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Category: Also in TR

  • Party Time

    Party Time

    Photo: Hanohiki

    The industry will not be present as the FCTC parties debate future tobacco and nicotine policies in Panama this autumn.

    By Taco Tuinstra

    From Nov. 20 to Nov. 25, delegates representing the countries that have signed to the Framework Convention on Tobacco Control (FCTC) will gather in Panama City to discuss tobacco and nicotine policies at the 10th Conference of the Parties (COP10). It’s an event that warrants close scrutiny because the decisions taken at the COP tend to have profound implications on the nicotine business and its customers, impacting the future of manufacturers, suppliers and tobacco growers along with stakeholders such as smokers and vapers.

    “COP is a highly influential global policy center for tobacco,” explains Flora Okereke, head of global insights and foresights at BAT. “It covers everything in the tobacco value chain from ‘seed to smoke.’” Even though the forum’s guidelines are just recommendations, many of the guidelines make it into national legislation.

    Major policies, such as plain packaging and flavor restrictions, were floated at the COP before they were adopted by leading markets. The COP also inspired the bans on industry science that have proliferated in recent years—a development that Okereke considers to be even more detrimental to the cause of tobacco harm reduction (THR) than the event’s well-established restrictions on industry engagement.

    In addition to impact at the national level, the COP also holds considerable institutional sway globally. “The FCTC is lodged not under the WHO but under the U.N., which means it has implications for trade, agriculture and finance as well,” notes Derek Yach, a global health expert who was deeply involved in the crafting of the treaty two decades ago. Through its interactions with bodies such as the World Health Organization, the World Trade Organization (WTO) and the World Bank, the COP is able to spread its tobacco control philosophies, which tend to favor prohibition over more progressive approaches.

    All this implies that the COP bears an outsized influence on the future of the nicotine business.

    So, what can the industry expect from COP10? Experts who have been following the preparations expect debates about the “tobacco endgame,” which includes nicotine reduction, retailer quotas and generational tobacco purchasing bans. They also anticipate talks on contents and emissions testing and measurements, filters and ventilation, and pricing and tax increases.

    At press time, documents had been released for discussions about extending advertising/sponsorship restrictions to corporate campaigns and newer media; supporting anti-tobacco litigation; and discouraging industry diversification into pharmaceuticals and other areas. Also on the agenda: a proposal to redefine aerosol from tobacco-heating products as smoke—a move that critics have described as an attempt to rewrite basic scientific principles.

    In addition, the COP delegates will consider recognizing tobacco control as fundamental to the right to health, clearing the way to attack the industry as a violator of human rights and subject it to additional liability. However, they will not discuss the negative impact of such an approach on smokers and tobacco farmers—two highly stigmatized groups. Participants in the Panama event will likely also debate emerging evidence on new products. Worryingly, they may push for e-cigarettes and tobacco-heating products to be regulated like combustible cigarettes, a development that critics say is not based on science and would discourage the THR that has been underway in many countries.

    Rejecting Harm Reduction

    To tobacco harm reduction proponents, the COP’s growing aversion to THR and the potential of new nicotine products is among its most disturbing characteristics. Even though FCTC Article 1(d) identifies harm reduction as a fundamental tobacco control strategy, THR has been given short shrift during the biennial conferences, with delegates pushing increasingly prohibitionist policies with each subsequent gathering.

    That attitude, says Okereke, is particularly unwarranted considering the emergence of reduced-risk alternatives to smoking. While acknowledging that the first port of call should be smoking cessation, she believes that those who do not wish to quit using nicotine deserve access to better alternatives. “Despite years of tobacco control, more than 1 billion people continue to smoke,” says Okereke. “What do we do with those people? Can we at least offer them alternatives to reduce risks? Years ago, there would have been no options. But thanks to technology, smokers now have real alternatives.”

    Yach is bothered by the inability of the COP delegates to engage in the science. “That’s a failure of imagination,” he says, especially when considering how their colleagues in medicine and other areas have embraced the concept of harm reduction. According to Yach, some of the ambassadors who negotiated the FCTC were also involved in the WTO Doha round about AIDS drug pricing at the start of the new millennium. But whereas the WTO approach was all about patents and innovation, the FCTC never mentions those words. “The people negotiating that treaty simply assumed there was no possibility for improvement in tobacco,” he says.

    Despite years of tobacco control, more than 1 billion people continue to smoke. What do we do with those people? Can we at least offer them alternatives to reduce risks? Years ago, there would have been no options. But thanks to technology, smokers now have real alternatives.

    Flora Okereke, head of global insights and foresights, BAT

    Yach suspects that the resistance to progressive policies is fueled by the fear that THR is an industry trick to sustain sales. But while there may have been legitimate concerns in the early years of THR, he says those should have evaporated as more science became available. “Once we started seeing the big shift out of combustibles and better science showing that the exposure levels [of the new products] were almost unmeasurable, one would expect change.”

    The other factor that has pushed hostility to THR, according to Yach, is the U.S. response to e-cigarettes. “The U.S. approach puts kids—even the theoretical concern about underage vaping—above the real gain to adult smokers who could benefit from new products,” he says. “This ‘kiddification’ policy became the norm internationally once the billionaire philanthropist Michael Bloomberg started pouring hundreds of millions of dollars into extending the campaign across India, Pakistan and other countries. The impact was significant. In 2019, India, one of the world’s largest tobacco markets, banned e-cigarettes, depriving some 100 million combustible cigarette smokers of safer alternatives.

    Bloomberg’s resistance to THR is puzzling given that his charitable foundation funds some of the best harm reduction programs outside of tobacco control, tackling tough issues such as HIV and drug abuse, for example. Reliable sources indicate that the foundation’s unwillingness to extend the harm reduction philosophy to tobacco control has caused divisions even within the organization, providing a sliver of hope that Bloomberg may over time become more amenable to THR.

    Resisting Engagement

    For the time being, however, the COP’s opposition to THR is likely to persist, especially in light of its reluctance to hear dissenting views. Just like the rejection of THR, the ban on industry engagement is not spelled out in the treaty. FCTC Article 5.3 instructs parties to protect public health polices from the tobacco industry’s commercial and other vested interests, but it does not prohibit discussions or engagement outright, which the framers of the treaty realized would be unworkable. “We knew at the time that such a ban was impossible in the case of the Chinese government [which operates the world’s largest tobacco conglomerate] and other countries with state monopolies,” says Yach. Yet the Secretariat took an extreme interpretation of Article 5.3., and it is the nonbinding guidelines—but not the treaty itself—that contain the words “prohibit,” “ban” and “do not involve,” according to him.

    As a result, the FCTC is the only treaty in the UN system where key stakeholders often lack the ability to share their views and insights. Whereas energy companies, including those working in fossil fuel industries, have had ample opportunity to engage during the U.N. Climate Change Conferences and share their insights into how to bring about the desired transition to green energy, the tobacco industry and the rest of the general public will be excluded from having input in Panama, just like at virtually every COP since the creation of the FCTC.

    Such exclusion is detrimental because it means the best available science on tobacco issues will not be taken on board during the COP discussions. Conducting research is expensive—often prohibitively so for noncommercial actors. The industry spends a lot of money on science, according to Okereke. “Nobody else will do that level of research except if they are paid,” she says. But if the industry pays a third party to conduct science, that work will still be treated with suspicion. “Despite industry conducting most science related to new products, COP has historically dismissed our research. Industry is also unable to communicate its findings to consumers because it is prevented from doing so.”

    This situation, says Okereke, has contributed to unhelpful misperceptions, even among specialists. For example, a recent survey commissioned by the Foundation for a Smoke-Free World found that nearly 80 percent of doctors worldwide mistakenly believe that nicotine causes lung cancer, thwarting efforts to help smokers quit with the help of less harmful products.

    Remember the Mandate

    Okereke and Yach believe COP delegates should remember their original mandate—to reduce the death and disease caused by tobacco use. Over the years, the FCTC has expanded its scope from a narrow focus on tobacco to targeting nicotine and the industry as such. This has led to bizarre positions such as opposition to diversification. “On the one hand, they want industry to move out of tobacco—yet when the industry takes steps to do that, they try to block it,” says Okereke. The ultimate objective of the FCTC, she notes, is not to increase the number of laws or to turn the screws on industry but to improve public health.

    In this context, it is telling that some of the countries with the most progressive approaches to new nicotine products have made the greatest progress. Smoking rates in Japan, the United States and Britain, for example, have fallen to record low levels without the prohibitionist measures recommended by the COP. In Japan, the slump in smoking is attributed largely to the success of heat-not-burn products while e-cigarettes are likely to have contributed to the declining popularity of traditional cigarettes in the U.S. Britain’s success in lowering smoking—by the end of 2022, prevalence had fallen to just 13.3 percent—is widely credited to that country’s progressive regulatory approach to vaping.

    By contrast, many early adopters of the FCTC that have been attending the COP for the past 17 years continue to struggle with high smoking rates. With a smoking prevalence of more than 80 percent among adult men, Jordan, which ratified the FCTC in June 2004, has the world’s highest share of male cigarette consumers, for instance.

    The moment you use the phrase ‘appropriate for the protection of public health,’ you run against the rationale given for banning involvement of the industry, which is that there is an irreconcilable difference between the tobacco industry and public health. If something is APPH, then there is no irreconcilable conflict—there is a way to reconcile it through reduced-risk products.”

    Derek Yach, global health expert

    Given the prevailing restrictions on industry engagement, THR activists hope that representatives of countries with progressive policies toward new products will share their success stories with other COP delegates, many of whom come from developing countries with particularly high smoking rates and more limited regulatory capacity. The U.K. is particularly well placed in this regard because its government has actively supported moving smokers to less harmful products. Sweden’s success in reducing smoking is also worthy of discussion at COP10; thanks to snus, smoking prevalence in Sweden is poised to dip below the 5 percent that is widely considered to be the hallmark of a smoke-free society.

    The other candidate is the U.S. Having signed the FCTC but not yet ratified it, that country is entitled to intervene during the COP discussions. “The U.S. Food and Drug Administration simply needs to highlight the products it has authorized based on the phrase ‘appropriate for the protection of the public health,’ or APPH,” says Yach. “If something is APPH in the U.S., it must be APPH everywhere. The moment you use that phrase, you run against the rationale given for banning involvement of the industry, which is that there is an irreconcilable difference between the tobacco industry and public health. If something is APPH, then there is no irreconcilable conflict—there is a way to reconcile it through reduced-risk products [RRPs].”

    Yet, while Yach believes that the U.K., the U.S. and other countries with more progressive tobacco control policies have an obligation to speak about their successes, he is not holding his breath. The demonization of the industry runs so deep, he notes, that they may hesitate to boast about the success of their accommodative regulatory frameworks.

    So, deprived of a voice, the nicotine business will be left off of the guest list again as COP delegates descend on Panama this autumn. The worst outcome of this conference, from the industry’s perspective, would be a series of prohibitionist policy recommendations, with delegates urging bans on flavors and disposable e-cigarettes, for example, along with tax structures that would make it unviable to move ahead with RRPs. Without flavors and risk-proportionate taxation, smokers will have fewer incentives to switch to smoking alternatives, and if governments ban RRPs altogether, the only product available will be the riskiest of all—the combustible cigarette.

