Category: Also in TR

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  • 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.
  • Ignorance Is Not Bliss

    Ignorance Is Not Bliss

    Photo: bongkarn

    Professional research institutions can help nicotine companies carry out surveys that they may be reluctant to conduct themselves.

    By Neil McKeganey and Gabe Barnard

    In the 2012 Hollywood action thriller Zero Dark Thirty documenting the hunt for Osama Bin-Laden, there is a scene in which a CIA lead outlines to the president’s national security advisor the agency’s latest intelligence identifying the occupant of a fortified compound within Pakistan as possibly being the Al-Qaeda leader. On leaving the meeting and fearing that the proposed raid on the compound will have been rejected because of the risks involved, the CIA lead asks the national security advisor a critical question: Alongside the risks of the operation itself, what, he asks, are the risks of doing nothing? That scene underlines a fundamental of public policy, namely the importance of addressing both the risks of interventions as well as the risks of failing to intervene.

    And so with the tobacco industry. When it comes to tobacco products, there are few more sensitive matters than youth use of the products involved. In the world of manufacturing, selling, studying, treating and preventing tobacco consumption, the simple fact that the use of these products typically starts in the teen or preteen years makes youth use of tobacco products a hugely impactful issue. For decades, the tobacco industry has been reluctant to initiate research on teenage and underage adult use of their products, fearing that they may be accused of harvesting sensitive data on young people that may, in time, be used to market their products. While the risks of industry-supported research on youth are understandable, the risks of not undertaking that research are increasingly important.

    The consequences of initiating tobacco product use in the teen and preteen years, and of embedding a behavior that may last many decades, resulting in serious adverse health consequences, are too serious to disregard. Those involved in tobacco control, those with an interest in regulatory action and those involved in the media are all hugely interested in the results of research reporting the extent and determinants of teenage tobacco product use.

    By removing itself from research in this area, the tobacco industry repeatedly finds itself having to respond to accusations that its products are indeed being widely used by young people. By failing to support research in this area, the impression may be conveyed that industry as such are either uninterested in teen use of their products or frightened at what that research might show. That fear is understandable. If there was any doubt about the potential impact of reports of teen use of tobacco products, then think only of the fate that has befallen Juul, Puff Bar and Elf Bar. Each of these companies have been characterized as a major driver of youth vaping, and each of them have paid the price as a result.

    The ground is now changing in relation to the tobacco industry studying or supporting research in this area. There is, for example, Altria’s Underage Tobacco Use Study, gathering data on youth and underage adult use of a range of tobacco products. Not only has Altria overcome their own anxiety around research in this area, but in an extraordinary act of transparency, they have opened up the data from this study to external agencies and researchers. Similarly, other major tobacco companies are now actively considering how to undertake or support research in this area. There are multiple benefits that are likely to flow from this change. By collecting data on which products are being used by youth and young adults, tobacco companies can make a contribution both to tackling teenage tobacco use and utilizing such information in their own applications for regulatory approval where the research identifies those tobacco products that are not being used by youth and underage adults. Research in this area can help companies by providing “early warning” data on which of their products are being used by youth in which parts of the country, thereby better equipping the companies with data that can help them tackle the problem of underage tobacco use.

    In the face of a growing willingness to support youth research, the tobacco industry will still face notable barriers. Along with the large cost of undertaking research involved, there is also the fact that few in the industry have experience of undertaking research with young people.

    In both these regards, the industry can benefit from the services of professional research institutions. The Centre for Substance Use Research in Glasgow, Scotland, for example, collects detailed information on the extent to which specific named tobacco products and brands are being used by young people in the U.S. through its Tobacco Product Prevalence Survey (TPPS).

    The results of this survey have already assisted a number of companies in their submissions under the premarket tobacco product application process in the U.S. Because the TPPS study is funded by the research center rather than tobacco companies, the accusation that industry is harvesting data on young people, or that commercial interests are biasing the results, cannot be applied.

    In time, we will see more of the output of industry-supported research, with the results of that research hopefully changing the perception of an industry that while profitable is reluctant to ask the question of how widely their products are being used by young people.

