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  • Reviewing Their Peers

    Reviewing Their Peers

    Photos courtesy of CoEHAR

    CoEHAR’s REPLICA Project evaluates nicotine-related science to ensure that policymakers and the public receive correct and reliable information.

    By Stefanie Rossel

    Riccardo Polosa

    Nicotine products, stakeholders agree, should be regulated based on scientific evidence. Unfortunately, an increasing volume of research underpinning policy appears to be based on questionable science, where researchers are unable to replicate the results. This “reproducibility crisis” occurs across various disciplines, including psychology, medicine and natural sciences. The phrase was coined in the early 2010s, and efforts to remedy the problem have led to the creation of a new scientific discipline, meta science.

    To tackle the reproducibility crisis in the nicotine sector, the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) in November 2019 launched the REPLICA Project, an initiative to independently validate the results of e-cigarettes and heated-tobacco products (HTP) studies.

    “Annually, billions of dollars are poured into biomedical research, yet more than half of these studies cannot be replicated due to flawed experimental designs, inadequate methodologies and faulty statistical analyses,” explains Riccardo Polosa, the founder of the CoEHAR, who also is a full professor of internal medicine in the Department of Clinical and Experimental Medicine of the University of Catania in Italy. “Bad science holds back medical progress,” he says. “The challenge of replicability is widespread, spanning numerous scientific domains, including the field of THR.”

    According to Polosa, the problem is amplified due to the contentious nature of tobacco and nicotine. “Often, the focus seems more centered on perpetuating controversy rather than prioritizing public health concerns,” he says. “The unfortunate reality is that there appears to be minimal interest in resolving the replicability crisis within the field of THR science, as it may conflict with the mainstream anti-THR narrative.”

    Unique Approach

    The REPLICA Project replicates published in vitro toxicity studies with the help of seven research laboratories spread over various countries, including the U.S., Indonesia and Serbia. According to Polosa, this approach is unique. “Its success hinges on complete harmonization between these research labs, necessitating ongoing international training, adherence to standard operating procedures and uniformity in lab equipment/material,” he says.

    “We uphold the highest tobacco research standards, employing ISO-regulated setups for smoking/vaping laboratories and approved standardized smoking/vaping machines in our replication studies. While you cannot directly compare the REPLICA’s approach with the individual studies we replicate, many of the studies we aim to reproduce lack adherence to the best tobacco research standards. They often overlook smoking/vaping laboratory standards regulated by ISO guidelines and resort to unregulated homemade smoke/vape machines. Our methodology aligns with the open science principle—in contrast to the works we assess, which frequently present methodological ambiguities and sometimes obscure interpretations of data.”

    According to Polosa, the advantage of REPLICA’s cooperation model lies in the consensus reached when results from one laboratory align with those from others. This, he says, ensures a more reliable basis for new knowledge. Replication, Polosa adds, bolsters confidence in scientists’ findings.

    “Furthermore, this networking model of multiple research labs united in pursuing a common objective fosters unique opportunities for knowledge sharing and building capacity, thereby ensuring elevated standards in THR research,” says Polosa. “In line with [the] CoEHAR vision and mission, nascent labs in low-[income] and middle-income countries can connect with the REPLICA consortium, providing them with the chance to thrive. Specifically, young researchers from Serbia and Indonesia have been offered CoEHAR mobility training programs at the University of Catania under the guidance of REPLICA researchers.”

    Promoting Understanding

    In the first phase of the REPLICA Project, which ran until 2022, researchers replicated seven studies. The project initially focused on independently verifying science published by the tobacco industry. As it gained expertise, the project also began evaluating papers published by academia in scientific journals.

    “Each decision to replicate a study revolves around identifying topics vital for better understanding of the THR paradigm and for improved protection of human health,” explains Polosa. “In addition, feasibility considerations for all partners within the study’s framework become paramount. Although consideration about studies that appear to be flawed are secondary, we occasionally opt for studies that are partially well-executed, recalibrating inadequately set parameters. This meticulous approach aims to inform the scientific community, regulatory bodies and lay public with credible and comparable data that mirrors the normal condition of use of combustion-free nicotine products.”

    In several studies, the REPLICA Project researchers were able to replicate outcomes. “Specifically, our investigations revealed consistent evidence indicating the reduced capacity of e-cigarettes and HTPs to induce cytotoxicity, inflammation, endothelial damage, genotoxicity and mutagenesis in human lung epithelial and endothelial cells,” says Polosa.

    Other studies revealed irregularities, however. “We’ve pinpointed noteworthy methodological flaws in at least three recently replicated studies,” says Polosa. “For instance, one study encountered issues due to an inadequately supplemented culture medium, resulting into abnormal cytotoxicity in cells. In another instance, researchers used incorrect fluorochromes, hindering the clear distinction of adhesion events of inflammatory cells to the vascular bed. Lastly, flavors were vaporized at excessively high temperatures using a furnace instead of the intended vaping machine under standard conditions of use. These identified flaws are either in the process of being addressed or have been thoroughly examined and will be disclosed in forthcoming peer-reviewed publications.”

    According to Polosa, the reported shortcomings relate not only to scientists’ mistakes but also the editors and reviewers who approved the publication of low-quality research.

    Providing Accurate Information

    Polosa says that CoEHAR’s researchers actively seek out the original authors to discuss methodological shortcomings and to request additional information with the goal of establishing productive collaboration and enhance the replication protocol. “Unfortunately, this is not as straightforward as it should be,” he says. “Previously, we encountered situations where authors offered only partial responses to our concerns, leading to increased confusion regarding their ‘irregular’ approaches in their scientific work.

    “Regrettably, this lack of comprehensive information resulted in the abandonment of replication attempts in most cases. Often, eminent scholars in this field, despite their expertise, unintentionally make errors in their study approaches. However, some may hesitate to acknowledge or fail to grasp these errors. Through focused scientific engagement, our aim is to educate researchers, especially those new to the THR paradigm, facilitating a deeper comprehension of these intricacies.”

    While the CoEHAR team hasn’t encountered many studies that warrant retraction, there have been instances that would justify such a course of action, like the most recent one investigated, which has not been published yet. “We’re considering this course of action pending discussions with the original author,” says Polosa. “It’s important to note that while some studies may not be inherently flawed, they might be inadequately aligned with the subject matter. For example, certain studies might provide valuable insights in other areas but fall short in their relevance to evaluating the effects of vaping. When the study setting is drastically different from the context of vaping, its conclusions can’t be responsibly applied to this specific practice. It’s akin to studying the impact of a bicycle accident at 350 km/h and then advocating to ban bicycles due to their perceived risk, a distortion of reality that fails to accurately address the intended subject.”

    The project’s foremost objective, Polosa insists, is to provide accurate information to the public rather than preserving the reputation of the scientists behind the original studies. “While retractions aren’t taken lightly and involve careful consideration, our obligation remains toward ensuring the public and policymakers receive correct and reliable information.”

    Phase Two

    CoEHAR is funded by the Foundation for a Smoke-Free World (FSFW), which was financed exclusively by Philip Morris International until Oct. 20, 2023, when the organization announced it would no longer accept tobacco funding in an effort to address concerns about is independence.  Polosa emphasizes that credibility of his team’s work is not an issue if REPLICA studies debunk original science. “Although we’re relatively new, our credibility is steadily building,” he says. “The strength of CoEHAR’s REPLICA project rests in its robust, high-quality research, consistently published in reputable scientific journals. Despite funding ties with FSFW, our project has swiftly garnered a positive reputation worldwide. This funding association doesn’t diminish our research’s significance. REPLICA’s growing scientific output unequivocally proves this point.”

    Increased funding should be directed toward replication studies of THR products, notes Polosa. “Stakeholders need to commit additional resources to this vital research area,” he says. “We are grateful to the FSFW that has recognized the importance of replicability in science and has generously provided cutting-edge equipment and other resources, supporting our mission to reinvigorate replication science in THR.”

    Engaging with media outlets to communicate findings from replication studies is an essential aspect of the project. “However, a significant challenge arises when the original study’s results were sensationalized, as there might be little motivation to rectify misinformation if the correction lacks the same attention-grabbing quality,” says Polosa.

    He cites the example of the 2019 EVALI crisis in the United States, when an initially mysterious outbreak of lung injuries was at first erroneously attributed to nicotine vaping but later turned out to have been caused by adulterated (and illegal) THC products. Once the original, sensationalized narrative had spread, it became difficult to correct.

    “Similarly, in the realm of in vitro toxicological studies investigated by the REPLICA researchers, algorithms often prioritize popularity over accuracy, complicating efforts to disseminate corrected information effectively,” say Polosa. “Despite these hurdles, our commitment remains steadfast in sharing our findings extensively with the public, academia and relevant stakeholders.

    “While our replication efforts are starting to gain traction in shaping public opinion and influencing regulatory bodies, the primary goal of our studies is to assess ongoing and future research and prevent recurring errors within THR science. Ultimately, our aim through this correction process is to dispel substantial misconceptions about the health risks associated with combustion-free nicotine products. As we progress, we anticipate a reduction in sensationalized and inaccurate reporting by the media, leading to a more informed and balanced understanding among the public and policymakers.”

    In 2023, the REPLICA Project entered its second phase, which among other things aims to align the project’s studies with academic research while elevating the complexity level. “Our focus is on replicating and expanding studies conducted in collaboration with partners,” says Polosa.

    “Specifically, we’ll conduct thorough screenings for cytotoxicity and mutagenicity, examining increasing concentrations of most common vaping flavors. These results aim to ascertain the safety of these flavors and their concentrations for inhalation. Within our REPLICA 2.0 project, we aim to shed light on the potential impact of nicotine on cancer development. Employing a comprehensive approach, we’ll utilize various assays to screen for carcinogenicity. Regulatory bodies like the U.S. Environmental Protection Agency and the International Agency for Research on Cancer heavily rely on these models’ data to classify substances and make informed regulatory decisions.”

    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.
  • Aiming Low

    Aiming Low

    Photo: Taco Tuinstra

    Producing tobaccos with ‘minimally addictive’ levels of nicotine presents significant challenges for breeders and growers.

