Author: Marissa Dean

  • Get Packing

    Get Packing

    Once the EU Packaging and Packaging Waste Regulations come into force, tobacco companies will have around 18 months to ensure all their packaging in the market is compliant. | Photos: Parkside

    Preparing for Europe’s new waste regulations

    By George Gay

    In July, Parkside issued a press note describing some of the ways in which flexible packaging might be used to help manufacturers in responding to the EU’s nascent Packaging and Packaging Waste Regulations (PPWR), ideas that Tobacco Reporter followed up on in a conversation with the company’s sales account manager of tobacco, Laura Haggerty.

    Parkside’s Recoflex range includes plastic and paper-based materials that are suitable for recycling.

    Tobacco Reporter: Would you please explain to those not entirely familiar with the world of packaging how you define the term “flexible packaging?”

    Laura Haggerty: Flexible packaging refers to any item of packaging that is made from a nonrigid material. In the tobacco industry, it’s most commonly seen in the form of loose-tobacco pouches, the shrink-wrap film that we use to protect cigarette cartons, and cigarette carton liners.

    However, flexible packaging can be made of almost any material, including plastic, bioplastic, paper and aluminum foil. Each material has its own pros and cons, which is why they are often combined in the form of laminates. A tobacco packaging will often contain several laminate materials to help keep its contents fresh by protecting against moisture and oxygen.

    Your press note says a preliminary deal on the PPWR was reached in April. Do you know when the regulations will be finalized?

    The provisional text of the deal has been finalized and will come into force at the end of 2024, but some key details will not be decided for several years.

    The EU will investigate the viability of bio-based materials in 2027 while the design for recycling guidelines will not be set until 2028. This means PPWR will not take its final form until the end of the decade at the earliest.

    When will the regulations be enforced?

    While PPWR comes into force at the end of this year, businesses have 18 months to ensure they comply with the new rules. That means, in practice, they will be enforced from mid-2026.

    What will be the main differences between the packaging regulations under PPWR and those under the Packaging and Packaging Waste Directive (PPWD) already in force?

    The main difference is that PPWR is a regulation whereas PPWD is a directive. In EU law, directives set a goal that is legally binding, but member states have a degree of freedom in how they reach that goal. Regulations are entirely legally binding, setting out policies that member states must follow in full, even if that means rewriting that country’s laws. This will also harmonize regulations across the EU, which should help with implementation.

    This is important as it will see extended producer responsibility (EPR) rollout across the EU. EPR is a policy approach that makes packaging producers responsible for the cost of packaging waste management. These costs are meant to encourage producers to design out unnecessary packaging while also incorporating recyclable materials where possible.

    PPWR also introduces new, more ambitious targets for waste reduction that each country must meet. These targets are to reduce packaging waste per capita by 5 percent by 2030, 10 percent by 2035 and 15 percent by 2040 compared to 2018 levels. It includes mandatory reuse and refill targets for certain packaging types, more restrictions on single-use plastics and PFAS [perfluorinated and polyfluorinated alkyl substances] chemicals, and new labeling requirements, among many other things.

    What are the main ways in which the new regulations will affect the tobacco/nicotine industry?

    The introduction of EPR will have a major effect. Tobacco companies operating in the EU will have to cover the costs of waste disposal, so they will find margins squeezed unless they can redesign packaging to be easier to recycle—or use less packaging altogether. When the design for recycling guidelines is finalized, this may become mandatory.

    This will affect the use of materials like shrink-film, which is currently problematic to recycle in existing infrastructure, so tobacco companies may have to look at other barrier materials to protect their products through the supply chain.

    Part of PPWR also includes new labeling requirements, which tobacco companies will have to incorporate alongside their existing strict labeling obligations.

    At this stage, can and should tobacco/nicotine product businesses start considering their options and even taking steps to change at least some of their packaging?

    Tobacco companies should absolutely look at ways they can change their packaging. Once PPWR comes into force, they will have around 18 months to ensure all their packaging in the EU market is compliant. This does not leave much time to evaluate, redesign and produce new packaging. Remember that as tobacco packaging is already highly regulated in the EU, any changes must also comply with existing legislation.

    Looking at the wider tobacco industry, including its new-generation nicotine products, which of its packaging materials will be affected by the likely changes brought in by the PPWR?

    Flexible packaging like pouches will likely be affected as they rely heavily on soft plastics, which are difficult to recycle. As mentioned, this will also affect the shrink-wraps and the inner liners commonly used in flip-top cartons and other rigid packaging, so it will likely have wide-reaching consequences for all tobacco packaging.

    Should the industry try to eliminate all “plastic materials” from its packaging, however that term is defined, or should it aim to eliminate only those plastics that do not break down in an environmentally friendly manner and become “forever” particles?

