Category: Also in TR

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  • Not Lost Yet

    Not Lost Yet

    Photo: JTI Poland

    While struggling with rising cost and mounting regulations, Polish tobacco companies can cheer the retreat of the illicit market.

    By Vladislav Vorotnikov

    In the next few years, Poland may lose a part of its competitive edge as a regional tobacco superpower owing to controversial European Commission policy. This will happen unless common sense prevails or the government finds the courage to stand up to Brussels, according to market players.

    Poland is one of 12 countries in the EU that grows tobacco. For eight, including Poland, this is a strategic economic sector. Poland is also the largest exporter of tobacco products in the EU, with nearly 10 percent of the country’s agricultural and food exports, 80 percent of which goes to the EU market.

    The last few years have been rough for Polish tobacco growers, primarily owing to surging operating costs in Europe, according to Lukasz Szymanski, owner of Solidus Tobacco, a trading company.

    “Unfortunately, in recent years, we have observed a systematic shrinking of the tobacco-growing sector in Poland. This was caused by systematically rising energy and labor costs, which were the main obstacle for many growers,” Szymanski said.

    Szymanski, who has been in the tobacco business since 2015, selling mostly green tobacco and tobacco in the form of strips primarily to European customers, last year moved to expand activities and open an additional branch in the port of Trieste, Italy, eyeing markets outside the EU, specifically in the Middle East.

    Weak demand in the European market might be a key rationale for Polish tobacco businesses to seek opportunities overseas.

    “For many years, market tobacco purchase prices remained at the same level, which effectively discouraged many farmers from further cultivation,” Szymanski said, adding that since he stepped into the market, he saw a gradual decline in the sales volumes, which, he calculated, nearly halved between 2016 and 2022.

    In the coming years, the lives of Polish tobacco growers could become even more challenging. Market players are increasingly concerned about the fallout of the November summit of the World Health Organization in Panama. This summit, in the opinion of some Polish tobacco businesses, has been perceived as a public declaration of war on the industry.

    “We are afraid that the Polish tobacco industry will be killed by [the] Panama [summit]. The threat of unemployment hangs over us. We do not understand why employees of legitimate businesses should fall victim to international interference in Polish affairs,” said Marcin Klimczyk, chairman of the National Section of Tobacco Industry Workers.

    Polish leaf producction has steadily declined in recent years. (Photo: Solidus Tobacco)

    Bracing for Impact

    At the end of 2023, Polish businesses, united in their concerns, appealed to the government, seeking protection. Among other things, the National Chamber of Commerce, a prominent business union, has questioned the rationale behind participating in the WHO tobacco convention, voluntarily accepting constraints on tobacco business. The organization indicated that the countries not taking part in the initiative, specifically the United States and Great Britain, are more successful in fighting tobacco addiction.

    Accepting new rules will have a heavy impact, not only in Poland but also in the entire EU, players believe.

    “I am surprised that Europe is moving in this direction,” Marek Kowalski, chairman of the Federation of Polish Entrepreneurs, told Rzech Pospolita. “There will come a time when the EU will no longer be competitive on the tobacco market with countries outside it, which will willingly fill this gap.”

    Poland is the world’s largest manufacturer of nicotine sachets, noted Zbigniew Jankowski, a spokesperson from Swedish Match.

    “We are convinced that the implementation of the WHO recommendations by the EC after Panama may lead to a ban on their sale in Europe and, in fact, to the destruction of this fledgling market. Companies will go bankrupt; people will go out of business,” Jankowski said.

    On top of that, many people who have given up cigarettes in favor of less harmful alternative products, such as nicotine sachets, will be deprived of them if the WHO recommendations are implemented. This could have a significant impact on public health and the industry’s revenue.

    Polish tobacco companies are increasingly looking for opportunities overseas.

    Flourishing Industry

    In the long run, new regulations can undermine the investment attractiveness of the Polish tobacco industry, which secures roughly 8 percent of taxes for the national budget.

    In the past few years, the general mood in the Polish tobacco industry was predominantly positive.

    Cigarette volume sales declined by less than 1 percent in 2023 while the value grew due to increased prices, Euromonitor International, a think tank, calculated.

    “In 2022, the influx of refugees from Ukraine strongly revived cigarette sales, but the impact of this factor weakened in 2023. This factor also resulted in lower volume sales of fine-cut tobacco. Meanwhile, novelty nicotine and tobacco products, such as e-vapor products, heated-tobacco products and nicotine pouches, continued to show a significant increase in demand,” said Lina Sidorenke, an analyst with Euromonitor International.

    “Closed-system disposable devices emerged as the big winner with the strongest growth in 2023. Demand for cigars remained stable; however, high demand in Asian markets and the USA has led to fewer cigars being imported to Poland. Despite regular excise duty increases, Poland still stands out in the region for low prices of tobacco products,” Sidorenke said.

    Moreover, Poland has recently achieved drastic progress in fighting against illicit trade in the tobacco market.

    In recent years, the illegal sales of cigarettes in Poland have declined dramatically, Sidorenke claimed.

    “As of 2023, the gray market comprised less than 5 percent of all cigarette volume sales. Poland has demonstrated significant success in combating illicit trade, thanks to a united effort by the police, Border Guard and National [Revenue] Administration,” Sidorenke indicated, adding that in the past, a significant portion of contraband previously originated from Belarus and Ukraine, but the imposition of sanctions on Belarus and the war in Ukraine has led to stricter border controls, resulting in a significant decrease in illegal inflows to Poland.

    JTI Poland has invested heavily in reduced risk product manufacturing.

    Emerging Niches

    The positive developments encourage international giants to pump more money into their Polish operations, primarily eyeing the segment of heated-tobacco products.

    “While sales of traditional tobacco products in Poland are relatively stable, the heated-tobacco products category has been constantly growing in the last five years, accounting for about 11 percent of the entire nicotine market in the country today,” commented Adrian Jablonski, corporate affairs and communications director of Japan Tobacco International Poland.

    “In response to these evolving consumer trends, we introduced Ploom X—JTI’s third-generation heated-tobacco product—to the Polish market in September last year. Our heated-tobacco sticks [HTS] are produced at the state-of-the-art factory in Stary Gostkow, where we have already invested over $200 million in the reduced-risk products factory,” he added.

    Jablonski added that JTI plans to continue to develop the HTS category in Poland, though the company cannot reveal details for competitive reasons.

    However, the segment may also feel the sting of the tightening regulations in the foreseeable future.

    In February 2024, Polish Health Minister Izabela Leszczyna announced that the government was considering a ban on the sale of disposable electronic cigarettes, as reported by the local newspaper Business Insider.

    Leszczyna added that she would like to pursue the fastest possible legislative path to such a measure, given that as many as 64 percent of young people in Poland had “contact” with the product.

    “Single-use e-cigarettes currently dominate the e-vapor product market in Poland. This trend has surged over the past three years. If Poland were to follow the U.K.’s lead and implement a ban on disposable e-cigarettes, it could significantly impact the entire e-vapor market,” Sidorenke said.

    Sidorenke added that while some consumers may transition to other alternatives within the sector, a decline in overall e-vapor market demand is likely.

    Heated-tobacco products in Poland currently face fewer regulatory restrictions compared to combustible cigarettes, with lower taxation and continued availability of flavored products. Despite calls from the European Commission for Poland to adhere to EU regulations prohibiting flavored heated-tobacco products, they remain on sale as of April 2024.

    “However, it’s anticipated that new regulations will be implemented rather soon. It’s worth noting that the market has historically adapted to regulatory changes, as seen after the ban on flavors in traditional cigarettes. Thus, even with a potential flavor ban, the market is expected to adjust accordingly,” Sidorenke indicated.

    In the next five years, the tobacco and nicotine market is expected to advance toward the development of next-generation novelty products, partially at the expense of traditional cigarettes and smoking tobacco, Euromonitor International analysts forecast.

    A negative or uncertain forecast is anticipated for cigars, cigarillos, snuff and pipe tobacco. Beginning May 20, 2024, all tobacco products in Poland will be subject to the track-and-trace system. Previously, the EU track-and-trace system only covered cigarettes and fine-cut tobacco. However, as of May 2024, cigars, cigarillos, snuff and pipe tobacco will also fall under this system.

    “This expansion will impose additional burdens on manufacturers and retailers due to the costs, complexity and compliance requirements. In anticipation, some distributors have already indicated plans to withdraw these items from their offerings after the system comes into effect,” Sidorenke said.

  • A Case for Consensus

    A Case for Consensus

    Photo: pavelkant

    A global alignment on health policy is necessary to make a smokeless world a reality.

    By James Murphy

    With renewed attention on smoking and vaping regulation around the world, now is the time for action that will realize global smoke-free ambitions and ensure cigarettes become a thing of the past.

    Achieving this vision requires a global consensus on the most effective approach to create sustained and lasting changes to consumer behavior—tobacco harm reduction (THR).

