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  • 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.
  • Rewriting the Rules

    Rewriting the Rules

    Will the next EU Tobacco Products Directive embrace harm reduction?

    By Stefanie Rossel

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

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

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

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

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

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

    Missing Its Target

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

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

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

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

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

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

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

    More Stringent Rules Anticipated

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

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

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

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

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

    Damian Sweeney, partner in the European Tobacco Harm Reduction Advocates

    Pouches in Peril

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

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

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

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

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

    Out of Proportion

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

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

    By George Gay

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

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

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

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

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

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

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

    Misplaced Priorities

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

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

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

    Including an Outlier

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

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

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

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

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

    The Scent of Spite

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

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

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

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

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

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

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

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

    A Drop in the Ocean

    Photo: digieye

    The FDA’s first premarket approval of a mentholated vape product reflects poorly on the agency’s authorization process.

    By Stefanie Rossel

    Lindsay Stroud

    On June 21, the U.S. Food and Drug Administration for the first time authorized nontobacco-flavored vape products through its premarket tobacco product application (PMTA) pathway. The agency issued marketing granted orders (MGO) for two Njoy Ace menthol flavor pods and two disposable e-cigarettes, Njoy Daily Menthol 4.5 percent and Njoy Daily Extra Menthol 2.4 percent. The news was hailed as a “significant decision” and a “watershed moment for the sector” that will have a “huge and significant impact” on the global reduced-risk products market.

    Upon closer inspection, however, the authorization is less of a breakthrough than these superlatives suggest. Instead, it again highlights the many problems with the agency’s authorization process for electronic nicotine-delivery systems (ENDS) and novel nicotine products.

    Lindsey Stroud, senior fellow with the Taxpayers Protection Alliance, describes the recent FDA authorization as a small step in the right direction in what has otherwise been a regulatory nightmare. “While allowing the sale of a nontobacco-flavored ENDS, FDA seems to understand that adults who use menthol-flavored combustible cigarettes should have access to products which are significantly less harmful,” she says. “Unfortunately, the FDA still continues to deny the sale of all other flavored ENDS, despite their effectiveness in helping adults quit smoking and remain smoke-free.”

    Stroud is also concerned about the informal market. “Despite FDA not having issued authorization orders for flavored ENDS, a large, unregulated marketplace exists in the United States—99.9 percent of which are nontobacco flavored,” she says. “FDA must recognize the role that other flavors play in tobacco harm reduction because denialism isn’t stopping the flourishing non-FDA-authorized ENDS marketplace.”

    Jeffrey Smith

    Jeffrey Smith, a senior fellow in harm reduction at the R Street Institute, says he welcomes any action by the FDA Center for Tobacco Products (CTP) that supports reduced-risk options for those who smoke. “Unfortunately, in the grand scheme of things, the awarding of an MGO to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP,” he says. “If the regulatory environment does not change through external pressures, it is unlikely that the actions of the CTP will evolve in a swift and effective manner.”

    Gray Market to Persist

    While optimists may detect a new willingness to approve reduced-risk products (RRPs) in the CTP’s recent product authorizations, few expect the regulatory floodgates to open to an avalanche of product approvals.

    “Since the awarding of the Njoy menthol products, there haven’t been any additional actions or signals that more may be coming,” says Smith. “The only additional communications I have seen from the CTP since the Njoy announcement was a letter from the FDA to the clerk of the Supreme Court informing the court that the CTP had granted a marketing order to four menthol-flavored e-cigarette products. The case is the Logic v. FDA, where Logic is arguing that the CTP had adopted a blanket policy of rejecting menthol-flavored products.”

    Stroud says the menthol announcement is a positive development but notes that the FDA remains opposed to any flavors that don’t exist in traditional tobacco products. “Dr. Brian King, director for the Center for Tobacco Products, is very anti-flavor, if not anti-vape,” she says. “Going back to at least 2015 and his time at the CDC [Centers for Disease Control and Prevention], King has been first to tout the Bloomberg party line that ‘flavors hook kids.’ This is in direct contrast to U.S. youth survey data, which finds flavors as one of the least-cited reasons why youth vape. FDA must recognize the role of flavors, their appeal to adults who smoke and how flavors help to reinforce a negative taste—literally—associated with combustible cigarette smoke. Until FDA recognizes this, the U.S. ENDS market will remain a large gray market.”

    Unlike most other vape products that have received FDA authorization to date, the Njoy menthol variants are technologically up to date and relatively popular with consumers. “According to Altria’s first-quarter 2024 report, Njoy made up 4.3 percent of the U.S. retail market, but this will likely grow as Njoy is now the only menthol-flavored—and nontobacco-flavored—ENDS product legally permitted to be for sale in the U.S.,” says Stroud.

    She is undecided about the FDA decision’s potential impact on the global RRP landscape. “I would imagine that with FDA recognizing the importance of menthol, most countries would follow the agency’s findings,” she says. “Unfortunately, due to a de facto flavor ban in the U.S., there is precedent for countries to restrict flavors, despite them not experiencing a huge surge in youth vaping as the U.S. did in 2019.”

