By 1998, HTMS moved again to a larger space across the road, which is where it currently resides.

    Over the next couple years, HTMS bought the rights, technical drawings and casting patterns for the high-speed XL Hinge Lid Packer from John Payne Engineering and GBE making and packing, and Robert Brown, a Molins packing expert who worked with Woodthorpe at John Payne Engineering, was hired. The hinge-lid packer became HTMS’ flagship machine, and Brown’s addition to the team allowed Woodthorpe to further develop the high-speed hinge-lid packer and its associated downstream machinery.

    Woodthorpe was determined, a hard worker, a hard taskmaster and a man who generally would not take no for an answer. The tough standards he placed on himself were reflected in his work ethic and care—he tried every day to do the best he could for his business and his family. Those who knew him felt he was a very fair man who would always get you where you wanted to be and would support you in a time of need.

    “Ron always saw the best in people and encouraged those to find it in themselves,” said Brown. “In that way, he inspired others to achieve levels that they never thought possible, and I was certainly one of those. As long as you tried your best, you were never a failure in Ron’s eyes.”

    HTMS continues Woodthorpe’s ethos of service—the ability to supply immediately and support in times of need. HTMS understands that off-the-shelf supply is paramount to the business and its customers, thanks to Woodthorpe’s dedication and care over the years. Today, the company’s main focus is cigarette and cigar packaging, but it still provides primary equipment in the form of tobacco-cutting machinery and cigarette/cigar making machinery and spares. 

    “People talk about a work-life balance—well, Ron was one of the only people I’ve ever known who loved to ‘live to work’ as much as he did ‘work to live,’ simply because he had an equal amount of love and passion for work as he did his family,” said Sara. “Ron worked longer and harder than most because he wanted to make sure his family were taken care of but also because he loved the job and everything that it encompassed.

    “Ron’s dedication to taking care of ‘all of us’ over the years gave us, the HTMS team, the drive to continue in succeeding where he left off after his retirement, even more so now to continue further to honor his memory,” she said.

    Dedication is a clear theme of Woodthorpe’s life. He retired in 2020 at age 83 after a full life and career, leaving his company under the care of Peter, Sara and Jeff Perress. Even when he retired, it was less from a desire to retire and more from Covid-19 pandemic concerns, according to his son.

    In 2021, Woodthorpe was diagnosed with vascular dementia. Despite the struggles that caring for a loved one with dementia brings, Peter remembers his dad’s lessons of “Never put off till tomorrow what you can achieve today” and “If it’s not fun, don’t do it.”

    HTMS carries Woodthorpe’s core beliefs in quality, value and service at the heart of the business. And though he will be missed, his legacy will live on. “Ron’s enthusiasm, dedication and enjoyment for the job was passed on to all who worked for him,” said Howard Rich, a former colleague.

    Marissa Dean joined Tobacco Reporter in the summer of 2018 as a copy editor.Since that time, she has taken on additional responsibilities, including feature writing.Her skills span the publishing industry from layout and design to copy editing to content creation.
  • A Drop in the Ocean

    A Drop in the Ocean

    Photo: digieye

    The FDA’s first premarket approval of a mentholated vape product reflects poorly on the agency’s authorization process.

    By Stefanie Rossel

    Lindsay Stroud

    On June 21, the U.S. Food and Drug Administration for the first time authorized nontobacco-flavored vape products through its premarket tobacco product application (PMTA) pathway. The agency issued marketing granted orders (MGO) for two Njoy Ace menthol flavor pods and two disposable e-cigarettes, Njoy Daily Menthol 4.5 percent and Njoy Daily Extra Menthol 2.4 percent. The news was hailed as a “significant decision” and a “watershed moment for the sector” that will have a “huge and significant impact” on the global reduced-risk products market.

    Upon closer inspection, however, the authorization is less of a breakthrough than these superlatives suggest. Instead, it again highlights the many problems with the agency’s authorization process for electronic nicotine-delivery systems (ENDS) and novel nicotine products.

    Lindsey Stroud, senior fellow with the Taxpayers Protection Alliance, describes the recent FDA authorization as a small step in the right direction in what has otherwise been a regulatory nightmare. “While allowing the sale of a nontobacco-flavored ENDS, FDA seems to understand that adults who use menthol-flavored combustible cigarettes should have access to products which are significantly less harmful,” she says. “Unfortunately, the FDA still continues to deny the sale of all other flavored ENDS, despite their effectiveness in helping adults quit smoking and remain smoke-free.”

