Author: Marissa Dean

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    The effort to correct nicotine risk misperceptions will be a marathon rather than a sprint.

    By Stefanie Rossel

    “Nicotine contained in tobacco is highly addictive, and tobacco use is a major risk factor for cardiovascular and respiratory diseases, over 20 different types or subtypes of cancer and many other debilitating health conditions.” With phrases like this, the World Health Organization links the undisputed harms of burning and inhaling plant tissue with the ingredient smokers seek in a cigarette.

    Regardless of its form of delivery, such statements suggest, nicotine is the devil incarnate. In spreading this message, it appears, the WHO has done a good job. In a 2021 study funded by the National Cancer Institute, 83.2 percent of surveyed U.S. physicians “strongly agreed” that nicotine directly contributes to the development of cardiovascular disease. Nearly 81 percent thought it contributes to chronic obstructive pulmonary disease (COPD), and 80.5 percent associated nicotine with cancer.

    While recognizing that nicotine is responsible for the addictive nature of tobacco products, the study authors pointed out that the strongest evidence for direct causality for nicotine is for birth defects (neurodevelopment), with only limited evidence supporting causal links to cancer and cardiovascular disease and scarce data for COPD. The misperception that nicotine is responsible for smoking-related health risks, they observed, is not only common among the public but also among other healthcare professionals.

    “Correcting misperceptions should be a priority given that in 2017, the FDA [U.S. Food and Drug Administration] proposed a nicotine-centered framework that includes reducing nicotine content in cigarettes to nonaddictive levels while encouraging safer forms of nicotine use for either harm reduction (e.g., smokeless tobacco) or cessation (pharmacologic NRT [nicotine-replacement therapy]),” the study concluded.

    In product use, risk perceptions play a critical role; they can influence smokers’ decisions on whether to switch to products with lower risk profiles. The messaging is an essential part of changing misperceptions. Studies on nicotine corrective messaging have shown that it was effective in decreasing misperceptions of nicotine harm, but repeated exposure to such messaging was necessary to reduce false beliefs about nicotine and tobacco products.

    With physicians and other healthcare professionals often being the first point of call for people seeking to quit smoking, it is obvious that their misperceptions should be corrected first so that they can educate their patients and accurately convey nicotine’s relative and absolute risks.

    Carolyn Beaumont

    Carolyn Beaumont, a general practitioner (GP) from Victoria, Australia, has taken on the challenging task of educating her colleagues. Since July 1, 2024, all nicotine vapes in Australia have been regulated as therapeutic goods, which means they are available only at pharmacies to help people quit smoking or manage nicotine dependence. Currently, all buyers of nicotine vapes require a prescription from a doctor or a nurse practitioner.

    Starting Oct. 1, the rules will be somewhat relaxed. From that date, people 18 years or over will be able to purchase therapeutic vapes directly from a pharmacy without a prescription. People under 18 will still need a prescription to access vapes, where state and territory laws allow it, to ensure they get appropriate medical advice and supervision.

    The concentration of nicotine in vapes sold in pharmacies without a prescription will be limited to 20 mg per milliliter; people who require vapes with a higher concentration of nicotine will still require a prescription.

    The law requires pharmacists to consult customers of both prescription and nonprescription vapes before allowing them to make a purchase.

    Following the announcement of the new rules, several major pharmacy chains in Australia stated that they will no longer stock vapes. Beaumont is not surprised: “They simply don’t have the time, product knowledge or resources to advise customers on appropriate products and use. It is greatly complicated because any pharmacist-only product must be an approved medical product, yet there are no approved vapes in Australia. They are listed but not approved. Fortunately, there are some online pharmacies who specialize in vapes, and these will continue to operate but likely will require a script to avoid the ‘nonapproved’ issue.”

    “There is no official doctor education in Australia that adequately presents the fuller context of smoking, vaping and nicotine.”

    Enjoyment Doesn’t Feature

    Despite the hostile environment for nicotine, Beaumont says she has found that her colleagues are quite interested in the field of tobacco harm reduction (THR). “Yet, to communicate THR on a larger scale, typically via continuing medical education (CME) courses or webinars, is difficult. These generally require support from the Royal Australian College of General Practitioners (RACGP), and to date, there is no official doctor education in Australia that adequately presents the fuller context of smoking, vaping and nicotine,” she says.

