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  • EPA Ruling Threatens FDA’s Tobacco Plans

    EPA Ruling Threatens FDA’s Tobacco Plans

    Photo: renaschild

    The U.S. Supreme Court’s recent decision to block the Environmental Protection Agency from curbing power-plant emissions also threatens the Food and Drug Administration’s attempts to limit nicotine and ban menthol in cigarettes, according to an article published by Bloomberg Law.

    In their ruling, the Supreme Court judges endorsed a legal approach that requires agencies to obtain Congressional approval to address issues of major financial or political importance in novel ways. The court’s conservative members have lamented the power agencies have to create and enforce their own rules.

    According to Lindsay Wiley, a professor at UCLA School of Law, the decision will be considered in any situation where an administrative agency is trying to solve a problem using authority given to it by Congress in more general terms.

    In the case of tobacco, the FDA will face greater pressure to prove it is authorized by Congress to propose its draft ban on menthol in cigarettes and cigars and other major rule changes, according to Marc Scheineson, a former FDA commissioner.

    While the Tobacco Control Act gives the FDA the authority to adopt product standards—including on the content of cigarettes—through notice and comment rulemaking, legal experts believe the June 30 court ruling will embolden tobacco manufacturers to challenge the menthol ban and other policies once they are finalized.

    “It definitely provides a roadmap that the industry will follow trying to attack the menthol regulation with everything they can come up with,” said Joelle Lester, director of commercial tobacco control programs at the Mitchell Hamline School of Law’s Public Health Law Center.

  • RJR Vaping Technology Claims Invalidated

    RJR Vaping Technology Claims Invalidated

    Photo: utah51

    A U.S. administrative tribunal has invalidated two claims in a R.J. Reynolds vaping patent, reports Law360.

    The Patent Trial and Appeal Board said on June 30 that two claims in U.S. Patent No. 9,814,268, which covers “a tobacco-containing, electrically-powered smoking article” designed to burn a minimal amount of tobacco, can’t stand because they are obvious in light of previous e-cigarette patents.

    The ruling represents a second win for Philip Morris Products after a Virginia federal jury awarded it more than $10 million last month in drawn-out clash between the tobacco giants.

  • Court Tosses Punitive Award Against PM

    Court Tosses Punitive Award Against PM

    Photo: burdun

    A U.S. federal appeals court tossed out a $9 million punitive-damages award awarded by a lower court against Philip Morris USA in a case filed by a woman who suffered a smoking-related illness that led to her legs being amputated, reports The Free Press.

    Donna Brown filed the lawsuit in 2007 in the federal Middle District of Florida, and a jury sided with her on claims for strict liability, negligence, fraudulent concealment and conspiracy to fraudulently conceal. It awarded Brown nearly $8.29 million in compensatory damages and $9 million in punitive damages.

    In its appeal, Philip Morris pointed to a recent Florida Supreme Court opinion that said plaintiffs must show that they relied on misleading information from cigarette makers to prevail on claims for fraudulent concealment and conspiracy to fraudulently conceal.

    In its June 30 ruling, the 11th U.S. Circuit Court of Appeals said Brown had presented “insufficient evidence” to show that she relied on specific false or misleading statements by the company.

    The Atlanta-based court overturned the verdicts on the fraud-related claims but upheld the verdicts against the cigarette maker on strict liability and negligence.

    The lawsuit was one of thousands of cases filed against tobacco companies after a 2006 Florida Supreme Court decision established critical findings about issues such as the dangers of smoking and misrepresentation by cigarette makers. Those lawsuits are known as Engle Progeny cases.

  • Report Supports Vaping as Smoking Alternative

    Report Supports Vaping as Smoking Alternative

    Photo: andriano_cz

    A new report published by Belgian’s Superior Health Council supports vaping as a safer alternative to smoking or as a quitting aid that can significantly reduce health risks.

    Based on the current state of knowledge, the report concludes that the exclusive use of e-cigarettes by (ex-)smokers—provided that they actually stop smoking—could lead to a significant reduction in health risks

    The report also states that vaping is not risk-free and is therefore not recommended for nonsmokers, especially the young. Further long-term safety data are needed.

    The council prepares scientific advisory reports to guide Belgian political decisionmakers and health professionals. The report took two years to prepare and was a consensus document prepared by a wide range of experts with different views.

    While restrictions on vaping are prudent the report warns that “limiting vaping and other nicotine use does not jeopardize the goal of reducing the prevalence of smoking.”

