Author: Staff Writer

Covid Border Closures Yield Tax Windfall

Photo: marcyano79
The U.K. treasury received a £1.35 billion ($1.88 billion) windfall last year as Covid-related border closures made cigarette smuggling nearly impossible, reports The Express.
The huge rise in duty has prompted tobacco manufacturers to push for tougher sanctions on those involved in the smuggling, production and distribution of illegal cigarettes.
“Covid stripped some illegal volumes into the market, and there was a revenue bounce for the Treasury as a result,” said Ian Howell, fiscal and regulatory affairs manager for Japan Tobacco International.
“It shows how we need to tackle illicit tobacco as every illegal product that is sold takes money away from the government and the increased revenue during lockdown shows the scale of it.”
HM Revenue and Customs estimates that the sale of illegal tobacco products has resulted in a tax revenue loss of more than £47 billion since 2000.
An HMRC spokesman said the agency would continue to work with authorities to tackle the illicit tobacco trade problem.
August 3, 2021
Zimbabwe: Farmers Start Registering for Next Season

Photo: Taco Tuinstra
More than 14,000 farmers have already registered to grow tobacco in Zimbabwe next year, reports The Herald, citing statistics from the Tobacco Industry and Marketing Board.
Of these, 7,537 are communal farmers, 4,871 A1 farmers, 817 small-scale farmers and 880 A2 farmers.
Mashonaland Central has the highest number with 5,744 registered farmers, followed by Mashonaland West with 5,307, Mashonaland East with 1,707, Manicaland with 1,303, Midlands with 31, and Masvingo with 13.
The sector is expecting the volumes to surpass the 200 million kg target in the next tobacco marketing season.
Zimbabwe sold 186.6 million kg of leaf tobacco valued at $515.9 million during the 2021 marketing season. The figures are up 16.8 percent in volume and 31 percent in value over the 2020 sales.
August 3, 2021
SRNT Urged to Undo Industry Exclusion

David O’Reilly (Photo: BAT)
BAT has asked the board of directors of the Society for Research on Nicotine and Tobacco (SRNT) to reverse its decision to ban employees of the tobacco industry from attending the society’s annual conference in 2022.
“We share in SRNT’s stated commitments to the open dissemination of rigorous, peer-reviewed nicotine and tobacco science, with the ultimate goal of reducing public health impact of tobacco use,” wrote BAT Director of Scientific Research David O’Reilly in a letter to the SRNT.
“However, your recent exclusion of employees of the tobacco industry and the contributions of tobacco industry scientists to dialogue at the annual meeting is contrary to your code of conduct and guiding principles.”
Exclusion, O’Reilly noted, impedes “the generation and dissemination of new knowledge concerning nicotine and tobacco.” “In an FDA-regulated market, the industry must routinely provide FDA regulators with scientific evidence about its products. As a result, some of the best science in the tobacco and nicotine space is being generated from tobacco companies,” he wrote.
Exclusion also undercuts the SRNT’s commitment to “open science without bias,” “promoting scientific dialogue” and “empowering members to make their own informed decisions,” according to O’Reilly. “The board’s decision contradicts the evidence-based principles that underpin the U.S. policy approach, which prioritizes science, irrespective of the source,” O’Reilly wrote.
“In light of our concerns, we respectfully request that the SRNT board reconsider its decision and reaffirm that ‘SRNT is committed to nicotine and tobacco researchers around the world.’”
August 2, 2021
Ukrainian Lawmakers Crack Down on Vaping

Photo: slava2271
Lawmakers in Ukraine passed a law on July 31 prohibiting the use of electronic nicotine-delivery systems (ENDS) in public places as well as advertising, sponsorship and promotion of e-cigarettes. The law also bans the sale of flavored e-liquids other than tobacco flavors.
Justifying their action, the parliamentarians referred to a recent World Health Organization report, which suggests that e-cigarettes are a gateway to smoking and that they are as harmful as conventional cigarettes, according to the Independent Women’s Forum. Lawmakers also claimed the flavor ban would reduce underage vaping in Ukraine.
In its July 27 report, the WHO lauds countries that have banned the sale and use of vaping devices.
Tobacco harm reduction advocates and vaping industry representatives denounced the WHO report as “nonsensical and dangerous.”
“The WHO has a long-standing anti-vaping stance and this latest attack on a sector that is literally saving millions of lives worldwide flies in the face of scientific evidence, common sense and harm reduction,” said John Dunne, director general of the U.K. Vaping Industry Association (UKVIA).
“This report demonstrates that, sadly, the WHO still doesn’t understand the fundamental difference between addiction to tobacco smoking, which kills millions of people every year, and addiction to nicotine, which doesn’t,” said John Britton, professor of epidemiology at the University of Nottingham.
August 2, 2021
That Fleeting Scent

Photo: kasetch
The FDA’s proposed ban on menthol cigarettes and cigars remains highly controversial.
By Stefanie Rossel
Almost exactly a year after the European Union imposed a ban on the manufacture and sale of menthol cigarettes, the U.S. Food and Drug Administration said it would ban menthol as a characterizing flavor in cigarettes and cigars at the federal level. With the move, the agency hopes to significantly reduce youth initiation to smoking, increase the chances of smoking cessation among current smokers and address health disparities experienced by communities of color, low-income populations and LGBTQ+ individuals, all of whom are more likely to use these tobacco products, according to acting FDA Commissioner Janet Woodcock.
The proposed ban, announced on April 29, has been under discussion for more than a decade. While the 2009 Family Smoking Prevention and Tobacco Control Act (TCA), which gave the FDA regulatory authority over tobacco products, banned all characterizing flavors in cigarettes, it allowed the continued use of menthol cigarettes but instructed the agency to consider what to do about the additive. The FDA’s recent decision was forced by a federal lawsuit brought by public health groups in 2020 after the agency failed to respond to their 2013 petition, which called on the FDA to ban menthol products.
Menthol can be extracted from mint plants or made synthetically. In tobacco, it is used to mask the harshness and irritation caused by cigarette smoke. The minty flavor creates a cooling, slightly anesthetic sensation, which, according to a 2013 FDA report, makes cigarettes more appealing to new smokers, thus getting them more easily addicted. The substance is also believed to increase the degree of addiction; menthol smokers are reportedly less likely than nonmenthol smokers to successfully quit smoking despite having a higher urge to end their tobacco dependence. Around the globe, mentholated smokes account for about 10 percent of cigarette consumption, according to the World Health Organization.
In the U.S., menthol cigarettes represented 36 percent of all cigarette sales in 2018, according to the Centers for Disease Control and Prevention. Although U.S. smoking prevalence has dropped below 40 million, the share of mentholated cigarettes has risen significantly after the TCA prohibited all other characterizing flavors.
What makes the FDA’s proposed ban controversial is the fact that menthol cigarettes are also considered a racial justice issue in the U.S. According to the 2019 National Survey on Drug Use and Health, 85 percent of African American smokers smoke menthol cigarettes compared to 30 percent of white smokers and compared to less than 10 percent of African American smokers in the 1950s—a situation that critics attribute to racially targeted marketing strategies by the tobacco industry. African Americans typically smoke fewer cigarettes and start smoking at an older age than white smokers, but they die from tobacco-related illnesses at much higher rates, CDC data indicates.
Menthol cigarettes also appeal to Hispanic (48 percent) and Asian (41 percent) smokers, according to the survey, whereas about half of smokers aged 12–17 smoke menthols compared with about 40 percent for smokers aged 18 and older. With a market share of 49 percent, menthol cigarettes also featured prominently in in the LGBTQ+ community.