    “In medical school and as a trainee GP, we were taught of the many smoking-related health and social issues. But a more nuanced understanding of working with smokers wasn’t appreciated. We all knew the ‘three A’s’ approach—ask, advise, assist—the measure of nicotine dependence—time to first cigarette—and the first line NRTs. Yet it stopped there as though magically, smokers would be motivated to quit, and this would happen within six months. If not, repeat the process ad nauseum.”

    According to Beaumont, doctors aren’t taught that some smokers like nicotine and simply want a less harmful alternative. “Enjoyment doesn’t feature in medical education,” she says. “Doctor support can truly help some people reduce their use. But it’s not enough for many heavy smokers, and they often become disengaged with the same messaging they keep hearing from doctors.”

    Beaumont is encouraged, though, that Australia’s GP College recently revised its smoking cessation guidelines and increased the recommendation of vaping from “low” to “moderate.” “I hope this will have a reasonable impact on doctors’ willingness to prescribe, or at least be open to the conversation,” she says. “I also hope this signals a greater willingness by the RACGP to support vape-related CME that is broader in scope and includes input from ‘progressives’ such as myself.”

    Beaumont first became aware of vaping as a cessation tool in 2020 when Australia was on the verge of making vapes prescription-only. “My approach was simply this: I listened to the needs of smokers and vapers,” she says. “It didn’t take long before I was convinced of [the] merits [of vaping], and also, I developed a deeper understanding of nicotine use and addiction. Compassion and health improvements were, and still are, the underlying reasons why I’ve remained involved in this field.”

    Beaumont aims to help disadvantaged groups, which are among the most affected by smoking-related death and disease. “It is simply unjust that smokers are also affected by nicotine myths, and it is getting to the point where people think that smoking is better than vaping.”

    “Like so many areas where science is contested, adherents of contrarian positions are rarely persuaded by more science or data.”

    Open Dialogue Required

    Derek Yach

    While some believe that science will correct misperceptions of nicotine, others are skeptical, pointing, for example, to the WHO’s proposal to define aerosols as smoke. Derek Yach, a global health expert originally from South Africa who played a key role in crafting the WHO’s Framework Convention on Tobacco Control, says that while some topics require more research, these gaps should not delay WHO support for THR, noting that they have not prevented the U.S. Food and Drug Administration and other government agencies from authorizing a range of reduced-risk products.

    “Like so many areas where science is contested, including vaccine benefits, climate change or even beliefs that the earth is flat, adherents of contrarian positions are rarely persuaded by more science or data,” says Yach. “Their views deeply reflect emotional, ideological and sometimes cultural views based on their life experiences. A mother whose child gets autism after a vaccine is easily convinced that vaccines are dangerous. A tobacco control advocate who experienced tobacco industry subversion of public policies keeps that view and doubts anything new coming from industry.”

    Having worked on all sides of the issue and having spoken with a wide variety of stakeholders, Yach says that there is no shortcut to finding safe spaces to not only talk honestly about the science but also examine the reasons behind the mutual suspicion. “I saw this bear fruit in the declining years of apartheid when talks about talks led to a peaceful transition of power,” says Yach. “It is possible in that setting; it must be possible in our world.”

    The Morven Dialogues, a series of meetings between U.S. public health officials and tobacco industry representatives first held in 2012, have been a modest example of what is needed, according to Yach.

    “They recently reported on their March 2024 meeting, which brought together industry with some public health leaders in the U.S.,” says Yach. “Further, I see signs of hope in a recent article by authors from public health I have long respected. They argue for dialogue between scientists in the public sector and industry—as I have—and not for boycotts and bans.”

    Without agreement on the basic scientific issues and progress on correcting disinformation, sound policies are unlikely. “A study of how change happens in public health shows that it always starts with physician acceptance of the evidence,” says Yach. “They apply that evidence to themselves, to their patients and through organized efforts to public policy. Recall that no country has ever seen a reduction in their smoking rate before it goes down in physicians. I suspect that is true regarding uptake of THR products. And that starts with doing more to have disagreeing groups talk.”

    It’s going to be an uphill struggle, though: In mid-June, the WHO in a press release expressed “grave concern over the tobacco industry’s manipulative tactics aimed at influencing healthcare providers through continuing medical education programs and thereby advancing the interests of the tobacco industry.”

    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.
  • Out of Proportion

    Out of Proportion

    A fine cigar is a basic product that is probably as “natural” as any consumer product can be. | Photo: Laurenx

    The inclusion of fine cigars in the UK generational ban proposal makes no sense.

