Category: Also in TR

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  • Looking Back at the Vaping Industry in 2023

    Looking Back at the Vaping Industry in 2023

    Regulatory challenges and misinformation continued to test the vaping industry in 2023.

    By TR staff

    It remains a frustrating business environment. The vaping segment has survived despite setbacks in 2023 and continues growing as a global market. However, divergent regulatory perspectives on vaping’s harm reduction potential continue to hinder its uptake by cigarette smokers. The past 12 months could also be labeled the year of the great exodus as several vaping retailers and manufacturers went out of business. Despite the challenges, more and more former smokers continue to switch.

    While several countries banned, enacted regulations or continued heavily regulating vaping products, the United States’ denials of numerous premarket tobacco product applications (PMTAs) had the greatest impact on the industry this year. The U.S. Food and Drug Administration’s ban on most products has allowed a black market of disposable vapes to become a multibillion-dollar industry. Disposable e-cigarettes account for almost 40 percent of the global vape sector, according to ECigIntelligence.

    Critics have accused the industry of avoiding responsibility for the environmental damage caused by disposable vaping products while federal regulators have failed to pass measures that would make vaping components easier to recycle or more eco-friendly. Some regulations have been proposed to lessen the products’ environmental impact. For example, standards could be put in place requiring them to be reusable or mandating that manufacturers fund collection and recycling programs.

    Disposable e-cigarettes currently account for about 53 percent of the multibillion-dollar U.S. vaping market, according to the Centers for Disease Control and Prevention, more than doubling in size since 2020. Several states, including New York and California, have extended product responsibility laws in place for computers and other electronics, but those rules don’t apply to vaping products. At the federal level, there are no regulations specifically for the disposal of vaping products. Without action, some experts say the devastating environmental impact could last for centuries.

    Misinformation surrounding the vaping industry also continued to spread in 2023. Nearly half of cigarette smokers and young adult nonsmokers think that nicotine-based e-cigarettes have the same amount or even more harmful chemicals than regular tobacco-based cigarettes, according to a Rutgers study.

    Another study found that there are also a lot of exaggerations and misinformation about vaping on social media. Some tweets exaggerate or distort claims about nicotine and addiction while others misinterpret scientific studies to promote vaping. There are also tweets that downplay the harmful effects of nicotine and promote its benefits, which are potentially problematic. Below is a month-by-month recap of the vaping industry’s biggest headlines in 2023.

    January

    Credit: Cerib

    The upscale U.K.-based grocer Waitrose halts sales of single-use vaping products due to environmental concerns. The FDA says it will “decide within months” how to regulate legal cannabis (it still hasn’t). Vaporesso becomes the first open-system vaping device brand to obtain the ability to sell in the United Arab Emirates. The Netherlands bans flavors, and Belgium says it plans to restrict flavor names and vape devices. A 2022 article that claimed e-cigarette users faced the same cancer risk as combustible cigarette smokers is retracted by the World Journal of Oncology. Lawmakers in Taiwan ban vaping products. A U.S. district judge preliminary approves a $255 million settlement resolving consumer claims that Juul Labs deceptively marketed e-cigarettes.

    February

    FDA
    Credit: Adobe

    Hong Kong begins enforcing its ban on CBD, labeling it as a “dangerous drug” and imposing harsh penalties for its possession. Bloomberg Philanthropies commits $420 million over four years to the Bloomberg Initiative to Reduce Tobacco Use. Australia reschedules the psychedelics psilocybin and MDMA to provide access to people with post-traumatic stress disorder. Connecticut sues five companies for selling delta-8 products. Alex Norcia resigns from Filter for a job at Altria. RAI Services Co. submits a citizen petition asking the FDA to adopt a new enforcement policy directed at “illegally marketed disposable electronic nicotine-delivery system [ENDS]” products. Matthew Farrelly, former chief scientist and director of the Center for Health Analytics at RTI International, is named director of the FDA’s Center for Tobacco Products’ (CTP) Office of Science. The FDA files the first civil money penalties for illicit sales of ENDS products.

    March

    Credit: Ascannio

    Altria Group exchanges its entire investment in Juul Labs for a nonexclusive, irrevocable global license to certain of Juul’s heated-tobacco intellectual property. Altria also agrees to acquire Njoy Holdings for approximately $2.75 billion and asks the U.S. Federal Trade Commission (FTC) to drop its 2020 challenge to the company’s 2018 acquisition of a 35 percent share in Juul Labs. The FDA proposes new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of vaping and other tobacco products. RLX Technology reveals that its 2022 financial performance was heavily impacted by new industry regulations and e-cigarette taxes, along with Covid-related disruptions, in China. A U.S. federal judge throws out a tobacco industry lawsuit against California’s statewide ban on the sale of flavored vaping and other tobacco products. The FDA updates its definition of “tobacco products” to include nontobacco nicotine products. Two menthol Vuse flavors that received a marketing denial order (MDO) can continue to be marketed by R.J. Reynolds Vapor Co. after the federal 5th Circuit Court of Appeals issues a stay. Argentina bans imports and sales of ENDS products. Former CTP Director Mitch Zeller joins the advisory board of Qnovia, a “platform pharmaceutical” company that is developing a prescription inhaled smoking cessation therapy.