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Great Expectations
The FDA expects its proposed ban to have a significant impact. A Canadian study quoted by the agency suggests that the measure would prompt an additional 923,000 U.S. smokers to quit, including 230,000 African Americans, in the first 13 months to 17 months after taking effect. According to an earlier study, such a measure would avert 633,000 premature deaths, including 237,000 African American deaths.
While many public health and civil rights groups welcomed the FDA’s decision, lauding it as a win for both public health and racial justice, critics cast doubt on the health effects and warned that it could create more problems for minorities.
“In this country, we have found out that prohibition doesn’t work,” says Jeff Stier, senior fellow at Taxpayers Protection Alliance. “The ban is supposed to protect African American smokers, but they are likely to switch to a different, nonmenthol combustible cigarette brand or buy their mentholated cigarettes on the black market. We already have a pretty active illicit market; a ban would make it even worse.”
In the view of some civil rights organizations, a ban on menthol would create new, unwelcome opportunities for negative interactions between law enforcement and Black Americans.
The FDA plans to implement its ban by 2022, but experts expect a flood of lawsuits from the tobacco industry. Apart from a long fight regulators may face in court, along with resistance in Congress, most notably from tobacco-state lawmakers, the process of shaping respective legislation is likely to take time as it will comprise two detailed proposals that are open to public comments and will then be reviewed by the White House. When the FDA last proposed to ban menthol cigarettes in 2013, it received 174,000 public comments. The agency is obliged by law to read every single one and consider them carefully.
Questionable Effect
While several countries, including Brazil and Turkey, have banned menthol cigarettes over the past decade, data on the impact of the measure remains scarce. Studies from Canada show that smokers of menthol cigarettes were considerably more likely to quit their habit altogether after that country banned menthol cigarettes nationwide in 2017. A more recent study by the National Bureau of Economic Research in Cambridge, Massachusetts, USA, however, concludes that there was “almost no direct evidence on [the] effects” of a menthol cigarette ban “using real-world policy variation.” The study also found that many youths switched to nonmenthol cigarettes and that many adults started buying their menthol cigarettes from Native Canadian reserves, which are exempted from the ban. With a pre-ban market share of 5 percent, the Canadian menthol cigarette market is also more like that of the EU, where menthol cigarettes account for 7 percent of all cigarette sales, than that of the U.S.
The EU prohibited the manufacture and sale of menthol cigarettes in May 2020. The ban extends to the sale of rolling tobacco with mentholated filters or papers. Exempted from the ban are menthol-flavored e-liquids for vape products, separately available mentholated smoking accessories, menthol-flavored oral nicotine pouches and cigarillos. Outside of Germany, mentholated consumables for heated-tobacco products (HTPs) also remain legal.
Cigarette manufacturers responded with innovative solutions to the ban. Apart from broadening their portfolios of menthol-flavored and mint-flavored reduced-risk products (RRPs), they introduced mentholated flavor cards, which smokers could buy separately to mentholate conventional cigarettes. Tobacco companies also started offering cigarillos with mentholated filter capsules. Cigarillos are exempt from the EU ban as they are wrapped in tobacco leaf.

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Choosing Alternatives
To determine whether the EU ban met its objective of discouraging people from smoking or encouraging them to quit, Euromonitor International, on behalf of the Foundation for a Smoke-Free World, surveyed more than 6,000 adult menthol cigarette smokers in eight EU countries before and after the menthol cigarette ban. While the pre-ban surveys queried awareness and intention to quit or switch, the post-ban surveys queried behavior.
Main takeaways of the surveys included a lower rate of quitting smoking completely (8 percent) than indicated in the pre-ban survey (12 percent) and higher use of products that allow consumers to manually add a flavor to regular tobacco products. Thirteen percent of respondents said they had started buying products such as menthol flavor cards or menthol filter tips after the ban as opposed to 8 percent who had the pre-ban intention to do so.
Thirty percent of respondents said they had reduced consumption of menthol cigarettes after the ban. Twenty-eight percent indicated they had stopped smoking menthol cigarettes but continued to consume regular cigarettes (pre-ban intention: 35 percent). Twelve percent said they had stopped consuming menthol cigarettes after the ban but increased their consumption of nonmenthol cigarettes (pre-ban intention: 13 percent). Eighteen percent stated post-ban they had switched to other menthol products not affected by the ban, such as menthol cigars, cigarillos, e-cigarettes and HTPs (pre-ban intention: 19 percent).
Thirteen percent had started buying menthol cigarettes from other sources (pre-ban intention: 12 percent), more precisely from friends or family who had travelled to countries where menthol cigarettes were still legal or from online retailers shipping from other countries.
Interestingly, when unprompted, only 43 percent of respondents considered menthol cigarettes to be illegal in the post-ban surveys. While 10 percent were unsure of the legal status of menthol products, 27 percent still believed them to be legal or to be banned in the future (20 percent).
Harm Reduction Instead of Prohibition
Interestingly, the EU menthol ban appears to have nudged smokers a bit toward less hazardous forms of nicotine consumption. Of the 18 percent of respondents who said they had switched to other menthol products not affected by the ban, the majority chose RRPs. On average, 57 percent of respondents said they had switched to e-cigarettes, with the highest percentages being observed in Poland (67 percent) and the U.K. (57 percent), two markets with high vaping prevalence. Overall, 12 percent of switchers indicated they had switched to nicotine-replacement therapy products.
It’s a development Stier would like to see in the United States, which has yet to fully embrace the concept of tobacco harm reduction by promoting products such as e-cigarettes and snus as safer alternatives to combustible cigarettes. “Instead of going back to prohibition that will bring about unintended consequences, we should encourage smokers, as they do in the U.K., to quit smoking and switch to lower risk vape products. The FDA is sitting on applications to authorize these e-cigarettes now. Instead of banning products the African American community smokes, it should undo the misperceptions surrounding RRPs, offer better alternatives and be truthful about the risks,” he says.