    A better outcome would be for COP delegates to acknowledge that THR has a role to play in mitigating the health impact of tobacco use and to provide for an unbiased review of evidence related to new products. For example, an independent commission could be convened to review the scientific evidence on RRPs that has come out since the last COP, including the FDA product authorizations and the decisions of the U.K. government and others based on science.

    Though clearly concerned about what might transpire in Panama, Okereke and Yach remain optimistic about the outlook for THR in the longer term. “I believe the story we are telling is compelling,” says Okereke. “The data and the narrative support our positions. In the 10 years since BAT launched its first e-cigarette, we now count over 24 million adult consumers of less risky alternatives to smoking.” While acknowledging concerns about youth uptake and the environment, she is convinced that these issues can be addressed without resorting to prohibition and depriving smokers of such alternatives. Yach, too, sees reason to be hopeful, albeit not immediately. The data, he says, speaks for itself: “In the end—after everything else has been tried—science does win.”

    The millions of smokers looking for less harmful alternatives will be hoping that victory comes sooner than later.

    Welcome to the Party: Meet Your Hosts

    The Framework Convention on Tobacco Control (FCTC) is an international agreement established to combat the global health problems caused by tobacco use. A framework convention establishes broad commitments and leaves the setting of specific actions and targets either to subsequent more detailed agreements (usually called protocols) or to national legislation.

    The first treaty to be negotiated under the auspices of the World Health Organization, the FCTC defines tobacco control as “a range of supply demand and harm reduction strategies that aim to improve the health of population by eliminating or reducing their consumption of tobacco products and exposure to tobacco smoke.”

    The FCTC was adopted by the World Health Assembly (the highest decision-making body of the WHO) on May 21, 2003, and entered into force on Feb. 27, 2005. To date, 182 countries have signed and ratified the FCTC. Six countries have signed the convention but not ratified it; nine have done neither. This makes the FCTC one of the most widely adopted U.N. treaties.

    The Conference of the Parties is the governing body of the convention. Meeting every two years, it is the venue for discussions about the implementation of the FCTC. All countries, whether they have ratified the treaty or not, can actively participate in discussions. Countries that have ratified the convention are known as “parties.” Countries that have not ratified have observer status and may intervene during the discussions. Delegations typically comprise health officials, although other domestic departmental interests along with nongovernmental organizations and subject specialists might also attend. Past COPs have taken place in Geneva, Durban and Seoul, among other cities. The 2021 gathering took place virtually due to the Covid-19 pandemic.

    The FCTC Secretariat supports and implements the business of the COP between meetings. While in theory, this body simply administers the COP, it plays a significant role in determining the agenda of each meeting.

    The above descriptions are based on a COP10 briefing paper published by The Global State of Tobacco Harm Reduction, which is available in multiple languages. The full text of the FCTC is here.

    Taco Tuinstra is Tobacco Reporter’s editorial director. Based in Raleigh, North Carolina, USA, he coordinates the work of staff writers and contributors. On his watch, Tobacco Reporter has won several awards for editorial excellence. Since joining the magazine in 1997, Taco has visited more than 75 countries to meet industry representatives in their markets and to report tobacco news firsthand.
  • Under the Gun

    Under the Gun

    Photo: Avrora Tobacco

    Sanctions, fraud and the rising popularity of vaping weigh down Russia’s traditional tobacco market.

    Contributed

    The Russian tobacco industry is facing multiple challenges, spanning from uncertainty around the future of foreign factories in the country to flourishing illegal trade.

    In 2022, Russia manufactured 222 billion cigarettes, 7 percent down compared with the previous year, the Russian state statistical service Rosstat estimated. This dynamic partly reflects the harsh problems Russian factories encountered last year as Western sanctions disrupted logistics. On the other hand, the figures also show that the industry managed to bounce back in the second half of the year.

    In January 2022 to June 2022, Russia saw a nearly 15 percent slump in cigarette production while the steepest decline of around 25 percent was observed in May.

    There is no consensus about what the key factor was in driving Russian cigarette production down last year. Sergey Ryabukhin, first deputy chairman of the financial committee of the Federal Council, blamed a surge in sales of counterfeit tobacco products. He expressed confidence that a batch of new laws tightening regulation on the market could solve this issue.

    Indeed, independent studies showed that the share of counterfeit cigarettes on the Russian market had been steadily growing over the past few years, exceeding 12 percent in 2022. An opinion poll conducted by the think tank Ipsos revealed that as many as 49 percent of smokers would be prepared to purchase a pack of counterfeit cigarettes.

    A Booming Niche

    Not everyone, however, agrees that counterfeit is to blame for a decline in cigarette production last year. Pavel Shapkin, chairman of the National Union for consumer rights protection, links the trend with a meteoric rise in the popularity of e-cigarettes. Over the past three years, sales in this segment skyrocketed by a factor of 50, reaching 67 million pieces. Shapkin explained that Russians massively switched from conventional tobacco products to e-cigarettes.

    In 2022, Russia saw a 32 percent jump, to 16,900, in the number of stores selling vapes and e-cigarettes compared with the previous year, the Russian mapping service 2GIS calculated. E-cigarette retail has even exceeded conventional tobacco retail: In this segment, the number of outlets was estimated at 14,600, also higher than in the previous year.

    These figures, however, are about to lose their meaning soon. Conventional tobacco retailers are massively expanding their range with e-cigarettes to catch up with the trend, Anton Belyikh, general director of the DNA Realty consulting firm, explained. Selling e-cigarettes in Russia has become so profitable that players forget about the rules of fair competition and pay no attention to renting costs when launching new outlets, Belyikh said.

    It is not clear whether the rise in e-cigarette consumption hampers sales in the Russian tobacco market. The Russian Institute of public opinion surveys calculated that the number of smokers has not changed noticeably during the last five years. On average, every third respondent surveyed in the big cities identifies themself as a smoker.

    In January 2023, the Russian State Duma, the lower chamber of the federal parliament, discussed the idea of banning e-cigarettes in the country. Sergey Leonov, a member of the State Duma, shared the results of a study indicating that 99 percent of e-cigarettes and 68 percent of liquids for their refilling were not matching any quality standards. He also cited several examples of e-cigarettes exploding in the hands of consumers, causing severe injuries.

    The Russian Healthcare Ministry backed the proposal to prohibit selling e-cigarettes in the country, referring to harmful and potentially harmful ingredients that these products contain. The discussions, however, have not led to any concrete steps, and e-cigarettes are still available at virtually every shopping center in Russia.

    The PMI Izhora factory in Russia

    No Exodus

    In February 2023, BAT, which sells the Lucky Strike, Kent and Java brands in Russia, announced a decision to exit the Russian market by the end of the year. BAT’s then CEO, Jack Bowles, told the Financial Times that the timeline was not guaranteed and that finalizing the terms could be delayed until 2024.

    BAT sought to transfer control over its Russian tobacco factories to a consortium of local distributors, though certain details of the deal remain unknown. So far, only Imperial Brands has pulled out from Russia completely. In July 2022, BAT calculated that withdrawal from Russia would cost it £957 million ($1.2 billion).

    Other leading Western firms are not rushing to sever their ties with Russia. Philip Morris International (PMI) rolled out plans to quit the country in early 2022 but hasn’t done so yet. Japan Tobacco International, which accounts for 40 percent of sales in the Russian cigarette market, suspended investments but remains present in the country.

    After temporary supply disruptions in the second quarter of 2022, imports also bounced back. In the first quarter of 2023, Russia nearly doubled cigarette import to 70 million packs. Surprisingly, Germany appeared to be among the leading sources, boosting export to Russia to 42 million packs against 19 million packs in the first quarter of 2022. Bulgarian cigarette export to Russia jumped tenfold while Korea triples its sales to Russia, a Russian government agency estimated.

    The growth in imports is driven primarily by wealthy Russians, who are prepared to abandon popular brands produced in Russia in order to buy products that they consider to be of higher quality, explained Maxim Korolev, editor-in-chief of the Russian Tabaco publication. For example, the products of one of the oldest and largest tobacco factories in Germany, Von Eiken, are popular among Russians, Korolev said. South Korea, in turn, exports Esse cigarettes to the country.

    While importers ramp up export, foreign owners of Russian factories might have lost their chance to exit the country.

    The Russian government has recently seized control over the property of beer manufacturer Carlsberg and dairy firm Danone, both of which had been working to quit the country in the previous months.

    Citing local lawyers and analysts, Russian Forbes interpreted this as a beginning of a new chapter in the sanction standoff.

    Vladimir Poklad, spokesperson of the local consulting firm Delovoy Profile, told the publication that the government consolidates control over the assets of the companies willing to exit Russia to ensure the return of the Russian financial assets seized overseas.

    In 2022, the Russian government demanded foreign firms leaving the country to seek permission from a government commission on foreign investments and sell their assets at a 50 percent discount to market price. This year, this might not be enough.

    Illicit trade remains a challenge in many of the former Soviet repulbics (Photo: Segodnya)

    Investments Amid the Hostilities

    In neighboring Ukraine, sales on the domestic cigarette market plummeted by nearly 20 percent in 2022, primarily owing to unprecedented immigration as roughly 7 million fled the country. Besides, a large part of the territory is currently controlled by Russian forces, and whatever cigarette consumption exists out there, it is no longer included in the official statistical data.

    PMI used to be the largest player in the Ukrainian cigarette market. In 2020, it accounted for 29.96 percent of sales followed by BAT with 19.46 percent, JTI with 17.45 percent and Imperial Tobacco with 8.78 percent. Last year, however, the balance of power on the market supposedly changed after PMI suspended the operation of a factory in the Kharkiv region following a missile strike.

    “The damage is not critical. Production can be resumed. However, no such decision was made because the threat of further shelling remains substantial,” said Maxim Barabash, head of PMI Ukraine.

    “The production cannot be repeatedly launched and stopped depending on the situation in the region. It is technically easy to resume production. But this means putting the lives of 300 [workers to] 400 workers at great risk. And we cannot do this,” Barabash added.

    The Kharkiv factory boasted a designed production capacity of around 40 billion cigarettes. To compensate for that loss, PMI embarked on a bold project of investing $30 million into a new factory in Western Ukraine, far away from the battlefield. In August 2022, PMI started manufacturing cigarettes at an Imperial Tobacco factory in the Kyiv region.

    The new factory should manufacture 7 billion units of cigarettes per year, though there is no clarity as to when and where it is going to be launched.

    Aside from the hostilities, Ukraine keeps suffering from illegal sales. Barabash said that Ukraine annually raises the excise rate on tobacco products by 20 percent, but the losses that the national budget suffers from the illicit trade only grow. In 2022, the country lost EUR600 million ($658.8 million) in taxes to the black cigarette market. This year, the figure is expected to climb to EUR720 million.

    The only thing Ukraine needs to take down the counterfeit cigarette manufacturers is political will. Barabash said that in the EU countries, the problem primarily arises from smuggling, while in Ukraine, borders are closed now, and the illegal production comes from local underground factories and workshops “that everybody knows about.”

