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  • Top Court to Hear Triton PMTA Denial Order Suit

    Top Court to Hear Triton PMTA Denial Order Suit

    supreme court of USThe U.S. Supreme Court agreed on Tuesday to hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.

    The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

    The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.

    Two e-cigarette liquid makers, Triton Distribution and Vapetasia LLC, filed FDA applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

    An FDA rule that took effect in 2016 deemed e-cigarettes to be tobacco products, like traditional cigarettes, subject to agency review under a 2009 federal law called the Tobacco Control Act. The rule said manufacturers of the products would need to apply for approval to continue selling them.

  • Swedish Match Presents to FDA on General Snus

    Swedish Match Presents to FDA on General Snus

    Image: Tobacco Reporter archive

    Experts from Swedish Match USA, an affiliate of Philip Morris International, presented to the Tobacco Products Scientific Advisory Committee on June 26, 2024, according to a PMI press release. The committee, comprising independent scientific researchers, provides regulatory guidance to the U.S. Food and Drug Administration’s Center for Tobacco Products.

    The half-day meeting was part of the FDA’s review of Swedish Match’s request to continue marketing General Snus products in the U.S. as modified-risk tobacco products (MRTPs) and to expand permitted use of the reduced-risk claim to reach, and transition, more legal-age smokers away from cigarettes.

    Initially granted by the FDA in October 2019, Swedish Match can communicate to legal-age consumers that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” Currently, that message is accessible only on the General Snus website.

    Swedish Match presented to the committee real-world evidence showing the claim is delivering on its promise to reduce harm to individual tobacco users and benefit the health of the population and should be renewed.

    In its renewal submission, Swedish Match is seeking to expand use to additional lawful marketing channels, such as point-of-sale display and direct mail to age-verified consumers.

    “As FDA’s Center for Tobacco Products Director Brian King said when unveiling its new five-year strategic plan, this is a critical moment in the history of tobacco product regulation,” Gerry Roerty, general counsel for Swedish Match, said to committee members. The center’s mission is to make smoking-related disease and death a part of America’s past, and “today, together, we can meaningfully advance that goal,” Roerty told committee members.

    During the meeting, representatives from Swedish Match and committee members discussed a range of scientific, technical and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented evidence and research demonstrating low levels of use by unintended populations.

    General Snus is a smokeless tobacco product, traditionally produced in Sweden, that is nonfermented and air cured. The modified-risk products submitted for renewal include eight General Snus varieties that have been made available in the U.S. for more than a decade: General Snus Original (pouch); General Snus Original (loose); General Snus White (pouch); General Snus Mint (pouch); General Snus Wintergreen (pouch); General Snus Mini Mint (pouch); General Snus Classic Blend (pouch); and General Snus Nordic Mint (pouch).

    “We are understandably proud of our commitment to a cigarette-free America, which is achievable much faster if policy is guided by science,” said Stacey Kennedy, president of the Americas region and CEO of PMI’s U.S. business. “America’s 28 million adult smokers have been bombarded with misinformation about smoke-free products, which can cause confusion and prolong the most harmful form of nicotine consumption—smoking. We look forward to continuing dialogue with the FDA as it continues to consider renewal of this modified-risk authorization.”

    The General Snus products were first authorized as “appropriate for the protection of the public health” through the premarket tobacco product application (PMTA) process in 2015 following a PMTA submission earlier that same year.

    Since then, Swedish Match USA has submitted eight annual reports over as many years, the last four of which were combined with MRTP annual reporting.

  • WHO Releases Guideline for Cessation

    WHO Releases Guideline for Cessation

    Image: Tobacco Reporter archive

    The World Health Organization has released a comprehensive set of tobacco cessation interventions, including behavioral support delivered by healthcare providers, digital cessation interventions and pharmacological treatments, in its first guideline on tobacco cessation.

    The guideline focuses on helping tobacco users who want to quit all forms of tobacco. The recommendations are relevant for all adults seeking to quit various tobacco products, including cigarettes, water pipes, smokeless tobacco products, cigars, roll-your-own tobacco and heated-tobacco products.

    “This guideline marks a crucial milestone in our global battle against these dangerous products,” said Tedros Adhanom Ghebreyesus, WHO director-general. “It empowers countries with the essential tools to effectively support individuals in quitting tobacco and alleviate the global burden of tobacco-related diseases.”

    “The immense struggle that people face when trying to quit smoking cannot be overstated,” said Ruediger Krech, director of health promotion at the WHO. “We need to deeply appreciate the strength it takes and the suffering endured by individuals and their loved ones to overcome this addiction. These guidelines are designed to help communities and governments provide the best possible support and assistance for those on this challenging journey.”