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August 1, 2021
Scientific Partnerships for Sustainable Change

Photo: BAT
Options for the tobacco industry to demonstrate its responsible approach
By Stephane Colard
The objective to limit or even to ban tobacco is on the health and regulatory agenda. The so-called endgame strategy is an official goal in countries such as New Zealand¹ and Ireland.² More globally, the World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) was adopted by the World Health Assembly in 2003 and has been ratified by more than 180 countries to date. This convention is composed of a set of articles to reduce tobacco demand and supply and is seen as an accelerator for sustainable development.³
Even if a total ban seems unrealistic at the moment because politicians know that prohibition leads to criminality, tobacco product manufacturers cannot ignore this objective and its possible consequences on the performance of their tobacco business, which is legal. It appears clearly that such a regulatory agenda will have massive impacts along the whole value chain from the production of the raw material up to sale, and sustainable value creation may well require serious business transformations in the near future.
Article 5.3⁴ of the FCTC recommends to “denormalize and, to the extent possible, regulate activities described as ‘socially responsible’ by the tobacco industry, including but not limited to activities described as ‘corporate social responsibility.’” These elements tend to show that corporate and social responsibility (CSR) initiatives having the sole objective of improving the image of tobacco companies will be combatted and will fail and that the needed tobacco business transformation for ensuring sustainable value creation will not be an easy journey; it will succeed only if CSR initiatives support a genuine ambition and if corresponding impacts are assessed with internationally acknowledged methods.
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There are several options for the tobacco industry to demonstrate its responsible approach: compliance with regulations (mandatory); ISO certification or other acknowledged standard(s) (voluntary); disclosure of relevant information to the public and/or the authorities (mandatory or voluntary); and scientific research and publication in peer-reviewed journals (voluntary). The possibility to link company strategies with the United Nations’ Sustainable Development Goals⁵ is also an opportunity to consider.
The U.N. recognizes that a successful sustainable development agenda requires partnerships between governments, the private sector and civil society. The players of the tobacco and alternative product sectors fully understand that no goal can be achieved alone and that partnerships with multiple stakeholders are necessary to meet sustainable development ambitions. For example, some manufacturers prepare their program for child labor prevention in collaboration with the Eliminating Child Labor in Tobacco-growing Foundation (ECLT) and the International Labor Organization (ILO), and others contribute to WASH⁶ programs led by UNICEF.
Dialogue and co-development of solutions to the issues faced by business partners, such as suppliers and retailers, are also collaborative approaches for building a sustainable future together. The misinterpretation of article 5.3⁷ of the FCTC tends to forbid any contact with the tobacco industry, and the strategy of denormalization and isolation aims to prohibit partnerships. However, how could one improve the population health without encouraging or collaborating with the industry to develop and sell reduced-risk alternative products? How could one help millions of tobacco farmers worldwide to combat poverty and hunger without working with them on diversification? How could one combat criminal organizations making profits by the illicit trade of tobacco products without collaborating with the legal businesses? More pragmatically, how could one align government and industry testing laboratories without collaborative studies?
Science should step away from politics, and there is no good reason for justifying absence of partnerships or reluctance to build them in total transparency. This would simply delay the implementation of positive changes. The U.N. underlines that partnerships shall be built upon principles and values, and this is why it is crucial for the tobacco industry to make the meaning of the word “sustainability” very clear in the context of partnership.
It does not mean building partnerships for a sustainable development of tobacco businesses; it means building long-term partnerships to support transformation enabling the creation of sustainable shared value. It is essential to make a distinction between partnership types, as there are at least four different levels of engagement and shared responsibility: a partnership to elaborate a program that the manufacturers will own and manage autonomously and independently; a partnership to prepare a consensual program that the partners will own and manage together; a partnership to prepare a consensual program that a third party will manage; and a full delegation to a partner for elaborating and managing a program.
There is always a reason to choose one type of partnership rather than another, depending on the level of interaction, shared responsibility or independence expected. Each type of partnership can be justified and understood for some given situations, but the reporting of partnerships in a public integrated report should be associated with a transparent communication of the governance rules. The analysis of the degree of interaction and interdependence between stakeholders and the related risks is an essential step because a key stakeholder involuntarily ignored and isolated (for example, the community) could impair the success of the joint project; ISO Standards 26000 and 44001⁸ provide useful guidance in this area.
Transparency is a way to avoid misinterpretations or even the worst suspicions that can totally undermine the good intentions of the partners. Governance is a way to avoid unintended consequences of partnerships, for example, a conflict of interest. The need for science-based methods for assessing impacts of actions for transformation should open a field for transparent and productive scientific partnerships, contributing to accelerate the U.N. agenda and to achieve a shared vision of a better world. There are principles and values in science that are universal (common to public and private sectors), such as transparency on assumptions and results, honesty and clarity in interpretations or capacity to replicate experiments.
The process of peer-reviewed publication is also a good protection against junk science; the fact remains that several journals have decided not to publish any work from scientists working for, or from independent scientists working with, the tobacco industry⁹, peer-reviewed or not. However, it is unfortunate to observe that too many battles of numbers still highlight a lack of consensual methods among specialists, which extends the time spent on discussions and finally postpones the implementation of actions. An example illustrates this point: In 2018, the WHO published a global environmental footprint¹⁰ relative to cigarette smoking. The document reported a 2.6-ton carbon dioxide equivalent per million cigarette sticks while British American Tobacco and Philip Morris International reported 0.79 ton and 0.6 ton carbon dioxide equivalent per million sticks, respectively. The WHO was unable to understand why the figures were different but assumed a difference in scope and varying assessment methodologies. This point highlights a need for more transparency in scope and consensus in methodologies even if general publicly available protocols already exist.¹¹
An association like Coresta,¹² promoting cooperation, can be the platform that the stakeholders need. It is in a privileged position to initiate new scientific and transparent partnerships and forge a consensus on methodologies for measuring the transformations of tobacco companies, far from political positioning, strategic fragmentation and the isolation of legitimate players.
References:
¹ www.health.govt.nz/our-work/preventative-health-wellness/tobacco-control/smokefreeaotearoa- 2025
² https://health.gov.ie/wp-content/uploads/2014/03/TobaccoFreeIreland.pdf
³ www.who.int/fctc/implementation/publications/who-fctc-undp-wntd-2017.pdf?ua=1
⁴ www.who.int/fctc/guidelines/article_5_3.pdf
⁵ www.un.org/sustainabledevelopment/sustainable-development-goals
⁶ Water, Sanitation and Hygiene
⁷www.who.int/fctc/guidelines/article_5_3.pdf
⁸ ISO 44001 Collaborative business relationship management systems—Requirements and framework
⁹ See www.tobaccoreporter.com/2016/06/bat-criticizes-science-censorship
¹⁰ www.who.int/fctc/publications/WHO-FCTC-Enviroment-Cigarette-smoking.pdf
¹¹ See, for example, the Carbon Disclosure Project www.cdp.net/en and the GHG protocol https://ghgprotocol.org
¹² www.coresta.org
Stephane Colard is secretary general of Coresta.

