Author: Staff Writer

  • Oral Tobacco

    Oral Tobacco

    New oral tobacco products have the power to dethrone cigarettes as the leader in nicotine delivery.

    Think of combustible cigarettes as dinosaurs. Regulators want them to become extinct. Next-generation oral tobacco products are like the furry little animals scurrying about under the feet of the dinosaurs. These small creatures have the potential to take over when the dinosaurs are gone.

    This analogy was presented to attendees of the recent Global Tobacco & Nicotine Forum (GTNF) by health behavior consultant Cheryl Olson while moderating the panel “Oral Tobacco Products — The Road Less Travelled … Until Now?” Olsen said that oral tobacco products are growing in market share and are less-risky alternatives to combustible cigarettes. However, getting consumers to make the switch to any less-risky product is difficult, especially an oral product that doesn’t mimic any of the properties of a combustible cigarette.

    Karl Fagerstrom, clinical psychologist at the Smokers Information Center in Sweden, said that a cigarette and an oral product are very different objects, and it can be difficult for smokers to switch from a cigarette to a pouch-style product that is designed to be held between the upper lip and gum. Smokers become addicted to the mouth feel and other properties of the cigarette, not just the nicotine. “The reason for this difficulty is that an individual’s dependence to a drug or whatever is tied to a product. Our brains are not craving an invisible substance but the object that contains the substance,” he explained. “In many circumstances, the individual may not even be aware of the dependence to the substance.”

    George Adams, cardiologist for Rex Healthcare at the University of North Carolina Chapel Hill, said that the behavior that goes into the thought process of people who smoke is more personalized than what most people would think. He explained that there are different reasons that people smoke and use these different types of nicotine-delivery systems. He said that a major difficulty in getting smokers to switch are the misconceptions surrounding nicotine in general.

    “There’s multiple different products. There are multiple technologies out there. Going from smokeless tobacco products to vaping, gums, pouches, tablets. I mean there’s a whole host of them rather than just the combustible cigarettes that we commonly know,” he said. “As a practicing physician, the thing is that we are not educated on these types of different products. When we think about beneficial effects of choosing products, to help our people who smoke, that causes detrimental effects.”

    Doctors are untrusting of the tobacco community, according to Adams. This has led to a disconnect between the science conducted by tobacco companies and health professionals. “I think it’s a detriment to the patients not to have a collaborative effort between the two entities to figure out the best solutions [to help people quit smoking]. We [doctors] are ignorant. We don’t have enough education in terms of the products that are out there and the benefit that they could possibly offer [to our patients],” said Adams. “We know that nicotine is a stimulant; how it affects at the cellular level. And there’s a large group of us—or physicians—that believe that all nicotine products are the same.”

    Fagerstrom said that the misconceptions surrounding nicotine are a detriment to public health. He said that many physicians and consumers wrongly believe that nicotine “causes cancer … is causing cardiovascular disease. He believes these misconceptions are the main reason next-generation tobacco products like oral have such difficulties gaining mainstream acceptance.

    Adams agreed that many doctors wrongly believe nicotine causes cancer. This makes it difficult for them to recommend any product that contains nicotine, even if a product is 95 percent less harmful than traditional cigarettes. He said the mistrust between the tobacco and health communities runs deep, and doctors do not understand all the different types of nicotine-delivery systems. “It’s a lack of education,” he said.

    Mohamadi Sarkar, scientific and regulatory strategist at Altria, said that oral tobacco products have been shown to be safer than combustible cigarettes. He said the vision of oral products is grounded in the foundation of the continuum of risk, which has not only started to gain acceptance in public health but has also been embraced by the U.S. Food and Drug Administration (FDA). “Combustible products are in the extreme end, and noncombustible products, including inhaler and oral products, are on the other end of the spectrum.”

    Sarkar showed attendees the results of a study he conducted on harmful and potentially harmful constituents (HPHCs) in oral products compared to traditional cigarettes. “The levels of many of the HPHCs are either not detectable or below levels of quantification. Harmful carcinogens and [other chemicals] are not even detectable,” he explained. “It’s not surprising that these products will completely either eliminate or substantially reduce the exposure to HPHCs, and if this is sustained on a long enough time period, we expect that they would also see a reduction in smoking-related diseases.”

    Olsen said she conducted two primarily web-based surveys for another oral tobacco product. She said that her studies found that 43 percent of the never-smokers perceived a high or very high risk of getting a serious illness from using [the oral product] versus 18 percent of smokers not planning to quit,” she said. “And similarly, half of the smokers not planning to quit saw low or no risk versus a quarter of the never-smokers.”

    Adams said the solution is education. The FDA needs to allow for better communication about the levels of risk in different types of tobacco products. Nicotine is dangerous and addictive, but if you [are] going to use nicotine, consumers should be able to choose the safest delivery method. “That is a testament to the lack of education that we have across the spectrum. You can’t just group everything together,” he said. “There may be a benefit with certain patient populations to get them off combustible cigarettes … but if you have a closed mind and your shutters are up, you’re never going to have the opportunity to help those patients because you don’t believe in them. It’s a lack of education.”

  • Innovations on the Horizon

    Innovations on the Horizon

    In their comparatively short time in the market, electronic nicotine-delivery systems (ENDS) have revolutionized the consumption of nicotine. While the next big thing in the category remains anyone’s guess, the continuous developing pipeline of these products shouldn’t be underestimated. In the early days, a lot of innovation was inspired by consumers; these days, new developments mostly come from the leading ENDS manufacturers.

    Regulations across the world have so far been rather friendly toward innovations, creating an open atmosphere for the industry to innovate, noted panelist Ming Deng, a professor at Yunnan University. In the U.S., the world’s largest market for e-cigarettes, which is often pointing the way for policymaking in other countries, all innovations are now regulated under the Food and Drug Administration’s (FDA) premarket tobacco product application (PMTA) guidance.

    Critics say the long-winded, costly PMTA approval process was inherently designed to stifle innovation. Jon Glauser, co-founder and chief strategy officer at Demand Vape, believed the market would adjust but that it would take time for U.S. consumers to get new products.

    Eve Wang, vice president of Shenzhen Smoore Technology Co., expected future innovation in the U.S. to focus more on demand of the existing consumer following FDA approval requirements. She was confident that U.S. consumers would still have choices for devices and e-liquids as companies could plan innovation rather than rushing into something.

    James Xu, CEO of Avail Vapor, said that with FDA approval as a barrier, small players would disappear, but bigger players would invest more. Furthermore, they were able to collect data in, for example, Asian markets in order to access the U.S. market. Development of new products, he stated, now was a more meaningful, thought-through process.

    While the time PMTA orders take to be processed (they can take up to two years) represents a major hurdle for innovations to be marketed, the guidance has led to significant investments in ENDS manufacturers’ in-house lab facilities, enabling them to better evaluate their products. Due to FDA regulation, the amount of scientific data and studies on ENDS has increased significantly, which panelists hoped would contribute to the public’s understanding and differentiation between ENDS and combustible cigarettes.

    For the switch from cigarettes to ENDS, flavor bans or partial bans in the U.S. were counterproductive, according to the panelists. A large variety of flavors offering former smokers more choice is pivotal to the category as only a small percentage of first-time switchers is interested in tobacco flavors. Besides, studies have shown that smokers who start using ENDS without tobacco flavors are more likely to stay away from combustible cigarettes. The benefit of flavor bans, however, was that they forced e-liquid manufacturers to work on their tobacco flavor liquids, Deng said. If that happened, he predicted a switch time 10 times as high as the current one.

    As far as ENDS sales in 2019 and 2020 are concerned, Glauser spoke of a perfect storm: Last year’s EVALI crisis, followed by partial flavor bans, PMTA regulation and the Covid-19 pandemic, have had quite an impact on the U.S. vapor industry. Jonathan Ng, global head of external affairs for Relx Technology, criticized the misinformation spread during the EVALI crisis, saying that more consumer education was needed and required to be allowed. For the better information of the public, Deng suggested publications on ENDS in leading magazines such as Nature whereas Glauser saw the responsibility of consumer education with the industry.

  • Population Modeling

    Population Modeling

    Population modeling has a major influence on the regulatory framework of tobacco products.