    Advocates of tobacco harm reduction welcomed the report. “Wisely, the guidelines advise risk-proportionate regulation of vaping,” wrote Colin Mendelsohn, a medical professional and founding chairman of the Australian Tobacco Harm Reduction Association, on his website. “Vaping is much less harmful than smoking and should be regulated much more lightly in line with the lower risk.

  • Panama Bans Vaping Imports and Sales

    Panama Bans Vaping Imports and Sales

    Photo: searagen

    Panamanian President Laurentino Cortizo has signed legislation banning the sale of vapor products, reports Vaping360. The country had already prohibited e-cigarette sales in 2014 by executive decree.

    The new law prohibits not only sales and imports of e-cigarettes, but also bans consumption in any place where smoking is not allowed. The ban includes internet purchases and authorizes customs officials to inspect and seize shipments. Resellers are still allowed to import vapor products intended for export to third countries.

    Consumer vaping advocates have warned that restrictions on vaping products will push vapers to illegal products of questionable quality.

    Panama joins more than a dozen Latin American and Caribbean countries with vape bans. On May 31, Mexican President Andrés Manuel López Obrador signed a decree outlawing the sale of e-cigarettes.

    Panama will host the 1oth Conference of the Parties to the Framework Convention on Tobacco Control in 2023.

  • Activists Outraged Over Vaping Policy Guidance

    Activists Outraged Over Vaping Policy Guidance

    Photo: pixarno

    Tobacco harm reduction activists are outraged over a new Australian government document on vaping.

    The National Health and Medical Research Council (NHMRC) recently published its 2022 CEO Statement on Electronic Cigarettes, which provides guidance to public health policymakers.

    According to the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA), the document falsely claims that vaping is not an effective quit-smoking tool, but a gateway to smoking with most vapers becoming dual users. Vaping, the document states, also increases the risk of smoking relapse. The NHMRC exaggerates the health impacts, poisoning and explosion risks of e-cigarettes, according to CAPHRA, while references to toxins and potential harms are made without a fair comparison to smoking.

    “This latest government document on vaping makes outrageously false claims and will only cost more Australian smokers their lives,” says Nancy Loucas, executive coordinator of CAPHRA.

    “Ridiculously, Australia’s chief medical officer considers vaping the next biggest health issue after COVID-19. Has he ever heard of smoking which kills over 20,000 Australians every year? This 18-page document is a complete joke. It is full of statements that can be easily debunked by international science and human evidence the world over,” says Loucas.

    This egregious document is not worth the paper it’s written on, yet it’s now the bible for public health guidance in and around Australia.

    CAPHRA says Australia’s hardline anti-vaping approach is increasingly out of step with other Asia Pacific countries, with the Philippines, Malaysia and Thailand set to lift their vaping bans. What’s more, New Zealand, across the Tasman, is already operating under a regulatory framework that has seen smoking rates decline.

    “This egregious document is not worth the paper it’s written on, yet it’s now the bible for public health guidance in and around Australia,” says Loucas.

    It is illegal to sell, supply or possess nicotine vaping products, with Australia the only Western democracy that requires a nicotine prescription to vape. Alarmingly, 2.3 million Australians continue to smoke cigarettes.

    Last year Australia’s Therapeutic Goods Administration expanded its prescription-only model with customs clamping down at the border on the likes of personal imports of nicotine vaping liquids from overseas websites.

  • Smoore Recognized for Industrial Design

    Smoore Recognized for Industrial Design

    Photo: Smoore

    Smoore has been recognized by the Shenzhen Municipality Industrial Design Development Support Program for its innovation and design capabilities.

    The municipality singled out the vaping technology’s specialist for its “innovative design and achievement transformation of closed-pod electronic atomizer based on leadless ceramic heating technology.”

    The industrial design team of Feelm, Smoore’s flagship atomization brand, has designed a number of solutions that combine consumer experience with advanced smart manufacturing.

    Between 2020 and 2022, Feelm’s industrial design team won eight prestige International design awards, including the Red Dot Award, the iF Design Award, the German National Design Award and the MUSE Design Award.

    In 2022, won a Red Dot Product Design Awards for four products, including a lipstick-inspired vaporizer with a twistable nozzle that prevents dust from collecting on the mouthpiece, and an eco-friendly disposable e-cigarette composed of recyclable and reusable aluminum foil.

    “Feelm design is devoted to helping clients in improving the user experience from the perspective of a vaping tech brand,” said Totom Lu, head of Feelm Industrial design team, in a statement. “I think the future direction of design of closed-pod vaping solution should lean on three dimensions: product experience, emotional experience—to identify problems before users notice them—and sustainable experience, to focus on product sustainability.”