    By Stefanie Rossel

    In recent years, several countries have been considering mandates for manufacturers to reduce nicotine in combustible tobacco to “minimally addictive levels”—that is, under 0.5 mg/g. By decreasing the habit-forming ingredients, the thinking goes, cigarettes will become less attractive and consumption will decrease.

    A webinar organized by Coresta on Dec. 5, 2023, highlighted the current understanding of LNT production capabilities as well as the successes and failures of applied research in the areas of genetics and agronomy.

    Ramsey Lewis, a university faculty scholar at North Carolina State University in Raleigh, North Carolina, USA, spoke about the opportunities offered by modified plant genetics to reduce tobacco nicotine levels. A standard cigarette filler contains 15 mg to 25 mg of nicotine per gram or 1.5 percent to 2.5 percent, he noted; the World Health Organization recommends a 35-fold reduction, which corresponds to 0.4 mg/g or 0.04 percent of nicotine.

    Nicotine is the most abundant alkaloid in tobacco, accounting for 90 percent to 95 percent of the alkaloid content. As alkaloids are natural plant products, nicotine levels in a tobacco variety depend on genetics and the environment. In the U.S. Nicotiana tabacum collection, there are several lower nicotine species. A decrease in nicotine, however, means an increase in nornicotine, a carcinogenic tobacco-specific nitrosamine.

    Lewis described various low nicotine genetics experiments his team had conducted in 2023, where different known nicotine-expressing genes had been inactivated. While a transgenic approach got them close to a 0 mg nicotine content, the plants in the field were dramatically reduced. In addition, the LNT was high in nornicotine, and its cured leaf quality was altered—both side effects that regulatory authorities wouldn’t accept, Lewis explained. His experiments, which also included a greenhouse trial, showed altered gene expression and altered physiology in low-nicotine plants.

    Plants are living things and complex, Lewis pointed out, which results in several issues for tobacco growers and buyers of low-nicotine tobacco. At present, there are only a small number of commercially available varieties, which means that if LNT was suddenly mandated in a market, the regulation could practically not be translated into action.

    Nicotine is also the natural defense mechanism of tobacco plants. The lower its content, the more the plant is susceptible to disease and insect pests. Lower nicotine also results in lower yields and higher production costs. In addition, Lewis predicted global issues with the “new breeding methodology” and problems with co-mingling. He also raised the question of what should be done with tobacco containing more than 0.4 mg/g of nicotine.

    An Ambitious Target

    Anna Malpica, breeder and R&D manager of Bergerac Seed and Breeding (BSB), a seed company owned by the French growers’ association, introduced her organization’s breeding programs for low-nicotine and ultra-low nicotine tobacco varieties and evaluated the impact of lower alkaloid lines on plant defense. BSB focuses entirely on practical breeding projects. Being based in Europe, the company uses non-GMO and non-gene-editing techniques in its programs. For LNT, the breeder target is to achieve reduced and stable nicotine levels with an industrial variety.

    Nicotine is synthesized exclusively in tobacco roots, transported to leaves and stored in the leaf cell vacuole to protect the plant when it is stressed. The biggest stress for the plant occurs during topping, which is done to reduce the dry matter production in the leaves and improve the plant’s quality. The genome sequence of tobacco provides a large inventory of structural and regulatory genes involved in the now well-known and described nicotine pathway, Malpica related. Researchers benefit from ever more precise studies that quantify the influence of the production environment and the crop management on the nicotine rates in tobacco leaves.

    In its plant breeding strategies for low-nicotine and ultra-low nicotine flue-cured (FC) tobaccos, BSB resorts to three key raw matter sources: a germplasm collection including wild tobaccos with nicotine levels of 0.01 mg/g to 3.97 mg/g; U.S. FC historical lines; and short-cycle, ripening breeding lines originating from North Europe. The shorter the plant cycle, the less nicotine accumulation is observed in the plant, she noted.

    BSB creates large segregating populations from the best seeds, applying strong selection pressure oriented on nicotine rates. It also secures and selects yield quality and some target resistance genes. The objective is to obtain low-nicotine varieties with nicotine levels under the company’s threshold of 10 mg/g. For its ultra-low nicotine breeding programs, BSB adds lines with mutations as initial donor material. The company is capable of breeding very-low nicotine lines with a controlled average nicotine rate of under 1 mg/g. A look at BSB’s low-nicotine breeding activities between 1997 to 2023 revealed that the threshold of 0.4 mg/g has not been reached yet in BSB’s usable lines, though.

    In 2023, the company investigated the impact of low-nicotine breeding on yield, quality and plant defense in a trial using burley, dark and FC varieties. On average, no decrease of yield was observed in the low-alkaloid (LA) varieties. BSB says it has been able to compensate for the genetic yield decrease of the LA lines by population breeding. This, however, could not make up for the lower quality, which on average declined by 24 percent. The lowest nicotine level was obtained in an XC stalk position with 1.5 mg/g in a burley variety. Higher nicotine varieties were less susceptible to budworms whereas there was no significant impact of the nicotine rate on the plants’ susceptibility to the tobacco flea beetle. The role of nicotine on the plant defense front, researchers presumed, may vary from one insect species to another.

    In conventional breeding, Malpica concluded, low nicotine levels of 5 mg/g to 15 mg/g can be obtained with conventional breeding and adapted agronomical practices. They are available from BSB as commercial varieties. Ultra-low nicotine contents of under 0.4 mg/g with acceptable behavior regarding quality and aroma, however, seem difficult to achieve with stability from conventional breeding and are not part of BSB’s portfolio yet.

    Time of Topping

    T. David Reed, extension agronomist for tobacco at the Virginia Tech Agricultural Research and Extension Centers, provided a closer look at the agronomic practices impacting nicotine concentration of FC tobacco. He referred to a 2019 study by Henry, Vann and Lewis, which suggested that proposed regulations mandating lower nicotine concentrations in tobacco products would likely require changes in tobacco production while maintaining yield and quality.

    In standard FC tobacco production practices, Reed pointed out, a population of 13,600 plants per hectare to 16,100 plants per hectare is typical. The topping height is between 18 leaves to 22 leaves per plant, and the total number of leaves amounts to around 296,000 per hectare.

    Topping is a standard production practice, and its timing impacts yield and sucker control. When topping is delayed past the early flower stage, a yield loss of 17 kg per hectare per day may occur. With late topping, the cured leaves are thinner and less bodied.

    Regarding fertilization, nitrogen is the most responsive nutrient in terms of tobacco yield and quality. The nitrogen fertilization rate is determined based on soil texture and depth to a clay layer as well as field history. The recommended nitrogen rate is 67 kg to 90 kg per hectare but can be as high as 112 kg/ha.

    While tobacco is relatively drought tolerant, it is responsive to rainfall and irrigation, with too much rain being a more common occurrence. Unlike other crops, such as certain grains or soybeans, tobacco is not as dependent on timely rainfall to produce an adequate yield. Dry conditions paired with high temperatures can impact cured leaf quality and leaf chemistry.

    According to Reed, the number of harvests or primings has decreased in recent years. For most growers, three harvests are typical; some harvest four times. The time from topping to harvest can range from 8 weeks to 14 weeks or more on a given farm.

    Tobacco growers, Reed emphasized, choose their agronomic practices in order to maximize their yield potential of high-quality, marketable tobacco. Leaf chemistry, sugar or nicotine content are not part of their consideration.

    Reed quoted three studies by Caleb Hinkle that investigated plant population, topping time and topping height of low-nicotine FC production practices in field trials in 2019 and 2020 as well as a collaborative Coresta study of the low-nicotine tobacco agronomic production practices task force. Modified production practices with low-nicotine FC varieties, he concluded, did not consistently reduce nicotine to the proposed target levels. While plant population, topping height and nitrogen fertilization rate had minimum impact, delayed topping had a significant effect, with no topping having the greatest impact on nicotine. Not topping tobacco, Reed stressed, is not commercially viable in the U.S. The growing season was a major factor on nicotine levels. Both yield and leaf quality, as currently measured, were significantly lower with low-nicotine flue-cured varieties. Leaf texture and body were altered, which impacts the handling of the cured leaf.

    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.
  • On a Roll

    On a Roll

    image: Miquel y Costas

    Driven by cost considerations and growing environmental awareness, do-it-yourself cigarette papers continue to gain popularity.

    By Stefanie Rossel

    Traditionally, roll-your-own (RYO) products thrive in difficult economic periods, and for the time being, it appears, the challenges won’t cease. As the Covid-19 pandemic ebbed, the world was shaken by war in Ukraine, worsening inflation and cost-of-living crises in many countries. Since October, global stability and confidence has been further eroded by the war between Israel and Hamas.

    The economic slump means that many consumers are coping with lower disposable incomes. Among smokers, such a development often encourages a shift from factory-made cigarettes to more affordable RYO or make-your-own (MYO) products.

    Market research companies are hence upbeat about the rolling papers market. Future Market Insights (FMI), for example, expects the value of the global cigarette paper market to grow from $714 million in 2023 to $1.19 billion by 2033, registering a compound annual growth rate (CAGR) of 5.2 percent during that period. “The rising popularity of smoking rolled cigarettes along with an increasing number of states legalizing recreational cannabis are the key factors expected to augment the demand for rolling papers,” the report states. The U.S., where 24 states permit recreational cannabis use, accounts for 16.9 percent of the global rolling papers market.

    In emerging economies, meanwhile, growing demand for rolling tobacco is creating opportunities for manufacturers to expand their footprints in untapped markets, FMI writes. In some of these countries, restrictions on reduced-risk products also play a role. India, for instance, which banned vape products in 2019, is predicted to witness a CAGR of 6.9 percent in sales of rolling papers through 2033.

    Adult smokers increasingly seek all-in-one packaging solutions, rather than making multiple separate purchases.

    Jose Rubiralta, global manager, Rizla

    Careful Navigation Needed

    The global rolling papers market is dominated by several large players. Lately, however, smaller entrants to the category have been offering niche or novelty products in terms of sizes, colors and ingredients.