    Stroud is also concerned about the informal market. “Despite FDA not having issued authorization orders for flavored ENDS, a large, unregulated marketplace exists in the United States—99.9 percent of which are nontobacco flavored,” she says. “FDA must recognize the role that other flavors play in tobacco harm reduction because denialism isn’t stopping the flourishing non-FDA-authorized ENDS marketplace.”

    Jeffrey Smith

    Jeffrey Smith, a senior fellow in harm reduction at the R Street Institute, says he welcomes any action by the FDA Center for Tobacco Products (CTP) that supports reduced-risk options for those who smoke. “Unfortunately, in the grand scheme of things, the awarding of an MGO to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP,” he says. “If the regulatory environment does not change through external pressures, it is unlikely that the actions of the CTP will evolve in a swift and effective manner.”

    Gray Market to Persist

    While optimists may detect a new willingness to approve reduced-risk products (RRPs) in the CTP’s recent product authorizations, few expect the regulatory floodgates to open to an avalanche of product approvals.

    “Since the awarding of the Njoy menthol products, there haven’t been any additional actions or signals that more may be coming,” says Smith. “The only additional communications I have seen from the CTP since the Njoy announcement was a letter from the FDA to the clerk of the Supreme Court informing the court that the CTP had granted a marketing order to four menthol-flavored e-cigarette products. The case is the Logic v. FDA, where Logic is arguing that the CTP had adopted a blanket policy of rejecting menthol-flavored products.”

    Stroud says the menthol announcement is a positive development but notes that the FDA remains opposed to any flavors that don’t exist in traditional tobacco products. “Dr. Brian King, director for the Center for Tobacco Products, is very anti-flavor, if not anti-vape,” she says. “Going back to at least 2015 and his time at the CDC [Centers for Disease Control and Prevention], King has been first to tout the Bloomberg party line that ‘flavors hook kids.’ This is in direct contrast to U.S. youth survey data, which finds flavors as one of the least-cited reasons why youth vape. FDA must recognize the role of flavors, their appeal to adults who smoke and how flavors help to reinforce a negative taste—literally—associated with combustible cigarette smoke. Until FDA recognizes this, the U.S. ENDS market will remain a large gray market.”

    Unlike most other vape products that have received FDA authorization to date, the Njoy menthol variants are technologically up to date and relatively popular with consumers. “According to Altria’s first-quarter 2024 report, Njoy made up 4.3 percent of the U.S. retail market, but this will likely grow as Njoy is now the only menthol-flavored—and nontobacco-flavored—ENDS product legally permitted to be for sale in the U.S.,” says Stroud.

    She is undecided about the FDA decision’s potential impact on the global RRP landscape. “I would imagine that with FDA recognizing the importance of menthol, most countries would follow the agency’s findings,” she says. “Unfortunately, due to a de facto flavor ban in the U.S., there is precedent for countries to restrict flavors, despite them not experiencing a huge surge in youth vaping as the U.S. did in 2019.”

    “The awarding of a marketing granted order to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP.”

    Depressing Number

    Nicotine companies have long lamented the FDA’s product authorization process, which they say is needlessly time-consuming and costly and favors deep-pocketed players over less generously resourced applicants. Stroud and Smith believe the process can be streamlined only through external interventions.

    To illustrate the challenge, Stroud recalls the tremendous technological progress in ENDS products, which went from cigalikes to larger open systems, back to pods and then on to disposables. “The FDA’s draconian regulations don’t account for the technological improvement that has been applied to ENDS,” she says. “FDA and Congress could reform the Tobacco Control Act [TCA] in a huge way if they pushed the predicate date further ahead than February 2007. Requiring ENDS to undergo extensive testing and a massive bureaucratic application process is not only a farce to public health, but it restricts innovation and competition, which is very un-American.”

    With Congressional assistance and a reworking of the TCA, the FDA could establish a notification process for new products and then focus on post-market surveillance to monitor the public health effects of the new products, according to Shroud.