  • Staying the Course

    Staying the Course

    Photos: KT&G

    KT&G continues to make progress toward its ambition of becoming a top-tier global player.

    By Stefanie Rossel

    It’s an ambitious goal: By 2025, South Korea’s leading cigarette manufacturer, KT&G, wants to play in the top tier of global tobacco companies. At the time of writing, the company appeared to be well on track to achieve its ambition, weathering unprecedented macroeconomic challenges along the way.

    In the first quarter of 2022, KT&G’s sales soared to krw1.4 trillion ($1.11 billion), an increase of 16.1 percent over the same period in 2021. Operating profit stood at krw333 billion, up 6.3 percent year-on-year. The double-digit growth in sales was driven by strong exports and the performance of KT&G’s overseas cigarette subsidiaries as the company concentrated on the global business arena.

    KT&G sold 11.5 billion cigarettes overseas in the first quarter of 2022, a 43.8 percent increase over the same quarter last year. “Amid an easing pandemic situation, demand for cigarettes has increased in the Middle East, Asia-Pacific and Indonesia,” a KT&G spokesperson told Tobacco Reporter. “Total overseas sales—krw226.3 billion—were up 62.6 percent compared to the same quarter last year. The dramatic increase can be explained by the volume increases in high average selling price regions, such as [the] Middle East and Asia-Pacific.”

    Covid-19 brought about significant challenges for KT&G. In response, many parts of the company, from daily operations to engagement with business partners, underwent major changes.

    One of the most difficult challenges, according to KT&G, was to expand its global business amid a pandemic. Despite the situation, the company added 23 new export markets in 2020 alone—a remarkable accomplishment given that many countries imposed nationwide lockdowns during that year. Since face-to-face meetings with overseas business partners and physical market visits were impossible, the company had to strengthen its digital and online business model. It conducted rigorous market research on target markets and communicated with overseas business partners by utilizing digital platforms. KT&G even managed to establish a subsidiary in Taiwan in March 2021.

    After experiencing the pandemic in 2020, KT&G set “resilience” as the keyword for its 2021 business management goal. “The keyword ‘resilience’ reflects our determination to not only recover from the negative impacts of Covid-19 but also leap forward and achieve greater advance amid the pandemic situation,” said KT&G’s spokesperson. “During last year, we tried to act fast and seize opportunities in the rapidly changing global economic order.”

    KT&G’s ambitions to become a global top tier player are spearheaded by CEO Baek Bok-in.

    Strong Growth in Indonesia

    KT&G’s long-term strategy to become the fourth-largest player in the global tobacco industry is comprehensive: Next to driving business diversification and maximizing both financial and nonfinancial values, the company intends to bolster marketing capabilities by channeling more investments into distribution networks as well as the marketing infrastructure in key markets, especially in its overseas subsidiaries in Indonesia, Russia and Turkey.

    The plan appears to be working out for most of its overseas operations; growth in the first quarter of 2022 came mainly from KT&G Indonesia, the country’s sixth-largest independent kretek manufacturer, previously known as Trisakti. KT&G acquired Trisakti in 2011, thereby benefitting from the kretek manufacturer’s well-established sales network.

    Indonesia holds great significance for KT&G, considering its market size. To increase its presence in Indonesia, KT&G is developing its brand portfolio to better satisfy local consumers’ needs while at the same time investing in the marketing and sales infrastructure.

    The U.S. turned out to be a different story, however: Instead of expanding its distribution channels as envisaged, KT&G in December 2021 announced the suspension of its U.S. business, located in Fort Worth, Texas, for an unspecified period. KT&G says it is reviewing its U.S. business amid intensifying regulations and growing competition.

    According to the Korea Herald, the decision will cost the company about krw205.8 billion in lost sales, representing around 3.9 percent of KT&G’s overall sales revenue in 2021. Furthermore, the newspaper reported, mandatory tobacco escrow accounts for smoking-related legal settlements had added burdens to the already difficult business environment. A KT&G spokesperson told Tobacco Reporter that the company will offset the lost U.S. business by focusing on growth in new markets and other overseas subsidiaries.

    In early 2020, KT&G and PMI entered into a three-year supply and distribution contract to commercialize KT&G’s Lil products outside of Korea.

    New Lil Variant Introduced

    Unlike international competitors who have suspended or discontinued their operations in Russia after that country’s invasion of Ukraine, KT&G continues to operate its cigarette manufacturing plant in the Kaluga region, located about 150 km southwest of Moscow. The site has an annual production capacity of 4.8 billion cigarettes. Among other products, it manufactures KT&G’s leading Esse brand. According to KT&G, the war has had only a limited impact on its Russian operations because the factory is geographically far removed from Ukraine. KT&G said it was keeping a close eye on the situation to ensure that local business operation and employee safety are not compromised.