    By George Gay

    On May 22, the then U.K. prime minister, Rishi Sunak, announced that Parliament was to be dissolved on May 30 and a general election held on July 4.1 The announcement caught even political commentators by surprise because the election could have been held any time during 2024 or January 2025. Clearly, Sunak had decided that his policies were not going to improve the circumstances of most voters, at least in the short term.

    There was certainly a note of desperation in the timing of the announcement because it meant Sunak was abandoning many of what had been referred to as his flagship policies, a move that led The Guardian newspaper to report that his legacy was looking “increasingly threadbare.”

    But it’s an ill wind and, from the point of view of certain sections of the tobacco industry, the announcement came as a relief because it meant the tobacco and vapes bill, which was being pushed through Parliament with cross-party support, was holed below the waterline. The bill contained a provision for banning tobacco sales in the U.K. to anybody born from Jan. 1, 2009, onward, a so-called generational ban.

    It seemed to say something about Sunak that he chose to scupper this policy while it had the wind in its sails, especially since, notwithstanding the timing of events, it could have been pushed through in the last days of Parliament, and given he had so emphasized his commitment to the health of the next generation. In fact, a BBC interviewer on May 24, apparently incredulous that the policy had been abandoned, asked a minister how this could have been the case, only to be told that Sunak had at least won the argument.

    But this was not true because there had been no argument, if “argument” is used to mean a debate during which different ideas are put forward and resolved in a rational manner. Speaking at a Beat the Ban lunch held in London on May 21, Simon Clark, the director of the Freedom Organization for the Right to Enjoy Smoking Tobacco (Forest), had been scathing about the way the bill was being “steamrollered” through Parliament. Following a short public consultation before Christmas, he said, the government had announced that it would not consider any submissions from groups with links to the tobacco industry, which, for instance, included Forest and even retailers. “To the best of my knowledge, that has never happened before,” he added.

    But, once again, this speaks to the makeup of Sunak, who apparently does not like to hear counter arguments and becomes tetchy when he does. So it is hardly surprising that, after the bill’s second reading, when it entered its committee stage, 16 of the 17 Members of Parliament appointed to the committee had voted for the bill, and the other was known to support it. And when it came to inviting people to give oral evidence to the committee, witnesses were almost exclusively supporters of the bill.

    The August court ruling put the FDA in a position where it could regulate as tobacco products vaping articles that contain no tobacco but not premium cigars that contain only tobacco.

    Misplaced Priorities

    Sunak’s scuppering of the bill is unlikely to be the end of the matter because it had near-universal parliamentary approval. This means that a tobacco and vapes bill is likely to be refloated in some form, so it is worthwhile looking at some of the thinking behind this initiative. Any number of stories have been written about proposed generational tobacco bans, but here I would like to consider one aspect of it that I think makes no sense: the fact that the proposed U.K. ban, in encompassing all tobacco products, seems to lack any sense of proportion, something that can be demonstrated by citing the case of fine cigars.

    At a time when, belatedly, serious health concerns are being raised in public about the consumption of alcohol, processed foods, caffeine and social media, and even about gambling and lack of sleep, why would the government’s attention be focused on something as benign as fine cigars, defined here as those cigars comprising only tobacco, water and vegetable-based gum?

    As here defined, a fine cigar is a basic product that is probably as “natural” as any consumer product can be. Fine cigars are not implicated in concerns about flavors, and they cause no problems in relation to filters, batteries and all the other tobacco/nicotine product parts implicated in environmental issues. I would guess that only a tiny minority of the U.K. population smokes fine cigars, that the proportion of such smokers is relatively stable, that fine cigar consumption raises no ethnic or gender issues and that where these products are smoked is already restricted, meaning that certain aspects of concerns about population-level harm must be minimal.

    Including an Outlier

    To examine this issue a little closer, it is instructive to look across the Atlantic at what happened in relation to fine cigars in the U.S., where they are usually referred to as premium cigars. On August 9, 2023, in response to a lawsuit filed by the Cigar Association of America, the Cigar Rights of America (CRA) and the Premium Cigar Association, Judge Amit P. Mehta, sitting in the District Court for the District of Columbia, vacated the Food and Drug Administration’s 2016-imposed deeming regulations2 in so far that they applied to premium cigars. This meant that from that date, the FDA no longer had regulatory authority over premium cigars.