    It is unclear why the authorities are not cracking down on these operations, especially since this would help fill the strained national budget with money.

  • The Bigger Picture

    The Bigger Picture

    Photo: Alicia

    The FDA is fiddling with menthol and nicotine while undermining some of the most powerful tools in the tobacco harm reduction armory.

    By George Gay

    Earlier this year, the secretary general of the United Nations, Antonio Guterres, warned that the era of global warming had ended and given way to the era of “global boiling.” In other words, our world is heading for hell in a handcart, a direction of travel partly determined by our failure to see the wood for the—burning—trees. Let me elucidate using an example close to home.

    Also this year, the U.S. Food and Drug Administration turned down a marketing application for a menthol vaping product, in part on the grounds that the applicant company had failed to present “sufficient scientific evidence to show the menthol-flavored e-cigarette products provided an added benefit for adults who smoke relative to tobacco-flavored e-cigarettes.”

    I find it incongruous that, at a time of existential crisis, this issue was even partly occupying the time of one of the top scientific agencies charged with protecting public health in the world’s third most populous and, arguably, its most technically advanced state.

    Of course, it could be argued that life goes on up to the point of complete environmental breakdown, and, anyway, I cannot blame the FDA, which, I assume, is merely following orders. But the agency must take some responsibility for allowing itself to follow the now well-trodden path that has “advanced” science to the point where it is drowning in its own minutiae to the point where scientists are largely unable to step back and look at the bigger picture inhabited by people—adults who don’t need scientists to tell them whether or not menthol provides them with a benefit.

    In fairness, I should say that this phenomenon is by no means restricted to science and scientists. Those in authority are generally wading through the treacle of microeconomics and micropolitics but are seemingly unable to understand life at a street level. They—we—are fiddling while Rhodes burns.

    Nevertheless, it is the FDA that I am interested in here because it seems to be fiddling with menthol and nicotine while undermining some of the most powerful tools in the tobacco harm reduction armory and encouraging cigarettes to burn on. 

    Menthol

    In a news story dated April 28, 2022, the FDA announced it was proposing “product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars.” These actions, the agency wrote, “have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction and increasing the number of smokers … [who] quit.”

    On face value, this proposal seems to represent an important step in improving public health, but if it is, you have to ask why it has taken the FDA more than 14 years just to reach the proposal stage. In passing in 2009 the Family Smoking Prevention and Tobacco Control Act (TCA), Congress handed the FDA authority to regulate the manufacturing, marketing and distribution of tobacco products with the aim of protecting public health. The TCA, among other provisions, banned the manufacture, import or sale in the U.S. of cigarettes and roll-your-own tobacco with characterizing flavors, including mint, but it exempted menthol, thereby handing the FDA a logical absurdity—an absurdity that the FDA underlined recently when, in the announcement about its proposed menthol product standards, it described menthol as a “flavor additive with a minty taste and aroma.”

    Nevertheless, the menthol exemption wasn’t a free pass, and in 2010, the FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) was asked to review the scientific evidence concerning menthol, which it did, concluding the next year that a ban on menthol in cigarettes would benefit public health. Through the courts, the tobacco industry successfully questioned the validity of the TPSAC review, and subsequently, the FDA conducted its own evaluation of menthol cigarettes, which also concluded that such a ban would benefit public health.

    On my reading, the case against menthol is flimsy even though the FDA claimed in a summary of its Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes that consistent patterns emerged. “While there is little evidence to suggest that menthol cigarettes are more or less toxic or contribute to more disease risk to the user than nonmenthol cigarettes, adequate data suggest that menthol use is likely associated with increased smoking initiation by youth and young adults,” the FDA reported. “Further, the data indicate that menthol in cigarettes is likely associated with greater addiction. Menthol smokers show greater signs of nicotine dependence and are less likely to successfully quit smoking.”

    Leaving aside the question as to whether it is possible to quit smoking unsuccessfully, it is valid to ask whether there is enough evidence here to convict. Clearly, the FDA concedes that the presence of menthol in cigarettes does not increase the risk of smoking, and youth initiation is a policing issue. And what would a jury make of “… adequate data suggest [my emphasis] that menthol use is likely [my emphasis] associated …” and “… data indicate [my emphasis] that menthol in cigarettes is likely [my emphasis] associated ….”

    Finally, while a ban on menthol cigarettes and the FDA’s seemingly de facto ban on menthol vapes might seem to be a consistent approach, it is surely counterproductive. Since providing access to advanced vaping products is the most efficient method of getting smokers to quit, it would seem logical to assume that the best way of encouraging the smokers of menthol cigarettes to quit would be to provide them with access to menthol vapes.

    Nicotine

    Meanwhile, just over a year ago, the FDA issued a press note on reducing the addictiveness of cigarettes in which the agency’s commissioner was quoted as saying that nicotine was “powerfully addictive” and that “[m]aking cigarettes and other combusted tobacco products minimally addictive or nonaddictive would help save lives.”

    The next paragraph had it that “[a] paper published by the FDA in the New England Journal of Medicine in 2018 projected that by year 2100, a potential nicotine product standard could result in more than 33 million people not becoming regular smokers, a smoking rate of only 1.4 percent and more than 8 million fewer people dying from tobacco-related illnesses.”

    Sounds impressive? Perhaps, though “… potential nicotine product standard could …” sounds less than convincing to me, and the above should have read, I hope, “… 33 million people, who otherwise would have, not becoming regular smokers ….” But the important question you need to ask is would the number of smoking-related premature deaths fall in the period up to 2100? Let me explain.

    The second paragraph of the press note opens with the statement that has become almost de rigueur in the case of FDA communications: “Each year, 480,000 people die prematurely from a smoking-attributed disease ….” Now, 480,000, that is the same number of people who were said to have died prematurely from smoking-attributed diseases annually between 2005 and 2009.

    In 2009, the year the TCA was signed into law, the U.S. population was about 306 million, and the adult smoking rate was about 21 percent, meaning there were about 64 million smokers in the country. Currently, the population is about 334 million, and the smoking rate is about 12 percent, meaning there are about 40 million smokers. What this seems to mean is that the FDA has managed to hold the annual premature death toll from smoking-attributed diseases at 480,000 during a period when the number of smokers has fallen by more than 37 percent. That gives a whole new meaning to the word “control” in the Tobacco Control Act.

    Even if these figures are not quite as they seem to be, the question must be asked whether the FDA is on the right track. I think there are a number of reasons to suggest that it is not, but the most important is that the agency seems to favor the speculative over the obvious. For instance, if you follow one of the links from the press note, you will come to a passage titled “Where do e-cigarettes fall on the continuum of risk,” which includes a statement saying, “many studies suggest e-cigarettes and noncombustible tobacco products may be less harmful than combustible cigarettes,” a statement qualified by “[t]hough more research on both individual and population health effects is needed.”

    This is obfuscation—a two-way bet. You’ll notice the statement doesn’t spell out why this extra research is needed. And, typically, it gives no indication of how long is needed for such research. Of course scientists say more research is needed. I believe more stories are needed.

    E-cigarettes and noncombustibles clearly provide a fast-track route for many people out of smoking, and relatively harmless recreational drugs for nonsmokers, but the FDA seems intent on holding up the development of such products and their launch onto the market and even seeks to remove them from the market, especially if they even whisper the word menthol.

    Contrast this obstructive attitude to e-cigarettes with the FDA’s promotion of low-nicotine cigarettes, the consumption of which will keep smokers inhaling tar, which the agency sees as the dangerous component of tobacco smoke. Such promotion has been allowed even though the “science” of low-nicotine cigarettes and addiction seems little understood by the FDA. The press note was titled “FDA Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes and Other Combusted Tobacco Products.” Plans for proposed rule? That is one mighty qualification. It brings to mind the strapline to the movie O Brother, Where Art Thou?: “They had a plan but not a clue.”

    The heading uses the term “addictiveness,” implying there are levels of addictiveness, an idea I have always found odd. Surely, addiction implies a compulsion to do or consume something that causes harm, and there can be no degrees of compulsion. Smoking might be considered addictive, but vaping cannot because vaping does good, not harm, in allowing a smoker to quit. But the press note speaks of nicotine as being powerfully addictive even though the FDA concedes elsewhere that nicotine is not harmful while at the same time saying tobacco products are potentially minimally addictive even though the agency believes the tar from cigarettes is harmful.

    To me, the language used and the thinking behind the low-nicotine project are all over the place, and this seems to indicate that the FDA does not truly consider how its words will be received and how its plans will play out in the real world.

    Menthol and Nicotine

    Of course, those people who, in the U.S., enjoy cigarettes, menthol or not, need not be concerned that their favorite products are going to disappear from the shelves anytime soon. A June 29 news piece by the director of the FDA’s Center for Tobacco Products (CTP), Brian King, pointed out that the CTP was “in the process of finalizing [my emphasis] rules related to menthol cigarettes and flavored cigars and continues to work toward publishing a proposed [my emphasis] rule that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.”

    And the CTP has other things on its mind. It is responding to the evaluation of certain of its tobacco program operations by an independent expert panel, including by developing a new strategic plan due to be announced by the end of this year.

    To my way of thinking, the CTP needs to replot its direction of travel. It seems to have been panicked by the panel’s evaluation so that it is now doubling down on the minutiae of its operations, as if it were building a space vehicle set for a billion-light-year journey. What it should be doing, or what another agency should be doing, is thinking for itself, loosening up and adding a little common sense to the mix. It is not dealing with a space vehicle. It is supposed to be dealing with consumer products used by ordinary people as they go about their often messy lives, stressed and spooked by the idea that their world is boiling ….

    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.
  • Cracks in the Barriers

    Cracks in the Barriers

    Photo: Sashkin

    How to communicate tobacco products’ relative risks more effectively

    By Cheryl K. Olson

    As part of its new strategic plan, the U.S. Food and Drug Administration’s Center for Tobacco Products is committing to sharing “timely, clear and accessible” information. This includes communicating with adults who smoke about tobacco product relative risks.

    Last month, I highlighted dangerous tobacco-related misconceptions and groups of people in dire need of accurate relative risk information. Studies suggest we’re moving backward on accurate perceptions of nicotine harm and product relative risks. Why is this so hard to fix? Let’s look at a few examples of things that get in the way of harm reduction communication and how we might start to circumvent those barriers. 

    Knowing Does Not Equal Doing

    Health communication campaigns often measure successes in facts and attitudes. Such as, what percentage of the population of Argentina is aware that smoking causes lung cancer?

    This study, “Beyond Educating the Masses: The Role of Public Health Education in Addressing Socioeconomic[-Based] and Residence-Based Disparities in Tobacco Risk Perception,” is typical. The authors are with the Harvard School of Public Health, where I received my training in health communications. They assessed exposure to anti-smoking messages and risk perceptions of smoking. Some subgroups have lower risk perceptions? Expose them to more facts about the dangers of smoking. It’s assumed that changing risk perceptions will lead to different risk and protective behaviors and thus to improved health.