    Neil McKeganey is director of the Center for Substance Use Research in Glasgow, Scotland.
    Gabriel Barnard is a director of the Center for Substance Use Research in Glasgow, Scotland.
  • Beyond Hot Air

    Beyond Hot Air

    Photo: Valerii Honcharuk

    Designing effective heated-tobacco products

    By Malcom Saxton

    Heated-tobacco products (HTPs) heat tobacco to a high temperature without combusting it. Intended as a tobacco harm reduction tool, good product design is a key aspect in encouraging HTP adoption among adult smokers looking to quit combustible cigarettes. Here, Malcolm Saxton, senior consultant for chemistry at Broughton, which operates a dedicated HTP testing and compliance facility, shares advice on designing an appealing HTP.

    Although a small number of brands currently dominate the HTP market, more businesses are working to bring competitive HTPs to adult smokers by investing in research, development and marketing. For example, in 2023, Japan Tobacco announced that it would invest ¥300 billion ($2.05 billion) in HTPs, with ¥200 billion allocated for marketing internationally.

    Manufacturers can create effective and competitive products by investing heavily in device design—carefully scrutinizing the product’s design requirements, its capabilities and understanding how it will achieve the desired results for target users. 

    Concept and Engineering

    One of the first steps in designing an HTP is creating a target product profile (TPP), which outlines the desired characteristics or “profile” of the product. According to the World Health Organization, TPPs “state intended use, target populations and other desired attributes of productions, including safety and efficacy-related characteristics.” Usually, manufacturers will have a vision of what they want their HTP to look like. While some may try to emulate market-leading products, others will opt for very different flavors, form factors and aesthetics.

    A growing trend in device design is personalization, with some brands launching limited edition products and providing colored panels to personalize their HTPs. Also, Bluetooth connectivity is now standard on many products, such as the latest Glo Hyper Pro, which also has an LED display and can provide real-time feedback. Another notable improvement has been reduced consumable warm-up time, which promises a more effective user experience by making the device faster to use.

    Due to the complexity, cost and time associated with designing HTPs, many manufacturers choose to work with third-party specialists. These expert partners can frame what an ideal finished product will look like and help manufacturers build a TPP that meets both user and market needs. Then, once the manufacturer and partner have agreed upon the TPP, these specialists help turn this vision into actionable targets and design parameters.

    When working toward the TPP, design considerations include the HTP’s thermal design and heating profile. During the heating process, the water in aerosol is distilled off, but unless the hot water is managed effectively, the first puff will be steam—a situation called “hot puff,” which can be dangerous for users. Consequently, manufacturers can design the device airflow to minimize the risk of hot puff by adding a preheating function to drive off the water before the user takes a puff. Another option is adding ventilation capabilities to the stick, which cools the water by drawing in air.

    Iterative Testing

    In these early stages of product realization, it’s important to capture as much data about the HTP’s design and its performance as possible. Regular, iterative tests are essential and so are short development cycles so that manufacturers can quickly capture the data, identify areas for design optimization and make the necessary changes.

    While it’s important to test multiple parameters, manufacturers must be selective with these to avoid costly delays. Some of the key parameters include total particulate matter, the amount of nicotine that the HTP delivers and the presence of a visible cloud upon inhale and exhale. This iterative stage is also a good opportunity to assess toxicological touchpoints, such as combustion markers, and whether the product meets regulatory requirements. Consequently, iterative testing allows manufacturers to understand their product’s suitability from a consumer and regulatory standpoint.

    Toxicological Considerations

    Although HTPs aim to offer smokers a less harmful alternative to combustible cigarettes, these products still carry a toxicological risk, which manufacturers must manage during the design process.

    Data from the Philip Morris International Scientific Update reports that, on average, there were 90 percent to 95 percent lower levels of harmful and potentially harmful constituents (HPHCs) in the aerosol of IQOS compared with combustible 3R4F cigarettes. However, manufacturers should treat toxicology with caution, with a WHO report noting that “some HTPs may emit unique harmful chemicals because of their distinctive characteristics and how they are used.”

    The choice of tobacco and blend is an important toxicological influence. Tobacco-specific nitrosamine—a carcinogen found on tobacco leaves—can form during the curing phase and, depending on the nitrate levels, when the device stick is heated. Therefore, it’s important to control the blend as early as possible in the development cycle, and working with an analytical testing partner can help manufacturers understand the toxicological impact of different blends.

    For a detailed understanding of toxicological risk, manufacturers can evaluate aerosol chemistry. Priority toxicant lists for cigarettes have been developed by a number of organizations, including the U.S. Food and Drug Administration, Health Canada and the WHO Study Group on Tobacco Product Regulation (TobReg). The most widely accepted list of HPHCs to test in the aerosol of HTPs, both for regulatory submission and for producing evidence of potential harm reduction, is the PMI58, a list developed specifically by Philip Morris International to focus on analytes most relevant to IQOS and, more generally, HTPs.

