Examining the impact of flavored e-cigarettes on adult smokers: insights from a three-month experimental study
By Jessica Zdinak
Much ink has been devoted to the dichotomy presented by electronic nicotine-delivery systems (ENDS)—are they a friend or a foe?
For several years now, we have seen a surge of a variety of different e-cigarette products, overrunning the U.S. commerce both legally and illegally. The question remains for some, including our regulator: Do they serve as an alternative to traditional combustible cigarettes, or do they serve as an initiator for youth and young adults? This dichotomy revolves heavily around the authorization of and use of flavored e-cigarette/e-liquid products.
Continuously, and in my opinion, rightfully so, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) presents manufacturers with marketing denial orders that state things like “… your PMTA lacks sufficient evidence demonstrating that your flavored ENDS will provide a benefit to adult users that would be adequate to outweigh the risks to youth.” To demonstrate this, a reliable and robust study must be conducted. “Reliable and robust” means different things with each of the different scientific areas contained within an application. For the behavioral sciences, it means using a design that inherently has a level of methodological and statistical control, such as a randomized control trial, known in our scientific area as a “between-subjects experimental design.”
To address the CTP’s concerns and gain a better understanding of the effects of flavored e-cigarettes, the research team at Applied Research and Analysis Company (ARAC) conducted a three-month randomized experimental study. This study was sponsored by Accorto Regulatory Solutions, in conjunction with Freenoms, an e-liquid manufacturer and subsidiary of Lotus Vaping Technologies, creator of the Nomenons e-liquid. In this article, we will explore the key findings and insights from this study, shedding light on how flavored e-cigarettes may influence adult smokers’ habits and vapes’ potential as a smoking cessation tool.
Study Context
The study, conducted by a team of experts led by ARAC Chief Research Officer Jessica Zdinak, was designed to provide evidence related to the public health impact of flavored e-cigarette products on adult smokers. The study’s design played a crucial role in ensuring the validity and reliability of the results. Expertise in behavioral science and research methodologies were instrumental in crafting the study’s plan, design and analysis. After a recent meeting with the CTP, it is acknowledged that ARAC’s key behavioral science framework meets the mark from a scientifically rigorous perspective. Here are just a few key aspects of ARAC’s study designs that underscore the importance of such expertise:
Statistical power: The study’s design took into account statistical power, ensuring that there were enough participants to detect significant effects should differences or effects exist and not to detect such differences or effects should they not exist. (Think, “Can you generalize your results?”)
Effect size considerations: Researchers considered effect size, an important factor in determining the practical significance of findings. (Think, “How generalizable are your results?”)
Hypothesis generation: The study involved the formulation of hypotheses that guided the research, enabling a systematic investigation of the impact of flavored e-cigarettes on smoking behaviors.
Awareness of behavioral factors: Researchers were keenly aware of the behavioral factors at play behind nicotine consumption, adding depth to the study’s approach.
Study Design
The study was conducted using a between-subjects randomized experimental design, which involved two conditions: one with flavored e-liquids and another with tobacco-tasting e-liquids. The primary dependent variables were cigarettes per day (CPD) and candidate product usage. The use of a randomized experimental design is a rigorous and reliable approach to investigate the effects of flavored e-cigarettes on smoking behaviors, as it minimizes bias and allows for causal inferences.
Following Institutional Review Board approval, participants were recruited from several locations across the U.S. They were then randomly assigned to one of two conditions: flavored candidate e-liquids or tobacco-tasting candidate e-liquids. Over a three-month time period, participants returned to facilities each month to select additional products as needed and to complete follow-up surveys. The follow-up surveys asked participants to specify their CPD over the past 30 days and the past 24 hours as well as their use of the candidate e-liquids. These responses were used for the primary analyses in which reduction and cessation were defined and analyzed as:
computed reduction of 50 percent or more of cigarette stick usage from baseline to follow-up
complete elimination of cigarette sticks
Results: Descriptive Insights
At the end of the three-month study, a total of 382 participants completed the final follow-up survey (n=181 in flavor condition; n=157 in tobacco-tasting condition). Using this data, we conducted both descriptive and inferential statistics. Coupled together, but with a focus on the inferential statistics, this study’s results offer valuable insights into the impact of flavored e-cigarettes on smoking behaviors.
Flavors over time: The study tracked how participants’ preferences for specific e-liquid flavors did (or did not) change over the three-month study period.
2. CPD between conditions over time: The results show the descriptive differences in cigarettes smoked per day between the flavored and tobacco-tasting conditions over the course of the study.
3. CPD between conditions over time: The results show the inferential statistics assessing the experimental effect of flavors on CPD compared to tobacco-tasting. Specifically, the study found that the portfolio of flavored e-liquids led to a significant reduction in CPD compared to tobacco-tasting products. This suggests that flavor plays a role in encouraging smokers to cut down on their cigarette consumption.
4. Switching rates: The research examined the rates at which participants switched from smoking cigarettes to using e-cigarettes, with specific attention to the flavored e-liquids, which led to a higher quit/cessation rate than tobacco-tasting e-liquids.
5. Individual flavor assessments: The study explored how individual flavors affected CPD reduction and cessation, providing insights into the specific flavors that had the most significant impact. Specifically, different flavors had varying effects on CPD reduction and cessation, with some flavors showing statistically significant differences. This highlights the complexity of the relationship between flavor and smoking behaviors, such as reduction in CPD and cessation of combustible cigarettes.
Summary of Findings
In summary, the study found that flavored e-liquids had a positive impact on smoking behaviors among adult smokers. Specific findings include:
CPD reduction: The portfolio of flavored e-liquids were associated with a statistically significant reduction in cigarettes smoked per day compared to tobacco-tasting products, suggesting that flavors encourage smokers to cut down on their cigarette consumption.
Variability among flavors: The impact of flavored e-liquids on CPD reduction and smoking cessation varied among different flavors. Certain flavors had a more pronounced effect, highlighting the need to consider the specific flavor profiles when evaluating their impact on smoking behavior.
Preference changes over time: Some participants’ preferences for specific flavors changed throughout the study, indicating that flavor appeal may evolve and influence its effectiveness in encouraging smokers to switch to e-cigarettes.
Qualitative insights: Open-ended questions provided valuable qualitative insights into how flavors influenced participants’ perceptions and decisions to quit or reduce cigarette consumption. These insights offer a more comprehensive understanding of the relationship between flavor and smoking behavior.
Overall, the study’s findings underscore the complex interplay between flavored e-cigarettes and smoking behaviors among adult smokers. While some flavors show promise in reducing cigarette consumption and promoting switching, there is no one-size-fits-all approach, and individual preferences and perceptions play a significant role.
One of the most powerful aspects of science is replicability. If industry is serious about getting new products, including flavors, authorized for market, replicability of studies such as this one is fundamental to success. Let’s hope this study is just the first of many at building that library of rigorous scientific evidence that the CTP has been looking for.
Jessica Zdinak is a U.S. Eastern Shore Virginia native with almost 20 years’ experience leading psychological research across a variety of domains, including a decade of which serving in tobacco harm reduction. She leads a team focused on product development and behavioral science consumer research supporting innovation, “next-generation” products and regulatory applications, including investigational tobacco products, premarket tobacco product applications, modified-risk tobacco product applications and substantial equivalence applications. Zdinak has substantial experience within the U.S. federal government sector, leading research evaluation teams with a focus on the Centers for Disease Control and Prevention, the National Institutes of Health, the National Science Foundation, the Food and Drug Administration, and other large-scale grants and projects.
Musings on the movements of tobacco products from the field to the store shelf
By George Gay
I suppose that when a person decides it is time to buy a tobacco product, let’s say a pack of cigarettes, she enters the world of tobacco logistics, one of the last links in the multi-branched logistical chain that might be thought of as stretching from the tobacco seed through the consumer-level purchase to what is to be hoped will be the proper disposal of the butt.
In England, where I live, French was the official language for about 300 years from 1066, so it is not surprising that many of our English words have been borrowed from French, and “logistics” is one such word. It was originally applied, I believe, to the complexities of moving and accommodating armies, a task that has presumably become more complex, if easier on the feet, over time. The order to “walk to the next village and recharge yourselves on food plundered from the villagers” has become outdated, I guess, at least the bit about walking.
The logistics of buying cigarettes in England has similarly become more complex, with more uncertainties having been introduced, though it must be granted that, in some instances, it, too, has become easier on the feet. I cannot think, for instance, of any other consumer product apart from tobacco that you cannot see, handle and compare, at least at a packaging level, before you buy it. Indeed, I would have thought that such sales should have been made illegal; they certainly seem to be unethical and, from the point of view of the smoker, unwise. It is not for no reason that for at least 500 years, people here have been advised not to buy a “pig in a poke”—not to buy something without first being able to appraise it properly. And I believe it is still the case in U.K. restaurants that a customer cannot be forced to pay for food before eating it, which is no doubt a rule imposed by the French in 1077 after sampling what was on offer.
Hidden from View
Why go to the effort of requiring graphic health warnings if you then prevent anybody but those committed to buying them from seeing them? (Photo: Taco Tuinstra)
It is nevertheless the case that cigarettes are sold from behind the closed doors of aesthetically challenged cabinets and, even when those doors are opened to allow the retailer to take a pack out, it is just about impossible to see what other brands are available because those tobacco control people and politicians who are convinced that they should use their superior wisdom to save smokers from themselves have determined that all packs should look the same—grotesque. The hugely dominant feature of each pack is a so-called graphic health warning, which in fact is nothing of the sort but merely a bit of scaremongering showing some type of medical condition that smokers are supposed to assume is the outcome of indulging their habit but which they know could be related also to poverty, pollution, faulty genes and other lifestyle choices, including those involved in drinking alcohol.