    When popular theories that underlie these messaging campaigns are rigorously tested—not just in lazy studies that ask samples of university students to report on themselves—they aren’t that great at predicting behavior in the real world. We see this in a new analysis of U.S. National Youth Tobacco Survey findings. The focus was on “How much do you think people harm themselves when they use e-cigarettes?” and e-cigarette addictiveness compared to cigarettes.

    Over six years, harm beliefs shifted in the approved direction. Researchers gave credit to campaigns such as The Real Cost and to (bogus) publicity about vaping-caused lung injury for this increased perception of risk. However, they were puzzled to find that over time, beliefs about harmfulness became less and less useful for predicting teen interest in and use of e-cigarettes.

    Arguments about the accuracy of campaign messages aside … humans don’t always change their behavior in response to facts and beliefs. Sometimes, behaviors change first, and attitudes and beliefs adapt.

    Websites that share stories of people who accidentally switched from smoking to vaping are a great example. Responses like this one upend our expectations of how people change: “I was firmly committed to smoking and didn’t care what anyone had to say about it. I was OK with dual use for convenience and ended up quitting cigs altogether without planning to.” Research studies on “smokers with no plans to quit” bear this out.

    I’m not suggesting we throw out all theory-based behavior change campaigns. But let’s incorporate more real-world experience. Why not study the factors that encourage people to try and switch to alternatives in the real world and test the effects of communications based on their stories?

    Institutional Barriers

    In a wonderful article on lessons from success and failure in risk communication from Swedish government agencies, the most entertaining examples come from campaigns gone wrong. One lesson learned: When multiple agencies communicate about a risk issue, the message must be consistent.

    This may be an impossible ask when it comes to nicotine misinformation and tobacco product relative risks. The current emphasis of government communication and regulation has been on keeping youth away from nicotine. Accumulating data show that vaping is not a gateway to smoking and that youth smoking has reached unprecedented lows. This ought to lead to rearrangement of priorities to focus attention on those at highest risk, such as older people who are longtime smokers. Because, as Kenneth Warner has put it, it is difficult to think, not feel, about tobacco harm reduction, it may be a long time before government entities can reach consensus on the facts.

    It seems possible that agencies could agree on a simple, brief message that nicotine does not cause cancer. However, as the article about Swedish government notes, the goals of a risk communication campaign affect how we measure its success or effectiveness. Do we seek to persuade and manipulate with information or to empower free agents?

    One example is this study on the “Dilemma of Correcting Nicotine Misperceptions.” The title refers to concerns that people who smoke, when informed of the true risks of nicotine, will draw the “wrong” conclusions. Instead of using nicotine-replacement therapies, they might choose to use e-cigarettes! Other well-intended researchers, when testing comparative risk messages, have fretted that such education could deter quitting or increase dual use. These are exactly the kinds of concerns that could bog down a bureaucratic entity and end with inaction. 

    Another difficulty is that issues of tobacco harm reduction don’t lend themselves well to simple slogans. A recent focus group study looked at creating effective messages about switching from cigarettes to e-cigarettes. They found that simple statements often created doubt and mistrust or even spawned new misinformation. Discussion was needed to address underlying issues, such as the health effects of nicotine.

    No agreement on core facts. No simple and clear behavioral goal (in contrast to “don’t smoke”). Traditional health message campaigns may be the wrong tool for the task of relative risk education.

    Person to Person

    A more promising approach may be person-to-person, story-based communication about tobacco harm reduction.

    Jeffrey Smith is a neuroscientist who has moved from academia to industry, and most recently to R Street, a Washington, D.C., think tank. He has learned the hard way that when it comes to nicotine and tobacco, data are almost impossible to separate from context and connotations.  

    “I was always taught, and have taught others, that science isn’t personal. It is just a conversation related to theory, methods, analyses and conclusions,” he says. “I was truly disheartened when I would approach scientists at scientific meetings and was completely ignored and shunned due to my affiliation with industry.”

    “I came into industry believing that my data are what mattered; I learned very quickly that was not the case,” he added.

    That experience shapes his views on how best to move forward with harm reduction education. He doesn’t see industry, or academics, or the national regulatory or health agencies as optimal outreach partners in the current climate. He’s an advocate of working from the grassroots up rather than the top down.

    Smith refers to the concept of “nothing about us without us,” where advocacy comes from those most directly affected by it: “That means people who have improved their health by switching to reduced-risk products, communicating that story to members of the community and with their healthcare providers.”

    “It is much more of an arduous process starting at the national level first,” he concludes. “Things can change, and change quickly, in communities.”

    Bethea (Annie) Kleykamp, a tobacco harm reduction researcher, shared her experience with peer-to-peer education. She recently started a post as assistant professor in psychiatry at the University of Maryland Baltimore School of Medicine. For decades, they have run an addiction treatment clinic focused on reducing harm for people who use opiates.

    Kleykamp found that her new colleagues, focused on overdoses, wound care, HIV and other crises, had simply lacked time for and exposure to tobacco harm reduction concepts. She was able to show how her focus on tobacco was a good fit with their existing values and approach.

    “Just talking to them. Explaining that a little over half of people in addiction treatment will actually die of tobacco-related disease,” she says. “I want the harm reduction thread to extend across all behaviors. And they hear that.”

    She is also respectful of their constraints and competing priorities. As a starting point, she’s working toward a simple change in clinic procedures to wedge in one message. “My goal, that they’re open to, is educating patients briefly about the tobacco harm continuum with a graphic,” says Kleykamp.

    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.
  • A Common Thread

    A Common Thread

    Photo: Celanese

    Filter manufacturers face higher prices and tow shortages, though not everybody has been equally affected.

    By Stefanie Rossel

    Of the roughly 5.2 trillion cigarettes consumed globally each year, 98 percent feature a filter made from cellulose acetate (CA) tow, a thermoplastic cellulose fiber with excellent absorption characteristics manufactured from dissolved wood pulp. Over the past years, suppliers of this base material faced many challenges, among them the continuous decline in global cigarette consumption since 2013, which also meant decreasing demand for tow and cigarette filters.

    Since last year, however, the situation has reversed: The market for acetate tow has tightened. In May 2022, Celanese Corp., one of the world’s leading suppliers of acetate tow products, declared force majeure on western hemisphere acetyl chain and acetate tow products because of unanticipated interruptions in raw material supply in the Texas Gulf Coast. The condition was lifted again in December. Celanese Corp. was unavailable for comment.

    In the meantime, other tow manufacturers announced price hikes. Cerdia, for example, announced a cost surcharge of $0.46 per kilogram on all acetate tow grade shipments as of March 2022.

    Christian Chavassieu

    “Last year, prices for acetate pulp went through the roof because of rising costs for wood, chemicals, labor, energy and shipping,” says Christian Chavassieu, managing partner at CelCo Cellulose Consulting in Geneva. “Manufacturers could either accept the price increase or risk a shortage.” Acetate tow suppliers also suffered from other issues, such as a lack of essential chemicals. Acetate tow is made by dissolving wood pulp in a mixture of acetic anhydride and sulfuric acid. The resulting solution is then extruded through small holes to form thin fibers, which are cut into small lengths after cooling.

    To create high-purity cellulose pulp as used in acetate tow, 95 percent to 97 percent of the cellulose content has to be extracted. Only a handful of specialized companies are capable of this process. The cellulose “bank” is the world’s biggest source of organic raw material with 700 billion tons, according to CelCo Cellulose Consulting. The overwhelming part of cellulose products manufactured every year is used to manufacture paper, packaging and tissue.

    The specialty cellulose industry, of which acetate tow manufacturers are a part, accounts for only 2.5 percent of the entire processed cellulose spectrum. “Hit with higher pulp prices, suppliers of acetate tow have been forced to pass the increase on to their customers. In its recently published second quarter results, Eastman Chemical said that prices for acetate tow went up 33 percent, leading to 32 percent higher selling prices,” says Chavassieu.

    Higher selling prices were also due to more efficient use of production facilities. “Some players, such as Eastman, have diversified their mills to produce textile fibers to improve their capacity utilization,” explains Chavassieu.

    HTPs Drive Demand

    Hyunyoung Park

    Hyunyoung Park, sales and business development manager at Taeyoung Industry Corp., a South Korea-based supplier of mono, dual and triple filters, says the scarcity of acetate tow occurred in part to an unplanned production stoppage at a leading supplier. “This trend has not ended and will continue until the balance shows stable figures,” he says.

    The increasing popularity of heated-tobacco products (HTPs), too, has contributed to the tight market, according to Robert Pye, CEO of specialty filter manufacturer Filtrona. “We see rapid double-digit growth in HTPs, which basically use different grades of tow but actually increase the amount of tow that is used in comparison with combustible cigarettes because of the filter design. It eats up the decline in demand we have seen from traditional cigarettes.”

    Pye also attributes the current challenges in the acetate tow market to the Covid-19 pandemic, which decoupled supply chains. “Before, we were all in a just-in-time sort of mode, developing strategies for our supply chains,” he says. “This has changed—we have seen people wanting to have more inventory in their supply chain. Basically, manufacturers have reduced the risk of shortage and developed a different way of managing supply chains.”

    The Russia-Ukraine conflict has left its mark too, with some supply from those locations affected. “This has definitely made the supply chain more complex,” says Pye. Like Chavassieu, he expects these developments to continue. “We’re seeing an inflationary market in acetate tow,” Pye says. “Supply is somewhat tight. It won’t continue up, but how much it comes back would be something the market would have to see. I don’t see too much change for next year.”

    Their views are reflected by another major acetate tow manufacturer, Japan-based Daicel, whose management recently forecast that the worldwide demand for cigarettes would gradually start increasing after 2026. Daicel’s management said it anticipated demand for acetate tow to remain stable or increase, driven by the proportion of demand for HTPs, which currently account for 3 percent of the global tobacco market and are expected to increase by 0.5 percent to 1 percent annually in the future.

    An increase in the length of cigarette filters to cater to consumers’ growing health awareness and an increase in filter use in countries such as Indonesia, Bangladesh and India were named as further contributing factors. Daicel expected the recent increases in raw material and fuel prices to level off soon but the demand for acetate tow to consistently exceed supply.

    Sustainable Solutions

    Robert Pye

    As a long-time global player with long-term supplier contracts, Filtrona has been unaffected by the shortages, according to Pye. “The way we had our supply chains organized allowed us to grow in double digits that year. We also supply a sustainable range of products, which helped customers in some markets.”

    Park adds that his company has noticed new requirements for a secure supply chain and sourcing stability. “Customers are benefiting from the stable supply chain network we have built up and continued during the pandemic,” he says.

    Pye notes that the shortage of cellulose acetate has been driving interest in Filtrona’s biodegradable filters, such as the Eco range of products, in more regions, predominantly around western Europe but also elsewhere. “Also, products like BiTech, a mono-segment filter produced in a single pass and offered in various ratios of tow and either paper or other nonwoven materials, thus using less acetate tow than a normal filter, were more sought after,” he says.