    Preparing for Market

    Building a strong picture of the target market can help manufacturers understand the regulatory requirements and ensure that these are built into their HTPs. Aerosol testing requirements will vary according to the regulatory framework being followed. At the most basic, the European Union and U.K. require a minimum of tar (nicotine-free dry particulate matter), nicotine and carbon monoxide to be measured. While with the far more rigorous requirements of a premarket tobacco product application, required for launch into the U.S., where a full understanding of aerosol chemistry and, more generally, the understanding of the product’s appropriateness for the protection of public health is required.

    Whichever regulatory pathway the manufacturer follows, experts, including analytical chemists, toxicologists and clinical scientists, must design testing protocols that include all the relevant parameters for regulatory approval.

    As investment in HTPs grows, manufacturers will continue to innovate and develop new designs to meet user needs. This means developing products that are both effective and comfortable to use so that smokers adopt them as smoking cessation tools. Working with an experienced partner can make the design process easier by creating an achievable TPP and helping them get the product to market.

    Malcolm Saxton is senior consultant at Broughton.
  • The Takeaways

    The Takeaways

    Image: Parin April

    What can we learn from the first FDA marketing order for menthol ENDS?

    By Chris Allen

    In good news for the next-generation nicotine industry, the U.S. Food and Drug Administration recently granted marketing orders (MOs) for four menthol-flavored e-cigarette products. This marks the first time that the FDA has granted MOs for nontobacco-flavored products via the premarket tobacco product application (PMTA) pathway. In this article, Chris Allen, CEO of PMTA specialist Broughton, summarizes the documentation and shares some pertinent learning points from the decision summaries of the applications from the technical project lead (TPL) review.

    The new products that were granted MOs are Altria’s Njoy Ace Pod Menthol 2.4 percent, Njoy Ace Pod Menthol 5 percent, Njoy Daily Menthol 4.5 percent and Njoy Daily Extra Menthol 6 percent. The Ace products are sealed pod-based systems whereas the Daily products are disposable e-cigarettes with a prefilled, nonrefillable e-liquid reservoir. At the time of writing, Njoy Ace is the only pod-based e-cigarette product with an MO.

    A Big Step for Tobacco Harm Reduction

    Granting an MO for a menthol e-cigarette is a huge step in the right direction for the FDA, opening up a new avenue for tobacco harm reduction to millions of adult smokers across the U.S.

    It is crucial that we have a diverse portfolio of convenient, satisfying and appealing smoke-free products to meet adult smokers’ preferences and needs as they transition away from combustible cigarettes (CC). We hope the fact that the FDA has granted MOs for menthol products will encourage adult smokers to opt for regulated alternatives to smoking rather than illicit products. However, we must bear in mind that these products are now eight years old, so it’s imperative that the FDA streamlines the PMTA process to reduce the time to market for products that are aligned with changing consumer behaviors.

    The PMTA Process

    Compiling a PMTA is a rigorous and lengthy task, with manufacturers required to provide data and evidence to demonstrate that the product is “appropriate for the protection of public health” (APPH) as required under the Tobacco Control Act. Manufacturers must consider the risks and benefits of the product, both to users and nonusers. To date, 27 products and devices have been granted marketing orders, and a full list is kept here.

    The FDA’s approval of menthol products demonstrates that it is possible to achieve the requirements of PMTA approval with a high-quality menthol product and compelling data. Shannon Leistra, president and CEO of Njoy, said, “We believe these marketing orders are a testament to the quality of the Njoy products and the strength of evidence supporting the authorizations of the Njoy menthol e-vapor products.”

    It will be interesting to see the FDA’s next move regarding flavored electronic nicotine-delivery systems (ENDS) and whether granting MOs for menthol opens up the door to other flavors. Njoy has resubmitted PMTAs for blueberry-flavored and watermelon-flavored pod products that work exclusively with the new Njoy Ace 2.0 age-gated device and is awaiting the outcomes.

    What Can We Learn from These Products?

    PMTAs are reviewed on a case-by-case basis, and the MO is specific to these products only. Understandably, many in the industry are looking to learn from this industry first to apply it to their own products and PMTAs.

    The most interesting outcome, naturally, is that the FDA determined there was robust and reliable evidence of an added benefit from the menthol flavor relative to that of tobacco-flavored products in facilitating adult smokers switching from CCs. This was deemed to outweigh the increased risk of youth use.