    THR is one the greatest public health opportunities today, representing a pathway for hundreds of millions of smokers who would not otherwise quit to transition from combustible tobacco products to smokeless alternatives.

    Countries that have recognized the opportunity THR presents, and which have adopted supportive policies, have seen striking success in reducing their smoking rates. The U.S., U.K. and Japan are all currently witnessing their lowest smoking rates on record while Sweden is on track to declare themselves smoke-free this year—defined as having less than 5 percent daily smokers in the population—16 years ahead of the 2040 EU target.

    These remarkable transformations have been driven by widespread THR acceptance from policymakers, regulators, health officials and consumers in these markets, enabling and encouraging smokers to migrate from combustible tobacco products such as cigarettes to vapor, oral nicotine pouches, snus and heated-tobacco or herbal products.

    The widespread accessibility of smokeless products is essential for the success of THR. However, at present, this is being hamstrung by many countries limiting access to these alternative tobacco and nicotine products. For example, 60 percent of the world’s population live in just 15 countries. Of these, only about 40 percent permit the sale of smokeless products, leaving millions who would otherwise continue to smoke without the option to switch to such alternatives.

    In order to fully realize the public health potential of THR and significantly reduce the more than 8 million deaths attributed to smoking cigarettes each year, regulators around the world should embrace evidence-based science to drive positive public health outcomes. This means implementing a supportive regulatory framework that encourages adult smokers who would otherwise continue to smoke to switch while also protecting consumers with stringent safety standards and preventing underage use.

    In addition, the global success of THR depends on governments and regulators correcting persistent misperceptions of smokeless products compared to cigarettes.

    A University College London-led study published earlier this year highlighted that most smokers in England wrongly believe vaping is at “least as harmful as smoking,” with 57 percent of respondents saying they thought vaping was “equally” or “more harmful.” This echoes trends reported in the U.S., with research showing that perceptions of e-cigarettes as more harmful than cigarettes doubled year on year between 2018 and 2020. Not only are these misperceptions flawed, but they also have significant implications for public health by actively discouraging smokers who would otherwise continue to smoke from making the switch to smokeless products.

    Greater efforts are needed to counter these misperceptions—something that BAT is trying to tackle. As the world’s largest vapor company and a leader in smokeless products, BAT is committed to producing innovative products backed by world-class science and industry-leading product safety and quality standards. BAT’s THR approach is based on the growing body of research and weight of evidence approach that substantiates its belief of the reduced-risk profile of these products compared to cigarettes, which have been accepted by many international public health bodies. BAT publishes its science research to increase understanding of THR and raise awareness with stakeholders.

    Indeed, the industry developing and producing these products has a critical role to play. But to achieve the conditions required to make a success of THR, an inclusive, open and honest dialogue with all stakeholders is required. That includes policymakers, regulators and the healthcare and medical communities. Unfortunately, this is not yet the case, with the industry all too often excluded.

    We have an opportunity to usher in a new smokeless world, grounded in scientific research and a firm commitment to public health. The solutions are available today. All that is required is for the relevant stakeholders to actively work together to prioritize THR and the well-being of millions of people worldwide.

    James Murphy is the director of research and science at BAT.
  • Unforeseen Costs

    Unforeseen Costs

    Image: Alexandr Byerdugin

    How the Florida e-cigarette registry will harm nonvapers

    By Peter Clark

    This year, many U.S. states have considered imposing heavy-handed registries that aim to ban most vaping products sold today. In Florida, Governor Ron DeSantis wisely refused to follow along with other states. However, his solution—a sort of reverse registry that gives Florida’s attorney general the authority to ban specific products—will create more problems than it solves.

    It’s understandable how many nonvapers would see this law as being reasonable. But there are many unforeseen costs that they will need to bear.

    This law focuses on the dangers of vaping devices attractive to children, but there are many drawbacks to nonvapers. These include state resources wasted on ligation, unfair benefits to tobacco companies and healthcare costs of smokers imposed on all Floridians. 

    HB1007 will run into legal trouble if not correctly applied. Multiple factors need to be satisfied for a vaping product to be restricted. If Attorney General Moody erroneously finds a vaping device to be illegal, this opens Florida up to lawsuits. 

    This impacts Floridians since it costs tax dollars and ties up the court system. The Florida court system is already stressed. Between March 2022–2023, Florida led the country in the number of lawsuits filed. 

    Plus, the courts would require additional tax revenue to adjudicate the influx of claims. Fiscal year 2023 already saw a 7.2 percent increase in the budget over 2022. That budget has soared to $114.7 billion for fiscal 2024–2025. 

    The government should have a compelling interest in restricting sales of e-cigarettes. The public health justification is flimsy at best. 

    Teen vaping is on the decline. It isn’t flavored products that entice kids to start vaping. They vape to rebel and to reduce stress, using nicotine to self-medicate. Targeting flavored electronic nicotine-delivery systems (ENDs) based on a myth theorizing why kids start vaping will jeopardize the health of adult vapers, leaving us with an ineffective policy that burns tax dollars and overloads the courts.

    HB1007 also advantages the tobacco companies. The influx of non-FDA-approved e-cigarettes has severely eaten into the market share of big tobacco. Analysts suggest the only way to remedy slumping cigarette sales would be to “clamp down on disposable e-cig growth.” The CEO of Altria has even described the market as being “overrun” by these devices. 

    Barring vapes that lack FDA approval benefits tobacco companies in two ways. For one, most of the products granted premarket approval were Big Tobacco-owned. In 2022, all the e-cigarettes greenlighted by the FDA were sold by R.J. Reynolds, Altria, and JTI. By the attorney general blocking Big Tobacco’s competition, they can regain some of the sales lost to popular single-use devices like Elfbar.

    Even Florida voters who don’t vape should be concerned about this outcome. Upholding this law gives precedence to similar approval processes for other products. The legislature could pass additional laws to ban the sale of dietary supplements and even food deemed to be harmful. Much like the choice to vape, adults should have the right to evaluate the harm in what they choose to consume for themselves. 

    Florida restricting single-use ENDs would impose higher healthcare costs on Floridians. A study found that only 12.9 percent of vapers polled would abstain from nicotine if their preferred e-cigarette was banned, leaving many e-cigarette users going back to tobacco. The total healthcare cost to Florida from smoking is $10.04 billion, an annual tax burden of $854 per household. These figures do not include the impact of secondhand smoke or the $21.1 billion in lost productivity. 

    If a policy doesn’t directly impact you, it is easy to be apathetic. Banning popular vaping products hurts more than e-cigarette users. It wastes resources, gives tobacco companies an unfair advantage and costs Florida billions in healthcare costs. Even if you have never picked up a cigarette or vape, this law will still negatively impact you.

    Peter Clark is a fellow with the World Vapers’ Alliance. You can follow him on X at @blog_logic.
  • Food for Thought

    Food for Thought

    (Photos: Stuart Mitchell)

    “You couldn’t make it up.” That was how Simon Clark, the director of the Freedom Organization for the Right to Enjoy Smoking Tobacco (Forest), summed up the way in which the U.K. government had, in October last year, renegued on earlier assurances and announced a generational ban on tobacco sales.

    Clark was speaking as co-host of a Beat the Ban lunch held at the Boisdale Restaurant in London on May 21. The proposed ban, currently being pushed through parliament, would make it illegal in the U.K. to sell tobacco products to anyone born on or after Jan. 1, 2009.

    Clark pointed out that this would mean a person of a certain age would be able to buy tobacco while another person, one year, or, in some cases, just one day younger, would not be able to do so legally. Eventually, a person 70 years of age would not be able to buy tobacco legally.

    Forest is opposed to the proposed ban for several reasons, but mainly because it believes the ban would infantilize young adults and increasingly older adults, driving some of them towards the black market and criminal gangs, while doing nothing to stop sales of tobacco products to children, which are already illegal.

    What was extraordinary, Clark said, was that while, in April 2023, the government had made it clear it did not intend to raise the minimum age for the sale of tobacco, in October, the prime minister, Rishi Sunak, announced plans for the generational ban.

    “In our view, the Tobacco and Vapes Bill is a desperate attempt by a desperate prime minister to leave a legacy—any legacy—however unconservative, before the next general election [due to be held this year or, at the latest, January 2025],” said Clark.

    Clark was scathing, too, about the way the bill is being “steamrollered” through parliament. Following a short public consultation before Christmas, the government had announced it would not consider any submissions from groups with links to the tobacco industry, which, for instance, included Forest and even retailers. “To the best of my knowledge, that has never happened before,” he added.

    After its second reading, the bill entered its committee stage, when 17 MPs were appointed to the Committee, 16 of whom had voted for the bill and the other of whom was known to support it. And when it came to inviting people to give oral evidence to the Committee, witnesses were almost exclusively supporters of the bill.