    While paper-based solutions have traditionally been more expensive than CA filters, the price gap has narrowed recently. “These days, the cost and capability of the nonwoven products are more interesting,” says Pye. “There are certain characteristics to the product line that make them more interesting to compete with acetate tow.”

    Excluding China, special filters account for 5 percent of the global market. Of these, Filtrona has a market share of nearly 50 percent. The remaining share is divided between smaller local players. “We see the market growing, mainly in areas where tobacco companies may want to differentiate themselves from other brands, for example, when they operate in regions with plain packaging,” says Pye. “Special filters are also becoming increasingly popular with manufacturers with a maturing customer base, i.e., when consumers are moving up from their gross domestic product, more specialty products come into these markets. India is an example of this: A few years ago, the country had very limited flavor-based products. Today, it has lots of flavors, tubes and other complex filters. The market has more specialty filters in the last two years than in the last 10 years combined.”

    Pye thinks this trend will continue. “Filtrona’s task is to bring new filter technologies into these markets,” he says. “That’s why we have a joint venture in China. The Chinese market uses all sorts of slims, such as super slims or demi slims, but not too many combined filters, and previously, there hasn’t been a market for additives either.”

    Despite the challenges, the market is quite dynamic, according to Pye, with different regions having requirements for different filters and specialty filters and even in filter supply. “We see this dynamic playing out not on a daily but on a quite regular basis, with sustainability and HTPs becoming more important,” he says. “The challenges in supply chains haven’t quite left us, so I think it’s an interesting time. As a supplier and committed partner to this industry, we’re making sure that we can help the industry move into more sustainable solutions but also ensure they get the supply because their supply chains are challenged as well.”

    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.
  • Half-Baked

    Half-Baked

    Photo: vchalup

    Germany’s comparatively high smoking rate shows that cessation-only policies are insufficient to end cigarettes.

    By Stefanie Rossel

    Alexander Nussbaum | Photo: PMI

    Germans, it appears from anecdotal experience, are a stubborn species when it comes to smoking cessation. During a recent holiday at the French Riviera, we had a heavily smoking couple from the Lower Rhine as neighbors at our resort. Out of professional interest, I asked them whether they had ever tried to quit. The husband showed me a scary-looking scar on the side of his ribcage and said, yes, he had stopped for two years after his surgery but then relapsed to smoking what looked like at least a pack per day. Quitting again was clearly not on his agenda nor on his wife’s. At the mention of less hazardous alternatives to combustible cigarettes, they gave me a skeptical look.

    That smokers like these are the rule rather than an exception confirms a survey commissioned by Philip Morris Germany (PMG) that looked at the barriers to quitting. Carried out first in 2021 and updated in 2022, the research found that last year, 51.3 percent of the 1,000 participating German adult smokers representing all age groups, genders and federal states did not want to give up smoking—only slightly less than in the first edition of the study (53.5 percent).

    The German Survey on Smoking Behavior (DEBRA), a bi-monthly representative, face-to-face household survey on the use of tobacco and alternative nicotine-delivery systems (ANDS) conducted by Heinrich Heine University Duesseldorf, measured an even lower motivation to quit smoking in Germany, relates Alexander Nussbaum, head of scientific and medical affairs at PMG. “Almost three-quarters of the nearly 19,000 smokers surveyed did not express the intention to quit smoking,” he said. “Our own survey from 2022 confirms what we already measured in 2021: More than half of German smokers do not currently express the intention to quit smoking. Even those who are motivated to quit smoking are rarely specific in their plans: Only 3 percent to 5 percent of them plan to quit in the next month.”

    At 64.4 percent, it’s particularly smokers over 65 years who are uninterested in stopping. In addition, the PMG study found, every third smoker over 50 years of age has never seriously tried to quit. There’s a pronounced correlation between motivation and actual quitting attempts; 76.4 percent of smokers who never tried to stop smoking were also unmotivated to quit.

    Motivation for smoking cessation also varied between socioeconomic groups: 64.5 percent of participants in the lowest income group said they had no intention to quit whereas in the highest income group, the figure was 43 percent. “Even among smokers with the highest educational level in our survey—‘college, university without/with degree’—almost half were not motivated to quit smoking in 2021,” said Nussbaum. “However, this proportion increased to 61 percent for smokers with the lowest educational level—i.e., ‘elementary school with/without completed apprenticeship.’ The motivation to stop smoking is not solely dependent on education. Rather, our results from 2022 show a strong correlation with income.”

    Beyond Smokers’ Reality of Life

    Depending on the sources, between 23 percent and 34 percent—that is, between 17 million and 18.9 million of the more than 83 million Germans—currently smoke. Smoking prevalence in the country is significantly higher than in other European nations. Germany, which ratified the World Health Organization’s Framework Convention on Tobacco Control (FCTC) in 2005, has repeatedly been criticized for being too lax in implementing tobacco control measures, most recently by Ruediger Krech, the WHO director for health promotion. On the occasion of the publication of the ninth WHO Report on the Global Tobacco Epidemic on July 31, 2023, Krech noted that the country’s ban on indoor smoking was inconsistent, advertisements against the harmful effects of smoking in public spaces were poorly enforced and inflation had little impact on the affordability of tobacco products.

    Whether higher prices or expanded smoking bans would significantly reduce prevalence is questionable when looking at the reasons people named for continuing to smoke, however. According to PMG’s survey, 50.1 percent of participants stated that they enjoy smoking, making this the biggest barrier to smoking cessation. That share was particularly high among older smokers (58 percent) and those with no motivation to quit (62 percent). More than half of the people surveyed had been smoking for more than 20 years, making habits and learned behavior another major barrier to quitting smoking. “Lack of discipline” was quoted as a further hindrance. Only 12 percent named “cost” (of offers or products to support quitting cigarette smoking) as keeping them from stopping smoking.

    It’s not that there weren’t any smoking cessation programs or initiatives available. Since 2014, for example, the S3 guideline, “Smoking and tobacco dependence: screening, diagnosis and treatment,” has provided healthcare professionals with recommendations on how to help smokers quit. S3 means that the guideline has undergone all elements of a systemic development, including decision and outcome analysis and assessment of the clinical relevance of scientific studies. The recommendations of the current S3 guideline include low-threshold tools such as short motivational counseling and envisage nicotine-replacement therapy (NRT) only as a last measure after education and psychotherapeutic support. The guideline advises explicitly against using e-cigarettes as a smoking cessation aid.

    “A medical smoking cessation guideline is primarily effective among smokers who are already motivated to stop smoking and who seek advice from their family doctor or pharmacist on how they can completely give up tobacco and nicotine, which is always the best option,” says Nussbaum. “However, it is also a fact that the majority of smokers in Germany are currently not motivated to quit smoking, and this is reflected in the stable or even increasing smoking rate. This in turn suggests that the measures taken to date, including the smoking cessation guideline, are missing the needs of the majority of smokers.”

    This is also evident from the fact that e-cigarettes are now used by 10 percent of smokers to wean themselves off of cigarette smoking, according to the DEBRA study. This makes vapor products the most frequently used form of cessation support in Germany, despite the fact that they are not recommended in the guideline and despite the prevailing misperceptions about comparative health risks. According to a survey by the German Federal Institute for Risk Assessment (BfR), 63.3 percent of smokers consider e-cigarettes to be at least as risky as combustible cigarettes.

    “The results [of the PMG survey] clearly show that the best measures, such as the gold standard of NRT and behavioral therapy recommended in the medical smoking cessation guideline, are of little use if they do not reach the smokers’ reality of life, for instance, because the motivation to stop smoking is lacking,” says Nussbaum. “That said, alternative nicotine products, such as e-cigarettes, heated-tobacco products or nicotine pouches, are not cessation tools but rather consumer products for adult smokers who for whatever reason are not quitting cigarette smoking.”

    Wanted: Clear Communication

    Nussbaum calls for support of measures that promote complete smoking cessation. “This includes education among medical professionals and their adequate remuneration, e.g., by health insurances, for smoking cessation treatment as well as low-threshold access to therapeutics,” he says.

    For adult smokers who would otherwise continue to smoke, alternative noncombusted nicotine products could better address their barriers and significantly reduce exposure to harmful substances from cigarette smoke as intended by the concept of harm reduction, he adds. The German government, he insists, should invest more in education campaigns to help smokers properly assess the relative risks of cigarettes versus noncombusted alternatives and make better choices than continued smoking if they do not quit nicotine use altogether.

    Nussbaum calls for a clear, unambiguous education. “For example, as in the U.K., simple-worded flyers that say: ‘The harmfulness of cigarette smoking is primarily related to the toxicants from tobacco combustion’ and: ‘Alternative nicotine products such as e-cigarettes, heated-tobacco products, or nicotine pouches are not risk-free and still contain the addictive nicotine, but, for all we know today, have considerably less potential for harm than cigarettes,’” he says.

    The sole focus on the protection of young people is obviously not having the intended effect, notes Nussbaum. On the contrary, according to the DEBRA study, cigarette smoking—by far the most harmful form of nicotine consumption—is currently rising among young people while the smoking rate among adults continues to stagnate.

    “I believe that all stakeholders in the healthcare system who are interested in differentiated risk communication have a responsibility, including the Federal Drug Commissioner and authorities such as the Federal Center for Health Education and the BfR,” he says. “The same applies to medical societies and health insurance companies—many of which, however, have not treated smoking, smoking cessation and the scientific evidence for harm reduction with the necessary focus.”

    For its study update, PMG also surveyed former smokers who had switched to e-cigarettes or tobacco-heating products. Interestingly, they cited similar barriers to quitting smoking in retrospect. “What surprised us: Many aspects, such as ‘enjoy smoking,’ ‘can’t see it through’ or ‘don’t want to cut down,’ were even more pronounced in this sample in retrospect than among current smokers,” said Nussbaum.

    “Nevertheless, they have managed to abandon cigarette smoking. We are currently investigating whether the level of information about alternative nicotine products was decisive for the switch. Overall, this shows us: Alternative nicotine products without tobacco combustion have the potential to open a pathway away from the by far most harmful form of nicotine use, cigarette smoking, for a large group of smokers with no motivation to stop smoking and with barriers such as ‘I enjoy smoking.’” Due to misperception, this potential remains largely unused, according to Nussbaum.

    U.K. Leads the Way

    To reach this base of smokers unwilling to quit, both manufacturers and regulators have a responsibility, stresses Nussbaum. “Alternatives developed by the industry must […] address the needs of the many smokers who are not motivated to quit smoking,” he says. “In addition to the development of alternative products, their regulation in comparison with cigarettes regarding tax/price, communication options, product testing in specialist shops, etc., plays a decisive role in ensuring that they are attractive to adult smokers who would otherwise continue to smoke, without attracting nonsmokers. To achieve the ideal solution of quitting all tobacco and nicotine products, NRTs remain a valid option, especially for motivated smokers willing to use them. NRTs are most effective when used in combination with behavioral therapy or adjunctive support.”

    Nussbaum points to the U.K. as an example for Germany to follow in its efforts to reduce smoking prevalence. “Alternative nicotine products are an important pillar in the strategy to curb cigarette smoking in the U.K., which is part of the FCTC. Remarkably, this is in line with the FCTC, which lists ‘harm reduction’ as one of several pillars of tobacco control,” he says.