The logistics of buying alcoholic drinks in England is allowed to be a much simpler affair even though the consumption of alcohol is a greater scourge on society than the consumption of cigarettes. All you need do is go along to your local supermarket, and there the drinks are laid out, row after row of them. In fact, row after row, right down to floor level so, presumably, children can run their little fingers along the bottles and cans and innocently admire the pretty colors and designs, including the odd cartoon. And, of course, those children watch adults put the bottles and cans into their trolleys and no doubt figure that this stuff is food, just like the other products on display. Although they don’t realize it, at least at the time, this is one of the lessons in traditional hypocrisy that adults will unthinkingly or uncaringly pass on to them.
I would have thought that from a logistics point of view, it would be logical to place alcoholic drinks inside cabinets where they cannot be seen, simply because these products, like cigarettes, are age restricted and raise health concerns but, unlike cigarettes, do not include graphic health warnings. But where is the logic in putting tobacco products inside cabinets where they cannot be seen? Why go to the effort of requiring the inclusion on cigarette packs of graphic health warnings, which, presumably, are meant to be visually off-putting, if you then prevent anybody but those committed to buying them from seeing them?
Logical Logistics
One trap that can spring when you start thinking about consumer logistics is that which I have moved close to above. Although the words logical and logistical are superficially similar in form, they have different roots, though you might expect that a good hand would be made of applying logical concepts to logistics. But, as can be seen, the logistics applied to the retail sales of cigarettes and alcohol are not logical, though they apparently appear to make sense to some people, perhaps because we live in an irrational world.
Logistics, I guess, is largely about choice. If you grow tobacco inland and want to export it, you and your customer must weigh up whether you should, in the name of efficiency, send your leaf by truck or train, to which port and company you should send it and to which carrier you should entrust it. But at the consumer end of the logistics chain, there is very little in the way of choice, at least in England. A combination of manufacturer efficiencies, and the imposition of unconscionable levels of taxes and pointless tar and nicotine delivery-level limits have meant that cigarettes are all largely the same.
Successive governments, while superficially criticizing the major tobacco manufacturers, have contrived to squeeze the logistical channels and hand to those manufacturers an almost closed market that cannot in any way be justified on the grounds of reducing the risks to smokers. Limiting the range of cigarettes has had no benefit for smokers. But limiting the range of cigarettes has benefited tobacco manufacturers while de facto limiting the number of manufacturers on the market has made the government’s tax collection much more cost effective and provided bigger targets for tobacco control, which can rightly point out that there are almost no cigarette manufacturing jobs available in England and, setting aside taxes, only costs. Logistical logic apparently has it that it is better to transport cigarettes across Europe and what is known here as the English Channel while the world drives nonchalantly past 1.5 degrees Celsius of global warming and environmental catastrophe.
I don’t believe what we are expected to swallow about there being no safe level of tobacco consumption but a safe level of alcohol consumption, an idea that is used to support proposals to limit the sale of the tobacco but not of alcohol. The government in England, which says that people should limit alcohol consumption to 14 units a week, would have conniptions if anybody set a limit of 14 cigarettes a week. But in a country where more than 90 percent of people spend their lives in polluted air, 14 cigarettes a week is going to be neither here nor there. But again, the logistics do not reflect this. While alcohol is on open sale, cigarettes are not, and now, noises are being made about limiting the number of retail outlets allowed to sell the latter, something that the good and the great will no doubt latch onto in due course and something that will simply increase the inconvenience for smokers and the polluting, environment-wrecking distances they will drive to obtain their cigarettes. If there is one thing that should be left to the market, it is the number of retail outlets that sell a particular consumer product.
Of course, you don’t have to visit a local retail store to obtain your cigarettes. You have other logistical options open to you, some of which will help preserve your footwear. You can buy them while you are on an overseas holiday or make a special trip across the Channel to buy them—by car if you are not concerned about the environment. And you can also buy them online if you are reasonably technically literate, and once bought, they can be delivered to your home or your workplace, even to the pub, though you will have to smoke them outside, possibly at a distance greater than that from which they were delivered.
The Generational Ban
One of the interesting aspects of cigarette-buying logistics arises if you start to wonder what will happen when and if the government brings in its generational smoking ban. So far, the U.K. government has issued a consultation document on smoking and vaping that includes a proposal to make it an offense to sell any product containing tobacco to those born on or after Jan.1, 2009, which would raise the legal “smoking age” by a year each year until it applies to the whole population.
Currently, retailers are obliged to prevent sales of tobacco products to those under the age of 18, and, as reported in the December issue of Tobacco Reporter, age identification technology is available that is good at helping retailers signed up to the Challenge 25 scheme in carrying out this task. The technology works by examining faces, determining whether somebody is younger than or older than 25. If the prospective customer appears to be over 25, the sale of cigarettes can go ahead while if she appears to be under 25, the retailer is obliged to ask for identification.
Although I have no real insights into this, I cannot help thinking it is going to be difficult updating the technology each year as the age limit is raised under the generational scheme. If, in the future, you want to separate the 49-year-old born in 2008 from the 48-year-old born in 2009, will the technology be adjustable to a Challenge 56 scheme, or will it have to be modified to examine people’s hands, which become a more accurate gauge of aging than faces as people get older? Perhaps other parts of the body are even more telling of age, but I simply refuse to let my imagination dwell on the scene in the retailers with a line of middle-aged and older smokers stripped to their underwear for examination.
Perhaps under a generational scheme, smokers will have to be issued with annually updated, smoker-specific identity cards. Or perhaps they could circumvent the whole merry-go-round and grow their own tobacco. In fact, there might be an opening here for kits that could help people convert raw tobacco to smokeable cigarettes, something that I believe is not possible on a small scale as things stand. A move to artisanal cigarette making could significantly reduce the logistical chain of these products and their environmental impact.
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.
Policymakers are having second thoughts about generational tobacco bans.
By Stefanie Rossel
On Nov. 24, 2023, New Zealand’s new conservative government scrapped the Smoke-Free Aotearoa 2025 Action Plan that was passed under former Prime Minister Jacinda Ardern with the goal to reduce the share of smokers in the country to 5 percent or less by 2025.
The law required a drastic reduction of legal retail outlets for tobacco products, from currently 8,000 to less than 600 starting in 2024, and the mandatory sale of very low-nicotine cigarettes from 2025. The most spectacular element of the legislation, however, was what would have become the world’s first generational smoking ban. Under this provision, those born after 2008 would never be able to legally buy cigarettes. The first part of the new law entered into force in January 2023, when gifting or selling combustible tobacco products intended for smoking to people born on or after Jan. 1, 2009, became illegal.
At 6.8 percent in 2023, New Zealand already has a low adult smoking rate compared to other countries. Smoking prevalence, however, is considerably higher among the indigenous population and Pacific Islanders: According to the most recent Ministry of Health statistics, 17.1 percent of Maori adults smoked in 2022/2023. Smoking rates among Maori women and Maori men were 17.5 percent and 16.8 percent, respectively, during that period, with Maori women having one of the highest lung cancer rates in the world. Pacific peoples had a smoking rate of 6.4 percent.
The ban was expected to save 5,000 lives a year. According to recent modeling, it could have saved New Zealand’s healthcare system $1.3 billion over 20 years.
The repeal of the plan is part of the new government’s three-party coalition agreement in which both minor partners demanded the retraction. Critics have accused the parties of ditching the measure to ensure sufficient cigarette tax revenues to fund their planned tax cuts. The new government, however, cited concerns about illicit trade among other reasons. A generational smoking ban as envisaged, incoming premier Christopher Luxon said, would have created a flourishing black market.
Uncertain Outcome
Marewa Glover
Public health experts expressed shock at the retraction, calling it “public health vandalism,” a “disastrous, terrible move” and a “squandered opportunity.” Marewa Glover, director of the Centre of Research Excellence: Indigenous Sovereignty and Smoking, takes a different view. “There was no real-world evidence for any of these policies,” she says. “No one in the world knows what would have resulted or what positive or negative consequences would have occurred. We can surmise what modeling does. Data for 2022/2023 shows smoking prevalence is continuing its decline. The 40 percent of adults living in the least deprived neighborhoods are already below 5 percent. Even the 40 percent in the most deprived areas are around 10 percent. Smoking prevalence among under 18-year-olds was already very low.”
The ban on sales of tobacco to adults aged 18-plus, she adds, was not going to take effect until 2027. “Some jurisdictions already have restricted tobacco sales to persons who have obtained the age of 21 years or over. So, there was plenty of time for future governments to repeal it before it ever impacted adults.”
She says that the big economic and social impact of the Action Plan would come from the reduction of tobacco retailers to 600 in a nation nearly as big as Japan. “What’s more, the convenience store industry retailers of combustible tobacco products—and a majority now also sell a limited range of vaping products—are largely owned by small family-owned businesses popular with our New Zealand Indian/Asian population. Many would have reportedly suffered loss because of loss of impulse trade as buyers of cigarettes were lost. The reduction to only 599 stores was due to take effect on July 1, 2024.”
The measure did not include a phase-in time, compensation or financial assistance to those affected, according to Glover. “My research on the robberies of stores for tobacco products highlighted the serious injuries and harm this sector was already experiencing due to the burgeoning black market demand for tobacco,” she says.