    April

    Credit: Jo Panuwat D

    Malaysia removes e-liquid containing nicotine used in e-cigarettes and other vaping products from the country’s Poisons List of controlled substances. Greentank Technologies closes a Series B financing round worth $16.5 million with a “strategic investor group” that includes BAT-funded Canadian cannabis producer Organigram Holdings. Vuse’s U.S. market share rises from 41.5 percent while Juul’s declines to 26.1 percent. Altria’s youth marketing suit in California begins. The U.K. announces plans to give 1 million smokers free vaping starter kits to encourage them to give up tobacco products. Juul Labs settles youth marketing lawsuits with six states, bringing the total of state settlements to 45 states, with a combined price tag of more than $1 billion. Panama rejects a proposal to regulate vaping products. The High Court of Justice in London rules that Philip Morris Products’ patents protecting its tobacco-heating technology are valid. Delaware becomes the 22nd U.S. state to pass a recreational marijuana bill. Altria’s youth marketing suit in California begins.

    May

    Credit: MdIqbal

    Australia announces that it will ban the importation of all nonprescription vaping products, including those that do not contain nicotine. R.J. Reynolds sends letters to several small vape shops threatening to sue them if the shops do not stop selling flavored vaping products. A U.K. report shows inmates are spending more than £7 million ($8.5 million) a year on e-cigarettes. Logic Technology challenges the FDA’s marketing denial of its menthol vape products. Altria strikes a $235 million deal to end a California lawsuit alleging that the company marketed vaping products to youth. Flonq launches the world’s first fully recyclable vape device—the Flonq Plus-E. Yolonda Richardson succeeds Matthew Myers as president of Tobacco-Free Kids. The FDA issues “Import Alert 98-06” detaining new tobacco products such as e-cigarettes without marketing authorization at the border. Altria completes its purchase of Njoy.

    June

    Credit: Timothy S. Donahue

    Hawaiian law makes shipping of vaping and other tobacco products valued at more than $10,000 a misdemeanor. ANDS launches Slix, a disposable vape that it says is 99.29 percent recyclable.

    Bidi Vapor sends the initial shipment of Bidi Sticks to over 900 Kwik Trip and Mapco locations.

    A federal appeals court rules that the FDA acted reasonably in denying Magellan Technology’s application to market flavored vaping products.

    The FDA issues warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands. Zanzibar bans the use and imports of vape products. The CTP announces that it has made significant strides in putting its Reagan-Udall Foundation recommendation-based plan for improvement into action.

    July

    Credit: Ascannio

    Juul Labs asks the U.S. International Trade Commission (ITC) to block sales and imports of the Njoy Ace vapor device, claiming that the product infringes several Juul patents. The FTC dismissed the complaint against Njoy parent Altria Group for its purchase of a 35 percent stake in Juul Labs after Altria’s pullout. New York City accuses Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. of racketeering for selling illegal flavored vapes. Jason Carignan moves to Chemular. The FDA gives the Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on the smoking behaviors of current adult smokers. Philip Morris International acquires Syqe Medical, an Israeli company, for an estimated $650 million. Juul Labs submits a PMTA to the U.S. FDA for the Juul2 system. China’s State Tobacco Monopoly Administration releases the guidelines for vape exports. A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research. The FDA sends more warning letters for Esco Bars and Elf Bar sales. China vape exports top $3.36 billion for the first half of 2023.

    August

    Credit: Natanaelginting

    Ukraine imposes a consumption tax on disposable vapes. Venezuela bans all vaping products. The Philippines passes a law forcing importers of raw materials for vaping products to seek special clearances to release shipments. High Light Vape, which sells a vape pen disguised as a highlighter, is lambasted by the media. Njoy asks the ITC to ban the import and sale of certain Juul products. New Zealand imposes new regulations to limit youth vaping. The Coalition of Asia Pacific Tobacco Harm Reduction Advocates launches its shadow report on the World Health Organization’s failing tobacco harm reduction strategy. Juul Labs announces a company restructuring aimed at reducing operating costs. Romania bans flavors for heated-tobacco products. Suriname bans the sale of all vaping products. The U.S. Court of Appeals for the D.C. Circuit sides with Fontem U.S. in a ruling that the FDA failed to conduct a proper analysis before rejecting some vaping product marketing applications.

    September

    Credit: Gevorg Simonyan

    The U.K. Vaping Industry Association announces that it will exclude tobacco companies from its membership. Indonesia legalizes vaping. Esco Bars’ manufacturer files a lawsuit challenging the FDA’s import ban of its products. Vaporesso becomes the first licensed company to sell open systems in the UAE. New York opens state cannabis licensing to the public. The FDA sends warning letters to 15 companies that market products under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech. A massive fire destroys U.K. e-liquid and hardware brand Dinner Lady’s factory. Ispire announces that its fiscal year 2023 saw a 100.4 percent and a 10.9 percent surge in cannabis and tobacco vaping product revenues, respectively. Healthier Choices Management Corp. sues R.J. Reynolds Vapor Co. seeking royalties from sales of its Vuse Alto vape pens, chargers and pre-filled liquid pods, alleging the products infringe a patent. The FDA imposes civil money penalties on 22 retailers for the illegal sale of Elf Bar/EB Design products.

