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Category: Also in TR

  • Unwavering Commitment

    Unwavering Commitment

    Katrin Hanske | Photos courtesy of SWM international

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

    TR Staff Report

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    How have customers responded to the acquisition?

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

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

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

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

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

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

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

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

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

  • Testing the Waters

    Testing the Waters

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

    By Stefanie Rossel

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

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

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

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

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

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

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

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

    Pieter Vorster, managing director, Idwala Research

    Market With Potential

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

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

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

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

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

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

    Stepping Up Production

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

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

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

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

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

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

    Ensuring Excellence

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

    By Elizabeth DeMartini

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

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

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

    The Role of Site Visits in Research Integrity

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

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

    Quality Controls in Research: A Multidimensional Approach

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

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

    Challenges and Solutions in Implementing Site Visits and Quality Controls

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

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

    Conclusion

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

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

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

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

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

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

    Rebuilding the Value Chain

    Photos: Taco Tuinstra

    Tabaterra wants to lift Azerbaijani tobacco to global quality standards.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Thank You!

    The GTNF, scheduled Sept. 24–26 in Athens, is made possible by the generous support of these sponsors.

    TR Staff Report

    Accorto Regulatory Solutions is a boutique regulatory firm committed to providing unparalleled regulatory and compliance solutions for its global clientele across a range of U.S. Food and Drug Administration-regulated sectors. It specializes in helping small-sized to mid-sized domestic and international companies navigate the regulatory landscape to bring their regulated product concepts to market and ensure ongoing compliance following market authorization.

    Its team has extensive experience in the tobacco harm reduction industry, with a proven track record of delivering high-quality, data-driven FDA regulatory submissions for its clients’ nicotine-containing products. Its bespoke multi-phase submission approach reduces overall project time and cost while ensuring compliance with the FDA’s most current thinking. It strives to be a trusted partner in navigating and overcoming regulatory challenges, driving success for its clients in a complex market.

    Alliance One International (AOI) is a leading independent leaf tobacco supplier. Working with tobacco farmers in 20 countries, AOI is recognized for producing sustainable and traceable leaf tobacco. The company purchases tobacco on five continents and ships to customers in 90-plus countries.

    Through direct contracts, AOI is able to provide agronomic expertise and technical guidance to help growers improve the quality and yield of their crops. The company is dedicated to supporting efforts to address human rights concerns in the tobacco supply chain by using on-farm good agricultural practices assessments to evaluate contracted farmers’ compliance with labor practices. Additionally, the company establishes contract terms and conditions with tobacco farmers related to issues such as forced and child labor, and it conducts social compliance due diligence throughout its tobacco-growing regions.

    AOI’s Sentri track-and-trace platform provides transparency into the life cycle of agricultural products by monitoring information and obtaining data related to the growth, cultivation, harvest, processing, formulation, testing and release of individual batches of products. By obtaining data on products at each stage of the supply chain, Sentri permits proactive decision-making for both the company and its customers.

    AOI believes that everything it does is to transform people’s lives in order to grow a better world. The company’s global ESG strategy was built off its strong sustainability legacy and achievements over the years. Given its diverse global footprint, AOI is well positioned to have a wide-reaching impact on systemic issues. AOI’s sustainability strategy aligns with the United Nations Sustainable Development Goals, and the company is committed to doing its part to help make those goals a reality.

    AlphaScale Technologies develops industrial-grade and high-reliability analog/mixed-signal integrated circuits (ICs) and systems for industrial and consumer markets. The company’s product portfolio includes battery and power management ICs, sensors, LED display drivers, analog-to-digital converters, microprocessors and micro-controller ICs. The company’s solutions focus on addressing the performance, reliability, power and cost challenges. The company’s mission is to be an indispensable provider of highly scalable and highly reliable building blocks for the world’s most demanding electronic manufacturers.

    AlphaScale was founded by a team of seasoned IC designers from Silicon Valley with a proven track record of developing leading-edge analog and mixed-signal ICs and systems. The company has R&D and operation facilities in the San Francisco Bay Area and China.

    Applied Research and Analysis Co. (ARAC) is a social and behavioral sciences research firm that designs, executes and leads scientifically rigorous, customizable Module 6 studies to support manufacturers, regulatory agencies and industry consulting firms.

    ARAC is a fully staffed contract research organization with in-house psychologists, behavioral scientists, statisticians and survey methodologists offering tailored research solutions with unparalleled integrity and an exceptional client experience. In-depth knowledge of U.S. consumer behavior, leveraging in-house internal expertise to deliver quicker, streamlined results to client partners.