  • Biden Asks Judge to Drop Menthol Ban Suit

    Biden Asks Judge to Drop Menthol Ban Suit

    TR Archive

    The Biden administration asked a federal judge to dismiss a lawsuit by anti-smoking groups demanding that it end nearly a year of delay and ban menthol cigarettes, which are used disproportionately by Blacks and younger people.

    In a court filing late last week, the U.S. Food and Drug Administration said the delay was not unreasonable because it had yet to determine that a ban was “appropriate for the protection of the public health.”

    The FDA also said the plaintiffs had no direct stake in a ban, having alleged at most “a setback to their abstract social interests,” and therefore had no standing to sue,” according to Reuters.

    It cited the U.S. Supreme Court’s June 13 rejection of a bid by anti-abortion groups and doctors to restrict access to a widely used abortion pill.

    The lawsuit was filed on April 2 in the Oakland, California federal court by the American Medical Association, the African American Tobacco Control Leadership Council, Action on Smoking and Health and the National Medical Association.

    Last month, the FDA authorized four menthol NJOY products through the premarket tobacco product application (PMTA) pathway.

    The FDA issued marketing granted orders to NJOY, an Altria subsidiary, for two pods for its Ace closed e-cigarette device, which was authorized in April of 2022, and two disposable e-cigarettes—NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 2.4%.

  • WHO Wants Cambodia to Raise Tobacco Taxes

    WHO Wants Cambodia to Raise Tobacco Taxes

    Image: VDZ3 Media

    Ada Moadsiri, World Health Organization representative in Cambodia, called for an increase in the special tax on cigarettes in the kingdom, reports the Khmer Times. According to Moadsiri, the current tax is not enough to discourage cigarette use or to raise enough revenues to offset the cost in terms of healthcare and economic output caused by tobacco-related illnesses.

    Moadsiri said, at the Youth Forum on Tobacco Tax Measures event, that an effective increase in the special tax would require stakeholders to keep cigarette prices higher and make it more difficult for Cambodians to start smoking.

    “We see that this delusion of the tobacco industry that claims that raising taxes on cigarettes will lead to tax evasion is fake, and I think the tobacco industry uses these fantasies for the sole purpose of preventing or delaying the special tax on cigarettes,” Moadsiri said.

  • PMI Accused of ‘Manipulating Science’

    PMI Accused of ‘Manipulating Science’

    Image: Xistudio

    Philip Morris International has been accused of “manipulating science for profit” through funding research and advocacy work with scientists, according to The Guardian.

    Leaked documents from PMI and its Japanese affiliate revealed plans to target politicians, doctors and the 2020 Tokyo Olympics as part of the company’s marketing strategy to attract nonsmokers to its IQOS heated-tobacco product. Japan is a launch market for IQOS.

    A Tobacco Control Research Group paper from the University of Bath stated that Philip Morris Japan (PMJ) funded a Kyoto University study into smoking cessation via a third-party organization. The researchers found no public record of PMJ’s involvement, however. According to a PMI spokesperson, the company’s involvement was attributed when the results were presented at a scientific conference in Greece in 2021.

    PMJ reportedly paid £20,000 ($25,287.48) a month to FTI-Innovations, which is a life sciences consultancy run by a professor from Tokyo University. The payments were for tasks like promoting PMI’s science and products at academic events, which, according to an internal email, a PMJ employee claimed they had been told “to keep it a secret.”

    The paper, which was published in Nicotine & Tobacco Research, is based on 24 leaked company documents from between 2012 and 2020.

    “These activities resemble known strategies to influence the conduct, publication and reach of science and conceal scientific activities,” the researchers said.

    “The manipulation of science for profit harms us all, especially policymakers and consumers trying to make potentially life-changing decisions,” said Sophie Braznell, one of the paper’s authors. “It slows down and undermines public health policies while encouraging the widespread use of harmful products.”

    The leaked documents undermined PMI’s claims to conduct “transparent science,” according to Braznell, who called for reforms to funding and governance of tobacco research “to protect science from vested corporate interests.”

    In a different report from Stopping Tobacco Organizations and Products (STOP), also based on leaked documents, PMJ appeared to lobby for IQOS to be permitted in places where smoking was banned.

    Entities like medical and hospitality groups and Japan’s Fire and Disaster Management Agency were targeted for endorsements, “which, if secured, could give the appearance of organic, widespread acceptance of IQOS,” said STOP.

    Moreover, the report stated that aiming for a presence at the Tokyo Olympics “echoes a known industry tactic of advertising addictive, harmful tobacco products at sports events—associating these products with health, misleading consumers and reaching children and young people.”

    “PMI’s intentions with IQOS seem to extend far beyond what they’ve stated,” said Jorge Alday, director of STOP. “This revelation adds weight to the mounting evidence questioning the credibility of PMI’s claims about their intentions and their products.

    “Disturbingly, it hints at a broader pattern of deceptive tactics, potentially laying the groundwork for a new chapter in the tobacco epidemic,” he said.