    Plastic is often painted as a villain, but the truth is much more nuanced than that. Unnecessary plastic use is a problem, but solving it needs a holistic, considered approach. Simply eliminating all plastics would have a disastrous effect on the environment in the form of increased product waste.

    Compostable materials are a possible solution and an area where we are a market leader. We produce accredited compostable pouches that can break down in domestic compost heaps and industrial organic recycling facilities. These materials are commonly used for pouches, but they also have applications as wraps for cigars and liners for cartons.

    Which of the Parkside packaging innovations mentioned in your press note would be appropriate for tobacco industry application?

    We work closely with our customers in the tobacco sector, so many of our solutions are ideal for tobacco packaging applications. Our Recoflex range includes plastic and paper-based materials that are suitable for recycling and can be tailored with high barrier coatings, metallization and more. We produce pack wraps, individual wraps for cigars, inner liners, resealable lock-and-peel pouches, and compostable pouches, all of which are suited to many applications within tobacco packaging.

    Will the arrival of the PPWR regulations provide an opportunity for the tobacco/nicotine industry to make radical changes to its packaging, or do tobacco/nicotine industry-specific regulations make such moves impossible or unlikely?

    The strict industry-specific regulations do pose some challenges when it comes to labeling. Packaging will need to contain labeling that describes its material composition and recyclability, so incorporating these new labels in a way that complies with existing restrictions may require some redesigning.

    Restrictions on pack shape, such as restrictions on slimline cartons, mean it is difficult to radically rethink many tobacco packaging formats. However, it may be possible to reduce the weight of packs using lighter weight materials combined with water-based barrier coatings to ensure performance.

    Presumably, there will be a cost associated with tobacco industry players changing their packaging. How can they minimize such costs while remaining compliant?

    We recommend working closely with a trusted packaging partner. At Parkside, we have worked closely with many tobacco companies for many years. That means we have developed the expertise needed to tailor packaging solutions to ensure they meet the needs of our customers in terms of both pack performance and compliance. This ensures packs can be designed and produced efficiently, which is always the best way to minimize costs.

    Progressive businesses are generally not opposed to reasonable regulations provided they are evenly applied and competition remains on a level playing field. Do you have any insights, based on your experience with the PPWD, of how strictly and how evenly the new regulations are likely to be applied?

    Part of the idea of PPWR is to harmonize regulations across the EU, so that would indicate the intention is to create a level playing field. However, it could still be subject to some variations as different member states have differing infrastructures. A country that already has robust recycling and waste management infrastructure in place will find it much easier to adapt.

    As a result, we anticipate PPWR will be applied more evenly than PPWD was—but there may still be some divergence in places.

    Finally, while the EU is hugely important to your business, does Parkside focus on other parts of the world?

    Certainly. We have invested heavily in our Malaysian site in recent years, meaning we now offer a comprehensive suite of services and solutions to tobacco companies across APAC [Asia-Pacific] countries as well as Europe. This gives us a greater level of agility and flexibility to operate on a global scale.

    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.
  • At the Crossroads, Again

    At the Crossroads, Again

    Photo: jorisvo

    There are still more unknowns than knowns about the shape of future European regulation for novel nicotine products.

    By Barnaby Page

    Europe’s relationship with novel nicotine products has always been a mixed one. On the one hand, the more extreme forms of hysteria about youth vaping or supposed health risks have been relatively absent from the European scene; the U.K. in particular has been regarded as perhaps the most pro-vaping major economy in the world. And regulation—in most countries, heavily shaped by the European Union’s Tobacco Products Directive (TPD)—is in some respects light-touch.

    Most notably, rather than following the U.S. model, which in theory requires marketing authorization by the Food and Drug Administration before products can be sold, the EU has eschewed the premarket approval approach and simply asks for products and businesses to be compliant with the TPD’s requirements.

    But if Europe (which for the rest of this article mostly means the EU and its member states) has been looser in its regulatory approach than the U.S. in some ways, many of the requirements that it does make are quite onerous: the 20 mg per milliliter limit on nicotine strength, for example. It is also well known that the TPD as originally conceived was going to be far more restrictive and was only scaled back after pressure.

    And there have been distinct signs lately of Europe becoming more cautious. Most flavors were banned EU-wide in heated-tobacco products; several countries have enacted, or will enact, disposable e-cigarette bans; the Netherlands, usually famed for its tolerance, is an example of a country that has started showing a lot of skepticism toward novel nicotine products; even in the U.K.—no longer an EU member—government support for tobacco harm reduction seems to be ebbing away a little, though it certainly hasn’t turned into outright opposition yet.