    The company is not present with its brands in Ukraine but markets its heated-tobacco product (HTP) Lil in the country through a partnership with Philip Morris International.

    In early 2020, KT&G and PMI entered into a three-year supply and distribution contract to commercialize KT&G’s Lil products outside of Korea. Lil first launched in Russia, Ukraine and Japan—in the same year the agreement was signed. A year later, the product was commercialized in 10 more international markets. Today, the product is present in 25 markets. KT&G says it is strengthening its R&D and device technology in order to satisfy various needs of global consumers. Since 2017, it has filed over 3,000 patents related to heat-not-burn technology. With the commercialization of Lil in Europe, KT&G has stepped up its patent filings on the Old Continent as well. Last year alone, the company filed 233 patents in Europe.

    One of the results of the company’s R&D efforts is Lil Hybrid EZ, which debuted in South Korea in May. Lil Hybrid EZ shares the same platform with the original Lil Hybrid. Just like the original Lil Hybrid, it features a “Smart On” system, which instantly starts heating the stick as it is inserted. The differentiator is price: Lil Hybrid EZ is offered at a more affordable price point without compromising the quality, according to KT&G.

    KT&G’s Lil heat-not-burn product is currently available in 25 markets.

    Increasing Domestic Share

    Despite challenging times, KT&G has managed to expand into many new markets. In 2019, the company’s products were present in around 80 countries. In 2020—after the outbreak of the coronavirus—KT&G’s geographic footprint grew to cover 103 markets, many of them in Europe and Africa. Today, KT&G is present in more than 120 countries. But the company insists it is not merely looking to increase the number of export destinations. Rather, KT&G is invested in expanding sales coverage and elevating market presence in each market in a qualitative manner, according to a company spokesperson.

    KT&G has also managed to strengthen its domestic leadership by expanding its brand portfolio of low-tar/low-nicotine and “smell-down” products. South Korea’s market for combustible cigarettes declined by 2.7 percent in the first quarter of 2022 compared to the same period last year due to a shift in consumer demand toward HTPs. Despite this, the company managed to grow its market share by 1.2 percent to 65.7 percent.

    Amid intensifying competition in the market, KT&G says it strives to maintain its leadership position and competitiveness in the domestic market by improving its products’ quality and developing a brand portfolio that aligns with market trends. It is continuously adding new low-tar and low-nicotine, “smell-down” and super-slim variants to its main brands, Esse, Raison and Bohem.

    The “smell-down” segment is typical of South Korea. KT&G has developed various technologies, such as the cigarette breath reduction technology and a “finger zone” on the tobacco rod that reduces cigarette smell on fingers. Most of the newly launched combustible products produced by KT&G and other cigarette manufacturers in Korea come with such smell-down features. The potential of such technologies overseas will depend on the regulatory and competitive environments of the target markets, according to KT&G.

  • Craving Normalcy

    Craving Normalcy

    Photos: Taco Tuinstra

    Climate change, war and a lingering pandemic exacerbate the typical challenges presented by leaf tobacco supply and demand.

    By George Gay

    I have a question. Given the environmental crisis the world faces, why are the tobacco industry’s operations dominated by flue-cured tobacco varieties rather than sun-cured varieties? I mean, why cut down trees and burn them as part of the flue-curing process when it is possible to rely on the energy freely and directly available from the sun to cure tobacco? It cannot be a quality thing because whereas, for example, sun-cured classical oriental tobaccos are sublimely aromatic, flue-cured Virginia tobaccos are unremarkable at best.

    Another argument that cannot be made is that the industry was not aware of the deforestation it was causing by flue-curing tobacco and therefore hasn’t had time to switch from flue-cured to sun-cured tobaccos. The issue of tobacco-driven deforestation was being widely discussed in the early 1980s and probably before that. Of course, not all flue-curing relies on burning wood, but that which doesn’t, as far as I am aware, requires, directly or indirectly, burning fossil fuels.

    So what is the answer to the question posed above? I think there are probably very many answers, none of them particularly convincing, so I believe that even now efforts should be made to switch production from flue-cured varieties to sun-cured and, perhaps, air-cured varieties. And maybe this will happen, partly because of the growing alignment of environmental and health activists and arguments.

