Category: Print Edition

  • Kicking Butt

    Kicking Butt

    Photo: Filtrona

    With its plastic-free products goal at the forefront, Filtrona’s new filter technology allows for a sustainable RYO option. 

    By Marissa Dean

    When thinking about filters, most people immediately picture pre-rolled cigarettes. They think of discarded butts and microplastics. But those images are changing as the industry evolves and consumers demand more sustainable options. Filtrona is working to fill those needs with its recently debuted trademarked Rip-a-Tip plastic-free filter for the roll-your-own (RYO) market. 

    “Made entirely from cellulose, the Rip-a-Tip is designed with convenience and configurability in mind,” says Filtrona CEO Robert Pye. Cellulose is a naturally occurring molecule made up of carbon, hydrogen and oxygen, and it is found in plant cell walls as part of the main structure. Being made completely of cellulose means that the filters will break down entirely upon disposal—removing the potential of microplastics leaching into the environment.

    The product is also highly customizable. “It also gives RYO tobacco companies the freedom and options to customize the filter to a preferred diameter, pressure drop and choice of substrate—such as white or unbleached sustainable materials,” says Pye.

    “In practical terms, each Rip-a-Tip stick is expertly crafted to hold six individual filter tips measuring 14 mm in tip length. Rip-a-Tip features the EasyRip System, which allows users to rip off the filter tips easily and quickly along the perforated line. This not only delivers an easy and enjoyable user experience but also importantly ensures there is no wastage after the filter tips are ripped off from the outer wrap,” Pye says.

    According to Pye, the outer wrap of the product can also be customized with color or print, and the design of the packaging boxes for the filters, which come in flip top, cigarette, push and slide, and side push and slide formats, can be customized. 

    The Boreas CoolBridge combines Filtrona’s sustainable cooling segment, ECO Bridge, with monoacetate and the company’s patented Fine Wall Acetate Tube.

    A Sustainable Future

    Like most companies, Filtrona has environmental, social and governance goals that it aims to reach every year. By 2050, Filtrona’s goal is to offer a complete portfolio of plastic-free products.

    The Rip-a-Tip supports that goal as “a biodegradable RYO filter solution that meets growing consumer regulatory demand for tobacco products grounded in sustainability,” according to Pye. It “marks an exciting material advancement in the RYO market,” which is expected to reach $45 billion in global value by 2033. 

    Along with the Rip-a-Tip filters, Filtrona has also launched its trademarked Boreas range of heated-tobacco product (HTP) filters, filling a market need as more consumers switch from traditional combustible cigarettes to HTPs and other reduced-risk products.

    The new range includes Boreas SideFlow, a patent-pending filter with a simplified design, and Boreas CoolBridge, a filter that combines Filtrona’s sustainable cooling segment, ECO Bridge, with monoacetate and the company’s patented Fine Wall Acetate Tube to create a balanced retention and cooling mechanism.

    “With this new Boreas range,” says Pye, “we are giving customers the option to create a customized, multi-segment filter by combining various types of base rods that are available in Filtrona’s comprehensive collection. As more of our customers move into the rapidly growing HTP market, we are thrilled to be able to support our customers with a dedicated range of HTP filters that bear the hallmark of our innovative and unique designs.

    “As consumer demand for HTPs continues to grow, our new Boreas range will enable HTP manufacturers to deliver the next generation of products that deliver the expected level of quality and user experience compared to conventional cigarettes while also meeting regulatory requirements.”

    What’s Next?

    The industry is constantly changing and evolving as regulations, requirements, health concerns, environmental concerns and consumer desires morph. According to Pye, Filtrona is well positioned to cater to the rapidly changing business environment.

    “We have a century of filtration experience and chemistry delivery expertise at Filtrona, coupled with an unparalleled drive for innovation and R&D and world-class global manufacturing capabilities,” Pye says. “In addition, our Scientific Services laboratories in Indonesia offer independent and accredited testing facilities for all our products.

    “Our industry knowledge helps companies to catch emerging trends, adapt to changes and build strong brands. We see an exciting future ahead in the industry where Filtrona will play a significant role in driving change and enabling business growth through product innovations, advanced technology and sustainable solutions.”

    Marissa Dean joined Tobacco Reporter in the summer of 2018 as a copy editor.Since that time, she has taken on additional responsibilities, including feature writing.Her skills span the publishing industry from layout and design to copy editing to content creation.
  • Rewriting the Rules

    Rewriting the Rules

    Will the next EU Tobacco Products Directive embrace harm reduction?

    By Stefanie Rossel

    Things may take a bit longer in Brussels. The European Commission (EC) started preparations in 2021 to revise its Tobacco Products Directive (TPD), but the process remains in its evaluation phase, with an impact assessment expected in 2025.

    The commission’s draft proposal is anticipated in late 2025. By 2027 or 2028, member states are expected to implement the new legislation. Shaping the new policy will be the job of the next commission. In June 2024, the common market elected a new European Parliament for the next five years.

    The TPD currently under evaluation was issued in 2014. While already covering vape and heated-tobacco products in addition to traditional cigarettes, it does not include products that emerged after the legislation was adopted, such as nicotine pouches. How these and other novel nicotine products will be regulated in TPD3 remains the subject of speculation.

    “We know only that the evaluation phase should have long been concluded,” says Jan Muecke, managing director of the German Association of the Tobacco Industry and New Products. One reason for the delay, he suggests, could be the EU ombudsman’s investigation of the commissioning of the European Network for Smoking and Tobacco Prevention (ENSP), which advises the EU Commission in the evaluation process. As a network of anti-tobacco nongovernmental organizations, the ENSP can’t be objective, according to Muecke.

    Muecke expects the new commission, which will take up its official duties this autumn, to close the evaluation and push for far-reaching changes to the directive. The question, he says, is whether these changes will include a recognition of tobacco harm reduction (THR). While proponents claim novel nicotine products are significantly less harmful than combustible cigarettes and should therefore be treated differently, the EU, which has ratified the World Health Organization Framework Convention on Tobacco Control, insists that “less harmful” means “still harmful” and worries about yet-unknown long-term health effects and the protection of youth.

    Jan Muecke | Photo: German Association of the Tobacco Industry and Novel Products

    Missing Its Target

    However, critics contend that continuing the existing approach or adopting an even more hostile stance toward novel nicotine products may prevent the EU from achieving its goal of a “‘tobacco-free generation” (defined as a smoking prevalence of less than 5 percent) by 2040.

    According to the most recent Eurobarometer survey, the EU smoking rate decreased by only 1 percent between 2020 and 2023. At 24 percent, nearly a quarter of EU adults still smoke cigarettes. Since the TPD took force in 2016, EU smoking prevalence has fallen 3 percent. At this pace, the advocacy group Clearing the Air calculated, the EU will reach its tobacco-free goal 70 years after the target date.

    “So far, EU tobacco policy has been focusing on paternalism against consumers, manufacturers and retailers,” says Muecke. “As this approach has not led to any relevant results, a real strategy change is needed. Instead of plain packaging and high taxes, politics should actively promote smokers’ switching to less hazardous products such as vapes, THPs [tobacco-heating products] or pouches. By having chosen such an approach, Sweden will soon have reached the status of a smoke-free nation. For such a reorientation of politics, however, a lot of persuasive efforts in Brussels will be required. But recently, there were very few signals from the EC that it might dare turn away from its regulatory approach of ‘quit or die.’ The civil servants in Brussels still consider e-cigarettes and the likes as a problem and not as part of the solution.”

    “The big takeaway point from Eurobarometer is that there isn’t a hope of the EU achieving its smoke-free or tobacco-free targets, particularly when they continue to demonize safer nicotine products, which actually help people quit smoking,” echoes Damian Sweeney, a partner in the European Tobacco Harm Reduction Advocates (ETHRA), a consumer advocacy group. “It’s important to keep in mind that policymakers may not be aware of the detail in reports like Eurobarometer and certainly not success stories like Sweden and the U.K. This is why advocacy is so vital to educate policymakers and make them aware of what can and does work in reducing the burden on health from smoking.”

    Nevertheless, Sweeney is cautiously optimistic about TPD3 as there seems to be a growing number of Members of Parliament (MEPs) that understand the concept of tobacco harm reduction. In a February 2022 report, for example, the European Parliament’s Special Committee on Beating Cancer (BECA) acknowledged the concept of harm reduction.

    “Of course, the BECA report and the more recent report from the subcommittee on noncommunicable diseases, which adopted the same language as BECA in relation to safer nicotine products, is a positive in that respect,” says Sweeney. “Both reports are useful tools that advocates can utilize when speaking to MEPs about the role of SNPs in reducing smoking. It is important to note that we do not see these positive signs replicated in the European Commission.”

    At this pace, the advocacy group Clearing the Air calculated, the EU will reach its tobacco-free goal 70 years after the target date.