    Set against this background, there is concern that the next version of the TPD may make major changes to the EU’s regulatory framework for novel tobacco products, reflecting conservative positions.

    So far, nothing is known for sure about the actual content of the next TPD or about any updates to the lesser-known Tobacco Advertising Directive and Tobacco Excise Directive—though a European Commission spokesperson did confirm to Tamarind Intelligence, late last year, that vaping would be a focus of the TPD. The commission’s job with the TPD is essentially to formulate the legislation, which representatives from all the EU member states, in the European Parliament and the Council of the European Union, then vote on.

    However, looking at what is already happening across Europe gives some indicators of what’s possible—action against disposable vapes in France and Belgium, for example, or against flavored products in Finland and Hungary. Though it’s true that EU policy certainly does not derive directly from localized policy in member states, there are trends visible that are bound to be reflected in Brussels. It’s also worth noting that the much-anticipated swing to the populist right in the most recent European elections failed to fully materialize, which may well mean that the EU will continue to favor tight, precise regulation and not care too much whether it is seen as “business-friendly.”

    First, disposable bans: There have been debates or even legislation in most major European countries over banning disposables, partly because of youth usage but also because of environmental impacts. Even if not all of these come to pass, the fact that an outright prohibition on disposable vapes is so widely seen as a reasonable, proportionate regulatory response—not an unrealistic or extremist one—must make an EU-wide ban a possibility.

    Second, flavors: There is a precedent for some kind of vape flavor ban in the existing EU ban on flavors in heated tobacco, and a number of EU health ministers have given such a measure their support. This would be a greater blow to the industry than a disposables ban, though a crucial question would be exactly what is outlawed and what is permitted.

    The most draconian position would be a reduction of the market to tobacco and perhaps menthol/mint flavors. There could, however, be a middle ground with some other flavors allowed that still removed the more outre and (supposedly) youth-tempting ones from the market; there have also been suggestions that a ban on extreme flavor descriptions, rather than the actual flavors, could achieve the same end. So there are quite a lot of options on the table when it comes to regulation of flavors, and this is perhaps the area to watch most closely.

    Other major areas likely to come under consideration include taxation, and an extension of the existing EU ban on snus (from which only Sweden is exempt) to tobacco-free nicotine pouches.

    An equally big question, however, is when any of this will happen. The process of revising the TPD has been underway for more than two years now, suffering several delays and changes in its schedule.

    For example, the European Commission’s Directorate-General for Health and Food Safety (DG Sante) had originally promised to finalize its evaluation report on tobacco policy last year, but when the commission published its work program for 2024, it made no mention of revising tobacco policy. Therefore, it seems unlikely that there will be major announcements on the TPD or other Europe-wide tobacco regulation in 2024.

    When it eventually does happen, it will be the culmination of a process that started more than two years ago, when the commission launched a call for evidence, which ran from May 2022 to June 2022. This was then followed by a public consultation from February 2023 to May 2023. Eventually, the results of these consultations should be taken into account by the commission when it drafts a directive to be discussed by the Parliament, but so far … nothing.

    So it’s been a long period of near silence even though many expected action—and debate—much sooner. The delays may be partly down to divergence in member states’ positions on tobacco control—it’s going to be hard to come up with Europe-wide policies that at least partially satisfy enough member states and enough competing principles.

    Although the European Commission will be the one to propose the new policies, it is the legislators in the Parliament (and the Council of the European Union, the other “house” of the European legislature) who ultimately vote for or against it. So, while the commission may well be likely to maintain a conservative or even quasi-prohibitionist stance, it’s very possible that Members of Parliament (MEPs) may disagree. Some MEPs who spoke with ECigIntelligence said that they were prepared to fight conservative approaches to novel nicotine products that may be counterproductive for harm reduction, and the influx of new MEPs after this year’s election adds a further level of uncertainty.

    Moreover, positions on novel nicotine products cannot easily be predicted from political affiliation. Generally, the more right-wing a party is, the more easygoing toward novel nicotine products it tends to be (and this would in theory make the broadly rightward trend in politics a positive one for harm reduction’s proponents), but this is far from consistent and there are many exceptions (as indeed there are to that rightward trend).

    For example, arguments prioritizing consumer education and freedom of choice over strict policies, historically usually attributed to right-wing parties, are often also shared by left-wing parties. The national origin of a politician may be just as significant as their nominal position on the left-right spectrum—a left-winger from a country with very strict regulation of tobacco products is often likely, we find, to be more sympathetic to that kind of legal regime than a left-winger from a country with a much lighter touch.