    “The FDA must also recognize what percentage of youth is permittable,” she says. “No other consumer good in America has been forced to deal with so much scrutiny that even one kid using the product is one kid too many. While youth vaping was a problem in 2019, it declined by more than 60 percent in the years since—all while the non-FDA-authorized ENDS market grew exponentially. FDA must recognize that adults are using these products and that their use is associated with a 10 percent decrease in cigarette units sold in America in 2023. That’s a win for public health. FDA must reform the process so we can accelerate even further declines in smoking.”

    As of June 21, the FDA had authorized more than 16,000 tobacco products—mostly cigarettes and cigars, according to Stroud. “Twenty-seven MGOs for ENDS is a depressing number and makes up less than 1 percent of authorized products,” she says. “Worse, only 49 products have been authorized by FDA using the PMTA pathway. FDA’s own budget is problematic; it’s entirely funded by user fees paid for by only six classes of tobacco products and not from e-cigarettes. There is more of an incentive to authorize the products that are paying for a $275,000 annual salary, as made by the CTP director in 2023, than authorizing products that pay nothing. While FDA has been asking Congress for years to be able to collect user fees on products including e-cigarettes, they refuse to issue orders—and instead denied tens of millions of products. That could have been a lot of fees and would have funded a significant amount of surveillance while also recognizing tobacco harm reduction. It is something the agency must recognize if the mission is to reduce smoking.”

    While optimists may detect a new willingness to approve reduced-risk products in the CTP’s recent product authorizations, few expect the regulatory floodgates to open to an avalanche of product approvals. | Photo: Tada Images

    Significant Ruling

    Smith says it is important to educate those affected by the failing 99.999 percent of all PMTA applications about the recent changes in the regulatory landscape and how those changes may lay a foundation for the significant changes necessary at the CTP.

    “The first is the recent announcement by the Supreme Court where the Chevron Deference has been overturned,” he says. “This action by the court will now require that regulatory agencies follow the letter of the law and that the regulators would now have little leeway in the interpretation of how to apply regulatory law.

    “The Chevron Deference has allowed the CTP to define the meaning of ‘appropriate for the protection of public health’ when conducting a review of the PMTAs and MRTPAs [modified-risk tobacco product applications]. Now, post-Chevron, if the Tobacco Control Act does not clearly outline the actions and process of enforcement of regulatory oversight in a manner that allows for the regulatory agency to action the law, the law will have to be amended to clarify the process, so legislators will have to work to make the law actionable … not the regulators that monitor the marketplace.”

    Second, according to Smith, the Supreme Court may review four relevant lawsuits—Triton, Magellan, Lotus and Logic. Such a review may trigger action to change the TCA. “If the court decides to hear at least one of these cases, then the likely outcome is a requirement that the TCA be clarified so that the CTP will only enforce actions defined in the TCA,” says Smith. “If the TCA isn’t clear as to how to enforce it, then the law should be amended. Depending on how the policies are modified by the legislative branch, we may see shifts in the way that CTP reviews all tobacco and nicotine products, leading to a more effective regulatory environment. However, how the legislators refine the TCA will determine if the regulatory environment improves in a manner that supports the reduced-risk product marketplace.”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Good Reads

    Good Reads

    Photo: Broughton

    The importance of literature reviews in support of tobacco harm reduction.

    By Dean Hatt

    Toxicology plays an important role in bringing next-generation products (NGPs) to market, ensuring they meet global regulatory requirements and contribute to the global body of evidence supporting tobacco harm reduction. Alongside analytical testing of the product’s aerosol, literature reviews are an important step in the toxicology human health assessment to build an understanding of the product’s performance, improve safety and ensure regulatory compliance. Here, Dean Hatt, senior toxicology consultant at scientific testing and consultancy specialist Broughton, shares insight into literature reviews for next-generation nicotine product toxicology.

    Toxicological tests help build an informed, scientifically justified understanding of the risk that NGPs present to health. This involves considering the nature of any hazards presented by an ingredient, exposure levels during normal usage, and the physical dose response, to build a risk characterization for the overall product.

    Toxicology assessments must be developed using a tailored approach to study design, data gathering, and risk assessment based on the product requirements and the proposed regulatory pathway.