    More Stringent Rules Anticipated

    If common sense does not prevail, the EC’s draft proposal will likely contain considerably stricter regulations for all product categories, according to Muecke. “Brussels could try to introduce standardized rules that completely ignore product-specific characteristics,” he says. “The regulation of nicotine products according to their harm potential, as it was partly introduced for e-cigarettes in the current TPD, is also likely to be put to the test. Furthermore, the EC will try to anticipate the development of new products in their regulations. Tobacco-free nicotine pouches don’t fall into the scope of the TPD, which is why many member states in recent years felt obliged to pass their own regulations. The EC will try to prevent such a development for future innovations. This is something we must pay particular attention to because innovation should always be possible.”

    With vape flavors increasingly under scrutiny, Sweeney thinks it’s possible that the commission will propose a flavor ban. “This is where advocacy and building relationships with members of the European Parliament will be key, as proposals will have to be debated and voted on in committee and in the European Parliament as a whole,” he says.

    In June, EU health ministers discussed proposals by Latvia and Denmark to restrict flavors in vapes and nicotine pouches. The current TPD allows member states to set their own rules for flavors. Denmark, Estonia, Finland, Hungary, Lithuania, the Netherlands and Slovenia already ban vape flavors. Spain recently completed a public consultation on the topic; Latvia reportedly is in the process of introducing flavor restrictions.

    “It’s very concerning that member states would attempt to pressurize the commission to bypass the ongoing review of the TPD, but I don’t expect to see any actions at an EU level before the TPD,” says Sweeney. “Ahead of the June meeting, ETHRA wrote to all EU health ministers to highlight the serious unintended consequences of banning flavors: increase in smoking through reduced adult switching and increased relapse from vaping to smoking, a growing black market for flavored products, and potentially dangerous consumer workarounds, such as DIY [do-it-yourself] mixing, which can carry some risks.”  

    “Tobacco harm reduction shouldn’t be a right/left issue—it’s a people issue.”

    Damian Sweeney, partner in the European Tobacco Harm Reduction Advocates

    Pouches in Peril

    According to a commission spokesperson, snus will be part of the directive’s evaluation, but neither Muecke nor Sweeney expect the EU to legalize the product, which has been banned throughout the EU, except in Sweden, since 1992. “Sweden is on the verge of becoming smoke-free, 16 years ahead of the EU’s target, and snus has played a key role in that,” says Sweeney. “This success story could be emulated across the EU if the ban on snus was lifted; unfortunately, I can’t see that happening, and there’s a possibility the ban could be extended to nicotine pouches.”

    Prohibiting the latter would be difficult, however, according to Muecke, as nicotine pouches are already available in 16 member states.

    Despite increasing calls to ban disposable vapes, Sweeney expects single-use e-cigarettes to remain legal in the next TPD. However, the products are likely to disappear from the market anyway due to the EU Battery Directive, which will ban single-use batteries. “Manufacturers are already adapting and moving toward disposable-style devices that are rechargeable.”

    Whether the recent EU election, in which the center-right European People’s Party (EPP) gained seats, will impact TPD3 remains to be seen. “As far as tobacco harm reduction and the availability of safer nicotine products is concerned, this is a positive move as the EPP have been supportive of THR,” says Sweeney. “But I think it’s important to remember that THR isn’t and shouldn’t be a right/left issue—it’s a people issue. As advocates, we need to bring as many people as possible on board—no matter what their political leanings are.”

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

    Unwavering Commitment

    Katrin Hanske | Photos courtesy of SWM international

    Innovation, integrity and excellence remain at the core of SWM’s business under the company’s new ownership.

    TR Staff Report

    In late 2023, a relatively unknown company in the tobacco business, Evergreen Hill Enterprise, purchased the world’s leading supplier of cigarette paper, SWM International, from Mativ Holdings, which had decided that SWM’s tobacco focus would present a more attractive value proposition under new strategic ownership.

    Headquartered in Singapore, Evergreen Hill Enterprise is part of an Indonesian-based privately held group of companies serving the tobacco, banking and consumer electronics industries, among other sectors. One of its affiliates is BMJ, a supplier of tobacco packaging and paper with a strong presence in Asia, but the partners made clear that SWM and BMJ would continue to operate independently.

    Tobacco Reporter caught up with SWM President and CEO Katrin Hanske to learn what the deal has brought to SWM and its customers.

    What have been the biggest changes in SWM’s day-to-day operations since Evergreen Hill Enterprise announced its acquisition in August 2023?

    Nothing has changed because they don’t intervene in our day-to-day operations. SWM International is the same company everyone knew before. We still have the same values and culture that our customers, suppliers, partners and employees trust and appreciate. We haven’t changed from a cultural or value perspective, upholding the principles that define how we think, work and interact.

    After transitioning from a publicly traded to a privately held company, we relocated our headquarters from Alpharetta to Luxembourg. This shift has granted us greater flexibility to pursue key market opportunities and streamline our strategic decision-making process.

    Our priorities remain focused on our customers, unwavering commitment to innovating the industry, empowering our employees, maintaining integrity and striving for excellence in everything we do.

    What steps have been taken thus far to integrate SWM into Evergreen Hill Enterprise’s operations?

    The acquisition was not focused on integrating SWM but on strengthening Evergreen’s presence in the tobacco market. As a result, we do not have synergies or shared resources with Evergreen or BMJ.

    Have there been any senior personnel changes in the wake of the acquisition?

    The answer is no. In fact, we have retained our leadership team to ensure continuity, stability and expertise. This stability and accumulated generational knowledge allow us to create high-performance products and tailored solutions.

    What advantages has the acquisition brought to SWM customers thus far? What additional benefits do you expect them to receive from the deal in the future?

    Our focus is accelerating innovation to support our customers’ journey toward reduced-risk products and sustainability. We do this by optimizing the properties of botanicals, natural fibers and lightweight paper solutions. We continue to invest in innovative products and sustainability efforts along the supply chain. This directly benefits our customers, as they can expect us to remain at the forefront of innovation, committed to sustainability and with a strong presence in all geographies.

    Does the backing of Evergreen Hill Enterprise enable SWM to pursue projects that it wasn’t able to pursue before? Please explain.

    Clearly, we see a significant benefit now of aligned interest in being successful in the tobacco market, allowing us to pursue projects faster than before but also being strategically aligned with the agenda/requirements of our customer base. This includes our recent commitment to the SBTI [Science-Based Targets Initiative] decarbonization program,* which aims to significantly reduce the environmental impact of our operations.

    Evergreen Hill Enterprise is also affiliated with BMJ in Indonesia. What do you consider to be the respective strengths of SWM and BMJ? In what respects do they complement one another? What will be the relationship between SWM and BMJ under the Evergreen Hill umbrella?

    SWM International and BMJ continue to compete in the marketplace. SWM International is well positioned to support the industry’s shift to reduced-risk products, with a strong presence in the Americas and Europe. BMJ, on the other hand, has a significant foothold in Asia. As a result, looking from the outside, we complement each other with respect to our geographical presence and our product portfolio.

    How have customers responded to the acquisition?

    The transition to private ownership has been well received by our customers. They see the benefits of our increased focus on meeting their needs within the nicotine and tobacco industry.

    What segments of the tobacco paper market will SWM prioritize going forward? Please explain.

    SWM International prioritizes customer needs and aligns with their goals. In the traditional/legacy combustible segments, we emphasize performance, high quality and competitive pricing. Our innovation efforts focus on next-generation products as well as offering more sustainable solutions for our existing portfolio.

    SWM’s Evolute filtering media enables tobacco companies transition to more sustainable solutions in both their combustible products and heat-non-burn offerings. | Image: SWM

    Are you considering diversification into adjacent categories, given the long-term outlook for tobacco consumption—or is the acquisition an opportunity to double down on your tobacco focus? Please elaborate.

    Our company’s proficiency in developing light[weight] and ultra-lightweight papers with specific functionalities extends our reach beyond the tobacco industry. We offer intelligent, sustainable, flexible packaging solutions that are free from plastic and provide barrier effects, heat-seal capability and customizable features. Additionally, our expertise in filtration characteristics presents further opportunities for innovation.

    What is next for SWM in terms of manufacturing, product innovation and sustainability?

    Our commitment to science-based innovation, manufacturing excellence and the ingenuity of our people drives us to continually develop more sustainable filters that meet taste and sensory expectations. Our scientists and research and development teams collaborate closely with customers to design products with reduced health and environmental impacts. Simultaneously, our operations focus on decarbonizing manufacturing, improving asset efficiency and expanding capabilities to accelerate innovation.

    The industry can rely on our dedication to delivering sustainable solutions while maintaining high product quality.

  • Testing the Waters

    Testing the Waters

    Philip Morris International is getting ready to reintroduce IQOS in the US.