    So there are plenty of unknowns, and of course the unusual position of the U.K.—the biggest market for novel nicotine products in Europe—is another one. When the last TPD appeared, the U.K. was still a member of the EU, and so it adopted the TPD’s measures into its own domestic legislation (as all EU member states must do with European directives). But it has since left the union, via Brexit. The current British government certainly seems to have a hardline attitude on disposables, but there are also indications that it remains supportive of harm reduction, so how aligned the U.K. will remain with the rest of the EU in the future is very much an open question. One distinct possibility is that even if Britain starts to tighten regulation on some aspects of novel nicotine products, it remains more liberal than an EU that gets even tougher.

    Barnaby Page has been covering the tobacco harm reduction business as a journalist for more than 10 years as editorial director at Tamarind Intelligence, a pioneering data intelligence and strategic insight provider offering global market and regulatory data analysis for businesses operating in fast-growing industries. Tamarind currently covers the vapor sector with ECigIntelligence, other tobacco and nicotine alternatives with TobaccoIntelligence, and cannabis with CannIntelligence. This article also incorporates research from other Tamarind staffers.
  • All-Rounder

    All-Rounder

    Due to its versatility, homogenized tobacco remains key to tobacco companies’ operations.

    By Stefanie Rossel

    For reconstituted tobacco leaf (RTL), the only way seems to be up. Valuates Reports estimated the global RTL market at $305.47 billion in 2023 and expects it to reach $370.85 billion by 2030, which corresponds to a compound annual growth rate (CAGR) of 2.7 percent between 2024 and 2030.

    Also known as homogenized tobacco or recon, RTL was developed by Schweitzer-Mauduit International (SWM) in the 1930s. Initially, RTL was designed to reduce waste. By recovering “leftovers” such as tobacco dust, scraps and stems, and reintegrating them into the production process, manufacturers can save valuable raw materials.

    Today, homogenized tobacco has a wide variety of applications. Apart from its use as a material to reduce tobacco product filling cost, it is an essential ingredient in cigarette blend design, offering cigarette manufacturers a convenient tool to lower the nicotine content of their products. The advent of heated-tobacco products (HTPs) has created new opportunities for the product. RTL allows tobacco companies to develop blends that deliver the desired taste and nicotine when heated to a comparatively low temperature.

    According to SWM, the recon market is driven by several trends. For starters, the cigarette market is expected to exhibit a CAGR of minus 3.5 percent between 2023 and 2028. The trend, the company points out, is obviously not the same in every country, with the U.S. and Japan leading the decline and Africa and the Middle East enjoying slight growth. At the same time, the HTP market is projected to witness a 15 percent CAGR between 2023 and 2028. SWM anticipates global sales of HTP consumables to reach over 300 billion sticks by 2027.

    The traditional cigarette market and the HTP market are influenced by the same factors. Cigarette or stick designs have an impact due to their recon inclusion rate per stick while there is also customer capacity to self-source the recon, as for example Philip Morris International does. In addition, the availability and price of leaf tobacco can also drive interest in RTL. SWM stresses that the drivers are not the same for recon used in conventional cigarettes and recon used in HTPs.

    A Product With Many Benefits

    Tapuwa Pswarayi

    In traditional RTL, SWM works closely with its customers to develop materials for innovative applications, says SWM’s product manager, Tapuwa Pswarayi. “In addition, our ancillary services allow us to perform in-depth analysis of materials to ensure that recipes meet all regulatory specifications. We firmly contribute toward reconstituted tobacco having been a key part of the tobacco blender’s toolkit for decades. In recent years, more major tobacco players have been innovating with SWM recon solutions in an increasing number of applications—from cigarette blends [to] roll-your-own to shisha. The many benefits of recon span across operational efficiency, regulatory compliance and cost stability.”

    With increasing volatility in tobacco markets globally, the relative price stability of recon presents a great opportunity to mitigate the impact of fluctuating costs. “The past growing season was challenging for many tobacco farmers, resulting in reduced quantities produced and sharp price increases in the majority of the tobacco-producing world,” he says. “Reconstituted tobacco is therefore a valuable tool for creative blenders—performing complementary roles in blend segments while offering a more competitive price.”

    The functional advantages of recon produced with SWM’s papermaking process are also an important factor, according to Pswarayi. “It’s made from tobacco by-products, such as stems, scraps, fines and dust, which are mixed with water before undergoing a two-step papermaking process to produce a uniform sheet, known as a ‘web.’ The web closely mimics the aesthetic and physical properties of tobacco leaf. This means it can be processed in the same way as tobacco leaf—whether it’s intended for cigarettes, cut rag or roll-your-own—with several additional benefits for the manufacturer.”