    “At the same time, the U.K. applies a very strict regulatory framework around cigarettes. It is precisely this differentiation based on the scientifically supported differences between nicotine products—the ‘risk continuum’—that seems to account for the success of the British approach. The consequence is a very low smoking rate by international standards of just over 10 percent.”

    The U.K.’s success has also been bolstered by differentiated risk communications about alternative nicotine products and cigarettes through easily understandable messages such as “Clearing up some myths around e-cigarettes” by the U.K. Health Security Agency or the recently published fact sheet “Addressing common myths about vaping” by the U.K. public health charity Action on Smoking and Health (ASH).

    “One looks in vain for something like this from German health authorities,” laments Nussbaum.

    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 Captivating Compound

    A Captivating Compound

    The role of nicotine in tobacco harm reduction

    By Grant Churchill

    As a pharmacologist, I remain perplexed that most people, including scientists and doctors, are under the misconception that the harms of tobacco come from nicotine. Indeed, they believe that tobacco and nicotine are equivalent and that nicotine is carcinogenic. All not true. The thesis of this article is that the vast majority of the known harms of tobacco come from chemicals other than nicotine. Using the best current scientific evidence, I will first outline a few background concepts, including the scientific process, chemical terminology and a central concept of pharmacology. I will then cover the harms from tobacco and the harms from nicotine itself and compare them on a risk-benefit basis. I conclude that, based on the objective risks, nicotine is an excellent option for achieving tobacco harm reduction.

    Another common misconception is that science is a list of facts. Science is a process in which there is never absolute proof but rather a continuum of probabilities of belief. As Benjamin Disraeli said, “When the evidence changes, I change my mind, what do you do?” Therefore, if the scientific evidence changes, the conclusions of this article will also change. The experimental evidence also has degrees of strength and is often debatable and controversial, especially where results from studies using isolated chemicals on cells and animals in the lab are extrapolated to humans.

    In common parlance when we say something contains “chemicals,” it means artificial additives or synthetic compounds and comes with a negative connotation. Moreover, “organic” is taken to mean natural, no additives and “chemical-free,” which is impossible as everything is made up of chemicals, including us humans. Often, “synthetic” is associated with toxic and “natural” with harmless. From a pharmacologist’s point of view, a chemical is never given a binary classification of toxic or nontoxic but has a degree of harm related to the dose, as stated by Paracelsus that “the dose makes the poison,” which forms a central concept in pharmacology. So, stating that nicotine is toxic, in a certain sense, is very true, but so is water, as about 4 liters will kill a person. Conversely, botulinum toxin is both natural and one of the most toxic substances known, yet it is used safely at low doses for removing wrinkles. The proper question is not whether nicotine is toxic but rather: What is the exposure dose relative to the toxic dose?

    With the above as background, I now address the relationship of nicotine to tobacco through the lens of harm reduction. In terms of epidemiological data, smoked tobacco carries extensive harms in terms of cancers, lung disease and lost lives and shortened life expectancy. As a pharmacologist, it is patently obvious that tobacco, especially smoked tobacco, is not nicotine and that nicotine is not tobacco. As professor Michael Russell stated, “People smoke for nicotine, but they die from the tar.” Definitions vary, but tar is particulate matter made up of a very complicated mix of only partially known chemicals. Indeed, tobacco smoke is estimated to contain up to 7,000 chemicals, and around 100 are known toxins and/or carcinogens at exposure levels experienced by smokers.

    Most of the harmful chemicals form when tobacco burns (combustion). During combustion, tobacco provides the fuel in the form of chemicals composed mainly of linked carbon and hydrogen (akin to the chemical cellulose in wood fueling a log fire) that split apart and combine with oxygen to form carbon dioxide and dihydrogen oxide (water!). Total conversion is complete or clean combustion, but tobacco combustion is incomplete and results in carbon monoxide rather than dioxide and soot and tar, which are carbon-based chemicals created by the heat, which facilitates a process whereby the bonds that hold atoms together are rearranged to produce a bewildering complex array of new chemicals.

    One major class of chemicals in tar is polyaromatic hydrocarbons, which are large, flat molecules composed of six-membered rings (chicken wire) that insert between the stacked bases of DNA and cause errors when it replicates. Some chemicals are volatile organic compounds, such as aldehydes (formaldehyde and acetaldehyde), which are highly chemically reactive and modify DNA bases. Changes in DNA bases result in mutations, the genetic equivalent of spelling mistakes, and can cause cancer. Other harmful volatile chemicals have acute effects, such as carbon monoxide, which displaces oxygen from hemoglobin in blood.

    Some of these so-called toxic chemicals in tobacco smoke are natural metabolites produced in our bodies enzymatically, such as carbon monoxide and formaldehyde. All aldehydes are highly reactive and can be harmful, including glucose, but in low amounts, those produced or consumed are detoxified through metabolism. This further illustrates that it is not the chemical or its origin (natural or synthetic) but the dose that makes the poison. From an evolutionary perspective, we evolved consuming many toxic chemicals from our environment and have methods to detoxify and excrete these. Tobacco smoke is exceptionally harmful not due to the presence of a given chemical but crucially the dose to which a smoker is exposed.

    It seems perverse for humans to smoke, that is, to create a large and unknown mixture of chemicals through burning and then inhale them. Yet, humans have inhaled the smoke from plant material for millennia and continue to do so to get a fast rush from psychoactive drugs in them. It is interesting to examine the possible origins of this behavior. It has been suggested that this began with the use of fire to cook our food, which destroys pathogens and toxins, and the use of smoke, which preserves food from microbial spoilage. Evolutionarily, fire and smoke had health benefits over the short term (to enable us to pass on our genes through reproduction), but evolution does not select against long-term harms. We are the products of this evolutionary pressure and have a strong preference for the charred and caramelized flavors and “tobacco” notes in food and drink. Unfortunately, the desirable aromas and flavors are part of a large mixture of chemicals formed upon combustion, so with the antimicrobial chemicals also come, most unfortunately, irritants and carcinogens.

    The discussion above outlines why tobacco, particularly when burned, is harmful, but what about nicotine itself? Theoretically, nicotine could be harmful based on its chemical reactivity as carcinogens such as nitrosamines modify DNA or through pharmacological means with nicotine interacting with its biological target, the nicotinic acetylcholine receptor. Nicotine itself is unreactive, and although metabolic reactions in the body in the liver oxidize it and can make it into reactive metabolites, the dose is very low and not considered meaningful. Nicotine is commonly thought to be a carcinogen, but there is no scientific evidence supporting this. In some literature, the term “cancer promoter” has been conflated with carcinogen. In some studies, with cells in the lab, nicotine has been shown to be a cancer promoter. Promoters are compounds that stimulate cell growth and sensitize cells to chemical carcinogens that damage DNA. Any substance that enhances cell growth can potentially be a cancer promoter, such as glucose or even certain vitamins. So, while technically true in cells in culture, in intact humans, there is no evidence that this is a concern, and nicotine is not considered a carcinogen. These data illustrate a specific challenge in studying the potential effects and harms of nicotine as much of the research into the potential harms of nicotine comes from studies in cells and animals where the doses used are often very high, leading to results that are controversial and difficult to extrapolate to humans.

    Do the pharmacological effects of nicotine on the three subtypes of its receptor result in any toxicity? For acute toxicity, the lethal dose is between 60 mg and 600 mg (30 cigarettes to 300 cigarettes), with toxicity resulting from stimulation of the least sensitive subtype of receptor (neuromuscular) that is present on nerves that stimulate skeletal muscle. The most sensitive subtype are the brain receptors, which elicit the cognitive and mood effects of nicotine and have been suggested to underlie neurological developmental problems, but the data are correlative rather than causal. The third receptor subtype (ganglionic) resides in nerves controlling the “flight or fight” adrenaline response and mediates the most investigated and substantiated potentially harmful effects of nicotine per se and give rise to cardiovascular effects. For example, nicotine has been shown to increase blood pressure, heart rate and cause blood vessels to become atherosclerotic. However, the effects are not large and are currently not considered a concern except possibly for those with cardiovascular disease. Indeed, professor David Nutt has noted that the size of the effect is similar to watching a scary movie.

    The disconnect between the cellular/animal studies and human studies is not unique to nicotine and has been well documented for bacon, coffee and even vegetables. In bacon cured with nitrate salts, cooking results in the formation of nitrosamines, which are highly carcinogenic in rats but not humans because humans metabolize nitrosamines differently than rodents. In humans, there is an epidemiological risk from eating bacon, but it is far less than suggested by the rodent studies. Roasted coffee beans contain 826 volatile chemicals, and of the 21 tested, 16 are rodent carcinogens, but, paradoxically, drinking coffee has health benefits in the human population. Professor Bruce Ames’ work has shown that many chemicals from vegetables test positive in rodent carcinogenicity tests, but consuming vegetables in our diets is protective, illustrating that the results from individual chemicals at high concentrations cannot be reliably extrapolated to their effect on humans. The take-home message from these studies is that human epidemiological data are the ultimate test and trump any lab-based results, be they on DNA, cells or animals. Overall, the well-conducted studies that can separate the effects of nicotine from those of other chemicals, such as in tobacco smoke, have revealed minimal effects and harms from nicotine itself, but this area remains controversial.

    In regard to nicotine, the most informative studies are those done in humans. Somewhat ironically, the best evidence for the effects of nicotine itself come from use of a particular form of tobacco called snus. Snus is used in a packet placed between the gums and lips, and nicotine is absorbed through oral mucosal membranes. Snus is not burned nor does it contain high amounts of nitrosamines, which are carcinogens present in unburned tobacco at amounts dependent on the drying and curing process. If snus use were associated with health harms, it would be impossible to disentangle the chemical cause being nicotine or another chemical. Specifically, prevalence statistics and epidemiological data indicate that the use of snus confers a significant harm reduction benefit, which is reflected in the comparatively low levels of tobacco-related disease in Sweden when compared with the rest of Europe. The available scientific data, including long-term population studies conducted by independent bodies, demonstrates that the health risks associated with snus are considerably lower than those associated with cigarette smoking. By extension, one can infer minimal or no harm with nicotine use. But, as you might have guessed, interpretation of these data is controversial.

    To conclude, in regard to tobacco harm reduction, the question is not whether nicotine has any harm but rather how harmful is nicotine relative to tobacco. Given that tobacco smoke is exceptionally harmful, anything that can reduce smoking will have health benefits to both the individual and society. Nicotine, the chemical itself, is addictive, but from a pharmacological perspective, when used as intended through properly regulated means, the balance of evidence shows that it has minimal harm. Therefore, nicotine is an excellent means for tobacco harm reduction as it can combat smoking, the largest cause of preventable deaths worldwide.

    Grant Churchill is a professor of chemical pharmacology at the University of Oxford.
  • At Your Service

    At Your Service

    Photo: Phil McCarthy

    Tobacco Reporter’s Publisher, Elise Rasmussen, is Installed as Master of the Worshipful Company of Tobacco Pipe Makers & Tobacco Blenders.