    By Stefanie Rossel

    During its 2024 second-quarter financial results presentation on July 23, Philip Morris International at last confirmed the long-awaited reintroduction of its IQOS heated-tobacco product (HTP) in the U.S. In the fourth quarter of this year, the company will start test marketing its IQOS3 device in Austin, Texas, according to PMI Chief Financial Officer Emmanuel Babeau.

    A large-scale launch of IQOS, he stressed, will take place only after the Food and Drug Administration has authorized PMI’s most recent model, IQOS Iluma, which the company expects to happen in the second half of 2025.

    The company submitted premarket tobacco product applications (PMTAs) and modified-risk tobacco product (MRTP) applications for Iluma in October 2023. Until Iluma’s FDA marketing authorization, Babeau said, the company will sell its IQOS3 model in only a few U.S. cities, primarily to fine-tune its approach in anticipation of the nationwide introduction of IQOS Iluma.

    Once it has secured FDA approval for Iluma, the company will apply the IQOS marketing strategy that has been successful internationally, with some tweaks for the U.S. market. Among other things, this will involve engaging with consumers to explain the product, creating a dedicated sales force and setting up its own points of sale.

    The launch will be PMI’s second attempt to establish IQOS in the U.S. In April 2019, the company assigned the exclusive commercialization rights of the brand to Altria, which then launched IQOS in Atlanta and Richmond in the fourth quarter of 2019. One-and-a-half years later, IQOS was available in Georgia, Virginia, North Carolina and South Carolina. But plans for further commercialization were interrupted when the International Trade Commission (ITC) upheld a claim by BAT that IQOS products infringed two patents owned by British Tobacco America Group.

    In September 2021, the ITC ordered Philip Morris and Altria to stop importing and selling IQOS models 2.4, 3 and 3 Duo and their respective heat sticks. PMI then agreed to pay Altria $2.7 billion to take back the U.S. commercialization rights of IQOS as of April 30, 2024. In February 2024, PMI and BAT resolved all ongoing intellectual property disputes related to the former company’s HTP and vapor products.

    In 2020 and 2022, the FDA issued modified-risk granted orders for IQOS model 2.4 and model 3, respectively, as well as for three heat stick variants. These orders are valid for a fixed period. To continue marketing the MRTPs after the authorized term, the company in May 2024 applied to renew its IQOS3 exposure modification order.

    IQOS is the only HTP in the U.S. that has been granted not only a PMTA but also MRTP authorization.

    Pieter Vorster, managing director, Idwala Research

    Market With Potential

    PMI’s selection of Austin for its 2024 pilot may be a smart move, according to Pieter Vorster, managing director of Idwala Research. “Austin is known for having a vibrant tech industry, attracting young, tech-savvy people open to new technologies and innovation,” he says. “I suspect that the regulatory environment might also be somewhat less restrictive. Furthermore, PMI likely wanted to have a clean slate concerning product awareness.”

    Furthermore, Texas has a low cigarette tax rate, and IQOS will be taxed there as cigarettes, which will give PMI a clue how the product would perform when taxed similarly to cigarettes, according to TobaccoIntelligence. A progressive university town in an otherwise conservative state, the city also provides a unique variety of demographics. “This likely means that PMI will be able to assess IQOS’ attractiveness to an array of adult testers in a small area,” says Vorster.

    Expectations are high for IQOS’ nationwide rollout. Euromonitor expects the market for smokeless tobacco and smokeless alternatives to increase from $23.49 billion in 2022 to $32.05 billion in 2027, eating into the share of traditional cigarettes. The company predicts that the value of cigarettes, which currently account for most tobacco product sales, will drop by 30 percent from $97.80 billion to $68.37 billion during that period. Investors are waiting to see whether PMI can create a heated-tobacco market in a country where vapes dominate the sales of electronic nicotine-delivery systems.

    Vorster is optimistic, noting that the U.S. with its nearly 30 million smokers is significant for PMI’s transition strategy toward a smoke-free future. “The U.S. is one of the largest and most profitable markets for nicotine products globally,” he says. “Since PMI has no presence in cigarettes, it won’t be cannibalizing its own cigarette business. IQOS is the only HTP in the U.S. that has been granted not only a PMTA but also MRTP authorization by the FDA. Furthermore, very few vaping products have been given PMTAs, although this benefit is clouded by the rampant sales of illicit disposable vapes.”

    PMI aims to capture 10 percent of U.S. tobacco and HTP unit volume by 2030. While he does not consider the 10 percent target overly ambitious, Vorster lists a few caveats. “Vapers are unlikely to switch to an HTP as they would view it as a regressive step, closer to going back to smoking,” he says. “However, this could be influenced by the regulatory environment. If the current pace of PMTAs for vaping products is maintained and the sale of illicit, disposable vapes can be reduced significantly—which is unlikely in my view—then some vapers might be motivated to switch to IQOS. In the absence of what I described, new IQOS consumers will likely come from the smoking population, where the relatively high average nicotine content of cigarettes sold in the U.S. represents a significant hurdle for HTPs and, in particular, for the IQOS products that are currently authorized in the U.S.”

    If the U.S. bans menthol cigarettes, notes Vorster, the smokers of those products could represent a significant potential source of new IQOS consumers, provided IQOS’ menthol variants are allowed to stay on the market.

    Stepping Up Production

    In its second-quarter results, PMI estimated that more than 36 million people globally use the company’s smoke-free products. In the first half of 2024, PMI’s volume growth was driven by smoke-free products. The company shipped 68.7 billion HTP consumables units, an increase of 16.8 percent versus the previous year. This compares to 300.8 billion cigarettes, which grew by a mere 0.1 percent year-on-year. Shipments of oral smoke-free products increased 27.4 percent compared to 2023, up to 8.4 billion units. Zyn, PMI’s modern oral nicotine product, which became part of its portfolio through the company’s 2022 acquisition of Swedish Match, has grown exponentially and now dominates the U.S. nicotine pouch category. The product is so popular that PMI has been struggling to keep up with demand.

    However, Zyn has also attracted regulatory scrutiny. In response to a subpoena from the District of Columbia attorney, PMI in June suspended online sales of flavored Zyn variants on its U.S. website. In March, a law group in California filed a lawsuit against the company, claiming that PMI is targeting children and young adults with its flavored nicotine pouches.

    “Given the current trajectory and historical parallels with Juul, Zyn’s future will involve navigating through heightened regulatory scrutiny and social challenges,” says Vorster. “PMI’s ability to adapt its strategies, ensure regulatory compliance and address public concerns will be pivotal. If PMI can successfully manage these issues, Zyn could stabilize and continue to grow, albeit at a potentially slower pace. However, if the regulatory and legal pressures intensify, PMI might face significant hurdles that could hinder Zyn’s market expansion and profitability.”

    Swedish Match filed for a PMTA for Zyn in March 2020, but as of August 2024, the FDA had not decided on this application. “The delay in the FDA’s response to Zyn’s PMTA is likely due to a combination of high application volumes, resource constraints and the complexity of the review process,” says Vorster. “Current issues such as social backlash, regulatory scrutiny and legal challenges will significantly impact the FDA’s decision, potentially leading to more stringent regulations and conditions for approval. The FDA’s continued reliance on a scientific study that concluded that nicotine is harmful to developing brains means that products that are perceived to have youth appeal will find it hard to get approved as ‘for the protection of public health.’”

    While the regulatory approval process is outside its control, PMI has started tackling the product shortages by investing in production. On July 16, the company announced that it would invest $600 million to open a manufacturing facility in Aurora, Colorado, to produce Zyn pouches. The plant is expected to start preliminary operations in late 2025 and regular production in 2026. It will create 500 jobs. PMI is also increasing production of Zyn at its Owensboro, Kentucky site. Apart from meeting U.S. demand, the investments will help create capacity for export, the company said.

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

    Ensuring Excellence

    The critical role of site visits and quality controls in behavioral science research

    By Elizabeth DeMartini

    In the ever-evolving field of behavioral science research, ensuring the integrity and reliability of data is a critical aspect of quality research. This article details the importance of study site visits and quality controls in maintaining high research standards and ethical conduct for direct interactions between study site staff and participants when conducting behavioral studies, such as in-person consumer perception and intentions, label comprehension and human factors, actual use and switching, product use patterns, and abuse liability.

    Study site staff are directly engaging with participants during recruitment and screening for eligibility, explaining and gathering signatures for the informed consent forms, study product administration, data collection and general communication with participants. There are times prior to or during study conduct where important study execution information, which may seem clear to researchers intimate to a project, may be missed or unclear to study site staff. This could lead to issues with data quality and compliance.

    This potential knowledge gap can be alleviated by having a regular on-site and virtual presence and directly collaborating with the study site staff throughout the study with increased oversight during key study milestones. With this, stakeholders can ensure successful project implementation while maintaining the integrity of each individual research project.

