Author: Marissa Dean

  • Bangladesh Set to Ban Vapes

    Bangladesh Set to Ban Vapes

    Image: luzitanija

    Bangladesh is set to ban vapes and nicotine pouches, according to Filter.

    The government has been considering a vape ban since 2019 when the U.S. e-cigarette or vaping product use-associated lung injury outbreak occurred—later determined to be caused by adulterated illicit products.

    The health ministry has now drafted an amendment to Bangladesh’s Smoking and Using of Tobacco Products (Control) Act, which has been reviewed by the cabinet and must now be approved by parliament.

    If the proposed ban is approved, anyone caught vaping, regardless of nicotine content, will be subject to a fine of BDT5,000 ($46). Sales, production, import, export, storage and transportation of vapes would also be banned, with penalties starting at a higher fine, three months’ incarceration or both. Larger scale activity or repeat offenses would face longer sentences.

    The amendment would also ban flavors in tobacco products, increase the fine for smoking in public places and include further penalties for unlicensed tobacco sales.

    Organizations like the Bangladesh Medical Association support the proposed ban, equating vaping with smoking cigarettes.

    “A ban on vaping devices will have disastrous consequences for people trying to quit smoking cigarettes,” said Nafis Farhan, a member of Voice of Vapers Bangladesh. He attributed continued high smoking rates in the country to “limited availability of cessation tools, such as vapes.”

    The proposed ban represents “a missed opportunity for harm reduction and a setback for public health,” according to Michael Landl, director of the World Vapers’ Alliance.

  • TIMB Raises Red Flag On ‘Bogus Association’

    TIMB Raises Red Flag On ‘Bogus Association’

    Image: yganko

    Zimbabwe’s Tobacco Industry and Marketing Board (TIMB) has called out the Golden Leaf Advisory (GLA) as a suspected “bogus association” that is not mandated to represent farmers or the tobacco regulatory board, according to The Herald.

    According to the TIMB chief executive, Emmanuel Matsvaire, “there is no relationship whatsoever” between his organization and the GLA. He urged farmers to avoid the entity.

    “We have so many complaints from farmers who have been fleeced of their money by this organization purporting to represent tobacco growers,” said Matsvaire. “The organization has no mandate either from our Ministry (of Lands, Agriculture, Fisheries, Water and Rural Development) or from the TIMB to represent the farmers.

    “It is a bogus institution that has been extorting money from farmers and other stakeholders.”

    In April, the TIMB rejected a request from GLA to meet with farmer associations and contractors before loan disbursements. “We take note of your proposal and would like to inform you that it is regrettably rejected,” the TIMB informed the GLA. “GLA is not properly registered by either TIMB of the Ministry of Lands, Agriculture, Fisheries, Water and Rural Development.”

  • A Leap Forward for Public Health?

    A Leap Forward for Public Health?

    Image: waldemarus

    China’s new rules on vape manufacturing will help tackle illicit trade only if they are properly enforced.

    By Ian M. Fearon

    The vape industry is in the midst of a growing crisis and facing an existential threat. This may seem like a pessimistic, and perhaps provocative, statement, but without those within the industry taking action to change course, the lives of the billion smokers across the globe could be placed at an increased risk.

    The vape industry has always been controversial, although wrongly so. After all, nobody in their right mind doubts that when cigarettes are substituted with e-cigarettes, there are huge gains for both individual and population health. Despite this, those in “tobacco control” have become, and will remain, steadfastly resolute in their desire to remove vapes from markets across the world. While their motives are not abundantly clear, they certainly don’t appear to mesh with a desire to improve global health and may instead represent a nicotine prohibitionist standpoint. But their work is adding to the growing likelihood that vapes could be banished across the world. Or, as is currently the case in Australia, confined to prescriptions issued by physicians and not as freely available as, well, cigarettes.