    A recent report by the World Health Organization and Stopping Tobacco Organizations and Products (STOP), Talking trash: Behind the tobacco industry’s ‘green’ public relations, accuses the industry, mainly in the guise of the four major multinationals, of “greenwashing.” And though some of the report is lightweight and unconvincing, its uncomplicated messages are likely to register with a nonindustry audience. “Tobacco growing and curing are also both direct causes of deforestation,” the report says in part.

    In addition, according to Natalia Pujalte writing in May in The Parliament Magazine, the EU presented in November a proposal for new regulations that would allow “only deforestation-free and legal products” to be sold on the EU market. Tobacco wasn’t mentioned in Pujalte’s piece, but with the regulations still under consideration and the EU’s aversion to all things tobacco, it is unlikely the industry will slip through the net.

    The developed world is currently facing levels of inflation not seen in decades, so the entire supply chain has been suffering cost increases that are difficult to offset.

    Pressing Challenges

    I suspect that 99 percent of those working in the tobacco industry will disagree with my suggestion and come up with all sorts of reasons why sun-cured and air-cured tobaccos cannot be used as the main ingredients in cigarettes, at least in part because they have other things on their minds. According to a number of respondents to a Tobacco Reporter questionnaire, the leaf industry is suffering from the effects of everything from climate change to the war in Ukraine and long Covid.

    Jose Maria Costa

    Although Jose Maria Costa of NewCo said leaf tobacco demand from a wide range of customers was holding up well, he positioned a range of industry problems within that affecting just about every business and individual globally. The world had been through 15 difficult years since the financial crisis of 2007–2008, he said. And more recently, the war in Ukraine had been launched before economies around the world had a chance to recover from the impact of the Covid pandemic. The developed world was currently facing levels of inflation not seen in decades, so the entire supply chain was suffering cost increases that were very difficult to offset. Logistical challenges that had been evident for a year were adding to the problems, with prices for a container quadrupling for certain routes. At the same time, there were smaller-than-desirable tobacco crops in key markets such as Brazil, and prices were going through the roof in all markets.

    And whereas the tobacco industry had been through a lot of changes and cycles over the years, things were different now, Costa said, implying, I think, that there were now more, worse problems that were proving harder to overcome. The world needed a period of stability, and the tobacco industry did too, throughout its supply chain, he said.

    Craving Consistency

    Meanwhile, Christian Adi Njoto Njoo, the president of Mangli Djaya Raya, which for more than 60 years has produced, processed and traded tobacco from its base in Indonesia, told Tobacco Reporter that his current main concerns are focused on how to ensure production is sustainable in the face of anomalous weather patterns and how to address market inconsistencies. Addressing the challenges caused by climate change would need an elaborate plan devised and supported by a broad range of stakeholders, including governments, and would be a long-term project, he said. And in the meantime, recent prolonged rainy seasons in Indonesia were predicted by the Indonesian Agency for Meteorological, Climatological and Geophysics to continue through at least this year and next, which could mean shorter crops and prices rising to previously unheard of levels.

    On the other hand, market inconsistencies could be improved in the short term, Njoto said. They were caused by a lack of central planning that allowed a vicious season-by-season cycle of production boom and bust to develop as growers, who were not fully informed, reacted to the prices paid in the previous season, not necessarily to the needs of the current season. Some market inconsistencies, he added, could be improved through government regulation and by better and consistent planning by medium to large corporations when deciding on their purchasing, production and price indications for future seasons.

    One indirect result of the boom-and-bust cycle was volatility in the stocks and prices of fertilizers and crop protection agents, followed inevitably by higher production costs and pressure for tobacco price rises. The scarcity of fertilizers in recent times had seen their prices increase hugely to the point where the government was currently trying to control the sale of fertilizer on the domestic market and to limit and even ban its export.

    Around the world, leaf dealers are pondering how to ensure that production is sustainable in the face of anomalous weather patterns and how to address market inconsistencies.

    On the Bright Side

    The Tobacco Reporter questionnaire asked, basically, what is currently positive about the leaf tobacco industry, what is negative and what can be done to improve things.

    Njoto identified unhelpful regulations as being a problem for the industry, though he recognized that regulations were necessary in respect of protecting certain industry stakeholders, especially farmers and workers, and also the environment. In fact, he accepted that, in Indonesia, regulations were less strict and made more sense business-wise than those in some other countries and regions. It was also helpful that government-owned tobacco research facilities, laboratories and other institutions had been steadily improved in recent years through increased budget allocations drawn from various tobacco industry-related tax revenues. At the same time, government and private extension services, including the gradual implementation of sustainable tobacco programs required by the major multinationals, were aiding tobacco farmers, workers and other industry stakeholders.