    Population modeling is a key component in meeting regulatory requirements for traditional tobacco and next-generation tobacco products, such as oral and electronic nicotine-delivery system products. Population modeling is a complex process that requires vigorous fundamental procedures for safeguarding clean data, proper computing platforms, suitable resources and effective communication.

    Saul Shiffman, senior scientific advisor of behavioral science, study design and analysis at Pinney Associates, said population health is at the center of the U.S. Food and Drug Administration’s (FDA) framework for regulating tobacco products.

    “We want to understand what the impact is of the entire population. And that includes people who perhaps are intended to use the product, such as the adult smokers, and people who are not intended to use the products, so those former smokers or perhaps youth,” said Shiffman. “So, there’s a balance of benefits and harms, and the purpose of modeling is to integrate all of those to look at the net effect.”

    Although there are many ways that researchers can implement population models, the basic principles are simple, according to Schiffman. The model defines the transitions or flows between the stages of tobacco use (going from being a never smoker to a smoker and going from being a smoker to being an abuser of cigarettes). “We start with a model that’s referred to as the base case—that is, what does the world look like now before a policy change or product introduction?” he explains. “And then, we contrast that to [a] counterfactual case, which is basically what do we expect to happen once this policy change or product introduction is implemented?”

    Everyone models. They just do it very informally, said Shiffman. “If you [or] someone has ever thought to themselves, ‘How much does the harm that a new product might do to youth compare to the benefit to adult smokers?’ you’re doing modeling,” he said. “You’re just doing it nonquantitatively, intuitively. [What experts] have done is to do it very systematically and quantitatively.”

    Ray Niaura, professor of social and behavioral science for the College of Global Public Health at New York University, said that conventional statistical analyses of data gathered is all about the past. It’s analyzing what happened, and by definition, the results are the results—it’s over and done with. However, population modeling is very different.

    “It’s very hard to look at what happened in the past and project that into the future without a formal toolbox and framework to do that, and that’s what modeling represents,” he said. “It’s really the tools that allow us to go from the past to the future, the multiple futures. Any other statistical analysis just does not permit it. So, that’s why population modeling is a great set of tools.”

    Population models are based on complex algorithms, according to Ryan Black, senior director of psychometrics, analytics and methods at Juul Labs. However, at its core, it’s quite straightforward.

    “It really is. It’s posing the question whether or not—in the tobacco regulatory research—more people are going to move down the continuum of harm versus move up, and it does a fair assessment, taking into account both beneficial pathways—that is, cigarette smokers switching exclusively to noncombustible products as well as initiation, as well as relapse,” he said. “But a model is only [as] good as its inputs.”

    Benjamin Apelberg, director of the Division of Population Health Science at the Center for Tobacco Products in the Office of Science at the FDA, said that Black touched on one of the more challenging questions faced by tobacco companies: trying to understand how new products, novel products, are going to behave once they’re on the market.

    “Ultimately, it tends to be a kind of triangulation of different types of information that can be informative in a premarket setting. Sometimes we see actual use studies, so over a short period of time trying to understand how consumers respond to a product. We’ve seen experimental studies, consumer perception studies trying to understand at least the marketing and the positioning of a product.”

    Schiffman said that while modeling is a powerful tool, it isn’t perfect. He said an example of the fallacies can be seen in most surveys pertaining to youth use. “I’m thinking here not about publications, but what’s in the press often neglects the fact that when they’re talking about use, they’re talking about any use in the past 30 days,” he said. “Someone who had a puff on a friend’s cigarette at a party is counted as a user, and that obviously leads to confusion because that has no health impact, and yet it’s what we count as use.”

    According to David Levy, professor of oncology at Georgetown University, models become useful in not what they tell researchers but in that they suggest what is important. “We live in a world that can be simplified … what models can do is get us started thinking about what factors are important,” he said. “They ultimately tell us what pathways are important.”

  • Republic Buys French E-Liquid Maker

    Republic Buys French E-Liquid Maker

    Republic Technologies International (RTI) has bought Innovative – So Good to expand the scope of its business. The acquisition bolsters RTI’s presence in the e-cigarette segment and establishes the company as a major player in premium certified French origin e-liquids.

    Based in Angouleme, France, Innovative – So Good manufacturers e-liquids and distributes equipment exclusively available through the tobacconists’ network.

    “So Good is a recognized brand and customers appreciate the high quality of its liquids,” said RTI Managing Director Olivier Partouche, who oversaw the purchase. “Thanks to the work of Cedric Lacouture and his teams, it has become a major premium brand available through the tobacconist network. The complementary nature of our E-CG liquids was obvious to us and this merger will help us further expand our product offering and enable us to support tobacconists as they grow this new segment.”

    “Our joining forces with Republic Technologies through the E-CG brand is excellent news for our customers,” said Lacouture, So Good’s founder. “In the short term, they’ll get access to a comprehensive offering of e-liquids, e-cigarettes and items for smokers. Of all the acquisition proposals that we received, [RTI’s] was the most persuasive as far as So Good’s future and its development are concerned.”

    For more than 150 years, the Republic Technologies group has been developing and manufacturing cigarette paper under the OCB, Job and Zig-Zag brands. Building on its industrial experience, the group has been selling e-liquids and vaping accessories under the E-CG brand since 2015.

  • Exposing Claptrap

    Exposing Claptrap

    Photo: Myriam Zilles | PixaBay

    If England wants to achieve its target of reducing smoking incidence to 5 percent by 2030, it should debunk the myriad stories that are presenting vaping in an inaccurately negative light.

    By George Gay

    One figure in a recent report on smoking habits in the U.K. seemed to be of special note. According to the report, “Adult smoking habits in the U.K.: 2019”*, which was published on July 7 by the Office for National Statistics (ONS), 52.7 percent of Great Britain’s smokers say they intend (my emphasis) to quit smoking.

    Only 52.7 percent? That is below the figures usually quoted in respect of the proportion of smokers who want to quit. For instance, according to the September 2018 edition of Public Health England’s (PHE) Health Matters, about 60 percent of England’s smokers wanted (my emphasis) to quit.

    So these figures raise an interesting issue, assuming the numbers are correct and are reasonably comparable*. For one thing, it seems odd that something of the order of 7.3 percent of smokers want to give up but don’t intend to do so because that means more than half a million people are seemingly acting irrationally, even looked at from their own subjective point of view. I mean, if our actions are observed by others, we are probably all seen to be acting irrationally at one time or another, but it is quite another matter for an individual to knowingly act in what she regards to be an irrational manner.

    There could, however, be another explanation for this phenomenon. It could be that roughly half a million smokers in Great Britain have decided that while they want to quit, they are so sure they cannot that they don’t intend to try. If these people are fatalist or determinists, so be it. But it is a different matter if they have been convinced that they cannot quit. And this could be the case. Some of those in tobacco control have seemingly done what they would consider to be an excellent job of convincing smokers that quitting is almost impossible.

    But this, of course, is nonsense. The ONS report also says that “62.5 percent of those who have ever smoked [in Great Britain] said they had quit, based on our estimates from the Opinions and Lifestyle Survey.” Interestingly, the ONS report presents, too, a comparison with the equivalent figure for 1974, 26.7 percent, which perhaps casts doubt on the claim that manufacturers in recent years have rigged formulations to make cigarettes more addictive—whatever more addictive might mean.

    In fact, you would have to doubt whether the 52.7 percent figure is meaningful. The report also says that 21.2 percent of smokers intend to quit within the next three months, so it has to be assumed the other 31.5 percent have put no time limit on their intentions. In this case, I would suggest that while the “intention” expressed by the 21.2 percent of smokers is akin to a student’s multi-colored study plan, the “intention” expressed by the 31.5 percent of smokers who are looking beyond three months is nothing more than a pipe dream.

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    Why it matters

    This is important for the authorities because England has a target of reducing its incidence of smoking to 5 percent or lower by 2030. As of last year, the ONS reports, the incidence was down to 13.9 percent, so if the proportion of smokers in England falls during the next 11 years by the same amount as it fell between 2018 and 2019 in Great Britain (14.7 percent to 14.1 percent), the target is not going to be met.