    About the approval, Brian King, director of the FDA’s Center for Tobacco Products, said, “It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome. This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”

    Reducing the Risk of Youth Use

    A shared concern of the general public, manufacturers and regulators is the youth appeal of nontobacco-flavored products. The FDA has placed stringent marketing restrictions to prevent youth access and exposure, and for flavored products, there is a higher burden of proof on the manufacturer that the benefit to adults who use CCs outweighs the increased risk of youth use.

    While the application did include studies of youth use with low prevalence estimates for the new products, the FDA deemed the sample size insufficient. It noted the recent National Youth Tobacco Survey on popular flavors and devices, referencing the increased risk of youth appeal of menthol-flavored ENDS compared with tobacco-flavored ones, but adding the risk is lower than some other flavors (e.g., fruit).

    The TPL noted, “FDA’s experience shows that advertising and promotion restrictions and sales access restrictions cannot mitigate the substantial risk to youth from flavored ENDS sufficiently to reduce the magnitude of adult benefit required to demonstrate APPH. Rather, for flavored ENDS, only the most stringent mitigation measures have such potential; to date, the only such measures identified with the potential for that kind of impact have been device access restrictions.”

    The FDA’s ruling highlights that “stringent mitigation measures” such as device access restrictions have the mitigation potential to demonstrate APPH. However, the Njoy menthol-flavored PMTAs did not propose such mitigation restrictions and therefore required reliable and robust evidence of a potential benefit to adults who smoke, i.e., cessation of combustibles with continued ENDS use or cessation of combustibles leading to cessation of ENDS use.

    The application also proposed limiting youth exposure by not engaging in social media promotions, limiting human portrayals to those over 45 and prohibiting these products from being sold on third-party websites.

    Comparisons from Adult Smokers

    In this case, the FDA found “acceptably strong evidence” from submitted data from an online, observational longitudinal cohort study comparing its menthol Njoy Daily product with its tobacco-flavored Njoy Daily device. The study suggested a 21 percent to 31 percent rate of switching over a period of six months (three months primary outcome cohort), higher than the rate of ENDS in the literature.

    The comparison analyses showed the menthol Daily products were associated with statistically significant and higher rates (32 percent to 43 percent) of complete switching than the rate of tobacco-flavored Njoy Daily ENDS (21 percent to 37 percent) at three months or six months.

    Additionally, the comparison analyses demonstrated a 24 percent to 45 percent substantial added benefit from the menthol-flavored Njoy Daily ENDS in switching away from CCs among smoking adults compared with their tobacco-flavored equivalent. The submitted clinical studies demonstrated a similar abuse liability to CCs, suggesting they are a suitable substitute.

    For Njoy Ace menthol products, the longitudinal cohort study found behavioral benefits compared with tobacco-flavored Njoy Ace products in robust and reliable rates of switching from CCs, though the exact figures were redacted.

    Overall, the studies showed that the products have the potential to promote CC cessation, or significantly reduced use, compared with tobacco-flavored comparator products. The review concluded that there was a benefit to public health in the significantly higher smoking cessation rates achieved as compared with equivalent tobacco-flavored products.

    Biomarker data showed fewer and lower levels of harmful and potentially harmful constituent exposure compared with CCs, and toxicological evaluation of the aerosol suggested a lower excess lifetime cancer risk using Njoy Daily than using CCs. Ultimately, the FDA ruled that this data “demonstrated the potential for these new products to benefit adults who smoke combustible cigarettes as compared to adults who continue to use combustible cigarettes exclusively.”

    All of these points contributed to the FDA’s decision to designate the products as APPH. This monumental ruling has excited many in the next-generation nicotine industry, as it helps us achieve our shared goal of tobacco harm reduction for millions of adult smokers across the U.S. We are likely to see manufacturers working closely with regulatory consultants like Broughton to ensure their PMTAs contain robust and rigorous data and that their regulatory dossier is presented to support the best chance of success.

    Chris Allen is the CEO of Broughton.
  • No Shortcuts

    No Shortcuts

    The effort to correct nicotine risk misperceptions will be a marathon rather than a sprint.

    By Stefanie Rossel

    “Nicotine contained in tobacco is highly addictive, and tobacco use is a major risk factor for cardiovascular and respiratory diseases, over 20 different types or subtypes of cancer and many other debilitating health conditions.” With phrases like this, the World Health Organization links the undisputed harms of burning and inhaling plant tissue with the ingredient smokers seek in a cigarette.