The third radical change, according to Glover, was the ban on the sale of tobacco products containing more than 0.8 mg/g of nicotine from April 1, 2025. “This would have rendered tobacco cigarettes useless—well before the sinking lid on age of purchase began to take effect,” she says. “Insufficient real-world evidence exists to inform the public and policymakers of the implications of such a policy. Evidence would need to consider the social and cultural implications as well as the health benefits. Is it really necessary, especially given the costs and risks, when effective and attractive—to the consumer, at their cost—pathways to very low smoking prevalence exist, such [as] has been proven in Sweden, Norway and Iceland?”
The new government has proposed to reform the regulation of vaping and smokeless tobacco products. Among other measures, it wants to reverse the previous government’s ban on oral nicotine pouches and snus and tax only smoked tobacco products. The restrictions on disposable vaping products are going ahead but with more serious penalties for anyone selling vaping products to under 18-year-olds, and consideration will be given to requiring vape vendors to obtain a liquor license.
According to Glover, some subgroups are already at or below the smoke-free 2025 prevalence goal of 5 percent. “If tobacco harm reduction (THR) was fully adopted, then 5 percent is possible nationally,” she says. Allowing oral nicotine products and exempting noncombustible products from New Zealand’s high tobacco taxes, she believes, would allow manufacturers to reduce the prices for tobacco-heating products, making them more accessible to people who smoke. Oral nicotine pouches and snus would give people another smoking cessation option. “Based on the experience of Iceland and Sweden, we could expect New Zealand to experience ongoing rapid reductions in smoking prevalence,” says Glover.
The war-on-drugs assumption that demand for the drug itself can be eliminated by measures on the supply side has not served society well more generally.”
A Desperate Measure
Tobacco control advocates appear to view the generational smoking ban, first proposed by Singaporean researchers 2010, as a tool to force down cigarette consumption figures that have decreased little in the 20 years since the creation of the World Health Organization’s Framework Convention on Tobacco Control (FCTC). Despite the many restrictions implemented globally, there are still about 1.3 billion smokers in the world.
“The objectives of the FCTC are to ‘eliminate or reduce consumption of tobacco products—and reduce exposure to tobacco smoke,’” says Derek Yach, who as a cabinet director and executive WHO director was instrumental in creating the convention. “The FCTC does not set deadlines to achieve this, but subsequent sustainable development goals call for large declines in chronic disease deaths by 2030,” he says. “The WHO’s latest reports prepared for COP10 [the tenth meeting of the Conference of the Parties to the FCTC], which is now set for February 2024, indicate that most countries are off track to achieve these goals. Note that unless smoking rates decrease fast, death rates from many major chronic diseases will not change.”
While the FCTC does not envisage a generational smoking ban, some tobacco control activists view it as a key component of their “tobacco endgame” strategy. Most smokers, the measure’s proponents argue, start smoking at a young age; stopping the start by consecutively raising the smoking age would break the cycle of nicotine addiction.
Despite New Zealand’s U-turn and a similar decision by Malaysia, where lawmakers abandoned plans for a generational tobacco ban due to constitutional concerns, the idea still finds support internationally.
Singapore has been reported to be “open” to such plans. In 2022, Denmark unveiled proposals to ban the sale of cigarettes and nicotine products to any citizens born after 2010. On Oct. 5, 2023, U.K. Prime Minster Rishi Sunak expressed his support for a generational tobacco ban, saying it was the right step to tackle the leading cause of preventable ill health. According to a spokesperson, he upheld his proposal even after New Zealand repealed its version of the plan.
The consultation period for the proposed legislation closed on Dec. 6, 2023. It has received support from organizations such as the Society for Research on Nicotine and Tobacco (SRNT), which advised the U.K. government to extend the measure to all forms of recreational nicotine that are not approved as medical therapy for smoking cessation, including heated-tobacco products, e-cigarettes, smokeless tobacco, snus and oral nicotine pouches.
Yach thinks this is a bad idea. “I don’t like the smoke-free generation measure, but it is sort of tolerable if confined to smoked products and if there are smoke-free options for nicotine use,” he says. “However, the war-on-drugs assumption that demand for the drug itself can be eliminated by measures on the supply side has not served society well more generally.”
In a poll conducted on behalf of smokers’ lobby group Forest, nearly three-fifths of respondents agreed that when people are 18 years old—and thus legally adults—they should be allowed to purchase cigarettes and other tobacco products. The legislation may be published in Parliament in early 2024. However, at press time, reports suggested that the U.K. was backpedaling on the measure as well, saying the country might raise the legal smoking age to 21 instead.
Untoward Effects
Christopher Snowdon
Due to the lag between smoking initiation and health outcomes, a generational tobacco ban would not affect tobacco-related deaths and disease for at least 40 years, according to Yach. “Given the reality that smoking rates among youth today in the U.K. and New Zealand are in low single digits, while rates are substantially higher among middle-aged adults, the policy would have negligible impacts on population measures of smoking,” he says. “The current youth trends simply need governments to stick with what is working already.”
Any policy decision, Yach emphasizes, must be weighed against alternative ways to achieve the same objectives and against the probability of untoward effects. “The ‘generational ban’ has failed to consider both,” he says.
Public health experts have warned that a generational ban would bring about many unintended consequences. In addition to restricting personal liberty, the arbitrary age restrictions would create absurd situations, such as a 28-year-old being deemed capable of purchasing tobacco, while a 27-year-old is not, according to Christopher Snowdon, head of Lifestyle Economics at the Institute of Economic Affairs, who also views prohibition as a driver of illicit trade.
Yach fears a generational tobacco ban could set precedent that will make it easier to apply similar measures to other products such as alcohol and marijuana. And he warns against unintended consequences. “Will the experiences learn[ed] during the alcohol prohibition era apply?” he asks. “Will youth switch to more, other psychoactive substances, some having deadly consequences? Many will argue that, provided THR products are made substantially more available and attractive, young people may try and use a range of current and future psychoactive substances. Is this likely? We cannot know the answer to these questions until the policy starts rolling out. On balance, it seems prudent to not experiment with the lives of future generations.”
Like Glover, he regards tobacco harm reduction, which is included in the definition of tobacco control of the FCTC text, scaled to reach adults who smoke and suffer the health effects, as having the greatest potential to save lives in the shortest possible time when compared to other measures, including the generational ban.
“We know this to be the case based on empirical epidemiological and toxicological studies, foresight models by academics and industry, and the national experiences of Japan, Sweden and the U.K,” says Yach. “My own estimates suggest that if THR and more effective cessation products were fully scaled, we could expect 3 million fewer tobacco deaths annually from the early 2050s. All these deaths would be in adults who are smoking today—not among youth. There is no other intervention that comes close to doing this.”
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.
Regulatory challenges and misinformation continued to test the vaping industry in 2023.
By TR staff
It remains a frustrating business environment. The vaping segment has survived despite setbacks in 2023 and continues growing as a global market. However, divergent regulatory perspectives on vaping’s harm reduction potential continue to hinder its uptake by cigarette smokers. The past 12 months could also be labeled the year of the great exodus as several vaping retailers and manufacturers went out of business. Despite the challenges, more and more former smokers continue to switch.
While several countries banned, enacted regulations or continued heavily regulating vaping products, the United States’ denials of numerous premarket tobacco product applications (PMTAs) had the greatest impact on the industry this year. The U.S. Food and Drug Administration’s ban on most products has allowed a black market of disposable vapes to become a multibillion-dollar industry. Disposable e-cigarettes account for almost 40 percent of the global vape sector, according to ECigIntelligence.
Critics have accused the industry of avoiding responsibility for the environmental damage caused by disposable vaping products while federal regulators have failed to pass measures that would make vaping components easier to recycle or more eco-friendly. Some regulations have been proposed to lessen the products’ environmental impact. For example, standards could be put in place requiring them to be reusable or mandating that manufacturers fund collection and recycling programs.
Disposable e-cigarettes currently account for about 53 percent of the multibillion-dollar U.S. vaping market, according to the Centers for Disease Control and Prevention, more than doubling in size since 2020. Several states, including New York and California, have extended product responsibility laws in place for computers and other electronics, but those rules don’t apply to vaping products. At the federal level, there are no regulations specifically for the disposal of vaping products. Without action, some experts say the devastating environmental impact could last for centuries.
Misinformation surrounding the vaping industry also continued to spread in 2023. Nearly half of cigarette smokers and young adult nonsmokers think that nicotine-based e-cigarettes have the same amount or even more harmful chemicals than regular tobacco-based cigarettes, according to a Rutgers study.
Another study found that there are also a lot of exaggerations and misinformation about vaping on social media. Some tweets exaggerate or distort claims about nicotine and addiction while others misinterpret scientific studies to promote vaping. There are also tweets that downplay the harmful effects of nicotine and promote its benefits, which are potentially problematic. Below is a month-by-month recap of the vaping industry’s biggest headlines in 2023.
January
Credit: Cerib
The upscale U.K.-based grocer Waitrose halts sales of single-use vaping products due to environmental concerns. The FDA says it will “decide within months” how to regulate legal cannabis (it still hasn’t). Vaporesso becomes the first open-system vaping device brand to obtain the ability to sell in the United Arab Emirates. The Netherlands bans flavors, and Belgium says it plans to restrict flavor names and vape devices. A 2022 article that claimed e-cigarette users faced the same cancer risk as combustible cigarette smokers is retracted by the World Journal of Oncology. Lawmakers in Taiwan ban vaping products. A U.S. district judge preliminary approves a $255 million settlement resolving consumer claims that Juul Labs deceptively marketed e-cigarettes.