    “Not only has the process been absolutely scandalous, the bill as it stands is illiberal, unenforceable, and has significant unintended consequences,” said Clark. “It will drive the legitimate sale of cigarettes and tobacco underground,” he added, before calling on those so minded to write to their MPs in protest,

    Clark’s co-host, Ranald Macdonald, the founder and MD of the Boisdale restaurants, was unable to attend the lunch but sent a message of support along with a special pleading for the smokers of fine cigars.

    And the 60 lunch guests, who included MPs, parliamentary researchers, think tank staff, retailers, tobacco industry representatives and journalists, heard from a string of speakers representing or simply speaking up for retailers, young adults and a variety of tobacco products, including pipe tobacco and snuff that will also be covered by the bill should it go through. —George Gay

    Editors’s note:

    Hours after this story had been submitted, U.K. Prime Minister Rishi Sunak announced that a general election would be held on July 4, meaning that parliament was due to be dissolved on May 30 and leaving too little time for the tobacco and vapes bill to complete its passage through parliament. This is unlikely to be the end of the matter, however, because the policy underpinning the bill had cross-party support and could well arise like the phoenix in the future.

    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.
  • The Takeaways

    The Takeaways

    REDPIXEL

    What did we learn from the E-Cig Summit in Washington, D.C.?

    By Derek Yach

    The E-Cig Summit comes at a time of change in how tobacco harm reduction (THR) products are regarded by those who oppose or support their use as a means of ending smoking. In recent months, new reports, editorials and comments in leading medical journals have highlighted the benefits of vapes for smoking cessation.1,2,3,4 Further, calls for medically licensed vapes have increased from academics who rarely agree on THR policies.5

    Robin Mermelstein, director of the Institute for Health Research and Policy at the University of Illinois, opened the meeting by noting that diverse perspectives are needed for innovations required to end combustible use. With no scientists from the private sector allowed to present research (except for former Center for Tobacco Products [CTP] Director Mitch Zeller, who is currently an advisor to Qnovia), this goal was tough to achieve. And it comes shortly after an editorial in Nicotine and Tobacco Research, the lead journal of the Society for Research on Nicotine and Tobacco, calling for complete exclusion of industry scientists.6 One wonders how widely supported this view is.

    I summarize key inputs from the Summit that address six questions:

    1. What are the major trends in cigarettes and vape use in the United States?

    Rafael Meza of the BC Cancer Research Institute showed that smoking and vaping prevalence in youth has declined. Frequent use (20 days or more over 30 days) is about 6 percent for smoking and vaping in both boys and girls. Among adults in middle age, cigarette consumption has declined in tandem with vaping increasing. Smoking rates, however, have not declined among people over 65 and remain highest among those with the lowest incomes and education. Meza’s projections of future trends are flawed by excluding probable impacts of heated-tobacco products and nicotine pounces joining vapes as providing alternatives to combustibles over the next few years.

    Only 4 percent of all smokers live in the U.S. Resources and debate about global policies are shaped heavily by U.S. federal, academic, nonprofit, philanthropic and private sector perspectives. Global realities need to be brought into summits. To mention two. First, smoking rates exceed 40 percent in men across most Middle East and Eastern European countries and in China and Indonesia. Smoking rates exceed 20 percent in women across Eastern Europe and small island states. These were rates in the U.S. 40 years to 50 years ago. THR provides a route to leapfrog over the road taken by the USA.

    Second, toxic smokeless tobacco products are commonly used, especially across South Asia, and cause about 350,000 oral cancer deaths. Nicotine pouches could well be the route to eliminating this dreadful cancer. A global perspective would place this as an achievable goal.

    1. Is there greater balance in addressing the needs of adults who smoke and those who have early disease compared to what has been a dominant focus in past summits on youth?

    CTP Director Brian King stressed that youth issues remain his priority. In response to Mermelstein, he could not explain why this remains a priority, given extremely low vape use in youth and the absence of convincing evidence that vapes are a gateway to combustibles. In contrast, both the U.K. and New Zealand give priority to ending combustible use in adults.

    King repeated his advice to adults who smoke: first use Food and Drug Administration-approved cessation medications and only then FDA-authorized reduced-risk products. Dual use is not supported. This advice is not in line with current evidence presented at the conference or multiple reports.1,2,3,4,5 Vapes are the most effective means to quit. Dual use lowers overall risks.

    Scott Sherman of New York University stressed that the ultimate goals of tobacco control are to prevent the burden of tobacco-related disease. About 70 percent of people smoke when diagnosed with chronic obstructive pulmonary disease, peripheral vascular disease, schizophrenia, alcohol use disorders and several cancers, to name some major outcomes. The majority are still smoking years after their diagnosis. Sherman believes such patients would benefit from trying vapes. There are few studies in this area. He outlined a small pilot study of patients with chronic diseases comparing vape use to nicotine-replacement therapy (NRT) use that motivates for larger studies. Patients with early-stage chronic diseases who are between 40 years and 55 years of age who quit are likely to yield major health benefits.

    1. Is there evidence of the benefits of nicotine pouches, snus and heated-tobacco products as cessation interventions to complement studies of vapes? And are there studies comparing these products to NRTs and medicated solutions?

    There are few such studies. Jamie Hartmann-Boyce of the University of Massachusetts and the Cochrane Collaboration presented a Cochrane review using indirect methods to compare a range of interventions. Vapes, NRTs and cytosine showed the strongest evidence of cessation effectiveness compared to other medications and interventions. She stressed the need for more high-quality studies. Public, philanthropic and industry funders should invest in such research among populations and countries where smoking and toxic smokeless tobacco rates are extremely high.

    1. Were the benefits of using biomarkers to demonstrate the effects of switching from tobacco products to THR options on proxy health outcomes discussed?

    Zeller mentioned new real-world evidence using biomarkers that suggest benefits of dual use (of vapes and combustibles) in terms of proxy health outcomes. Mike Cummings briefly mentioned the need to use biomarkers of exposure and outcome to accelerate knowledge about THR impact on health outcomes. As an epidemiologist, I have long felt that we need to complement self-reporting and mortality-based studies with use of 21st century biomarkers that allow for more accurate assessment of exposure and earlier determination of outcomes. Tobacco industry scientists currently lead in developing and using biomarkers. Their extensive list of peer-reviewed publications should be cited and used by academics.

    1. There have been important discussions recently in the New England Journal of Medicine (NEJM) and JAMA about the benefits of medical licensing THR products. What are the views of the regulators, industry and academics in going this route and, more broadly, in supporting vapes as an effective way to quit?

    Zeller believes improved medically approved tobacco harm reduction products are part of increasing access for adults to reduced-risk products. Nancy Rigotti of Mass General Hospital stated that a medical pathway is needed despite no medically approved products being available. Her views are based on knowledge that physician practices have widespread impact on their patients and on policies. She is concerned that the U.S. Preventive Services Task Force, the American Cancer Society, the Centers for Disease Control and Prevention, and the American Heart Association are still unclear about the benefits of vapes as being the most cost-effective means of achieving cessation. Their statements are either ambiguous or explicitly oppose vape use for cessation. She restated her NEJM call for clinicians to strongly advise patients who smoke to try vapes.2

    King did not address this, and he deflected issues related to cessation to the FDA’s Center for Drug Evaluation and Research (CDER). The lead FDA tobacco chief should have an integrated approach to ending smoking that involved the CTP and the CDER. That is the spirit of the messages in recent influential journals by leading academics and former FDA heads.3,5 Further, the FDA 2015 CDER guidance on alcohol shows how it accepts abstinence and harm reduction endpoints used for drug approvals. It seems time that the CTP and the CDER could learn how well this is working to end the harm of tobacco use.

    Both Neal Benowitz and Clive Bates of Counterfactual Consulting said we need to address the benefits of nicotine as a range of new products become available. This has implications for future medical licensing and recreational use. We need innovative ways to tease nicotine effects from combustible smoke effects to make progress on the regulatory front and to inform messaging to health professionals and smokers. A recent paper by Jasmine Khouja and her colleagues that used biobank data and multivariable Mendelian Randomization elegantly showed that most harms of smoking are unrelated to nicotine.8 Hopefully, work looking at the benefits of nicotine for Parkinson’s disease will follow. I recommend readers watch this space.

    1. Can THR practices outside of the U.S. inform U.S. policy?

    Like the U.S., adult smoking rates in the U.K. and New Zealand have declined as vaping has increased. Deborah Arnott of Action on Smoking and Health (ASH) U.K. indicated that dual use has followed the path seen years ago when NRTs were introduced and regarded this as a transitional route to eventual cessation. This is an important insight for U.S. policymakers to acknowledge.

    The U.K.-proposed legislation includes a ban on disposables, a new tax on e-liquid (which may reduce illicit trade from China and will maintain a differential tax relative to cigarettes) and measures to reduce the appeal of vaping to children in ways that allow adults to have continued access. Arnott supports vape promotion approaches that have more clinical and fact-based features and other policies that regulate proportionate to risk.