    “In general, we see an upward trend in the global market for rolling papers being driven by increasing preference for hand-rolled tobacco due to the value offer they provide compared to factory-made cigarettes as well as the rise in prominence for more environmentally friendly and innovative products,” notes Jose Rubiralta, global manager of Rizla, which is part of Imperial Brands. “For Rizla specifically, the more recent negative global developments mentioned bear limited impact. We are actively expanding our presence in different markets to build on our position as the world’s most iconic rolling paper brand.”

    Santiago Sanchez, executive president of France-based Republic Technologies Group, which is best known for its OCB, Zig-Zag and JOB brands, says that the Covid-19 pandemic had boosted his company’s sales. The more recent series of crises has made it difficult to find shipping vessels, however. It has also boosted inflation and caused a scarcity of raw materials. “I usually say that our products sell better during a crisis—and this is what is happening—though I personally regret very much the suffering of so many people in the present wars.”

    Republic has been doing well in its core markets. “Besides, we see an opportunity in new markets, mainly on the American continent,” says Sanchez. “This is not yet linked very much to the RYO tobacco expansion but the depenalization of certain substances such as cannabis that were prosecuted until recently.”

    For Xavier Garcia, commercial director of the RYO division at Miquel y Costas, the geopolitical challenges pose new hurdles that require careful navigation. “While we celebrate the positive impact of changing consumer habits, we must remain vigilant in the face of geopolitical complexities. The challenges are formidable, but they present opportunities for innovation and strategic adaptation.”

    Smoking Paper, Miquel y Costas’ rolling paper brand that will celebrate its 100th anniversary in 2024, currently experiences significant growth in various markets. “The growth of the brand is something transversal and not specific to just a few markets,” says Garcia, who attributes its growing popularity of RYO and MYO products to shortages of affordable cigarettes and higher taxation of factory-made products, among other factors.

    We see that consumers ask for new products that are more environmentally friendly.

    Santiago Sanchez, executive president, Republic Technologies Group

    More Regulatory Hurdles

    The next challenge for tobacco-related rolling papers will be regulation, according to Sanchez. “We have the intrusion of the politicians with constant new regulations,” he says. “We will see what happens with the revision of the European Union Tobacco Products Directive and new laws trying to overregulate [the industry] such as [those] trying to have tobacco-free generations and forbidding filters.”

    Another challenge comes from the EU Single-Use Plastics Directive (SUPD), which entered into force in 2021 and bans the sale of single-use plastic items such as plates, cutlery, straws and plastic/cotton bud sticks as well as food containers and expanded polystyrene cups. The law exempts cigarette filters but will oblige tobacco manufacturers to cover the costs of consumer awareness-raising measures and extended producer responsibility schemes tackling the cleanup of litter and its subsequent transport and treatment and other issues starting this December.

    “While personally I have always been a great defender of the environment, I would have preferred a smoother application of the directive,” he points out. “The commission has not fulfilled its own timetable and now, in November, we still do not know about taxes to be paid next year, especially considering that some will be retroactive to 2023. Once again, the pressure for the smaller manufacturers is enormous and disproportionate.”

    Whether driven by regulation or other factors, eco-friendliness is a major trend in rolling papers, according to Rubiralta. “In line with key consumer trends in the broader fast-moving consumer goods industry, there is a growing demand for more environmentally sustainable products,” he says. “As part of our ongoing efforts, we are actively exploring strategies to reduce the impact to the environment. This includes different product and packaging initiatives of Rizla products, amongst other contributions.

    “This summer, for example, we have introduced our Natura filter tips as well as our plastic-free tips in selected markets, such as Greece. This is our first plastic-free tips range, made with biodegradable paper, which is a milestone that our team takes great pride in. This complements our recent environmentally friendly paper launches of Rizla Classic, which are unbleached papers, Natura hemp papers and our innovative Rizla Bamboo papers offer, which have received favorable consumer responses.”  

    Sanchez’s experience is similar. “We see that consumers ask for new products that are more environmentally friendly,” he says. “For centuries, our industry has used flax and hemp as fibers to produce rolling cigarette paper. Different fibers are now in demand, such as bamboo and rice. There is a preference of some people for rice paper, a raw material that was used many years ago to produce paper. With the improvement of paper technology, these fibers were abandoned because of their fragility. Many products still claim to be ‘rice paper,’ although they’re not made of rice. Republic has gone back to the origins, and it is now producing a special blend of rice plus organic hemp paper, which is the only product in the market containing real rice.”

    Several months ago, Republic Technologies introduced the first bagged filter paper. The company is also reviewing all its packaging to remove plastic wherever possible. “Most of our boxes are no longer plastic-wrapped but they still can guarantee the freshness of the product,” says Sanchez. “We have never been fans of closing devices such as magnets because we feel it goes against the environmental target, so we have developed a new way to close some of our booklets just with a paper flap.”

    While we celebrate the positive impact of changing consumer habits, we must remain vigilant in the face of geopolitical complexities. The challenges are formidable, but they present opportunities for innovation and strategic adaptation.

    Xavier Garcia, commercial director, RYO division, Miquel y Costas

    Seeking Convenience

    In addition to natural papers and innovative materials, demand is also shifting toward larger paper formats and more advanced products, such as thinner papers, according to Rubiralta. Convenience is a big driver as well. “Adult smokers increasingly seek all-in-one packaging solutions, rather than making multiple separate purchases,” he says. “In response, we are placing a strong emphasis on our combi-packs, expanding our product offerings, and ensuring that this product is readily available to our key customers where this format is relevant.” The company launched its combi-packs of papers and paper filters in the U.K. this year.

    “Customers are steering the industry toward a future marked by sustainability, exploration of materials and a demand for convenient solutions,” confirms Montse Bonjorn, director of marketing of Miquel y Costas’ RYO division. “At Miquel y Costas, we’re not merely observing these trends; we’re actively shaping the future of smoking experiences in alignment with our customers’ evolving preferences.”

    The company recently introduced a range of eco-friendly, biodegradable paper filters. “As part of our commitment to setting new industry standards, we are set to launch Smoking Supreme, a product that transcends the ordinary,” she says. “Crafted with meticulous attention to detail, this new rolling paper is characterized by its feather-light weight of 12 grams and an ultra-soft surface texture—a harmonious blend for a supreme smoking experience.”

    In 2021, the company launched Smoking Cones, a collection of pre-rolled cones crafted in a unique spiral design, a layout that requires less paper and glue to manufacture.

    Potential for Growth

    Cannabis is playing an ever more important role for rolling papers manufacturers. As further legalization of recreational cannabis is expected in the U.S. and Europe, Sanchez expects demand for RYO papers to increase. “We have developed a patented system to infuse CBD in the natural gum used in the papers. These new products are now available under the Roor trademark that the group acquired a few years ago. Moreover, we have developed a new slim paper, including tips with a length of 125 mm, for the cannabis market.”

    “While global trends indicate a surge in cannabis-related products, our focus remains on identifying markets with the greatest potential,” Bonjorn explains. “Regions where cannabis legalization or cultural acceptance is on the rise are particularly promising. Latin America, North America and parts of Europe are among the regions showing considerable potential for growth.”

    Miquel y Costas is actively navigating the evolving dynamics of the cannabis market. The company, says Garcia, is ready to contribute innovative solutions to cater to the evolving needs of cannabis enthusiasts. “As we anticipate developments, our strategic approach includes identifying markets where the potential for growth aligns with our commitment to quality and innovation,” he says.

    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.
  • Beyond Face Value

    Beyond Face Value

    Images: Innovative Technology

    Applied properly, age estimation technology can be a valid tool to discourage youth access.

    By George Gay

    One of the most effective arguments available to those opposed to tobacco harm reduction (THR) is based on what they describe as the child vaping epidemic because, no matter whether such an epidemic is occurring, there is no rational argument that can overcome the emotional tug of politicians crying “child vaping epidemic!” as they trawl for votes and attempt to reset their flagging careers.

    Of course, children—here taken to mean those under the age at which it is legal to buy vaping products—should not be sold vapes because this is against the law in many, perhaps most, countries. But they are sold vapes—so the question arises as to how this is possible. Well, in the U.K. at least, it is possible largely because many of those politicians now fuming about the child vaping epidemic have, with 13 years of austerity, undermined the effectiveness of public services, including those, such as Trading Standards, that are charged with policing retailing.

    In the face of these problems, one of the few hopes the vaping industry has is to try to help bolster the policing of what happens in retail outlets, in part by using age estimation technology. Anybody who listened to the video presentation by Robert Burton, group scientific and regulatory director of Plxsur, which was part of the Bonus Content of the September Global Tobacco and Nicotine Forum in Seoul, South Korea, will have heard him make a case for age estimation technology to be used in stores selling vapes. In fact, such technology is currently being tested in two outlets in Italy run by Puff Store, part of Plxsur, before a planned wider rollout. Puff Store is using Innovative Technology’s MyCheckr system, which Puff Store’s CEO, Umberto Roccatti, described as “an excellent example of how vaping businesses can support vital legislation and responsible business practices through innovation.”

    Proper Terminology

    But before looking at the MyCheckr system, a little housekeeping is in order. The sorts of technologies in question are sometimes referred to as “facial recognition” or “age verification” systems, but I shall use the phrase “age estimation” because that is how Andrew O’Brien, the product manager at Innovative Technology, referred to it during a conversation with me. I doubt there is much wrong with using the term “age verification,” though, as will become obvious later in this piece, the way the system operates means there is nothing to “verify.” But “facial recognition” I would think is to be avoided, partly because it is misleading in respect of MyCheckr and partly because it would be as well to heed the lesson from the introduction of the electronic cigarette. The word “cigarette” in this phrase established a link in many people’s minds between the new, noncombustible product and the old, combustible product even though there was a world of difference between them; and it is only now, a decade and more later, that the term “vape” is starting to take the edge off this issue. I cannot help thinking that, for the same reason, THR advocates should, from the start, try to avoid the use of the term “facial recognition,” which in many people’s minds is linked, not unfairly, to mass-surveillance—in which Innovative Technology has decided not to become involved—overly intrusive policing, discrimination and human rights abuses.