    The Role of Site Visits in Research Integrity

    Study site visits are a fundamental aspect of research oversight, serving multiple functions that collectively uphold the integrity of research studies. These visits facilitate direct interaction and collaboration between the research team and study site staff, allowing for real-time monitoring and support. Here are key reasons why site visits are indispensable:

    • Training and Support—Study site staff play a vital role in the successful execution of studies. The study site’s proper understanding of the study outcomes and methods enhances the quality of the data collection processes, communication between all parties, compliance requirements and overall health of the study. The study site staff will be intimately involved in the project from start to finish, and it is of utmost importance that they are well versed in study protocol, data collection methods and ethical considerations. Being on-site allows researchers to educate the study site staff through each step of the study. Many projects involve study products that participants are trained to use. For study site leaders to train these participants, researchers must feel confident that they have trained each research site well. Being on-site at these trainings allows for a hands-on approach, enhancing the competency of the study site staff and fostering a collaborative environment where questions and concerns can be addressed promptly.
    • Ensuring Protocol Compliance—Adherence to institutional review board-approved study protocols is crucial for the validity and reliability of research findings. Site visits oversee and verify that study procedures are being followed as outlined. This helps identify deviations or noncompliance issues early, allowing for timely corrective actions. Researchers’ presence on-site throughout project milestones ensures that the study site staff feels confident in implementing these critical study procedures. Remote monitoring of adverse events and clinical assessments of side effect severity related to research study product use is a critical responsibility. It is good practice to have a medical monitoring team on call for this service. Consistent with the informed consent form, participants should be educated on what adverse events may be and when to call, and encouraged to always err on the side of caution. By providing this surveillance, researchers can detect any potential safety concerns and address the next steps promptly.
    • Building Relationships—Face-to-face interactions during site visits strengthen the relationship between the central research team and site personnel. This is essential for effective communication and coordination throughout the study. A strong relationship facilitates smoother operations and encourages site staff to proactively report issues and seek guidance when needed.
      Many contract research organizations view study sites mainly as a transactional engagement, often with limited oversight. However, this approach is fundamentally short-sighted. The strength and integrity of a study’s data hinge on the meticulous execution of the research protocol, which can only be achieved through genuine, trusted partnerships with study sites. By fostering collaborative relationships and investing in mutual trust, organizations should ensure that the research is conducted with the highest level of precision and dedication. This partnership-based approach not only enhances the quality of data but also drives successful outcomes that meet both regulatory standards and the nuanced needs of clients.
    • Assessing Facility Capabilities—Evaluating the layout of the research sites infrastructure and assessing their capabilities is a necessary component of site visits. Research protocols include standards for product storage, document storage, product disposal, and in some cases survey administration. By being on-site, research organizations can assess the facility’s capabilities and preparedness to ensure they are complying with all regulations. Site visits can also help the research team work with the study site staff to create a comfortable flow and environment for participants engaging in the research. A proper study environment is necessary to produce high-quality data.

    Quality Controls in Research: A Multidimensional Approach

    Quality controls are the backbone of any research endeavor, ensuring that the data collection is accurate, reliable, robust and valid. In the case of social and behavioral science research, quality controls encompass a range of activities designed to maintain high standards and ethical conduct. Key aspects of quality control include:

    • Data Integrity—Maintaining the integrity of data collected during a research study is essential for producing credible results. Professional research organizations employ an in-house survey methodologist who is responsible for a multitude of quality control measures surrounding data integrity, including validation checks built into the survey and real-time data audits with daily reports on any data that would reflect any discrepancies. The survey methodologist works closely with the team and sites throughout each step of the entirety of the research process and especially during the first days of study implementation, confirming correct participant eligibility, assignment and data quality.
    • Ethical Conduct—Upholding ethical standards in research is a fundamental principle. Quality assurance processes are designed to ensure that all study activities are conducted with a focus on human subject protections. This includes obtaining informed consent, ensuring confidentiality and conducting research in a way that respects participants’ rights and dignity, which the study site staff are trained prior to and on the same day as first-participant-in.

    Challenges and Solutions in Implementing Site Visits and Quality Controls

    Despite the clear benefits, implementing site visits and quality controls can present challenges. Addressing these challenges requires a proactive and adaptive approach.

    • Resource Constraints—Conducting site visits and maintaining rigorous quality controls are essential components of any successful study, but they can be resource-intensive endeavors. Adequate funding, staffing and logistical support are crucial to carrying out these activities effectively. Medical monitoring teams play a pivotal role in this process, ensuring that every site adheres to the highest standards of patient care and protocol compliance.
      To address these challenges, research organizations should focus on optimizing resource allocation, ensuring that their teams are well supported and strategically deployed geographically. Leveraging technology for remote monitoring allows organizations to maintain oversight without the need for constant physical presence, which not only conserves resources but also increases agility in responding to emerging issues.
    • Geographical Barriers—Research studies often involve multiple sites across diverse geographic regions, making the logistics of conducting frequent site visits a significant challenge. To address this, it is advisable to employ a risk-based approach to site selection, prioritizing visits based on project timeline milestones and the specific needs of each study. This strategic approach ensures that resources are directed toward the most critical sites where oversight can have the greatest impact.
      Professional contract research organizations place a strong emphasis on rigorous project management across multiple geographic regions. This involves close collaboration with the institutional review board, whose oversight and guidance should be integral to the organization’s approach. Oversight plans should involve initial site evaluations, frequent and transparent communication between sites and the research team, and ongoing supervision to uphold protocol integrity and data quality. By integrating these elements into the project management plan, organizations can maintain consistency, compliance and excellence across all study sites, no matter where they are located.
    • Standardization Across Sites—Ensuring consistency in study conduct across multiple sites is crucial for data comparability. Developing comprehensive procedures and conducting training sessions can help standardize procedures. Regular communication and site support also play a vital role in maintaining consistency. For example, with the research team’s presence on-site during first-participant-in, the research team can provide oversight and intervene to correct any errors in study administration, and the study site staff are able to discuss any questions they may have in real time. This allows for high-quality compliance to be achieved. It also allows the research team to address reoccurring issues and modify their site training materials to be more comprehensive for all study sites.
    • Evolving Regulatory Requirements—Regulatory landscapes are dynamic, with frequent updates and changes. Staying abreast of regulatory requirements and ensuring compliance can be challenging. Engaging with regulatory bodies, participating in industry forums, and continuous education for study site staff are effective strategies to navigate regulatory complexities.

    Conclusion

    The importance of site visits and quality controls in behavioral research cannot be overstated. These practices are essential for ensuring the integrity, reliability and ethical conduct of research studies. By fostering close collaboration between the central research team and study sites, providing thorough training, support, availability, strong relationships, as well as implementing robust monitoring and quality assurance processes, contract research organizations can ensure that their research endeavors produce credible, high-quality data that advance innovation and regulatory compliance in the nicotine industry. Ultimately, these efforts contribute to the overarching goal of protecting human subjects, quality data collection and enhancing public health outcomes.

    Elizabeth DeMartini is a medical monitor and researcher at Applied Research and Analysis Co. (ARAC). She brings a wealth of experience from diverse roles in the healthcare and wellness sectors spanning the last two decades.

    An alumna of James Madison University, DeMartini holds a Bachelor of Science degree in nursing. Demartini is a licensed registered nurse through the Virginia Board of Nursing and is authorized to practice in 38 additional U.S. states. Together with Brianne Becht, DeMartini initiated ARAC’s medical monitoring team, enhancing standardization with on-site facility trainings, clinical assessments and compliance oversight.

    ARAC is a social and behavioral sciences research firm known for designing, executing and presenting creative, customizable Module 5 and 6 studies to support manufacturers, regulatory agencies and industry consultants. The fully staffed contract research organization employs in-house psychologists, behavioral scientists, statisticians and survey methodologists.

    ARAC’s data-driven approach ensures rigorous, evidence-based insights to support innovation and regulatory compliance in the nicotine industry.

    The ARAC team services clients worldwide in product development and consumer research supporting innovation and “next-generation” products, with focused expertise on the regulatory sciences for U.S. applications, including ITPs, premarket tobacco product applications, modified-risk tobacco product applications and substantial equivalence applications.
  • Rebuilding the Value Chain

    Rebuilding the Value Chain

    Photos: Taco Tuinstra

    Tabaterra wants to lift Azerbaijani tobacco to global quality standards.

    In addition to investing in cigarette production, Tabaterra has been working to revive Azerbaijani tobacco cultivation. During Soviet times, the republic was a prominent leaf producer, but that activity fell by the wayside as the USSR disintegrated and its value chains perished. To diversify its economy beyond oil and gas, Azerbaijan has been reviving tobacco production, boosting rural employment and developing new sources of export revenue.