    The question is: Will the incidence fall by 0.6 of a percentage point year-on-year? In which case, it would drop to 7 percent to 8 percent by 2030. The ONS researchers referred to the 0.6 percentage point fall between 2018 and 2019 as “significant,” so it could be difficult to maintain such a fall every year given that it is probably reasonable to assume that the further the overall percentage falls, the more the smoker base will be reduced to a hard core. On the other hand, the further the overall percentage falls, the smaller the community of smokers will become, which raises the question of how long even committed smokers will continue with their habit once most of their acquaintances no longer join them outside the pub for a smoke.

    And, of course, there is the million-dollar question around what effect the spread of Covid-19 has had and is having on the incidence of smoking. How many smokers are going to believe those who suggest that smoking and/or consuming tobacco or nicotine can help prevent the onset of the disease, and how many are going to worry that, as some claim, smoking and/or the consumption of tobacco or nicotine is likely to make their health outcomes worse if they do contract the disease?

    But there is a billion-dollar question too. Are those intent on stopping smokers quitting their habit by switching to less risky tobacco or nicotine products going to continue to enjoy “success”? It has been said many times that the switch to vaping has stalled in the U.K., something that is strange because public health in the country has generally acted in a reasonably supportive way when it comes to vaping and its benefits. For instance, take this passage from Health Matters:

    “There is a widespread misconception amongst smokers and health professionals that most of the harm of smoking comes from nicotine. This is perhaps the greatest obstacle we face as it leads to both nicotine-replacement therapy (NRT) and e-cigarettes being perceived as harmful, and as a result, smokers may not make a quit attempt using one of these routes.

    Leading health organizations, including the Royal College of Physicians, Royal College of General Practitioners and the British Medical Association have all provided advice on the important role of e-cigarettes in helping smokers to quit.”

    One of the issues that holds smokers back from switching to vaping is that smokers enjoy smoking and will clutch at any straws that help them, in good conscience, to continue with their habit, so if somebody comes along and casts doubt on the safety of consuming nicotine by other means, they will latch on to that doubt, no matter how ludicrous the ideas on which that doubt is based are. As is described in the accompanying piece, even though the lung injury saga of 2019 played out in the U.S. and involved a substance not permitted for vaping in the U.K., it probably damaged the cause of vaping in the U.K.

    And there is no end to such tales. One story precis I saw recently claimed in its first sentence that “New research … shows that there are more unknown dangers associated with vaping.” What is written here makes no sense. More than what? And how do we who are not Donald Rumsfeld know that there are unknown dangers? In addition, the research seemed to assume that flavor molecules that attacked plastic would have the same effect on human tissue—somewhat akin to assuming that your stomach lining ends up looking like the inside of a teapot.

    I cannot help thinking that if progress is to be made in reducing the U.K.’s smoking incidence in line with its 2030 target, organizations such as PHE should, as well as continuing their helpful work in trying to publicize the positive aspects of vaping, act quickly to debunk in the public sphere the myriad stories that are presenting vaping in an inaccurately negative light.

    *The report’s figures come from two separate data sources, with those for the U.K. (England, Wales, Scotland and Northern Ireland) coming from the Annual Population Survey and those for Great Britain (England, Wales and Scotland) coming from the Opinion and Lifestyle Survey. I have taken the liberty of conflating some data in respect of Great Britain and England, and I have also conflated data that refers to adult smokers as being over the age of 16 and data referring to adult smokers as over 18. I have done this because it is the concepts behind the figures rather than the figures themselves that are of interest here.

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    Philip Morris’ progress toward a smoke-free England

    Picture of Patrick Muttart
    Patrick Muttart

    It is now about three years since Philip Morris posed the question, Can Britain go smoke-free in the next 10 years? and Tobacco Reporter in July took the opportunity of this anniversary to ask Patrick Muttart, director of external affairs for the U.K. and Ireland at Philip Morris Limited, what progress had been made.

    Tobacco Reporter: Part of the problem that Britain faced three years ago was that while vaping had helped a lot of people quit smoking, the switch from smoking to vaping had, for a number of reasons, stalled. Assuming that there has been some uptick in switching from smoking to the consumption of less-risky products, which products have been responsible for that uptick?

    Philip Morris U.K.: Smoking prevalence rates are falling in the U.K. as more people either quit cigarettes altogether or switch to alternative products. Official figures from the ONS [Office for National Statistics] in July show that the proportion of current smokers in the U.K. has dropped from 14.7 percent in 2018 to 14.1 percent in 2019—continuing a downward trend since 2011. Central to this decline has been the role of smoke-free alternatives, such as e-cigarettes and heated-tobacco and more recently nicotine pouches.

    In Great Britain, nearly 3 million people use an e-cigarette. Despite this, regular e-cigarette use has plateaued in recent years. A growing number of smokers in the U.K. mistakenly believe that vaping is equally or more harmful than smoking following the highly publicized reports in the U.S. of the lung injury outbreak in 2019. The substance identified as the primary cause of the outbreak in the U.S. is banned in regulated vaping products in the U.K. Nevertheless, these false fears have clearly affected smokers’ views towards vaping in the U.K. and come as the number of smokers who intend to quit continues to fall.

    With product development and scientific substantiation working in lockstep together, tobacco manufacturers must therefore offer smoke-free alternatives that adult smokers can have confidence in. This will go some way in easing safety concerns, so smokers aren’t deterred from switching if they cannot quit altogether.

    Philip Morris has invested significantly in its smokefree portfolio to offer products that are a better alternative to smoking and meet adult consumer preferences. IQOS, a heated-tobacco product, produces up to 95 percent less harmful chemicals* compared to cigarettes and by using real tobacco instead of liquid, delivers a more familiar and satisfying tobacco experience.

    In the U.K., heated-tobacco volumes during the second quarter of 2020 increased more than five-fold over the prior year quarter, demonstrating the growing popularity in the category while underlining the huge role that tobacco-based smoke-free products can play in helping people switch to less harmful alternatives.

    Do you think the U.S. Food and Drug Administration’s (FDA) authorization of the marketing in the U.S. of IQOS as a modified-risk tobacco product (MRTP) will help progress toward your smoke-free target in the U.K.?

    The FDA’s authorization of the marketing of IQOS in the U.S. is an important milestone on our journey to becoming smoke-free. It marks the first time that [the] FDA has granted MRTP marketing orders for an innovative electronic alternative to cigarettes.

    Following a multi-year review of PMI’s [Philip Morris International’s] evidence as well as a number of independent studies, the FDA decided that smokers who switch completely from conventional cigarettes to IQOS significantly reduce their exposure to harmful or potentially harmful chemicals in accordance with their interpretation of the U.S. law. Their authorization confirms that IQOS is distinctly different to cigarettes because it has been demonstrated to reduce exposure to harmful chemicals and that this information should be communicated to consumers to help guide their choice.

    While the MRTP designation applies in the U.S., it is consistent with earlier conclusions of other leading regulatory and scientific bodies, including those in the U.K., which found that IQOS emits lower levels of harmful toxicants.

    We believe that this latest decision by the FDA—and its previous decision to grant an oral tobacco alternative a modified-risk status—strengthens the argument for the U.K. to carefully review these next-generation tobacco-based alternatives, which have undergone comprehensive and robust scientific assessment. —G.G.

    *Philip Morris points out that this does not necessarily equal a 95 percent reduction in risk. IQOS is not risk free.

  • Communication

    Communication

    The modified-risk tobacco product (MRTP) authorization comes with challenges. The brand needs to communicate its message to adult smokers without allowing youth to misconstrue the risks of using nicotine products. That is the conundrum faced by the two companies who currently have MRTP authorizations from the U.S. Food and Drug Administration (FDA).

    During the Global Tobacco & Nicotine Forum (GTNF) held in September, Robyn Gougelet, director of health policy and regulatory strategy at Pinney Associates, moderated a panel representing 100 percent of the companies that have earned an MRTP designation: Swedish Match and Philip Morris International (PMI). Currently, three other products are under MRTP review by the FDA: 22nd Century’s low-nicotine cigarettes, Camel brand snus and Copenhagen snuff.

    The panelists agreed that the MRTP authorization is complicated for consumers to understand. Consumers may think a product is safe or “FDA approved,” and this is not true. So, manufacturers are challenged to find a way to explain what the MRTP order means without confusing the consumer. The message must also be conveyed in a way that does not entice youth to try the products. The panelists said that none of the organizations they represent have perfected the process of communicating the MRTP’s complicated messaging. However, “helping people to understand how this process works is imperative,” said Gougelet.

