Author: Marissa Dean

  • 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.”

  • 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.

    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.

  • 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.

  • 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.

    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.

  • Rewriting the Rules

    Rewriting the Rules

    Will the next EU Tobacco Products Directive embrace harm reduction?

    By Stefanie Rossel

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

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

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

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

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

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

    Missing Its Target

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

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

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

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

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

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

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

    More Stringent Rules Anticipated

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

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

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

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

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

    Pouches in Peril

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

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

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

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

  • Thailand: Home Vaping is Domestic Violence

    Thailand: Home Vaping is Domestic Violence

    Image: Zerophoto

    Exposure to secondhand vapor from vaping at home could be considered a violation of Thailand’s child protection laws, according to child health and rights experts who are calling for more awareness of the dangers of vaping around children, reports The Pattaya Mail.

    Under national laws, vaping around children could be considered “domestic violence,” according to Thai authorities. They are calling for stricter enforcement.

    The Royal College of Pediatricians of Thailand wants stronger government measures to restrict the import and sale of e-cigarettes and increase educational campaigns about the risks of nicotine.

  • U.S. Court Reverses ‘Elf’ Trademark Suit

    U.S. Court Reverses ‘Elf’ Trademark Suit

    Image: Olivier Le Moal

    A ban on a Chinese company selling “Elfbar” vapes can’t stand because a district court failed to analyze whether the rightsholder’s use of “Elf” on an illegal product negated its trademark rights, the Federal Circuit court stated.

    “Elfbar” seller Shenzhen Weiboli Technology Co. Ltd. argued the “unlawful use doctrine” precluded a preliminary injunction as plaintiff VPR Brands LP failed to clear its “new tobacco product” with the government as required under federal law, according to Bloomberg.

    The U.S. Court of Appeals stated in its opinion that the district court wrongly dismissed the defense without considering the propriety of the doctrine, a proper standard or Weiboli’s evidence.

    The Federal Circuit ruled that the district judge who ordered the injunction “misread” precedent and relied on a “deficient” legal analysis.

    A U.S. federal judge on Feb. 23 ordered Shenzhen Weiboli Technology to stop marketing its Elfbar e-cigarettes in the U.S., finding that VPR Brands, which makes and sells Elf brand vapes, is likely to succeed on its claims that the Elfbar vapes infringe its trademark.

    According to U.S. District Judge Aileen M. Cannon, VPR has shown there is a likelihood of confusion and the company stands to suffer harm if its Chinese competitor is allowed to keep selling the Elfbar vapes.

    In November, VPR asked for an injunction blocking Shenzhen Weiboli from continuing to use the Elfbar mark, arguing the alleged infringement is costing VPR about $100 million because of the effect on future sales.

    VPR claims Shenzhen Weiboli is not only infringing VPR’s Elf trademark but also its patent for its e-cigarette device.

  • Virginia Commission Mulls Grant Requests

    Virginia Commission Mulls Grant Requests

    Photo: Sarah Vogelsong | Virginia Mercury

    Virginia’s Tobacco Region Revitalization Commission has $12 million to spend on energy projects as part of a legislative mandate to revitalize the economies of two regions that are no longer receiving economic benefits from the tobacco industry, reports Virginia Mercury.

    The Energy Ingenuity Committee, at the commission’s last meeting, discussed applications it received for two rounds of the funds that opened this year. A third round of funds is expected to open following the commission’s next meeting scheduled for September.

    “We rolled it out earlier this year,” said Jerry Silva, director of regional energy development and innovation for the commission. “We really did not know what the application level would be.”

    The Tobacco Region Revitalization Commission was formed in 1999 with 28 legislative and citizen members representing Southside and Southwest Virginia. The commission allocates funds from the 1998 Master Settlement Agreement, which was the beginning of the demise of the tobacco industry’s footprint in the two regions.  

    The Energy Ingenuity Fund was recently created by the commission to help increase economic activity surrounding energy development projects. The fund allocated $6 million to each of the two regions and solicited energy development projects.

    To apply for the grants, applicants must be a government entity or nonprofit, have one-for-one matching funds and identify the number of jobs that could be created by the project. Private companies can apply for the grants as long as they partner with a locality to create economic incentives.

    There is a pre-application phase where applicants present ideas to Silva on what the funds could go toward before staff determine what needs more information and what can be submitted as a full application. Silva received 17 pre-applications in round one, with three moving forward to a full vote in May. Round two saw 11 pre-applications, with four expected to move to a vote in September.

    “These are projects that we’re trying to help bridge opportunities that would normally not be opportunities unless we helped them,” Silva said. “We’re trying to make sure we’re the best stewards of the commission’s money and dollars. We want to fund viable projects.”