    However, he said, it was concerning that “international regulations” were starting to be introduced, and introduced without enough consultation, which meant some were poorly received and adapted and therefore hindered the industry’s stability and development. This situation needed to be improved by ensuring a balance was struck between the health and economic interests of all stakeholders.

    Interestingly, ITC, India’s dominant tobacco manufacturer that has been closely linked to the success of the country’s flue-cured tobacco industry, mentioned no problems in its response to the questionnaire, preferring to concentrate on what it sees as the “world’s best public/private partnership model in agriculture,” namely, the Indian tobacco auction system, which was introduced in 1984.

    ITC made the point that while flue-cured tobacco occupied less than 0.10 percent of the country’s total arable land area, it was an important, sustainable commercial crop, generating enormous socioeconomic benefits in terms of agricultural employment, farm incomes, revenue generation and foreign exchange earnings. In part, this was down to the Tobacco Board’s e-auction system for this type, which provided for fair assessments of growers’ bales in respect of both weight and grading, healthy competition, fair prices and, importantly, prompt digital payments.

    Also accentuating the positive was Frederick de Cramer, a tobacco industry doyen now involved with the production of Latakia tobacco. In Turkey, opportunities were being created by a tobacco law instigated last year requiring cigarette manufacturers to include 10 percent locally grown Virginia in their blends, he said, a figure that was due to rise to 30 percent in four years. Local cut rag operations that bought domestically grown sun-cured Virginia (SCV) and flue-cured Virginia (FCV) were looking into the possibility of providing access to their leaf sources to cigarette manufacturers. But de Cramer pointed out, too, that, currently, there was a need to apply better agricultural practices to increase the quality of the SCV and FCV produced in Turkey for both the domestic and export markets. And there was a need, too, for a good big-leaf processing line.

    Turning to the issue of locally grown classical oriental tobacco, de Cramer said a reduction in demand for these varieties was causing concern for the long term. Multinational tobacco manufacturers had reduced their demand for these varieties for a number of reasons but mainly because of price/cost considerations. In recent months, though, the Turkish lira had devalued substantially against the dollar, and it was possible that demand for Turkish oriental tobacco could increase. But there is danger nevertheless, said de Cramer. While classical oriental tobacco had been and still was a vital component of high-quality American-blend cigarettes, multinational manufacturers were no longer supporting this traditional leaf as they had in the past. Demand had been reduced due to several factors, including the switch to nontraditional cigarettes such as e-cigarettes, lower oriental inclusion rates in traditional blends, even the removal of such tobaccos completely from some blends, and import duties in some countries imposing de facto import restrictions.

    Demand for classical oriental tobacco has declined due to the switch to nontraditional cigarettes such as e-cigarettes, lower oriental inclusion rates in traditional blends and import duties in some countries.
    (Photo: Tobacco Reporter archive)

    The Greek Outlook

    This partly mirrors what has been happening in Greece, where the future of the leaf tobacco industry is apparently under threat. I say “apparently” because industry experts in Greece are reluctant to say anything even though problems have been apparent since at least 2019. Little wonder perhaps. From what I can surmise, it seems possible that within three years to 10 years, Greece may no longer produce classical oriental tobacco—possibly no tobacco at all.

    Assuming this is correct, how did things reach such a pass? For many years, the Greek tobacco industry operated in a country that supported production. The industry had easy access to finance, good extension services and a lot of skilled growers who, in general, were paid fairly. It had good processing facilities, a stable customer base and well-established export systems.

    It is true that production levels were sometimes out of kilter with the market, but there were multiple reasons for this, not all of which were within the control of the Greek industry. And, in any case, production of classical varieties of oriental tobacco were cut back hugely in 2006 to 20,000 tons a year after the decoupling of EU crop-specific agricultural support, a move that seemed to stabilize the industry and align it more closely with the new market realities.

    Clearly, what is at the root of the problem is demand. Again, from what I can surmise, the classical oriental tobacco crop last year fell to 11,900 tons, the smallest crop of classical oriental tobacco ever in Greece, while next year’s production might or might not hit 10,000 tons. Why? One major factor is that Philip Morris International, which had, for a number of years post-decoupling, agreed to buy a significant proportion of Greece’s crop, pulled out of that agreement in 2019, partly, I guess, because of its commitment to switch its production away from traditional cigarettes to IQOS. Subsequently, its orders placed with Greek processors seem to have fallen to a fifth or even a tenth of what they were.