    Instead of growing the local semi-oriental varieties previously cultivated for the Soviet market, the new efforts focus on flue-cured Virginia (FCV), which enjoys demand worldwide. In 2021, Tabaterra Leaf started operations with four receiving and curing stations, 10 greenhouses and a green-leaf threshing (GLT) factory along with a laboratory for physical tests.

    Since then, it has been working to increase yields and quality along with farmer incomes. “Our goal is to bring Azerbaijani leaf up to international standards,” says Ibrahim Mammadov, Tabaterra Leaf’s head of finance. “We want to build a brand for the country.”

    While acknowledging that Azerbaijan is not in the same league as flavor tobacco powerhouses like Zimbabwe and Brazil, Mammadov is confident of the nation’s long-term potential in the global filler market. By providing inputs tailored to the local soils and by promoting proper agricultural practices, Tabaterra has been gradually increasing nicotine and sugar levels.

    It has also improved farmer viability. When the company entered the market, tobacco growers were making azn500 ($294.13) per hectare on average, according to Tabaterra Director Elman Javanshir. This year, the per-hectare profits of its contracted farmers, including government subsidies, are expected to reach azn2,000. “So we have quadrupled their profitability in three years,” says Javanshir. The company is also providing its contracted growers with pesticides and personal protective equipment free of charge.

    Such improvements will help Tabaterra not only to retain its farmer base, but they also put farmers in a better position to attract and retain labor. Azerbaijan’s northwestern region is famous for its hazelnuts, which are harvested at the same time as tobacco, thus creating fierce competition for farmhands in August and September.

    Because the GLT was in good condition at the time of its acquisition, Tabaterra only needed to perform a few upgrades. It also constructed a chemical laboratory to help it keep track of its progress in improving Azerbaijani tobacco to the desired quality standards.

    This year, Tabaterra is cultivating tobacco on 700 hectares, mainly in northwest Azerbaijan. But the company also plans to revive tobacco production in the Karabakh region. According to Javanshir, there are natural restraints on the growth of tobacco in the northwest of Azerbaijan, including temperatures and dropping water levels—an important consideration given that tobacco is a thirsty crop.

    In the new areas, by contrast, there is plenty of water. “The rivers there don’t dry up during the summertime like they do in the northwest,” says Javanshir. “Considering the abundance of water resources there, we think we can grow better quality tobacco there—not only Virginia but also burley and some of the other varieties.” The company aims to grow up to 800 hectares in the new areas.

    Along with Ethiopia and Uzbekistan, Azerbaijan is one of a handful of countries where tobacco growers sell their leaf “wet,” i.e., uncured. With average property sizes of between 7 hectares and 8 hectares, Azerbaijani tobacco farms are relatively large, but few growers own curing barns. To boost quality and minimize losses, Tabaterra is encouraging farmers to apply good agricultural practices (GAP). “If they follow GAP, the product will come out of the barn properly, without the brown tobacco that nobody wants,” says Mammadov. Getting long-time growers to change their work habits can be challenging, however. Because farmers’ responsibility ends with the harvest, they tend to be more interested in volume than quality. For example, they may plant the tobacco too densely or skip steps such as topping or sucker control, which they view as costs rather than investments.

    “By reducing the in-row spaces, farmers think they can plant more tobacco and boost their yields, but if you increase the row space, it will make your leaves bigger, and you will get the same weight—plus higher nicotine levels,” says Mammadov. And while skipping topping and sucker control may seem like a labor-saving strategy, it causes the plant to direct its energy toward producing organic material rather than flavor. “You get more leaf but lower quality,” says Mammadov.

    Aware that showing is often more effective than telling, Tabaterra has established demonstration plots throughout its sourcing areas where the tobacco growers can see for themselves what happens with best practices. In addition, the company is providing financial incentives. If the grower plants with proper spacing, applies the appropriate amounts and formulations of fertilizer, and carries out the required topping and sucker control, he will receive a bonus on top of the agreed price.

    Azerbaijan’s leaf tobacco business has come a long way in a short time. Already, it has managed to sell some of its leaf on the international market through a leading tobacco merchant. At the same time, Tabaterra knows there’s still a ways to go. With each growing season, however, the company’s contracted farmers gain skills and experience, and Mammadov is confident that in time, more global customers will find their way to Azerbaijan. “We are now in the third year of our project,” he says. “We hope this will be our best year yet.”

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

    Out of Proportion

    A fine cigar is a basic product that is probably as “natural” as any consumer product can be. | Photo: Laurenx

    The inclusion of fine cigars in the UK generational ban proposal makes no sense.

    By George Gay

    On May 22, the then U.K. prime minister, Rishi Sunak, announced that Parliament was to be dissolved on May 30 and a general election held on July 4.1 The announcement caught even political commentators by surprise because the election could have been held any time during 2024 or January 2025. Clearly, Sunak had decided that his policies were not going to improve the circumstances of most voters, at least in the short term.

    There was certainly a note of desperation in the timing of the announcement because it meant Sunak was abandoning many of what had been referred to as his flagship policies, a move that led The Guardian newspaper to report that his legacy was looking “increasingly threadbare.”

    But it’s an ill wind and, from the point of view of certain sections of the tobacco industry, the announcement came as a relief because it meant the tobacco and vapes bill, which was being pushed through Parliament with cross-party support, was holed below the waterline. The bill contained a provision for banning tobacco sales in the U.K. to anybody born from Jan. 1, 2009, onward, a so-called generational ban.

    It seemed to say something about Sunak that he chose to scupper this policy while it had the wind in its sails, especially since, notwithstanding the timing of events, it could have been pushed through in the last days of Parliament, and given he had so emphasized his commitment to the health of the next generation. In fact, a BBC interviewer on May 24, apparently incredulous that the policy had been abandoned, asked a minister how this could have been the case, only to be told that Sunak had at least won the argument.

    But this was not true because there had been no argument, if “argument” is used to mean a debate during which different ideas are put forward and resolved in a rational manner. Speaking at a Beat the Ban lunch held in London on May 21, Simon Clark, the director of the Freedom Organization for the Right to Enjoy Smoking Tobacco (Forest), had been scathing about the way the bill was being “steamrollered” through Parliament. Following a short public consultation before Christmas, he said, the government had announced that it would not consider any submissions from groups with links to the tobacco industry, which, for instance, included Forest and even retailers. “To the best of my knowledge, that has never happened before,” he added.

    But, once again, this speaks to the makeup of Sunak, who apparently does not like to hear counter arguments and becomes tetchy when he does. So it is hardly surprising that, after the bill’s second reading, when it entered its committee stage, 16 of the 17 Members of Parliament appointed to the committee had voted for the bill, and the other was known to support it. And when it came to inviting people to give oral evidence to the committee, witnesses were almost exclusively supporters of the bill.

    The August court ruling put the FDA in a position where it could regulate as tobacco products vaping articles that contain no tobacco but not premium cigars that contain only tobacco.

    Misplaced Priorities

    Sunak’s scuppering of the bill is unlikely to be the end of the matter because it had near-universal parliamentary approval. This means that a tobacco and vapes bill is likely to be refloated in some form, so it is worthwhile looking at some of the thinking behind this initiative. Any number of stories have been written about proposed generational tobacco bans, but here I would like to consider one aspect of it that I think makes no sense: the fact that the proposed U.K. ban, in encompassing all tobacco products, seems to lack any sense of proportion, something that can be demonstrated by citing the case of fine cigars.

    At a time when, belatedly, serious health concerns are being raised in public about the consumption of alcohol, processed foods, caffeine and social media, and even about gambling and lack of sleep, why would the government’s attention be focused on something as benign as fine cigars, defined here as those cigars comprising only tobacco, water and vegetable-based gum?

    As here defined, a fine cigar is a basic product that is probably as “natural” as any consumer product can be. Fine cigars are not implicated in concerns about flavors, and they cause no problems in relation to filters, batteries and all the other tobacco/nicotine product parts implicated in environmental issues. I would guess that only a tiny minority of the U.K. population smokes fine cigars, that the proportion of such smokers is relatively stable, that fine cigar consumption raises no ethnic or gender issues and that where these products are smoked is already restricted, meaning that certain aspects of concerns about population-level harm must be minimal.

    Including an Outlier

    To examine this issue a little closer, it is instructive to look across the Atlantic at what happened in relation to fine cigars in the U.S., where they are usually referred to as premium cigars. On August 9, 2023, in response to a lawsuit filed by the Cigar Association of America, the Cigar Rights of America (CRA) and the Premium Cigar Association, Judge Amit P. Mehta, sitting in the District Court for the District of Columbia, vacated the Food and Drug Administration’s 2016-imposed deeming regulations2 in so far that they applied to premium cigars. This meant that from that date, the FDA no longer had regulatory authority over premium cigars.

    Ironically, this ruling put the FDA in a position where it could regulate as tobacco products vaping articles that contain no tobacco but not premium cigars that contain only tobacco.