    Perhaps the biggest single threat to the vape industry is the mass marketing of both illegal and illicit products across the world. Wherever you look, in the United States and Canada, across Europe, in Australia and New Zealand, and pretty much any other global market in which vapes are sold, illegal products are abundant. They are causing problems by being made available to youth with scant regard for the impact this may have on public health and on the future of a lifesaving industry. In the U.K., recent assessments of vapor from illegal and illicit vapes have found them to contain high levels of poisonous metals, such as lead, or contain levels of nicotine higher than those allowed under U.K. regulatory law. And a recent investigation found evidence of the production of counterfeit products with inadequate manufacturing quality control and unhygienic product testing processes. The illicit trade is hugely damaging to the legitimate industry and makes the work of vape prohibitionists in tobacco control so much easier.

    One way of stemming the flow of potentially dangerous illicit products is to act at the source. China is acknowledged as the birthplace of the modern e-cigarette, following the pioneering work of the Chinese pharmacist, Hon Lik, in the early 2000s. Chinese companies are also by far the world’s biggest e-cigarette manufacturers, with production coming mainly from the estimated 1,000 factories located in China’s Silicon Valley, Shenzhen. Recent figures show that Chinese e-cigarette manufacturing is growing at record levels, with $5.5 billion worth of vapes manufactured in the country in the first half of this year, up by almost 30 percent compared with the first half of 2022. Between $300 million and $400 million worth of these are imported each month into the U.S. and the U.K., the largest export destinations for Chinese e-cigarettes. Remarkably, $20 million worth are exported each month to Australia, a marketplace in which e-cigarettes are legal only on prescription. In that country, the end result will undoubtedly be greater restrictions on vaping, perhaps even for authorized prescription products, and many other countries are considering similar actions.

    Regulating the expanse and diversity of Chinese vape manufacturing is not an easy task, but doing so would have a profound impact globally as it could make a huge dent in the supply of illicit vapes across the world. Recently, the Chinese State Tobacco Monopoly Administration (STMA) issued guidelines that may promise to clean up Chinese vape manufacturing. These guidelines are lengthy and complex but focus on a single area: the establishment of quality management systems in vape manufacturing facilities. To comply, manufacturers must, at least, implement quality and safety standards, assess and control their e-cigarette production, properly train their personnel, ensure manufacturing and distribution traceability, and complete export registrations and declarations. Products must not only be manufactured under stringent conditions, but they are also required to meet any relevant legal requirements in their export destination. And importantly, manufacturers must halt production if any safety issues arise or are brought to their attention in order to prevent and reduce harm. According to the guidelines, governments and other international organizations can report issues to Chinese authorities and have their concerns addressed.

    The biggest question on everyone’s lips has to be this one: Will the STMA guidelines be enforced—and how? If we look at the status quo, regulations elsewhere are being ignored by many manufacturers and distributors of illicit vaping products, putting profit first and public health second. In the U.S., the Food and Drug Administration issues a constant stream of warning letters threatening enforcement action. But much like the fairground game whack-a-mole, as soon as one company or vape source has action taken against it, another one takes its place. The FDA’s finite resources cannot tackle this constant evolution. In the U.K., despite the scale of the vape black market, a recent assessment of enforcement actions showed that even when action is taken against distributors of illicit and potentially dangerous vapes, local Trading Standards teams have issued fines lower in aggregate than the maximum allowed by law of £2,500 ($3,181). The situation is analogous to the illicit cigarette trade of years past in which the potential financial gains far outweighed the likely punishment.

    The question then becomes: Will the new STMA guidelines change the supply and distribution of illicit vapes, or, as has been the case in other jurisdictions, will the guidelines be weakly enforced? This concern, that the new guidelines will be meaningless and unenforced, is shared by the U.S. Smoke-Free Alternatives Trade Association (SFATA). When asked for their views on the new guidelines, SFATA President and CEO April Meyers suggested that while the new guidelines could theoretically increase the quality of vapor products coming out of China, she was unwilling to place any bets on such an outcome. Citing the scope and complexity of the political landscape in China, Meyers doubts that protecting the youth of other nations is at the top of regulators’ minds in Beijing, especially when there is so much money involved. Such a view is understandable given that the guidelines are suggesting that the Chinese government can fix enforcement issues elsewhere in the world.

    Without doubt, the new Chinese guidelines are a positive step. The guidelines recognize the public health issues regarding the manufacturing and distribution of illicit vapes and offer a potential mechanism through which this damaging illegal trade can be eroded. But without strict enforcement, and instead relying on manufacturers to interpret the guidelines, implement appropriate quality control procedures, and to self-police, the guidelines may do little to alter the current status quo.