February
Credit: Adobe
Hong Kong begins enforcing its ban on CBD, labeling it as a “dangerous drug” and imposing harsh penalties for its possession. Bloomberg Philanthropies commits $420 million over four years to the Bloomberg Initiative to Reduce Tobacco Use. Australia reschedules the psychedelics psilocybin and MDMA to provide access to people with post-traumatic stress disorder. Connecticut sues five companies for selling delta-8 products. Alex Norcia resigns from Filter for a job at Altria. RAI Services Co. submits a citizen petition asking the FDA to adopt a new enforcement policy directed at “illegally marketed disposable electronic nicotine-delivery system [ENDS]” products. Matthew Farrelly, former chief scientist and director of the Center for Health Analytics at RTI International, is named director of the FDA’s Center for Tobacco Products’ (CTP) Office of Science. The FDA files the first civil money penalties for illicit sales of ENDS products.
March
Credit: Ascannio
Altria Group exchanges its entire investment in Juul Labs for a nonexclusive, irrevocable global license to certain of Juul’s heated-tobacco intellectual property. Altria also agrees to acquire Njoy Holdings for approximately $2.75 billion and asks the U.S. Federal Trade Commission (FTC) to drop its 2020 challenge to the company’s 2018 acquisition of a 35 percent share in Juul Labs. The FDA proposes new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of vaping and other tobacco products. RLX Technology reveals that its 2022 financial performance was heavily impacted by new industry regulations and e-cigarette taxes, along with Covid-related disruptions, in China. A U.S. federal judge throws out a tobacco industry lawsuit against California’s statewide ban on the sale of flavored vaping and other tobacco products. The FDA updates its definition of “tobacco products” to include nontobacco nicotine products. Two menthol Vuse flavors that received a marketing denial order (MDO) can continue to be marketed by R.J. Reynolds Vapor Co. after the federal 5th Circuit Court of Appeals issues a stay. Argentina bans imports and sales of ENDS products. Former CTP Director Mitch Zeller joins the advisory board of Qnovia, a “platform pharmaceutical” company that is developing a prescription inhaled smoking cessation therapy.
April
Credit: Jo Panuwat D
Malaysia removes e-liquid containing nicotine used in e-cigarettes and other vaping products from the country’s Poisons List of controlled substances. Greentank Technologies closes a Series B financing round worth $16.5 million with a “strategic investor group” that includes BAT-funded Canadian cannabis producer Organigram Holdings. Vuse’s U.S. market share rises from 41.5 percent while Juul’s declines to 26.1 percent. Altria’s youth marketing suit in California begins. The U.K. announces plans to give 1 million smokers free vaping starter kits to encourage them to give up tobacco products. Juul Labs settles youth marketing lawsuits with six states, bringing the total of state settlements to 45 states, with a combined price tag of more than $1 billion. Panama rejects a proposal to regulate vaping products. The High Court of Justice in London rules that Philip Morris Products’ patents protecting its tobacco-heating technology are valid. Delaware becomes the 22nd U.S. state to pass a recreational marijuana bill. Altria’s youth marketing suit in California begins.
May
Credit: MdIqbal
Australia announces that it will ban the importation of all nonprescription vaping products, including those that do not contain nicotine. R.J. Reynolds sends letters to several small vape shops threatening to sue them if the shops do not stop selling flavored vaping products. A U.K. report shows inmates are spending more than £7 million ($8.5 million) a year on e-cigarettes. Logic Technology challenges the FDA’s marketing denial of its menthol vape products. Altria strikes a $235 million deal to end a California lawsuit alleging that the company marketed vaping products to youth. Flonq launches the world’s first fully recyclable vape device—the Flonq Plus-E. Yolonda Richardson succeeds Matthew Myers as president of Tobacco-Free Kids. The FDA issues “Import Alert 98-06” detaining new tobacco products such as e-cigarettes without marketing authorization at the border. Altria completes its purchase of Njoy.
June
Credit: Timothy S. Donahue
Hawaiian law makes shipping of vaping and other tobacco products valued at more than $10,000 a misdemeanor. ANDS launches Slix, a disposable vape that it says is 99.29 percent recyclable.
Bidi Vapor sends the initial shipment of Bidi Sticks to over 900 Kwik Trip and Mapco locations.
A federal appeals court rules that the FDA acted reasonably in denying Magellan Technology’s application to market flavored vaping products.
The FDA issues warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands. Zanzibar bans the use and imports of vape products. The CTP announces that it has made significant strides in putting its Reagan-Udall Foundation recommendation-based plan for improvement into action.
July
Credit: Ascannio
Juul Labs asks the U.S. International Trade Commission (ITC) to block sales and imports of the Njoy Ace vapor device, claiming that the product infringes several Juul patents. The FTC dismissed the complaint against Njoy parent Altria Group for its purchase of a 35 percent stake in Juul Labs after Altria’s pullout. New York City accuses Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. of racketeering for selling illegal flavored vapes. Jason Carignan moves to Chemular. The FDA gives the Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on the smoking behaviors of current adult smokers. Philip Morris International acquires Syqe Medical, an Israeli company, for an estimated $650 million. Juul Labs submits a PMTA to the U.S. FDA for the Juul2 system. China’s State Tobacco Monopoly Administration releases the guidelines for vape exports. A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research. The FDA sends more warning letters for Esco Bars and Elf Bar sales. China vape exports top $3.36 billion for the first half of 2023.
August
Credit: Natanaelginting
Ukraine imposes a consumption tax on disposable vapes. Venezuela bans all vaping products. The Philippines passes a law forcing importers of raw materials for vaping products to seek special clearances to release shipments. High Light Vape, which sells a vape pen disguised as a highlighter, is lambasted by the media. Njoy asks the ITC to ban the import and sale of certain Juul products. New Zealand imposes new regulations to limit youth vaping. The Coalition of Asia Pacific Tobacco Harm Reduction Advocates launches its shadow report on the World Health Organization’s failing tobacco harm reduction strategy. Juul Labs announces a company restructuring aimed at reducing operating costs. Romania bans flavors for heated-tobacco products. Suriname bans the sale of all vaping products. The U.S. Court of Appeals for the D.C. Circuit sides with Fontem U.S. in a ruling that the FDA failed to conduct a proper analysis before rejecting some vaping product marketing applications.
September
Credit: Gevorg Simonyan
The U.K. Vaping Industry Association announces that it will exclude tobacco companies from its membership. Indonesia legalizes vaping. Esco Bars’ manufacturer files a lawsuit challenging the FDA’s import ban of its products. Vaporesso becomes the first licensed company to sell open systems in the UAE. New York opens state cannabis licensing to the public. The FDA sends warning letters to 15 companies that market products under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech. A massive fire destroys U.K. e-liquid and hardware brand Dinner Lady’s factory. Ispire announces that its fiscal year 2023 saw a 100.4 percent and a 10.9 percent surge in cannabis and tobacco vaping product revenues, respectively. Healthier Choices Management Corp. sues R.J. Reynolds Vapor Co. seeking royalties from sales of its Vuse Alto vape pens, chargers and pre-filled liquid pods, alleging the products infringe a patent. The FDA imposes civil money penalties on 22 retailers for the illegal sale of Elf Bar/EB Design products.
October
Credit: Maurice Norbert
Philip Morris International unveils LEVIA, a zero-tobacco stick for use with its IQOS heat-not-burn device. A new study, E-Cigarette Flavor Restrictions’ Effects on Tobacco Product Sales, finds that flavor bans boost sales of traditional combustible cigarettes. U.K. Prime Minister Rishi Sunak proposes a tobacco endgame plan. The U.S. Supreme Court declines to hear Avail Vapor’s arguments against the FDA’s regulatory authorization process. ECigintelligence reports that disposable e-cigarettes account for almost 40 percent of the global vape sector. The American Vaping Association ends operations; Greg Conley joins the American Vaping Manufacturers Association. The FDA declines to issue a marketing order for flavored Vuse Alto pods. Elf Bar changes its name to defy a U.S. import ban. Njoy files lawsuits against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable vaping products. Logic Technology Development loses a court appeal to halt the FDA’s ban on the company’s menthol-flavored pods. Czechia bans flavors for heated-tobacco products. Altria says a booming illegal disposable flavored vape market is causing a major decline in the sales of its authorized vaping products.
November
Credit: Chetroni
Italy’s Regional Administrative Court of Lazio (TAR) suspends a decree that would make CBD oil a narcotic substance until Jan. 16, 2024. The global vaping market will reach $93.94 billion in value by 2030, registering a CAGR of 16.27 percent from 2022 to 2030, according to Straits Research. BAT announces a $90.5 million investment in Organigram. Ohio becomes the 24th U.S. state to allow adult marijuana use for nonmedical purposes. Research from the United Nations suggests that toys are a much larger contributor to electronic waste than vaping products. The FDA again sends warning letters to online retailers for selling disposable products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars and Lava. The 10th Conference of the Parties (COP10) to the World Health Organization Framework Convention on Tobacco Control is postponed, officially due to unrest in the host nation, Panama.