    By David Roach

    “The best way to find yourself is to lose yourself in the service of others.”

    As the industry gathered last month in the grand setting of Vintners’ Hall in the city of London, home to the Worshipful Company of Vintners since the 1440s, I was reminded of this wise maxim from Mahatma Gandhi.

    Elise Rasmussen has built her career in the industry, whether through this publication, Tobacco Reporter, the GTNF or Women in Tobacco. Not only can she boast an impressive CV as a woman who has made it in a man’s world, but over the past 10 years, she has devoted herself to the service of others as well. Through both fellowship and philanthropy, she has played an active part in the Worshipful Company of Tobacco Pipe Makers & Tobacco Blenders, one of London’s renowned Livery Companies. 

    Elise’s installation, as only the second female master in the Livery’s 400-year history, affirmed that devotion when she swore an oath while being gowned at a meeting of the Court, the governing body of the Livery Company. 

    In addition to playing an integral role in the governance of the city of London, the Livery Company supports people in need through its charitable works, a centuries-old tradition of the Livery movement. Its members donate to the company’s Benevolent Fund, which supports a broad range of U.K.-registered charities, with a particular focus on the advancement of education, the arts, culture and heritage, the relief of those who are disadvantaged and His Majesty’s Armed Forces.

    Elise has taken on the awesome responsibility of leading this four-centuries-old institution, and it is to be admired. As Elise, and her predecessor, reminded the 150 Liverymen, Freemen and invited guests during the speeches that followed her installation lunch in the main Livery Hall, the next year will be a real test of stamina. 

    Over 100 engagements await her, promoting the work of the Livery, supporting the two affiliations it has, chairing Court meetings and performing numerous ceremonial duties. 

    Muhammad Ali once said that “service to others is the rent you pay for your room here on earth.” In Elise’s case, she will have earned a very large one by the time she hangs up her chain next June.

     

  • Learning From the Past

    Learning From the Past

    Photo: Lukas

    This year’s GFN looked at past successes and continuing challenges for tobacco harm reduction.

    By Stefanie Rossel

    “Tobacco harm reduction—the next decade” was the theme of this year’s Global Forum on Nicotine (GFN), which took place in Warsaw June 21–24, 2023. For the first time, the presentations stretched over four full days. Some 220 delegates from 40 countries attended the event, which also marked the 10th anniversary of the conference—a good time for a look back not only on the progress of and the opportunities but also on the challenges facing tobacco harm reduction (THR).

    The picture of THR currently is highly fragmented, as became clear during a workshop on global regulation. Regulatory treatment of safer nicotine products varies widely among countries. There’s Australia, where vape products are available on prescription only and just 5 percent of doctors can prescribe nicotine. By contrast, the Philippines, after a 10-year debate, last year introduced a law that treats vapes differently than tobacco products, offering nicotine users easier access to less hazardous products.

    In the European Union, there is a double layer of regulation, which relates to the harmonization of the 27 member states and the national adoption of the Tobacco Products Directive (TPD2). Trends influencing legislation include polarizing views of member states, so countries are advocating for more regulatory freedom within the EU. Mexico has banned the sale and production, but not the use, of reduced-risk products (RRPs). Kenya’s RRP taxes are so high that they constitute a de facto ban.

    For many countries, tobacco control is a relatively low priority, and smokers have been left behind in the discussion.

    GFN participants cited Australia as an example of how not to regulate vaping. Nicotine can be legally bought from pharmacies only with a prescription. This has led to a flourishing unregulated market. Ninety-two percent of Australian vapers source their e-cigarettes from the black market. To curb illicit trade, Australia plans to ban the import of all nonprescription vaping products, including those that don’t contain nicotine. Colors, flavors, volumes and nicotine content of prescription e‑cigarettes will be restricted, and packaging must be pharmaceutical-like.

    Consumers trying to get a prescription in Australia face many barriers, many of which are due to the country’s geography. Doctors have an inadequate understanding of smoking and nicotine addiction, and they must be registered as an authorized nicotine prescriber. Once they have the prescription, consumers must convince a pharmacist, who usually has limited stock, to get nicotine. While several Australian states have legalized possession of drugs, vape products are becoming an illicit product. In a survey, 81 percent of Australian vapers said that they would return to smoking if they had no access to vaping.

    Tobacco Control: A Substitute Religion

    The stigmatization of THR bears a strong resemblance to religion, according to participants in the panel discussion on science, regulation and morality. Bans are about social engineering, and the regulatory wording reveals an ideology of people who want to control others. As an example, panelists cited the imagery used to scare people off vaping (“vaping causes brain worms”).

    There is still a lot of disinformation, misinformation and misleading science, and knowledge of THR in the wider harm reduction community remains limited. And although certain debates, such as the cause of e-cigarette or vaping product use-associated lung injury (EVALI), have been settled by science, they remain a topic of discussion, a phenomenon that panelists found very frustrating.

    A panel evaluating the past 10 years of science reminded the audience that first attempts at safer products date back 30 years to 40 years, when the first heated-tobacco products (HTPs), Eclipse and Accord, hit the market. The introduction of modern HTPs in 2014 changed the landscape. Snus in Sweden has an even longer history. If this type of oral nicotine was accepted in the rest of Europe, 3 million smoking-related deaths could be avoided, the panelists pointed out.

    Thanks to advances in technology, the new generation of e-cigarettes provides safer nicotine delivery than its predecessors. As years go by, data on vaping accumulates. Recently, the Oxford Foundation confirmed there was strong evidence that e-cigarettes help people quit.

    Tobacco control advocates apply double standards to nicotine, however: In their minds, the benign nicotine in medical smoking cessation products becomes a lethal, toxic substance as soon as it leaves the pharmacy. This leads to some grotesque situations. In Austria, for example, nicotine-replacement therapies are flavored and can be sold to children from the age of 12.

    While in the 1980s and 1990s, tobacco control was about the “endgame” against cigarettes, the war has now turned against nicotine, according to GFN panelists. Countries such as Finland, for example, discuss nicotine ceilings in nicotine pouches. To convince tobacco control that their science is reliable, panelists agreed that the industry must change its communication strategies and talk about science outside of the usual places. Real-data science, which is already available, will make a big difference in the next decade, one speaker predicted. It could help drive the policy debate and improve the reputation of the tobacco industry. Industry science should be based on geographies and sales of RRPs, according to the speaker.

    Getting the Message Out

    Scientific publishing is important as it creates transparency and builds trust. According to a panel on the politics of such publishing, more than 2 million peer-reviewed articles were published in 2021. Good journals have at least two referee reports; three tend to improve the quality of the article. Rejection rates are high. Most journals have little expertise with the tobacco and nicotine industries. Scientific publishing is a massive, $28 billion-a-year industry built on the backs of volunteers. Despite the barriers to publication, the two largest tobacco companies have published more than 350 manuscripts on RRPs.

    Next to the established publications are open access journals. Their selection criteria are purely financial, as each accepted manuscript attracts a fee. While they are looking to publish as much sound science as possible, the downside is that the hurdle to becoming a publisher has dropped, and industry scientists should beware of untrustworthy, predatory journals.

    One of the critical issues regarding tobacco industry transformation is the question of whether it is reaching low-income and middle-income countries (LMICs), where around 80 percent of smokers live. Currently, RRPs barely feature in the 137 LMICs, partly due to regulatory restrictions. Twenty-six LMICs, including major markets such as Brazil, India and Argentina, ban RRPs. Many consumers are unaware of reduced-risk options, with some even believing they are more harmful than smoking. If available, RRPs are expensive and difficult to access in LMICs.

    While lumped together into a single category, LMICs in fact comprise a collection of very different countries with greatly varying consumer preferences. The World Health Organization, a declared opponent of THR, tends to enjoy considerable credibility in these regions. Other hurdles to RRPs in LMICs include the tendency of regulators to view the terms “tobacco” and “nicotine” as interchangeable and the low awareness in the medical community about the role of nicotine.  

    BAT’s introduction of modern oral nicotine in Kenya and Pakistan is an example of a promising first step and shows that products need to be designed from the point of view of the consumer.

    The Pros of Nicotine

    Tobacco control has turned its war on cigarettes into a war on nicotine, but the supposedly evil substance has a vast pharmacological potential, according to one presenter. The positive effect of nicotine in the treatment of Parkinson’s disease or schizophrenia is already known. A more recent studies revealed nicotine to be an efficient therapy for mild cognitive impairment as well.

    Other conditions, such as late life depression, also benefit from nicotine stimulation. Nicotine can help modulate aggressive behavior in autistic patients, and scientists are currently examining its efficiency in combating the loss of hearing. In the next six months, researchers will also start investigating whether nicotine could help treat the cognitive syndrome (“brain fog”) that sometimes accompanies Long Covid.

    Unfortunately, the progress of THR over the past decade, with more than 100 million people using RRPs today, has also had a less welcome effect in the form of electronic waste. The growing popularity of disposable vapes in particular has led to an increasing number of batteries and other components ending up in landfills and causing fires.

    To solve the problem, manufacturers should consider standardizing the materials in their products, looking at biodegradable components for tanks and making the batteries removable, according to GFN panelists. Retailers should offer to take back used products for recycling, and consumers, too, must take their responsibility. One panelist said he wanted to set up a study to find out what motivates people to bring back their devices and to what extent such behavior could be spurred by financial incentives.

    Stigmatize, Exclude, Silence

    So who has a stake in the THR game? Certainly, the industry should have one, one panelist argued, as it has the will and the money, which unlocks science in toxicology, behavioral research or postmarket surveillance surveys. The industry also knows how to make consumers switch quickly, and it has the scale of manufacturing and distribution to deliver these products to the biggest possible audience in a short time.

    Vulnerable communities, which represent a large percentage of smokers, appear to have no such stake, however—an equity issue that needs to be addressed. While article 5.3 of the Framework Convention on Tobacco Control, which aims to protect tobacco control policies against tobacco industry influence—does target smokers, this group remains conspicuously absent from discussions about the tobacco control process.

    Medicinal licensing of vape products was not considered a solution by panelists since many smokers don’t view their habit as a medical problem. Besides, such an approach stifles innovation, as the authorization of medicinal products takes a long time, and the resulting products are not necessarily the ones consumers want.

    Children, too, should be seen as stakeholders in the debate, according to one panelist. If they lose their parents to smoking-related death, they are traumatized, and this will influence their later relationships. That means THR is a child welfare issue, the speaker claimed, quoting a 2013 study that found that if all tobacco control policies were implemented, there would still be 523 million smokers in the world.

    A plenary discussion focused on “the tobacco control playbook” revealed the methods that tobacco control activists have been using since RRP started gaining traction years ago. Measures include attempts to delegitimize, stigmatize, silence and exclude THR proponents and people with ties to the tobacco industry, however tenuous, from smoking cessation conferences.

    Academic journals have silenced authors with research funding, however indirect, from tobacco companies. The University of Bath, which on its TobaccoTactics website keeps a running tab of people linked to the industry, has planted stories with journalists, including those it funded.