    Regardless of its form of delivery, such statements suggest, nicotine is the devil incarnate. In spreading this message, it appears, the WHO has done a good job. In a 2021 study funded by the National Cancer Institute, 83.2 percent of surveyed U.S. physicians “strongly agreed” that nicotine directly contributes to the development of cardiovascular disease. Nearly 81 percent thought it contributes to chronic obstructive pulmonary disease (COPD), and 80.5 percent associated nicotine with cancer.

    While recognizing that nicotine is responsible for the addictive nature of tobacco products, the study authors pointed out that the strongest evidence for direct causality for nicotine is for birth defects (neurodevelopment), with only limited evidence supporting causal links to cancer and cardiovascular disease and scarce data for COPD. The misperception that nicotine is responsible for smoking-related health risks, they observed, is not only common among the public but also among other healthcare professionals.

    “Correcting misperceptions should be a priority given that in 2017, the FDA [U.S. Food and Drug Administration] proposed a nicotine-centered framework that includes reducing nicotine content in cigarettes to nonaddictive levels while encouraging safer forms of nicotine use for either harm reduction (e.g., smokeless tobacco) or cessation (pharmacologic NRT [nicotine-replacement therapy]),” the study concluded.

    In product use, risk perceptions play a critical role; they can influence smokers’ decisions on whether to switch to products with lower risk profiles. The messaging is an essential part of changing misperceptions. Studies on nicotine corrective messaging have shown that it was effective in decreasing misperceptions of nicotine harm, but repeated exposure to such messaging was necessary to reduce false beliefs about nicotine and tobacco products.

    With physicians and other healthcare professionals often being the first point of call for people seeking to quit smoking, it is obvious that their misperceptions should be corrected first so that they can educate their patients and accurately convey nicotine’s relative and absolute risks.

    Carolyn Beaumont

    Carolyn Beaumont, a general practitioner (GP) from Victoria, Australia, has taken on the challenging task of educating her colleagues. Since July 1, 2024, all nicotine vapes in Australia have been regulated as therapeutic goods, which means they are available only at pharmacies to help people quit smoking or manage nicotine dependence. Currently, all buyers of nicotine vapes require a prescription from a doctor or a nurse practitioner.

    Starting Oct. 1, the rules will be somewhat relaxed. From that date, people 18 years or over will be able to purchase therapeutic vapes directly from a pharmacy without a prescription. People under 18 will still need a prescription to access vapes, where state and territory laws allow it, to ensure they get appropriate medical advice and supervision.

    The concentration of nicotine in vapes sold in pharmacies without a prescription will be limited to 20 mg per milliliter; people who require vapes with a higher concentration of nicotine will still require a prescription.

    The law requires pharmacists to consult customers of both prescription and nonprescription vapes before allowing them to make a purchase.

    Following the announcement of the new rules, several major pharmacy chains in Australia stated that they will no longer stock vapes. Beaumont is not surprised: “They simply don’t have the time, product knowledge or resources to advise customers on appropriate products and use. It is greatly complicated because any pharmacist-only product must be an approved medical product, yet there are no approved vapes in Australia. They are listed but not approved. Fortunately, there are some online pharmacies who specialize in vapes, and these will continue to operate but likely will require a script to avoid the ‘nonapproved’ issue.”

    “There is no official doctor education in Australia that adequately presents the fuller context of smoking, vaping and nicotine.”

    Enjoyment Doesn’t Feature

    Despite the hostile environment for nicotine, Beaumont says she has found that her colleagues are quite interested in the field of tobacco harm reduction (THR). “Yet, to communicate THR on a larger scale, typically via continuing medical education (CME) courses or webinars, is difficult. These generally require support from the Royal Australian College of General Practitioners (RACGP), and to date, there is no official doctor education in Australia that adequately presents the fuller context of smoking, vaping and nicotine,” she says.

    “In medical school and as a trainee GP, we were taught of the many smoking-related health and social issues. But a more nuanced understanding of working with smokers wasn’t appreciated. We all knew the ‘three A’s’ approach—ask, advise, assist—the measure of nicotine dependence—time to first cigarette—and the first line NRTs. Yet it stopped there as though magically, smokers would be motivated to quit, and this would happen within six months. If not, repeat the process ad nauseum.”