    October

    Credit: Maurice Norbert

    Philip Morris International unveils LEVIA, a zero-tobacco stick for use with its IQOS heat-not-burn device. A new study, E-Cigarette Flavor Restrictions’ Effects on Tobacco Product Sales, finds that flavor bans boost sales of traditional combustible cigarettes. U.K. Prime Minister Rishi Sunak proposes a tobacco endgame plan. The U.S. Supreme Court declines to hear Avail Vapor’s arguments against the FDA’s regulatory authorization process. ECigintelligence reports that disposable e-cigarettes account for almost 40 percent of the global vape sector. The American Vaping Association ends operations; Greg Conley joins the American Vaping Manufacturers Association. The FDA declines to issue a marketing order for flavored Vuse Alto pods. Elf Bar changes its name to defy a U.S. import ban. Njoy files lawsuits against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable vaping products. Logic Technology Development loses a court appeal to halt the FDA’s ban on the company’s menthol-flavored pods. Czechia bans flavors for heated-tobacco products. Altria says a booming illegal disposable flavored vape market is causing a major decline in the sales of its authorized vaping products.

    November

    Credit: Chetroni

    Italy’s Regional Administrative Court of Lazio (TAR) suspends a decree that would make CBD oil a narcotic substance until Jan. 16, 2024. The global vaping market will reach $93.94 billion in value by 2030, registering a CAGR of 16.27 percent from 2022 to 2030, according to Straits Research. BAT announces a $90.5 million investment in Organigram. Ohio becomes the 24th U.S. state to allow adult marijuana use for nonmedical purposes. Research from the United Nations suggests that toys are a much larger contributor to electronic waste than vaping products. The FDA again sends warning letters to online retailers for selling disposable products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars and Lava. The 10th Conference of the Parties (COP10) to the World Health Organization Framework Convention on Tobacco Control is postponed, officially due to unrest in the host nation, Panama.  

    Louisiana’s state Office of Alcohol and Tobacco Control releases a list of nearly 400 approved vape products for legal sale in the state. Juul Labs raises an estimated $1.3 billion in funding. Ispire Technology reports revenue of $42.9 million and gross profit of $6.9 million in the quarter that ended Sept. 30. The FDA increases the penalties for violations of federal nicotine product laws. PMI expands IQOS Iluma in the Middle East. New Zealand’s new coalition government announces a cancelation of the country’s controversial generational tobacco ban. The Foundation for a Smoke-Free World, which was originally funded by PMI, says it will no longer accept any monetary support from the nicotine industry. The WHO announces the dates for the resumed in-person sessions of COP10 for February 2024. Australia will ban imports of disposable vapes beginning Jan. 1, 2024. France plans to ban disposables by 2025.

    December

    Credit: Oleksii.

    (Editor’s Note: This magazine went to press in December, so the month may be incomplete.) The FDA announces that it is now estimating that completion of PMTA reviews may be delayed as the agency considers the D.C. Circuit’s opinion in Fontem U.S. v. FDA, affirming in part and vacating and remanding in part MDOs for certain vaping products. U.S. House lawmakers demand information from federal officials on what they are doing to stop the influx of kid-appealing electronic cigarettes from China. Mexico’s Supreme Court of Justice rules that the presidential decree banning the sale of e-cigarettes is unconstitutional. The FDA announces that it has filed civil money penalty complaints against 25 brick-and-mortar and online retailers for selling unauthorized Elf Bar, EB Design and other e-cigarette products. France’s National Assembly unanimously approves a bill to ban single-use electronic cigarettes. Vuse’s market share rose from 41.5 percent to 42 percent, surpassing No. 2 Juul which dropped from 24.7 percent to 24.3 percent. Guam proposes rules to stiffen the fees and penalties for vape sales to minors.  

    Looking ahead

    It’s impossible to predict what the vaping industry will look like by the end of 2024. Industry insiders expect regulators to crack down on disposable vaping products, and misinformation will likely continue to run wild.

    The U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, globally, especially in the EU and the U.K., the industry should continue to thrive and expand. More importantly, innovation should continue to thrive outside the U.S.

    Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, predicted at the end of 2022 that the FDA’s policy on vaping products would continue to be characterized by regulatory paralysis and the search for the least politically controversial regulatory option, and the industry wouldn’t hear rulings on many PMTAs until 2024 or later. He was correct on both counts.

    Looking forward to 2024, Conley told Vapor Voice that the vaping industry should expect a turbulent ride, particularly in the United States. He predicts that the most significant hurdle remains the FDA’s CTP.

    “Under the current leadership of Brian King, the agency’s stance toward vaping products has become even more antagonistic despite a drop in youth vaping to its lowest levels in a decade,” said Conley. “This tension is heightened by ongoing court cases that might force reforms within the CTP, but these changes are likely to be met with considerable internal resistance and intransigence.

