Blog - Tobacco Reporter

Accorto Joins Institute for Novel Nicotine

Accorto Regulatory Solutions has joined the Global Institute for Novel Nicotine (GINN), an organization dedicated to advancing tobacco harm reduction through supporting the research and development of non-vaporized tobacco alternatives for adult smokers. The GINN also promotes compliance standards, focusing on youth access prevention, responsible marketing and product quality.

Accorto Chief Scientific Officer Vince Angelico will join the GINN’s science and standards committee, which helps shape regulatory recommendations for the industry.

“Becoming a member of GINN is a pivotal move in our ongoing commitment to advancing public health through robust, evidence-based regulation,” said Accorto Regulatory Solutions CEO Tom Beaudet in a statement. “GINN’s dedication to upholding industry integrity and prioritizing consumer safety mirrors our own values. We are eager to collaborate with fellow members to drive impactful progress in the tobacco harm reduction space.”

Through this collaboration, Accorto Regulatory Solutions aims to contribute to the development of comprehensive, science-driven regulations that will enhance public health outcomes and promote responsible industry practices. Additionally, Accorto says it is dedicated to helping GINN members with novel, science-backed reduced-risk products fortify their regulatory applications, enabling these products to reach the market.

“Accorto Regulatory Solutions joining GINN marks a significant step forward in our shared mission to advance tobacco harm reduction through evidence-based regulation,” said GINN Director Shem Baldeosingh. “Accorto’s deep expertise in regulatory compliance and their commitment to public health align perfectly with GINN’s core values. We are particularly excited about Dr. Vince Angelico’s involvement in our science and standards committee, as it will further enhance our ability to develop comprehensive, science-driven regulatory frameworks that support the safe and responsible marketing of reduced-risk nicotine products.”

September 5, 2024

Study: HTPs Increase Likelihood of Quitting

Switching to heated tobacco products (HTPs) can significantly increase the likelihood of smokers quitting smoking entirely, reports the Inquirer, citing a study conducted by South Korean researchers.

Conducted by experts at the Korea Institute for Industrial Economics and Trade, the study also found no evidence to support concerns that HTPs serve as a gateway to smoking.

Using data from the Korea National Health and Nutrition Examination Survey, the researchers observed that 99.4 percent of HTP users either switched from traditional cigarettes or are dual users, with only 0.6 percent being new smokers.

Anton Israel, president of the Nicotine Consumers Union of the Philippines, said the Korean study demonstrates how technology can mitigate the risks associated with nicotine consumption. “Nicotine isn’t the problem,” he was quoted as saying. “It’s the way it’s delivered through combustion. Smoke-free products like HTPs eliminate the harm from smoke.”

The Korean study, which surveyed 4,514 adults, also concluded that adolescents are more likely to start smoking with traditional cigarettes rather than HTPs. Among the study’s participants, 2,356 were nonsmokers, 1,316 were traditional cigarette smokers, and 842 were HTP users.

Heated tobacco products accounted for 12 percent of South Korean tobacco sales in 2021, up from 2.2 percent in 2017.

September 4, 2024

Supreme Court Urged to Overturn Triton Ruling

A group of congressional lawmakers urged the Supreme Court of the United States to overturn a lower court ruling that blocked federal regulators from rejecting certain e-cigarette products, reports, reports Courthouse News.

They argued that the move could hinder government efforts to keep illegal vaping products off store shelves.

The Supreme Court is set to tackle the FDA’s power to regulate vape sales altogether this term, in FDA v. Wages and White Lion Investments, LLC. The forthcoming case challenges a January ruling from the Fifth Circuit, which found that the FDA overstepped its authority when it rejected marketing applications from two manufacturers looking to sell flavored liquids for e-cigarettes.

In an amicus brief filed with the Supreme Court Sept. 2, the group of legislators—led by Senate Majority Whip Dick Durbin, Oregon Senator Jeff Merkley and New Jersey Representative Frank Pallone—argued that the FDA’s decision to reject these marketing applications was “carefully” reasoned.

“Guided by Congress’ chief directive—to deny such authorization unless a product under review would be ‘appropriate for the protection of the public health’ … FDA has been appropriately mindful of children and teenagers, the most vulnerable pool of nontobacco users,” the lawmakers wrote.

They contended that judicial oversight of the agency’s authority had been “generally consistent” until the Fifth Circuit’s ruling and had not impeded it from accomplishing its regulatory responsibilities.

The legislatures told the high court that allowing the lower court’s ruling to stand would not only force the FDA to waste resources reevaluating the rejected marketing applications but could also invite other manufacturers previously rejected by the FDA to relitigate their own marketing requests.

“While those applications are once again pending FDA review, the tobacco products they cover would continue to be sold, despite the law’s clear pre-market authorization regime,” the lawmakers said. That provides a “powerful financial incentive” for manufacturers to reapply for FDA approval, even if they know the agency will ultimately deny their applications.

A group of health organizations has filed a separate amicus brief, making similar arguments, in the case.

September 4, 2024

Dominican Republic to Build Tobacco School

The National Institute for Technical and Professional Training of the Dominican Republic will establish a school to meet the growing demand for skilled labor in the tobacco sector.

Set up in collaboration with the Association of Cigar Producers of the Dominican Republic (ProCigar), the facility will be located in Tamboril, Santiago, a key area for tobacco production. The facility aims to provide formal training and certification for workers, many of whom have previously gained skills through informal means.