    Importance of Literature Reviews

    Literature reviews are useful in two key areas of NGP development. Firstly, for hazard assessment, to gather data on specific toxicology endpoints for any chemical in the product and/or its aerosol. Hazard assessment is usually conducted relatively early in the product development process. By doing so, scientists can provide input into the sensitivity of analytical studies to establish if the identified components may be a health risk at the quantities identified.

    Literature reviews are also required as part of certain submissions, later in the product development process when completing the regulatory dossier. A thorough literature review is essential for manufacturers seeking approval via the marketing authorization application pathway to get their product approved as a nicotine-replacement therapy in the U.K. It is also necessary for those targeting premarket tobacco product application approval for consumer products in the U.S.

    Conducting a Literature Review

    A literature search for an NGP is a large body of work that can take several hundred hours to complete, depending on how wide the scope is. It encompasses assessing specific chemicals using authoritative sources or pre-agreed search terms and libraries.

    The literature search will typically involve hazard assessments for product-specific chemicals, where the scientist will look up various endpoints, e.g., carcinogenicity, genotoxicity, reproductive and developmental toxicity, irritation and sensitization from a number of sources to identify whether there is evidence that the chemical has toxicity associated with those endpoints.

    A CAS Registry Number is used as a unique identifier for a chemical, as some chemicals are referred to by different names or have different isomers. Menthol, for example, can take many forms: D menthol, L menthol, levomenthol and more.

    The researcher may also look for health-based guidance values, which demonstrate the level at which a chemical is deemed not to be of any concern. This is compared against the exposure concentration, which is derived from analytical data and estimated product consumption to quantify the risk.

    Wider Research

    When conducting wider research via a literature search as part of the regulatory application, the process will typically begin by agreeing on the search terms, such as “nicotine,” “toxicity” and “inhalation.” The researcher can then search agreed platforms, such as PubMed, PubChem and The British Library, to create a list, which often exceeds 2,000 references. The researcher will then prioritize these according to quality, recency and relevance to narrow the list down to the papers with the most appropriate information.

    If, during the literature search, a chemical is flagged for a specific toxicity, the researcher may recommend a more comprehensive assessment of that chemical, particularly if they have identified something the research team was not aware of.

    Further research may be required if there is a gap in the literature. It may be that the chemical has not been studied before or that it has not been included in any previous products due to its likely toxicity. There is also modeling (in silico) software available, such as Derek Nexus and Leadscope Model Applier, which can help predict the likelihood of a chemical structure being carcinogenic or genotoxic by comparing it against a library of other structures. This is utilized where experimental data of the chemical in question is unavailable.

    The toxicologist can also build a toxicity profile in support of product safety. This is tailored to the relevant regulatory pathway based on the existing hazard data, published scientific studies and expert body reviews. Toxicologists can also produce a quantitative risk assessment and create a comprehensive regulatory report evaluating the potential health risks associated with both individual ingredients and the whole product. These reports would be the output from the literature review and subsequent toxicology assessments.

    Due to the scale and complexity of the task, many NGP manufacturers choose to outsource their literature searches to a trusted analytical testing and integrated consulting partner. This partner can then provide swift expert toxicological advice to ensure the product is safe and compliant with relevant regulatory requirements while saving the manufacturer time and ensuring quality.

    Dean Hatt is senior toxicology consultant at Broughton.
  • The View From Down Under

    The View From Down Under

    Sometimes it seems that vaping regulations in Australia are more changeable than the weather.
    (Photos: George Gay)

    Impressions from Australia, one of the world’s most hostile countries for the nicotine business.

    By George Gay

    It is my belief that luggage is evolving at a faster rate than the travelers who use it. At least this was the main observation I made while people-watching at the end of May as I waited to complete the formalities necessary before I could board my flights from Britain to Australia via Singapore. Luggage, seemingly to suit every conceivable travel need, was being carried, dragged, rolled and even ridden by travelers, most of whom it was difficult to imagine fulfilling any need. Frankly, these travelers looked devoid of agency as they moved robotically, heads lowered, slavishly submitting to the instructions being delivered by the cell phones they wrongly believed were acting in their service.