    Clifford E. Douglas, director of the Tobacco Research Network and an adjunct professor in the Department of Health Management and Policy at the University of Michigan School of Public Health, said that tobacco companies have to navigate a difficult path in collecting youth data. Douglas said he could not offer any advice on how tobacco companies should proceed, and he was “unclear on [any] best approach” to collect the youth data. “In the end, there has to be careful attention given to what is happening with youth use of products and the dynamics of youth use,” he said. “It also has to be done in real time … the data on youth use, it moves month-to-month.”

    In a note on its website, the FDA states that to receive an MRTP order, a company must establish that submitted modified-risk data for a product is supported by scientific evidence, which shows “the product (as actually used by consumers) can significantly reduce the harm and risk of tobacco-related disease to individual tobacco users as well as benefit the health of the population.” Gougelet says that companies struggle with helping consumers understand the claims being made as well as the potential risks.

    Tryggve Ljung, vice president of scientific affairs at Swedish Match, which received an MRTP authorization for its General brand snus products last year, says that while he understands why the Swedish Match claim reads like it does—it’s very evidence based—he fails to grasp how the message can be effective from a communications viewpoint.

    In June of 2014, Swedish Match filed an MRTP application for its General snus brand. It was the first such application to ever be accepted for review by the FDA. In mid-December 2016, the FDA responded to the 135,000-page document. The regulatory agency decided to defer any decisions on whether to allow the company to claim the products cause less harm than cigarettes or whether to allow removal of a warning that the products may cause mouth cancer.

    Then, on Oct. 22, 2019, the FDA announced for the first time that it had authorized the marketing of products through its MRTP pathway. The authorization order allowed Swedish Match to market these specific products with the claim, “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.”

    The FDA stated that it had made this authorization after reviewing scientific evidence submitted by the company that supports the claim. To help prevent youth access and exposure, the agency also placed stringent advertising and promotion restrictions on the products, including a requirement to restrict advertising to adults.

    “It has helped to transform the company and the market,” Ljung told attendees. “It was a learning experience for both us and the FDA … it’s changing the industry.”

    There are two types of MRTP orders the FDA may issue: a “risk modification” order or an “exposure modification” order. PMI’s IQOS tobacco-heating system was the second product to receive an MRTP and the first tobacco product to receive “exposure modification” orders, which permits the marketing of a product as containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is expected to benefit the health of the population.

    Moira Gilchrist, vice president of strategic and scientific communications at PMI, says the important aspect of the MRTP order is that it allows for exposure reduction communication, information PMI believes can help guide consumer choices toward less risky products.

    “The IQOS authorization was a validation for what we set out upon as a viable path … IQOS has the potential to not only benefit health across the United States but also around the world,” explained Gilchrist. “The decision was an important milestone for our industry overall. Now we have a really clear example of evidence-based decision making that was done in an inclusive and transparent way and really clearly recognizes a continuum of risk.”

    Gougelet said that the MRTP review is one of the most transparent regulatory processes. A company’s MRTP application is available for the public to review. The application also goes before the FDA’s Tobacco Products Scientific Advisory Committee, a panel created to provide advice, information and recommendations to the FDA commissioner on matters related to the regulation of tobacco products. “It is important for everyone to remember it didn’t end with a ‘yes’ decision. There is continual oversight,” she explains. “In order to remain on the market, we have to be able to show that the product is appropriate for public health through its entire life cycle.”

    The MRTP authorization requires the company to conduct post-market surveillance and studies to determine whether the MRTP orders continue to be appropriate, including assessing the potential for increased use among youth. Ljung said that Swedish Match has been carrying out its post-market study, but “it’s too early to say” what the data shows about consumer understanding of the MRTP authorization. Gilchrist said that PMI has submitted its plans for post-market surveillance to the FDA. She added that even though the company has not seen any data to support an uptick in youth use in other countries where IQOS is available, “we still think about it every minute of every day.”

    Gilchrist added that people in public health were caught by surprise by the FDA’s decision to approve an MRTP application, especially the Swedish Match decision (because it was the first). She said she can understand why public health groups are cynical about large tobacco companies, but there is a general misunderstanding about how these products can help adult smokers and the guardrails the FDA put in place to prevent youth use and to stay abreast of developments to prevent it from happening. “Why this visceral reaction to hard work by scientists to figure out if a product is a benefit to public health?” she asked.

    Douglas suspects U.S. tobacco control organizations view any FDA campaign placing e-cigarettes or heated-tobacco products in competition with combustible cigarettes as support for tobacco companies. “If the industry favors it, it immediately becomes suspect,” he says. “There are strong feelings about distrust on both sides.”

    Another worry for both regulators and tobacco companies is that the “public in general, not to mention the medical community, suffers from a significant misunderstanding” of nicotine, according to Douglas. This is supported by a recent study from Rutgers University, published in the Journal of General Internal Medicine, that concluded that most specialists from fields that treat lifelong smokers believe that nicotine contributes to cancer, heart disease and chronic obstructive pulmonary disease.

    “As long as people are under the misconception [of] the effects that nicotine has physically and pharmacologically and the role it plays in different products … it is going to, to put it bluntly, is going to screw up this whole process,” he said.

     

  • Taming The Beast

    Taming The Beast

    Cormac O’Rourke (Photos courtesy of JTI)

    JTI’s Cormac O’Rourke reflects on Malaysia’s struggle against the illicit trade in tobacco products.

    By Stefanie Rossel

    Malaysia holds a sad record: It’s the market most affected by illicit cigarettes. According to Nielsen, about 12.2 billion sticks of contraband cigarettes were sold and consumed in Malaysia last year, outstripping the number of cigarettes sold legally in the country.

    Most illegal cigarettes are brought into the country, which has a total coastline of 4,675 km, through one of its numerous ports or through neighboring Singapore. Declared as nontaxable goods destined for a third country, they are not examined by customs. Instead of being shipped to their destinations, however, the cigarettes are smuggled into Malaysia.

    Tobacco Reporter spoke with Cormac O’Rourke, general manager of Japan Tobacco International (JTI) Malaysia, about the strategies required to address the issue.

    Tobacco Reporter: Illegal cigarettes accounted for 62.3 percent of the Malaysian cigarette market in 2019, up from 58.9 percent one year previously, according to Nielsen. What’s the situation today?

    Cormac O’Rourke: The illegal cigarette trade situation in Malaysia remains critical in 2020. The latest reading of the Illegal Cigarettes Study for June 2020 shows illegal trade at 60.5 percent of the market. Malaysia continues to be No. 1 in the world for illegal cigarette trading, costing the country approximately $1 billion in lost tax revenues annually.

    To what extent has the outbreak of Covid-19 and the related “movement control order” (MCO) contributed to the problem?

    The MCO period posed several operational issues for the legitimate tobacco industry. In effect, supply of legal products was severely disrupted albeit not fully halted. During this period, the illegal trade syndicates pivoted to the e-commerce channel for sale. Even food delivery services were engaged for distribution. This resulted in a loss of earnings for retailers—[there are] approximately 60,000 throughout Malaysia who rely on the sales of tobacco as a primary source of income. The vacuum was filled by illegal traders where it is estimated that approximately $250 million alone of the annual $1 billion was lost in tax revenue during this short period. Normal supply has since resumed but illicit trade incidence remains stubbornly high at 60.5 percent.

    The Malaysian Ministry of Finance has established a multi-agency task force (MATF) to combat illicit cigarette trade. How effective has this initiative been?

    The establishment of a MATF in January 2020 led by the Royal Malaysian Customs has paved the way for a public-private sector partnership with a clear term of reference to comprehensively address the illicit trade issue in Malaysia.

    Addressing the long-standing illegal trade problem in Malaysia requires a whole of government approach involving ministries and law enforcement agencies. We believe that the MATF with the involvement of the Royal Malaysian Police Force, Ministry of Domestic Trade and Consumer Affairs, [and] Ministry of Finance, among others, can drive enforcement efforts and also ensure sensible regulatory policies are discussed and validated so as to not exacerbate the problem any further. We are optimistic that the current government is now relooking into this issue seriously and [has] recently initiated a meeting in early August to reinstate the MATF with all stakeholders.