    “Those in the industry should not be naive. The regulatory landscape in the U.S. for vaping businesses, regardless of their size, is likely to get worse before it gets better. This is a hard truth we need to brace for.”

    Beyond the federal level, a critical challenge will continue to come from state governments and major tobacco companies like Altria and R.J. Reynolds. The rise of synthetic nicotine-containing disposable vaping products, which are impacting cigarette sales and the vapor market shares of the major tobacco companies, is leading to a push for state-level PMTA registries, according to Conley.

    “In essence, these bills seek to deputize state regulatory agencies to behave as mini-PMTA enforcement divisions. The true effect of these registries is to ban all products that submitted their PMTAs after September of 2020. In plain English, this means nearly every disposable vaping product on the market becomes illegal to sell,” Conley explains. “Such measures have already been implemented in Alabama, Oklahoma and Louisiana, leading to a disruption in the market dynamics. Law-abiding retailers and average adult consumers are suffering as a result.”

    Globally, Conley predicts that the vaping industry will continue to go up against well-funded prohibitionist campaigns spearheaded by organizations bankrolled by Michael Bloomberg. However, there’s a silver lining: The evidence supporting regulation over outright bans continues to grow.

    “I’m cautiously optimistic that we’ll see countries in Latin America and Southeast Asia begin to revisit their previous, misguided policies. Regrettably, however, the anti-disposable furor is likely to get even more heated in Europe,” said Conley. “For adult consumers looking for hassle-free nicotine consumption, there’s never been a better time than now. The market has evolved tremendously in terms of product quality and variety. However, the picture is starkly different for businesses in the vaping industry. Until there is real reform that regulates the products adults want, like flavored disposables, being successful in this industry may require risking your livelihood and potentially your freedom.”

    Conley said the industry must remain vigilant because regulatory challenges, particularly in the U.S., coupled with global policy shifts and market dynamics suggest that the industry’s path will be rocky in the short term. “The hope is for a future where nicotine control policies are grounded in harm reduction principles rather than mirroring a drug war,” he said. “However, we’re currently seeing a trend that veers toward the latter.”

  • Desert Summit

    Desert Summit

    Photo: Will Rasmussen

    World Tobacco Middle East Dubai remains the premier tobacco trade show in the region.

    TR staff report

    World Tobacco Middle East Dubai (WTME) is one of the oldest and most successful tobacco trade shows still operating. This year, the 2023 event continued that storied success. Held Nov. 27–28, 2023, the event featured the latest trends, innovations and products from around the world, according to a report by Wingle Group Electronics, a data resource firm.

    The exhibition was also accompanied by conferences where experts and industry leaders shared their knowledge and experience.

    This year, more than 7,000 visitors and more than 250 exhibitors from more than 90 countries made the WTME 2023 one of the most popular in the event’s history. WTME is the flagship exhibition of the World Tobacco series, which annually gathers over 13,000 professionals.

    WTME is “where the past meets the future, and innovation converges with tradition, facilitating a rich tapestry of discussions that will influence strategies, policies and the very essence of the tobacco industry. It serves as a platform where knowledge is not just shared but cultivated and refined through collaborative discourse,” Orchid Tobacco Dubai wrote in a blog post.

    “This exhibition is not just about showing tobacco products,” the company added. “It’s like looking into the future. You can expect to see new and better ways of farming tobacco, the latest technology in making tobacco products and smarter ways to get these products to people.”

    With new exhibitors from HTL Human Trust Lean, Khyber Tobacco Co., Multi Tabak, Ora Tobacco and Mind Spirit Designs and Works as well as returning companies such as Sopariwala, Kaane, ARD, Gulbahar and Premium Tobacco, WTME 2023 offered visitors an even wider range of products and services than previous years.

    According to WTME attendees, WTME has helped to redefine industry standards, set new trends and shape practices in the tobacco industry. The gathering is not just about showcasing products; it’s a dynamic exchange of ideas and a catalyst for transformation.

    Getmore Mangundu, managing director at Sub Sahara Tobacco, said WTME is a complete experience that goes beyond just doing business. “It’s been a very successful show for us; it has been quite an exciting time,” she told Quartz Media representatives. “We’ve managed to catch up with our old clients but also managed to meet some new clients in this [industry] from all over [the world].”

    One of the best attributes of WTME is that the show is a place where the old meets the new, where innovation meets tradition and where discussions take place that will influence the strategies, policies and the essence of the tobacco industry. Yohanes Priatama, brand and marketing manager for BMJ, said the WTME platform fosters collaborative discourse that cultivates and refines knowledge rather than just sharing it.

    “The presence of our brands is very important for us,” he said. “It’s the right place to make new connections.”

  • 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.”

  • Strategic Impairment

    Strategic Impairment

    Images: BAT

    BAT’s write-down of its U.S. cigarette brands is a positive step in its journey toward a resilient future.