    Ben Youdan of ASH New Zealand showed that for years, New Zealand and Australia had similar rates of decline in adult smoking. Over five years, however, adult rates have diverged, with New Zealand rates falling faster. He believes this is based on differences in vape policies and messaging. New Zealand media and policies support vaping to quit, especially among the Indigenous population. Martin Dockrell of the U.K. Department of Health and Social Care described U.K. government-funded programs to provide vapes to homeless people, people with mental illness and other groups with high smoking rates. The hope is that these initiatives will lower social class inequalities in chronic diseases that are strongly driven by differences in smoking rates.

    Ben Youdan stated that Australia “treats people who vape as criminals or as sick people incapable of self-determination.” The result of this is that 90 percent of vapes on the Australian market are illicit while cigarette access is universal. The opposite is true in New Zealand.

    King mentioned that the FDA is committed to health equity. The FDA should learn from the U.K.’s and New Zealand’s vape policies.Concluding Comments

    The extent of misinformation was a topic that pervaded sessions. Alex Clark of the Consumer Advocates for Smoke Free Alternatives Association gave examples of how the FDA’s youth education campaigns have contributed to negatives views about vapes and nicotine. This could accelerate with the deployment of Chatbots that are explicitly programmed to spread misinformation about vapes and nicotine, the latest WHO one being a notable worrying example.9 Researchers need to rapidly engage computer scientists in building AI-driven ways to address misinformation continuously and at scale before the digital space is dominated by those who oppose harm reduction. This could draw upon the promising results of correcting misbeliefs about nicotine causing cancer and about vapes reported by Andrea Villanti of Rutgers.

    For several years, E-Cig Summits and related standalone vape meetings have led thought leadership about the value of tobacco harm reduction. With the growth of a spectrum of reduced-risk products now available, is it time to consider transitioning such meetings into opportunities to address emerging ways to end smoking and the use of toxic smokeless tobacco products through a wider range of products? That would encourage comparative studies and for a deeper examination of how consumers use products throughout the day. It would also allow for policy discussions that focus more on harnessing a wider community of users and innovative companies to compete to accelerate an end to smoking.

    David Levy of Georgetown University and Bates both made these point very strongly by placing the needs and interests of consumers first and seeing competition between companies and products as beneficial to meeting consumer needs to improve their health.

    For that to succeed, future conferences will need to adopt Mermelstein’s opening words in practice and end boycotts and bans of industry scientists so that all actively developing innovative ways to make progress can debate the best ways forward together.

     

     

     

    A global health expert and anti-smoking advocate for more than 30 years, Derek Yach is the owner of Global Health Strategies. Previously, Yach was the director of the Foundation for a Smoke-Free World and a World Health Organization cabinet director and executive director for noncommunicable diseases and mental health. He was deeply involved with the development of the Framework Convention on Tobacco Control.

    References

    1. Electronic cigarettes for smoking cessation – Lindson, N – 2024 | Cochrane Library
    2. Electronic Cigarettes for Smoking Cessation — Have We Reached a Tipping Point? | New England Journal of Medicine (nejm.org)
    3. Bolstering FDA Pathways for Reducing Death and Disease from Tobacco | JAMA Health Forum | JAMA Network
    4. E-cigarettes and harm reduction: An evidence review | RCP London
    5. How the FDA Can Improve Public Health — Helping People Stop Smoking | New England Journal of Medicine (nejm.org)
    6. Commercial Tobacco and Nicotine Industry-Funded Research Has No Place in SRNT and Nicotine & Tobacco Research | Nicotine & Tobacco Research | Oxford Academic (oup.com)
    7. https://www.fda.gov/files/drugs/published/Alcoholism—Developing-Drugs-for-Treatment.pdf
    8. Estimating the health impact of nicotine exposure by dissecting the effects of nicotine versus non-nicotine constituents of tobacco smoke: A multivariable Mendelian randomisation study – PubMed (nih.gov)
    9. Philanthro-colonialism: Bloomberg and the WHO — Marc Gunther
  • Mastering the Maze

    Mastering the Maze

    Photo: Istock

    Toxicological considerations to be considered when bringing HTPs to market

    By Malcolm Saxton

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

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

    The absence of combustion substantially reduces the number of chemicals released, with harmful and potentially harmful constituents (HPHCs) in HTP aerosols shown to be significantly reduced from cigarette smoke. Data from the Philip Morris International Scientific Update showed a 90 percent to 95 percent reduction in the average levels of HPHCs in the aerosol of IQOS,1 the leading HTP brand, compared with combustible 3R4F reference cigarettes. In addition, there is thought to be little youth appeal.

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

    Bringing an HTP to market

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

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

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

    Toxicological Considerations

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

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

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

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

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

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

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

    Malcolm Saxton is senior consultant at Broughton.

    Citation

    1Afolalu EF, Langer P, Fischer K, Roulet S, Magnani P. Prevalence and patterns of tobacco and/or nicotine product use in Japan (2017) after the launch of a heated-tobacco product (IQOS): a cross-sectional study. F1000Res. 2021 Jun 25;10:504. doi: 10.12688/f1000research.52407.2. PMID: 35528952; PMCID: PMC9069173.

  • The Great Scramble

    The Great Scramble

    Buyers have been paying record prices to secure their shares of Brazil’s smaller-than-expected tobacco crop.

    By Taco Tuinstra

    On March 21, a ferocious storm tore through Brazil’s southernmost state, Rio Grande do Sul. The wind flattened numerous outdoor pavilions at the Expoagro exhibition in Rio Pardo, forcing its organizer, tobacco growers’ association Afubra, to close the event for a day and repair the damaged stands. In a more welcome development, the tempest brought relief from the heat wave that had been making life tough for those toiling in the region’s numerous fields and leaf processing facilities.

    But while Expoagro reopened to large crowds and the temperature dropped to more tolerable levels in the wake of the storm, other pressures on the industry continued unabated throughout the selling season. Alliance One Brazil Leaf Production Director Samuel Streck, who has worked in the business for two decades, described this year’s crop as the most challenging in his career, and his view was echoed by many other industry veterans throughout the Brazilian tobacco sector during Tobacco Reporter’s visit to the region in March.

    A significantly smaller-than-expected crop, acute labor shortages and record-high prices, along with heightened scrutiny of tobacco farming in the wake of the 10th Conference of the Parties (COP10) to the Framework Convention on Tobacco Control (FCTC), have kept the Brazilian leaf sector on its toes this year.

    Having been forced to temporarily cease operations due to storm, Afubra’s Expoagro reopened to large crowds. (Photos and videos: Taco Tuinstra)

    Low Yields, High Quality

    It wasn’t supposed to be that way. When planting for the 2023-2024 crop started in May last year, the industry predicted a volume increase of about 10 percent over the previous season, when the country’s growers harvested some 605.7 million kg of all tobacco types, according to Afubra.

    At first, the weather conditions appeared to validate that assessment, but then El Nino hit. The recurring weather phenomenon, which typically boosts precipitation in South America, had been anticipated but turned out much more intense than normal. From mid-July until the end of November, El Nino dumped unprecedented volumes of rain on southern Brazil, leading to flooding in lower lying areas. Accompanied by many sunless days, the wet conditions depressed yields not only in Rio Grande do Sul but also in Santa Catarina and Parana, the three southern states that together account for 98 percent of Brazil’s tobacco production. (The remaining volumes grow primarily in Bahia and are used to make cigars.)

    Crop

    Hectares planted

    Production (million kg)

    Leaf export earnings

    2023

    261,740

    605.7

    $2.66 billion

    2022

    246,590

    560.18

    $2.24 billion

    2021

    273,356

    628.49

    $1.31 billion

    2020

    290,397

    633.02

    $1.47 billion

    2019

    297,310

    664.36

    $1.99 billion

    2018

    297,460

    685.98

    $1.85 billion

    2017

    298,530

    705.93

    $1.96 billion

    2016

    271,070

    525.22

    $2.01 billion

    2015

    308,260

    697.65

    $2.06 billion

    2014

    323,700

    731.39

    $2.35 billion

    2013

    313,575

    712.75

    $3.09 billion

    Sources: Afubra/SindiTabaco

    Instead of a 10 percent boost, the industry was now looking at a 20 percent drop in volume from 2023. By late March, Afubra was expecting about 470 million kg of flue-cured Virginia (FCV) and roughly 40 million kg of burley.

    But even as the excessive rainfall slashed yields, it worked wonders for leaf quality. Brazil’s 2024 crop boasts good color, uniformity and smoking properties, according to buyers. High oil levels give this year’s leaf a better visual appearance than in 2023. What in the previous year was predominantly light orange to orange is this year orange to deep orange, observed Kohltrade in a recent crop report. “It’s perfect, in my opinion,” said Kohltrade Account Executive Simone Velasques.