    Mehta apparently decided that the FDA’s decision to regulate premium cigars was arbitrary and capricious, a damning decision given the FDA claims always to act on scientific evidence. According to Drew Perraut, the CRA’s regulatory affairs expert, speaking during a post-court-decision video conference posted on the CRA’s website, the science the CRA provided and its comment on the deeming rule were instrumental in bringing about the court ruling. The CRA, he said, presented evidence to the FDA that there was no detectable evidence of youth usage of premium cigars, along with scientific evidence from the National Institutes of Health showing there was no appreciable rise in morbidity or mortality associated with smoking premium cigars. Judge Mehta found that the FDA had not considered those scientific issues and had not responded adequately.

    It seems to me that even if the FDA does not fully accept the CRA’s evidence that smoking premium cigars does not significantly increase morbidity and mortality levels, that these products do not appeal to young people and that there is no evidence of their addictiveness, it must concede that premium cigars comprise an outlier in these areas. You can work that out on the back of an envelope.

    The danger posed by fine cigar smoking is a planetary system away from that caused by cigarette smoking.

    The Scent of Spite

    But the FDA immediately appealed Mehta’s decision, so the question arises as to why. What is the problem here? Would it not have been more efficient not to prioritize premium cigars but spend the resources of the FDA on dealing with what seems to be an already burdensome workload created by more troublesome products? Would it not have been better to allow an industry that does little harm, creates pleasure and employs a lot of people relative to its size to get on with what it does without undue interference?

    The pursuit of premium cigars looks like vindictiveness, as does the pursuit of fine cigars in the U.K. There must be a sense that the people who seek to regulate unduly and ultimately do away with premium/fine cigars cannot understand the pleasure that these products provide and for this “reason” want to get rid of them.

    Sailing back across the Atlantic, one might wonder what the U.K. Parliament’s beef with fine cigars is. Surely, even given that many parliamentarians seem in recent times to have become culturally impaired to the point of boorishness, those in government must realize that the appeal of fine cigars is a world away from that of cigarettes. They must realize that the danger posed by fine cigar smoking is a planetary system away from that caused by cigarette smoking. In fact, the world of fine cigars is close to that of fine wines because the consumption of each is not about addiction or even habit but about pleasure, fulfilment and, often, enjoying the company of like-minded people.

    A generational ban will have no immediate effect on sales of fine cigars in the U.K. because of the age profile of those who smoke them. But it will mean that, in the future, when those born after the end of 2008 are in their mid-thirties and want to consume a sophisticated product that does not addle their brains, make them fat or deprive them of sleep, they will have the devil of a job finding somebody who is willing to sell them fine cigars.

    A ban on the sales of fine cigars makes no sense. And, for similar reasons, it makes no sense when it is applied to pipe tobacco and snus. It is to be hoped that if in the U.K. the prospect of a generational tobacco sales ban is raised again, it is considered carefully and not made the subject of sledgehammer policies.

    1 The Conservative government led by Sunak was defeated at the July 4 election and replaced by a Labour government led by Prime Minister Sir Keir Starmer.

    2 The FDA was granted regulatory authority over the manufacture, distribution and marketing of tobacco products under the Tobacco Control Act of 2009, but, initially, such authority was applied only to cigarettes, roll-your-own tobacco and smokeless tobacco. In 2014, as was its right, the FDA started the process of bringing other “tobacco” products under its authority. At first, urged by the premium cigar industry, it considered exempting premium cigars but later decided not to, and all other products were the subject of its 2016 “deeming” regulations.

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.
  • Nicotine 2040

    Nicotine 2040

    Photo: Artinun

    The market for tobacco and nicotine is transforming—how could it look by 2040?

    By Clive Bates

    “Prediction is very difficult, especially if it’s about the future,” said the great Danish physicist Niels Bohr. The future is a burial ground for expert reputations, but that should never be a reason to shy away from predictions. Much of what we do today will shape the world in 2040, and our view of how the world should be in 2040 should shape what we do today. So let us consider the evolution of the market for tobacco and nicotine products out to 2040. There’s a lot to think about, so buckle up!

    First, three epochs. I see the evolution of the tobacco and nicotine policy as three overlapping epochs covering 1960 to 2040.

    (1) The tobacco control epoch stretched from 1960 to 2010. It was triggered by reports from the U.K. Royal College of Physicians and U.S. Surgeon General. It involved an all-out struggle between public health and the tobacco industry over the multiple harms of cigarette smoking, culminating in the World Health Organization Framework Convention on Tobacco Control, agreed in 2003.  

    (2) The tobacco harm reduction (THR) epoch started around 2000 with the increasing recognition that smokeless tobacco, especially Swedish snus, was much safer than cigarettes and could displace smoking. That epoch took hold in 2010 with the rise of vaping, then heated tobacco, and now nicotine pouches. The THR controversy is focused on reducing the harms associated with smoking and exploiting (or resisting) a massive public health opportunity (or risk). However, this is an interim phase.

    (3) The rethinking nicotine epoch is already underway and beginning to shape thinking about the future. We will need to confront the fundamental question: What is the place of nicotine in society? What does nicotine use mean if few people are smoking and there is not that much harm to reduce? This is already a live question; around half of American vapers aged 18–24 have not previously smoked, though some might have smoked had there been no vapes. We will undo the deep conflation between the relatively benign stimulant nicotine and the harms of smoke inhalation and place it alongside caffeine, alcohol and, increasingly, cannabinoids as legal recreational substances.

    Second, the persistence of the demand for nicotine. Many tobacco control activists have hoped that the relative decline in cigarette smoking would also eventually lead to a nicotine-free society. However, they misjudged the underlying behavioral drivers. The decline in smoking was driven by the harm to health and welfare, reinforced by policy-induced pain, such as taxes, smoking restrictions or “denormalization” designed to create a deterrent to uptake and motivation to quit. However, without the underlying harms, the deterrents are greatly weakened, and there is no justification for a punitive, coercive and stigmatizing policy. We are left to answer the question: Why is there a demand for nicotine? The demand derives from a simple proposition: For some people, nicotine use makes them feel or function better. Looking out to 2040, we should see the demand for nicotine as robust and resilient. The demand for any particular way of taking it is much more fluid or, as economists say, “elastic.” In fact, without the harms of smoking and related deterrents, demand might increase. That may seem unnerving, but should we care if the harms are low or negligible? As a 1991 Lancet editorial put it: “There is no compelling objection to the recreational and even addictive use of nicotine provided it is not shown to be physically, psychologically or socially harmful to the user or to others.”

    Third, technology and innovation. Can smoke-free nicotine products entirely replace smoking to meet all nicotine demand? Many smokers have tried the alternatives and chosen not to switch. There is more to smoking than nicotine self-administration, including the speed and peak of nicotine delivery, other psychoactive agents, sensory experiences such as “throat hit,” flavors and aromas, behavioral and ritual aspects, and perhaps deep brand loyalties that reach right into the individual’s identity. However, the pace of change in alternative technologies has been extremely rapid since the emergence of cigalike vapes at a noticeable scale about 15 years ago. Imagine the product landscape 15 years from now. That will include better versions of the product categories we have today: vapes, oral nicotine, heated tobacco and smokeless tobacco, but perhaps also sprays, inhalers and nasal products. Who knows? Competitive innovation meets consumer demand in novel and sometimes surprising ways. Many public health commentators, and perhaps tobacco industry die-hards, believe that these products will remain a niche alternative for only some smokers. Don’t count on it. Over time, that niche will expand through innovation until it dominates the market. That trend is inevitable and unstoppable.

    Fourth, regulation and markets. The twin forces of consumer demand and innovation will squeeze the cigarette market into contraction and lower profitability. The greatest danger is that the rise of smoke-free alternatives will be treated as a threat, not an opportunity, and be met with prohibitions or excessive regulation and taxation. Although such regulation will aim to reduce nicotine use by constraining supply, its effect will be to switch from lawful commercial supply to illicit, criminal and informal supply. This effect is already visible in supposedly strong regulatory jurisdictions like Australia and the United States, where authorized products from approved suppliers meet less than 10 percent of the vape market. Jurisdictions such as Brazil and India have imposed prohibitions, but all that means is that the regulator is missing in action along with any consumer protection. Prohibitions trigger the nasty triad of more smoking, more illicit vapes and more risky workarounds. Whatever the regulation, there will be supply. Banned products do not simply disappear. Whether the supply is lawful or illegal will become the nicotine and tobacco policy conflict of the coming decade. The market will remain lawful if (and only if) the policies adopted for smoke-free alternatives are risk-proportionate, focus on consumer protection and meet the adult demand for low-risk nicotine.

    “If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee!”