    Based in the U.S., ARAC focuses on achieving global market success by combining regulatory expertise, consumer understanding and cultural competency expertise applied to international markets. Its triangular approach focuses on government regulations, the consumer and its clients’ business objectives. This approach has proven successful across a variety of studies, including label development and comprehension, human factors/usability, clinical behavioral studies, specifically randomized experimental trials, TPPI and postmarket surveillance systems.

    The BAT Group is a leading multi-category consumer goods business that provides tobacco and nicotine products to millions of consumers around the world.

    BAT’s purpose is to create “A Better Tomorrow” by building a smokeless world. A smokeless world built on smokeless products, where, ultimately, cigarettes have become a thing of the past.

    In order to deliver this, BAT is transforming into a smokeless business, with a target for 50 percent of its revenue to come from smokeless products by 2035.

    BAT’s portfolio of smokeless tobacco and nicotine products includes vapor products, heated products and modern oral products, which are collectively termed the “new categories,” as well as traditional oral products.

    The business continues to be clear that combustible cigarettes pose serious health risks, and the only way to avoid these risks is not to start or to quit. To help build a smokeless world, BAT encourages those who would otherwise continue to smoke to switch completely to scientifically substantiated smokeless alternatives.

    BMJ is the world’s No. 1 partner in specialty paper and packaging by responsibly providing high-value products to its customers. With sustainability goals in mind, the company exceeds the industry’s standard through intimate knowledge of customers’ articulated expectations, service excellence, high productivity, high quality and rapid innovation. It is the partner of choice of many leading players in the industry.

    Boegli-Gravures designs, develops and manufactures state-of-the-art embossing tools and solutions for an exacting worldwide clientele. The company’s combination of artistic vision and engineering excellence has brought it recognition as a world leader in high-precision embossing and as an original equipment manufacturer supplier. The secret of Boegli-Gravures’ success lies in the company’s vision and passion for innovation.

    FEELM, an atomization technology brand affiliated to Smoore, is a high-quality closed system and disposable solution provider that leverages the world’s leading ceramic coil heating technology, faithful flavor reproduction technology and innovative electronic technology. With the vision of “Atomization makes life better,” FEELM continues to extend the boundaries of atomization technology with

    FEELM has won numerous prestigious industry awards, including a Golden Leaf Award and Vapouround’s Award for innovation, and global design awards, such as the IF Design Award, the Red Dot Award and the German National Design Award. Products equipped with FEELM’s ceramic coil, with a total production volume of 3.5 billion, have been sold in more than 50 countries and are widely praised.

    Greentank is a business-to-business technology company that specializes in the design, development and manufacturing of precision-made inhalation devices and atomization technology. Greentank’s latest innovation in atomization is called Quantum Vape, which replaces cotton wick and ceramic heating elements with a state-of-the-art patented Heating Chip (see “Heated Breakthrough,” Tobacco Reporter, June 2024).

    Greentank believes the Heating Chip outperforms all other leading atomization products. For example, it performs better on key safety metrics, such as harmful and potentially harmful constituents and heavy metal testing, than other leading technologies in the market. It also produces superior flavor and a consistent consumer experience.

    The company has won multiple industry accolades and honors, including a Red Dot Design Award and Independent’s Vape Tank and Single-Use Vaporizer of the Year distinctions.

    Founded in 2009, Hangsen International Group is a world-leading supplier of e-liquid solutions integrating R&D, manufacturing, sales and services. Since its establishment, Hangsen has been committed to producing safe and reliable e-liquid products and solutions for the global e-cigarette industry.

    Headquartered in Shenzhen, China, Hangsen has offices and R&D centers in many places around the world. Its business covers more than 80 countries and regions, and it has established a complete global supply chain system. Hangsen also has a production base in Poland.

    The domestic manufacturing center has 6,000 square meters of 100,000-class dust-free workshops, covering a total area of more than 30,000 square meters. It has passed ISO9001, GMP, HACCP, CNAS and other international authoritative certifications. Hangsen can provide a complete supply chain solution for the e-cigarette industry, and the service scope includes design, research and development, production, compliance testing, after-sales and other links.

    As the pioneer of e-cigarette technology, Hangsen has obtained more than 300 industrial technology patents and intellectual property rights.

     The Haypp Group is focused on the global transition from smoking to reduced-risk nicotine product alternatives, especially nicotine pouches. Originating in Scandinavia, the group has extensive experience in the pioneering smoke-free markets of Sweden and Norway and is a leader in the e-commerce sector. The Haypp Group is present in seven countries, where it served more than 1 million active consumers with eleven e-commerce brands in the 12 months to June 2024.