    According to Beaumont, doctors aren’t taught that some smokers like nicotine and simply want a less harmful alternative. “Enjoyment doesn’t feature in medical education,” she says. “Doctor support can truly help some people reduce their use. But it’s not enough for many heavy smokers, and they often become disengaged with the same messaging they keep hearing from doctors.”

    Beaumont is encouraged, though, that Australia’s GP College recently revised its smoking cessation guidelines and increased the recommendation of vaping from “low” to “moderate.” “I hope this will have a reasonable impact on doctors’ willingness to prescribe, or at least be open to the conversation,” she says. “I also hope this signals a greater willingness by the RACGP to support vape-related CME that is broader in scope and includes input from ‘progressives’ such as myself.”

    Beaumont first became aware of vaping as a cessation tool in 2020 when Australia was on the verge of making vapes prescription-only. “My approach was simply this: I listened to the needs of smokers and vapers,” she says. “It didn’t take long before I was convinced of [the] merits [of vaping], and also, I developed a deeper understanding of nicotine use and addiction. Compassion and health improvements were, and still are, the underlying reasons why I’ve remained involved in this field.”

    Beaumont aims to help disadvantaged groups, which are among the most affected by smoking-related death and disease. “It is simply unjust that smokers are also affected by nicotine myths, and it is getting to the point where people think that smoking is better than vaping.”

    “Like so many areas where science is contested, adherents of contrarian positions are rarely persuaded by more science or data.”

    Open Dialogue Required

    Derek Yach

    While some believe that science will correct misperceptions of nicotine, others are skeptical, pointing, for example, to the WHO’s proposal to define aerosols as smoke. Derek Yach, a global health expert originally from South Africa who played a key role in crafting the WHO’s Framework Convention on Tobacco Control, says that while some topics require more research, these gaps should not delay WHO support for THR, noting that they have not prevented the U.S. Food and Drug Administration and other government agencies from authorizing a range of reduced-risk products.

    “Like so many areas where science is contested, including vaccine benefits, climate change or even beliefs that the earth is flat, adherents of contrarian positions are rarely persuaded by more science or data,” says Yach. “Their views deeply reflect emotional, ideological and sometimes cultural views based on their life experiences. A mother whose child gets autism after a vaccine is easily convinced that vaccines are dangerous. A tobacco control advocate who experienced tobacco industry subversion of public policies keeps that view and doubts anything new coming from industry.”

    Having worked on all sides of the issue and having spoken with a wide variety of stakeholders, Yach says that there is no shortcut to finding safe spaces to not only talk honestly about the science but also examine the reasons behind the mutual suspicion. “I saw this bear fruit in the declining years of apartheid when talks about talks led to a peaceful transition of power,” says Yach. “It is possible in that setting; it must be possible in our world.”

    The Morven Dialogues, a series of meetings between U.S. public health officials and tobacco industry representatives first held in 2012, have been a modest example of what is needed, according to Yach.

    “They recently reported on their March 2024 meeting, which brought together industry with some public health leaders in the U.S.,” says Yach. “Further, I see signs of hope in a recent article by authors from public health I have long respected. They argue for dialogue between scientists in the public sector and industry—as I have—and not for boycotts and bans.”

    Without agreement on the basic scientific issues and progress on correcting disinformation, sound policies are unlikely. “A study of how change happens in public health shows that it always starts with physician acceptance of the evidence,” says Yach. “They apply that evidence to themselves, to their patients and through organized efforts to public policy. Recall that no country has ever seen a reduction in their smoking rate before it goes down in physicians. I suspect that is true regarding uptake of THR products. And that starts with doing more to have disagreeing groups talk.”

    It’s going to be an uphill struggle, though: In mid-June, the WHO in a press release expressed “grave concern over the tobacco industry’s manipulative tactics aimed at influencing healthcare providers through continuing medical education programs and thereby advancing the interests of the tobacco industry.”

    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.
  • 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.
  • Hot Commodity

    Hot Commodity

    Photo: Taco Tuinstra

    Leaf tobacco remains in short supply.

    By Stefanie Rossel

    Ivan Genov | Photo: ITGA

    Tobacco remains a scarce commodity. Universal Leaf estimates world leaf production, excluding China, at 4.66 billion green kg in 2023, down from 4.86 billion kg in 2022. This year, the merchant expects global production to rise to 5.2 billion kg, but there are issues that might alter this forecast.