    Ironically, this ruling put the FDA in a position where it could regulate as tobacco products vaping articles that contain no tobacco but not premium cigars that contain only tobacco.

    Mehta apparently decided that the FDA’s decision to regulate premium cigars was arbitrary and capricious, a damning decision given the FDA claims always to act on scientific evidence. According to Drew Perraut, the CRA’s regulatory affairs expert, speaking during a post-court-decision video conference posted on the CRA’s website, the science the CRA provided and its comment on the deeming rule were instrumental in bringing about the court ruling. The CRA, he said, presented evidence to the FDA that there was no detectable evidence of youth usage of premium cigars, along with scientific evidence from the National Institutes of Health showing there was no appreciable rise in morbidity or mortality associated with smoking premium cigars. Judge Mehta found that the FDA had not considered those scientific issues and had not responded adequately.

    It seems to me that even if the FDA does not fully accept the CRA’s evidence that smoking premium cigars does not significantly increase morbidity and mortality levels, that these products do not appeal to young people and that there is no evidence of their addictiveness, it must concede that premium cigars comprise an outlier in these areas. You can work that out on the back of an envelope.

    The danger posed by fine cigar smoking is a planetary system away from that caused by cigarette smoking.

    The Scent of Spite

    But the FDA immediately appealed Mehta’s decision, so the question arises as to why. What is the problem here? Would it not have been more efficient not to prioritize premium cigars but spend the resources of the FDA on dealing with what seems to be an already burdensome workload created by more troublesome products? Would it not have been better to allow an industry that does little harm, creates pleasure and employs a lot of people relative to its size to get on with what it does without undue interference?

    The pursuit of premium cigars looks like vindictiveness, as does the pursuit of fine cigars in the U.K. There must be a sense that the people who seek to regulate unduly and ultimately do away with premium/fine cigars cannot understand the pleasure that these products provide and for this “reason” want to get rid of them.

    Sailing back across the Atlantic, one might wonder what the U.K. Parliament’s beef with fine cigars is. Surely, even given that many parliamentarians seem in recent times to have become culturally impaired to the point of boorishness, those in government must realize that the appeal of fine cigars is a world away from that of cigarettes. They must realize that the danger posed by fine cigar smoking is a planetary system away from that caused by cigarette smoking. In fact, the world of fine cigars is close to that of fine wines because the consumption of each is not about addiction or even habit but about pleasure, fulfilment and, often, enjoying the company of like-minded people.

    A generational ban will have no immediate effect on sales of fine cigars in the U.K. because of the age profile of those who smoke them. But it will mean that, in the future, when those born after the end of 2008 are in their mid-thirties and want to consume a sophisticated product that does not addle their brains, make them fat or deprive them of sleep, they will have the devil of a job finding somebody who is willing to sell them fine cigars.

    A ban on the sales of fine cigars makes no sense. And, for similar reasons, it makes no sense when it is applied to pipe tobacco and snus. It is to be hoped that if in the U.K. the prospect of a generational tobacco sales ban is raised again, it is considered carefully and not made the subject of sledgehammer policies.

    1 The Conservative government led by Sunak was defeated at the July 4 election and replaced by a Labour government led by Prime Minister Sir Keir Starmer.

    2 The FDA was granted regulatory authority over the manufacture, distribution and marketing of tobacco products under the Tobacco Control Act of 2009, but, initially, such authority was applied only to cigarettes, roll-your-own tobacco and smokeless tobacco. In 2014, as was its right, the FDA started the process of bringing other “tobacco” products under its authority. At first, urged by the premium cigar industry, it considered exempting premium cigars but later decided not to, and all other products were the subject of its 2016 “deeming” regulations.

    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.
  • Hot Commodity

    Hot Commodity

    Photo: Taco Tuinstra

    Leaf tobacco remains in short supply.

    By Stefanie Rossel

    Ivan Genov | Photo: ITGA

    Tobacco remains a scarce commodity. Universal Leaf estimates world leaf production, excluding China, at 4.66 billion green kg in 2023, down from 4.86 billion kg in 2022. This year, the merchant expects global production to rise to 5.2 billion kg, but there are issues that might alter this forecast.