    Fifth, young people and nicotine. By 2040, a more sophisticated discussion of youth nicotine use will emerge. If we accept that adult use of nicotine will persist indefinitely, then we should expect some young people to try it, and for some, it will make them feel or function better. To the extent that youth vaping displaces smoking, it provides net benefits to public health. No reasonable person, including me, wants young people to smoke, vape or use nicotine in any form. However, it is one thing to express an opinion on what is best for young people, but it is quite another to believe this can or should be achieved by various forms of prohibition imposed on adults. Four strategies will emerge to provide reasonable protections to young people. The first will be an imperative to keep the adult nicotine market lawfully supplied and thus inhibit the formation of large criminal supply networks that will also supply youth. The second will be age-secure retailing, drawing on technology and licensing. The third will be controls on marketing, including branding, packaging imagery and flavor descriptors. Finally, we need to be candid and not hysterical in communicating the risks of nicotine use. The global public health problem is not youth vaping but the millions of existing adults who have already been smoking for a decade or more.  

    Sixth, the tobacco control complex. The abstinence-only tobacco control field will face a bruising contest with reality. As the wide range of negative consequences of prohibitions are increasingly visible and articulated scientifically, major funders will become wary and back away. The research funding agencies will become more skeptical. The “realists” will grow in stature and begin to prevail over the “idealists” (see “Realists and Idealists,” Tobacco Reporter, June 2024). Pragmatism will drive out hubris, and grand regulatory schemes will fall into disrepute. The original goal of tobacco control has been to address the range of serious diseases and other harms caused by smoking. But that game is up. In comments to the New York Times almost 20 years ago, the then president of the Campaign for Tobacco-Free Kids, Matthew L. Myers, endorsed a world of nicotine use without significant harm: “The challenge to me is not to eliminate smoking but the death and disease from smoking,” Myers said. “That should be the end goal. If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee! I have to believe that if the marketplace incentives were such that over time, someone could devise a product that would give the same satisfaction as tobacco but didn’t kill them, people would flock to it.”

    Then you’d have coffee! Yes, precisely. But there is no gigantic “coffee control” movement. There is no multimillion-dollar Campaign for Caffeine-Free Kids. As Myers’ statement unintentionally suggests, the tobacco control movement is profoundly threatened by nicotine use without significant harm. Without harm, it has no purpose.

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

    Playing with Numbers

    Photo: Hafiez Razali

    How research methods distort nicotine effects and risks

    By Cheryl K. Olson

    “The paper seems like a joke.” That’s what Harvard researcher Miguel Hernan said recently to the journal Science about a report linking e-cigarettes and strokes.

    The article was concocted by a dubious research group, founded to help young international medical school graduates get coveted authorship credits. Its analysis of U.S. government survey data claimed that respondents who vaped had a higher risk of stroke, at younger ages, than those who smoked. Its glaring flaws included inflating the number of survey takers by tens of thousands and failing to correct for the relative youth of vapers.

    Despite this, the 2022 paper’s findings found their way into media headlines and anti-vaping advertising. The Science article credits Gal Cohen and Floe Foxon with sounding the alarm on this appalling study.

    Subtler issues that affect research quality, and how research is perceived by the public, are harder to spot. Research methods may seem a dull or arcane topic. But a peek at how the research sausage is made reveals some simple yet surprising ways that the process can go wrong.

    Sometimes old habits or unquestioned assumptions are to blame. Just as typewriters affect how we text on our mobiles, legacy cigarette research methods and mindsets influence how we study noncombustible nicotine products.

    Hours of Vaping?

    Everyone understands cigarettes. When it comes to totting up use, cigarettes are easy. They come in standard units. You light, puff and extinguish. Not so for products such as vapes. How, then, do researchers compare smoking with these new nicotine-delivery systems?

    “There’s a lot of research showing that people who use e-cigarettes graze throughout the day,” says Arielle Selya, who conducts nicotine product research at Pinney Associates. “Unlike cigarettes, there’s no defined stopping and starting. They don’t have to finish a discrete unit; they just puff on and off.” Measuring this kind of variable, intermittent activity is a challenge.

    This problem is not unique to vaping. Studying nicotine pouch use, I found unexpectedly wide variations in what people did and what they thought was normal. Some tossed a pouch in the trash after 10 minutes or 15 minutes. Others kept one in their mouth for a couple of hours. A few sometimes reused a pouch they’d started earlier or cheeked pouches of two different flavors at once.

    As an example of what can go wrong, Selya pointed to a recent study of vaping and respiratory symptoms. To the authors’ credit, they tried to measure heaviness of e-cigarette use. The problem was the poor fit between their question and the behavior. They asked, “How many hours did you use electronic cigarettes per day?”

    “I’m not a vaper, but that seems like such a strange question,” says Selya. “Like asking how many hours do you spend drinking water?”

    Better approaches to measuring nicotine product use include writing down what you’re doing whenever a device pings you (ecological momentary assessment) or in a daily diary.

    Twisted Terminology

    Another holdover from cigarettes is the way tobacco is seen as the default flavor for all nicotine-containing products. “With e-cigarettes, you have to add a tobacco flavor,” notes Selya. “But researchers often say ‘flavored’ when they mean ‘non-tobacco flavored’–in some communications even the NYTS team does this–but tobacco itself is a flavor! This generates misunderstandings.”

    Nicotine research terminology can defy common sense. Consider the concept of “abuse liability.” In everyday English, abuse implies harm. When the U.S. Food and Drug Administration assesses new drugs, stricter regulation may be required if there’s abuse potential, defined as “intentional, nontherapeutic use” to “achieve a desired psychological or physical effect.” An effect like euphoria, hallucinations or distorted thoughts or perceptions. 

    When it comes to reduced-harm nicotine products, abuse potential becomes, weirdly, a plus. A backhanded compliment. If you want to attract someone away from cigarettes, features like rapid nicotine absorption, relaxation and relief of withdrawal encourage that transition.

    Abuse liability also illustrates another nicotine methodology vexation: there is no agreed-on way to measure it. One article looked at comments made by the FDA on manufacturers’ submissions for multiple types of nicotine products. Regulators considered a whole range of measures related to abuse liability, from product chemistry and pharmacokinetics to subjective factors. Of the latter, “liking” the product turned out to be the most reliable and sensitive abuse liability measure!

    Misleading Measures

    Again, cigarettes are simple and familiar. Novel nicotine products, by contrast, come in ever-evolving variations. U.S. government surveys, such as the Population Assessment of Tobacco and Health (PATH) and National Youth Tobacco Survey (NYTS), measure trends in who is using what products. The results are widely used and reported. However, for survey results to make sense, people must understand the questions.

    Discrepancies in results suggest that research participants often misunderstand nicotine products and/or the terms being used to describe them. For example, answers about vaping brands and device types often don’t match. In the NYTS, just two-thirds of teens who said they “usually” used a pod/cartridge brand of e-cigarette (such as Juul, Logic or Vuse) also said they “most often” used a pod/cartridge device. Almost one in five adults in the PATH study had these kinds of mismatched answers about their vaping behavior. 

    Some questions have even larger errors. “The NYTS asks whether your e-cigarette product contains nicotine salts,” says Selya. “And overall, about 50 percent said they don’t know.”

    This is also true for so-called “concept” flavors, she notes. “Not strawberry-banana, but something like cosmic fusion. When youth are asked about concept or ice flavors, they don’t know the characteristics of their product, or maybe don’t understand those words.”

    NYTS first asked youth about tobacco-free nicotine pouches in 2021. That year, just 1.9 percent of teens reported ever using one. Checking the details, I found a flaw: The questionnaire defined nicotine pouches as “flavored.” However, over a third of teen ever-users said the pouch product they used was unflavored. (Perhaps they confused pouches and snus?) 

    A further example: the 2023 NYTS found that 1 percent of youth—an estimated 370,000—had ever used a heated-tobacco product. At the time, that product category was not sold in the United States.

    As Ray Niaura of New York University told me, “That can’t be right. Literally, it’s impossible. So that means it’s measurement error.”

    This suggests young survey takers were befuddled. “Kids aren’t going to know,” says Niaura. “‘Heated tobacco: Yeah. I smoked a cigarette. It’s heated. I light it on fire.’”

    Yet the Centers for Disease Control and Prevention reported the result without comment or explanation.

    If a product is only used by a small percentage of people, these sorts of errors could create unreal changes in year-to-year trends. The reporting of those potentially misleading trends affect the perceptions of academics, regulators and the public. “With that amount of uncertainty and some of the low numbers, it’s hard to figure out what’s the signal versus the noise,” notes Selya.

    Questionable Choices

    Another seemingly simple but complicated issue: Who counts as a current product user? Youth surveys typically ask “have you used e-cigarettes at all, even a puff, in the last 30 days?” Surveys aimed at adults commonly ask, “Do you currently use e-cigarettes some days, every day or not at all?”

    If you assume capturing any youth e-cigarette use is important, then “even a puff” makes sense. But it also makes it difficult to separate teens who are briefly experimenting from teens at risk for problematic ongoing use.