    Imperial Brands is a global consumer organization operating in more than 100 markets and the world’s fourth-largest international tobacco and nicotine company. Its brands include JPS, Gauloises and Davidoff cigarettes, Blu vapes, the Pulze and iD heated-tobacco systems, and Zone oral nicotine pouches. In the U.S., the company’s ITG Brands subsidiary offers a broad portfolio of cigarette and mass-market cigar brands, including Winston and Backwoods.

    Driven by insights and data, Imperial Brands seeks to meet the expectations of adult smokers by putting the consumer at the center of everything it does. The business is also refining its ways of working and its culture to foster a strong challenger mindset among its 25,000 employees worldwide.

    Japan Tobacco International (JTI) was formed in 1999 when its parent company, JT Group, acquired the non-U.S. operations of RJR Nabisco. Since then, the company has achieved over two decades of growth. As a leading international tobacco company, it sells its products in more than 130 markets and is the global owner of both Winston and Camel, the second-largest and third-largest cigarette brands in the world, respectively. JTI’s other global brands include Mevius and LD. JTI is also a major player in the reduced-risk products category with its heated-tobacco brand Ploom, its e-cigarette brand Logic and its Nordic Spirit nicotine pouches.

    Creating fulfilling moments. Creating a better future. This is JTI’s purpose; what inspires every single one of its employees. JTI is committed to serving the needs and demands of its adult consumers, supporting the communities it operates in and making its business not only the fastest growing of its kind but also the most innovative and sustainably run.

    Today, JTI has more than 46,000 employees driving its success all over the world. Headquartered in Geneva, Switzerland, it was awarded Global Top Employer for the 10th consecutive year in 2024.

    Juul Labs is on a mission to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use and combat underage usage of its products. The company believes that vapor products can offer adult smokers an alternative to combustible cigarettes and, in so doing, reduce the harm associated with tobacco.

    Körber is an international technology group with more than 12,000 employees at over 100 locations worldwide. In its Digital, Pharma, Supply Chain and Technologies business areas, the Körber Group offers products, solutions and services that inspire. The Körber business area Technologies develops customized solutions in the areas of machinery, equipment, software, measuring instruments, flavors and services with a focus on the tobacco, food and beverage industries. Beyond this, its range of offerings includes innovative concepts for battery cell production. With its 25 global production, sales and service locations, the company sees itself as a strategic partner to its customers. Always keeping their goals in mind, the company delivers and integrates outperforming technologies with passion, precision and performance to help them reach their full potential.

    As part of Certified Group, Labstat is committed to delivering high-quality technical solutions that its customers can feel confident in—on time, every time—“so the world can trust in what it consumes.” As one of the world’s largest independent testing laboratories, Labstat specializes in analytical chemistry, in vitro toxicology, microbiology, method development and customized technical services for global clients in the tobacco, nicotine, cannabis, hemp and natural health product categories.

    Reynolds American Inc. (RAI) is a wholly owned subsidiary of the BAT Group and the U.S. parent company of R.J. Reynolds Tobacco Co., Santa Fe Natural Tobacco Co., American Snuff Co., R.J. Reynolds Vapor Co., and Modoral Brands. RAI’s vision is to build “A Better Tomorrow” by reducing the health impact of its business through offering a greater choice of innovative products for adult tobacco consumers.

    Founded in 2009, Smoore is a global leader in atomization technology solutions, covering reduced-risk products, medicinal, special-purpose vaping devices and beauty atomization technologies.

    Continually investing in R&D and leading in manufacturing capacity, Smoore has nine technology research centers worldwide, and its products are available in more than 100 countries and regions.

    With a focus on interdisciplinary atomization research and a diverse product portfolio, Smoore is committed to becoming an advanced platform with the aspiration to make life better.

    SWM International is a leading global provider of highly engineered fine papers, with a deep expertise in natural fiber-based solutions. The company has historically provided solutions for conventional cigarettes, rolling papers, tubes, machine-made cigars and cigarillos as a partner of the tobacco industry.

    Recently, significant investments have been made in next-generation product categories, such as heated-tobacco products, modern oral and recreational cannabis applications. SWM’s unmatched product and capability portfolio and expert service offerings cater to both the combustible and the smokeless markets.

    Driven by innovation, SWM focuses on accelerating the transition toward safer and more sustainable solutions across the industry.

    Global brands across industries rely on Systech to help them achieve compliance, combat counterfeiting and detect diversion. Systech partners with electronic nicotine-delivery system companies to prevent youth usage with age-gating and root out illicit products.