    During a telephone interview on Oct. 23, O’Brien told me that age estimation, as provided by MyCheckr, was different from facial recognition, crucially because the data produced by this device was not capable of identifying a person and therefore was not considered to be “special category” data under the General Data Protection Regulation (GDPR) in force in the EU, the European Economic Area and the U.K. In particular, the U.K.’s Information Commissioner’s Office had clarified that processing biometric data for the purposes of the Age Appropriate Design Code could lawfully be done to meet the “substantial public interest” exception in the U.K. GDPR. In practical terms, this means retailers may operate the MyCheckr system for age estimation and may do so without needing to get permission from those entering their stores.

    The MyCheckr device is positioned next to a retailer’s till from where it scans the face of anybody who comes within its range.

    How it Works

    The MyCheckr device is positioned next to a retailer’s till from where it scans the face of anybody who comes within its range, which covers people in wheelchairs and those well over six feet in height—in all, about 98 percent of the U.K.’s adult population. If the system determines the person is more than 25 years of age, a green light shows and the store assistant may sell the customer age-restricted goods, including vapes, while if it determines the person to be under 25 years of age, a red light shows and the assistant is obliged to ask for a form of identification that provides proof that the person is more than 18 years of age.

    MyCheckr’s system is based on the use of algorithms that are composed during machine “deep learning” exercises. No, I don’t understand it either, but basically, the machine is presented with millions of facial images of people whose ages are known, and from the particularities of these images it builds a database of age-related facial characteristics. To avoid bias and inefficiency, care is taken during the learning phase to ensure the machine is presented with similar numbers of male and female faces and similar numbers of skin tones, as defined by the Fitzpatrick scale.

    Importantly, the machine learning seems to have worked. The MyCheckr was tested in March 2021 under the Age Check Certification Scheme when it was found to have been sufficiently accurate, to be used as part of a “challenge 25” program. The device did not “pass” anybody under 18 as over 25, and, on average, it underestimated the age of 18-year-olds by only 0.19 of a year. Remarkably, perhaps, O’Brien told me his company had improved the system during the year and a half since that test had been carried out. And he also mentioned that the device could now tell the difference between a face and a picture of a face presented either on paper or on a mobile screen.

    Privacy Protections

    One reason why MyCheckr is not, and could not be, used as a mass-surveillance facial recognition system is that it cannot store the scans it makes of customers’ faces. And since all the processing is done within the device, there is no need for it to be connected to the internet, which means no images leave the device.

    Interestingly, the efficacy of MyCheckr in preventing underage customers from obtaining age-restricted products from retail outlets goes beyond its scanning operations. O’Brien said that Innovative Technology had taken part in a trial of an earlier version of the MyCheckr in conjunction with the U.K.’s Home Office, which had wanted to understand how technology could help to ensure people complied with the Licensing Act 2003, covering the sale of alcoholic products. One of the things to come out of the test was that the mere presence in a store of an age estimation system tended to discourage underage visitors from trying to buy age-restricted goods. And another finding was that the device gave confidence to store assistants, especially younger and less experienced ones, to ask customers for forms of identity that provided proof of age because it was less likely that a challenged customer would make a fuss if the assistant pointed to the device and said, “the computer says ‘no.’”

    Although the device stores no facial images, it can gather and store analytical data concerning the demographics of a store’s customer base and the times of day that particular types of customers are most likely to visit, but, again, none of this data can be used to identify individuals. And another useful app that can be enabled allows the device to show adverts appropriate to the age and gender profile of a scanned customer.

    Finally, there is one area where the MyCheckr could be used in respect of “age verification/facial recognition” but only temporarily and where people agree to their facial images being scanned for the purposes of, for instance, allowing them, customers or members of staff, to gain valid entrance to a frequently visited, restricted and gated area of a store without the need to prove their age each time. And this sort of system has been successfully stood on its head for “self-excluded” gamblers who want to ensure they are challenged when they attempt to use gaming machines.

    We’re starting to see that this is a really exciting product for us.

    Andrew O’Brien, product manager, Innovative Technology

    Collecting Feedback

    The MyCheckr device, which sells for about $500, is said to be easy to install and operate and uses about the same power as a low-powered laptop. It was released only a matter of months ago and so has not yet gone into commercial distribution, but it is in stores from where Innovative Technology is receiving feedback. Initial interest has been from smaller retailers, especially vape stores, but larger retailers are showing interest. “We’re starting to see that this is a really exciting product for us,” said O’Brien.

    I have no expertise in either retailing or technology, but it seems to me that, if used extensively and diligently, this device could be an exciting product too for the vaping industry and THR at a time when child access to vaping products is at the top of the agenda. But how much difference could it make and how quickly? One obvious problem is likely to be that those retailers who are less fussy about challenging customers in respect of age—those causing most of the problem—are less likely than others to take up the technology. Why should they when they are doing alright the way things are? Why should they buy into this new technology when they don’t want the fuss of challenging their customers?

    At this point, you realize that to encourage these retailers to change their ways, it is also necessary to have an adequately funded Trading Standards with the time and skills to challenge retailers who might be less than eager to be compliant. The government could consider making the use of such technology compulsory in all retail outlets where age-restricted products are on sale, but without the watchful eye of Trading Standards, there would be no guarantee that retailers would take any notice of the devices; they might not switch them on. The licensing of all retailers selling age-restricted goods might also help, but I’m certain this debate has been had by people far more in tune with these issues than I am.

    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.
  • Filling the Gaps

    Filling the Gaps

    Image: boldg

    As it seeks to reduce its reliance on tobacco, Zimbabwe is investing in cannabis research.

    By Daisy Jeremani

    In a bid to bridge the knowledge gap in Zimbabwe’s burgeoning cannabis industry, the Zimbabwe Industrial Hemp Trust (ZIHT) has identified 63 medical doctors for training to equip them with skills to conduct medical and clinical research on cannabis.

    They are in a flexible 12-month online program that was designed in Australia by the International College of Cannabinoid Medicine. Students can study at their own pace but are expected to finish the course within 12 months.

    Nesisa Ncube, a junior resident medical officer at Mpilo Central Hospital in Bulawayo, Zimbabwe’s second biggest city, views her selection to participate in the course as an honor and an opportunity to learn more about the new medicinal cannabis sector.

    She hailed the training as “insightful” as it delves, among other modules, into pharmacokinetics of medicinal cannabis and also what to consider when planning to prescribe medicinal cannabis to a patient.

    “It has been interesting to learn how some conditions which don’t have clear and effective treatments are now being treated with medicinal cannabis, and there have been some good outcomes,” she said in an interview with Tobacco Reporter.

    The southern African nation, which is also the continent’s biggest tobacco producer, has been working to diversify that sector amid the intensifying campaign against the golden leaf over environmental and health concerns. Zimbabwe identified cannabis production as among the possible pathways to diversification.

    In April 2018, it became Africa’s second country (after Lesotho) to issue licenses for production of cannabis for medicinal and scientific use. Thereafter, the government created a licensing and enforcement desk to administer the relevant statutory instrument on behalf of the health ministry. The desk’s mandate covers applications for licenses of sites, applications for renewal, variation or amendment of licenses for sites or persons, the production, handling, import and exportation of controlled substances and all compliance issues relating to controlled substances.

    Locally produced cannabis is largely for export purposes only, with domestic use restricted to research and development purposes.

    In its 2022 annual report, The Medicines Control Authority of Zimbabwe (MCAZ) says that it has issued 59 licenses for production of cannabis for medicinal and scientific use. Fifty-eight licenses were active with 56 of them being for cultivation and production and two for cultivation and research.

    Last year,, the MCAZ received two applications for production of hemp-based cannabidiol products as complementary medicines. It issued one of the applicants with a pharmaceutical manufacturer’s license restricted to complementary medicines manufacture.

    Among the major licensees is Swiss Bioceuticals, which launched a $27 million medicinal cannabis farm just outside Harare in May 2022.

    ZIHT CEO Zorodzai Maroveke said most of the ZIHT’s activities are to fill gaps and needs in the hemp industry, and one of the gaps it has identified is the lack of knowledge among local medical health professionals. It is against this background that the ZIHT has facilitated the year-long training program.

    “It is the study of a very huge biological system called the endocannabinoid system,” she said.

    The local medicinal cannabis industry has not developed as fast as expected since the first license was issued five years ago due to what Maroveke describes as tight compliance requirements by the regulator and failure to comply by most players. The enormity of resources required for entry is the biggest hurdle, she observed.

    ZIHT is worried over these challenges, which are frustrating more effective participation into this specialized area by local investors.

    “The industry remains capital-intensive, the market dynamics present a market access challenge, [and] lack of localized expertise have all affected the participation of local investors,” said Maroveke.

    Although ZIHT’s primary area of interest is industrial hemp, she said, their support for medicinal cannabis is because there was no active representation of the sector by its major stakeholders.

    Ncube is optimistic that the training she is undergoing will advance her career as it covers an area that is not yet part of the curriculum at local medical schools. The increase in the number of health professionals who are conversant with this novel treatment system, she observed, will add diversity to the medical fraternity.

    “The training will help advance my career by educating me on the mechanisms of action and prescribing considerations for medicinal cannabis, which is not really a subject that was covered in med school, and this will benefit the medicinal cannabis sector because this increases the number of health professionals who have knowledge on the subject, which enables expansion of the sector into other countries like mine,” Ncube said.

    “I see expansion of the industry with distribution centers all over the world with safe prescription and monitoring of patients by properly trained health care professionals on the subject.”

    Zimbabwe is battling an increase in psychiatric cases due to abuse of various illicit substances, cannabis included. Up to 80 percent of all admissions to Ingutsheni Psychiatric Hospital in Bulawayo are due to drug and substance abuse, including marijuana, officials say.