    This is a national problem costing the country between $1 billion a year in lost tax revenue. It is further costing the small and medium enterprise sector, in particular retailers, billions of ringgits in lost margins. This is damaging not only from a jobs point of view but reputationally for the country as it strives to compete for its fair share of foreign direct investment.

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    You have named cigarette transshipment and repeated excise tax increases as issues that exacerbate the illicit trade problem. Furthermore, Malaysian smokers have mentioned corruption as the biggest hurdle to controlling illicit cigarette trade in a recent survey by British American Tobacco. What has been done recently to tackle these issues?

    Transshipment of illegal cigarettes through Malaysia is estimated to account for up to 50 percent of the illegal volumes coming into the country. This can only be done via the ports through a systematic approach to smuggling and abuse of documentation procedures. The industry has tabled recommendations for the government to ban the practice of transshipment for cigarettes. This, coupled with designating a single point of entry for tobacco products into Malaysia, would curtail the use of this channel for smuggling, remove the uncertainties related to processes and procedures as well as help address any corruption issues that may exist.

    We believe that implementing the right policies in addressing this problem has to be the focus while enhancing enforcement effectively by deploying the various enforcement assets and powers available to relevant agencies controlling the borders, ports and even retail outlets. This has to be underpinned by a predictable stable tax environment, thus the call by the industry for an excise increase moratorium for the next two years. This will ensure that affordability will continue to improve while allowing time for the MATF initiatives to take hold.

    What should be done in your view to better combat illicit cigarette trade in Malaysia? Is this a problem that can be solved at all?

    Stamping out the black economy in Malaysia requires a real concerted effort that can only be addressed by absolute and resolute enforcement, which is why the setting-up for the MATF under the Ministry of Finance earlier this year was a significant step in the right direction and the reestablishment of the MATF a key action point to pursue by the government. Provided there remains a predictable stable taxation environment, targeted policies that close the loopholes currently being exploited, strong political will and stringent enforcement, there is a real chance to bring the situation under better control.

    What are the consequences for your business in Malaysia, and what is your outlook on opportunities in that market?

    The industry has been forced to make significant adjustments, addressing costs as well as reducing investment to cope with the elevated illegal trade situation. Illegal trading has impacted all parties throughout the legal supply chain.

    Given the severity of the situation on the legitimate tobacco industry, retailers and associated enterprises, we call on the government to redouble its efforts to protect jobs and industry for Malaysia. A moratorium on excise tax would be a good start. Furthermore, there is an opportunity to lessen the load on the legitimate industry cashflows by deferring payment of excise and import duties, allowing for duty payment drawbacks for unsold goods as well as a reduction of import duties on ASEAN [Association of Southeast Asian Nations]-sourced products that is currently at 5 percent of cost. Releasing locked cash would ease some financial burden and more importantly would allow the industry to support retailer liquidity as they have been hard hit by the pandemic.

    Malaysia also has a problem with illicit vapes, which reportedly made up 10 percent of the total Malaysian market in 2019. What’s the current situation, especially regarding the MCO during the Covid-19 pandemic?

    The illegal vaping segment continues to grow unabated and accounts for an estimated 10 percent of the market. Nicotine-based vaping products are technically illegal in Malaysia given the provisions under the Poisons Act 1952 requiring any sale and distribution of nicotine-based products to necessitate a license from the Ministry of Health. However, no license has been issued to date.

    The proliferation of vaping products, for which the Ministry of Health has indicated that 90 percent are nicotine-based, has been aided by not only the smuggling of such products that are sold in traditional brick-and-mortar stores [but also by] illegal online sales, most of which are imported and misdeclared as food items. Our position to government has been consistent for an appropriate regulatory framework to be established allowing for the proper introduction of vaping products in the country.

    How is the problem of illicit vapor products also being tackled by the MATF and other stakeholders? How effectively has it been done so far?

    It remains too early to assess given the recent reestablishment of the MATF, but we are hopeful that with proper policies in place and stronger coordinated enforcement, there will be a positive impact on the situation. We estimated that if illegal cigarette trading is reduced by 50 percent, the country would benefit from at least a $500 million increase in tax revenues. The efficiency of the MATF and its constituent agencies should be assessed based on the revenues that it can recover from reducing illegal trade, and we are confident that proper key performance indicators will be put in place toward that end.

    Could you please describe the state of tobacco harm reduction in Malaysia?

    The reduced-risk products segment is still in its infancy in Malaysia. While open tank vaping products have been around for the past several years, albeit illegally, heated-tobacco products have only been introduced in the past two years. Nevertheless, there remains an absence of a proper regulatory and taxation framework that would cover especially nicotine-based vaping products, which adds to the illegal segment in the country.

    Our position has been consistent that a proper regulatory framework needs to be established to allow for the introduction of vaping products in the country. The current situation only allows for an unregulated and illegal industry to flourish.

  • Living With Uncertainty

    Living With Uncertainty

    Photo: Delfort

    Stagnating tobacco consumption and a persisting pandemic are challenging the cigarette paper business.

    By George Gay

    It is obvious that the effects of Covid-19 have not been evenly spread across businesses and industries. Since lockdowns and restrictions became the norm, that part of your business that manufactures personal protective equipment will have done a lot better than the division that sells overseas holidays, and, generally, the tobacco sector sits somewhere between these extremes on the continuum of business opportunities and risks created by the disease and its underlying virus, SARS-CoV-2.

    And if you zoom in a little closer, you will probably notice that there are pockets of activity within the tobacco sector that have fared better than others have. I would guess, for instance, that sales of tobacco products whose consumption does not require inhalation would have stood up better than those of others. But within other pockets of activity, Covid-19 has delivered only yet another injection of instability into businesses already faced with considerable changes and uncertainties brought about by those changes.

    For a long time, the tobacco papers sector had been operating on a reasonably stable market, albeit one that was the subject of much consolidation among its business consumers and, therefore, among its suppliers. Of course, many sectors have found themselves affected by such consolidation, but, for the tobacco sector, no sooner had consolidation reached a point where little more was reasonably possible than those suppliers that had navigated these consolidations were hit by a major technological disruption.

    Up to a point, that disruption, led by liquid-nicotine vapor devices, meant a partial reversal of the consolidation, so tobacco suppliers that could turn their activities toward the supply of liquid nicotine, and the suppliers of flavors, for instance, saw fresh opportunities open up.

    But if you were in the paper business, this disruption offered no new opportunities only the threat of a further reduction in the demand for cigarettes and, by extension, a reduction in demand for plug wrap and cigarette and tipping papers. Even now, with the arrival on the market of heat-not-burn devices, the picture has not improved to any great extent for the paper sector. After all, if a pack of heat-not-burn cigarettes replaces a pack of traditional cigarettes, the amount of paper required goes down, though admittedly not to zero as is the case when traditional cigarettes are replaced by vapor devices.

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    Additional challenges

    It goes without saying that the papers sector is being hit by the decline in cigarette smoking, a decline that is going to continue, but against that background, additional challenges have been and, to some extent, are being played out. And together, these challenges can be summed up in one word: uncertainty, which is perhaps one of the most despised words in the business lexicon. After all, even though the word “tax” has by no means a welcome ring about it, at least the inevitability of taxes raises them above the level of uncertainty.

    Having said that, uncertainty, at some level, is ubiquitous in the business world, and, indeed, it can be the life blood of industries. Certainty does not breed disruption, and disruption seems to be what is currently being sought after in all but the most conservative industries. But there is a point where uncertainty tips over into negative territory, even chaos, and, as is described above, those operating in the tobacco sector have had to learn to live with high levels of uncertainty, especially in recent years. For instance, while it has been known for some time that smoking is in decline, trying to guess what level of decline is going to be experienced in the future is probably more difficult now than it has ever been, partly because we are living in a time of coronavirus.

    And not only are markets for cigarettes declining, they are fragmenting with the appearance of a larger variety of products, some of them niche, a situation that translates into more but smaller orders for suppliers to tobacco manufacturers, such as those providing paper—in other words, a situation in which it is difficult if not impossible to maintain previous levels of efficiency. At the same time, the need to find solutions for the growing focus on cigarette litter is creating new demands in respect of filter-related papers.