    There was a time when it was said that people came weighed down with baggage of one sort or another, but now, it seems, luggage comes lumbered with human baggage. But for how much longer I wonder? Surely it would be more humane to cut out the middleman and woman and let the luggage, suitably AI enchanced, go traveling on its own, relaying its tourist or business experiences back to its owners safely ensconced at home. Given an AI uplift, luggage could certainly negotiate better than humans the automated bag-drop formalities at London airport and the immigration computers in Sydney. After all, it would be interacting with its own kind in a way that humans no longer do.

    Why do people travel to other countries? Is it, as I have sometimes heard, “to broaden the mind?” Perhaps this was once true, but it is looking increasingly threadbare as a reason or excuse. Nowadays, with high-speed travel the norm, flying is more likely to cause jetlag, damaging the brain and draining the mind of memory, and, in any case, all the information you need to know about far-away places is available to you while sitting at the kitchen table with a computer and a cup of coffee.

    But perhaps, as I have also heard, people travel “to get away from it all?” Well, I’ve got news for the people who think that way. Globalization and modern communications have conspired to make it impossible to get away from it all, except for the weather, if that is what you mean by “it all.” These days, people are incapable of getting away and enjoying new vistas because they are trapped within the horizons set by their phones or limited by their mental baggage.

    Once in Australia, I did try to get away from it all by reading various newspapers, but, after a while, I found myself buying each day the same paper, the Sydney Morning Herald (SMH), whose world view seemed to be aligned with the newspaper I read in the U.K., The Guardian. It was comforting, too, that the letter writers to the SMH seemed to share the same, generally caring attitudes exhibited daily in the pages of The Guardian.

    And soon I realized that not only was I reading a paper with similar views but also that the news itself was little different to what I had thought I had left behind. There were reports of housing shortages, debates about immigration and concerns about energy provision and the climate crisis and about a cost-of-living crisis that meant less money was being donated to charities. Violence against women was in the news as was a lack of care facilities for the elderly, waiting times for medical treatment, a lack of some prescription drugs, increasing cases of whooping cough, a rising need for food banks, infrastructure cost overruns and bird flu. I had left a relatively rich country where child poverty levels were scandalously high and arrived in another relatively rich country to be greeted by an advertisement for The Smith Family’s Winter Appeal in which it was stated that one in six Australian children lived with poverty.

    But it wasn’t all the same. I couldn’t help noticing, for instance, that whereas magpies in the U.K. mostly issue harsh, scolding cries, in Australia, they are more melodious. Perhaps the incidence of passive smoking among magpies is higher in the U.K., a more crowded country than Australia.

    At Singapore airport (left) there are comfortable smoking areas in the terminal, but, at Sydney, smokers and vapers are out in the cold and dark.

    Confused and Conflicted

    Australia and the U.K. have different approaches to tobacco smoking and trying to ensure the safety and health of their citizens more generally, but both approaches, in my opinion, are often confused and conflicted. Australia seems to be trying to take a comprehensive view when warning of the dangers of certain activities, so, for instance, televised public health announcements call on Australians to beat cravings, one at a time. But such announcements, like the adverts they mimic, work only if they create a craving—In this case, a craving to live a healthier lifestyle. Not all cravings are bad—some are essential for life.

    And even if the people responsible for public health announcements don’t feel they are conflicted, some of those hearing the messages might well feel that way. Announcements about the use of cameras to make sure that drivers are wearing their seat belts are no doubt well-meaning but might run into opposition from those on the libertarian wing of society. And I would imagine there will be a long debate over the calls being heard for social media health warnings.

    In Australia, with long stretches of little-used country roads, it was common while I was there to see on television public health announcements warning drivers to be careful when approaching train level crossings. But, at the same time, you can see roadside hoardings advertising beer, and it cannot but cross one’s mind that perhaps if the hoardings were taken down, there would be less need for the railway crossing safety warnings.

    Beer advertisements appear on television during the breaks in broadcasts of football games, where presenters sometimes seem blokeish to the point of caricature. But on the other hand, alcohol in Australia is not sold alongside food in supermarkets as it is in the U.K., and I guess you could argue until the cows came home what it is that normalizes drinking in the minds of the young—its connection with sport and blokeishness or its connection with supermarkets and the everyday.