    By Richard Haigh

    Earlier this month, BAT announced a $31.5 billion impairment on the value of some of its U.S. cigarette brands. The affected brands, including Newport, Camel, Pall Mall and Natural American Spirit, will see their value on BAT’s balance sheet adjusted to a finite lifetime of 30 years, resulting in a noncash impairment charge. This signifies the first instance where a major global tobacco company has written off some of the value of its traditional cigarettes business in a significant market such as the United States.

    BAT’s write-down highlights the challenges faced by traditional tobacco businesses in the wake of evolving industry dynamics. BAT attributes the move to economic challenges in the U.S., where inflation-weary consumers are shifting to cheaper brands, as well as the rise of illicit disposable vapes. Furthermore, intensifying regulatory environments and the heightened awareness of health risks have resulted in a decline in cigarette sales volumes in certain markets. These are predicted to continue to fall, with BAT adding that global tobacco industry sales volumes will be down around 3 percent in 2023.

    Responding to Change

    The decision to write down the value of some of its brands was a bold step for BAT because, despite the short-term pain, the reality is that the market for cigarettes is shrinking, and pretending otherwise would be irresponsible on the part of management.

    In the past, failure to embrace change has decided the fate of several top brands. Blockbuster, a giant in the video rental industry with thousands of stores worldwide, failed to recognize the shift toward online streaming and mail-order DVD services. In 2010, Blockbuster filed for bankruptcy, unable to compete with the likes of Netflix. Kodak, which resisted the shift to digital cameras, suffered the consequences, filing for bankruptcy in 2012. Nokia, once a dominant force in the mobile phone industry, struggled to adapt to the rise of smartphones and the popularity of app ecosystems. Nokia’s market share declined rapidly, and eventually, it sold its mobile phone business to Microsoft in 2014. These all serve as cautionary examples.

    BAT’s move is crucial in the context of the company consciously steering away from potential pitfalls, showcasing a commitment to survival and growth in new categories. The company is already investing heavily in alternative products, focusing on vaping and oral nicotine and wants 50 percent of its revenues to come from these by 2035.

    Appointed CEO in May 2023, Tadeu Marroco has played a crucial role in guiding the company through a transformative phase, emphasizing growth in emerging categories such as vapes and e-cigarettes.

    Correlation Between Leadership Tenure and Impairments

    Tadeu Marroco assumed the role of CEO in May 2023. Having previously served as BAT’s finance director, Marroco has played a crucial role in guiding the company through a transformative phase, emphasizing growth in emerging categories such as vapes and e-cigarettes.

    The correlation between tenure length and significant impairments is an interesting one to note. When assessing 2019’s largest impairments, a common thread emerges: new leadership, as depicted in the charts accompanying this text. In this context, BAT’s decision is not an isolated incident but rather a strategic response to industry challenges, reflecting a broader pattern observed in companies experiencing changes in leadership.

    When looking at 2019’s biggest goodwill impairments, except for Procter and Gamble and CenturyLink, all companies listed had either a new CEO, a new chief financial officer (CFO) or both. Most of these companies’ previous leaders decided not to take an impairment in 2018. CenturyLink did take an impairment in 2018, when it also had both a new CEO and CFO. Therefore, new leadership appears to have a significant impact on the likelihood a company will impair its goodwill. Among the entire sample, we found that 30 percent of all impairments occur within the first year of having a new CEO or CFO.

    For larger impairments, where the impairment represents at least half of the goodwill carrying amount, 41 percent of these occur within the first year of new leadership. At best, this analysis suggests that goodwill impairment can be influenced by varying personal opinions of management personnel and their perceptions of outlook and risk. At the worst, this analysis suggests that there may be an ulterior motive within the decision to impair goodwill. By taking an impairment at the beginning of your tenure as a CEO or CFO, it helps you to either set a precedent that suggests your predecessor was negligent/overoptimistic about their acquisitions or influence the share price to fall initially then rise throughout the rest of your tenure.

    Given these insights, the timing of the impairment—just nine months into Marroco’s tenure as CEO—aligns with broader trends observed in companies with leadership changes. Adding to the leadership transition, BAT has recently appointed a new CFO, scheduled to assume the role in April 2024.

    Looking Ahead

    BAT’s impairment announcement should be viewed as a positive and necessary step in the company’s journey toward a resilient future. Rather than focusing solely on the financial implications, stakeholders should recognize the strategic foresight behind this decision.

    However, the industry is consistently grappling with challenges. Plain packaging laws have notably evolved, gaining increased comprehensiveness in some countries. These regulations now extend their coverage from traditional tobacco products to encompass heated tobacco, tobacco accessories and other nicotine-containing items. Adding to the recent developments, this month, the World Health Organization has shifted its focus to vaping, urging governments to apply tobacco-style control measures to address this emerging concern.

    Therefore, BAT and other tobacco companies must proactively adapt their strategies, leveraging innovation and regulatory compliance, to navigate the evolving landscape and ensure long-term success in an industry marked by ever increasing health-related safeguards and regulatory barriers.

  • 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.