August 1, 2021
Messy Market

Photo: Taco Tuinstra
Ukraine’s anti-monopoly committee tries to break up a cartel it helped create.
By Stefanie Rossel
June 1, 2021, marked another step toward the end of a multimillion-dollar anti-competition lawsuit brought against four tobacco manufacturers and a distributor in Ukraine. On that day, the country’s Supreme Court ruled that a UAH460 million ($16.87 million) fine imposed by the Antimonopoly Committee of Ukraine (AMCU) against Imperial Tobacco Ukraine (ITU) and Imperial Tobacco Productions Ukraine for alleged violation of antitrust legislation was groundless.
The Supreme Court found that Imperial’s Ukrainian subsidiaries had not been involved in the events that had unlawfully left the country with only one cigarette distributor. In a press release, Imperial Tobacco Ukraine’s CEO, Ratislav Cernak, welcomed the decision, saying it was an encouraging sign for all foreign investors in Ukraine. The ruling followed the overturning of similar fines for British American Tobacco and Tedis in February and for Philip Morris International in April 2021. At the time of writing, Japan Tobacco’s case was still pending before the Supreme Court.
In October 2019, the AMCU imposed a record fine of UAH6.5 billion—one of the biggest in the country’s history—on the local affiliates of PMI, BAT and Imperial Brands, along with Tedis Ukraine, the country’s largest tobacco distributor, for conspiring to eliminate competition in cigarette distribution. The committee claimed that the tobacco companies and Tedis had conspired to keep new businesses from entering the market. The companies appealed but lost their cases in the first instance court. Both manufacturers and the American Chamber of Commerce (ACC) in Ukraine expressed concern about the anti-competition trial, arguing the defendants had not been given full access to the evidence on which the AMCU based its allegations and that insufficient attention was paid to the companies’ arguments during the trial.
The AMCU then asked the court to collect fines from all accused companies and freeze funds on their bank accounts, which could potentially have led to a manufacturing halt. In the face of such pressure, some of the companies paid up. However, some defendants also made clear their intention to defend their rights as foreign investors in arbitration.
On Dec. 21, 2020, PMI filed a lawsuit for bilateral investment arbitration at the International Center for Settlement of Investment Disputes in Washington, D.C., claiming their fine violated bilateral agreements on mutual protection of investments with the United States and Switzerland. Previously, the ACC had cautioned that such high-profile disputes, which involve consideration by international bodies and make Ukraine, not the AMCU, a party to the dispute, usually gain international publicity and could have a negative impact on Ukraine’s image among foreign investors. The organization had called for a quick, transparent and fair solution.

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Self-Made Problem
The story behind the AMCU’s antimonopoly accusation is long and contradictory. Tedis and its predecessor company, Metropolis Ukraine, have repeatedly been the subject of legal challenges for antitrust behavior. Metropolis was founded in 2010 as a subsidiary of Megapolis, a Russian firm. At that time, it held 50 percent of the Ukrainian tobacco market, in which more than 50 cigarette distributors were operating. After a scandal that allegedly involved supplying weapons to the separatists in the war in Donbas in 2016, the company changed its name to Tedis Ukraine.
Gradually, the company took over most of its competitors, with the AMCU approving the acquisitions. As of 2020, Tedis ranked eighth in the Forbes’ “Top 100 largest private Ukrainian companies” rating, generating an annual turnover of UAH49.7 billion. In 2019, Tedis aimed to generate a turnover of UAH60 billion, the company’s CEO Taras Korniachenko said in an interview with liga.net. According to Wikipedia, the company is one of the country’s largest taxpayers, employing 2,500 people spread over 35 regional branches in 2020.
According to openforbusiness.com.ua, which quoted AMCU spokesperson Olha Pischanska, Tedis’ share of the Ukrainian market rose to 99 percent between 2013 and 2015 but decreased to less than 75 percent by 2019. She pointed out that in addition to Tedis, other companies were buying cigarettes from manufacturers.
Soon after Tedis had been cleared of the October 2019 charge, it was fined UAH274 million by the AMCU, which in March 2021 said that the company had not complied with an earlier ruling. In December 2016, the antitrust committee claimed that Tedis had abused its monopoly position between 2013 and 2015 and imposed a UAH431 million fine on the firm. The AMCU had also ordered the company to restore competition in the tobacco market. Tedis said it planned to appeal the most recent ruling, calling the decision “completely unfounded.” In an official statement on its website, it announced that it had fully paid the original fine in 2020 and fully fulfilled other obligations imposed by the AMCU.