    “This is yet another specious story from an organization more interested in criticizing our company than helping reduce the harm from cigarettes,” said a PMI spokesperson. “Like any highly regulated multinational company, PMI regularly seeks to share our positions on issues that affect our consumers, our company and our communities. Not only is this type of engagement entirely legal and appropriate, [but] it is essential to the type of inclusive policymaking that will lead to better outcomes for the people affected by those policies.”

  • Reynolds Launches Non-Nicotine Vape

    Reynolds Launches Non-Nicotine Vape

    Image: Wall Street Journal

    R.J. Reynolds Vapor Company (RJRVC), an operating company of Reynolds American Inc. (Reynolds American), BAT Group’s U.S. subsidiary, is expanding its innovative vapor portfolio with SENSA, a zero-nicotine vapor product.

    As the market leader in vapor with its Vuse products, RJRVC is joining the growing marketplace for zero-nicotine vapor products and aims to establish the highest standards in the industry, according to an emailed press release.

    SENSA products include a locking feature to prevent unintended usage, and adult consumers of the device will have access to Call2Recycle’s battery recycling program, which will facilitate the responsible disposal of SENSA batteries.

    “Adult tobacco and vapor consumers across the retail marketplace are looking for more options,” said Valerie Mras, senior vice president for RJRVC. “Adding a zero-nicotine product to our growing vapor portfolio is driven by deep adult vapor consumer insights and enables us to responsibly compete within a category that is already well established in many countries.”

    The SENSA portfolio of flavors is intended for adult tobacco and vapor consumers and does not include flavors intended to appeal to those who are underage. The product will be responsibly marketed to adult tobacco and vapor consumers consistent with the Reynolds American organization’s marketing practices for tobacco and nicotine products, according to the release. All web properties will be age-gated.

  • Celebrating Diversity

    Celebrating Diversity

    Diversity and equal opportunities are an integral part of JTI’s business success.

    By Stefanie Rossel

    According to studies, diversity in the workplace can contribute to smarter decision-making, greater productivity and reduced rates of employee turnover, along with improved corporate reputations. In recent years, companies around the world have increasingly implemented diversity, equity and inclusion (DEI) programs—a collection of practices and policies intended to support people from varying backgrounds and give them the resources they need to thrive in the workplace.

    More precisely, diversity is embracing the differences everyone brings to the table, whether it’s someone’s race, age, ethnicity, religion, gender, sexual orientation, physical ability or other aspects of social identity. With different backgrounds come different perspectives, which ultimately lead to better ideas and solutions and better outcomes—or products, for that matter.

    To ensure equal circumstances for all individuals across the organization, employers must recognize that not everyone is starting at the same level. Rather than giving everybody the same tools, companies that strive for equity provide employees with what they individually need to have an equal opportunity for success.

    Inclusion means that while the workplace requires professionalism and etiquette, employees should not be barred from being themselves; they should not worry about “code-switching” or shielding part of their identity when going to work. Inclusion is what maintains diversity.

    Research conducted by McKinsey shows that in 2020, companies worldwide spent an estimated $7.5 billion on DEI-related efforts, a number that was projected to double by 2026. According to a LinkedIn analysis, the number of chief diversity and inclusion officer positions grew by 168.9 percent in the U.S. between 2019 and 2022. However, DEI programs have been under siege from some quarters recently, with U.S. state lawmakers launching efforts to restrict DEI efforts in public schools and universities and companies rolling back their efforts. DEI initiatives, opponents argue, are an overly political, damaging waste of time or a distraction from organizations’ primary activities.

    In fact, there has been little scientific research to evaluate the effects of DEI, which emerged at the time of the U.S. Civil Rights Movement in the 1960s. A 2023 review by Boston University researchers found that successful programs were composed of trainings that were grounded in theory. Effective trainings were longitudinal instead of one-time and not only focused on defining concepts but also provided additional support, trainings and skills, such as how to navigate challenging conversations. In successful programs, DEI was not limited to diversity but also emphasized inclusion, meaning companies engaged individuals or groups who had been historically excluded from decision-making activities. This, in turn, drove equity.

    Culture of Inclusivity

    Fernando Bonaduce

    Geneva-headquartered Japan Tobacco International has had a comprehensive DEI program in place since 2018. “We foster an environment that embraces diversity, ensures equal opportunities and provides a safe space for everyone to contribute,” says Fernando Bonaduce, JTI’s DEI director. “This commitment is integral to our business success. I am proud that all JTI branches worldwide have adopted DEI principles. Our employees play a crucial role in this endeavor. Starting from the highest levels of the organization and extending through our global team, we are nurturing a culture of inclusivity. This gives everyone the freedom to choose, think, express themselves and be authentic.”