    Is there any way back for Greece? Possibly not. Even if demand started to pick up, the industry would have to attract a new generation of growers to tobacco, which, on current evidence, might prove difficult. But never say never. There are many unknowns currently affecting the tobacco industry, not the least of which concerns how successful heated-tobacco products and e-cigarettes will be in a world starting to concentrate on environmental issues. And the issue of filters cannot be ignored. Will they be banned eventually, which would make sense environmentally? And if they are banned, along with flavors, how do you make a decent cigarette? Well, one obvious way would be to use classical oriental tobacco.

  • Not “A Solved Problem”

    Not “A Solved Problem”

    Photo: nikodash

    Acknowledging reality at the E-Cigarette Summit

    By Cheryl K. Olson

    After weary years of disdainful comments and dismissive studies about nicotine, and especially vaping, from my public health colleagues, the recent 2022 E-Cigarette Summit in Washington, D.C., gave me cause for hope. It was energizing to see researchers, advocates and regulators sincerely attempt to share and discuss their varied findings and experiences rather than “preach to the choir” more evidence supporting preexisting beliefs.

    For example, Peter Hajek of Queen Mary University of London discussed nicotine’s effects on the developing brain. He threw cold water on assertions that nicotine can cut IQ by 10 or 15 points. These claims, he said, come primarily from chronic large doses, close to a lethal dose, in animal studies. It’s unclear whether this is relevant to voluntary dosing among humans. He went on to question the basis for accepted wisdom on age of smoking initiation and nicotine dependence. At last, nuance instead of diatribe!

    The U.S. Food and Drug Administration and public health researchers have always been concerned about tobacco product effects on vulnerable populations: people at greater risk of starting to use tobacco, suffering from tobacco-related diseases or having problems stopping use of tobacco products. But the scales were tilted toward stopping youth from initiating use and thus away from all those adults getting sick who can’t or won’t quit.

    At the E-Cigarette Summit, a rebalancing seemed to be underway. Along with the usual (and appropriate) concerns about youth and vaping, there were sessions with titles such as “Let’s not forget the smokers” and “‘Smoke-free’ means smoke-free not vape-free.” Could we be approaching a point where the famous appropriate for the protection of public health standard gives protection of smokers’ well-being the weight it deserves?

    This reframing of tobacco harm involves acknowledging some unpalatable facts. First, smokers still exist in persistently large numbers, many in marginalized pockets of society. As Nancy Rigotti of Massachusetts General Hospital/Harvard Medical School noted, “Disparities in tobacco use really drive health inequities in the U.S. And that’s another reason why we need to be addressing the adult smokers.”

    Second, medical best practice approaches to quitting are not working and have no hope of getting us to a smoke-free society. Third, although cessation of use is preferable, harm reduction is a valid goal, sometimes the only realistic one—and it requires actively promoting appealing alternatives to smoking.

    Dated and Overrated

    Various media campaigns have urged us to “make smoking history.” Sadly, that’s not the path we’re on. According to Vaughan Rees of the Harvard T.H. Chan School of Public Health, the commonly recommended “safe and effective” medications fail to help most smokers, especially those from marginalized populations. Calculating their overall impact at the population level, he said, “We see a less than 1 percent reduction in the prevalence of smoking using current first-line smoking cessation medications.”

    He concluded, “The best evidence-based interventions are dated, overrated and cannot meet the challenge of reducing tobacco-related harm in this century.”

    One problem is that people who could encourage smokers to quit have become complacent. As Rigotti described in her talk, “Let’s Not Forget the Smokers: A Clinician’s Perspective,” “These days, for some of our clinicians, it’s really tobacco use is a solved problem.”

    Rigotti quoted a cardiologist colleague who told her, “Gee, most of my smokers have quit now.” This doctor’s patients are well-off, with good health insurance. “If instead she were working in a safety net hospital,” Rigotti noted, “she would know that there are lots of smokers but that their smoking behavior was very intractable.”

    Even before Covid-19, tobacco treatment struggled to gain physician mindshare. “We’re not very exciting because we haven’t had a new tobacco product on the market for more than 10 years,” said Rigotti. That is, physicians lack new pharmaceuticals to treat nicotine addiction.

    What might change clinicians’ attitudes and practices? The comfortable route, Rigotti said, would be e-cigarette products designated as medical devices, similar to the U.K. approach. But that is likely years away. In the meantime, promoting the fact that the FDA has authorized the marketing of some e-cigarettes “is an opportunity FDA could take advantage of to say the public health benefits outweigh the risks for some members of this class of products,” she noted.