  • Tanzania Tobacco Exports Hit $438 Million

    Tanzania Tobacco Exports Hit $438 Million

    Image: Tobacco Reporter archive

    Tanzania’s tobacco export value has hit $438.5 million, more than double the previous year, according to data from the Tanzania Revenue Authority (TRA) and Bank of Tanzania (BoT), reports The Guardian.

    The government’s target was $400 million.

    Tobacco exports have now surpassed coffee and cashews as the leading traditional export earning commercial crop. Tobacco is currently produced under contract.

    The value increase is a result of a crop production increase to 122 million kg as well as an increase in commodity price in the world market.

    Tanzania is now the second largest producer of tobacco in Africa following Zimbabwe.

    For the 2024/2025 season, Tanzania aims to produce 200,000 tons of tobacco, and for the 2025/2026 season, the country aims to produce 300,000 tons.

    The goal is to increase export earnings to between $600 million and $700 million annually, according to Hussein Bashe, the minister of agriculture.

    According to Bashe, more than 50 percent of tobacco was bought and sold abroad by local companies, marking a first for the country.

    Statista projections show Tanzania’s tobacco products market generating $644.9 million in revenue in 2024.

  • Brazilian Tobacco Suitable to Ship to China

    Brazilian Tobacco Suitable to Ship to China

    Image: SindiTabaco

    On Aug. 9, the Interstate Tobacco Industry Union (SindiTabaco) hosted a meeting to formalize the closure of the tobacco pre-inspection procedure for the 2023/2024 crop year, one of the requirements of the bilateral trade protocol between Brazil and China. The meeting was held in hybrid format, with the virtual presence of the technicians from the General Administration of Customs China (GACC) and the representative of the Ministry of Agriculture, Livestock and Food Supply (MAPA) and of the National Organization for Brazilian Phytosanitary Protection (ONPF), Pedro Carneiro Abreu.

    Other authorities from Brazil and China attended the event as well.

    “This is a primordial moment for compliance with the protocol. The samples were collected in a very effective manner, and it is with great satisfaction that I inform you that no pests were detected in the collected samples. This once again corroborates the quality of the Brazilian tobacco. China is one of our largest importers of tobacco, and this partnership plays a fundamental role for the continuity of the businesses between the two countries. We are sure that we will continue making strides in this relation,” commented Abreu from MAPA Brasilia.

    “Our participation consists in representing this commitment, which is also shared by minister Carlos Favaro, besides acknowledging this activity as relevant for the entire country. In our understanding, this expresses our responsibility with regard to the Chinese inspection organs,” said Jose Cleber de Souza, superintendent at MAPA RS.

    The MAPA was in charge of collecting the processed tobacco samples and sending them to the Central Analytical Laboratory of the University of Santa Cruz do Sul (UNISC) for laboratory tests that confirm the phytosanitary status of the product prior to shipment. Roque Danieli, tax auditor and head of MAPA’s Plant Health and Inputs Inspection Service in RS, presented details about the pre-inspection activities.

    “During these 23 days in which we worked jointly with the GACC representatives, in virtual format, it was possible to attest to the quality of the 2023/2024 crop and demonstrate that, at field level, the 2024/[20]25 crop is now under cultivation with all the necessary cares in compliance with the requisites set forth on the protocol. The integrated production system gets the credit for the fact that tobacco is the commercial crop that uses the least amount of pesticides at field level, a result of the constant work of the farm extension agents. We hope that the presentation of the works is cause for satisfaction, and next week, we shall send the final report to Brasilia to be forwarded to the GACC,” Danieli said.

    Zhang Nan Zhengrong, Leader of the China Leaf Company Delegation, presented the pre-inspection report to the attendees of the meeting jointly with the technician responsible for the Central Analytical Laboratory of UNISC, professor Adriana Dupont Schneider. She gave details of the analyses.

    “This year, we analyzed a total of 54 lots with samples collected in eight companies. The laboratory activities took 24 days, and they certified the phytosanitary safety with regard to the nine quarantine pests set forth in the agreement, of which, six are types of insects, two weeds and the fungus known as blue mold. All the results were negative for the pests included in China-Brazil trade protocol,” said Schneider.

    “Tobacco is an agricultural crop that suffers harsh criticism but has been vigorously defended by the MAPA,” said SindiTabaco President Iro Schuenke. “This has a lot to do with the social and economic importance of the crop for our country, especially for the South Region. China is our second-largest importer, coming only after Belgium, and every year purchases big amounts of our tobacco. And this is the moment for a special mention of the farmers that cultivate tobacco in Brazil who, along with the farm extension agents, have performed all the necessary works for our compliance with the necessary requisites that have kept Brazil as top leaf exporter over the past 30 years.”