    “The undersupply of leaf tobacco remains the key global trend,” says Ivan Genov, manager of tobacco industry analysis at the International Tobacco Growers’ Association (ITGA). “Leading tobacco purchasing companies continue to report very low levels of uncommitted stock. In general, sales go very fast. In Brazil, the flue-cured Virginia (FCV) crop was almost completely sold by the end of April, which is unusual (see “The Great Scramble,” Tobacco Reporter, May 2024). In Zimbabwe, export figures from early May are up significantly from last year. Burley is also in short supply.

    “The market in Malawi, one of the key countries for the variety, opened on April 15. In the U.S., our members see strong short-term opportunities in burley. They also believe that the supply shortage will recover, but more slowly than in the past, which also means that prices should improve to meet these market shortages.”

    At least the rapid rise in production cost that has been plaguing growers in recent years appears to be leveling off in some origins. While costs remain a concern, Genov has seen positive developments in key markets. “For example, in Brazil, where cost of production for FCV and burley was going upward of 30 percent year-on-year, for the current crop that is nearly fully realized on the market, the increase is limited to single digits,” he observes. “This goes in line with global inflationary and commodity price dynamics, where it seems we are now past the highest points. This being said, the pressure on growers remains. Even though such drastic increases are tamed, the new price levels remain at the higher end.”

    At the same time, tobacco prices in most of the leading markets have gone up in 2023–2024. “Growers are positive about this dynamic, but their margins remain thin,” says Genov. “Additional efforts need to be made to increase these margins. ITGA is currently undertaking a big research effort in collecting information from influential tobacco-growing regions in finding the so-called game changers that could increase farmer productivity and improve the long-term prospects of growers.”

    More than two years into Russia’s invasion of Ukraine, other factors worrying farmers in 2023 have also eased, according to Genov. “In the early stages of the conflict, there was a real uncertainty related to agrifood commodities, especially in Africa,” he says. “The continent has a big exposure to some essential products coming from Russia and Ukraine. However, our associations in Africa have recently reported that fertilizer supply has immensely improved, and pricing has stabilized, with some reduction. Navigating complicated geopolitical pressures in the future will likely keep the situation vulnerable.”

    China Boosts Production

    Chinese tobacco production is believed to be approaching 2 billion kg. | Photo: Jingmei Zhang

    Global FCV production, excluding China, rose to an estimated 1.92 billion kg in 2023, up from 1.64 billion kg in 2022, according to Universal Leaf’s data. For 2024, the company expects a slight drop to an estimated 1.88 billion kg.

    The world’s burley production stood at an estimated 443 million kg in 2023, up from 354 million kg one year previously. Production is anticipated to increase to an estimated 447 million kg in 2024.

    Oriental production declined to 109 million kg in 2023 from 116 million kg in 2022. The volume is expected to decrease even further to 104 million kg this year.

    Dark air-cured production rose from 115 million kg in 2022 to an estimated 119 kg in 2023. However, Universal expects production to fall to 109 million kg in 2024.

    With an FCV production of 1.97 billion kg in 2023, rising to an estimated 1,971 kg in 2024, according to the ITGA, China remains the leading tobacco-cultivating country by far. In addition to its huge FCV production, the country in 2023 grew 9 million kg of burley, anticipated to increase to 10 million tons this year.

    “China is a very restrictive market,” says Genov. “Nevertheless, available data shows that production is growing—approaching 2,000 million kg. In FCV, this represents approximately half of the global market. What is more interesting is that after Covid-19, China is continuously growing tobacco imports. In 2023, the country imported over 180 million kg of tobacco. China also resumed buying U.S. FCV, which has an impact on local growers. Chinese demand is likely to remain strong based on local consumption patterns.”

    The U.S.-China trade war heavily impacted the flue-cured tobacco leaf trade. In 2019 and 2020, China imported 100,000 kg and 0 kg of FCV, respectively, from the U.S., according to TMA’s Tobacco Trade Barometer. From 2021, imports began to rise back to pre-trade war levels. By 2023, Chinese FCV imports from the U.S. reached almost 25 million kg.

    Adverse Weather

    In the most recent season, key leaf-growing markets fared very differently in terms of leaf volume, quality and prices. Brazil’s 2023–2024 crop will be at least 14 percent smaller than the country’s previous harvest, Genov points out. “The initial estimate of Afubra, the Brazilian tobacco growers’ association, was for approximately 522 million kg—475 million kg of FCV and 39 million kg of burley,” he says. “All tobacco-growing areas in South Brazil were severely affected by adverse weather conditions. So, the final quantities produced are likely to be even lower—around 460 [million kg] to 470 million kg of FCV and 35 million kg of burley.”