    Her final recommendation was increasing doctors’ comfort with the idea and practice of harm reduction: helping patients who can’t or won’t quit. “Everyone’s comfortable with long-term NRT [nicotine-replacement therapy] now; you’re doing it [harm reduction] already,” she said to her fellow physicians. “And maybe you should be doing more of it.”

    In the last decade, recreational nicotine products have proliferated like wildflowers: pouches, gums, heat-not-burn and many more. I would add: Why not do more to educate physicians about those? Especially given the new recognition that alternatives to smoking should be (gasp) appealing.

    Push and Pull

    Treat nicotine addiction with a medicine: That’s the traditional approach to smoking. Another welcome development at the E-Cigarette Summit was hearing multiple speakers advocate for new options, even flavored ones.

    Dorothy Hatsukami of the University of Minnesota focused on factors that might push people away from smoking and pull those who won’t quit toward alternatives. Given that (as her slides noted) “nicotine maintains addiction, but other constituents kill people,” her recommended “push” was policies to reduce the nicotine in cigarettes.

    However, she noted, for those smokers who are unable or unwilling to quit, a “pull” is also needed toward alternative nicotine-delivery systems. Hatsukami described a colleague’s study supporting that “in the context of very low-nicotine cigarettes, you still need to have [alternative] products that are appealing. That have a range of flavors as well as higher nicotine doses.”

    “New technologies clearly are needed to fulfill the promise of tobacco harm reduction,” Rees asserted in his talk. “We need reduced exposure products that meet the needs of smokers.” Such products, he said, along with regulatory standards that reduce or eliminate known toxicants, are the way to prevent a pandemic of 1 billion deaths from smoking in this century.

    Rees showed a refreshing willingness to consider what works, whatever the source, including a 1991 paper from the Philip Morris archives. “One size does certainly not fit all. I learned that from seeing what were previously secret tobacco industry internal documents,” he said. “They designed cigarettes to meet the needs of specific subgroups of smokers. And were successful at creating demand for their products.”

    Along with a focus on rapid delivery of nicotine to the brain, “they also worked very hard to ensure that tobacco products are attractive, that they are convenient, that they are easy to use. That the chemo-sensory qualities of smoking are appealing enough to promote continued use,” said Rees.

    Several speakers made it clear, citing randomized trials and real-world evidence, that boosting continued use is key to reducing harm through e-cigarettes. This included Andrew Hyland of Roswell Park Comprehensive Cancer Center and the FDA-funded Population Assessment of Tobacco and Health (PATH) study. He talked about PATH data on the one in six U.S. daily smokers with no plans to ever quit and who don’t vape. About 2 percent of this group tried and stuck with e-cigarettes, becoming accidental quitters.

    These never-quitting smokers deserve more attention, said Hyland; they are “at much higher risk for a bad cigarette-caused health outcome because they are much older, heavier smokers and at the low end of the socioeconomics distribution.” Electronic nicotine-delivery system products have the potential to expand the pool of smokers engaged in cessation, thus raising overall quit rates.

    How can we get the level of switching success seen in randomized trials of e-cigarettes to happen for more smokers in the real world? David Ashley of Georgia State University, former director of the Office of Science at the FDA’s Center for Tobacco Products, focused much of his opening keynote, “Thinking Outside the Box on E-Cigarettes,” on that question. He stressed that smokers need the opportunity to try various products to find the right one for them as well as coaching on how to use the product.

    “Purchasing a poor device from a gas station or grocery store shelf, trying it out by yourself with no instructions, does not maximize the likelihood of successful quitting,” Ashley said. He contrasted this with a vape shop that takes a “hands-on interactive approach … working with smokers to find the best product for them.”

    Living with Uncertainty

    Jamie Hartmann-Boyce of the Centre for Evidence-Based Medicine at the University of Oxford, summarizing the latest Cochrane Review of electronic cigarettes for smoking cessation, made a plea in her talk’s title for “Living with and Addressing Uncertainty.” There is now moderate-certainty evidence from randomized trials, for example, that quit rates are higher with nicotine e-cigarettes than with NRT. As more results pour in, the Cochrane Review is now updated monthly.

    In closing, Hartmann-Boyce noted that this field “since its inception has been hampered by false dichotomies: Are [e-cigarettes] safe? Are they not safe? Do we protect children? Do we help adults? And now it’s ‘Is the evidence certain or is it uncertain?’”

    She pointed out that just as risk exists on a continuum, so does uncertainty, and that science is working as it should to move us toward firmer ground on e-cigarette effects. “We are getting more certain,” she said. “But what always remains certain is how harmful cigarettes are. And we should not let unnuanced discussions about the uncertainties of e-cigarettes get in the way of communicating that evidence as well.”