    “The undersupply of leaf tobacco remains the key global trend,” says Ivan Genov, manager of tobacco industry analysis at the International Tobacco Growers’ Association (ITGA). “Leading tobacco purchasing companies continue to report very low levels of uncommitted stock. In general, sales go very fast. In Brazil, the flue-cured Virginia (FCV) crop was almost completely sold by the end of April, which is unusual (see “The Great Scramble,” Tobacco Reporter, May 2024). In Zimbabwe, export figures from early May are up significantly from last year. Burley is also in short supply.

    “The market in Malawi, one of the key countries for the variety, opened on April 15. In the U.S., our members see strong short-term opportunities in burley. They also believe that the supply shortage will recover, but more slowly than in the past, which also means that prices should improve to meet these market shortages.”

    At least the rapid rise in production cost that has been plaguing growers in recent years appears to be leveling off in some origins. While costs remain a concern, Genov has seen positive developments in key markets. “For example, in Brazil, where cost of production for FCV and burley was going upward of 30 percent year-on-year, for the current crop that is nearly fully realized on the market, the increase is limited to single digits,” he observes. “This goes in line with global inflationary and commodity price dynamics, where it seems we are now past the highest points. This being said, the pressure on growers remains. Even though such drastic increases are tamed, the new price levels remain at the higher end.”

    At the same time, tobacco prices in most of the leading markets have gone up in 2023–2024. “Growers are positive about this dynamic, but their margins remain thin,” says Genov. “Additional efforts need to be made to increase these margins. ITGA is currently undertaking a big research effort in collecting information from influential tobacco-growing regions in finding the so-called game changers that could increase farmer productivity and improve the long-term prospects of growers.”

    More than two years into Russia’s invasion of Ukraine, other factors worrying farmers in 2023 have also eased, according to Genov. “In the early stages of the conflict, there was a real uncertainty related to agrifood commodities, especially in Africa,” he says. “The continent has a big exposure to some essential products coming from Russia and Ukraine. However, our associations in Africa have recently reported that fertilizer supply has immensely improved, and pricing has stabilized, with some reduction. Navigating complicated geopolitical pressures in the future will likely keep the situation vulnerable.”

    China Boosts Production

    Chinese tobacco production is believed to be approaching 2 billion kg. | Photo: Jingmei Zhang

    Global FCV production, excluding China, rose to an estimated 1.92 billion kg in 2023, up from 1.64 billion kg in 2022, according to Universal Leaf’s data. For 2024, the company expects a slight drop to an estimated 1.88 billion kg.

    The world’s burley production stood at an estimated 443 million kg in 2023, up from 354 million kg one year previously. Production is anticipated to increase to an estimated 447 million kg in 2024.

    Oriental production declined to 109 million kg in 2023 from 116 million kg in 2022. The volume is expected to decrease even further to 104 million kg this year.

    Dark air-cured production rose from 115 million kg in 2022 to an estimated 119 kg in 2023. However, Universal expects production to fall to 109 million kg in 2024.

    With an FCV production of 1.97 billion kg in 2023, rising to an estimated 1,971 kg in 2024, according to the ITGA, China remains the leading tobacco-cultivating country by far. In addition to its huge FCV production, the country in 2023 grew 9 million kg of burley, anticipated to increase to 10 million tons this year.

    “China is a very restrictive market,” says Genov. “Nevertheless, available data shows that production is growing—approaching 2,000 million kg. In FCV, this represents approximately half of the global market. What is more interesting is that after Covid-19, China is continuously growing tobacco imports. In 2023, the country imported over 180 million kg of tobacco. China also resumed buying U.S. FCV, which has an impact on local growers. Chinese demand is likely to remain strong based on local consumption patterns.”

    The U.S.-China trade war heavily impacted the flue-cured tobacco leaf trade. In 2019 and 2020, China imported 100,000 kg and 0 kg of FCV, respectively, from the U.S., according to TMA’s Tobacco Trade Barometer. From 2021, imports began to rise back to pre-trade war levels. By 2023, Chinese FCV imports from the U.S. reached almost 25 million kg.

    Adverse Weather

    In the most recent season, key leaf-growing markets fared very differently in terms of leaf volume, quality and prices. Brazil’s 2023–2024 crop will be at least 14 percent smaller than the country’s previous harvest, Genov points out. “The initial estimate of Afubra, the Brazilian tobacco growers’ association, was for approximately 522 million kg—475 million kg of FCV and 39 million kg of burley,” he says. “All tobacco-growing areas in South Brazil were severely affected by adverse weather conditions. So, the final quantities produced are likely to be even lower—around 460 [million kg] to 470 million kg of FCV and 35 million kg of burley.”