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Declining Legal Market
About one-third of Ukraine’s 45.4 million people smoke, according to worldpopulationreview.com. With a joint share of more than 90 percent, PMI, BAT, JTI and Imperial Brands dominate Ukraine’s tobacco market. They also rank among the country’s 10 largest taxpayers. In 2020, the country exported €227 million ($268 million) worth of cigars and cigarettes to the European Union.
Despite high domestic demand, cigarette sales in Ukraine have declined over the past few years. In 2019, the country produced 51 billion cigarettes, 15 percent less than in the previous year, a greater decrease than in the years 2011 to 2017 together, Imperial Brand’s country general manager said in an interview. His counterpart at PMI Ukraine expected a similarly steep drop for 2020.
Tax revenues from tobacco account for about eight percent of Ukraine’s total state budget. In the past years, the country has repeatedly raised the excise duty for cigarettes, most recently by 20 percent in January. Presently, the specific rate of excise duty is UAH1,088.64 per 1,000 cigarettes, and the minimum rate is UAH1,456.33 per 1,000 cigarettes. Taxation accounts for around 70 percent of the pack price in Ukraine.
The former Soviet republic is one of the poorest countries in Europe, with an average nominal salary of €300 ($354) in 2019. Amid rising prices of legal smokes, the illegal cigarette market in Ukraine has flourished: According to PMI Ukraine’s CEO, the share of illegal cigarettes—including smuggling, counterfeiting and cigarettes with counterfeit excise stamps—has grown from 1 percent in 2016 to 9 percent in 2020.
Ukraine is also the No. 1 country of origin for illicit cigarettes trafficked into the EU. In 2018 alone, inflows from Ukraine accounted for more than 4 billion cigarettes, according to the European Commission. Until recently, smuggling tobacco to other countries was not illegal in Ukraine. In April 2021, after years of pressure from the EU, Ukrainian President Volodymyr Zelensky introduced a bill that would make trafficking a crime punishable by up to 12 years in prison and a significant fine.
Important Matter
Solving the tobacco cartel dispute is essential for Ukraine as this is part of the Association Agreement between with EU that entered into force in September 2017. The contract establishes a comprehensive free-trade area between the parties and commits Ukraine to economic, judicial and financial reforms to converge its policies and legislation to those of the EU. Among other things, it requires the parties to “recognize the importance of free and undistorted competition in their trade relations.” The EU is Ukraine’s largest trading partner, accounting for more than 40 percent of its trade in 2019. Ukraine is preparing to formally apply for EU membership in 2024.
To break up the monopoly, the country’s cabinet published a resolution in September 2020, which foresees the establishment of a national operator in the tobacco market by the end of 2021. Starting out as a pilot project, the operator’s task will be to combat tax evasion, smuggling and counterfeiting by introducing a track-and-trace system. The move is supposed to attract investment and is expected to add more than $535 million to the state budget.
Critics, however, fear it would cement Tedis’ leading role and boost the illicit tobacco market. Legal challenges to the plan have been filed already. Ukraine’s road to EU membership is likely to be a long one.
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.

August 1, 2021
Rebirth of an Icon

Photo: Rizla
The legendary Rizla brand gets a makeover.
By George Gay
Having been told that the Rizla brand of rolling papers was being given “a very significant refresh to ensure it remains relevant, particularly for younger adult smokers,” I couldn’t help wondering how it was possible to know when a brand needed such a refresh. The answer, it turns out, is fairly simple, at least in theory. Andrew (Drew) Marfleet, the head of marketing for Rizla, told me during a Teams meeting toward the end of June that, in large part, it was a matter of asking the brand’s consumers.
Rizla, he said, had been talking to consumers for more than a year, and the feedback had included the message that, while during the past few years, changes had overtaken societies, the way consumers viewed brands and the way many brand owners presented their products, Rizla’s image had remained largely unchanged.
The message was clear and the solution seemingly simple, but this was not quite the case. In refreshing the brand, a number of other factors had to be taken into consideration, not least of which concerned the fact that while consumers wanted change, they were at the same time greatly attached to Rizla’s “iconic and legendary” status. Now words such as iconic and legendary are often bandied about where they really have no place, but this is not the case with Rizla. The Rizla brand, which was acquired by Imperial Tobacco, now Imperial Brands, in 1997, dates to 1796 and the granting of a license by Napoleon Bonaparte to the Lacroix family for the supply of its premium rolling papers to his troops, while the Lacroix family’s involvement with paper can be traced back to at least 1532 and Pierre Lacroix.
So there was something of a conundrum to confront because here was a rock-solid brand but one that had been around for the sort of timespan over which even rocks wear down. In other words, there was a tightrope for the marketing people to walk in trying to stay true to a venerable brand dating back more than 200 years, while bringing its image up to date. As Marfleet told the people around him, “no pressure then.”
In fact, negotiating the tightrope required an even trickier balancing act than is implied here. In recent times, Rizla has seen an uptick in demand from those in the 21–30 age group, and it was focus groups largely made up of such people who expressed a desire for a refresh. But the brand’s core consumers are men aged 35 and above, so any refresh needed to be mindful not to alienate them. Unsurprisingly then, Marfleet made the point that this group of older consumers also had been kept close to the research, though, ultimately, he added, it had been about listening to all of the brand’s consumers and keeping them at the center of everything that had been done.
I guess this approach goes to the heart of marketing, which is defined briefly as being about identifying consumer needs and determining how best to meet them. But care has to be exercised here; otherwise, like me, you can make an altogether wrong assumption. This refresh is about marketing, so these “needs” have to do with the brand messaging, not the product itself.

Visual Positioning
So, if the product remains the same, what is involved in a brand refresh? Well, according to Marfleet, it is ultimately about the brand’s strapline. “It is the visual positioning of the brand and the way that the brand communicates itself,” he said. “So, for as long as we can remember, Rizla has had the strapline of Never Settle [as, for instance, in: Keep Discovering—Never Settle; and Keep Creating—Never Settle]. What we have moved to, again after listening to our consumers, is celebrating our heritage and our legacy in a modern way. And that has led to our new brand positioning, which is, Roll with the Legend—Since 1796.”
Beyond the strapline, Marfleet said, the refresh was more generally about brand communication, which, of course, raises another question. Isn’t the communication of tobacco and tobacco-related products and brands banned in many jurisdictions, which certainly include most of the markets where rolling-tobacco products and accessories are popular?
Rizla was definitely limited in how it could communicate its message, Marfleet admitted, but it would be making changes in those channels open to it. So, instore materials would be changing, as would the brand’s online digital presence. A more specific example of the changes being made concerns a shift away from the sponsorship of motor sports and toward music and culture in general. Rizla has supported culture in the past, but now it is shifting all of its brand partnership efforts toward music and culture, which resonates more with the brand’s current consumers. Such a shift can be seen also in Rizla’s launch of a digital partnership with the global media platform Dazed, which positions it in the area of supporting emerging artists.
Return on Investment
This is a global refresh that, at the time I spoke with Marfleet, had been rolled out in two key Rizla markets, Italy and Spain, and that was due to be introduced elsewhere in the coming months. It was designed by the Rizla marketing team in close cooperation with a creative agency during a year and a half of weekly workshops that decided, following the sifting of something like 10 iterations, on the new brand positioning.
The Covid-19 pandemic raised some challenges in respect of these workshops, but the overriding challenge, Marfleet said, had been ensuring that those working on the project got it right. In other words, the crux of the matter is: has it worked as a marketing project, and will it be successful as an investment? Well, apparently there has been excellent feedback after rigorous testing, and consumers in both the 21-plus and 35-plus age groups are said to love the refresh.
But rolling papers comprise a niche product, and tobacco smoking is under attack, so will the market hold up to such an extent that the investment will turn out to have been worth it? Marfleet clearly believes so. The RYO market, which was the subject of healthy competition, was quite stable at the moment as a result of downtrading, Marfleet said, and Rizla had definitely seen an uptick in those aged 21-plus picking up on RYO. “Given the stable market and our predictions, we definitely feel that the investment into the brand refresh is completely justified and will pay off,” he said.