    “The awarding of a marketing granted order to the four Njoy menthol variants is unlikely to be a sign of a significant shift in the decision-making process at the CTP.”

    Depressing Number

    Nicotine companies have long lamented the FDA’s product authorization process, which they say is needlessly time-consuming and costly and favors deep-pocketed players over less generously resourced applicants. Stroud and Smith believe the process can be streamlined only through external interventions.

    To illustrate the challenge, Stroud recalls the tremendous technological progress in ENDS products, which went from cigalikes to larger open systems, back to pods and then on to disposables. “The FDA’s draconian regulations don’t account for the technological improvement that has been applied to ENDS,” she says. “FDA and Congress could reform the Tobacco Control Act [TCA] in a huge way if they pushed the predicate date further ahead than February 2007. Requiring ENDS to undergo extensive testing and a massive bureaucratic application process is not only a farce to public health, but it restricts innovation and competition, which is very un-American.”

    With Congressional assistance and a reworking of the TCA, the FDA could establish a notification process for new products and then focus on post-market surveillance to monitor the public health effects of the new products, according to Shroud.

    “The FDA must also recognize what percentage of youth is permittable,” she says. “No other consumer good in America has been forced to deal with so much scrutiny that even one kid using the product is one kid too many. While youth vaping was a problem in 2019, it declined by more than 60 percent in the years since—all while the non-FDA-authorized ENDS market grew exponentially. FDA must recognize that adults are using these products and that their use is associated with a 10 percent decrease in cigarette units sold in America in 2023. That’s a win for public health. FDA must reform the process so we can accelerate even further declines in smoking.”

    As of June 21, the FDA had authorized more than 16,000 tobacco products—mostly cigarettes and cigars, according to Stroud. “Twenty-seven MGOs for ENDS is a depressing number and makes up less than 1 percent of authorized products,” she says. “Worse, only 49 products have been authorized by FDA using the PMTA pathway. FDA’s own budget is problematic; it’s entirely funded by user fees paid for by only six classes of tobacco products and not from e-cigarettes. There is more of an incentive to authorize the products that are paying for a $275,000 annual salary, as made by the CTP director in 2023, than authorizing products that pay nothing. While FDA has been asking Congress for years to be able to collect user fees on products including e-cigarettes, they refuse to issue orders—and instead denied tens of millions of products. That could have been a lot of fees and would have funded a significant amount of surveillance while also recognizing tobacco harm reduction. It is something the agency must recognize if the mission is to reduce smoking.”

    While optimists may detect a new willingness to approve reduced-risk products in the CTP’s recent product authorizations, few expect the regulatory floodgates to open to an avalanche of product approvals. | Photo: Tada Images

    Significant Ruling

    Smith says it is important to educate those affected by the failing 99.999 percent of all PMTA applications about the recent changes in the regulatory landscape and how those changes may lay a foundation for the significant changes necessary at the CTP.

    “The first is the recent announcement by the Supreme Court where the Chevron Deference has been overturned,” he says. “This action by the court will now require that regulatory agencies follow the letter of the law and that the regulators would now have little leeway in the interpretation of how to apply regulatory law.

    “The Chevron Deference has allowed the CTP to define the meaning of ‘appropriate for the protection of public health’ when conducting a review of the PMTAs and MRTPAs [modified-risk tobacco product applications]. Now, post-Chevron, if the Tobacco Control Act does not clearly outline the actions and process of enforcement of regulatory oversight in a manner that allows for the regulatory agency to action the law, the law will have to be amended to clarify the process, so legislators will have to work to make the law actionable … not the regulators that monitor the marketplace.”

    Second, according to Smith, the Supreme Court may review four relevant lawsuits—Triton, Magellan, Lotus and Logic. Such a review may trigger action to change the TCA. “If the court decides to hear at least one of these cases, then the likely outcome is a requirement that the TCA be clarified so that the CTP will only enforce actions defined in the TCA,” says Smith. “If the TCA isn’t clear as to how to enforce it, then the law should be amended. Depending on how the policies are modified by the legislative branch, we may see shifts in the way that CTP reviews all tobacco and nicotine products, leading to a more effective regulatory environment. However, how the legislators refine the TCA will determine if the regulatory environment improves in a manner that supports the reduced-risk product marketplace.”

    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.
  • Hot Commodity

    Hot Commodity

    Photo: Taco Tuinstra

    Leaf tobacco remains in short supply.

    By Stefanie Rossel

    Ivan Genov | Photo: ITGA

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

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

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

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

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

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

    China Boosts Production

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

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

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

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

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

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

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

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

    Adverse Weather

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

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

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

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

    African Upswing

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

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

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

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

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

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

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

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Nicotine 2040

    Nicotine 2040

    Photo: Artinun

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

    By Clive Bates

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

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

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

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

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

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

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

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

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

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

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

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

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