    Brazil’s reduced volumes were a result of excessive rains, induced by the El Nino weather phenomenon, during the growing season. Adverse climate conditions are likely to impact next year’s harvest as well. In late April and early May, Brazil’s principal tobacco-growing state, Rio Grande do Sul, suffered its worst flooding in 80 years, temporarily bringing tobacco operations to a halt and causing some farmers to lose seedlings.

    Zimbabwe, by contrast, suffered from El Nino-induced drought. “As a result, a state of disaster was declared in early April,” says Genov. “Last year’s record FCV production volume of 297 million kg is unlikely to be matched, with a level of around 250 million kg much more likely. Last year’s record crop was also marked by a reduction in the average price for tobacco, particularly bad news for small-scale growers that are faced with issues, including a high level of indebtedness. This year, pricing is better—showing a double-digit increase compared to last year.”

    In the U.S., the season was stable, observes Genov. According to the ITGA, the country produced 142.9 million kg of FCV, 29.3 million kg of burley, 16.1 million kg of fire-cured and 5.5 million kg of dark air-cured tobacco as well as 2.3 million kg of cigar filler in 2023. “Market conditions will continue to weaken for dark-fired tobacco due to the growing pouch market,” predicts Genov. “Stronger short-term opportunities exist for burley. Separately, U.S. growers expect to be positioned well to benefit from company ESG activities as their tobacco is regarded as very high quality and does not suffer from sustainability-related issues present in other markets. However, alternative crops are offering greater opportunities for growers, and the continuation of tobacco farming is a real issue.”

    African Upswing

    Malawi, the world’s leading producer of burley, sold 120.5 million kg of leaf tobacco in 2023 against 85 million in the previous year. | Photo: Taco Tuinstra

    Malawi, the world’s leading producer of burley, sold 120.5 million kg of leaf tobacco in 2023 against 85 million in the previous year. Burley accounted for 103 million kg of this figure. “Average pricing was up to $2.35 per kilogram compared to $2.14 per kilogram in the year before,” says Genov. “Big global demand for burley against a short supply in recent years pushed up demand and therefore competition on the market. Entry of two more buying companies further increased the competition. The recently started 2024 season so far offers better prices to growers. Ten days after the start of sales, average burley prices exceed $2.60 per kilogram.”

    A remarkable jump in leaf production took place in Tanzania, where yield was increased from around 60 million kg in 2022 to 122 million kg in 2023. As of December 2022, Tanzania had earned $316 million from tobacco exports. According to local press reports, the country aims to sell $400 million this season. Tanzania’s recent production figures make it Africa’s second-largest producer after Zimbabwe and ahead of Malawi, Mozambique (65.8 million kg), Zambia (44 million kg; also see “Brand Zambia,” page 30) and Uganda (13 million kg).

    “The importance of Tanzania in the global leaf market is growing significantly,” Genov explains. “The country’s minister of agriculture, Husein Bashe, recently noted that for the 2024–2025 season, they are optimistic to reach 200 million kg against the target of 300 million kg by 2025–2026. He targets the No. 1 producer place in Africa, so Tanzania’s ambitions are now well known.”

    And it’s not just leaf traders who are keeping an eye on Tanzania. In February 2024, Philip Morris International announced that it would build a cigarette factory in Morogoro and buy at least 12 million kg of Tanzanian tobacco annually over the next five years. The company has not purchased leaf from Tanzania since 2017. Operations are expected to commence toward the end of this year.

    Genov emphasizes significance of growers to the supply chain and industry. “Often neglected, their role remains absolutely pivotal,” he says. “ITGA is working hard to defend the legitimate interests of tobacco growers, and we are actively supporting them to ensure the long-term survival of rural communities around the world.”

    One example of ITGA’s efforts was to prepare its members for the EU Corporate Sustainability Due Diligence Directive (see “Diluted Diligence,” Tobacco Reporter, June 2024), which was adopted by the European Parliament on April 24. “The directive will require the whole tobacco supply chain to address human rights and environmental concerns,” says Genov. “We conducted a survey among participants in our last year’s annual meeting focusing on the directive. A lot of them were worried about the necessary transformation that would lead to more pressure on them. Nevertheless, half of the participants have already taken proactive measures in preparation for it while only a quarter have not, showing that more adjustments will have to be made. Undoubtedly, making the entire process more transparent will have positive effects.”

    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.