    And it’s not just looks that set this crop apart; the tobacco smokes exceptionally well, according to Eduardo Renner, president and CEO of CTA-Continental. “That’s also the feedback we are getting from customers,” he said. On the flipside, the rain also suppressed nicotine levels in this year’s tobacco. According to Jay Barker of YTL, the excess rainfall has resulted in below-average chemistries across the board. Because the wet season followed three consecutive dry ones, the gap in nicotine levels between the current crop and the previous one is greater than normal, which may challenge some customers in creating their desired blends.

    Andie Spies of Hail and Cotton (left), and Eduardo Renner at CTA’s Venancio Aires headquarters

    Chasing Tobacco

    The combination of low volume and high quality, along with a persisting post-Covid-19 tobacco shortage at the global level, sparked a scramble among tobacco companies in Brazil to secure their requirements. As a producer of sought-after flavor tobacco, Brazil has only two true competitors on the world market—Zimbabwe and the United States. Zimbabwe, where El Nino brought drought instead of rain, is also looking at a smaller crop this year (albeit from a record volume in 2023), according to that country’s Tobacco Industry and Marketing Board. United States FCV production, meanwhile, has been stable for three years at just below 140 million kg, TMA figures suggest.

    The shortage has been aggravated by the fact that last year some customers didn’t buy everything they needed because they were expecting cheaper tobacco this year. Coming out of the pandemic, many customers adopted a wait-and-see approach, carefully managing their stocks to avoid buying at high prices. Now, with inventories running out, those who didn’t buy last year had to buy this year.

    According to local traders, Brazil’s leading tobacco buyers alone needed more leaf than the entire volume that was expected to come to the country’s market in 2024. Throughout the season, the vertically integrated companies—BAT, Philip Morris International, Japan Tobacco International and China Tobacco—were buying far above list prices, paying top rates for all grades and leaving independent traders with no choice but to follow their lead.

    Simone Velasquez (center)

    The result has been an unprecedented escalation of leaf prices and an acceleration of deliveries. In mid-March, farmers were receiving up to $5.50 per kilogram of green tobacco, according to Kohltrade. For processed leaf, customers were paying up to $9.50 for grades that cost perhaps $5 only three years ago. “Prices are up, up, up,” observed Afubra President Marcilio Drescher.

    Daison A. Kohl, who grows 2.7 hectares of tobacco in Vale do Sol, said he has never in his time on the farm witnessed such high prices and such fierce competition. Unlike many of his neighbors, Kohl contracts only with one buyer. Yet throughout the buying season, his phone rang nearly daily with representatives from other companies asking him to sell his leaf to them instead.

    Kohl had to disappoint them all. “It doesn’t matter how much they offer; the tobacco is just not there,” he said. Merchants have been telling their customers a similar story. Whereas in a more typical year, they may exaggerate and say, “there is no tobacco” as a price negotiation tactic, this season it is simply a statement of fact.

    The scramble for tobacco has also greatly accelerated the purchasing process, leaving some receiving stations struggling to keep up with the influx of leaf. At the time of Tobacco Reporter’s visit, leaf merchants were expecting farmers to run out of tobacco by the end of April—two months earlier than in 2023. “Customers who come late to Brazil may not find what they are looking for,” warned Velasques.

    Leaf tobacco exports have earned Brazil an average of more than $2 billion annually over the past decade.

    Labor Scarcity

    For the growers, the 2024 marketing season has been a mixed bag. Even with record per-kilo prices, the additional income may not make up for the reduced weight that they are bringing to market, according to Afubra. Kohl, who suffered a 26 percent drop in yield from last year, said that as long as the companies continue paying above list prices, his operation will remain profitable this year. “But if they resort to paying list prices, it will be a problem,” he said.

    While the cost of inputs such as fertilizer have been coming down from their Covid-19-induced and Ukraine war-induced spikes, a long-running shortage of labor has worsened in recent years, impacting both farmers and tobacco factories. But whereas tobacco buyers can mechanize operations such as rack loading and stripping, farmers have fewer options. With an average property size of 10.5 ha and an average area devoted to tobacco of only 3.29 ha, according to Afubra, the typical tobacco farm in southern Brazil is simply too small to justify the investment in equipment. What’s more, many of the tobacco growing activities lend themselves poorly to mechanization. There are no machines for delicate tasks such as sucker control and topping, for example.

    Meanwhile, aware of their growing scarcity, farmhands have started driving harder bargains. In Vale do Sol, they have organized themselves in collectives, forcing farmers to negotiate with groups instead of individuals, according to Kohl. To guarantee a group’s labor throughout the growing season, he must pay a premium on top of the already inflated salaries.

    Determined to control their cost of production, Kohl and his wife, Solange, carry out many of the tobacco farm activities, including land preparation, themselves. They hire labor for the first, second and third reapings, when the leaves are still thin and easily damaged and speed is of the essence. “If we don’t harvest quickly during that time, we will lose quality,” said Kohl. From the fourth reaping onward, the tobacco is thicker and less fragile, allowing the Kohls to harvest by themselves and save money on labor.

    Their workload has been lightened a bit by a recent switch from bundles to loose leaf. In the past, growers in Brazil would classify their tobacco according to quality and color and then tie the leaf into bundles—a laborious process that could take up to two months. As demand increased, some buyers told farmers to skip this step and deliver the tobacco in loose form instead. The practice spread rapidly and has now been adopted by all merchants. After drying the tobacco, the farmer can take his tobacco directly from the barn to the bale and put it on a truck, not only saving time and labor but also greatly accelerating the speed of delivery.

    While some buyers at first worried about how the new practice would impact processing, those concerns turned out to be manageable. “Loose leaf is not necessarily the best way to receive tobacco in terms of the feeding table and the presentation of each grade, but we quickly realized it’s possible,” said Streck. According to Renner, the process remains the same. “You can still tip and thresh the leaf because it is straight laid.”

    Farmer Succession

    The Kohls are happy with the change to loose leaf, as it allows them to focus on other farm activities. As they work their fields, they are occasionally joined by their oldest son of 34, who has no interest in farming but feels a duty to help on some evenings after he’s done with his day job. Their middle son (25) by contrast “does not even want to see the tobacco,” according to Kohl, while their youngest (8) is too little to work on the farm. (Brazilian law requires tobacco workers to be at least 18 years of age, and following intense industry-led awareness campaigns, the country’s sector today is considered a role model in in eradicating child labor.)

    The Kohls’ family dynamics hint at another challenge facing Brazil’s tobacco business: farmer succession. Like their counterparts around the world, many rural youngsters in Brazil aspire to work in the city, which has led to an exodus of skills and talent from the countryside. “Keiner will die Finger mehr dreckig machen”—nobody wants to soil their fingers anymore—observes Solange, who, like many people in southern Brazil, is more conversant in German than English as a foreign language.

    A 2023 survey conducted by the Federal University of Rio Grande do Sul at the request of the Interstate Tobacco Industry Union (SindiTabaco), revealed that with an average monthly income of BRL11,755.30 ($2,234.75), tobacco farming families in southern Brazil are relatively well off, earning considerably more than the average Brazilian family. The Kohls, for example, live in a spacious, well-built home equipped with plenty of conveniences and some luxuries, including a small swimming pool. Within agriculture, too, the golden leaf continues to generate the best returns, according to industry sources, contradicting the narrative pushed by certain nongovernmental organizations that tobacco leaves growers in poverty.

    Nadia Fengler Solf

    But while the earnings from tobacco farming exceed those of other crops, the golden leaf is also more demanding. Unlike some other agricultural products, the farmer cannot just plant it and watch it grow. A good tobacco farmer, notes Kohl, must constantly keep an eye on the plants. “The weather can change things very quickly,” he said. “If rain comes, it puts the leaves on the plants and—boom—they become big overnight. And if you don’t go in and take the flowers off and the wind comes, it can topple the plants.”

    With no one lined up to take over the farm, the Kohls’ tobacco volumes will disappear from Afubra’s production statistics after they retire. “We have another 10 years, and then we’ll be gone,” said Kohl. Unfortunately for tobacco buyers, their situation is not exceptional. According to the University of Rio Grande do Sul study, 27 percent of the growers in southern Brazil have no succession plan.

    Acutely aware of the demographic drain, the tobacco industry has been looking for ways to keep young adults in the countryside. Originally set up by SindiTabaco and its associate companies to help combat child labor in rural Brazil, the Growing Up Right Institute (also see “Alternatives for Adolescents,” Tobacco Reporter, April 2021) now also runs programs educating young people on the verge of adulthood about the opportunities on the farm. By teaching youngsters how to optimize farm operations through technology and professional management, the institute hopes to convince them that they can live good lives in the countryside.