    Brazil’s reduced volumes were a result of excessive rains, induced by the El Nino weather phenomenon, during the growing season. Adverse climate conditions are likely to impact next year’s harvest as well. In late April and early May, Brazil’s principal tobacco-growing state, Rio Grande do Sul, suffered its worst flooding in 80 years, temporarily bringing tobacco operations to a halt and causing some farmers to lose seedlings.

    Zimbabwe, by contrast, suffered from El Nino-induced drought. “As a result, a state of disaster was declared in early April,” says Genov. “Last year’s record FCV production volume of 297 million kg is unlikely to be matched, with a level of around 250 million kg much more likely. Last year’s record crop was also marked by a reduction in the average price for tobacco, particularly bad news for small-scale growers that are faced with issues, including a high level of indebtedness. This year, pricing is better—showing a double-digit increase compared to last year.”

    In the U.S., the season was stable, observes Genov. According to the ITGA, the country produced 142.9 million kg of FCV, 29.3 million kg of burley, 16.1 million kg of fire-cured and 5.5 million kg of dark air-cured tobacco as well as 2.3 million kg of cigar filler in 2023. “Market conditions will continue to weaken for dark-fired tobacco due to the growing pouch market,” predicts Genov. “Stronger short-term opportunities exist for burley. Separately, U.S. growers expect to be positioned well to benefit from company ESG activities as their tobacco is regarded as very high quality and does not suffer from sustainability-related issues present in other markets. However, alternative crops are offering greater opportunities for growers, and the continuation of tobacco farming is a real issue.”

    African Upswing

    Malawi, the world’s leading producer of burley, sold 120.5 million kg of leaf tobacco in 2023 against 85 million in the previous year. | Photo: Taco Tuinstra

    Malawi, the world’s leading producer of burley, sold 120.5 million kg of leaf tobacco in 2023 against 85 million in the previous year. Burley accounted for 103 million kg of this figure. “Average pricing was up to $2.35 per kilogram compared to $2.14 per kilogram in the year before,” says Genov. “Big global demand for burley against a short supply in recent years pushed up demand and therefore competition on the market. Entry of two more buying companies further increased the competition. The recently started 2024 season so far offers better prices to growers. Ten days after the start of sales, average burley prices exceed $2.60 per kilogram.”

    A remarkable jump in leaf production took place in Tanzania, where yield was increased from around 60 million kg in 2022 to 122 million kg in 2023. As of December 2022, Tanzania had earned $316 million from tobacco exports. According to local press reports, the country aims to sell $400 million this season. Tanzania’s recent production figures make it Africa’s second-largest producer after Zimbabwe and ahead of Malawi, Mozambique (65.8 million kg), Zambia (44 million kg; also see “Brand Zambia,” page 30) and Uganda (13 million kg).

    “The importance of Tanzania in the global leaf market is growing significantly,” Genov explains. “The country’s minister of agriculture, Husein Bashe, recently noted that for the 2024–2025 season, they are optimistic to reach 200 million kg against the target of 300 million kg by 2025–2026. He targets the No. 1 producer place in Africa, so Tanzania’s ambitions are now well known.”

    And it’s not just leaf traders who are keeping an eye on Tanzania. In February 2024, Philip Morris International announced that it would build a cigarette factory in Morogoro and buy at least 12 million kg of Tanzanian tobacco annually over the next five years. The company has not purchased leaf from Tanzania since 2017. Operations are expected to commence toward the end of this year.

    Genov emphasizes significance of growers to the supply chain and industry. “Often neglected, their role remains absolutely pivotal,” he says. “ITGA is working hard to defend the legitimate interests of tobacco growers, and we are actively supporting them to ensure the long-term survival of rural communities around the world.”

    One example of ITGA’s efforts was to prepare its members for the EU Corporate Sustainability Due Diligence Directive (see “Diluted Diligence,” Tobacco Reporter, June 2024), which was adopted by the European Parliament on April 24. “The directive will require the whole tobacco supply chain to address human rights and environmental concerns,” says Genov. “We conducted a survey among participants in our last year’s annual meeting focusing on the directive. A lot of them were worried about the necessary transformation that would lead to more pressure on them. Nevertheless, half of the participants have already taken proactive measures in preparation for it while only a quarter have not, showing that more adjustments will have to be made. Undoubtedly, making the entire process more transparent will have positive effects.”

    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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.