    Percy Mukwacha, who is also training in psychiatry at the University of Zimbabwe and is also undergoing training under the ZIHT scheme, said he was mostly impressed by the potential of cannabinoid not only to treat a number of illnesses but to also ease the burden on local healthcare.

    “In mental health, we get a lot of morbidity from cannabis use. That’s what interested me to join this training where cannabis can have positive effects on the society,” he told Tobacco Reporter.

    “I guess an understanding of this ubiquitous substance with problematic consequences has to be helpful in my career.”

    Treatments derived from cannabis, said Admire Machongwe, a medical doctor in private practice in Harare, have potential to revolutionize patient care in the country.

    “We were notified of the scholarship but were already intrigued by the way cannabinoid medicines were being used to treat chronic pain and other ailments,” he said.

    “It [training] will be quite beneficial,” he added. “We expect cannabinoid medicines to be licensed in Zimbabwe in the near future. Treatment of otherwise difficult-to-treat conditions like chronic pain and depression might be achievable.”

  • A Shot in the Arm

    A Shot in the Arm

    CME explores opportunities in packaging solutions for midsize and small tobacco companies and in areas like format changes, spare parts and mechanical and electrical upgrades with larger tobacco players. | Photo: CME Automation Systems

    Boosted by a significant private equity investment, CME Automation Systems is strengthening its offerings to the tobacco industry and other sectors.

    By George Gay

    Paul Knight

    In October, Tobacco Reporter had the opportunity of speaking with Paul Knight, the CEO of CME Automation Systems, which, two months earlier, following the receipt of what it described as “significant backing from private equity,” had announced in a press note that it would be looking to invest in strengthening its offering to its international customers in the pharmaceuticals, cannabis, tobacco and other fast-moving consumer goods (FMCG) sectors. Following are excerpts from our conversation.

    Tobacco Reporter: Is there overlap as far as you are concerned in the concepts underlying the technologies and performances of the machines used by the pharmaceuticals, cannabis, tobacco and other FMCG sectors, if not in the machines themselves?

    Paul Knight: The overlap is in some of the underpinning technology, not in the specific machine platforms. Some of the technology overlap is in our concepts for product handling, filling and packing. Our passion is for helping drive industries forward by improving production optimization.

    Will the investments specifically in tobacco machinery technologies form a significant part of the overall investment?

    We will definitely be expanding our offerings to the tobacco sector as part of our investment program, much of which will be around life extension and aftermarket support products.

    Does this mean that you have confidence in the longevity of the tobacco industry? Or do you think that with the right developments CME can increase its share of a decreasing market for tobacco packaging equipment?

    Yes, we do have confidence in the longevity of the tobacco industry, and we have confidence in our ability to increase our share of the marketplace with our new investments in mind.

    When you talk of the FMCG sector, do you include vaping products, or do they comprise a sector that you do not serve or intend to serve?

    Yes, we do work in both vaping and heat-not-burn sectors and anticipate strong growth as consumers move in bigger numbers toward these products from combustibles.

    Where will the overall investment be targeted mainly—at taking on more engineers, perhaps, obtaining new design tools, or investing in artificial intelligence (AI)?

    The investment is being targeted in several areas, particularly marketing, sales channels, new product development and existing product enhancement.

    In what areas, if any, does AI play a part in your overall operations or will play a part in the future?

    AI is starting to make an impact in the administrative areas of our business, and over the next several years, we will see it start to make its way onto machine platforms for predictive maintenance and self-diagnosis.

    Will you be investing in new facilities, perhaps outside the U.K., given the challenges thrown up by Brexit?

    Yes, we will be looking to move elsewhere within the U.K. over the next one [year] to two years. But in all honesty, Brexit has not been an issue for CME outside of customs-related administrative changes.

    Is this a brave time for an international player to be looking to expand, what with the various challenges facing manufacturing, including raw materials supply chain difficulties, inflation and rumblings about the demise of globalization?

    Yes, it is; there are many risks in the macroeconomic and global political environment, but we believe counter cyclic investment is a good play for CME at our current stage of development.

    In the August press note, CME said the new investor had identified “the potential to build on CME’s expertise and reputation for innovation, especially given the company’s recent success in developing new solutions for growth markets such as cannabis and clinical trials.” Could you describe briefly what form these successes took?

    For clinical trials, we have developed a system called PACE, which is designed to automate clinical trial provisioning for multinational pharma companies. Our first customer is a consortium including Astra Zeneca and GSK. This is a huge opportunity for CME’s future. In the cannabis market, we now have our widest product portfolio and plans to put a footprint in North America.

    Would you describe CME as a medium-sized player in the tobacco packaging field?

    Yes.

    How else would you describe CME?

    CME is a business that is passionate about innovation, solving problems for our customers and markets, adding value to their businesses and ensuring their future success. 

    The press note mentions bespoke machinery. Do you regard this as one of your main strengths in the tobacco packaging field?

    Bespoke machinery design and build is a strength of CME’s, but we do relatively little of this in the tobacco packaging sector.

    What are your other strengths in this field?

    A broad range of high-quality standard and flexible machinery products that cover the range of needs from small independent producers to multinationals up to 400 packs per minute.

    Do you see change coming in the environment in which tobacco packaging machinery companies compete?

    Change in our sector is already well underway! I think in terms of new packaging machinery, demand is moving toward higher speed equipment, particularly in the multinationals. We are not in the high-speed segment, so this leaves us to explore lower speed packaging in mid-size and small tobacco companies globally and in areas like format changes, spare parts and mechanical and electrical upgrades with larger tobacco players. There is also clearly a geographical demand shift away from developed economies to developing economies for combustible tobacco products and a shift toward vape/HEBB-style products in developed economies.

    The press note does not mention who is providing the investment funding. Is there a reason for this?

    The funder wishes to remain anonymous.

    The press note does not mention the level of the funding either. Are you able to provide a rough figure?

    It is a seven-figure number.

    Is there anything else you would like to say about the new investment funding and how it will affect CME’s future?

    The investment represents a new dawn for CME and our ability to focus significant investment capital on our target markets via new product development and product enhancement. We could not be more excited to have a committed investor that believes in our ability to grow into 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.
  • Shifting Sands

    Shifting Sands

    Image: Givaga

    Under pressure from the IMF, Egypt’s government reduces its share in Eastern Co.

    By Stefanie Rossel

    On Oct. 29, 2023, Egypt’s House of Representatives approved a long-expected tax hike on tobacco products. The amendment to the 2016 VAT law will expand the price ranges of taxed cigarettes by raising the minimum and maximum limits of each segment by 12 percent annually for five years. In addition, the draft law will increase the fixed tax by EGP0.50 ($0.02) on the three segments of cigarette prices, resulting in EGP4.5 for cigarettes retailing at less than EGP31, EGP7 for the mid-price cigarette range (those costing between GDP31 and GBP45) and EGP7.5 for cigarettes priced above EGP45.

    The bill also increases the tax on tobacco products by 75 percent, raising the minimum from the present EGP30 to EGP60 per kilogram. Imported and local molasses products will see a 25 percent tax hike whereas the tax on heated-tobacco products will rise from EGP1,400 per kilogram to EGP1,800 per kilogram. Under the new law, e-liquids will be taxed at EGP4 per milliliter instead of the current EGP2 per milliliter.

    The amendment will allow cigarette manufacturers, who have been facing increasing production costs and a plummeting Egyptian pound, to adjust prices without moving into higher tax brackets. The tax hike is expected to generate up to EGP8 billion annually in additional revenues for the state budget.

    According to the head of the House’s Planning and Budget Committee, the move is also designed to encourage tobacco companies to increase production in a way that will stem the rise in cigarette prices, thus putting an end to the country’s cigarette crisis. Since May, the Egyptian cigarette market has been in turmoil. According to observers, the problem emerged after the minister of finance called for an amendment to the 2023–2024 budget to increase its tax revenue from EGP81 billion to EGP87 billion. The government, however, was slow to implement the tax hike. What followed was a shortage of tobacco products, particularly cigarettes, and the rise of an informal, parallel market in which a pack of the country’s most popular brand, Cleopatra, sold at EGP50 instead of EGP24.

    As soon as they got wind of the tax increase, tobacco traders seized the opportunity to make additional profits by hoarding cigarettes. The artificial scarcity caused cigarette prices to soar, forcing smokers to buy unknown, adulterated or smuggled cigarettes, which in turn reduced tax revenues. After Egypt’s tobacco monopoly, Eastern Company, increased production by 40 percent and stepped up vigilance against illicit sales, cigarette prices decreased to EGP40 in September.

    In the short term, [the deal] is clearly positive,” says Vorster, “but the potential for more adverse excise and regulatory regimes could detract from that significantly.” 

    Pieter Vorster, managing director, Idwala Research

    Foreign Currency Crisis

    “Other than for the traders exploiting the situation, it is clearly an unfavorable environment, albeit one caused by tax increases telegraphed well ahead of their implementation, exacerbated by weak enforcement and currency shortages,” says Pieter Vorster, managing director of Idwala Research. “The tax hike helps to reduce margins in the parallel market, but stockpiling will likely continue if potential disruptions to production owing to currency shortages are viewed as possible.”

    Egypt was hit hard by Russia’s invasion of Ukraine in February 2022, which caused many foreign investors to abandon emerging markets. Consequently, the country has been struggling with rising global wheat and energy prices. According to a report by the U.S. Department of State, Egypt’s external debt reached $164.7 billion in June 2023.

    In December 2022, the International Monetary Fund (IMF) approved a 46-month $3 billion loan for Egypt to overcome its economic crisis under the condition that the government undertake several structural reforms. It insisted that Egypt adopt a flexible exchange rate, lift of import restrictions and privatize state-owned companies.

    Despite the government’s efforts to create a more favorable business environment, foreign investors continue to face challenges such as bureaucracy, lack of transparency, uneven enforcement, corruption, intellectual property issues and a shortage of skilled labor.