    According to program manager Nadia Fengler Solf, the initiative has had some success. Upon graduation from the program, she said, many students have a completely new perspective on the possibilities in the countryside. Some decide to develop their family properties, investing in new technologies and diversifying their business, while others elect to pursue degrees in agriculture.

    Solagne Kohl (left) and Daison A. Kohl grow 2.7 hectares of tobacco near their home in Vale do Sol. According to a study commissioned by SindiTabaco, tobacco growers are considerably better off financially than the average Brazilian.

    COP Fallout

    But even as the industry is working to keep farmers interested in tobacco, others are campaigning to steer them away. At COP10 in Panama, delegates vowed to step up action on Articles 17 and 18 of the treaty, which call for the promotion of economic alternatives for tobacco workers and the protection of the environment and health of tobacco workers, respectively. According to a speaker at this year’s Americas Regional meeting of International Tobacco Growers’ Association in Santa Cruz do Sol, the Panama COP could be the first to have a direct impact on the farm.

    SindiTabaco President Iro Schunke dismisses the talk about alternative crops in Southern Brazil as unrealistic. “If we had another crop that generates the same income, farmers would have switched long ago on their own accord,” he said. Part of the problem, he explains, is the small average size of farm properties. “To replace the money from one hectare of tobacco, you need to grow 7 hectares of soybeans or 10 hectares of maize.” The pressure for diversification, meanwhile, is unnecessary, according to Schunke. “Tobacco farmers in Brazil are diversified already,” he said. While generating between 60 percent and 70 percent of the average grower’s income, tobacco claims only 20 percent of their property, according to SindiTabaco. Part of the money earned from tobacco is used to plant supplemental crops.

    “If we had another crop that generates the same Income, farmers would have swItched long ago on theIr own accord.”

    Iro Schunke, president, SindiTabaco

    Brazil was one of the most vocal proponents of stricter tobacco controls at COP10, a position that Schunke considers odd, given that leaf tobacco accounts for 11 percent of Rio Grande do Sul’s exports, employs more than half a million farmworkers and earned Brazil an average of more than $2 billion annually through exports over the past 10 years (see chart). Schunke attributes the government’s tough stand to pressure from nongovernmental organizations and the exclusion of tobacco stakeholders from health policy debates along with an ideological aversion to capitalism.

    Some suspect the government’s position is driven partially by ignorance, with bureaucrats in faraway Brasilia unaware of how much rural communities in the south of the country depend on the golden leaf. “Although hostility against tobacco from agencies all over the globe is the new status quo and the path of least resistance, the fact is, the economic impact to the communities where tobacco is prevalent is very significant,” says Barker.

    Santa Cruz do Sul Mayor Helena Hermany believes that Brazil’s national health surveillance agency, Anvisa, grossly underestimates and misrepresents the industry’s economic significance. More than 50 percent of the city’s revenue comes from tobacco, she told participants in the ITGA Americas meeting. “If tobacco does well, we all do well,” she said.

    If tobacco does well, we all do well.

    Helena Hermany, mayor of Santa Cruz do Sul, Rio Grande do Sul, Brazil

    It terms of sustainability, the tobacco industry is also performing much better than it is given credit for. “We are doing quite well in terms of soil protection, reforestation and the prevention of child labor,” said Drescher. For example, Brazilian farmers are self-sufficient in curing energy, sourcing wood from dedicated plantations rather than indigenous trees.

    According to Renner, sustainability is already an integrated part of everything the tobacco industry does. “Whatever we supply must cover these three capital letters,” he said, referring to the environmental, social and governance considerations that the abbreviation stands for. “What we do for our people, our clients, in our operations and in the communities we work with … our suppliers need to do for us.”

    As they prepare for next season in the wake of this year’s short crop, industry stakeholders are keen to avoid a wild swing in the other direction. Emboldened by the high prices and keen to recover their lost volumes, many growers are likely to increase their plantings for the 2024–2025 season. Kohl, by contrast, is cautious, worrying that a surplus next year will depress prices, and he plans to plant the same hectarage as last year.

    Others predict that the era of cheap Brazilian tobacco is over, not only due to demand-and-supply factors but also as a result of the considerable investments the local industry has made in sustainability. These investments should serve Brazil well as it moves into the new era, giving the country a competitive advantage against origins with less robust practices. At the same time, leaf merchants insist that the effort should be supported throughout the supply chain. ESG initiatives, after all, come at a cost that should be reflected in leaf prices. “It must be sustainable for all parties,” insisted Renner.

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

    A Perfect Storm

    Image: StockImageFactory

    How India came to deny consumers legal access to safer ways of consuming nicotine.

    By Samrat Chowdhery

    India’s ban on commercialization of electronic nicotine-delivery systems (ENDS) in 2019 was the blunt political end to a meandering administrative and legal process that began after the World Health Organization Framework Convention on Tobacco Control (FCTC) stated of ENDS in a report presented at its sixth general body meeting held in Moscow in 2014: “while medicinal use of nicotine is a public health option under the treaty, recreational use is not.”

    This early denial of harm reduction principles and mistaking product evolution and substitution for market expansion by the tobacco industry led many developing nations to begin formulating policies to ban e-cigarettes even as they were undergoing rapid development by small-scale Chinese producers—becoming safer, affordable and more effective in helping smokers switch.

    In India, the then Union health minister, Harsh Vardhan, who was well-steeped in the WHO mindset through his earlier work in establishing smoke-free public spaces policies in the 1990s as a state health minister, formed committees soon after the FCTC meeting to evaluate the impact of e-cigarettes. Staffed with experts from the same WHO-linked tobacco control ecosystem, the committees recommended a complete ban. Notably, another panel formed by the commerce ministry to study ENDS favored the regulatory approach but was overlooked.

    In an unexpected twist, the health minister was thereafter reshuffled to another ministry in late 2014, and the issue remained on the backburner until 2019 under the incumbent, although a slow-paced administrative and legal battle continued. The health ministry, through various regulatory bodies, tried to outlaw e-cigarettes, first by claiming they contain nicotine, which requires these products to gain medical approval, and thereafter by stating nicotine is governed by the Poisons Act, which forbids its sale as a consumer product. Both claims were shot down by courts that consistently indicated favor toward the regulatory pathway.

    This deadlock continued until Vardhan was reappointed health minister when his party swept back to power in mid-2019 with an absolute majority. Strengthening his hand was a perfect storm. A major push to ban vaping was being led by tobacco control nonprofits linked to funding from Bloomberg Philanthropies. Among them were The Union, the Campaign for Tobacco-Free Kids (CTFK) and Vital Strategies, which had been lobbying state governments to ban e-cigarettes. With the central government now on board, the wave became a tsunami, and soon, over 15 Indian states had declared a ban on vapor products.

    An underlying economic factor could also be that U.S. e-cigarette maker Juul, which had captured 70 percent of U.S. market share in under two years, announced its entry into India earlier that year, spooking the Indian tobacco industry, which until then had made little effort to develop vapor products, perhaps because the regulatory cloud cast on them since 2014 made long-term investment a risky proposition. Data revealed recently through a Supreme Court directive shows that India’s dominant tobacco company, ITC, donated upward of $11 million to the ruling dispensation a few months before the vape ban. However, it is unclear if this was to influence the ban, to favor or oppose it, or if it was part of election-time funding corporations often provide.

    Nevertheless, the insistence by Juul, which publicly led the pro-vaping side, on relying on foreign experts who did not well understand the complex and opaque Indian tobacco ecosystem; lack of homegrown research and tobacco cessation researchers who could have countered the anti-vaping narrative from the local network developed by Bloomberg-funded nonprofits; as well as the absence of the local tobacco industry from the debate were all contributing factors.

    What followed in rapid succession was to counter the opposition from courts by first banning research into e-cigarettes, followed by a “white paper” by the country’s top government-controlled research body, which cherry-picked research to make a case for a complete ban. This became the basis for an executive order prohibiting the sale of e-cigarettes and heated-tobacco devices, which, breaking from tradition, was announced by the finance minister. Stocks of Indian tobacco companies spiked after the news.

    The bill was debated in Parliament a few months later, where after a lengthy but low-quality debate as many politicians admitted they had not seen these devices and despite allegations of favoring the local tobacco industry and over 60 specific objections to the law, it was passed by brute majority. Vardhan was honored by the WHO with its top award for implementing the e-cigarette ban while The Union and the CTFK congratulated the Indian government along with claiming credit for the legislation. It was win-win for all, those selling tobacco and the ones opposing them, except the over 100 million smokers who had been denied legal access to safer ways of consuming nicotine, as well as the independent e-cigarette vendors, most of whom moved shop to Dubai when a Juul-led court challenge to the ban failed to bring relief.