    Moreover, the product fits in well with current efforts to make production processes more sustainable. RTL allows for waste reduction through optimized utilization. “While the standard process typically generates waste during leaf-processing to packing and manufacturing, recon degrades less during production,” Pswarayi says. “This allows manufacturers to retain more material in the finished product, resulting in greater efficiency and reduced costs.”

    Almost any combination of tobacco by-products can be used to create high-quality recon, he says. SWM uses two main supply models—buying recon from its established portfolio of taste and performance characteristics, and developing unique recon blends. “To achieve this, we take the raw materials supplied by the customer and convert them into recon at our state-of-the-art facilities, with the customer owning exclusive rights to use the recipe that you create.”

    Beyond Tobacco

    Bruno Stefani

    SWM started to work on reduced-risk products in 2014. In 2017, it set up a dedicated reduced-risk products (RRPs) team, which today employs about 50 people, 20 of whom work in dedicated laboratories. “Our heat-not-burn recon solutions are designed to be easily used in existing cigarette-manufacturing assets,” explains Bruno Stefani, SWM’s HTP product manager of RRPs. “This allows our customers to go fast.

    “In that spirit, one of our pillars is to identify and select interesting tobacco grades for HTP application within tobacco material portfolio already sourced by customers for their cigarette production, which simplifies and secures the tobacco material sourcing. Every HTP is an inseparable combination of an aerosol-generating material—i.e., our recon, a consumable and a heating device. To create a unique consumer experience, we master the understanding of these three elements and their interactions.”

    The fact that SWM also manufactures cigarette paper allows the company to supply HTP wrapping papers and paper-filtering media to help customers reduce the plastic content of their products, according to Stefani. “We also invest a lot in securing freedom to operate to facilitate the access of this HTP market. Our role is also to identify potential reliable partners which can contribute to the final solution, covering all aspects of customers’ need and expectation.”

    SWM also benefits from its long-time experience in botanical fiber production. Botanical reconstituted with or without nicotine is another driver for growth in the HTP sector, says Stefani. “There is a strong interest for such tobacco-free products,” he says. “The big tobacco companies have really started to be active in this market since last year with the launch of Veo by BAT and then Levia by PMI and iSenzia by Imperial Brands. As we can process very different kinds of material shapes, leaves, nuts, roots, fruits, flowers and so on, reconstitution offers a very interesting solution to get an industrial product made with natural ingredients with well-mastered specifications and which is designed to smoothly run in an existing customer’s primary department. We also tightly master the addition of nicotine or other active ingredients to be added to the botanical on customers’ request.”

    Stefani says that SWM continuously scouts the market for new trends and needs, as well as the manufacturing technology offer, in order to be ready to develop and supply new materials and comply with its customers’ new developments. Judging from recent innovations in the HTP sphere, there’s certainly more to come.

    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.
  • Lifting the Veil

    Lifting the Veil

    A peek at the future of vaping technologies

    By Stefanie Rossel

    David Newns

    As sales of combustible cigarettes continue their downward spiral, reduced-risk products (RRPs) keep gaining ground. Euromonitor International estimated the retail value of the worldwide RRP market at $19.34 billion in 2023 and expects further growth.

    Plxsur, the world’s largest group of independent vaping companies, reckons that the 12 markets it operates in are together worth $20.8 billion and will grow to $59 billion by 2033. The company expects RRPs to overtake cigarettes over the next 10 years. “Looking at the U.K. alone, the number of cigarette users is currently at parity with RRP users at around 12 percent of the population, with the latter expected to become the dominant format this year,” says Plxsur’s chairperson and co-founder, David Newns.

    In terms of technology trends, a decade is a long time. In the past 10 years, vapers have moved from “cigalikes” to pods then to disposables and now back to reusables again. However, many current vape products still have shortcomings, particularly in areas such as user-friendliness, nicotine delivery and sustainability. Going forward, Newns sees two main considerations driving people to RRPs. “The first is cost-effectiveness, with reusables more cost effective than disposable vapes and certain cigarettes,” he says. “The second is user experience. Technology is constantly evolving, and the category continues to advance RRPs to replicate the delivery of nicotine in a cigarette in terms of speed of delivery and satisfaction.”

    Innovation in the category, Newns points out, will depend on two key factors: the delivery of nicotine in a reduced-risk format that satisfies users to a point that they don’t feel compelled to return to cigarettes and the behavioral aspect of smoking. “In order to ensure RRPs are attractive to smokers, the behavioral patterns must not differ dramatically,” observes Newns. This, he says, explains why nicotine patches or gum alone often aren’t successful in helping smokers quit. “Smokers are most successful at quitting when using vapes, either on their own or in combination with other products,” says Newns. “Given the ritualistic elements that vapes provide, which [are] similar to smoking, they are often seen as a natural next step for those looking to quit.”