    There is no getting away from these challenges. Demand for combustible cigarettes will continue to decline while the demand for the special and niche papers needed to meet the requirements for new and reformulated products will continue to increase. The decline in demand for combustible cigarettes is likely to be driven by a number of factors but certainly in part by increases in demand for vapor devices and heat-not-burn products, especially now that the U.S. Food and Drug Administration (FDA) has authorized the marketing in the U.S. of IQOS as a modified-risk tobacco product.

    But there is more to uncertainty than consumer-led demand. While laws and regulations on tobacco products differ from country to country and region to region, even within those countries and regions, regulations are subject to change as is clearly illustrated in the EU where the Tobacco Products Directive has the issue of change built into it. And while product preferences vary from country to country, such preferences are themselves the subject of change over time.

    And these are just some of the challenges thrown up by uncertainties specific to the papers sector. Paper suppliers, of course, have also faced all the hurdles thrown up by the general restrictions introduced by governments in response to Covid-19.

    Understandably enough, given that little was known about the SARS-CoV-2 virus when it first started to spread around the world, not all of these government responses have been consistent or coordinated, so, for instance, borders have been closed at short notice and some countries have reduced the number of border crossing points, causing long delays for commercial shipments.

    Such closures and delays would have been difficult to deal with at any time, but they have been especially trying in the present circumstances when businesses along the tobacco products supply chain have been increasing orders from paper suppliers in an attempt to keep those chains well stocked as a buffer against other disruptions, such as the enforced short-term or long-term shutdown of factories. And to make matters worse, the challenge presented by trying to keep supply chains stocked can easily go into reverse. Once the increased orders have been filled and the supply chains well stocked, demand flattens until those stocks have worked through the system or until a new wave of factory closures and border restrictions set the whole disruptive process back into being.

    The issues raised by Covid-19 have been considerable, and while some of them have been short-term, others are continuing. It is easy to forget that paper suppliers have had to respond to different customer ordering patterns and deal with new regulations and restrictions that differ from country to country and that can change from day to day, all while having to restructure their internal systems to deal with such things as working at home, video meetings and travel bans and restrictions.

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    Diversification

    Given all of the above, it would be easy to become downbeat about the future for the tobacco paper industry and, therefore, those supplying it. After all, while it might be the case that paper suppliers are free to offset reductions in demand for tobacco product papers by seeking new markets beyond tobacco, such a strategy can come up against technological and commercial challenges. On one hand, it has to be asked whether a supplier’s machinery is capable of producing the grades of papers required by other industries, and, if not, if it is worth investing in the necessary machinery when there is no guarantee about success on the markets of these so-far-untapped industries.

    And on the other hand, many paper suppliers are already diversified, offering papers across a number of industries, so, presumably, if making further inroads into these other markets was a simple matter, the suppliers would have done so already. In fact, such a strategy will be made more difficult by the fact that all of the paper suppliers currently engaged with tobacco will doubtless be looking into diversifying further into the same industries. As Albert Einstein is often quoted as having said: football is made more difficult by the existence of the other team.

    But perhaps there is another avenue of “hope” opening up. I place “hope” in inverted commas here because it is based on something that not many people would hope for or welcome—the possibility that increasing numbers of vapers will be “encouraged” to return to smoking traditional cigarettes and increasing numbers of smokers will be discouraged from trying to move to vaping.

    As I write this, the liquid-nicotine vapor industry in the U.S. is facing something approaching wipeout as the Sept. 9 deadline looms for applying to the FDA for premarket tobacco product authorization for vapor products—million-dollar authorization applications that are way beyond the means of small-sized and medium-sized companies.

    At the same time, the U.K. government has decided to abolish Public Health England (PHE) next year. PHE, an executive agency of the department of health and social care, is the body that has been supportive of the vapor industry’s efforts to help in the effort to reduce cigarette consumption and is famously known for having declared vaping to be 95 percent less risky than smoking. Although another body will take over some of PHE’s responsibilities, no decision had been made at the time of writing about what would become of PHE’s anti-smoking efforts.

    The trouble is, as Queen Elizabeth I reputedly said, “Hope is a good breakfast, but it is a bad supper.”

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  • Tyranny of the Majority

    Tyranny of the Majority

    Photo: Olha Brahina| Dreamstime.com

    The Covid-19 pandemic should not be used as an excuse to permanently restrict shisha lounges.

    By George Gay

    Since shortly after the start of this year, people around the world have been asked or required to change some of their habits to allow governments to implement strategies aimed at defeating Covid-19. Under these changes, people have been introducing certain hygiene regimes, staying at home except for essential outings, observing social distancing and wearing masks.

    There is, in my book, nothing controversial in this. Democracy involves an unwritten agreement, part of which has it that citizens can expect their governments to protect them as long as those citizens are willing to fall in line with the reasonable requirements of their governments.

    So far, so good. Of course, no system is perfect, and there are those who, brought up on a diet of neoliberal dog-eat-dog dogma, like to rail against any curtailments of their perceived rights while ignoring any social responsibilities they might have, even though, for many of them, the wearing of masks, for instance, would be aesthetically affirming. And there are those who, while believing that complying with such safety requirements is a good idea, believe it is a good idea only for others.

    Such attitudes are not helpful. Since it is known that the coronavirus that causes Covid-19 is transmissible in a number of ways, including through human-to-human contact, it is necessary, in order to defeat the pandemic, for as many people as possible to follow the rules set out by responsible governments. But such unity is undermined by people who believe they can be free agents while enjoying the advantages of a rules-based society. And it is undermined by governments when rules are not applied fairly, which usually means, in part, universally.

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    Touching lips

    According to a story in the Hindustan Times, on Aug. 3, India’s national government banned with immediate effect the use of hookahs in public places, purportedly as part of its strategy for defeating Covid-19. But I cannot help feeling there is more to this ban than its use in the fight against Covid-19.

    There has to be. The Hindustan Times reported that, in announcing the ban, the principal health secretary Vikram Dev Dutt had cited four reasons why the use of hookahs increased the transmission of Covid-19, but these reasons don’t stand up to scrutiny. The first reason was said to be that smokers were likely to touch their lips more often [presumably than were nonsmokers]. No evidence was given in the newspaper piece for this statement and, from my further reading, this seems to be an idea put forward in respect of cigarette smokers, which would at least align with common sense, given the way that a lot of cigarette smokers hold their cigarettes. On the other hand, my observations of hookah smokers tell me that they tend not to touch their mouths with their fingers when they place a hookah mouthpiece between their lips. Indeed, an Internet picture I saw of four Palestinian men enjoying shisha in a lounge showed the shisha-pipe mouthpieces being held with hands at least 25 cm from their faces and passing through face masks, which would have made it impossible for the smokers to touch their lips. I would suggest that any division between people who touch their lips with their fingers a lot and those who don’t has to do with factors other than hookah smoking or not.

    The second reason given was that smokers were likely already to have lung diseases or reduced lung capacity [compared with that of nonsmokers]. This might be true, if it applies to all smokers, not just hookah smokers. Again, there was no evidence given for this statement, and it wasn’t mentioned that while some people claim that tobacco smoking leads to worse outcomes if a smoker contracts Covid-19, others claim that smoking can protect against contracting the disease. I hasten to add that, to the best of my knowledge, neither of these claims has been corroborated.

    The third reason was that smoking hookahs involved sharing mouthpieces. This is simply wrong. It might be that some people share mouthpieces, but others don’t, as was the case with the four Palestinian men described above, who were each using not only separate mouthpieces but separate pipes. Sharing mouthpieces or pipes is not a condition of smoking hookahs.

    The fourth reason was that conditions likely to increase oxygen needs or reduce the ability of the body to use oxygen properly would put Covid-19 “patients” at a higher risk of developing complications. This might be true, but it concerns the outcomes of individuals who have caught the disease, not the transmission of Covid-19, which is purportedly what the ban was put in place to reduce. And, in any case, if it is true it applies to all smokers, not just hookah smokers.