    The Fallout

    After a year or two of realignment, which saw the vapor market change hands from rule-conscious vendors to black market operators who added e-cigarettes to their portfolio along with smuggled cigarettes (which constitute over a quarter of the market), mobile phones, gold and other prohibited or tax-evaded goods, the full scale of untended consequences some parliamentarians, policymakers and international experts had warned about started becoming apparent.

    The first was a product shift from mod-based devices to much cheaper disposables, which had lower barriers to entry and could be stocked by streetside vendors who have become accustomed to and adept at violating tobacco control laws such as the bar on selling loose cigarette sticks and the ban on gutka and pan masala. It did not take long for these substandard and untested, though affordable, single-use devices from becoming available in small towns across the country, growing the illicit vape market into an industry worth billions as smokers voted for their health by trying to switch while teens had a lot freer and cheaper access to them, the key rationale for the ban. The constituents that suffered were older and women smokers, for whom risk reduction could be most beneficial but who are least likely to engage with the black market. Many of them who had switched went back to smoking.

    A public health opportunity to convert over 100 million smokers and save lives with minimal stress on state resources while earning tax revenue and creating jobs, especially when unemployment rates are soaring, was lost and replaced by increased criminality, lost revenue, heightened risk for adult switchers as these products have not undergone quality checks, and easier access for teens and unintended users.

    The ban led to a short-term windfall for the local cigarette industry with most companies witnessing steady rise in valuations—ITC’s market cap recently overtook BAT’s—especially with the additional sop of the government not raising taxes on cigarettes and other tobacco products for three consecutive years. Yet, despite these remarkable industry concessions for a country hailed as the leader in tobacco control among developing nations, the picture is beginning to look less rosy by the day for local tobacco companies as these switchers are their lost customers who, given the high quit rates for smokers who try vaping, will likely never be back nor will those who are being introduced to recreational nicotine through e-cigarettes as there is little empirical evidence for the gateway theory.

    Failure to preempt shifting consumer behavior and the ensuing black market explosion, that too in a competing future category in which they are now prohibited from participating, could have significant implications for the Indian cigarette industry as no amount of protections and launching sticks in new flavors, which is partly responsible for sustaining cigarette sales, can compete with the users’ desire to safeguard their health and consume nicotine in less harmful ways.

    The Challenges Ahead

    Despite the central government’s ban on e-cigarette research and the media gag on publishing anything pro-vaping, despite the ban on carrying vapes through flights even though their use is not prohibited and despite Bloomberg Philanthropies pumping in a large tranche of funds for anti-vaping efforts, it is hard to miss the rapid transformation taking place in Indian towns and cities as smokers switch en masse to vapor devices.

    An additional pain point for the legacy industry could be the South African experience of the difficulty in shaking off the black market once it takes hold. Even if vaping was legalized in the near term, the legitimate taxed products will find it hard to compete with the cheaper illicit ones, more so when the consumers have been introduced to vaping through the black market.

    The challenge also lies in re-educating the medical fraternity on nicotine—eight of 10 doctors in India believe nicotine causes cancer—such that they understand the role risk reduction can play in reducing tobacco-related mortality and morbidity and sign on to help people struggling to quit toxic forms of nicotine use, or those who do not want to, lower risks by switching to much less harmful alternatives. This will be a tough barrier to cross because high nicotine illiteracy has led to proposals to overturn even the 2014 Moscow statement by restricting access to medical nicotine by making nicotine-replacement therapy (gums and patches) available only through prescription.   

    But it is never too late to course correct, and there appears to be some signaling from the ruling dispensation, which, if opinion polls hold, is set to return to power in the ongoing national elections (the opposition already favors regulation over a ban). The home ministry recently restricted the funding of the CTFK, a significant anti-vaping voice in the country, along with its key local partner while pro-government media is beginning to publish in favor of tobacco harm reduction again. It must not be hard to see the health and economic rationale for ending the ban on safer nicotine alternatives when it is not working anyway.

    Samrat Chowdhery is a journalist and tobacco harm reduction expert based in India.
  • Real-World Quitting

    Real-World Quitting

    Photo: Pressmaster

    What we know, and don’t, about how people stop smoking

    By Cheryl K. Olson

    Skip Murray was a failure at quitting. After trying countless times over the years to stop smoking, she was through. When she chose to try e-cigarettes, she says, “I had no intention of making a quit attempt. The purpose of my vape was to use it only when I could not smoke, as a temporary substitute.” Four months later, Murray realized that she could not remember the last time she’d lit up. She had accidentally quit smoking.

    Randomized controlled trials are the widely acknowledged gold standard in research. They are great for establishing whether a particular approach can create a meaningful effect. Thus, trials of smoking cessation methods typically recruit people who intend to quit, and assign them to use specific products in particular ways. The downside? This approach fails to capture the messy quitting experiences of millions. This includes Murray, a Minnesota-based tobacco harm reduction advocate and writer.

    Reviews by the Cochrane Collaboration that incorporate randomized trials and other planned intervention studies assure us that e-cigarettes have the potential to help people quit smoking. The Centers for Disease Control and Prevention’s National Health Interview Survey says 7.5 million adult Americans stopped smoking completely from 2020 to 2022. But how did they do it? Are people in the real world using reduced-harm alternatives to kick the habit?

    Raymond Niaura, professor of epidemiology at the New York University School of Global Public Health, has been looking into this. “Over the years, there have periodically been reports that have come out talking about methods people use to quit smoking or try to quit,” he says. “But most information is out of date.”

    For example, the 2014–2016 National Health Interview Survey (NHIS) listed 10 possible quit methods. The two most popular were giving up cigarettes all at once (a.k.a., “cold turkey”) and gradually cutting back. Although those unaided methods are popular, they aren’t considered to be evidence-based and often result in relapse down the line. E-cigarettes were a distant third in popularity but ahead of nicotine patches or gum. Most people indicated trying multiple quit methods.

    How We Quit Now

    Niaura and statistician Floe Foxon were already doing some analyses of NHIS data. They decided to detour and look at the latest publicly accessible figures on quitting methods, from 2022. Study participants who had stopped smoking completely in the previous two years were asked whether they had used any of a list of methods. They were also asked whether they had tried “to quit by switching to electronic or e-cigarettes.”

    “We found that use of e-cigarettes was pretty high. In fact, it was the No. 1 method used to quit smoking,” says Niaura. “That caught me a little by surprise.” These results hint at a quiet revolution. E-cigarettes may be playing a larger role than popularly assumed, in both attempted and successful quitting.

    Niaura and Foxon presented a poster of their findings at the March 2024 annual meeting of the Society for Research on Nicotine and Tobacco. Updated and expanded results will be published shortly. (Foxon consults for Juul through Pinney Associates. The poster and paper received no funding.)

    Survey Letdowns

    The NHIS is unusual in that it directly asks people how they stopped smoking. Most studies simply don’t ask. Nationally representative data on this question is surprisingly scarce. The alphabet soup of U.S. government studies such as NHANES, BRFSS and NSDUH inquire only about whether someone smokes now or used to smoke.

    Even the NHIS doesn’t ask annually about quitting. Because the survey covers a massive range of health issues, questions are often dropped or altered. The 2024 version asks whether in the past 12 months “a doctor, dentist or other health professional advised you about ways to stop smoking or prescribed medication to help you quit.” This is a worthy variation, but the approach thwarts year-to-year comparisons of change.

    Researchers are left to puzzle over what little information they can get. For example, the U.S. Food and Drug Administration’s Population Assessment of Tobacco and Health (PATH) survey asks about past-30-day use of cigarettes and electronic nicotine-delivery systems (ENDS). Because participants complete a series of PATH surveys over time, we can see that the link between quitting smoking and using ENDS has gotten stronger over time.

    Another problem with surveys? Varying or missing options for answers. In the 2022 NHIS, says Niaura, “We don’t know how many people quit cold turkey with no assistance. They didn’t ask that.” Instead, the response options included a variety of nicotine-containing medications and several behavioral help options, such as telephone quit lines and counseling. NHIS asked about ENDS but didn’t inquire about quitting smoking via other nonmedicinal reduced-risk products, such as pouches, snus or heated tobacco.

    Shifting response options do give glimpses into how assumptions change over time. “Back in the 1950s and 1960s, people were interested in things like, did you switch to a pipe or cigar to help you quit smoking,” notes Niaura. Oddly, the 2014–2016 NHIS questionnaire included the discredited cessation option of “switched to ‘mild’ cigarettes.”

    A third problem with nationally representative surveys is that they can’t tell us how people go about quitting. “We don’t really understand the whole process,” says Niaura. “The high numbers in the [NHIS] survey mean this is a frequent occurrence, that smokers are using e-cigarettes and quitting. How come there’s not a ton of research being conducted on those kinds of questions?

    Harking back to Murray’s experience, Niaura notes that many smokers “didn’t set a quit date, make a plan and go out and buy some e-cigarettes. And it still worked.”