Louisiana’s state Office of Alcohol and Tobacco Control releases a list of nearly 400 approved vape products for legal sale in the state. Juul Labs raises an estimated $1.3 billion in funding. Ispire Technology reports revenue of $42.9 million and gross profit of $6.9 million in the quarter that ended Sept. 30. The FDA increases the penalties for violations of federal nicotine product laws. PMI expands IQOS Iluma in the Middle East. New Zealand’s new coalition government announces a cancelation of the country’s controversial generational tobacco ban. The Foundation for a Smoke-Free World, which was originally funded by PMI, says it will no longer accept any monetary support from the nicotine industry. The WHO announces the dates for the resumed in-person sessions of COP10 for February 2024. Australia will ban imports of disposable vapes beginning Jan. 1, 2024. France plans to ban disposables by 2025.
December
Credit: Oleksii.
(Editor’s Note: This magazine went to press in December, so the month may be incomplete.) The FDA announces that it is now estimating that completion of PMTA reviews may be delayed as the agency considers the D.C. Circuit’s opinion in Fontem U.S. v. FDA, affirming in part and vacating and remanding in part MDOs for certain vaping products. U.S. House lawmakers demand information from federal officials on what they are doing to stop the influx of kid-appealing electronic cigarettes from China. Mexico’s Supreme Court of Justice rules that the presidential decree banning the sale of e-cigarettes is unconstitutional. The FDA announces that it has filed civil money penalty complaints against 25 brick-and-mortar and online retailers for selling unauthorized Elf Bar, EB Design and other e-cigarette products. France’s National Assembly unanimously approves a bill to ban single-use electronic cigarettes. Vuse’s market share rose from 41.5 percent to 42 percent, surpassing No. 2 Juul which dropped from 24.7 percent to 24.3 percent. Guam proposes rules to stiffen the fees and penalties for vape sales to minors.
Looking ahead
It’s impossible to predict what the vaping industry will look like by the end of 2024. Industry insiders expect regulators to crack down on disposable vaping products, and misinformation will likely continue to run wild.
The U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, globally, especially in the EU and the U.K., the industry should continue to thrive and expand. More importantly, innovation should continue to thrive outside the U.S.
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, predicted at the end of 2022 that the FDA’s policy on vaping products would continue to be characterized by regulatory paralysis and the search for the least politically controversial regulatory option, and the industry wouldn’t hear rulings on many PMTAs until 2024 or later. He was correct on both counts.
Looking forward to 2024, Conley told Vapor Voice that the vaping industry should expect a turbulent ride, particularly in the United States. He predicts that the most significant hurdle remains the FDA’s CTP.
“Under the current leadership of Brian King, the agency’s stance toward vaping products has become even more antagonistic despite a drop in youth vaping to its lowest levels in a decade,” said Conley. “This tension is heightened by ongoing court cases that might force reforms within the CTP, but these changes are likely to be met with considerable internal resistance and intransigence.
“Those in the industry should not be naive. The regulatory landscape in the U.S. for vaping businesses, regardless of their size, is likely to get worse before it gets better. This is a hard truth we need to brace for.”
Beyond the federal level, a critical challenge will continue to come from state governments and major tobacco companies like Altria and R.J. Reynolds. The rise of synthetic nicotine-containing disposable vaping products, which are impacting cigarette sales and the vapor market shares of the major tobacco companies, is leading to a push for state-level PMTA registries, according to Conley.
“In essence, these bills seek to deputize state regulatory agencies to behave as mini-PMTA enforcement divisions. The true effect of these registries is to ban all products that submitted their PMTAs after September of 2020. In plain English, this means nearly every disposable vaping product on the market becomes illegal to sell,” Conley explains. “Such measures have already been implemented in Alabama, Oklahoma and Louisiana, leading to a disruption in the market dynamics. Law-abiding retailers and average adult consumers are suffering as a result.”
Globally, Conley predicts that the vaping industry will continue to go up against well-funded prohibitionist campaigns spearheaded by organizations bankrolled by Michael Bloomberg. However, there’s a silver lining: The evidence supporting regulation over outright bans continues to grow.
“I’m cautiously optimistic that we’ll see countries in Latin America and Southeast Asia begin to revisit their previous, misguided policies. Regrettably, however, the anti-disposable furor is likely to get even more heated in Europe,” said Conley. “For adult consumers looking for hassle-free nicotine consumption, there’s never been a better time than now. The market has evolved tremendously in terms of product quality and variety. However, the picture is starkly different for businesses in the vaping industry. Until there is real reform that regulates the products adults want, like flavored disposables, being successful in this industry may require risking your livelihood and potentially your freedom.”
Conley said the industry must remain vigilant because regulatory challenges, particularly in the U.S., coupled with global policy shifts and market dynamics suggest that the industry’s path will be rocky in the short term. “The hope is for a future where nicotine control policies are grounded in harm reduction principles rather than mirroring a drug war,” he said. “However, we’re currently seeing a trend that veers toward the latter.”
World Tobacco Middle East Dubai remains the premier tobacco trade show in the region.
TR staff report
World Tobacco Middle East Dubai (WTME) is one of the oldest and most successful tobacco trade shows still operating. This year, the 2023 event continued that storied success. Held Nov. 27–28, 2023, the event featured the latest trends, innovations and products from around the world, according to a report by Wingle Group Electronics, a data resource firm.
The exhibition was also accompanied by conferences where experts and industry leaders shared their knowledge and experience.
This year, more than 7,000 visitors and more than 250 exhibitors from more than 90 countries made the WTME 2023 one of the most popular in the event’s history. WTME is the flagship exhibition of the World Tobacco series, which annually gathers over 13,000 professionals.
WTME is “where the past meets the future, and innovation converges with tradition, facilitating a rich tapestry of discussions that will influence strategies, policies and the very essence of the tobacco industry. It serves as a platform where knowledge is not just shared but cultivated and refined through collaborative discourse,” Orchid Tobacco Dubai wrote in a blog post.
“This exhibition is not just about showing tobacco products,” the company added. “It’s like looking into the future. You can expect to see new and better ways of farming tobacco, the latest technology in making tobacco products and smarter ways to get these products to people.”
With new exhibitors from HTL Human Trust Lean, Khyber Tobacco Co., Multi Tabak, Ora Tobacco and Mind Spirit Designs and Works as well as returning companies such as Sopariwala, Kaane, ARD, Gulbahar and Premium Tobacco, WTME 2023 offered visitors an even wider range of products and services than previous years.
According to WTME attendees, WTME has helped to redefine industry standards, set new trends and shape practices in the tobacco industry. The gathering is not just about showcasing products; it’s a dynamic exchange of ideas and a catalyst for transformation.
Getmore Mangundu, managing director at Sub Sahara Tobacco, said WTME is a complete experience that goes beyond just doing business. “It’s been a very successful show for us; it has been quite an exciting time,” she told Quartz Media representatives. “We’ve managed to catch up with our old clients but also managed to meet some new clients in this [industry] from all over [the world].”
One of the best attributes of WTME is that the show is a place where the old meets the new, where innovation meets tradition and where discussions take place that will influence the strategies, policies and the essence of the tobacco industry. Yohanes Priatama, brand and marketing manager for BMJ, said the WTME platform fosters collaborative discourse that cultivates and refines knowledge rather than just sharing it.
“The presence of our brands is very important for us,” he said. “It’s the right place to make new connections.”
CoEHAR’s REPLICA Project evaluates nicotine-related science to ensure that policymakers and the public receive correct and reliable information.
By Stefanie Rossel
Riccardo Polosa
Nicotine products, stakeholders agree, should be regulated based on scientific evidence. Unfortunately, an increasing volume of research underpinning policy appears to be based on questionable science, where researchers are unable to replicate the results. This “reproducibility crisis” occurs across various disciplines, including psychology, medicine and natural sciences. The phrase was coined in the early 2010s, and efforts to remedy the problem have led to the creation of a new scientific discipline, meta science.
To tackle the reproducibility crisis in the nicotine sector, the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR) in November 2019 launched the REPLICA Project, an initiative to independently validate the results of e-cigarettes and heated-tobacco products (HTP) studies.
“Annually, billions of dollars are poured into biomedical research, yet more than half of these studies cannot be replicated due to flawed experimental designs, inadequate methodologies and faulty statistical analyses,” explains Riccardo Polosa, the founder of the CoEHAR, who also is a full professor of internal medicine in the Department of Clinical and Experimental Medicine of the University of Catania in Italy. “Bad science holds back medical progress,” he says. “The challenge of replicability is widespread, spanning numerous scientific domains, including the field of THR.”
According to Polosa, the problem is amplified due to the contentious nature of tobacco and nicotine. “Often, the focus seems more centered on perpetuating controversy rather than prioritizing public health concerns,” he says. “The unfortunate reality is that there appears to be minimal interest in resolving the replicability crisis within the field of THR science, as it may conflict with the mainstream anti-THR narrative.”
Unique Approach
The REPLICA Project replicates published in vitro toxicity studies with the help of seven research laboratories spread over various countries, including the U.S., Indonesia and Serbia. According to Polosa, this approach is unique. “Its success hinges on complete harmonization between these research labs, necessitating ongoing international training, adherence to standard operating procedures and uniformity in lab equipment/material,” he says.
“We uphold the highest tobacco research standards, employing ISO-regulated setups for smoking/vaping laboratories and approved standardized smoking/vaping machines in our replication studies. While you cannot directly compare the REPLICA’s approach with the individual studies we replicate, many of the studies we aim to reproduce lack adherence to the best tobacco research standards. They often overlook smoking/vaping laboratory standards regulated by ISO guidelines and resort to unregulated homemade smoke/vape machines. Our methodology aligns with the open science principle—in contrast to the works we assess, which frequently present methodological ambiguities and sometimes obscure interpretations of data.”