    Egypt’s sale of a major stake of Eastern Co. on Sept. 3, 2023, was part of its commitment to sell shares in 35 state-owned firms. Global Investment Holding (GIH) of the United Arab Emirates paid EGP19.3 billion for a 30 percent stake of the 50.9 percent stake that the state-owned firm Chemical Industries Holding Co. had previously held—a price that Vorster deems steep. “It seems a high multiple for a noncontrolling stake without the synergies that a tobacco company might have been able to extract,” he says. According to Daily News Egypt, both Japan Tobacco International and United Tobacco Co., in which Philip Morris International controls most shares, also submitted offers for a stake in Eastern Co.

    Following the deal, 20.9 percent of Eastern Co. remains with Chemical Industries Holding Co., 35 percent is freely traded on the Egyptian Stock Exchange, and the remaining 15 percent is owned by various private stakeholders. GIH announced that it would invest $150 million to rejuvenate Eastern Co.’s raw material supplies. Whether it will be allowed to use its funds to import tobacco, however, remains unclear. Egypt prohibits tobacco cultivation and taxes leaf imports at 75 percent. According to Mada, an Egyptian media organization, the Emirati firm will work with banks to facilitate Eastern Co.’s access to foreign currency for imports. “In the short term, [the deal] is clearly positive,” says Vorster, “but the potential for more adverse excise and regulatory regimes could detract from that significantly.” 

    A Growing Market

    The deal might still prove to be a win-win for both parties. Egypt is in dire need of U.S. dollars to pay for imports. Eastern Co. accounts for 70 percent of tobacco sales in Egypt, which is one of the world’s few remaining growth markets for cigarettes. Statista anticipates the market to generate $6.3 billion in 2023 and projects it to enjoy an annual growth rate of 9.65 percent by 2028. According to Alternative Policy Solutions, a public policy research project at the American University in Cairo, around 18 million Egyptians over the age of 15 are smokers. Overall cigarette consumption increased 7 percent in 2022. Smoking is a male habit: The World Health Organization projects that by 2025, 63 percent of the country’s male population will be smokers, up from presently 41.8 percent. Only 0.3 percent of women currently smoke.

    According to Forbes Middle East, Eastern Co. is worth $1.2 billion. The company reported a net profit of EGP5.29 billion in the first nine months of fiscal year 2022–2023– 24 percent higher than in the comparable prior-year period. Its revenues rose to EGP14.6 billion from July 2022 to March 2023 compared to EGP12.78 billion in the comparative period of the previous fiscal year. The company supplied 88 billion cigarettes to the Egyptian market in 2022–2023.

    With the acquisition of its stake in Eastern Co., GIH will have effectively established control over 40 percent of the Egyptian tobacco market as the investment firm’s founders also hold shares in UTC, according to Mada. How their acquisition will impact on the overall market remains to be seen. Citing Turkiye as an example, Vorster points out that there are several examples where the excise tax and regulatory environments became significantly less favorable when the state exited former monopolies. “It also seems plausible that the market could become significantly more competitive with PMI now manufacturing themselves, and others potentially following in future,” he says.

    PMI Starts Local Production

    In its domestic market, Eastern Co. is rivaled by only JTI and UTC. BAT exited the Egyptian market last year, claiming a lack of economic viability. Its withdrawal came shortly after PMI in April 2022 had reached a licensing agreement with Eastern Co. to manufacture cigarettes in Egypt. More than a year earlier, Egypt’s Industrial Development Authority had invited companies to bid to become the country’s second tobacco company. However, the agency was forced to relaunch the tender after bidders complained that its conditions gave unjust advantages to Eastern Co. In the renewed tender, UTC was the only company to bid. Under the agreement, Eastern Co. acquired a 24 percent stake in UTC.

    Although meant as a first step toward privatization of the tobacco monopoly, the agreement stipulates that UTC manufactures only products owned by PMI, thus protecting Eastern Co.’s market share by preventing the newcomer from producing cigarettes in the same price category as Eastern Co.’s bestseller, Cleopatra.

    In September 2022, UTC started producing cigarettes at the manufacturing site of its predecessor Philip Morris Misr, the licensee for PMI products in Egypt established in 2013. PMI’s flagship brand Marlboro has been manufactured by Eastern Co. since 1985. Following the agreement, PMI products in Egypt are marketed under the label “Made by UTC.”

    UTC also has permission to manufacture e-cigarettes. In April 2022, Egypt legalized the import and commercialization of vape products. Statista estimates that the revenue generated in the country’s e-cigarette market will reach $400 million in 2023.

    The recent sale of the stake in Eastern Co. could also pave the way for more ambitious tobacco harm reduction in Egypt. To date, Eastern Co.’s portfolio has offered only high-risk products, such as cigarettes, shisha and cigars. Vorster is less optimistic. “In theory, it is slightly positive, but with cigarette prices below $2 per pack, it is hard to see reduced-risk products gaining significant traction,” he says.  

    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.
  • Taming the Cowboys

    Taming the Cowboys

    Image: JEANNE

    Altria has declared war on the illicit disposable devices that are impacting its bottom line.

    By Timothy S. Donahue

    The illicit e-cigarette market is soaring. Illicit products are estimated to account for more than 60 percent of the $8.3 billion U.S. vaping industry. Statista expects the U.S. electronic nicotine-delivery system (ENDS) market to grow at a compound annual growth rate of 3.93 percent from 2023 to 2028. If the illicit market continues to go unchecked, however, companies that market legal vaping products fear many consumers will simply switch back to combustible products.

    “It is very much worth noting that this rapid apparent substitution is happening in an environment where half the vapor market is illicit; the FDA [U.S Food and Drug Administration] has hugely hampered vaping products making it onto the legal market, and consumers are hugely misled on relative risks,” said David Sweanor, an adjunct law professor at the University of Ottawa and a longtime tobacco harm reduction advocate. “As with other markets seeing similarly historic drops in cigarette use as alternative sales soar, it raises the question of just how rapidly cigarette sales could fall if policies were aimed at facilitating that rather than doing things to stymie it.”

    Altria, parent to Njoy, a leading brand of legal vaping products in the U.S., according to Nielsen, told investors during a recent conference call that the current state of the market is “intolerable” for both legitimate manufacturers and consumers. Altria CEO Billy Gifford said the regulated market is being overrun by illegal flavored disposable products manufactured and distributed by companies violating the rules and guidance laid out by the FDA. He said that regulation not enforced is indistinguishable from no regulation at all.

    “Illegal e-vapor products circumvent the actions of regulators, responsible manufacturers and retailers by evading scientific review, quality manufacturing controls, marketing oversight and legal aids or purchase restrictions. Despite recent actions by the FDA, enforcement has been inadequate and ineffective,” explained Gifford. “We believe the FDA has good tools necessary to bring order to the market. For our part, we are actively engaged with regulators, state and federal lawmakers, and trade partners and other stakeholders to build awareness of these serious issues and drive marketplace enforcement.”

    According to Gifford, the lack of enforcement has forced Altria to take a “targeted but necessary action.” The company filed a lawsuit in the District Court for the Central District of California against 34 organizations. Njoy alleges that the defendants are manufacturing, marketing, distributing, selling and/or marketing their flavored disposable ENDS unlawfully for three primary reasons:

    • They are not authorized pursuant to FDA marketing granted orders as part of the premarket tobacco product application process.
    • California bans the retail sale of flavored ENDS.
    • The defendants do not comply with the Prevent All Cigarette Trafficking Act’s delivery sale age verification, registration and filing, record keeping, tax payment and labeling requirements.

    Altria is asking for the court to provide appropriate restitution for harm suffered by Njoy due to the defendants’ unfair competition.

    “We want to protect harm reduction and the opportunity for the 30 million smokers in the U.S.,” said Gifford. “We really need to have enforcement where the smokers can make informed choices as they are moving across categories. I think that there’s an underlying positive is that we see adult smokers moving over, so they’re ready to have potentially reduced harm products. We just need them to be regulated and based on science to be in the marketplace.”

    Sal Mancuso, Altria’s chief financial officer, said that traditional cigarette volumes continued to decline in the third quarter of 2023. He said that the decline is impacted by the number of illegal products on the market; however, because illicit products are largely distributed through nontraditional untracked channels, the company has had to refine its ability to estimate the illicit product impacts on the legal vaping industry.

    “With the information we have today, we believe that there is more cross-category movement than previously assumed. And we now estimate that growth of illegal flavor[ed] disposable e-vapor products contributed to industry, cigarette industry declines in the range of 1.5 percent to 2.5 percent and over the last 12 months,” said Mancuso. “We will continue to monitor this dynamic trend and are actively pursuing better data sources to enhance our estimates in this space.”

    “We believe the FDA has good tools necessary to bring order to the market.”

    Billy Gifford, CEO, Altria Group

    Amplifying Actions

    Altria Group completed its acquisition of Njoy Holdings in May. In 2022, Njoy Holdings received marketing orders for its Njoy Ace device along with several tobacco-flavored pods. At the time of writing, Njoy Holdings had received six of the 23 marketing orders granted by the FDA for the entire vaping product category, including pods, disposables and open systems. The regulatory agency is still reviewing Njoy’s premarket tobacco product applications for several Njoy menthol-flavored e-vapor products.

    Gifford said that the company executed Njoy’s business plans with “speed and focus,” adding that the goal is to grow the Njoy brand responsibly and sustainably. To set the foundation for success, Altria first strengthened Njoy’s supply chain. He said the company successfully solidified the entire Njoy supply chain from sourcing direct materials through the shipment to retail.

    “As a result, we do not anticipate capacity constraints as we execute our initial expansion plan. Next, during the third quarter, our teams prioritized closing inventory gaps at retail and expanding distribution of ACE,” said Gifford. “Prior to the acquisition, Njoy had a small-scale sales force, which resulted in inventory volatility and significant distribution gaps at retail …. Upon completion of the Njoy transaction, we immediately unleashed our sales force to focus on closing the inventory gaps in stores that already had distribution. We improved inventory conditions in stores and are actively working to close remaining gaps at retail.”