    In studies that look at how using nicotine products affect some aspect of health, researchers choose what outcomes to measure. Their choices can suggest biases or suspicious holes in what’s reported.

    A recent study using PATH data tried to compare e-cigarette use and the age at which people developed asthma. “Why age of asthma onset rather than whether they developed asthma at all?” says Selya. “Often, I read a study and think, did you look at these other related outcomes? If so, why weren’t they published?” This issue of results that may exist but aren’t reported are known as the “file drawer problem.” Preregistering study plans would avoid this issue.

    Researchers, Meet Users

    Before I dove deeply into tobacco harm reduction, my research focused on the effects of violent video games on youth. Finding discrepancies between research reports and what teens told me, I realized that many of the field’s most-cited “experts” had never actually played or even observed the games they studied.

    Similarly, many nicotine researchers seem to have never held or used the noncombusted products they study. This leads to findings that don’t reflect real-world situations. One example is an article by Sebastien Soulet and Roberto Sussman on metal contents of e-cigarette aerosols. They found that researchers were overheating tank vaping devices, generating aerosols that would be “likely repellent to human users.”

    “I think there’s a big disconnect and abysmally low involvement of actual consumers, the people affected by policies,” says Selya. Partnering with people who actually know and use novel nicotine products would be a giant step toward improved research quality.  

    References

    Foxon F. (2023). Discordant device/brand reporting among adolescents who used e-cigarettes in the National Youth Tobacco Survey. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntad228

    Joelving F. (2024). Prescription for controversy. Science. https://www.science.org/content/article/questionable-firms-tempt-young-doctors-with-easy-publications

    Selya A, Ruggieri M, Polosa R. (2024). Measures of youth e-cigarette use: strengths, weaknesses and recommendations. Frontiers in Public Health. https://doi.org/10.3389/fpubh.2024.1412406

    Soulet S, Sussman RA. (2022). A critical review of recent literature on metal contents in e-cigarette aerosol. Toxics. https://www.mdpi.com/2305-6304/10/9/510

    Vansickel A et al. (2022). Human abuse liability assessment of tobacco and nicotine products: approaches for meeting current regulatory recommendations. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntab183

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
  • Shock Absorber

    Shock Absorber

    Photo: Alessandro De Leo | Dreamstime

    With an appropriate tax regime, fine-cut tobacco can provide a useful buffer between high-priced cigarettes and illicit products.

    By Stefanie Rossel

    Across Europe, three countries offer showcase examples of unintended consequences created by ill-designed tax policies. The fiscal frameworks in France, the United Kingdom and the Netherlands prevent fine-cut tobacco (FCT) from fulfilling its buffer function in the nicotine ecosystem, leading to high levels of illicit trade. When taxed at comparatively low rates, FCT products can serve as a “shock absorber” between higher taxed factory-made cigarettes and illicit smokes. If the tax rates and retail prices of combustible cigarettes and FCT become too similar, fine roll-your-own (RYO) and make-your-own (MYO) products may lose their appeal to smokers with lower disposable incomes.

    In the European Union, home to some of the world’s leading RYO and MYO markets, France presents a prime example. “The market is riddled with illicit trade, as the taxation levels prevent FCT to fulfill its buffer function,” says Peter van der Mark, secretary general of the European Smoking Tobacco Association (ESTA). “Since 2020, volumes of FCT have consistently declined, by 8 percent in 2021, 13.7 percent in 2022 and 10.2 percent in 2023.” This decline is slightly more pronounced than that in other tobacco segments.

    On the bright side, according to van der Mark, French authorities appear to have belatedly recognized the negative impacts of their policies. Last month, the responsible minister acknowledged that beyond a certain point, raising taxes becomes counterproductive and boosts contraband, which benefits neither public health nor public finances. “We can only regret that it took one-third of the market to be illegal to come to that conclusion,” laments van der Mark.

    The U.K. faces a similar situation. According to van der Mark, that country’s government has nearly aligned the tax rates on FCT with those on cigarettes—and without consulting the industry. As a result, legal volumes have been declining substantially, benefiting smugglers and illicit traders. According to van der Mark, this is not only impacting manufacturers, distributors and retailers but also the finance ministry (and therefore U.K. citizens), which last year saw its tobacco tax receipts drop by nearly 15 percent compared to 2022—a loss of approximately £1.5 billion ($1.91 billion).

    Germany, the largest EU market for hand-rolling products, also hiked FCT taxes but managed to avoid the negative effects experienced by Britain and France, thanks to its incremental approach. “The ad valorem component on FCT increased progressively and moderately whilst step increases of the specific or minimum were always kept below 10 percent,” explains van der Mark.

    “In general, we consider the German tax model to be well crafted as it allows for predictability and ensures the market functions smoothly whilst allowing the government to pursue its treasury and health objectives,” says van der Mark.

    “Volume-wise, of course we note a decline in comparison with 2020 [consumption], which was exceptionally high due to the Covid-19 outbreak. In 2023, volume declined by 5 percent compared to 2022, confirming a declining trend in general.”

    This year, however, Germany’s market has benefitted from rising FCT taxes in the Netherlands. According to van der Mark, a 50 gram pouch now costs approximately €25 ($27.02) there, encouraging Dutch smokers to source their tobacco elsewhere, including in neighboring Germany.

    Across Europe, the general trend is toward less tobacco consumption, and FCT is no exception. “Inflation had a massive impact on consumer ability to buy tobacco products in 2022–2023,” says van der Mark. “Consumers down-traded or moved to FCT or illicit cigarettes. Although inflation has decreased, it remains very unequal from one country to another. Where inflation remains high, we expect sales of FCT to slightly increase, demonstrating once again the buffer function this product category can fulfill, provided it is taxed approximately.”

    “We consider the German tax model to be well crafted as it allows for predictability whilst allowing the government to pursue its treasury and health objectives.”

    STG Buys Mac Baren

    As the market contracts, the fine-cut industry has been consolidating. In June, Scandinavian Tobacco Group acquired family-owned Mac Baren Tobacco from Halberg for DKK535 million ($76.87 million). Founded in 1826, Mac Baren’s portfolio includes pipe tobacco brands such as Mac Baren, Amphora and Holger Danske as well as fine-cut tobacco brands such as Amsterdamer, Choice and Opal. The company also produces and sells nicotine pouches with the brands Ace and Gritt.

    Mac Baren sells its products in 74 countries and generates most of its net sales in the U.S., Denmark and Germany. Other key markets include the U.K., France, Spain and Italy. Headquartered in Svendborg, Denmark, the company has production facilities in Denmark and the United States (in Richmond, Virginia), and employs approximately 200 people full time.

    Both Mac Baren and STG are members of ESTA. “The reduction of family-owned companies in our sector is always regrettable, but at the same time, we are pleased to see that its traditional know-how will remain in the very capable hands of STG, a company that is committed to high-quality traditional smoking tobaccos,” says van der Mark.

    The FCT sector has consolidated at regular intervals, with the last wave being triggered by the EU Tobacco Products Directive (TPD) in 2014. At this time, van der Mark sees no indications of a new consolidation wave, however.

    New Regulations on the Horizon

    Whether the pending TPD revision will change that situation is up for discussion. The European Commission’s evaluation report, expected toward the end of 2024, should provide some insights into the future regulatory environment. According to van der Mark, a 2021 report on the TPD application identified topics likely to be discussed further in the future.

    “This includes the field of ingredient regulation, where we have seen several member states taking cavalier initiatives and establishing outright bans of certain ingredients,” he says. “In general, we fear that the notion of ‘flavors’ has been largely misunderstood and will be subject to debates that will most likely be based on assumptions more than on actual scientific underpinning. Labeling and packaging, where the commission is no longer hiding its preference for plain packaging, will also be an issue, and, of course, the regulation of novel tobacco products.”

    With a new commission poised to take office in November, van der Mark expects more emphasis on novel nicotine products and less impact on the FCT segment. “For fine-cut tobacco, the whole legislation has already been there since TPD2,” he says.

    “We are more concerned about the ingredients regulation. We believe that the ingredients which are in tobacco products, representing between 1 percent and 3 percent of the total weight, are nonconsequential, but the commission is continuously looking at the ingredients as if they would make the product even more problematic from a health perspective. We think that the commission simply has the wrong end of the stick.”

    Whether the EU’s approach toward tobacco products will change with the new crop of lawmakers remains to be seen. “At this stage, it is not sure whether the ‘shift to the right’ will affect the functioning of the EU Parliament and its ‘great coalition’ made of the Socialists and Democrats, Renew and center-right European People’s Party groups,” says van der Mark.

    “An interesting statistic, however, is that about 60 percent of the elected members of the European Parliament are coming from parties that are not governing in their national jurisdictions. This means that we could see a European Parliament ‘free’ from the guidance of the national government, at least to a certain extent.”

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