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    Terrible irony

    Indeed, it would apply much wider still. There is a terrible irony in the government’s having raised the issue of “conditions likely to increase oxygen needs or reduce the ability of the body to use oxygen properly.” The Indian national government sits in Delhi, which, according to a Wikipedia entry quoting a World Health Organization survey of 1,650 cities worldwide, has the worst air quality of any major city in the world. “On 25 Nov. 2019, the Supreme Court of India made statements on the pollution in Delhi, saying, “Delhi has become worse than narak (hell),” according to Wikipedia. “Supreme Court Justice Arun Mishra said that it is better to get explosives and kill everyone.” Quite.

    Looked at through the lens of the health secretary’s four reasons, it seems laughable to imagine that a ban on smoking hookahs in public places is going to have more than a snowball’s chance in narak of slowing the tide of Covid-19. But that is not to say that such a ban is not useful. It probably is, but the real reason why it is useful is that, along with similar measures applied to other public venues, it helps prevent people congregating for nonessential reasons. Going back to the four Palestinian men, only one seemed as though he might be socially distanced.

    It was and is perfectly logical for shisha lounges to be shut during lockdowns that have seen the closing of other public venues, including bars, restaurants and places of entertainment. And a quick check of the internet soon reveals that closures have occurred in many countries, including those where shisha use is traditional.

    But, by the same token, it is perfectly logical for shisha bars to reopen after lockdown rules on these sorts of venues are relaxed and once general and specific regimes for keeping customers as safe as possible have been put in place. One London council has asked shisha venue owners to limit the number of customers allowed into their lounges and ensure social distancing; to ensure customers wash their hands before and after smoking; to thoroughly sterilize pipes after use; to use disposable mouthpieces; and to ban the sharing of pipes.

    None of these requests is particularly onerous, and while limiting the number of customers might have implications for a business’ viability, this is an issue that all public venues are having to face as part of the trade-off between protecting health and reopening the economy.

    What should not happen, however, is temporary and justifiable bans on the opening of shisha lounges be extended unjustifiably in relation to what is happening with other comparable venues, or even turned into permanent bans. And this is happening, or at least being suggested, in some countries led by people with what I would describe as highly focused puritanical attitudes—in countries where political opponents can be made to disappear, but heaven forbid they should be allowed to harm themselves by smoking.

    And this sort of unjustifiable ban can be rendered “justifiable” in the eyes of many people by conducting polls. An Arab News Twitter poll of 1,500 people apparently found that 82 percent of people favored maintaining bans on the opening of shisha lounges even after lockdowns were otherwise lifted. But acting on the evidence of such polls is clearly unfair given that shisha smoking is a minority activity that has been given pariah status by authorities around the world but not banned. Such polls are like asking whether the authorities should ban the public playing of bagpipes—another activity defined by hoses and mouthpieces—in England, where I assume 99 percent of people not hearing-impaired would, somewhat selfishly, vote yes to a ban. Polls should not be used to enforce the tyranny of the majority.

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    Case study

    Faizan Aatif

    In August, Tobacco Reporter asked Faizan Aatif, who, with partner Mohammed Sheikh, runs Afzal Shisha UK, about some of the shisha business challenges and responses that had been elicited by the Covid-19 crisis. Aatif, whose business supplies a novel shisha tobacco product to individuals and businesses and was the subject of a recent feature story in Tobacco Reporter, is closely associated with the world of shisha lounges.

    Tobacco Reporter: Is it correct to say that shisha bars in the U.K. have been shut since the lockdown closed other venues, such as restaurants and pubs?

    Faizan Aatif: Yes, indeed, all shisha lounges in the U.K. were forced to close along with restaurants and pubs in March.

    Are these shisha bars now opening with new hygiene rules in place?

    Yes, the majority of shisha lounges have now reopened but with reduced capacity and precautions as per government guidelines.

    What sorts of rules are being introduced?

    Mainly, those to do with social distancing between tables, the wearing of masks by staff, bans on the sharing of pipes, the use of disposable hoses and the introduction of hand-sanitizing stations. Some businesses even check the temperature of patrons prior to allowing entry to the premises.

    Are these initiatives consistent across the country, or do they vary venue to venue? 

    As you would expect, some venues are better than others, but generally they are consistent in following guidelines.

    Do you think shisha bars can be viable with these new rules in place?

    For the time being, especially after such a prolonged lockdown, people are just thankful to have a venue so they can get out and socialize with friends. Many are nondrinkers, so the shisha lounge is their bar and club. The shisha is pretty secondary! All shisha lounges we deal with have been extremely busy ever since they reopened, so hopefully if there is not a significant second wave of infection and another lockdown, things will return to normal soon.

    How has the lockdown affected your shisha business? Have you seen increased sales to individuals?

    With lounges being forced to close, we were really worried as our trade sales dropped to zero literally overnight. However, we formed a strategy to focus on small retail packs, and that was very successful and kept us ticking over. A massive proportion of previously lounge-only smokers began purchasing shisha apparatus and shisha tobacco to smoke at home, and we spent a lot of time on social media giving advice to new home smokers to help them improve their sessions and troubleshoot any issues they were experiencing. We also ran some discount promotions and competitions for end customers, and those campaigns proved very successful.

    Is there anything else significantly impacting the shisha business in the U.K. right now?

    Our biggest problem in the U.K. shisha industry is the number of illegal black market “brands” emerging on the market, enticing lounges and retail customers with cheap, tax-free pricing. Many of these products are entirely unregulated and mixed up in underground factories, so there is a very real increased public health risk. We need greater policing of our segment of the tobacco industry by the authorities as it’s hitting the few official U.K. importers such as ourselves very hard. If the legitimate brands decide it’s no longer in their interests to pursue the U.K. as a viable market, then the entire industry will be driven underground and will be in the hands of criminals. —G.G.

  • The Women of Science

    The Women of Science

    BAT’s women scientists share their experiences working for one of the world’s leading tobacco companies.

    TR Staff Report

    Diversity and inclusion are hot topics and rightfully so. The gaps in opportunity between different genders, ethnicities and ages, among other identifying factors, have become more readily noticeable as reporting has grown and many companies work hard to make progress around these issues.

    British American Tobacco (BAT) has always championed diversity, and the company’s new ethos and diversity agenda reflects this ongoing commitment. With over 50,000 employees around the world, having diverse teams, cultures and skill sets are crucial to delivering success globally. The company is accelerating plans to create a more inclusive culture and has set some ambitions that include diversity of experience as well as having a range of nationalities across its leadership teams, and its gender ambitions remain a priority across the whole organization.

    Launched earlier this year, the new ethos is about being bold, fast, empowered, responsible and diverse to create a future-fit culture. It was developed with significant input from employees and designed to drive the company’s vision to “build a better tomorrow” by reducing the health impact of its business through offering a greater choice of enjoyable products for its consumers.

    To put this ethos into action, BAT introduced some new initiatives, such as Parents@BAT, which offers a range of benefits to support parents around the world, alongside its well-established programs such as Women in Leadership and B United, the firm’s self-governed global community of lesbian, gay, bisexual and transgender (LGBT+) employees and their allies.

    “Diversity is a key part of our ethos,” said David O’Reilly, director of scientific research at BAT. “We have initiated a range of training and development programs to support our teams, including women in leadership, a 30 percent mentoring club, Parents@BAT, how to guard against unconscious bias as well as career break reintegration.”

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    Recently, BAT published a series of interviews with some of their female scientists as part of the U.K.’s national Women in STEM campaign as well as a video as part of their own Women in Science campaign.

    “We launched our Women in STEM (science, technology, engineering and mathematics) initiative in July 2019,” according to BAT. “Using external partnerships and internal learning and development platforms, the initiative aims to attract, develop and retain more women across our research and development, operations and information and digital technology functions. In the U.K., we have joined WISE, an organization that enables people in business, industry and education to increase the participation, contribution and success of women in STEM roles by organizing knowledge-sharing and networking events, training and webinars.”

    BAT’s “Celebrating Our Women in Science” video was published to celebrate International Day of Women and Girls in Science, focusing on the achievements of the company’s female scientists and their work. Tobacco Reporter asked some of these scientists about diversity and inclusion and what it’s like to work in their fields.

    Linsey Haswell

    Tobacco Reporter: What drew you to science, and why did you choose to work in the tobacco industry specifically?