According to Polosa, the advantage of REPLICA’s cooperation model lies in the consensus reached when results from one laboratory align with those from others. This, he says, ensures a more reliable basis for new knowledge. Replication, Polosa adds, bolsters confidence in scientists’ findings.
“Furthermore, this networking model of multiple research labs united in pursuing a common objective fosters unique opportunities for knowledge sharing and building capacity, thereby ensuring elevated standards in THR research,” says Polosa. “In line with [the] CoEHAR vision and mission, nascent labs in low-[income] and middle-income countries can connect with the REPLICA consortium, providing them with the chance to thrive. Specifically, young researchers from Serbia and Indonesia have been offered CoEHAR mobility training programs at the University of Catania under the guidance of REPLICA researchers.”
Promoting Understanding
In the first phase of the REPLICA Project, which ran until 2022, researchers replicated seven studies. The project initially focused on independently verifying science published by the tobacco industry. As it gained expertise, the project also began evaluating papers published by academia in scientific journals.
“Each decision to replicate a study revolves around identifying topics vital for better understanding of the THR paradigm and for improved protection of human health,” explains Polosa. “In addition, feasibility considerations for all partners within the study’s framework become paramount. Although consideration about studies that appear to be flawed are secondary, we occasionally opt for studies that are partially well-executed, recalibrating inadequately set parameters. This meticulous approach aims to inform the scientific community, regulatory bodies and lay public with credible and comparable data that mirrors the normal condition of use of combustion-free nicotine products.”
In several studies, the REPLICA Project researchers were able to replicate outcomes. “Specifically, our investigations revealed consistent evidence indicating the reduced capacity of e-cigarettes and HTPs to induce cytotoxicity, inflammation, endothelial damage, genotoxicity and mutagenesis in human lung epithelial and endothelial cells,” says Polosa.
Other studies revealed irregularities, however. “We’ve pinpointed noteworthy methodological flaws in at least three recently replicated studies,” says Polosa. “For instance, one study encountered issues due to an inadequately supplemented culture medium, resulting into abnormal cytotoxicity in cells. In another instance, researchers used incorrect fluorochromes, hindering the clear distinction of adhesion events of inflammatory cells to the vascular bed. Lastly, flavors were vaporized at excessively high temperatures using a furnace instead of the intended vaping machine under standard conditions of use. These identified flaws are either in the process of being addressed or have been thoroughly examined and will be disclosed in forthcoming peer-reviewed publications.”
According to Polosa, the reported shortcomings relate not only to scientists’ mistakes but also the editors and reviewers who approved the publication of low-quality research.
Providing Accurate Information
Polosa says that CoEHAR’s researchers actively seek out the original authors to discuss methodological shortcomings and to request additional information with the goal of establishing productive collaboration and enhance the replication protocol. “Unfortunately, this is not as straightforward as it should be,” he says. “Previously, we encountered situations where authors offered only partial responses to our concerns, leading to increased confusion regarding their ‘irregular’ approaches in their scientific work.
“Regrettably, this lack of comprehensive information resulted in the abandonment of replication attempts in most cases. Often, eminent scholars in this field, despite their expertise, unintentionally make errors in their study approaches. However, some may hesitate to acknowledge or fail to grasp these errors. Through focused scientific engagement, our aim is to educate researchers, especially those new to the THR paradigm, facilitating a deeper comprehension of these intricacies.”
While the CoEHAR team hasn’t encountered many studies that warrant retraction, there have been instances that would justify such a course of action, like the most recent one investigated, which has not been published yet. “We’re considering this course of action pending discussions with the original author,” says Polosa. “It’s important to note that while some studies may not be inherently flawed, they might be inadequately aligned with the subject matter. For example, certain studies might provide valuable insights in other areas but fall short in their relevance to evaluating the effects of vaping. When the study setting is drastically different from the context of vaping, its conclusions can’t be responsibly applied to this specific practice. It’s akin to studying the impact of a bicycle accident at 350 km/h and then advocating to ban bicycles due to their perceived risk, a distortion of reality that fails to accurately address the intended subject.”
The project’s foremost objective, Polosa insists, is to provide accurate information to the public rather than preserving the reputation of the scientists behind the original studies. “While retractions aren’t taken lightly and involve careful consideration, our obligation remains toward ensuring the public and policymakers receive correct and reliable information.”
Phase Two
CoEHAR is funded by the Foundation for a Smoke-Free World (FSFW), which was financed exclusively by Philip Morris International until Oct. 20, 2023, when the organization announced it would no longer accept tobacco funding in an effort to address concerns about is independence. Polosa emphasizes that credibility of his team’s work is not an issue if REPLICA studies debunk original science. “Although we’re relatively new, our credibility is steadily building,” he says. “The strength of CoEHAR’s REPLICA project rests in its robust, high-quality research, consistently published in reputable scientific journals. Despite funding ties with FSFW, our project has swiftly garnered a positive reputation worldwide. This funding association doesn’t diminish our research’s significance. REPLICA’s growing scientific output unequivocally proves this point.”
Increased funding should be directed toward replication studies of THR products, notes Polosa. “Stakeholders need to commit additional resources to this vital research area,” he says. “We are grateful to the FSFW that has recognized the importance of replicability in science and has generously provided cutting-edge equipment and other resources, supporting our mission to reinvigorate replication science in THR.”
Engaging with media outlets to communicate findings from replication studies is an essential aspect of the project. “However, a significant challenge arises when the original study’s results were sensationalized, as there might be little motivation to rectify misinformation if the correction lacks the same attention-grabbing quality,” says Polosa.
He cites the example of the 2019 EVALI crisis in the United States, when an initially mysterious outbreak of lung injuries was at first erroneously attributed to nicotine vaping but later turned out to have been caused by adulterated (and illegal) THC products. Once the original, sensationalized narrative had spread, it became difficult to correct.
“Similarly, in the realm of in vitro toxicological studies investigated by the REPLICA researchers, algorithms often prioritize popularity over accuracy, complicating efforts to disseminate corrected information effectively,” say Polosa. “Despite these hurdles, our commitment remains steadfast in sharing our findings extensively with the public, academia and relevant stakeholders.
“While our replication efforts are starting to gain traction in shaping public opinion and influencing regulatory bodies, the primary goal of our studies is to assess ongoing and future research and prevent recurring errors within THR science. Ultimately, our aim through this correction process is to dispel substantial misconceptions about the health risks associated with combustion-free nicotine products. As we progress, we anticipate a reduction in sensationalized and inaccurate reporting by the media, leading to a more informed and balanced understanding among the public and policymakers.”
In 2023, the REPLICA Project entered its second phase, which among other things aims to align the project’s studies with academic research while elevating the complexity level. “Our focus is on replicating and expanding studies conducted in collaboration with partners,” says Polosa.
“Specifically, we’ll conduct thorough screenings for cytotoxicity and mutagenicity, examining increasing concentrations of most common vaping flavors. These results aim to ascertain the safety of these flavors and their concentrations for inhalation. Within our REPLICA 2.0 project, we aim to shed light on the potential impact of nicotine on cancer development. Employing a comprehensive approach, we’ll utilize various assays to screen for carcinogenicity. Regulatory bodies like the U.S. Environmental Protection Agency and the International Agency for Research on Cancer heavily rely on these models’ data to classify substances and make informed regulatory decisions.”
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.
BAT’s write-down of its U.S. cigarette brands is a positive step in its journey toward a resilient future.
By Richard Haigh
Earlier this month, BAT announced a $31.5 billion impairment on the value of some of its U.S. cigarette brands. The affected brands, including Newport, Camel, Pall Mall and Natural American Spirit, will see their value on BAT’s balance sheet adjusted to a finite lifetime of 30 years, resulting in a noncash impairment charge. This signifies the first instance where a major global tobacco company has written off some of the value of its traditional cigarettes business in a significant market such as the United States.
BAT’s write-down highlights the challenges faced by traditional tobacco businesses in the wake of evolving industry dynamics. BAT attributes the move to economic challenges in the U.S., where inflation-weary consumers are shifting to cheaper brands, as well as the rise of illicit disposable vapes. Furthermore, intensifying regulatory environments and the heightened awareness of health risks have resulted in a decline in cigarette sales volumes in certain markets. These are predicted to continue to fall, with BAT adding that global tobacco industry sales volumes will be down around 3 percent in 2023.
Responding to Change
The decision to write down the value of some of its brands was a bold step for BAT because, despite the short-term pain, the reality is that the market for cigarettes is shrinking, and pretending otherwise would be irresponsible on the part of management.
In the past, failure to embrace change has decided the fate of several top brands. Blockbuster, a giant in the video rental industry with thousands of stores worldwide, failed to recognize the shift toward online streaming and mail-order DVD services. In 2010, Blockbuster filed for bankruptcy, unable to compete with the likes of Netflix. Kodak, which resisted the shift to digital cameras, suffered the consequences, filing for bankruptcy in 2012. Nokia, once a dominant force in the mobile phone industry, struggled to adapt to the rise of smartphones and the popularity of app ecosystems. Nokia’s market share declined rapidly, and eventually, it sold its mobile phone business to Microsoft in 2014. These all serve as cautionary examples.