    According to Newns, devices will likely also feature more connectivity functionality in the future.

    Enhancing Nicotine Delivery

    Michael Wang

    Optimizing nicotine delivery has been front and center in recent innovations. The German startup Splash, for example, has developed a product that generates a foam instead of vapor (see “Bubbles of Bliss,” Tobacco Reporter, December 2023) while U.K.-based Qnovia has designed an inhaler that works without heating (see “High Tech Quitting,” Tobacco Reporter, March 2023).

    Ispire Technology Co-CEO Michael Wang expects constant introductions of novel and unique entries into the nicotine-delivery space going forward. “However, the key factor to consider is efficacy—the actual effectiveness of nicotine delivery, its impact on the body and its absorbency,” he says. “Methods like Splash, which deliver nicotine through a foam in the mouth, or pouches like Zyn result in a different neurological uptake of nicotine. These methods take longer to be absorbed into the bloodstream, delaying the time it takes to reach peak effect. Research supports [the idea] that aerosolization is the most efficient and optimized way to deliver nicotine into the bloodstream for immediate absorption. This efficiency is largely due to particle size and how it is distributed in the body. Aerosolized nicotine, delivered to the lungs, ensures rapid absorption and immediate effect, unlike oral or sublingual methods, which take longer to act.”

    Both Wang and Newns anticipate the development of better heating systems that eliminate the metal emissions associated with nichrome wire-based heating systems. “The performance and safety of the core vaporizer technology are critical concerns,” says Wang. “Many devices rely on ceramic heating elements, which, while cost-effective and easy to manufacture, present risks. If the manufacturers do not hold themselves to the highest standard in their manufacturing process, then over time and with repeated heating cycles, ceramics can become brittle and potentially release harmful particles into the vapor. This underscores the need for the industry to move away from ceramics and adopt safer alternatives.”

    Wang views the introduction of heating chip technology, as recently launched by Greentank (see “Heated Breakthrough,” Tobacco Reporter, June 2024), as a significant step forward as it performs better on key safety metrics, including the reduction of harmful and potentially harmful constituents. “By using biocompatible materials and moving away from ceramics and heavy metal-producing heating elements, we can improve the safety and performance of vape devices. These innovations aim to minimize health risks and enhance user experience by providing cleaner and more efficient vaporization.”

    Precision dosing and dosing control, Wang stresses, are essential yet often inadequately addressed aspects of vaping technology. “Accurate nicotine delivery is crucial for both consumer satisfaction and regulatory compliance,” he says. “There is a growing demand for solutions that help users manage and reduce their nicotine intake effectively.”

    Age-Gating is Key

    Progress will be driven not only by hardware developments but also by the characteristics of nicotine. “Certain clean technologies such as synthetic nicotine could further reduce risk and improve delivery,” says Newns. “We are already seeing this rolled out in markets across the world. We believe that such development can only be a positive thing if the developments are carried out from a scientific point of view. That is, keeping in mind the nicotine user’s journey from cigarettes to safer alternatives, complying with regulation and placing responsibility to the customer and environment front of mind.”

    Wang expects novel nicotine particulates to enhance the speed and efficiency of nicotine delivery, building on the foundation laid by innovations like nicotine salts. “Nicotine salts improved the speed of delivery and provided a stronger throat hit, closely mimicking the experience of smoking combustible cigarettes,” he says. “This similarity, along with the availability of various flavors, greatly contributed to the success and adoption of reduced-risk products.”

    According to Wang, the success of flavors in helping smokers transition to e-cigarettes underscores the importance of continuing to develop advanced nicotine-delivery systems that provide a satisfying and effective alternative to traditional tobacco products.

    Preventing underage access to nicotine products will remain an important objective for manufacturers. To ensure its products never get into the hands of minors, Puff Store rolled out MyChekr, a technology that uses artificial intelligence to estimate the ages of would-be buyers (see “Beyond Face Value,” Tobacco Reporter, December 2023). The system is being adopted by a growing number of companies.

    Ispire Technologies offers an age-verification system that uses a combination of Bluetooth and blockchain technology. “This system employs biometric verification, ensuring that only authorized users can access the devices, thus preventing underage usage effectively,” says Wang. “The integration of blockchain technology sets our solution apart from the competition by offering an unparalleled level of security and transparency. Blockchain’s immutable nature ensures that all age-verification data is securely stored and cannot be tampered with, providing a trustworthy system for both consumers and regulators. The use of Bluetooth enables a seamless and efficient user experience, making our age-gating technology not only secure but also highly accessible and convenient for users.”