  • The Risk of an Own Goal

    The Risk of an Own Goal

    Image: anekoho

    Making e-cigarettes available only on prescription may be a net negative for public health, writes Neil McKeganey.

    By Neil McKeganey

    In response to the rising level of vaping there have been discussions in the U.K. and elsewhere about making e-cigarettes available on prescription only. Within the U.K. Wes Streeting, shadow secretary for health and social care, recently announced that an in-coming Labour government would consider such a restriction as a way of reducing youth vaping.

    There is now clear evidence that e-cigarettes are both popular among smokers and that they can help smokers to quit. Alongside such positive evidence there is also the downside of rising numbers of young people using these devices irrespective of whether they are smoking.

    Whilst making e-cigarettes available on prescription may seem like an effective way of reducing youth use of these devices, the reality could prove very different. The fact that young people—including some below the legal age of purchase—are vaping underlines the reality that there are more routes to obtaining these devices than legal sale.

     It is entirely possible that even in a situation where e-cigarettes were available on prescription only that some young people would still source these devices through illicit routes. Whatever the impact on youth vaping, making e-cigarettes available only through prescription would reduce adult smokers access to these devices. In the event that such a policy were implemented, some adults would certainly go to their doctor seeking a prescription for these devices. Others, however, would be less inclined to go to their doctor. Some of those might source their e-cigarettes through illicit supply whilst others would simply continue to smoke.

    There is a further reason why making e-cigarettes available on prescription only may have a downside. Research has shown that using e-cigarettes can increase the likelihood of smoking cessation even when the individual had no prior intention of quitting. Analyzing data from the widely respected Population Assessment of Tobacco and Health study in the United States, Professor Karin Kasza and colleagues from the Roswell Park Comprehensive Cancer Center found that adult smokers who had no prior interest in quitting smoking still stopped smoking in impressive numbers following their use of an e-cigarette. Such “accidental quitting” has been found in other studies, with Professor Riccardo Polosa and colleagues in Catania, amongst others, showing that simply providing smokers with access to e-cigarettes helps many to quit even where they have expressed no prior interest in quitting.

    As is so often the case when it comes to regulating e-cigarettes, the question is one of how to balance the needs of young people, who ought not to be using these devices, with the needs of adult smokers who may benefit from their use. Whilst making e-cigarettes available on prescription only may reduce some young peoples’ use of these devices, regrettably it may have the same if not greater effect on adult smokers. 

    The public health goal of reducing smoking is too important to implement a policy that may be less effective than one might hope in reducing youth vaping whilst actually reducing adult smokers access to these devices. The challenge facing manufacturers, regulators and health educators is one of finding a way to reduce youth access to these devices whilst at the same time ensuring that any adult smoker wishing to use an e-cigarette can do so with the least possible difficulty. Requiring adult smokers to seek an appointment with their doctor before they can legally access an e-cigarette device is to place a huge barrier in the way of wider e-cigarette use by smokers and wider intended and accidental quitting on the part of those adult smokers. This is a restrictive regulation that needs to be given serious consideration before being implemented.

  • The Big Issues

    The Big Issues

    Photo courtesy of BAT

    Biodiversity in the tobacco and nicotine industry

    By Eirini Vlanti

    While biodiversity is quickly becoming the new climate change in terms of the growing recognition of and urgency around this topic, it presents significant challenges for companies whose business relies on nature.

    According to the 2023 Global Risks report by the World Economic Forum, biodiversity loss and ecosystem collapse are the main risks that will appear in a 10-year horizon. With half the world’s GDP highly dependent on nature, we can now see the same trend of goals, target-setting and regulations that were created to address climate change happening to address nature loss but much faster.

    Because climate change and biodiversity are highly interconnected, it is difficult to address climate change without taking biodiversity into consideration. Any company relying on agricultural production strongly depends on nature resources and ecosystem services. Discussing how to halt and reverse nature loss is key to securing a resilient supply chain.

    Investors are also paying ever greater attention to biodiversity in terms of their assessment of a company’s ESG risks. Investors have different levels of understanding and ambition when it comes to nature. BAT aspires to shape the narrative together with investors, utilizing the available supporting tools, frameworks and data.

    In addition, biodiversity-related reporting requirements are growing, demanding that companies dedicate significant resources to this. In 2023, for example, BAT plans to start disclosures aligned with the Taskforce for Nature Related Disclosure while working through water and land guidance for target-setting aligned with the Science Based Target Network. Both frameworks are important tools to standardize the way companies report and enable companies and investors to have greater insights.

    Both these frameworks are currently voluntary, but they are already starting to feed into standards, and we are seeing the first signs of these approaches being encapsulated in law, for example through the EU’s Corporate Sustainability Reporting Directive. The EU has started engaging with the main workstreams around this, and its laws are likely to influence legislation in other jurisdictions.

    The proliferation in sustainability requirements can also contribute to potential ESG reporting “fatigue.” My view is that biodiversity is nothing new; it is a way to address existing climate change commitments and environmental risks. Since the external environment shows biodiversity is an emerging topic to follow, companies need to decide whether they wait for regulations to enter into force or get ahead by exploring and understanding the topic before that happens.