    It’s a major irony that those companies already committed both to lawful distribution of vapor products and to the improvement of public health are facing action from regulators in the form of flavor bans and other restrictions while the illicit trade carries on regardless. The industry needs guidelines and product standards, but what it needs more than that is stricter enforcement. And stricter enforcement should include better approaches to identify and prevent illicit products from crossing borders, not just identifying them at the point of manufacture. This applies not just in China but everywhere in the world where vapor products can be sold. The existence of lifesaving consumer vapor products is at stake and, perhaps more importantly, so is public health. With the new Chinese guidelines, we are moving in the right direction. But without proper enforcement, we may carry on, in public health terms, walking backward.

    Ian M. Fearon is chief scientific officer at McKinney Regulatory Science Advisors.
  • Eyes on the Ball

    Eyes on the Ball

    Image: Maksym Yemelyanov

    Senior officials should approach COP10 with skepticism but not cynicism, with clarity about their national goals and with some tough questions about trade-offs, unintended consequences and evidence.

    By Clive Bates

    The tenth session of the Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC) will take place in Panama from Nov. 20–25, 2023. Hundreds of representatives of the 182 parties and further hundreds of observers will descend on Panama to advance the global accord on tobacco control.

    But how should an official government delegate prepare for and approach the meeting? As a former U.K. senior civil servant, I would like to offer some humble advice.

    First, delegates should be clear on their national public health and tobacco policy goals. Governments could set a wide range of objectives: to reduce disease and death, reduce smoking, reduce tobacco use, prevent addiction, achieve a nicotine-free society, focus exclusively on youth prevention, protect nonsmokers or even destroy the tobacco industry.

    Many delegates will be tempted to say, “All of the above.” That might have worked when the FCTC text was finalized in 2003, but it definitely does not work today. The reason is that there are now very significant trade-offs between these goals. For example, an effort to eliminate nicotine may mean fewer smokers switch to lower risk nicotine products, causing smoking to persist for longer and the burden of disease and death to be higher.

    An exclusive focus on youth may mean considerable additional harm to adults given that adults who smoke are at the most immediate risk of serious disease and premature death. A delegate should arrive at the COP with a strong sense of what they want the FCTC to achieve. I believe the proper public health priority should be to reduce disease and death as deeply and rapidly as possible. Setting any other goal implies that a greater toll of disease and death would be justifiable to meet some other objective. The FCTC and COP should focus on making rapid health and welfare gains, especially among disadvantaged populations—every other goal should be subordinate to that one.

    Second, delegates should approach the COP, the FCTC and the World Health Organization with considerable skepticism. Constructive skepticism will be the norm for many experienced officials, but the WHO does not welcome or expect this, especially from delegates from low-income and middle-income countries (LMICs). The WHO expects deference and to be regarded as an authority.

    However, the WHO has not earned and does not deserve the unqualified trust of delegates from its member states. Let me give three reasons why delegates should be skeptical. One: The WHO cannot be trusted to make reliable, evidence-based policy recommendations. For example, the WHO promotes the prohibition of e-cigarettes and heated-tobacco products in situations where far more dangerous smoked tobacco products are freely available and widely consumed. It promotes prohibition without evidence that it will benefit public health, without concern that it will lead to more smoking and without any apparent grasp of the likelihood of illicit trade taking over from a law-abiding supply chain. Two: The WHO cannot be trusted to tell the truth about tobacco and nicotine products. The WHO’s fact sheet on e-cigarettes is full of errors and misinformation, and the agency is unwilling to correct the record or take a balanced view. Three: The WHO is not independent but financially and institutionally compromised by funding from special interest groups. The recently published WHO Report on the Global Tobacco Epidemic 2023, is a good example. The acknowledgements on page xvii show the report was funded by the private foundation of an American billionaire and written with the assistance of many activists funded by the same foundation. Michael Bloomberg’s foundation is a substantial funder of the WHO, and  Bloomberg has been appointed as a WHO Global Ambassador for Noncommunicable Diseases. Delegates should carefully consider this funding and its influence on the WHO’s approach. Bloomberg’s policy priorities may differ from those of parties to the FCTC.