    Gambling advertisements on television seem to come with their own warnings. At least one advertisement I saw ended with a written suggestion that those watching should imagine what other things money destined for gambling could be spent on. But are such warnings effective? An SMH piece by Charles Livingstone, a gambling researcher and associate professor at Monash University, seemed to suggest not and to show up the conflict of interests that abound when habits are risky to those who partake of them but profitable to those who make them available.

    “But whatever happens, the cozy relationship between gambling, sport, government and broadcasting is as solid and entrenched as it could be,” he wrote. “The damage to the community, especially young people, and to the integrity of sport appears to matter little when everyone’s pockets are full.” Everybody’s pockets but those of most of the gamblers, I presume.

    Do people understand the risks they are taking, active and passive?

    Relative Risks

    One of the visits I made in Australia was to a long-standing friend who many years ago concluded that people were evolving in the direction of becoming more stupid and who seems not to have changed his mind. Is he right, I wonder? In Queensland one day, sitting at a delightful pavement cafe just across from a beautiful beach, the driver of a large utility vehicle parked in front of the cafe, started the vehicle’s engine and then got out of the cab and proceeded to perform a few tasks, including tying down his load. Predictably, the wind off the sea wafted the diesel fumes over the diners, but nobody seemed to mind, and I wondered what level of fuss those people would have made if somebody had started to smoke or vape. Are people stupid? Some certainly don’t seem to understand risk.

    Well, certainly relative risk. But then, can you blame them? A public health broadcast on television showed a youngish man from the 1970s smoking and coughing up blood, followed by a contemporary image of a youngish man vaping and coughing up blood. The message was clear. There was no difference between smoking and vaping. The risks were the same. Are people stupid? Perhaps the question should be: Are they being encouraged to be stupid?

    Australia seems to have had and to have a strange relationship with tobacco and nicotine. The country can claim to be the birthplace of graphic warnings on tobacco products, and I saw very few people smoking or vaping while there, but tobacconists, sometimes sophisticated-looking businesses selling “smokes and vapes,” were highly visible on high streets and in malls, so I guess there is a reasonable demand for their products. These tobacconists seemed not to be overrun with customers when I looked in, however, partly, I take it, because of the significant illegal trade in tobacco and nicotine products, which was the subject of at least one television news report while I was in the country.

    One tobacconist I came across was called a Tobacco Station, and, as I understand it, after I left Australia—and with a nod to the Australian poet and journalist Banjo Paterson, perhaps—there has been movement at the station. From July 1, all nicotine vapes in Australia have been regulated as therapeutic goods, so smokers wanting to buy vapes have had to do so from pharmacies. But, from Oct. 1, those over 18 will no longer have to comply with the government’s much-criticized requirement and find a doctor willing to give them a prescription for vapes—at least those up to a maximum nicotine content of 20 mg per mL. I am sure there will be much debate about how wise such moves are—how smokers and vapers will react.

    Is there a lesson here? Has the nicotine industry helped to bring about this move? Given that it always emphasizes the uniquely therapeutic roll of vaping as providing a safer substitute for smoking, the sale of vapes in pharmacies only has a certain logic. As I have said before, it is long overdue that the industry jettisons this baggage and accepts publicly that vaping is a habit separate from, but similar to, smoking (and drinking)—one that will attract some people who have never smoked. It is a consumer product not a medicine.

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.
  • Due Diligence

    Due Diligence

    Photo: Eugene

    Testing and toxicology of heated-tobacco products

    By Malcolm Saxton

    Heated-tobacco products (HTPs) are a type of reduced-risk nicotine device that offer a similar experience to combustible cigarettes but can help reduce exposure to potentially harmful toxicants. With the pressure on manufacturers to develop safer, smoke-free alternatives, Malcolm Saxton, senior consultant, chemistry, at Broughton, shares insight into the testing and toxicology associated with HTPs.

    In combustible cigarettes, temperatures can reach up to 950 degrees Celsius. As well as liberating the nicotine, this process breaks the tobacco down to produce over 8,000 known chemicals. However, in HTPs, tobacco is not burnt—the maximum temperature is 350 degrees Celsius, providing enough heat to liberate nicotine and aroma without being high enough to result in combustion. Instead, a pyrolytic process known as torrefaction takes place, which is the same process that occurs when roasting coffee beans to release flavor.