Custom Manufacturing
Of course, while Rizla says its products are aimed at the world’s adult tobacco smokers, it is likely that it will benefit from changes in some jurisdictions where marijuana smoking is being legalized. But on the other side of the coin, market challenges could be thrown up by revisions to the EU’s Tobacco Products Directives (TPD) and regulatory changes made by the U.S. Food and Drink Administration. However, Marfleet said these issues were on Rizla’s horizon. “What I can say is that we are proactively planning for multiple scenarios, especially with the TPD, so that we will be ready to take action whatever the outcome of that may be,” he added.
Meanwhile, there was another, unofficial focus group that was regularly kept appraised of what was happening with the refresh: the approximately 200 people who work at the Rizla rolling papers factory in Belgium, which supplies the world with such papers. And, according to Factory Manager Kris Smedts, all of the people working at the factory, who make up a wide range of ages, loved the refresh.
The factory, which was built in 1958 and which, over the years, has been expanded and automated to provide for an annual manufacturing capacity of up to 100 billion paper leaves, spread over a staggering number of SKUs (stock-keeping units), is located on the south side of Antwerp, at Wilrijk. It uses lean manufacturing techniques and is managed by an MRP (manufacturing resources planning) system because, though paper booklets might appear to comprise a simple product, their interleaved presentation is difficult to achieve, especially at high speeds, and the addition of innovations such as cut corners (to ease rolling) and pack-closing mechanisms have, over the years, added to the complexity of manufacture and logistical handling.
Another layer of difficulty is added because, since rolling papers are a niche product, it is not possible to buy off the shelf the machinery for manufacturing and packing it, so it has to be developed by the factory’s own engineers working with specialized partners. And because rolling papers comprise an evolving product, the factory has a special product development team that works on the design of the new or modified machinery required to manufacture the innovative products needed to stay ahead of consumer demands.
Finally, despite the refresh, some things will not change, or not much. During my chat with Marfleet, I mentioned a fairly raunchy Rizla marketing campaign used a good while ago, and he agreed that the brand’s marketing archives included campaigns that had been “on the edge of cheeky,” though, over the years, the cheek had been toned down in line with new advertising regulations. Nevertheless, he said, we’ll never forget that Rizla should always be a fun and quirky brand.
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.

August 1, 2021
Genetic Scissors

Image: vchalup
Demeetra AgBio offers tobacco companies a new tool to reduce nicotine levels.
By Stefanie Rossel
The goal of making combustible cigarettes less addictive by removing or significantly lowering their nicotine content to minimally or nonaddictive levels has long been on the U.S. Food and Drug Administration’s agenda. In July 2017, the agency announced a plan that became part of its multi-year roadmap for tobacco and nicotine regulation. When the FDA in late April 2021 revealed its intention to ban menthol cigarettes and cigars, it confirmed that the low-nicotine proposal was still under consideration.
For cigarette companies, a requirement to lower nicotine would present a cost-intensive and time-consuming challenge.
To date, no specific amount of nicotine has been identified as the threshold for addiction. In March 2018, the FDA issued an advance notice of proposed rulemaking to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. In its 2015 Global Nicotine Reduction Strategy, the World Health Organization defined nonaddictive levels of nicotine as “likely to be equal or possibly less than 0.4 mg/g of dry cigarette tobacco filler.” To reach such levels, conventional tools to control deliveries, such as ventilated filters, will not suffice.
Getting nicotine out of tobacco is a tall order; key considerations are cost and the impact of the treatment on produce quality. Until recently, there were basically three methods available to produce very-low nicotine (VLN) cigarettes—chemical extraction, genetic modification and microwave-assisted extraction.
Using solvents, the chemical extraction method is similar to that used for removing caffeine from coffee beans. Because it is a batch process, it is not selective to nicotine only, however. During the de-nicotinization process, some flavorings are also eliminated, which is detrimental to the taste of the tobacco.
Another strategy involves the use of genetically modified (GM) tobacco plants. The GM variety is presently offered by only one company, 22nd Century Group. Through its subsidiaries, 22nd Century has been supplying the U.S. National Institute on Drug Abuse with VLN cigarettes for research financed by the FDA and other U.S. federal government agencies since 2011.
A third approach comes from Canada-based Radient Technologies, which uses a proprietary microwave-assisted processing extraction technology. Both 22nd Century and Radient Technologies claim that their processes do not affect the taste of the tobacco and are suitable for nicotine extraction on an industrial scale.

Cas-CLOVER targeted tobacco shoots with knockout mutations for the phytoene desaturase gene, which results in a visually pale and white phenotype.
To the Core
Now, a new nicotine-reduction technology has entered the scene. Demeetra AgBio, a biotech company headquartered in Lexington, Kentucky, USA, recently introduced its Cas-CLOVER technology, with which it is currently designing gene-editing protocols specifically for the tobacco industry. Cas-CLOVER builds on the CRISPR-Cas9 gene-editing technique, which achieved worldwide fame in 2020 when Emmanuelle Charpentier and Jennifer Doudna received a Nobel Prize in Chemistry for its development. CRISPR-Cas9 is a molecular biological laboratory tool used to “edit” pieces of a living organism’s DNA.
Based on a simplified version of the bacterial CRISPR-Cas9 antiviral system, it works like a pair of genetic scissors by using a specially designed RNA molecule to guide a Cas9 enzyme to a specific sequence of DNA. Cas9 then cuts the strands of DNA at that point and removes a small piece, causing a gap in the DNA at a desired location, allowing existing genes to be removed and/or new ones added in vivo.
The method is considered highly significant in biotechnology and medicine as it allows for the genomes to be edited in vivo with high precision, at low cost and with ease. The system can be used in the creation of new medicines, agricultural products and has potential to help treat inherited genetic diseases, such as cancer and AIDS.
The technique, however, has downsides: CRISPR-Cas9 also introduces abundant off-target mutations, thus increasing the need for “backcrossing” the crop. What’s more, the opportunity for commercialization of products that use the technology is restricted by intellectual property rights. The current owner, the Broad Institute of MIT and Harvard, prohibits the technology from being used for applications that involve the commercialization of tobacco products.
Jack Crawford
Improved Approach
This is where Cas-CLOVER comes in. Because Demeetra has separate and issued IP for Cas-Clover, users need only a single license from the company to obtain commercial freedom to operate, according to Demeetra CEO Jack Crawford. What’s more, off-target mutations are nearly undetectable with Cas-CLOVER.
“This matters for several reasons, the first of which is time,” says Crawford. “Since there are little to no off-targets with Cas-CLOVER, it requires less back-crossing to remove those off-targets. For example, CRISPR/Cas9 or chemical mutagenesis might require six to 12 generations of back-crossing to remove most of the unintended mutations. This takes years to decades, and many undesirable traits are never removed.”
The second reason involves traits, according to Crawford. “Since unintended mutations are not a concern with Cas-CLOVER, one knows that a trait of interest, such as reduced nicotine, is related to the gene you targeted and will not be lost during back-crossing or breeding,” he says.
Like a pair of molecular scissors, Cas-CLOVER can cut and effectively turn off or “knock out” any gene in any organism, Crawford points out. The system can also be used to knock in genes at a specific location. “The traits that can be generated are virtually limitless,” he says. “By targeting specific genes, nicotine can be increased for extraction and use in nicotine-replacement therapy or decreased, and the carcinogen levels can also be reduced. Additionally, disease and drought-resistant crops can be generated in this way.”
If used for the creation of VLN tobacco, Cas-CLOVER would differ from competing processes in several ways, according to Crawford.
“Cas-CLOVER can rapidly and reliably target genes for nicotine reduction in a step-wise or all at once manner,” he says. “This can be done in many varieties at the same time, enhancing product quality and availability. Cas-CLOVER-edited plants will not be considered GM and would not require regulatory clearance on the level of introducing new GM varieties. This targeted approach could result in reduced nicotine without reducing yields, and downstream processing would be simpler, all contributing to lower costs.”
In the U.S., Cas-CLOVER and CRISPR-Cas9 are not considered GM because the intended mutation, which is typically a deletion, could have occurred by breeding or in nature, and there are no other changes or nonplant gene sequences “transgenes” in the genome. “The traditional GM crops contain transgenes from exogenous organisms that are inserted permanently into the genome of the crop. These transgenes typically include antibiotic selection markers, antisense or RNA interference genes. In fact, targeted gene-editing technologies are a huge improvement over transgenic GMs and chemical mutagenesis in terms of safety.”