BAT’s move is crucial in the context of the company consciously steering away from potential pitfalls, showcasing a commitment to survival and growth in new categories. The company is already investing heavily in alternative products, focusing on vaping and oral nicotine and wants 50 percent of its revenues to come from these by 2035.
Appointed CEO in May 2023, Tadeu Marroco has played a crucial role in guiding the company through a transformative phase, emphasizing growth in emerging categories such as vapes and e-cigarettes.
Correlation Between Leadership Tenure and Impairments
Tadeu Marroco assumed the role of CEO in May 2023. Having previously served as BAT’s finance director, Marroco has played a crucial role in guiding the company through a transformative phase, emphasizing growth in emerging categories such as vapes and e-cigarettes.
The correlation between tenure length and significant impairments is an interesting one to note. When assessing 2019’s largest impairments, a common thread emerges: new leadership, as depicted in the charts accompanying this text. In this context, BAT’s decision is not an isolated incident but rather a strategic response to industry challenges, reflecting a broader pattern observed in companies experiencing changes in leadership.
When looking at 2019’s biggest goodwill impairments, except for Procter and Gamble and CenturyLink, all companies listed had either a new CEO, a new chief financial officer (CFO) or both. Most of these companies’ previous leaders decided not to take an impairment in 2018. CenturyLink did take an impairment in 2018, when it also had both a new CEO and CFO. Therefore, new leadership appears to have a significant impact on the likelihood a company will impair its goodwill. Among the entire sample, we found that 30 percent of all impairments occur within the first year of having a new CEO or CFO.
For larger impairments, where the impairment represents at least half of the goodwill carrying amount, 41 percent of these occur within the first year of new leadership. At best, this analysis suggests that goodwill impairment can be influenced by varying personal opinions of management personnel and their perceptions of outlook and risk. At the worst, this analysis suggests that there may be an ulterior motive within the decision to impair goodwill. By taking an impairment at the beginning of your tenure as a CEO or CFO, it helps you to either set a precedent that suggests your predecessor was negligent/overoptimistic about their acquisitions or influence the share price to fall initially then rise throughout the rest of your tenure.
Given these insights, the timing of the impairment—just nine months into Marroco’s tenure as CEO—aligns with broader trends observed in companies with leadership changes. Adding to the leadership transition, BAT has recently appointed a new CFO, scheduled to assume the role in April 2024.
Looking Ahead
BAT’s impairment announcement should be viewed as a positive and necessary step in the company’s journey toward a resilient future. Rather than focusing solely on the financial implications, stakeholders should recognize the strategic foresight behind this decision.
However, the industry is consistently grappling with challenges. Plain packaging laws have notably evolved, gaining increased comprehensiveness in some countries. These regulations now extend their coverage from traditional tobacco products to encompass heated tobacco, tobacco accessories and other nicotine-containing items. Adding to the recent developments, this month, the World Health Organization has shifted its focus to vaping, urging governments to apply tobacco-style control measures to address this emerging concern.
Therefore, BAT and other tobacco companies must proactively adapt their strategies, leveraging innovation and regulatory compliance, to navigate the evolving landscape and ensure long-term success in an industry marked by ever increasing health-related safeguards and regulatory barriers.
Richard Haigh is group managing director at Brand Finance.
Producing tobaccos with ‘minimally addictive’ levels of nicotine presents significant challenges for breeders and growers.
By Stefanie Rossel
In recent years, several countries have been considering mandates for manufacturers to reduce nicotine in combustible tobacco to “minimally addictive levels”—that is, under 0.5 mg/g. By decreasing the habit-forming ingredients, the thinking goes, cigarettes will become less attractive and consumption will decrease.
A webinar organized by Coresta on Dec. 5, 2023, highlighted the current understanding of LNT production capabilities as well as the successes and failures of applied research in the areas of genetics and agronomy.
Ramsey Lewis, a university faculty scholar at North Carolina State University in Raleigh, North Carolina, USA, spoke about the opportunities offered by modified plant genetics to reduce tobacco nicotine levels. A standard cigarette filler contains 15 mg to 25 mg of nicotine per gram or 1.5 percent to 2.5 percent, he noted; the World Health Organization recommends a 35-fold reduction, which corresponds to 0.4 mg/g or 0.04 percent of nicotine.
Nicotine is the most abundant alkaloid in tobacco, accounting for 90 percent to 95 percent of the alkaloid content. As alkaloids are natural plant products, nicotine levels in a tobacco variety depend on genetics and the environment. In the U.S. Nicotiana tabacum collection, there are several lower nicotine species. A decrease in nicotine, however, means an increase in nornicotine, a carcinogenic tobacco-specific nitrosamine.
Lewis described various low nicotine genetics experiments his team had conducted in 2023, where different known nicotine-expressing genes had been inactivated. While a transgenic approach got them close to a 0 mg nicotine content, the plants in the field were dramatically reduced. In addition, the LNT was high in nornicotine, and its cured leaf quality was altered—both side effects that regulatory authorities wouldn’t accept, Lewis explained. His experiments, which also included a greenhouse trial, showed altered gene expression and altered physiology in low-nicotine plants.
Plants are living things and complex, Lewis pointed out, which results in several issues for tobacco growers and buyers of low-nicotine tobacco. At present, there are only a small number of commercially available varieties, which means that if LNT was suddenly mandated in a market, the regulation could practically not be translated into action.
Nicotine is also the natural defense mechanism of tobacco plants. The lower its content, the more the plant is susceptible to disease and insect pests. Lower nicotine also results in lower yields and higher production costs. In addition, Lewis predicted global issues with the “new breeding methodology” and problems with co-mingling. He also raised the question of what should be done with tobacco containing more than 0.4 mg/g of nicotine.
An Ambitious Target
Anna Malpica, breeder and R&D manager of Bergerac Seed and Breeding (BSB), a seed company owned by the French growers’ association, introduced her organization’s breeding programs for low-nicotine and ultra-low nicotine tobacco varieties and evaluated the impact of lower alkaloid lines on plant defense. BSB focuses entirely on practical breeding projects. Being based in Europe, the company uses non-GMO and non-gene-editing techniques in its programs. For LNT, the breeder target is to achieve reduced and stable nicotine levels with an industrial variety.
Nicotine is synthesized exclusively in tobacco roots, transported to leaves and stored in the leaf cell vacuole to protect the plant when it is stressed. The biggest stress for the plant occurs during topping, which is done to reduce the dry matter production in the leaves and improve the plant’s quality. The genome sequence of tobacco provides a large inventory of structural and regulatory genes involved in the now well-known and described nicotine pathway, Malpica related. Researchers benefit from ever more precise studies that quantify the influence of the production environment and the crop management on the nicotine rates in tobacco leaves.
In its plant breeding strategies for low-nicotine and ultra-low nicotine flue-cured (FC) tobaccos, BSB resorts to three key raw matter sources: a germplasm collection including wild tobaccos with nicotine levels of 0.01 mg/g to 3.97 mg/g; U.S. FC historical lines; and short-cycle, ripening breeding lines originating from North Europe. The shorter the plant cycle, the less nicotine accumulation is observed in the plant, she noted.
BSB creates large segregating populations from the best seeds, applying strong selection pressure oriented on nicotine rates. It also secures and selects yield quality and some target resistance genes. The objective is to obtain low-nicotine varieties with nicotine levels under the company’s threshold of 10 mg/g. For its ultra-low nicotine breeding programs, BSB adds lines with mutations as initial donor material. The company is capable of breeding very-low nicotine lines with a controlled average nicotine rate of under 1 mg/g. A look at BSB’s low-nicotine breeding activities between 1997 to 2023 revealed that the threshold of 0.4 mg/g has not been reached yet in BSB’s usable lines, though.
In 2023, the company investigated the impact of low-nicotine breeding on yield, quality and plant defense in a trial using burley, dark and FC varieties. On average, no decrease of yield was observed in the low-alkaloid (LA) varieties. BSB says it has been able to compensate for the genetic yield decrease of the LA lines by population breeding. This, however, could not make up for the lower quality, which on average declined by 24 percent. The lowest nicotine level was obtained in an XC stalk position with 1.5 mg/g in a burley variety. Higher nicotine varieties were less susceptible to budworms whereas there was no significant impact of the nicotine rate on the plants’ susceptibility to the tobacco flea beetle. The role of nicotine on the plant defense front, researchers presumed, may vary from one insect species to another.
In conventional breeding, Malpica concluded, low nicotine levels of 5 mg/g to 15 mg/g can be obtained with conventional breeding and adapted agronomical practices. They are available from BSB as commercial varieties. Ultra-low nicotine contents of under 0.4 mg/g with acceptable behavior regarding quality and aroma, however, seem difficult to achieve with stability from conventional breeding and are not part of BSB’s portfolio yet.
Time of Topping
T. David Reed, extension agronomist for tobacco at the Virginia Tech Agricultural Research and Extension Centers, provided a closer look at the agronomic practices impacting nicotine concentration of FC tobacco. He referred to a 2019 study by Henry, Vann and Lewis, which suggested that proposed regulations mandating lower nicotine concentrations in tobacco products would likely require changes in tobacco production while maintaining yield and quality.
In standard FC tobacco production practices, Reed pointed out, a population of 13,600 plants per hectare to 16,100 plants per hectare is typical. The topping height is between 18 leaves to 22 leaves per plant, and the total number of leaves amounts to around 296,000 per hectare.
Topping is a standard production practice, and its timing impacts yield and sucker control. When topping is delayed past the early flower stage, a yield loss of 17 kg per hectare per day may occur. With late topping, the cured leaves are thinner and less bodied.