    Third, recognize that the so-called civil society representatives with observer status at the COP are not necessarily neutral guardians of the public interest. They are carefully selected activists, chosen for their allegiance to the WHO and almost always funded by foreign interests. Unlike other conventions, such as the United Nations Framework Convention on Climate Change, the FCTC is highly restrictive on which nongovernmental organizations (NGOs) are permitted as observers to the COP. Only 26 NGOs are currently accredited, and participating NGOs must be approved by the COP, provide evidence that they support the FCTC and show that they are working toward its implementation. A single NGO, now known as the Global Alliance for Tobacco Control, acts as an umbrella for smaller NGOs but only if they meet its membership criteria. The Secretariat assesses their suitability and reports to the COP.

    This severe filter on who is eligible to participate has the effect and likely the intention of excluding any critics or skeptics or even diverse views of how to achieve public health goals through tobacco policy. The selective engagement of observers and NGOs creates an echo chamber and a significant bubble of groupthink in the COP. Through pressure and public shaming, the observers attempt to punish delegates who question orthodoxy or take a more pragmatic approach to the issues under discussion. Experienced diplomats will know they are not in Panama to please unrepresentative, unaccountable, opaquely funded interest groups that are often little more than obedient mouthpieces for foreign donors.

    Fourth, take a hard look at the FCTC policy proposals under discussion at COP10. Through the advanced publication of COP documents, it is possible to see the intent of the WHO and the FCTC Secretariat reflected in the COP documents. Since it was finalized 20 years ago, the FCTC has drifted far from its original purpose: to contain and reduce the health and welfare harms primarily arising from smoking. The 2023 COP10 documents show that much of its energy is now devoted to fighting “harm reduction.” This is a legitimate public health strategy, aiming to capitalize on the rise of much safer ways to use nicotine than cigarette smoking, aiming to dramatically reduce the 8 million deaths annually attributable to smoking.

    The problem with opposing harm reduction is that it is likely to cause harm increase. Hostile strategies for novel and emerging products are evident in the documentation. For example, an anonymously authored paper by the WHO for COP10 suggests three main strategies are in use: (i) falsely denying any health or reduced-risk benefits; (ii) treating low-risk products in the same way as high-risk products for the purposes of regulation; and (iii) positioning these products as no more than a tobacco industry survival strategy while ignoring the fact that such products have been deemed appropriate for the protection of public health by the U.S. Food and Drug Administration and that command considerable support in the public health community. Other documents reveal underhand tactics. For example, in a paper on definitions, the Secretariat tries to argue that the aerosols from vaping products should be classified as “smoke,” a scientifically baseless claim. But the purpose of this maneuver is to apply provisions in the FCTC that relate to “smoke” and “smoking” to products that do not involve combustion and are smoke-free. The problem with this approach is that, in practice, it will function to protect the cigarette trade from competition from much safer alternatives, implicitly promote smoking and cause more disease and death.

    Fifth, ask the tough questions. As the physicist Richard Feynman said, “I would rather have questions that can’t be answered than answers that can’t be questioned.” That is a good way for delegates to approach COP10. Government officials should not be expected to have all the answers, but they should have the best questions. In the tobacco control field, four questions will help guide any delegate through the policy discussion. One: Who disagrees with this and why? Much of the research and evidence in this field is contested among independent experts. It is not just in dispute between the WHO and the tobacco industry. Delegates should be aware of and insist on seeing all sides of the debate. Two: What are the trade-offs? Are the needs of adult smokers being ignored? Have they considered the implications of anti-vaping measures on young people who would otherwise smoke? Three: What are the plausible unintended consequences? Will strict policies on vaping lead to increased smoking, the development of black markets or consumers starting to make their own do-it-yourself products? Four: Where is the evidence? The original idea of the FCTC was to help all countries adopt evidence-based tobacco policies that had been tried and tested. Now the WHO and the Secretariat want to use Article 2.1 of the FCTC to promote untried measures for which there is no supporting evidence.

    I hope delegates find the COP10 meeting fruitful, but constructive skepticism from senior delegates will be healthy in the longer term and help to restore the FCTC’s credibility.

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