According to ProCigar President Litto Gómez, training is key in maintaining the international competitiveness and quality of Dominican tobacco products. Investing in skilled labor, he noted, not only supports the industry’s efficiency but also contributes to the economic development of local communities.

The tobacco industry in Santiago employs more than 110,000 people and generated over $400 million in the first four months of the year, according to the Ministry of Industry.

September 4, 2024

BAT to Host 2024 CORESTA Congress

The UK-based company will host the 2024 CORESTA Congress in Edinburgh, UK, from 13 – 17 Oct.

The Congress will bring together leading scientists, tobacco and related product experts, and regulators from over 165 member organizations to focus on the theme of “Advancing Tobacco Harm Reduction through Scientific Collaboration.”
Participants will share, discuss, and collaborate on tobacco and related product
science.

BAT has volunteered to host the upcoming Cooperation Centre for Scientific Research Relative
to Tobacco (CORESTA) Congress 2024, set to take place from 13 – 17 October at the Edinburgh
International Convention Centre, UK.

This year’s congress will bring together over 165 member organizations, from over 30 countries
and non-members, including companies, research institutes, laboratories, associations, and
regulatory bodies under the theme of “Advancing Tobacco Harm Reduction through Scientific
Collaboration”.

Formed in 1956, CORESTA is committed to exploring the latest scientific research to facilitate
positive change in the tobacco industry. This year’s iteration continues this ambition, specifically
seeking to advance the knowledge and understanding of the science related to Tobacco Harm
Reduction (THR) among its membership and attendees.

To achieve this goal, leading scientists from across the world will attend and present their work, bringing their expertise in a diverse range of disciplines to allow participants to explore all aspects of THR. Thanks to the collaborative work of the most experienced scientists in their field, CORESTA has gained international recognition.

With increasing regulatory requirements, CORESTA’s scientific work and outputs have become a worldwide reference point for tobacco policymaking and support the development of testing standards, such as ISO Standards.

As host, BAT looks forward to facilitating the conversations necessary to grasp the public health opportunity presented by THR to significantly reduce the risks for the estimated 1bn consumers who smoke and address misperceptions of alternative tobacco and nicotine products with the potential to reduce risks compared to cigarettes.

To learn more about the event and request an invitation, visit the official congress website: www.corestacongress2024.com. Registration is open until Sept. 20, 2024.

September 4, 2024

Fire Damages Universal Facility in Dominican

A fire broke out Sept. 2 at Inetab-Kaubeck, Universal Corp.’s leaf-sorting and sales facility in Moca, Dominican Republic.

In a letter sent to Universal clients obtained by Halfwheel, Inetab-Kaubeck Managing Director Philipp Schumacher said that there was “a material loss of tobacco and one part of the warehouse affected.”

The letter states that staff were not on-site at the time of the fire, and no lives were lost. It does not list the cause of the fire.

Video of the fire showed a large warehouse that appeared to still have tobacco in it, but images shared with Halfwheel show a mostly empty building with remnants of tobacco on the floor and tables as well as char marks around the walls and standing water on the floor.

In a subsequent video, Henderson Ventura of Tabacalera William Ventura and ADV & McKay Cigars Co. said that it is one of eight buildings at Inetab-Kaubeck and one that focused on Connecticut broadleaf and Pennsylvania tobaccos.

“We thank all emergency services present and [e]specially the fire departments from Moca and multiple other locations in the Cibao area for their assistance to the fire,” said Schumacher. “Thanks to their tireless efforts, it was controlled swiftly.”

September 3, 2024

Tobacco Reporter Recognized

Tobacco Reporter was recognized for editorial excellence in the Trade, Association, and Business Publications International’s most recent Tabbie competition.

The magazine received a bronze award in the Editor’s Column category for its “Developing Supplemental Value Chains” editor’s memo and an honorable mention in the Feature Article category for its “Broadening the Base” piece. Both articles deal with Malawi’s attempts to diversify its economy beyond tobacco.

Created two decades ago, the annual Tabbie Awards program celebrates journalists worldwide who cover their industries with passion, skill and creativity. The Tabbie Awards stands out from other similar programs in its distinctive global reach, with local, regional, national and international English-language publications in all countries encouraged to participate.

It’s not the first time that Tobacco Reporter’s work has been recognized in the Tabbie competition. Previous awards include gold, silver and bronze trophies for feature writing, along with honorable mentions in various categories.

September 3, 2024

ITGA to Hold AGM in North Carolina

The International Tobacco Growers Association (ITGA) will hold is 2024 annual general meeting (AGM) in Raleigh, North Carolina, USA, Oct.15-18. The event, which coincides with the organization’s 40^th anniversary, is hosted by the Tobacco Growers Association of North Carolina and brings together growers’ representatives and tobacco sector stakeholders from around the world.

Delegates to the meeting will visit an auction center, observe receiving station delivery, tour a processing plant, visit university and research farms and the North Carolina State Fair.

This year, ITGA’s focus is on farm productivity and tobacco yields. An extensive research effort revealed crucial variations between markets as well as between small scale and commercial growers. This will be the focus of the open day conference.

For more information, visit www.itgaevents.com.

September 3, 2024

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.

September 1, 2024

Rebuilding the Value Chain

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.

September 1, 2024