    “So, what’s happening there?” he wonders. “What’s their experience along the way? What difficulties do they run into? Where are they getting advice?”

    Finally, Niaura ponders how e-cigarettes might be made even more effective, perhaps with some form of counseling and support, such as vape shops have provided to customers. With vape shops closing due to regulatory restrictions, this question deserves urgent attention.

    Regardless of what the government says or doesn’t say, in many ways, we are in a golden era of quit methods.

    Raymond Niaura, professor of epidemiology, New York University School of Global Public Health

    Success Factors

    A few studies have looked at factors linked to successful quitting with e-cigarettes. In a 2021 online survey, vaping more often throughout the day was linked to good outcomes. So was an abrupt switch from smoking to vaping rather than a gradual one. Using a newer device type (e.g., rechargeable pods) rather than older cig-a-like products also helped. Researchers also noted that “most people reported trying more than one e-cigarette flavor and more than one device type when trying to quit smoking.”

    A qualitative study used online individual interviews with people who had quit smoking with e-cigarettes, looking for factors that separated long-term success from short-term attempts. Those who gave up had trouble finding a vape they could stick with that met their needs and prevented cravings.

    I asked Murray for a reality check. To her, it makes sense that newer vaping devices could more effectively help people quit smoking. “I tried a cig-a-like. I didn’t like anything about it—how it felt, what the hit was like or how it tasted,” she says. “It was more satisfying to smoke!”

    She noted that, as with all new technologies, vaping devices have improved along the way. “There were issues with earlier products that leaked or weren’t reliable.”

    Based on her experience as a former vape shop owner, Murray found that for people who smoked heavily, the newer pod systems that use nicotine salts can be a game changer. “Those products provide enough nicotine to replace what they got from combustible tobacco,” she states.

    “A Golden Era”

    Niaura finds it frustrating that the FDA does not do more to promote the visibility of studies like these, including ones that use the FDA’s own PATH survey data. “Regardless of what the government says or doesn’t say, in many ways, we are in a golden era of quit methods,” he points out. “The good news is there are more ways to stop smoking than ever before: e-cigarettes and other reduced-risk products as well as tried-and-true conventional methods.”

    “Go and try something,” he urges. “And if it doesn’t work, try something else.”

    “The one valuable lesson that society should have learned is that there is no one-size-fits-all solution to the smoking epidemic. So no one product is perfect for all consumers,” concludes Murray.

    “Someone who smoked six cigarettes a day for a couple of years has drastically different needs than someone who has smoked two packs a day for 30 years,” she adds. “What part of smoking was most important to them, why they smoked and when or where they smoked are all parts of the equation when it comes to finding what will work best to help them stop.”

    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.
  • The Path Less Traveled

    The Path Less Traveled

    Originally launched as a limited edition, Gizeh’s Pink collection proved so popular that the company kept producing additional volumes and developed products with filters and matching merchandise. | Photo: Gizeh Raucherbedarf

    German rolling papers manufacturer Gizeh is finding new ways to appeal to consumers.

    By Stefanie Rossel

    The growth of the rolling papers category is often attributed to smokers’ changing behavior in challenging economic periods. In times of lower disposable income, consumers may shift from expensive factory-made cigarettes to more affordable roll-your-own or make-your-own products.

    There are, however, considerations that go beyond financial ones. “It’s certainly the case that consumers spend less money on smoking if they roll their cigarettes themselves,” says Lisa Esser, head of corporate affairs and development at German rolling papers manufacturer Gizeh Raucherbedarf. But for many RYO lovers, she notes, that’s not the main criterion. “Most of the time, the enjoyment of seeing, feeling and smelling the tobacco, and then turning it into a cigarette is centerstage,” she says. “A smoking experience with all senses creates an individual moment of enjoyment.”

    It’s perhaps this aspect that contributes to a phenomenon seldom witnessed in other areas of the nicotine market: RYO smokers often feel a strong bond with their rolling paper brand. Gizeh has responded to this attachment by launching a series of unusual special editions, such as the “All Pink” collection, which was first introduced in 2022 and comes as a king-size slims and tips set with all-pink papers, filter tips and even a pink magnetic lock. At last year’s InterTabac trade fair, the company debuted a version with reusable active filters, catering to the growing popularity of active charcoal filters. A matching metal tray as well as a lighter and a grinder complement the offer.

    “The pink collection was meant as a limited edition to try out something new,” says Esser. “But demand didn’t cease, so we kept producing new volumes and developed a range of products with filters and matching merchandise. With the blockbuster movie Barbie, the pink edition experienced a real boost. Maybe we were ahead of the trend with our marketing instinct?”

    Illicit Cigarettes on the Rise

    Fandom aside, economic adversity remains a major driver for RYO sales. Gizeh, which was founded in 1920 and is part of the Mignot and De Block group, is best known for its Gizeh, Mascotte and Marie brands. The company is present in more than 80 markets, with Europe being its main areas of operation. Here, Gizeh also sees the greatest opportunities for its business. The Covid-19 pandemic and the war in Ukraine have driven up prices and taken a toll on disposable incomes in many markets, prompting smokers to be more judicious in their expenditures.

    Another beneficiary, unfortunately, has been the informal market. “Illicit cigarette trade in Germany has significantly increased since the end of the Covid pandemic and the reopening of borders,” says Esser. “A fifth of the cigarettes smoked in Germany are nonduty paid. Tobacco taxes account for about half of the retail price of cigarettes in Germany, hence the import of nonduty-paid tobacco products becomes interesting for smart spenders. According to estimates by market research company Ipsos, the share of nonduty-paid cigarettes in Eastern Germany, which borders on some of the European Union eastern member states, is almost 40 percent. In the western part of Germany, it is approximately 13 percent. In 2021, German customs seized about 117 million nonduty-paid cigarettes. Only recently, a ‘garage factory’ making illicit whites was uncovered in the Ruhr area. Financial constraints, it appears, rather drive illicit trade than RYO sales.”

    Cannabis as a Driver

    The global rolling papers market was worth $714.1 million in 2023, up from $678.8 million in the previous year, according to Future Markets Insights. By 2033, the market is expected to reach $1.19 million. Surging demand for hemp-based rolling paper is expected to steer the growth of the market at a compound annual growth rate of 5.2 percent during that period, the business intelligence firm predicts.

    Meanwhile, the spreading legalization of recreational cannabis is presenting rolling paper manufacturers with new opportunities. The most recent country to partially legalize the recreational use of cannabis was Germany, a move that made it the first EU member state and the second G7 country after Canada to permit adult use for fun.

    Since April 1, adults aged 18 and over may carry up to 25 grams of cannabis for their own consumption and store up to 50 grams at home. They are also permitted to keep three plants for home cultivation. The new law allows for public consumption, provided that is not within sight of children or near sports facilities or takes place in pedestrian zones between 7 a.m. and 8 p.m. The original goal of making cannabis available in licensed shops has not yet been implemented, however. Instead, special cannabis clubs that can have up to 500 members will be allowed to grow and purchase the drug on a limited basis from July 1, 2024.

    Gizeh caters to this market with various dedicated products. “Since April 1, papers and filters can be purchased by adult consumers to fulfill the purpose for which they have already been used for a long time—namely, for the consumption of cannabis,” says Esser. “Following the motto ‘For pleasure only,’ we want to contribute to destigmatize cannabis products and to get the consumer out of illegality. As one of the leading manufacturers for papers and other accessories worldwide, we want to become No. 1 in the recreational products segment, by which we mean the segment focused on conscious and enjoyable cannabis consumption by adults.”

    Roll With It

    In September 2023, Gizeh expanded its recreational portfolio with Gizeh Cones, a product line comprising three cone types, including conical filter tips, which are targeted at users who don’t want to make joints themselves, prefer evenly shaped joints or don’t have much practice in rolling them.

    “The highlight of the range is the patented cone-shaped Active Filter, which has a diameter of 6 mm to 7 mm and was especially developed for king-size papers,” says Esser. “The conical design prevents the filter from dropping out of the cone when rolling. The purified active charcoal in the core of the filter is based on coconut shells, a renewable raw material. Ceramic caps on both ends with seven holes each allow for an optimal airflow. Our cone-shaped filters are made in Germany and can be used multiple times, making them sustainable.”

    According to Esser, marijuana consumption was already commonplace in Germany before legalization. “The new law only removes existing truths from the gray area,” she observes. Esser expects the German market to follow the same path as Canada, where recreational cannabis for adult use became legal in October 2018. “Perhaps demand will increase at first, but then I expect it to even out at the level where it already stands.”

    Partnerships and network extensions are another part of Gizeh’s growth strategy in recreational cannabis. To inspire brand loyalty, the company last year launched a limited edition sneaker with shoe company Kangaroos. “Cultural influences are an important driver for the Gizeh brand and will be an essential part of communication in the future,” says Esser. “What exactly [that will be] will be a surprise.”

    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.