    In 2020, JTI launched its first employee resource group (ERG), PRIDE, for the LGBTIQ+ community. “Today, we have four ERGs with hundreds of change agents involved in key DEI areas such as gender equality, race and ethnic inclusion, gender identity and sexual orientations or diverse thinking,” says Bonaduce. Changes in corporate culture, he notes, require both time and effort and are “anything but an easy road.”

    In 2021, the company committed to increasing women in leadership roles to 30 percent by the end of 2023. “We achieved this ambition in August of that year, well ahead of schedule,” says Bonaduce. “Our commitment to gender equality reflects our efforts to foster a diverse, equitable and inclusive workplace, creating an environment where female colleagues are set up for success.”

    One year later, the company’s DEI division was merged with the human resources department, an initiative that has been guided by a DEI strategy focusing on four strategic pillars: strategic commitment, value diversity, building inclusion and nurturing employees’ well-being. “This strategic focus has influenced talent attraction, retention and promotion processes by ensuring all our decisions are geared toward bringing out the human best in our organization. For instance, embedding the DEI principles means that talent management needs to develop a diverse representation in leadership roles,” says Bonaduce.

    The company’s DEI-rooted approach, he says, implies that JTI constantly seeks to identify and remove barriers that prevent underrepresented groups from fully participating in the whole recruitment process. Initiatives to achieve this objective include encouraging and monitoring language to not exclude potential applicants based on their background and designing interviews and panels in a way to provide every candidate with the best chance for success. “This approach helps us remove biases from the selection process as best we can,” says Bonaduce.

    Work-Life Balance

    JTI uses channels and platforms that directly address underrepresented groups, like myGwork, to attract a more diverse applicant pool. The remarkable increase in the number of women in leadership roles, Bonaduce says, is a direct result of the company’s efforts, which aim to enhance the visibility of its top female talents and provide mentorship for them. “Every year, each member of JTI’s global executive committee, except for the CEO, sponsors a senior female talent from around the globe for a period of 12 months. This program aids our talented individuals in their career development, fostering an inclusive and diverse culture from the very top of our organization.”

    To help employees recognize and overcome unconscious biases and ensure managers become a catalyst for inclusion and nurture individuals as they are, the company offers various training programs.

    Mental health is also an important element in JTI’s DEI strategy. “Our employees dedicate a significant portion of their day to work-related activities,” says Bonaduce. “We know how important physical fitness is for our health and well-being. Unfortunately, people can still hesitate to openly seek psychological guidance or support with mental health due to uncertainty about others’ reactions or feelings of shame. At JTI, we are committed to helping people remove the stigma that still exists in some parts of society.”

    The company therefore offers its employees a mental fitness test so that they can check how balanced and healthy they are, live training sessions and a global employee assistance program that provides round-the-clock access to over 40,000 counselors, mental health trainers and specialists 365 days a year. “This service is free, confidential and professional, with assistance available in 200 different languages.” Additional mental health first-aid program modules promote peer-to-peer support on various mental health and personal well-being topics.

    Taking Pride in Being Different

    Rene Staebe

    PRIDE is a particular success story within the company’s DEI approach. “Having an LGBTIQ+ ERG like PRIDE at JTI is crucial for fostering an inclusive and supportive workplace,” says Rene Staebe, co-founder of PRIDE. “Such groups provide a safe space where individuals can express their true selves, share their experiences and find solidarity among peers. This sense of belonging not only boosts individual well-being and job satisfaction but also enhances overall company performance.” According to research, a third of LGBT+ people in the European Union hide their identity from co-workers, and even more have faced discrimination at work because of who they are.

    “Our initiatives focus on educating colleagues, promoting understanding and encouraging open dialogue,” says Staebe. He says he has witnessed remarkable and positive changes across the company since PRIDE’s creation, one of the most significant shifts being the noticeable increase in active allies. “Employees from all levels and departments have stepped up to show their support, especially at senior management level, who have been instrumental in setting a powerful example for others to follow whilst their endorsement has helped embed the values of PRIDE into the fabric of our corporate culture, making inclusivity a core component of our identity,” says Staebe. “We have seen a substantial increase in the number of internal webinars and educational sessions focused on LGBTIQ+ issues providing valuable platforms for sharing knowledge, raising awareness and fostering open dialogue. This has been aided by the implementation of more inclusive policies and practices to include more comprehensive nondiscrimination clauses and more inclusive healthcare and parental leave benefits.”

    Meanwhile, PRIDE has a global ERG footprint, with chapters in Canada, the U.S., Switzerland, the Philippines and 13 other countries. Staebe highlights that continuous support is being provided to employees in regions that are not friendly toward the queer community. PRIDE is exploring ways to empower local markets, such as the Middle East, by setting up resource groups while complying with local regulations.

     

    “We are always striving to create a confidential environment where LGBTIQ+ employees can feel safe and valued, which is why it’s so important to have a presence within countries where there are challenges for community members. For this to be possible, we are supported by JTI’s “embassy” model, which enables us to have a presence despite the challenges that people may face,” says Staebe.