    At BAT, as with any other material topic as identified through our double materiality assessment, we define what “good” looks like, set our ambition and then resource it accordingly. Sustainability is such a wide topic that each company needs to continuously and ruthlessly prioritize its focus area and create a roadmap to deliver against it. Biodiversity is no different.

    We began with assessing the materiality of biodiversity loss by conducting a Biodiversity Footprint Analysis as well as Geospatial Biodiversity Risk Assessment in 2022, combining different aspects of biodiversity to classify the farms of our directly contracted farmers as low risk, medium risk or high risk to biodiversity. This exercise supported us on designing and implementing more than 700 Biodiversity Management Plans together with our farmers for the farms that were classified as high risk. This has been a great educational tool for the farmers and our field technicians, and at the same time it provided guidance, based on data, as to where we should be putting more efforts.

    There are major differences, however, in terms of how we adapt our approach to the varied challenges in each region. Unlike climate change, where the ultimate metric is greenhouse gas emissions, there is no equivalent metric to measure biodiversity. Challenges in nature are location-specific, and an adverse action for biodiversity can have different impacts depending on the location and the significance of the ecosystem. Nature is not only our home but also the home of countless plants, trees, animals and insects.

    When we started looking at biodiversity in this way, it became clear to us the importance of working with local stakeholders, communities and experts to make the most out of every initiative. In the case of forests and biodiversity, we have a long history of community-based afforestation programs. Here, our role has been to transform those initiatives to demonstrate that they are far more than just “corporate engagement.” For example, Bonayan in Bangladesh, a program spanning more than 40 years, supplied over 100 million saplings to the local communities during that period. The program, which currently has 18 afforestation, biodiversity and conservation initiatives in 13 countries, is now moving into Bonayan 2.0 to expand its impact on nature.

    Through our integrated production system, we have been working with the farmers to protect biodiversity and forest resources, training them on sustainable agricultural practices and monitoring the sustainability of the wood used for curing.

    BAT is making progress, though we anticipate much more work ahead to address biodiversity challenges. I predict soil conservation—marked on Dec. 5 each year by the United Nations’ World Soil Day—will become a key area of importance in biodiversity. The millions of organisms that live within soil support habitats for all species and life forms. The mindset that biodiversity is a philanthropic activity needs to change—biodiversity is not a “nice to have”; it is a “must have” to achieve prosperity in the future for the environment and society and to continue supporting our needs in the years to come. Simplification and alignment of metrics is also necessary; we cannot improve something we cannot measure.

  • A Mixed Reception

    A Mixed Reception

    Photos courtesy of Vladislav Vorotnikov

    E-cigarettes enjoy booming popularity in the CIS region—but not among lawmakers.

    By Vladislav Vorotnikov

    A meteoric rise in the popularity of vapes in Russia, Belarus, Ukraine and Kazakhstan is pushing the governments to act. Severe measures up to a complete ban are on the table in many markets, but the looming risks of black market expansion prevent the authorities from hustling moves.

    As of March 1, 2024, selling flavored vapes will be illegal in Russia, according to a draft government decree.

    Among the additives due to be banned are vanilla, spices, ginger, cinnamon and sweeteners along with caffeine, guarana and taurine, which increase energy and mental and physical performance.

    No matter whether the measure will come into force, the end of the anti-vape campaign in Russia is nowhere in sight. In October 2023, a bill altogether banning selling vapes in the country was tabled in the Russian Parliament. 

    The bill was originally prepared two years ago and has recently been resubmitted by lawmakers, Yaroslav Nilov, a member of State Duma, the lower chamber of the Russian Parliament, stated.

    “We realize that the ban means certain lost revenues, but the health of citizens is more important, so we will strive to make the ban real,” Nilov commented.

    Restrictive measures against selling vapes are easily being circumvented by unscrupulous sellers in Russia, the lawmakers said in an explanatory note to the bill, referring to the law prohibiting selling vapes and e-cigarettes to customers below 18 years, which came into force earlier in 2023.

    In addition, the Russian government now struggles to ban selling vapes through the internet. In November 2023, it was disclosed that a Russian regulator seeks to close 250 online stores selling such products. These efforts have gained little traction so far. 

    Russian authorities are not alone in the CIS region in their vaping crackdown. In July 2023, the idea of banning all forms of e-cigarettes was put forward by the Youth Parliament of Belarus, a public organization designed to raise future lawmakers.

    In July 2023, a Kazakhstan government commission hammered out a recommendation to prohibit selling e-cigarettes, liquids and vape flavors, though no concrete timeframe for the measure to come into force has been disclosed yet.

    Again, potential harm to the health of the citizens has been cited as the primary rationale behind the initiative.

    “The harm of vaping is undeniable,” Nurgul Tau, deputy of the Kazakh Majilis, the lower chamber of the Kazakh Parliament, said, emphasizing that the Health Ministry had been advocating the prohibition on selling vapes since 2021.

    Ukraine is the only country in the CIS region where a ban on selling vapes and e-cigarettes has already been put into place.