Regarding fertilization, nitrogen is the most responsive nutrient in terms of tobacco yield and quality. The nitrogen fertilization rate is determined based on soil texture and depth to a clay layer as well as field history. The recommended nitrogen rate is 67 kg to 90 kg per hectare but can be as high as 112 kg/ha.
While tobacco is relatively drought tolerant, it is responsive to rainfall and irrigation, with too much rain being a more common occurrence. Unlike other crops, such as certain grains or soybeans, tobacco is not as dependent on timely rainfall to produce an adequate yield. Dry conditions paired with high temperatures can impact cured leaf quality and leaf chemistry.
According to Reed, the number of harvests or primings has decreased in recent years. For most growers, three harvests are typical; some harvest four times. The time from topping to harvest can range from 8 weeks to 14 weeks or more on a given farm.
Tobacco growers, Reed emphasized, choose their agronomic practices in order to maximize their yield potential of high-quality, marketable tobacco. Leaf chemistry, sugar or nicotine content are not part of their consideration.
Reed quoted three studies by Caleb Hinkle that investigated plant population, topping time and topping height of low-nicotine FC production practices in field trials in 2019 and 2020 as well as a collaborative Coresta study of the low-nicotine tobacco agronomic production practices task force. Modified production practices with low-nicotine FC varieties, he concluded, did not consistently reduce nicotine to the proposed target levels. While plant population, topping height and nitrogen fertilization rate had minimum impact, delayed topping had a significant effect, with no topping having the greatest impact on nicotine. Not topping tobacco, Reed stressed, is not commercially viable in the U.S. The growing season was a major factor on nicotine levels. Both yield and leaf quality, as currently measured, were significantly lower with low-nicotine flue-cured varieties. Leaf texture and body were altered, which impacts the handling of the cured leaf.
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.
Making e-cigarettes available only on prescription may be a net negative for public health, writes Neil McKeganey.
By Neil McKeganey
In response to the rising level of vaping there have been discussions in the U.K. and elsewhere about making e-cigarettes available on prescription only. Within the U.K. Wes Streeting, shadow secretary for health and social care, recently announced that an in-coming Labour government would consider such a restriction as a way of reducing youth vaping.
There is now clear evidence that e-cigarettes are both popular among smokers and that they can help smokers to quit. Alongside such positive evidence there is also the downside of rising numbers of young people using these devices irrespective of whether they are smoking.
Whilst making e-cigarettes available on prescription may seem like an effective way of reducing youth use of these devices, the reality could prove very different. The fact that young people—including some below the legal age of purchase—are vaping underlines the reality that there are more routes to obtaining these devices than legal sale.
It is entirely possible that even in a situation where e-cigarettes were available on prescription only that some young people would still source these devices through illicit routes. Whatever the impact on youth vaping, making e-cigarettes available only through prescription would reduce adult smokers access to these devices. In the event that such a policy were implemented, some adults would certainly go to their doctor seeking a prescription for these devices. Others, however, would be less inclined to go to their doctor. Some of those might source their e-cigarettes through illicit supply whilst others would simply continue to smoke.
There is a further reason why making e-cigarettes available on prescription only may have a downside. Research has shown that using e-cigarettes can increase the likelihood of smoking cessation even when the individual had no prior intention of quitting. Analyzing data from the widely respected Population Assessment of Tobacco and Health study in the United States, Professor Karin Kasza and colleagues from the Roswell Park Comprehensive Cancer Center found that adult smokers who had no prior interest in quitting smoking still stopped smoking in impressive numbers following their use of an e-cigarette. Such “accidental quitting” has been found in other studies, with Professor Riccardo Polosa and colleagues in Catania, amongst others, showing that simply providing smokers with access to e-cigarettes helps many to quit even where they have expressed no prior interest in quitting.
As is so often the case when it comes to regulating e-cigarettes, the question is one of how to balance the needs of young people, who ought not to be using these devices, with the needs of adult smokers who may benefit from their use. Whilst making e-cigarettes available on prescription only may reduce some young peoples’ use of these devices, regrettably it may have the same if not greater effect on adult smokers.
The public health goal of reducing smoking is too important to implement a policy that may be less effective than one might hope in reducing youth vaping whilst actually reducing adult smokers access to these devices. The challenge facing manufacturers, regulators and health educators is one of finding a way to reduce youth access to these devices whilst at the same time ensuring that any adult smoker wishing to use an e-cigarette can do so with the least possible difficulty. Requiring adult smokers to seek an appointment with their doctor before they can legally access an e-cigarette device is to place a huge barrier in the way of wider e-cigarette use by smokers and wider intended and accidental quitting on the part of those adult smokers. This is a restrictive regulation that needs to be given serious consideration before being implemented.
Neil McKeganey is the director of the Center for Substance Use Research in Glasgow, Scotland.
While biodiversity is quickly becoming the new climate change in terms of the growing recognition of and urgency around this topic, it presents significant challenges for companies whose business relies on nature.
According to the 2023 Global Risks report by the World Economic Forum, biodiversity loss and ecosystem collapse are the main risks that will appear in a 10-year horizon. With half the world’s GDP highly dependent on nature, we can now see the same trend of goals, target-setting and regulations that were created to address climate change happening to address nature loss but much faster.
Because climate change and biodiversity are highly interconnected, it is difficult to address climate change without taking biodiversity into consideration. Any company relying on agricultural production strongly depends on nature resources and ecosystem services. Discussing how to halt and reverse nature loss is key to securing a resilient supply chain.
Investors are also paying ever greater attention to biodiversity in terms of their assessment of a company’s ESG risks. Investors have different levels of understanding and ambition when it comes to nature. BAT aspires to shape the narrative together with investors, utilizing the available supporting tools, frameworks and data.
In addition, biodiversity-related reporting requirements are growing, demanding that companies dedicate significant resources to this. In 2023, for example, BAT plans to start disclosures aligned with the Taskforce for Nature Related Disclosure while working through water and land guidance for target-setting aligned with the Science Based Target Network. Both frameworks are important tools to standardize the way companies report and enable companies and investors to have greater insights.
Both these frameworks are currently voluntary, but they are already starting to feed into standards, and we are seeing the first signs of these approaches being encapsulated in law, for example through the EU’s Corporate Sustainability Reporting Directive. The EU has started engaging with the main workstreams around this, and its laws are likely to influence legislation in other jurisdictions.
The proliferation in sustainability requirements can also contribute to potential ESG reporting “fatigue.” My view is that biodiversity is nothing new; it is a way to address existing climate change commitments and environmental risks. Since the external environment shows biodiversity is an emerging topic to follow, companies need to decide whether they wait for regulations to enter into force or get ahead by exploring and understanding the topic before that happens.
At BAT, as with any other material topic as identified through our double materiality assessment, we define what “good” looks like, set our ambition and then resource it accordingly. Sustainability is such a wide topic that each company needs to continuously and ruthlessly prioritize its focus area and create a roadmap to deliver against it. Biodiversity is no different.
We began with assessing the materiality of biodiversity loss by conducting a Biodiversity Footprint Analysis as well as Geospatial Biodiversity Risk Assessment in 2022, combining different aspects of biodiversity to classify the farms of our directly contracted farmers as low risk, medium risk or high risk to biodiversity. This exercise supported us on designing and implementing more than 700 Biodiversity Management Plans together with our farmers for the farms that were classified as high risk. This has been a great educational tool for the farmers and our field technicians, and at the same time it provided guidance, based on data, as to where we should be putting more efforts.
There are major differences, however, in terms of how we adapt our approach to the varied challenges in each region. Unlike climate change, where the ultimate metric is greenhouse gas emissions, there is no equivalent metric to measure biodiversity. Challenges in nature are location-specific, and an adverse action for biodiversity can have different impacts depending on the location and the significance of the ecosystem. Nature is not only our home but also the home of countless plants, trees, animals and insects.
When we started looking at biodiversity in this way, it became clear to us the importance of working with local stakeholders, communities and experts to make the most out of every initiative. In the case of forests and biodiversity, we have a long history of community-based afforestation programs. Here, our role has been to transform those initiatives to demonstrate that they are far more than just “corporate engagement.” For example, Bonayan in Bangladesh, a program spanning more than 40 years, supplied over 100 million saplings to the local communities during that period. The program, which currently has 18 afforestation, biodiversity and conservation initiatives in 13 countries, is now moving into Bonayan 2.0 to expand its impact on nature.
Through our integrated production system, we have been working with the farmers to protect biodiversity and forest resources, training them on sustainable agricultural practices and monitoring the sustainability of the wood used for curing.
BAT is making progress, though we anticipate much more work ahead to address biodiversity challenges. I predict soil conservation—marked on Dec. 5 each year by the United Nations’ World Soil Day—will become a key area of importance in biodiversity. The millions of organisms that live within soil support habitats for all species and life forms. The mindset that biodiversity is a philanthropic activity needs to change—biodiversity is not a “nice to have”; it is a “must have” to achieve prosperity in the future for the environment and society and to continue supporting our needs in the years to come. Simplification and alignment of metrics is also necessary; we cannot improve something we cannot measure.
Eirini Vlanti is head of sustainability and business development at BAT and holds a Master of Science degree in supply chain and logistics as well as completed a further business sustainability management course at Cambridge. She is heading the agribusiness sustainability department at BAT that engages with approximately 200,000 farmers annually in about 30 countries.