    The absence of combustion substantially reduces the number of chemicals released, with harmful and potentially harmful constituents (HPHCs) in HTP aerosols shown to be significantly reduced from cigarette smoke. Data from the Philip Morris International Scientific Update showed a 90 percent to 95 percent reduction in the average levels of HPHCs in the aerosol of IQOS,* the leading HTP brand, compared with combustible 3R4F reference cigarettes. In addition, there is thought to be little youth appeal.

    Due to their reduced-risk profile and similarity in experience to smoking combustible cigarettes, interest in HTPs is growing, and IQOS now has around 20 million users worldwide.

    Bringing an HTP to Market

    Most countries do not have specific regulations for HTPs but regulate them in the same way as either combustible cigarettes or alternative tobacco products. In the EU and U.K., HTPs are regulated by the Tobacco Products Directive and the Tobacco and Related Products Regulations, respectively, which carry stringent requirements for testing, packaging and more.

    In the U.S., HTPs are regulated using the premarket tobacco product application (PMTA) or the modified-risk tobacco product (MRTP) process, with the PMTA being the established route to market. There are very few products that have been submitted and granted a PMTA or an MRTP from the U.S. Food and Drug Administration, which is required to make reduced-risk claims.

    To have the best chance of approval, it can be beneficial to work with a partner that offers a fully integrated service that covers product development, extractables and leachables, testing and characterization, toxicology, stability studies, and regulatory consultancy. In addition to freeing up internal capacity, outsourcing testing and toxicological assessments can help streamline the product design and regulatory application process, benefiting from the partner’s previous experience.

    Toxicological Considerations

    HTPs are intended to be a smoking cessation tool, so they must be tested to ensure a reduced toxicological risk compared with conventional combustible products. In addition, the individual toxicological risk profile should be understood to establish that new hazards are not introduced or that current ones have not increased. The first three stages of evaluating an HTP typically include: evaluating product design, testing aerosol chemistry and performing a toxicological assessment.

    The product design will vary based on the type of HTP, which can be electrically heated, carbon heated or aerosol heated. Heating mechanisms can comprise a resistive heat-blade system or may use induction heating. Product design is important in achieving an appropriate yield and aerosol cloud without increasing risk, and iterative testing can help ensure optimal design. Working with a partner who understands the intricacies of product design and how it impacts toxicological risk and regulatory approval can ensure manufacturers get it right the first time.

    The composition of the HTP aerosol will depend on the product design, including the materials in the hardware as well as the ingredients, such as flavors. Desk-based toxicology, including a literature search, can help assess whether listed ingredients and materials are associated with anything that is of high concern.

    Aerosol testing requirements vary according to the purpose of testing and the regulatory framework being followed. At the most basic, the EU and U.K. require a minimum of tar (nicotine-free dry particulate matter), nicotine and carbon monoxide. Other priority toxicant lists for cigarettes have been developed by a number of organizations, including the FDA, Health Canada and the World Health Organization Study Group on Tobacco Product Regulation. The most widely accepted list of HPHCs to test in the aerosol of HTPs, both for regulatory submission and for producing evidence of potential harm reduction, is the PMI-58, a list developed specifically by PMI to focus on analytes most relevant to IQOS and more generally HTPs.

    Analytical chemists will design a testing protocol that includes all relevant parameters for regulatory approval. For example, PMTAs typically require more data than other markets, and the testing package may need to be more rigorous as a result.

    The aerosol HPHC profile forms the basis of risk reduction characterization for various human diseases, such as cancer and respiratory disease, and can be contextualized against a combustible cigarette to establish the level of harm reduction. Exposure assessments can be generated from product-specific data by looking at how the product is used in the market or by using data from the literature.

    Compiling the relevant analytical testing and toxicological information for an HTP can be a challenging task. Working with an expert partner can make the process easier, reducing strain on resources and complementing the skills of an in-house team.

    *Afolalu EF, Langer P, Fischer K, Roulet S, Magnani P. Prevalence and patterns of tobacco and/or nicotine product use in Japan (2017) after the launch of a heated-tobacco product (IQOS): a cross-sectional study. F1000Res. 2021 Jun 25;10:504. doi: 10.12688/f1000research.52407.2. PMID: 35528952; PMCID: PMC9069173.

    Malcolm Saxton is senior consultant at Broughton.