    Transitioning to Reusables

    Meanwhile, disposable e-cigarettes face an uncertain future due to environmental concerns, with some markets banning the entire category and others considering restrictions. “Although the U.S. may not see immediate FDA [Food and Drug Administration] mandates on disposables, the long-term trend will likely favor pod systems and reusable products, significantly reducing e-waste and aligning with environmental sustainability goals,” says Wang. “We are confident that disposable vapes will either disappear altogether or become a smaller player in the market over time. While disposables are incredibly convenient, their environmental impact is prompting a shift toward more sustainable options. Moving forward, we anticipate a greater emphasis on devices with removable batteries and the adoption of pod systems to reduce waste.”

    Newns believes that vaping companies have a responsibility to ensure that new regulatory restrictions, such as a ban of disposable vapes, do not prevent adult smokers from transitioning to safer alternatives. “We also know that disposable vapes, given the products’ convenience and price point, are vital for many adult smokers in the initial phase of the switch from cigarettes,” he says. “We hope to see regulation as a driving force for new technology and innovation to allow safer products to be developed with better inhalation techniques and quality.”

    With this in mind, he says, Plxsur remains focused on supporting customers to migrate from disposables to pod-based systems. “We have worked closely with our partner companies to put commercial strategies in place to achieve this,” says Newns. “For example, in Q4 last year, Puff, the number one vaping company in Italy and part of Plxsur, successfully migrated many of its customers to pod and open devices, with these alternative products now outperforming disposable devices by volume for the company. As we remain focused on our responsibility to reduce our environmental impact, we continue to see such efforts on migration across the group.”

    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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Global Ambitions

    Global Ambitions

    Photo: Taco Tuinstra

    Having firmly established itself as a regional player, Tabaterra of Azerbaijan is preparing to take its operations to the next level.

    By Taco Tuinstra

    Azerbaijan has been on a tear recently. Whereas in the past, the country was known primarily for fossil fuels, its economy is rapidly diversifying, with investors taking advantage of Azerbaijan’s strategic location along the ancient Silk Road and at the intersection of modern commerce between Europe and Asia. In addition to hosting major international events, including the Formula One Grand Prix this month and the Conference of the Parties to the United Nations Framework Convention on Climate Change in November, Azerbaijan has also been enjoying a boom in manufacturing and services, with companies investing in areas as varied as information technology, logistics and agriculture.

    Among the new factories that have sprung up in recent years is also a cigarette-making facility. Eager to localize imports and create the conditions for exports, Tabaterra in 2018 built a factory in Sumgayit, just north of Azerbaijan’s capital, Baku, with eight production lines and an annual capacity of 18 billion cigarettes.

    Confident in their partner’s abilities, BAT and Japan Tobacco International immediately assigned their entire Azerbaijani portfolios to Tabaterra. In the fourth year of contract manufacturing, BAT and JTI also awarded Tabaterra their volumes for neighboring Georgia. The multinationals have not regretted their decisions judging by the number of customer accolades displayed at the Sumgayit facility. When JTI evaluated its worldwide contract manufacturers in 2023, for example, Tabaterra finished first.

    Tabaterra aims to achieve unprecendented levels of efficiency in its operations.

    Building Brands

    Buoyed by the success of its contract manufacturing operations, Tabaterra started developing its own brands. The first private label cigarettes, including Argo, Kingston and Senate, rolled off the Sumgayit production lines in 2019. More recently, Tabaterra debuted the Lincoln and X7 brands for export. Additional launches were scheduled for this fall.

    Of course, introducing new brands is notoriously challenging in the cigarette business. Not only must newcomers compete against long-established international trademarks, but they must also do so in increasingly “dark” markets. Like many other countries, Azerbaijan restricts tobacco promotions to the point of sale, severely limiting opportunities for developing brand awareness.

    “Brand building is not easy,” acknowledges Tabaterra Director Elman Javanshir. “It takes time and money.” In addition to competing with the name recognition of foreign cigarettes, he explains, local brands must overcome the prejudices of consumers, who in Azerbaijan and other markets tend to perceive global brands as “better,” even if the quality is comparable to that of their locally produced counterparts. “So you have to make sure that your brand is much better than its international equivalent,” says Javanshir. “That also means you must spend more than your competitors—even though you are smaller than them.”

    One way to compensate for limited resources is by being creative. For example, Tabaterra developed a smart phone app for its retail partners with information about the company’s portfolio. In addition to detailing product features such as low-odor technology, sweetened filters or cherry flavors, the app allows sellers to earn points that can be exchanged for products, mobile phone credits or cash. The goal, according to Business Development Manager Elchin Murtuzov, is to spread awareness of Tabaterra’s products among vendors. “So when the buyers come, retailers will know these brands and can educate the customers about Tabaterra’s value proposition,” he says.