    Pamala Kaufman, a financial analyst with Morgan Stanley, asked Gifford if he believed Njoy could be successful and grow in a marketplace dominated by illegal products. Gifford said that the FDA still needs to get through its authorization process, and the agency’s actions will translate to the marketplace.

    Since its acquisition by Altria, distribution grew to approximately 42,000 stores during the third quarter of 2023 for the Njoy Ace, the company’s flagship device. The product is now distributed in all the top 25 U.S. convenience store chains by vaping product volume, according to Gifford. The company has also started to amplify visibility with new point-of-sale and fixture signage at retail.

    “During the fourth quarter, we continue to expect ACE expansion to reach a total of 70,000 stores by year end, representing approximately 70 percent of e-vapor volume and 55 percent of cigarette volume sold in the U.S. multi-outlet and convenience scanner,” said Gifford. “As we continue to expand distribution and close inventory gaps, we expect to further enhance visibility and product fixture space at retail.”

    Last month, Njoy unveiled its first retail trade program. The program allows retail partners to sign up for the program at various levels with merchandising options designed to position Njoy “strategically and responsibly” to current combustible tobacco consumers while boosting the awareness of the Njoy brand. Gifford said the company is beginning to test various promotional plans and anticipates more disruptive execution at retail in the fourth quarter. Moving into 2024.

    “We will continue to refine our promotional plans, implement Njoy’s retail trade program, further expand distribution and evolve our consumer engagement strategy. Our strategies will focus on informing adult vapors and smokers of the attributes of ACE, such as battery capacity and pod size, relative to other leading brands, generating trial and growing brand loyalty,” said Gifford. “In addition, plans for a new brand equity campaign are well underway. We expect the equity campaign to further amplify the brand’s presence at retail and drive consumer engagement.”

    Jacob de Klerk, an analyst for Redburn Atlantic, asked Gifford what the impact would be on Njoy’s projected market growth if the FDA doesn’t approve any flavors other than tobacco. Would only allowing tobacco flavors create enough demand for Njoy to remain profitable? Gifford said he believes there is room, and he wouldn’t rule out the potential for an authorized menthol product.

    “I wouldn’t rule out menthol. We feel good about the application—the current application in front of the FDA from a menthol standpoint. I think if you look at some of the recent marketing denial orders, it was related to ‘new following,’” he replied. “When we made the Njoy transaction, there was virtually no new following. As far as additional flavors are concerned, we’re excited and currently looking forward to being able to file [marketing applications] in the near future. We believe that [flavor] allows for adult consumers to have it as an offramp but not an on-ramp for underage users. So, we still see the potential for flavors.”

    Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
  • The Potential of Pot

    The Potential of Pot

    Photo: Konrad

    Despite regional setbacks, global cannabis sales are still getting higher.

    By Stefanie Rossel

    Global cannabis sales continue to grow, albeit at a slightly slower pace than before, facing headwinds in comparatively mature markets, such as Colorado or California. Euromonitor International expects the value of the global legal cannabis market to grow from $41 billion in 2022 to $98 billion by 2027. Despite increasing access and acceptance, the stigma around cannabis remains and regulatory uncertainty prevails.

    The main growth drivers are innovation, investments from tobacco companies and consumer perception. Cannabis caters to the needs of consumers unnerved by economic, environmental and political uncertainties along with the spread of armed conflicts. Indeed, data from Israel’s ministry of health shows a spike in demand for a medical marijuana program one month into the war with Hamas. Meanwhile, the government of Ukraine—another country at war—is preparing to legalize medical cannabis.

    Euromonitor expects noncombustible cannabis products to gain share as consumers become more concerned about their health. Further legislation of adult-use cannabis would have significant implications for other fast-moving consumer goods, according to the market intelligence providers, with innovations in cannabis involving topicals, beverages or edibles.

    Alert to opportunity, the major tobacco players have already ventured into the sector. Philip Morris International has invested in Vectura Fertin Pharma, a contract development and manufacturing organization specializing in gums, pouches, tablets and other solid oral systems for the delivery of active ingredients. According to news reports dated July 2023, PMI is also planning to take over Syqe Medical, an Israeli company, which manufactures a metered-dose inhaler for pain reduction using medical marijuana.

    BAT, for its part, has stakes in 13 cannabis startups. In April, the company entered a joint venture with Charlotte’s Web Holdings, a cannabidiol (CBD) producer based in Denver, Colorado, USA. Since 2021, it also holds a minority stake in Organigram, Canada’s second-largest licensed cannabis producer. In early November 2023, BAT boosted its interest in the company through a cad124.6 million ($90.15 million) investment. Last year, it invested $37.6 million in a leading German cannabis company called Sanity Group.

    Imperial Brands acquired a stake in Auxly in 2019, while Altria is represented in the cannabis market through Cronos of Canada.

    Despite the growth of the market, Canadian companies are struggling to profit from legal cannabis.
    (Image: JHVEPhoto)

    Successful Experiment

    Presently, two markets are of particular interest for investors in the cannabis space: Canada, which in October celebrated the fifth anniversary of legal recreational cannabis; and Germany, which was supposed to legalize cannabis in November.

    Canada’s government had committed itself to reviewing its Cannabis Act after three years, but the Covid-19 pandemic delayed that exercise. In October, the government published a summary of feedback provided by industry, healthcare and community groups. Its conclusions were sobering. Despite the growth of the market, companies across the supply chain are struggling to profit from legal cannabis. Legal producers are burdened by significant regulatory fees, distributor markups and taxes in a hyper-competitive market. The illicit market, meanwhile, still represents 40 percent of the business.

    In their rush to compete with illegal products, sellers of legal cannabis have dropped their prices dramatically, selling products for as low as cad3 per gram instead of the cad10 per gram originally envisaged by the government. Due to advertising and packaging restrictions, communication with consumers, even to inform them about different varieties of cannabis and their effects, is nearly impossible. As a result of such challenges, several first players have exited the market or reduced manpower.

    Legalization has also impacted public health: The Canadian Institute for Public Health noted that cannabis-related emergency department visits and hospitalizations increased 14 percent between 2019 and 2021. Despite its shortcomings, Deepak Anand, principal of Vancouver-based ASDA Consultancy Services, deems legalization a success. “Legalization has resulted in about a 50 percent reduction in illicit market sales,” he says, quoting a recent survey in which 48 percent of cannabis-using respondents stated that they purchased all their products at a licensed retailer.

    “Retailer availability and proximity is an important metric in increasing overall market penetration and facilitating access,” says Anand. “No one expected the illicit market to disappear on day one or year five of legalization. The fact that we are at almost 50 percent reduction says a lot about the progress made.”

    Altogether, 64 percent of Canadians supported legalization, according to the probe. The survey also showed that people aged 45 and older increased their cannabis intake the most of all age groups following legalization, whereas those under 17 reduced their consumption.

    Legalization has resulted in about a 50 percent reduction in illicit market sales.

    Deepak Anand, principal, ASDA Consultancy Services

    Lessons to be Learned

    Anand emphasizes that legalization is a process rather than an event and that the experiences of Canada show other countries what works and what doesn’t. Lessons, he says, include the importance of avoiding over-taxation and overregulation of a nascent industry, particularly when one of the goals of legalization is to transition consumption from illicit to licit channels.

    What’s more, tax earnings derived from legalization must not be used solely to fill government coffers. “Revenues must be reinvested by providing the industry with data, research and tools to support the nascent industry and transition supply from criminal and illicit channels.”

    Governments must also guard against setting the age of access too high or the THC limits too low, according to Anand. Furthermore, they should make sure that social justice reform is baked into any legalization programs.

    Anand expects the final report on Canada’s Cannabis Act, which will be tabled before Parliament in March 2024, to take into account industry suggestions on taxation and THC levels, concerns from academics about the lack of research and a call for an overhaul of the medical system.

    The Canadian cannabis market, he predicts, will see only the fittest companies surviving. “Strong business fundamentals and financial discipline will be rewarded,” says Anand. ”Companies and teams that focus on the plant and the consumer will thrive as we are seeing in the market currently. Cannabis isn’t going anywhere; it is an industry that is here and will not only stay but also thrive in the future.”

    Disappointing Move

    Meanwhile in Germany, legalization appears to have lost some of its momentum. Hopes were high when, in 2021, a new coalition government announced it would permit licensed shops to sell recreational cannabis to adults, i.e., those from the age of 18. The move would have made Germany the biggest EU cannabis market by far. With the legalization, the government aimed to starve the illegal market, decriminalize occasional users, lower criminal justice expenditures and protect public health. The expected cannabis tax, experts predicted, could contribute up to €1.8 billion ($1.92 billion) annually to the state treasury.

    Two years on, all that remains of the lofty plans is a watered-down version. After realizing that full legalization of recreational cannabis would interfere with the U.N. Single Convention on Narcotic Drugs (1961) and EU legislation, the cabinet on Aug. 16, 2023, approved a bill that would allow adults to possess up to 25 grams of the drug, grow a maximum of three plants and acquire weed as members of nonprofit cannabis clubs. The government said it would also launch a pilot project to test the effects of a commercial supply chain for recreational cannabis over five years—a proposal for which it will need to present separate legislation.

    The legislation was scheduled to pass Parliament on Nov. 16, 2023, making cannabis legal from Jan. 1, 2024. However, after meeting fierce opposition from numerous parties, among them conservative policymakers who warned that legalization would encourage cannabis use and create more work for authorities, industry associations and consumer advocacy groups, the final reading was delayed to mid-December.

    In a Nov. 6 parliamentary hearing, the German Cannabis Association (DHV) pointed out that the possession cap of 25 grams per year made home cultivation impossible, as it referred to fresh flowers, which tend to lose weight after drying. “Under these conditions, no one will take the trouble to cultivate cannabis,” says DHV Managing Director Georg Wurth. “The limit would be a promotion scheme for the black market.”

    DHV also advocates to allow private growers to cultivate more than three plants and criticizes the distance rule, which stipulates that consumption will neither be allowed in cannabis clubs nor within a 200-meter distance of schools, kindergartens, playgrounds or cannabis clubs. “Such a distance—or any obligatory distance—would mean that in populated areas there would be no space left for legal consumption,” he says. “The idea to completely prohibit consumption on the premises of clubs whose only aim is to cultivate cannabis is unrealistic and makes no sense. The envisaged distance rule for cannabis clubs is similarly absurd, as it does nothing for youth prevention.”