    There have been attempts at making journal editors reject papers published by grantees of the Foundation for a Smoke-Free World (FSFW), which receives funding from Philip Morris International. While in many areas of health, governments consult with consumer groups, vapers are viewed with suspicion and suspected of being on Big Tobacco’s payroll. Academics have suggested links between vapers and tobacco companies where there aren’t any.

    Those in tobacco control who think differently but don’t speak up against these methods become accomplices, according to one panelist. Tobacco control, he observed, needs people to blame. In the future, every opportunity should be taken to raise objections—for instance, to university ethics committees who fail to protect people, to journal editors and editorial boards that publish inaccurate articles and to academic institutions that receive funding for activist tobacco control work. Finding enemies is now so embedded in the tobacco control psyche that these activists have no interest in finding common ground. Nevertheless, optimism prevailed in the panel. The question, they argued, is not if but when THR will succeed.

    Achievements and Obstacles

    For THR to make progress in the future, a look at the past may be useful. In 2012, massive protest by vapers helped avert a ban on vaping in the EU. In 2014–2015, Public Health England acknowledged the relative safety of e-cigarettes, opening many eyes to the promise of vaping as a smoking cessation tool. One year later, Kenya became the first country to regulate vape products. Around this time, the split between pro-vaping and anti-vaping advocates occurred.

    In 2016, the U.S. Food and Drug Administration started regulating all nicotine products as tobacco products. This had a domino effect around the world.

    Founded in 2017, the FSFW faced strong opposition. In 2018, consumers joined a legal challenge to the EU snus ban. One year later, the Indian government banned vaping while in the U.S., misinformation about EVALI created a panic.

    New Zealand embraced vaping in 2021, and in 2022, the EU endorsed vapes as part of its Beating Cancer Plan. Around the same time, the Philippines introduced reasonable vaping regulations. In all three cases, consumer advocates played a vital role.

    This year, Quebec introduced a vape flavor ban, Australia announced a crackdown on vaping, and the U.K. launched its “swap to stop” scheme to encourage smokers to switch to e-cigarettes.

    The developments in the past decade, panelists concluded, were driven by instinct and moral concern on the policy side, which leads to prohibition. Indifference to different products is a risk. Youth use is heavily emphasized by health activists, and silence has become subordinate to the political agenda. Consumer advocacy, however, has been working in favor of THR. On a global scale, vaping is rising.

    GFN 2023 closed with an outlook on THR in the next decade. Participants in the final plenary discussion were confident that THR will happen one day—simply because things always change, RRPs are there, and there’s no going back. Education of the general public is vital to drive the debate. Children’s uptake needs to be solved, and THR proponents should remember that the debate is about more than vaping.

    More attention must be paid to THR in LMICs, particularly those that have dictatorships in which criticism means rebellion and informing consumers is impossible.

    To free themselves from their guilt from the past and be taken seriously in their claim to create a smoke-free world, tobacco companies should eventually divest their cigarette units.

    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 Growing Household

    A Growing Household

    Photos: Annick Vernimmen

    The Vandermarliere Family of Cigars is expanding.

    By Stefanie Rossel

    Cigars are a “gourmet” niche within the tobacco industry, but in the mass market cigar segment, sales keep growing. According to Statista, the global cigar revenues segment will amount to $22.43 billion this year, and the market is expected to increase at a compound annual growth rate of 4.28 percent between 2023 and 2027.

    With a revenue of $12.7 billion in 2023, the U.S. is the world’s largest market for cigars, followed by the U.K., China, Germany and Italy. One reason for the recent growth, Statista analysts say, is the fact that cigars have started gaining popularity among younger adult consumers in many countries, reversing a decades-long downward trend.

    One cigar company that has been growing in line with global market development is VCF of Zwevegem, Belgium. Founded in 1926, the family-owned business has a long tradition as a manufacturer of high-quality cigars and cigarillos. In the 1970s, VCF’s predecessor became the owner of the J. Cortes brand through the acquisition of the Belgian cigar manufacturers Neos Cigar. Chairman Guido Vandermarliere reinvented the brand, with a characteristic deep-blue packaging and select tobacco varieties.

    For many years, the company traded under the name J. Cortes, which turned the firm into a global player in the 1980s. In 2016, it took over U.S.-based Oliva Cigar Co., a family-run manufacturer of hand-rolled cigars with whom the Vandermarliere family had long-standing ties. It then brought J. Cortes and Oliva Cigars together under the umbrella of VCF—the Vandermarliere Family of Cigars.

    Today, Oliva Cigars is the parent company for all of VCF’s handmade cigars whereas J. Cortes is the overarching brand for all of the company’s machine-made products. The takeover of Oliva Cigars turned the United States into VCF’s most important market overnight. VCF now caters to more than 85 markets with both handmade and factory-made cigars.

    “Historically, France has been very important for our family, and the U.S. for the Oliva family,” says VCF CEO Fred Vandermarliere, who leads the company in the third generation. “When looking to Europe, we are strong where we have our own sales teams. This is the case in the Benelux, France, Spain, Germany and Italy.”

    Growing the Business

    VCF grows its own tobaccos to help guarantee a consistent flavor and quality.

    VCF has been expanding its sales and distribution networks in the latter two countries.

    In July 2022, VCF acquired two German cigar companies, Woermann Cigars and Wolfertz—transactions that set the stage for VCF to become one of the leading premium cigar distributors in Germany, which is one of the largest markets for non-Cuban cigars outside the U.S. In addition to selling its own brands, Woermann is also a distributor. Wolfertz, too, is a leading cigar distributor in Germany; the company has been distributing Oliva Cigars since 2010. VCF’s German cigar business, which was operated by four different German distributors before, was transferred to the new organization in January 2023.

    In June 2023, VCF announced a partnership with Cuban American cigar manufacturer EPC, under which VCF will start distributing EPC cigars in Italy.

    “In Italy, we only cover the sales part,” explains Vandermarliere. “Since the early 2000s, we have been investing in a local sales team. Germany is a different story. It’s a big cigar country, and there is no real central distribution. Entering the market there was always rather difficult, so we never really put much effort into it. That changed since Oliva and Olifant joined the family. Suddenly, we had a stronger portfolio and more leverage. It opened our mind to think about alternative solutions. We talked to all our partners, and finally Woermann and Wolfertz decided to join our family, making us stronger to survive the heavy legislation that was coming to us. Concerning sales, we are strongly convinced that keeping focus is important for the company and the sales team. Consistently hitting the same nail over and over again is in my opinion the real key to success, even though it’s not always fun.”

    New Processing Centers

    The takeover of Oliva Cigars turned the United States into VCF’s most important market overnight.

    Regarding its production facilities, VCF hasn’t been idle either. The company, which sources its tobaccos from all over the world, works in three locations: In Sri Lanka, it runs a tobacco processing factory, to which it sends all leaf tobaccos. Once processed, the leaves are sent back to Europe and made into cigars at VCF’s Belgian manufacturing plant in Handzame. Zwevegem is the company’s logistics center, where most of its cigars are packed, stamped for tax purposes and eventually distributed all over the globe.

    In the past two years, VCF’s manufacturing focus has been on hand-rolled cigars. The company invested millions of U.S. dollars in two state-of-the-art processing centers in Nicaragua for its Oliva Cigars division. Las Llantas in Condega and Las Mesitas in Esteli, situated about 40 km apart in the northwest of the central American country, became operational in December 2021 and 2022, respectively.

    The idea behind the ventures was to be able to closely monitor every step of the production so that soil, tobacco and handling reinforce each other to create a first-class product for cigar aficionados. For the same reason, VCF has also purchased farms in Nicaragua and is now growing its own tobaccos.

    “We are strong believers that’s it’s essential,” says Vandermarliere. “If you want to produce a premium cigar, it is necessary to control every part of the process. Having your own fields and growing your own tobaccos are a few of the steps that guarantee a consistent flavor and quality for now and for the future. The fields also provide a certainty of supply and have an ecological benefit. It enables you to test new seeds, new variations, working with less pesticides and water, etc. But this doesn’t exclude the collaboration with local farmers; it enforces it. We start to gain knowledge in our own fields and are then helping the independent farmers as much as possible to follow our tests when they are successful.”

    The new facilities have jointly created jobs for 1,400 local workers. The project has also boosted the local community, an important consideration in the company’s philosophy. In addition to creating the best possible working conditions for its employees, VCF has started a number of initiatives in Nicaragua, such as setting up a preschool with the Oliva Helping Hands Foundation. “Besides that, we have been doing charity for many years and all over the planet, with a focus on youth and the next generation,” says Vandermarliere. “We want people to have a chance at a better life, and it all starts with education. We have supported mobile schools in Sri Lanka and Nicaragua. There’s also the Procigar Initiative, which provides better housing for the local communities that we support every year.”

    Smaller Carbon Footprint

    On the other side of the Atlantic, VCF has reintroduced tobacco farming in Flanders, the Dutch-speaking part of Belgium. It’s another move to support the community; with its initiative, VCF hopes to revive knowledge about tobacco cultivation and the seed species that promote biodiversity in the region. But it also contributes to more sustainable production, says Vandermarliere. The main reason, he says, is to shorten the supply chain. “It is true that the crops are quite small and the Belgian soil does not grow every kind of tobacco,” says Vandermarliere. “The leaves have a specific flavor, but blended with other tobacco, you can definitely use them. Moreover, it helps us to secure our stock.” 

    Sustainability plays an essential role in the company’s strategy. In 2022, VCF received its first annual certificate from Voka, Flanders’ chamber of commerce and industry, for having eliminated 100 tons of plastic and 600,000 cardboard outer packagings from its production chain. The company also analyzed its mobility and has started switching to hybrid and electric cars. The measures were only the first in a series; in 2021, VCF signed a sustainability charter and, in consultation with Voka, set itself 20 sustainable action targets linked to the United Nations Sustainable Development Goals—all of which it achieved.

    “Sustainability has always been very important to us, even long before it became a marketing asset,” says Vandermarliere. “Everything we do, we do for the next generation(s), so there is no other way than the sustainable way. Our further plan is to make every layer of the business sustainable. It is on top of our agenda because we want people to enjoy our cigars 100 years from now. Sustainability is not only about land but also about people and the market.”

    The new plant in Nicaragua, according to Vandermarliere, is a great example of the company’s vision on sustainability: “First of all, it has a small ecological footprint. Secondly, the working conditions for our people are great. And finally, it’s such a beautiful building, which hopefully helps to ensure the lifespan of the building.”

    With more than 7,500 employees worldwide, VCF manufactures more than 450 million cigars annually. Vandermaliere says he is not expecting radical growth of the cigar market, as the premium cigar market has always been stable. His company, he adds, is a family that sells relaxation. Fittingly, Vandermarliere is similarly relaxed about the future: “In all our history, we never planned any of the great milestones. Things happen as they do, and things seem to cross our path very naturally. This is part of our long-term vision to survive. If we find families with a similar philosophy and values to whom we can bring added value and vice versa, we will consider collaborating. Indeed, a lot happened in the last five years, but it is equally possible that nothing will change in the next five years.”

    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.