    In 2023, the company was honored with the Swiss LGBT Label award for the second time. Its progress was also awarded with EY’s Global Equality Standard certification in 2021, in which JTI received several of the highest assessment scores for equal opportunities and equal pay in the workplace. The company has also been recognized as a Global Top Employer.

    For a DEI program to be successful, it is important to maintain constant dialogue with underrepresented groups, Bonaduce says. “Feedback from our employees confirms that management is becoming increasingly inclusive. Almost 90 percent of our global employees experience a full sense of belonging to the organization. We also observe our leadership bench becoming even more diverse, with talent from different genders and cultural backgrounds.”

  • Gaining Momentum

    Gaining Momentum

    Photos courtesy of Cavandish Llloyd

    Cavendish Lloyd is eager to expand shisha tobacco production in Zimbabwe and elsewhere.

    By George Gay

    When I corresponded in 2022 with the president of Cavendish Lloyd, Koen Monkau, he was bullish about the market for shisha-style, low-nicotine flue-cured tobacco (LNFCT), the production of which his company was trialing in Zimbabwe. And, earlier this year, he was still bullish. The major manufacturers of shisha might have experienced a drop in sales recently, mainly due to vaping, he said, but a lot of new players had entered the market in the past few years, and shisha consumption was still growing worldwide. Five years ago, for instance, there were no shisha bars in Harare, but now there are plenty of establishments that offer shisha. “This is a worldwide trend,” he added.

    While this sounds like good news for Cavendish Lloyd, it seems to also be good news for Zimbabwe. As part of an email exchange in May, Monkau told me it was important for Zimbabwe’s tobacco industry that it diversified the portfolio of tobacco it offered buyers and, ultimately, manufacturers. “An industry is not sustainable in the long run if half its crop is sold to one customer, as is the case now,” he said. “LNFCT—and also other tobacco varieties—can assist in diversifying the industry so that it is able to stand the test of time.”

    Although Cavendish Lloyd is the only company currently producing LNFCT in Zimbabwe, it is certainly the case that the country’s tobacco industry, at least in the guise of the Kutsaga Tobacco Research Board (TRB), seems aware of the desirability of diversification. Monkau said his company had enjoyed a good cooperative relationship with the TRB, which had this season, 2023–2024, grown 7 ha for it on a commercial basis. At the same time, the TRB was continuing to experiment with alternative growing methods and different shisha tobacco seeds.   

    This season, Cavendish Lloyd is hoping that its Zimbabwe crop will reach 600,000 kg, and Monkau is looking for investors to help him expand LNFCT production into other countries, including Malawi, South Africa, Tanzania and Zambia. His company, he said, was now looking to hold talks with the tobacco research institutes of these countries, following initial approaches that had been made by the chief executive officer of the TRB, Frank Magama. In fact, Tanzania had already expressed serious interest in growing this crop, and representatives of the country’s Tobacco Research Institute had attended this year’s sales, which were ongoing at the time this story was written.

    Many Zimbabwean farmers are growing it for the first time this season.

    Challenges

    It would be wrong, however, to give the impression that everything has been going without a hitch. Monkau readily admits that his company was hit by financial and other constraints during the 2022–2023 season and that its crop of 150,000 kg was well below what had been initially targeted. And while the 600,000 kg crop expected this season would represent a major increase, it would have been even bigger, perhaps 1 million kg, but for the El Nino weather effect.

    But then El Nino affected all tobacco (and other) crops in Zimbabwe (and elsewhere, and the resulting drought was eventually declared a national disaster. The unhelpful weather conditions did not come out of the blue, however, and, in mitigation, Cavendish Lloyd was able to focus on growing an irrigated crop from the start. At the same time, Monkau said, the dryland crop had had to be scaled back to ensure that growers did not plant crops that they would not have been able to sell.

    Unfortunately, the current situation implies that things could reverse next season and create problems for those who use irrigation for growing tobacco because there has not been enough rain to fill dams and reservoirs.

    Despite these setbacks, it is not proving difficult to attract farmers to LNFCT. Cavendish Lloyd started out on this project three seasons ago with just one grower, who is still on board, but he has been joined by about 40 others, ranging from commercial to small-scale farmers. Monkau said that LNFCT was relatively easy to grow and provided good returns when cultivated well, so farmers had been lining up to produce this variety.

    LNFCT is closer grown than standard flue-cured tobacco; it requires the application of less fertilizer; it is not topped; it provides for faster harvesting because more leaves are reaped with each pass; and it requires less energy during curing. All this adds up to efficiency savings and better returns, not to mention environmental gains.