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Leaf with Potential
Located in the heart of tobacco country, Demeetra is one of several companies in the region that use tobacco as a universal plant research model. The company has validated and optimized the Cas-CLOVER technology in commercial varieties of tobacco for high-efficiency gene-editing and intends to license it to tobacco companies for multiple applications. The technology is currently being applied in a laboratory setting and will eventually move to field trials in commercial tobacco strains, such as burley.
And its potential could extend beyond the lowering of nicotine levels. Demeetra is working on using its technology to modify carcinogen levels to reduce the cancer risk from smoking combustible cigarettes for various ethnic groups. “The bulk of the carcinogens are produced when the leaf is cured and nicotine is converted to tobacco-specific-nitrosamines (TSNAs), which are known carcinogens,” Crawford explains. “By using Cas-CLOVER, we can specifically turn off the genes responsible for the conversion of nicotine to TSNAs. This would result in a far safer combustible cigarette for all ethnic groups, and a by-product is increased nicotine.
“[Different] ethnic groups metabolize TSNAs differently, which is thought to contribute to cancer disparities. These improvements with Cas-CLOVER may help close that disparity gap. The tobacco industry has generated low converter lines by conventional breeding and chemical mutagenesis. However, since this is not a targeted gene-editing approach, other undesirable traits come along with the low converters, such as low yield. Conventional breeding takes many years. Since most cigarettes contain multiple varieties of tobacco to enhance taste and other attributes, a rapid Cas-CLOVER approach in many varieties could produce low converters without sacrificing cigarette quality and tobacco leaf yield.”

The Cas-CLOVER structure
Vast Range of Applications
Crawford sees similar potential for his method in the treatment of cannabis plants. “Biopesticides could be produced in the plant or manufactured in an exogenous system, such as yeast, and then applied to crops. Cannabis is a blank canvas of opportunities and challenges. Once gene-editing conditions are worked out in cannabis, Cas-CLOVER would be best utilized to modify bioproduction of specific cannabinoids, such as CBD and THC, but also rare cannabinoids.”
Currently, Demeetra is exploring use of its gene-editing technology to uncover the therapeutic value of tobacco plants. Crawford says his company had generated Nicotiana benthamiana-edited plants, which is the host variety for manufacturing biologic therapies. “There are many improvements that could be made to this manufacturing system with Cas-CLOVER, such as enhancing the quality of the biologic therapeutic produced in tobacco and removing components that complicate downstream processing.”
Demeetra is also working to generate tobacco plants with advanced traits for biotherapeutic production. “This is not only applicable to vaccines but any biotherapeutic, such as an antibody,” says Crawford. “A primary example is by knocking out the plant post-translational modifications. When a biologic is produced, the plant adds certain sugars and other molecules to the protein just as it would with naturally produced proteins. Since these protein side groups are not the same as human, it causes undesired immune response, which can limit the efficacy of the product. With Cas-CLOVER, we can eliminate these and other genes to improve tobacco as a biotherapeutic manufacturing platform.”
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.

August 1, 2021
Clearing the Smoke

James Murphy (Photos: RAI)
Reynolds’ James Murphy discusses the challenges and
opportunities for tobacco harm reduction.
By Stefanie Rossel
In September 2020, James Murphy took over as executive vice president of research and development at Reynolds American Inc. (RAI), a subsidiary of British American Tobacco and the second-largest tobacco company in the U.S. Tobacco Reporter caught up with Murphy to discuss the challenges and opportunities he faces in his position.
Tobacco Reporter: Upon assuming your position, you conducted a poll among 2,000 U.S. consumers. What were the main findings, and what do you make of them?
James Murphy: We did a poll of 21-plus adults to examine issues related to tobacco harm reduction [THR] because it is an incredibly important priority for us. The results were consistent with other published research; there is confusion about whether innovative products—such as e-cigarettes—present less risk, and in particular, the role of nicotine as a cause of harm.
A similarly large proportion misunderstand nicotine as a cause of smoking-related diseases. Many adult smokers simply do not know that the toxicants generated from tobacco combustion—rather than nicotine or tobacco itself—is the leading cause of smoking-related health harm. Lack of information creates steep barriers for adult smokers to consider a switch to smoke-free tobacco and nicotine alternatives that are potentially less harmful to their health.
Misunderstandings about innovative alternative products, and nicotine itself, are a hurdle toward shared progress. The good news is that reducing harm from combustible tobacco products was considered an important public health priority by more than two-thirds—70 percent—of the adults we surveyed. Thus, there is strong public recognition of the need for innovative solutions to the harms caused by smoking.
This data underscores our commitment and focus on building productive working relationships with legislators and regulators around the country in pursuit of our common goal: reducing smoking rates, keeping tobacco products away from teenagers and ultimately reducing the harm from smoking in America.
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Amid all restrictions on tobacco industry communications, what can the sector do to change consumers’ misperceptions on these issues and encourage smokers’ movement to less hazardous products?
This is a significant issue, and we are engaging with policymakers and legislators—many of whom share such misunderstandings—and the larger scientific and regulatory community. Misunderstanding of nicotine impairs harm reduction, and it must be addressed. As is well studied and understood, the toxicants from the combustion of tobacco drive smoking-related morbidity and mortality.
Yet behavioral research confirms consumer confusion on this point, and recent population-level data published by the Society for Research on Nicotine and Tobacco (SRNT) highlight that up to 80 percent of U.S. adults incorrectly believe that nicotine is responsible for most of the cancer caused by smoking.
Similarly, misunderstanding vapor and vapor flavors can lead to detrimental policies banning products, flavors and even categories of products, whose removal from market could create the unintended consequence of indirectly pushing adults and minors toward cigarettes. We saw this recently in the Yale School of Public Health study regarding San Francisco’s ban on flavored products, where the author found that it was associated with a significant increase in youth smoking there but not in other jurisdictions without the ban.
Regulatory policy should be based on the relative risks of tobacco products. We are committed advocates for a legislative and regulatory framework that recognizes the continuum of risk and includes risk-proportionate policies on taxation, public use and flavors and other aspects of the product that are important to encouraging adult smokers unwilling to quit to switch from cigarettes. Where regulation is based on scientific evidence and not opinion, public policy will benefit public health and contribute to better understandings of these important products.