    Following the success of its contract manufacturing business, Tabaterra started producing its own brands.

    Relocation

    While Tabaterra’s Sumgayit factory is barely six years old, the company has already outgrown the facility. To accommodate its growing volumes and elevate production quality and efficiency to the next level, the company has built a new plant in Aghdam, nearly 400 km west of Sumgayit. The relocation process will start in October, and the company plans to move two production lines every month. In addition, it will install two new lines at the Aghdam factory, bringing the total to 10. The process is scheduled to be completed by the end of February.

    According to Javanshir, Tabaterra is going out of its way to make the relocation attractive for its workforce. In addition to increasing salaries by between 30 percent and 50 percent, the company has purchased six buildings with 210 apartments in Aghdam. The residences will be fully furnished and offered free of charge, including utilities and residential fees. “All inventories are supplied by the company,” he says. “Employees just need to bring their clothes and personal possessions.” In addition, Tabaterra will change the work schedule from three eight-hour shifts to two 12-hour shifts, and provide regular transportation to Baku. This means that staff will be off one week every three weeks—time that they can spend in Aghdam, Baku or elsewhere. “The choice is to the employee,” says Javanshir.

    Many employees have already indicated their interest in relocating, and Javanshir is confident that a significant share of the workforce will follow their employer to Aghdam. Recently, Best Places to Work, an international ranking organization, recognized Tabaterra as one of the top employers in Azerbaijan for 2024–2025, with 90 percent of employees indicating they were happy with their working conditions.

    When you have efficiency, you make the machine work; when you do not have efficiency, the machine makes you work.

    Elman Javanshir, director, Tabaterra

    Working Smarter

    Of course, building a factory from scratch presents not only challenges but also opportunities. Starting from a blank slate permitted Tabeterra to design the factory exactly as it wanted without the constraints of its existing facility. According to Javanshir, the new factory will not only be 30 percent bigger than its Sumgayit plant but also significantly “smarter,” with state-of-the art technology and a high degree of digitalization. “We will have a visual representation of the plant at our Baku head office,” he says. “Management will be able to see in real time which line is working, what brand is being produced and what are the efficiency and waste rates.” In addition, the smart factory will enable Tabaterra to keep track of individual employees’ performances, enabling it to improve both its employee recognition system and efficiency.

    Down the road, Tabaterra also wants to integrate artificial intelligence into its operations, allowing it to further boost efficiency and carry out preventative maintenance, for example. Such applications already exist at some multinationals, but Javanshir insists Tabaterra, as a regional player, must create a good basis first. “We will build everything in a rational way,” he says. “The first task is to get all the data visualized and online.”

    If done correctly, this should allow Tabaterra to achieve unprecedented levels of efficiency in its operations, which in today’s competitive environment is essential, according to Javanshir. “When you have efficiency, you make the machine work; when you do not have efficiency, the machine makes you work,” he observes.

    A growing share of Tabaterra’s output is exported.

    Tabaterra’s commitment to quality and efficiency have served it well. Not only has it won the trust of leading cigarette manufacturers, but it also has managed to establish a respectable private-label business in a relatively short time. The company’s brands currently account for 11 percent of Azerbaijan’s 14.5 billion-stick market, and they are making inroads in Georgia and Iraq.

    But Tabaterra is not content to rest on its laurels. “Eleven percent is not our target,” says Javanshir. “Our aim is to get 20 percent of the market in Azerbaijan.” Meanwhile, the company is already looking further afield, analyzing opportunities in additional overseas markets. To further raise awareness internationally, the company regularly participates in international tobacco expositions. This month, for example, it is scheduled to exhibit at Intertabac in Dortmund, and in November, it will participate in the Word Tobacco Middle East show in Dubai. The company has also been investing in leaf production.

    Asked to explain the company’s success, Javanshir cites good relationships with industry leaders and an eagerness to learn. For example, in preparation for its Sumgayit factory, Tabaterra sent many of its staff members to its partner companies’ facilities. In return, experts from the multinationals came to Azerbaijan to provide hands-on training. The company has also benefited from the recent trend toward localization, with businesses rediscovering the value of physical proximity to end markets.

    A healthy combination of ambition and realism has helped as well. Even though cigarette volumes in Azerbaijan have been stable, Tabaterra is well aware of the dimming outlook for traditional tobacco products worldwide. That’s why the company has also started exploring new platforms, such as heat-not-burn devices. “If you want to be sustainable, you must keep up with technology,” says Javanshir, noting that many companies who failed to do so don’t exist anymore. “We will not have the same fate,” he says.

    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.
  • 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.