    Nevertheless, the switch from growing a regular flue-cured crop to LNFCT requires some adjustments on the part of the grower, who is presented with logistical challenges if he grows LNFCT alongside regular flue-cured. For instance, because LNFCT cures faster than regular flue-cured, growers need good barn management skills when scheduling curing. In fact, Monkau believes it is preferable for growers to concentrate on either LNFCT or regular flue-cured.

    To help growers further, Cavendish Lloyd is currently looking at employing more sophisticated ways of crop management than are now used. “By using satellite imaging to monitor crops, we can deploy our agronomy team more efficiently to areas that need immediate and special attention rather than have them do their weekly rounds of farmers,” he said. “It is a relatively cheap way of potentially increasing crop yields dramatically, and it is quite amazing what kind of information can be gathered on a day-to-day basis.”

    Looking to the future, I asked if African-grown LNFCT might be used for purposes beyond shisha manufacture, to which Monkau replied that his company had already had inquiries from companies operating in the cigarette and RYO markets that were interested in obtaining a bright, low-nicotine-style tobacco that fitted their established blends. In addition, a recent sale of 10,000 kg of LNFCT to a flavor extraction plant in Zimbabwe had shown that there were other outlets for this type as well.

    In finding and establishing these other outlets, it probably helps that as well as being involved in LNFCT production, Cavendish Lloyd has contacts made through some of its other operations, which include the marketing and distribution of cigarettes, and the trade in tobacco, cut rag and tobacco production materials, such as packaging. And since 2023, cigarette manufacturing can be added to that list since the company last year established a manufacturing plant in Lusaka, Zambia.

    This season, Cavendish Lloyd is hoping that its Zimbabwe shisha tobacco crop will reach 600,000 kg.

    Limits to Production

    Looking away from the demand side and toward the supply side of the LNFCT business, I also asked what limited the amount of this type that could be grown. “Limits are mainly defined by how much capital we can raise to fund the growers,” Monkau said. “I believe there is room to expand production to 5 million kg in Africa on a sustainable basis,” he added before providing an interesting comparison, “which would be comparable with the crop size of Germany.”

    This comparison chimes with a point Monkau had made to me in response to an earlier question about whether LNFCT could now be seen as an established commercial crop in Zimbabwe. No, it was not, he replied. Many farmers this season were growing it for the first time, so it would be an experiment to see if it worked for them. Only one farmer was growing it for the third time, and for several, it was their second season. Even with the volume of all Zimbabwe’s flue-cured crops expected to total less than 250 million kg this year because of El Nino, LNFCT would account for only 0.2 percent of the total.

    That, for sure, seems to be only a modest amount of LNFCT, but I was interested to know if it had been a smooth ride getting to that point. There was no such thing as a smooth ride in Zimbabwe, Monkau told me. The financial/economic situation in the country always kept you on your toes. For instance, on Cavendish Lloyd’s first sales day of 2024, April 5, the government had abolished the Zimbabwe dollar and introduced a new currency, the ZiG, which put the whole financial system on hold for a few days, and the company was still dealing with the fallout from that. Such changes did not make doing business easier, but, apart from that, things had gone quite well. There was a lot of interest and support from the government to make the LNFCT business successful, and the company’s efforts were the subject of regular local press reports.

    Of course, the real test of how things are going and will go in the future concerns whether growers are content with the prices they are receiving, and, in the short term, the answer is probably that they are. Nevertheless, Monkau made the point that pricing was something of a thorny issue in respect of LNFCT. His company was required to follow the pricing arrangements specified by the Tobacco Industry and Marketing Board (TIMB), arrangements that could lead to anomalies since LNFCT fell outside the regular classifications of the TIMB. It wasn’t too much of an issue for the tobacco that met shisha standards, but, in the case of lower grades that were unsuitable for shisha, the company was obliged to pay regular market prices for tobacco of substandard quality.

    But at least the next season, 2024–2025, should see farmers keen to grow LNFCT—in fact, any tobacco type or variety. “Overall, prices for all tobacco have been good this year, so I don’t see many farmers complaining,” said Monkau. “I expect current prices will push more farmers back into tobacco growing until we see more balance between supply and demand.”

  • Puffs with Papers

    Puffs with Papers

    Under the cumbersome U.S. product authorization system, it’s easier to bring new cigarettes to the market than to gain approval for lower risk products such as vapes. | Photo: Jet City Images

    U.S. states are passing vape product registry bills to compensate for meek federal enforcement.

    By Timothy S. Donahue

    Vaping product registry bills are gaining momentum in the U.S. This surge is a direct response to the perceived lack of action from the Food and Drug Administration in curbing the influx of illegal disposable vaping products. Currently, three states have implemented registry rules, with four more set to follow suit in 2025. Several other states are drafting similar bills.

    Critics claim that registry bills favor big tobacco companies over independent vape manufacturers, and many continue to condemn the premarket tobacco product application (PMTA) process as excessively onerous. They point out that it’s easier to bring new cigarettes to the market than it is to gain authorization for lower risk products such as vapes.