    Furthermore, the punishments for violations described in the proposed legislation are too harsh, according to Wurth. The bill stipulates imprisonment of up to three years for the possession of 26 grams of cannabis or the cultivation of four plants. Consumption-related offences involve high fines. Smoking pot in a 190-meter radius from a school, for example, could cost the user up to €100,000. The DHV also calls for a legal opportunity to consume self-cultivated cannabis with friends. “After all, the goal is to deprive the black market of as much consumed cannabis as possible,” Wurth says. The association also calls for equal treatment of cannabis and alcohol in road traffic and an alignment of sanctions.

    At press time, an amended version of the bill that takes into account stakeholders’ input had not been released. The first part of the planned cannabis reform in Germany is now expected to become effective on April 1, 2024, at the earliest.

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • A Widening Gap

    A Widening Gap

    Image: WindyNight

    Tobacco harm reduction for people with mental health needs

    By Cheryl K. Olson

    “I firmly believe a lot of us, people like me, are self-medicating, pure and simple,” says Skip Murray. A Minnesota-based tobacco harm reduction specialist, Murray began smoking at age 10. She was diagnosed initially with autism and attention deficit/hyperactivity disorder (ADHD) and later with depression, anxiety and post-traumatic stress disorder (PTSD) as well. She vapes to manage her symptoms.

    Brian King, director of the U.S. Food and Drug Administration’s Center for Tobacco Products, has called for greater focus on health equity. One group he cited as disproportionately affected by smoking is people living with mental health conditions. If you’re among this crowd, you are more likely to smoke (and smoke heavily) and less likely to quit compared to the general population.

    Plenty of research details this serious disparity. Among U.S. adults scored as having serious psychological distress (SPD) in the National Health Interview Survey, nearly 40 percent smoked. That’s compared to 13 percent of people without SPD. Of all cigarettes consumed by U.S. adults, nearly one-third are smoked by someone with a mental illness.

    A new analysis of Population Assessment of Tobacco and Health survey data found that among adults ever diagnosed with psychosis, 41 percent had used any kind of tobacco in the past month, and 31 percent had smoked. Having multiple mental health conditions is linked to higher smoking rates.

    The disparity is growing. U.S. national surveys find that smoking rates for those with mental health diagnoses are either stagnant or are declining more slowly compared to the general population. In particular, smoking rates for black and Hispanic adults experiencing serious psychological distress have not budged in years.

    What stands in the way? How can we better support tobacco harm reduction for people with mental health needs and persuade mental health professionals to take smoking seriously?

    A Culture of Smoking

    Historically, mental health care systems tolerated or even encouraged a smoking culture. Smoking breaks helped build relationships between patients and providers. Cigarettes were used as rewards for “good” behavior or for complying with treatment.  

    Studies find that mental health professionals frequently believe that their patients who smoke aren’t interested in quitting. Or that giving up cigarettes is too much to take on when also dealing with mental illness. Many therapists view smoking as not part of their turf but belonging to the physical health side of things.

    Amid the stresses and crises of mental health practice, granting lower priority to smoking cessation may seem practical. But ignoring cigarettes costs their patients years, even decades, of life. A recent editorial in the British Journal of General Practice called smoking the single biggest contributor to the seven-year to 25-year reduced life expectancy for people with mental health conditions.

    “To ignore their smoking, and only focus on their mental health, in the long run harms their overall health,” says Murray. “Why aren’t we looking at why they smoke? Do they not have healthcare, a home, enough food?”

    “I’m more than my mental illness,” she continues. “We need to treat the whole person.”

    Another barrier to encouraging smoking cessation has been lack of research on, and provider knowledge about, effective interventions. People with schizophrenia are at highest risk for earlier death, and their rates of smoking are especially high. Randomized trials suggest that smoking cessation medications are not risky for them to use. The issue is not safety but effectiveness.

    For example, a large Canadian community-based smoking cessation study found that many people with schizophrenia who smoke want to stop. They were as able as others to reduce their smoking but much less successful at quitting altogether.

    For people living with mental health conditions, as with the general population of people who smoke, there is an urgent need for more effective cessation approaches. A 2002 commentary titled “Smokers with Schizophrenia Will Benefit From More Flexible Treatment Approaches” put it this way: “New and creative NRTs [nicotine-replacement therapies] and pharmacological and psychosocial interventions are needed to compete with the high reinforcement value of smoking.”

    Today, we have nicotine alternatives undreamed of in 2002, including e-cigarettes.

    A Role for Vaping?

    In a 2017 review on Smoking, Mental Illness and Public Health, Stanford researchers wrote that “Additional data are needed to more fully understand the long-term potential of [e-cigarettes] for harm/harm reduction, particularly in vulnerable groups of smokers, including those with mental illness.”

    Six years later, many in public health are unfortunately still on the fence about whether vaping causes or reduces harm. We now have high-certainty evidence from a respected Cochrane review of research that vaping works better than NRT to help people quit smoking.

    But what evidence do we have for persons with mental illness in particular? The studies summarized in the Cochrane review either didn’t mention mental health or specifically excluded people with conditions such as depression, anxiety and psychosis from participating.

    More often than not, even the newest studies on helping people with mental illness quit smoking ignore the existence of vaping and other non-NRT nicotine options. However, evidence from recent population surveys that give results for people with mental health conditions suggests that vaping merits a closer look.

    A 2023 report analyzed data on people reporting depression and anxiety from the 2018 and 2020 Four Country Smoking and Vaping Surveys. The authors state, “It appears that smokers with depression are motivated to quit smoking but were less likely to manage to stay quit and more likely to be vaping if successfully quit.”

    A 2020 English population survey report by Brose and colleagues found that smokers with mental health problems were just as likely as others to successfully quit smoking if they tried. People who had ever had a mental health diagnosis were nearly four times more likely to choose vaping over nonprescription NRT (37 percent versus 9.8 percent) when making quit attempts—more than the sample overall. The authors suggest that “e-cigarettes used in quit attempts currently are more likely to positively affect inequalities than other smoking cessation interventions,” especially if their reach among people with mental health problems can be increased.

    Wanted: Better Studies

    Caponnetto and Polosa have summarized the results of some small but promising studies, involving first-generation or second-generation e-cigarettes, to help people with schizophrenia spectrum disorders stop smoking. Vaping showed potential as an acceptable substitute even among people with severe mental illness who don’t intend to quit smoking. Are larger studies in the research pipeline?

    A 2021 research letter in JAMA Psychiatry describes registered clinical trials looking at e-cigarettes to reduce or stop smoking. Just eight of the 66 ongoing or completed trials recruited individuals who smoke who have a psychiatric condition. The authors note that very few studies (and no completed ones) tested “newer e-cigarette devices that are designed to deliver nicotine more similarly to cigarettes.” They call for more, higher quality studies. We’ll keep an eye out.

    Ways to encourage harm reduction after inpatient mental health treatment also need more study. A 2023 U.K. study by Shoesmith and colleagues in Nicotine & Tobacco Research describes the development of a complex behavior change intervention to follow discharge from a smoke-free mental health stay. You have to dig into the supplemental material to find that mental healthcare worker training in use of e-cigarettes is part of the recommended intervention.

    We need more research to better understand what may block or encourage people with mental health conditions from trying and switching to vaping. A 2017 study analyzed discussions on Reddit by people with mental illness about motivations and limitations associated with vaping. Self-medication was a common theme.

    One person who reported PTSD and anxiety wrote, “For me, vaping is pretty much the same as smoking, in terms of how it helps me calm down and handle stress.”

    Many wrote on Reddit about the importance of education about and support for vaping from friends, family and online communities. Informed mental health professionals could likely play a critical role in saving lives. A U.K. study found that among people who have used tobacco, those with serious mental distress are more likely to have inaccurate harm perceptions of nicotine and nicotine products, including vaping.

    “A Clear and Definite Message”

    A U.K. government-funded community interest company, the National Centre for Smoking Cessation and Training, just released a much-needed guide to vaping for health and social care professionals. The guide states that “some people from disadvantaged groups may vape for temporary abstinence (e.g., at work or while in a mental health inpatient setting) before deciding to switch completely.” Also, “it is important that people from disadvantaged groups receive a clear and definite message that vaping is much less harmful than smoking.”

    Some mental health professional associations have endorsed vaping, however grudgingly or conditionally. For example, the Royal Australian and New Zealand College of Psychiatrists issued a sensible e-cigarette position statement in 2018 (due for updating soon). Acknowledging the high smoking prevalence and low quit rates among people who live with mental illness, they say that “e-cigarettes and vaping devices may provide a less harmful way to deliver nicotine to those who are unable or unwilling to stop smoking tobacco.”

    The college would like more data on vaping’s long-term health effects and on switching success. However, “This does not justify withholding what is, on the current evidence, a lower-risk product from existing smokers while such data is collected.”

    The position of the U.K. Royal College of Psychiatrists is similarly pragmatic. Vaping devices, they note, have become the most popular real-world quit-smoking aid. Although using neither is preferable, “using an EC [electronic cigarette] is always better than smoking a cigarette.”

    By contrast, a 2022 position statement on vaping products from the American Psychiatric Association does not mention harm reduction. They focus only on potential risks to youth.

    Knowledge can flow the other way, from patient to mental health professional. Murray received counseling for a year from a therapist who was initially highly skeptical of vaping. “She was one of those who believed that nicotine causes cancer and depression,” Murray recalls.

    After seeing the difference in Murray’s focus when she had forgotten her vape at work and gone without nicotine for hours, the therapist became curious. “That’s when we figured out that nicotine helps my ADHD,” Murray says. Upon request, she shared published studies on nicotine and mental health with her therapist.

    Adds Murray, “It was cool to meet somebody who was willing to look at information and think about if what they believed was actually true.”

    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.