    The idea of banning vapes has been brewing in the Ukrainian Verkhovna Rada, the national Parliament, for the past few years. Retailers and tobacco companies urged the authorities to consider alternative options, including partial restrictions, but the legislators appeared to be adamant about banning vapes.

    A Booming Market

    Public discussions about banning vapes in the post-Soviet area have been spurred by a skyrocketing rise in sales in the past few years.

    In 2022, the Russian market of single-use vapes has nearly tripled, NielsenIQ, an international consultancy, estimated without providing concrete figures. Companies operating in this segment saw their revenues rise by about 350 percent.

    Between 2018 and 2021, the Russian vaping market expanded by a factor of 50, estimated an alliance of participants of the electronic nicotine-delivery systems market. Last year, the sales were nearly RUR250 billion ($2.5 billion).

    The scale of the market boom can be seen with the naked eye. While in 2021, only 7 percent of tobacco stores sold vapes, by May of 2022, this figure reached 35 percent, NielsenIQ said. Another study indicated that at the beginning of 2023, the number of stores selling vapes in Russia was equal to that of conventional tobacco products.

    The picture is similar on the neighboring markets. Since 2020, sales of vapes in Kazakhstan jumped by a factor of 300 times, the Kazakh finance ministry estimated.

    In Ukraine, the state budget collected UAH2 billion ($55.6 million) from the companies selling vapes, calculated Yuri Suptel, head of the Ukrainian Vaping Association. In 2023, this figure was projected to reach UAH5 billion, but the actual figure will be much lower due to the ban that came into force in July.

    Over the past few years, nearly 1 million Ukrainian smokers “migrated” to vapes, so the restrictions will be quite painful for a large number of customers, Suptel estimated.

    Time for the Black Market

    Ukrainian retailers have largely ignored the government ban on vapes imposed in July, local press reported, showing numerous pictures of tobacco stores selling vapes after the restrictions were enacted.

    Since August 2023, the black market of vapes has been flourishing in Ukraine, Suptel said, estimating that smugglers illegally delivering vapes to Ukraine from neighboring countries earn around UAH500 million per month.

    “In the shadow market, it is impossible to ensure compliance with the laws that regulate the sales of cigarettes, electronic devices and other tobacco products. For example, the access of minors to nicotine products is not limited. The National Police of Ukraine must fight this phenomenon. But unfortunately, they simply do not have enough resources,” Suptel admitted.

    “We hope that the government and members of the parliament will think about the absurdity of the ban and make the right decision,” Suptel added.

    The risk that the ban will push the entire vape market underground is believed to be one of the key reasons why Kazakhstan is not rushing to implement the restrictions.

    “I’m sure that our deputies, due to their naivety or bias, will ban vapes eventually. In a year or two, we will come to the point where this ban will have to be lifted,” commented Dmitry Zhukov, executive director of the QazSpirits Ale, a local vaping company.

    It is one thing to ban a product that is difficult to import into the country and challenging to make and entirely another to ban vapes, which “any schoolchild can assemble on his knee,” Zhukov said.

    Currently, Kazakhstan companies selling vapes have no plans to curtail their activities, even if the ban gets a green light. They explained that the demand on the market is not likely to be affected. On the other hand, when the entire market moves underground, there will no longer be a need to pay excise fees, according to Zhukov.

    Russia would lose RUR38 billion per year in tax revenue from a ban on vapes while the black market is going to flourish, reaching RUR500 billion to RUR600 billion in annual sales, calculated Dmitry Vladimirov, head of the Union of Enterprises of the Industry of Nicotine-Containing Products.

    “Significant losses of the Russian budget in such a difficult geopolitical situation, the growth of the black market, and the rising number of deaths due to the use of counterfeit products are just the tip of the iceberg [Russia will face],” Vladimirov stated.

    In the countries that opted to ban e-cigarettes, their illegal sales skyrocketed by a factor of 200 to 300, Vladimirov estimated.

    Russia analysts also pointed out that the black market of vapes will find itself on fertile ground as illegal sales of conventional tobacco products still exist in the country, especially in the provinces remote from Moscow. This business is doing well and even growing despite the government’s efforts to take it down, and there are reasons to believe that the ban will only buttress it.

    Production Perks Up Despite Uncertainty

    While all countries in the region are primarily importing vapes, there are signs that local production is also on the rise.

    “The industry could develop under the balanced control of the state; some operators, for example, planned to start producing such products on the territory of Ukraine, contribute to the economy through exports, help GDP growth [and] create jobs,” Suptel said.

    However, even if the ban is removed now, it will take time for the market players to reconsider their plans, owing to high uncertainty about the legal status of this business, according to him.

    Some capacities for producing e-cigarettes are being established in Russia, though the lion’s share of the sold products still comes from China.

    One local publication wrote about an entrepreneur who managed to earn RUR90 million in one year, investing a relatively small amount of money into the production of vapes. On the other hand, most vape manufacturers prefer to keep a low profile. One possible reason is that some plan to continue operations when the ban is enforced.

  • 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.

    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.

    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.

    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.

  • 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.

    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.