    “The FDA’s Center for Tobacco Products [CTP] is supposed to comply with a statutory, 180-day deadline to review new tobacco product applications, many of which are potentially less harmful than combustible cigarettes,” says Nick Orlando, president of the Florida Smoke-Free Association. “However, as Florida’s vape manufacturers have experienced, working through this process is often a painstaking, costly and onerous ordeal that has resulted in a backlog of thousands of applications that have sat with the CTP for years.”

    There are currently 13 million vapers across the U.S., according to Tony Abboud, executive director of the Vapor Technology Association. Out of millions of applications, the FDA has authorized only six different types of e-cigarettes—all made by large cigarette manufacturers, which have the resources to meet the onerous PMTA standards. To date, the FDA has not authorized any nontobacco-flavored vaping products.

    Abboud compares the impact of the registry bills to a scenario in which all beer except for Bud Light and Miller Lite are removed from stores. “Bud and Miller would love it, right, because they are definitely going to pick up some more customers,” he says.

    Gregory Conley, director of legislative and external affairs at the American Vapor Manufacturers Association, says there is no need to guess why companies like Altria have dedicated massive resources to support the passage of PMTA registries. In its investor reports, Altria has acknowledged that disposable vapes have been hurting the company’s cigarette sales.

    “This is not about giving a competitive advantage to [Altria subsidiary] Njoy products; it’s about selling more combustible cigarettes, which kill over 400,000 people each year,” says Conley. “Fortunately, the more politicians learn about these bills, the less they like them, which is why most states that considered these bills in 2023 and 2024 have rejected them.”

    Yet plenty of states are pushing ahead. Alabama, Louisiana and Oklahoma already have PMTA registry bills in effect while laws in Kentucky, Utah, Virginia and Wisconsin are set to take effect in 2025. Many vape directories are similar. Louisiana and Oklahoma, for example, nearly mimicked Alabama’s vaping registry rules. It should be noted that both the Alabama and Oklahoma registry rules, while technically in effect, are not currently being enforced. Bills to fund the enforcement of regulations in both states have been defeated by vaping industry advocates.

    “This is not about giving a competitive advantage to [Altria subsidiary] Njoy products; it’s about selling more combustible cigarettes, which kill over 400,000 people each year.”

    Florida’s Fortune

    Florida has a reputation of doing things differently. According to Orlando, Florida’s House Bill 1007 addresses the state attorney general’s concerns without forcing retailers out of business.

    Unlike other state registries, Florida’s system will not create a list of FDA products that have marketing authorization or are currently under PMTA review. Instead, Florida Attorney General Ashley Moody will compile a registry of products deemed illegal only after an administrative review process and a public comment period. The law focuses on disposable products and allows for the sale of most open system and pod system products.

    “The list does not currently have any products on it. The state must create a list, SKU by SKU, meeting specific criteria,” explains Orlando. “The list and the products listed are then placed on a referral to a rules committee, which would then open up for public comment any items that made the ‘unauthorized’ list. There would also be mediation with the product owner. The real benefit is that this process is very long, and it only deals with single-use products. You can keep a product on your store shelves until the entire process is completed.”

    Orlando says several state vapor industry associations are trying to figure out ways to tailor the Florida bill to their respective states.

    Not everyone is excited about Florida’s approach, however. “While undoubtedly better than a full-blown ban on 98 percent-plus of the current vaping market, Florida’s bill should not be a model for other states,” says Conley. “Politicizing vaping by putting unilateral control into the hands of attorneys general does not make sense, particularly in light of the decline in youth usage we have seen since 2019 …. Adult use of vaping products has grown significantly since 2020 all while youth vaping has continued to fall. In any other reality, this would be celebrated as a significant public health victory. On the plus side, Florida does have strong due process rights built into its administrative law statutes, so Florida businesses and consumers will have the opportunity to weigh in on future bans and potentially bring litigation.”

    Other manufacturers praise the Florida rules. “Properly constructed and effectively enforced product directory laws can be an important supplement to federal enforcement against illegal vapor products,” Juul Labs wrote in a statement.

    “Properly constructed and effectively enforced product directory laws can be an important supplement to federal enforcement against illegal vapor products.”

    Disciplinary Reaction

    Another difference in Florida’s vaping rules is that the regulations have teeth to combat underage retail sales. Any person who sells a nicotine product, including vapes, to someone under 21 for a third or subsequent time will face a third-degree felony charge, punishable by up to $5,000 in fines and five years in prison.

    Beginning March 1, 2025, manufacturers that sell prohibited products in the state will face a $1,000 daily fine for each such product until it’s removed from the market. This stricture will also apply to retailers, wholesalers and distributors who ship products into Florida.