    Systech provides digital traceability and authentication solutions that deliver essential product data, ensure digital connectivity and enable real-time insights across supply chains. With decades of experience in highly regulated industries such as pharmaceuticals and medical devices, Systech delivers solutions that customers trust to bring billions of critical products to the market safely.

    Tamarind Intelligence provides essential guidance and data-based strategic insights to professionals in fast-moving sectors focusing on consumer-facing products. The areas its selects to cover are in opaque regulatory environments and difficult policy areas where businesses need to be on top of industry developments to make informed decisions and optimize their strategy.

    Operating since 2014, the company provides the most accurate information available through consolidated, consistent methodology and research. Its team of lawyers, economists and journalists has long-term expertise in these markets, enabling the company to provide relevant and actionable guidance to its clients. Since the company is independent from the sectors it covers, it gives its clients access to objective analysis often not available to other industry participants.

    Founded in 1975 in Maryland, Tobacco Technology Inc. (TTI) develops customized flavors and casings for smoking products, including cigarettes, water pipe, snuff, snus, chew, kretek, RYO, pipe tobaccos, e-liquids and white nicotine pouches. TTI also offers consulting services to facilitate flavor, process and product development.

    E-LiquiTech (ELT), a TTI subsidiary established in 2016, is dedicated to the development and manufacturing of the highest quality e-liquids in addition to offering both bottle and cartomizer filling services. ELT is also the exclusive global distributor to the tobacco industry for Zanoprima, a research-driven, innovation-led life sciences company, offering SyNic high-purity synthetic (S)-nicotine in pure, bitartrate and polacrilex resin form.

    TTI Flavors is its manufacturing facility in Assisi, Italy, making TTI products for the EU and Middle Eastern markets.

    In 2022, TTI established Emerald Green Technology (EGT). With the rise of the emergent cannabinoid marketplace, EGT was born as a natural extension of TTI’s family of flavor companies. It offers a vast array of cannabinoid flavor profiles for CBD and hemp products. Infinite cannabinoid possibilities—if you can imagine it, EGT can create it!

    Universal Corp. is a global agricultural company with over 100 years of experience supplying premium ingredients and innovative solutions to meet its customers’ evolving needs and precise specifications. Through its diverse network of farmers and partners across 30 countries on five continents and its commitment to sustainability, the company is a trusted provider of high-quality, traceable products. It leverages its extensive supply chain expertise and state-of-the-art agri-product capabilities to provide a range of products and services designed to drive efficiency and deliver value to its customers.

    Founded in 2016 and headquartered in Shenzhen, China, Zinwi Biotech Co. is a high-tech company that specializes in providing integrated solutions, including research, production, sales and services, to global e-cigarette manufacturers and brands. Today, Zinwi Biotech is one of the world’s leading e-liquid companies owing to its strong research and development, strict quality control procedures, stable product quality and large client network.

    With innovation at its core, Zinwi Biotech focuses heavily on product research and development. In addition, it focuses on reduced harm technology innovation and application. In 2020, Zinwi Biotech established its Atomization Technology Research Center focused on breaking technological barriers and obtaining patents.

    In terms of production and quality control, Zinwi Biotech has gained a number of certificates, including the National CNAS Laboratory Certification, ISO9001, ISO14001 and ISO45001, along with the American GMP Certification. Its products are sold through the network of clients to many countries and regions in Europe, America and the Middle East and have been unanimously recognized by more than 300 brands.

     

  • 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.
  • 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.
  • Ignorance Is Not Bliss

    Ignorance Is Not Bliss

    Photo: bongkarn

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

    By Neil McKeganey and Gabe Barnard

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

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

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

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

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

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

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

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

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

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

    Beyond Hot Air

    Photo: Valerii Honcharuk

    Designing effective heated-tobacco products

    By Malcom Saxton

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

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

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

    Concept and Engineering

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

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

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

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

    Iterative Testing

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

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

    Toxicological Considerations

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

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

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

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

    Preparing for Market

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

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

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

    Malcolm Saxton is senior consultant at Broughton.
  • The Takeaways

    The Takeaways

    Image: Parin April

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

    By Chris Allen

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

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

    A Big Step for Tobacco Harm Reduction

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

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

    The PMTA Process

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

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

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

    What Can We Learn from These Products?

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

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

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

    Reducing the Risk of Youth Use

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

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

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

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

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

    Comparisons from Adult Smokers

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

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

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

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

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

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

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

    Chris Allen is the CEO of Broughton.