RAI’s R&D center
During your recent presentation at the GTNF In Focus event, you hinted at the challenge of assessing the risk profiles of other next-generation products, such as modern oral nicotine, for which no epidemiological data are available yet. Can you elaborate?
The FDA is carefully vetting these products, and I have every confidence that their assessment is science-driven and made against the rigorous statutory standard of “appropriate for the protection of public health.” For newer products, such as THP and modern oral nicotine pouches, like vapor with less than a decade on the market, epidemiological data is still in progress.
In the absence of epidemiology, we use a weight-of-evidence approach comprised of laboratory, clinical and real-world population level studies. In our studies, we include both smokers and smokers who quit smoking as epidemiological gateposts and compare clinical and population outcomes for smokers who switch to the next-generation products (NGPs) against these two smoker statuses.
Consider snus usage in Sweden as a strong illustration of THR in action. Smokers have switched to using snus over several decades, and the country now has the lowest lung cancer rates in the whole of the EU. This epidemiological data is the cornerstone of substantiating the beneficial population health impacts of products like snus in countries like Sweden but also within the USA.
In studies we have conducted and published to date, we have demonstrated that users switching to NGPs have similar biological outcomes to smokers who quit. As quitting has known favorable epidemiological outcomes, we can bridge the switch to NGP to quitting and conclude that both will have similar epidemiological outcomes, which would benefit population health in the long run.
The FDA has announced plans to ban menthol as a characterizing flavor in combustible cigarettes and has suggested that the agency may also reduce the nicotine content in cigarettes. Do you consider such measures as a sufficient incentive for smokers to switch to less harmful alternatives? What else needs to be done?
My concern is that any risk-based product standards on cigarettes will lead to confusion in the marketplace. For example, if a menthol product standard is introduced, smokers might wrongly perceive nonmenthol cigarettes as less risky. We know already that the general population misperceives the risks of nicotine when administered in a combustible product versus a noncombustible product and that there are misperceptions regarding the relative risks of vaping compared to smoking. THR presents a better way of reducing the harms from combustible tobacco use. Today in the U.S., millions of smokers have switched to products like vapor or nicotine pouch products. I have spent my career focused on THR and believe we must enable the introduction of satisfying, reduced harm alternatives that will facilitate the switching of smokers down the risk continuum while at the same time ensuring that adequate safeguards are in place against youth usage.
The FDA has recently spoke of finding this “sweet spot,” and ideally, all stakeholders in the THR debate will collaborate to make that happen.

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What are your current research priorities?
Topline, we’re focused on reducing the health impact of our business based on scientifically substantiated reduced-risk products. These products will improve public health and ensure we have a sustainable future. That means establishing and supporting the weight of scientific evidence that appropriately stewarded noncombustion tobacco and nicotine products manufactured to high-quality standards have a role in THR.
In the U.S., we believe that the FDA will play a key role with their stewardship of the PMTA process to ensure that products which are appropriate for the protection of public health remain on market. This regulatory verification will improve smokers’ confidence in these products and facilitate the mass migration of smokers down the risk continuum. There is a large and growing body of evidence—including from Reynolds’ scientists—to support the reduced-risk potential of these categories.
We take two approaches for assessing the risk profile of noncombustible products: if a product has robust epidemiological data, then that data is used as a basis for risk assessment, but for newer products, in the absence of epidemiology—such as THP, vapor and modern oral products—we use a three-stage assessment of emissions, exposure and risk.
Judging from the results of your poll and from recent FDA moves, such as the proposed ban on menthol and planned maximum, nonaddictive nicotine levels in combustible cigarettes, which direction is THR taking in the U.S.?
We believe our broad portfolio of alternatives to combustible cigarettes can accelerate the population-level health benefits supported by the Family Smoking Prevention and Tobacco Control Act and envisioned by the FDA in its consistent endorsement of a comprehensive nicotine regulatory framework.
Potentially less harmful products must be able to compete effectively with the most harmful products, thus moving smokers down the risk continuum of nicotine products. Vaping bans and high taxes on alternatives that may present less risk than cigarettes will not help us reduce the harm from cigarette smoking.

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What are the gaps in THR science from your point of view?
The biggest gap in THR science is caused by an ongoing boycott by various scientific conferences to publicize and share the latest THR research. The recent news from SRNT banning the tobacco industry from future conferences is particularly disappointing. The largest U.S. scientific conference on nicotine and tobacco research banning industry scientists seems counterintuitive. Moreover, the learning process is not merely what we share, but what we can learn from others. Personally, some of the most valuable professional insights I have received were from other U.S.-based academics commenting on our research during SRNT poster sessions.
Science—particularly science that underpins such important public health goals—deserves to be debated on its merits, particularly when the science on those same products is under scientific review by the FDA.
There is room for more consistent methodologies to ensure the consistent assessment of products as there is sometimes conflicting data published on both sides of the THR debate. There is also a gap in evidence for assessing THR products in that we do not have epidemiological data for newer products like THP, vapor [and] modern oral, which have only been on market for five [years] to ten years. That data gap points to a need for agreed proxies to assess individual risk reduction, such as biomarkers of potential harm and quality-of-life measurements, and other real-world evidence which may play a role.
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.

August 1, 2021