    Orlando says retailers have embraced Florida’s new rules. The options were either an outright ban on all flavored vaping products or HB 2007, which allowed for adult vapers to have access to a variety of flavors and hardware options to help a broader swath of combustible smokers make the switch to vaping. “Once I explain to them what really happened and they understand the dynamics of it and what it takes, actually, to get something on the list and that open systems are totally excluded, they’re happy with it,” he says.

    Orlando says that, at the end of the day, the vaping business needs reasonable regulations and industry players need to be responsible. He believes the Florida regulations are a step in the right direction for tobacco harm reduction. “Let’s get real. Let’s get accountable and start doing business like we should,” he says.

    Generational Bans Growing

    The idea of banning access to legal nicotine products, even for those born after January 2007, originated in New Zealand. The proposal then spread to other countries, including the United Kingdom and the United States. In the U.S., states such as California, Tennessee and Massachusetts are all pushing for generational smoking bans under the guise of protecting youth and promoting social well-being.

    New Zealand ditched its plans after a new government was elected earlier this year. Then, a month later, the U.K. government announced its intention to introduce a bill in Parliament prohibiting nicotine sales for future generations, aiming to phase out smoking among young people.

    The U.K.’s Tobacco and Vapes Bill, if passed unamended, will be one of the world’s most rigid anti-tobacco laws and prevent children turning 15 this year or younger from ever being able to be legally sold nicotine products. Under the new law, each year, the legal age for cigarette sales—currently 18—will increase by one year. It means that people born in or after 2009 will never be able to buy cigarettes legally. The law will not affect those who are already allowed to buy cigarettes.

    Critics say the Conservative Party’s proposal is “unconservative,” and some have derided it as a desperate attempt by Prime Minister Rishi Sunak to leave a legacy amid an otherwise ineffective tenure. Former Prime Minister Liz Truss is one of several members of the governing party who have said they will vote against the legislation. However, the U.K. bill was put on hold after Sunak called a general election for July. The House of Commons unveiled a list of bills it would take up before the U.K.’s Parliament dissolves ahead of this summer’s elections; the generational tobacco ban was not included. The postponement will not necessarily mean the U.K. will follow New Zealand’s example, however, as Britain’s Labour Party, which is expected to win the elections, has appeared committed to the ban.

    In the U.S., generational bans recently gained some legal support after the Massachusetts Supreme Judicial Court upheld a generational tobacco ban instituted by the town of Brookline in 2020. Since the ruling, several other localities in the Greater Boston area have quickly followed suit.

    The Boston suburb of Brookline law makes it illegal for anyone born after Jan. 1, 2000, to purchase tobacco products—including cigarettes, cigars and vaping products—for their entire life. The law went into effect in 2021, and despite legal challenges that pushed the ruling all the way up to the Massachusetts Supreme Judicial Court, the law has remained intact.

    It was the first time legislation of this kind had become law in the United States. Just three weeks after the court decision, Stoneham, Massachusetts, became the first town to follow Brookline, approving a generational tobacco ban for anyone born after Jan. 1, 2004. Now, several other communities in Massachusetts are also considering generational bans.

    Detractors claim generational bans infringe upon civil liberties and could have negative economic consequences, including boosting the black market and causing job losses. These bans also raise concerns about enforcing age restrictions and protecting the rights of adults to make their own choices.

    “The tobacco industry and their clients are resurrecting all the old arguments that we have come to expect in their efforts to delay and divert this important legislation,” Martin McKee, professor of European Public Health at the London School of Hygiene and Tropical Medicine, says. “Once again, we see loaded polling questions and discredited claims about increasing illegal sales. Inevitably, these ludicrous arguments will have some traction among MPs [Members of Parliament] that reject any public health measure or have accepted the industry’s hospitality, but most will, rightly, not give them the time of day.”

    In Australia, where a ban on disposable vaping products has caused a violent war between motorcycle gangs and other crime syndicates over the illegal trade of black market vapes, dozens of vape and tobacco shops have gone up in flames. According to media reports, police in Victoria were forced to investigate 27 fires linked to the illegal tobacco trade over a seven-month period. 

    Experts believe a convenience store crime wave could reach Britain, and the black market could explode if the U.K.’s generational ban comes into effect. “These crime groups are in the midst of a dangerous turf war as they try to gain ultimate control over the vape and illicit tobacco black market,” Theo Foukkare, CEO of the Australian Association of Convenience Stores, says. “Tobacconists are being firebombed on a weekly basis. In Victoria alone, there have now been more than 50 firebombings of retail stores in the last 12 months. They target any store that will not sell their black market product.”

    The anti-nicotine agenda behind many of the government and public health groups that support generational nicotine bans is relentless and could eventually target other consumer goods, according to experts, who add that the bans are not just about nicotine but about individual freedoms and democracy.

    THR advocates say that generational bans are simply another form of prohibition with dangerous consequences.