    Linsey Haswell, clinical research scientist: I’ve been interested in science since I was a child. I remember going to visit natural history museums with my mum when I was little and being fascinated by the exhibits, and my dad reminded [me] recently that once I started to study science in secondary school, I had a periodic table pinned up on my wall. So I had a real interest in science before I realized you could make a career out of it. Until I saw a job advertised by BAT, I hadn’t thought of the tobacco industry as a career path. Then I started to read about the work and the science that BAT did, and when I went to the job interview, I really liked the facilities at the R&D hub in Southampton and how passionate and enthusiastic the people were about their work. I enjoy the variety my job offers and the fact that two days are rarely the same. I have spent 15 years in the preclinical team in the lab growing cells, but I equally enjoy engaging with people and communicating the science and work we do in R&D.

    Emma Cheung, biological platforms scientist: I have always enjoyed science, and following chatting to my A-level biology teacher, I decided to apply for pharmacology courses at university. As part of my undergraduate degree, I undertook a year in industry and came to work at BAT, Southampton. I really enjoyed my year, the science that BAT was doing and the focus on in vitro work. Following my graduation, I was offered a temporary contract in the team and then a permanent contract, and I’m still here 13 years later.

    Summer Hanna, principal science manager in the new sciences department: I didn’t seriously consider a career in science until I was approached by a professor during my first year of university who suggested I consider majoring in chemistry. Once I had the opportunity to take part in undergraduate research, I developed a passion for better understanding the world around me through science. I chose to work in the tobacco industry partially by chance. While I was in graduate school at Wake Forest University, there was a person in my adjoining lab who was working on their Ph.D. part time while working full time at R.J. Reynolds, so I learned a little about the company as a Ph.D. student. We wound up sitting next to each other at graduation, and he mentioned that there were opportunities in their summer internship program as I was still looking for a job. I thought it would be a good way to gain career experience, applied and was offered an internship in analytical research. I was a little apprehensive, but shortly before I started, a professor said to me, “You’ll be pleased at the quality of research that goes on there,” and it turns out he was right. I’ve had the pleasure of working with really fantastic scientists throughout my career, and I’ve always appreciated the welcoming culture within the industry. Colleagues both inside and outside BAT invest in the development of early career scientists, and there are lots of [ways] to get involved externally through technical organizations like CORESTA. It’s a great environment in which to build your professional network.

    Anais Hoffmann, analytical scientist: I was interested in science from a young age and was drawn to physics. I remember collecting anything to do with planets and space as a child—and then getting into chemistry. The decision to go into science was made by discovering forensic chemistry, which is a fascinating area. I was drawn to the tobacco industry for its vastness in terms of products and in terms of scientific capabilities. All my experiences were very complementary—I have a background in forensic science and biophysics—and think it was very helpful to me.

    Cristelle Antunes Santos, toxicologist: Science was the only option on the table for me. It was a natural choice from a really young age.

    Isn’t it an exciting world right now? Nowadays, we have so many innovations in the market that give consumers a greater choice than before. As toxicologists, we conduct risk assessments, generate toxicological limits and take decisions about consumer products.

    BAT has exceeded my expectations in both the quality of the science produced and the career opportunities available.

    Emma Cheung

    Can you tell me more about your work?

    Cheung: A main part of my role is to develop and deploy biological testing techniques to assess our products and provide supportive data to our Consumer Product Safety colleagues. We also publish our in vitro data in peer-reviewed journals.

    Hoffmann: I’m an analytical scientist, which means I work with techniques aimed to detect and measure different entities (compounds and materials). For me, it’s the sudoku/puzzle area of chemistry. The other aspect of my work is project management. I therefore divide my time between laboratory work and desk-based work. This is also dependent on the projects I am working on.

    Santos: We identify possible risks by thorough assessment of our products throughout the development lifecycle. We identify the appropriate scientific package that will allow us to evaluate any potential concerns. It has also been seen through the years how continuous innovation is leading to more options for our consumers to choose from.

    How do regulations and the differences in regulations across the globe affect your work?

    Hanna: I have spent most of my career focused exclusively on U.S. regulations, but with the opportunity to participate in a multi-year international assignment based in the U.K. R&D Centre, I’ve gotten to think about regulations with a global lens. It has been a great learning experience to better understand how an international organization balances the needs of 180 markets and supports the regulations across all of them. Moving from exclusively a U.S.-based regulatory construct to considering the requirements across so many markets has helped me think differently about how I approach my work and respond to challenges I encounter.

    Santos: BAT readily contributes to the debate and offers experience and expertise to governments and regulators to help address key issues. The U.K. is an excellent example of what can happen when toxicologists and regulators discuss science and the impact on the population.

    Summer Hanna

    How frequently do you collaborate with other scientists in other specialties, either within your company or globally?

    Cheung: R&D is very collaborative between people in different departments. We usually work between teams to complete projects. We also have collaborative links to our U.S.-based site and other competitor companies.

    Hanna: I’ve had the opportunity to collaborate with other scientists, internally and externally, throughout my career and continue to do so on a near daily basis. BAT’s R&D facilities in the U.K., U.S., Brazil and Germany allow for continuous global collaboration internally. We regularly have projects which depend on an international effort with a cohesive team mindset supported through scientific dialogue. Externally, I’ve participated in Coresta working groups, which are comprised of global teams of scientists, presented at international conferences such as GTNF and been active in the development of international technical standards via ISO/TC 126, which is comprised of 71 different National Standard Bodies.

    Hoffmann: In my current role, I have the opportunity to collaborate with different teams within the company, which is really interesting and enjoyable.

    Santos: As a toxicologist, we need to bring together a wide variety of expertise, including chemistry, biology, microbiology and many others. As it is impossible to be an expert in every field, we constantly seek support from these specialized professionals and incorporate their expert opinions into our assessments and recommendations. This very close relationship is extremely important to the development of our products.

    Anais Hoffmann

    What obstacles have you faced in your career? Do you feel like any of these obstacles are the result of being a woman in a traditionally male-dominated field?

    Haswell: Becoming a parent is tough, and it is hard to balance home and work life. But the recent Covid situation has shown us all new ways of working and managing our work/life in a flexible environment. I hope some of these solutions will help parents find a better balance.

    Cheung: I don’t think any obstacles I have faced have been particular to this industry. I think the attributes that make me a good scientist (quiet, reflective and analytical) can sometimes be seen as career-limiting in a business environment as it can be difficult to push yourself forward. This is something I particularly struggled with in my early career—how to be true to myself but also ‘raise my profile’ in the business.

    Santos: I haven’t faced many obstacles throughout my career. As a student in different European countries, I have always observed a very low number of male colleagues compared to females. In Southampton’s R&D, I feel that gender is very equal. In engineering departments, there are more men than women but, for example, in my toxicology department, the team are 60 percent women, and I think many of the senior positions in the department are occupied by women as well. I believe this is a trend that we see in biological and biomedical sciences, but this is definitely not the reality in the STEM space as a whole.

    Cristelle Antunes Santos

    Have you seen a shift in focus as the industry, and companies as a whole, have put more pressure on themselves to create a more diverse and inclusive workforce?

    Haswell: As long as I have worked at R&D, it has sought to be a diverse community, and this makes R&D a really interesting place to work and grow. The better we become at being a more diverse and inclusive workforce, the broader the range of experience and expertise we will have. And it will be great to be able to collaborate and capitalize on that.

    Cheung: BAT has launched many campaigns and initiatives to promote diversity and inclusivity. As a global company, there are many opportunities for people to work in different geographical locations, which promotes diversity of culture and thinking.

    Hanna: BAT has made diversity and inclusion a key part of the new company ethos. I think that really demonstrates that there’s a commitment from the top down to recognize and value different perspectives and experiences as part of how we operate. Within BAT, there are numerous company-sponsored organizations, such as B United, which supports the LGBTQ+ community, the Women’s Employee Resource Group or our Strength from Diversity team, which all help to support a more inclusive and engaged workforce.

    Hoffmann: I’ve seen an increase in focus, in general, to promote diversity and inclusivity in the workforce, either with communications, events or representation either internally or externally. Women in science, for one, is something that has a good coverage. Other communities also start to have more focus and representation, such as the LGBTQ+ community—at BAT we have the B United network, which is great.

    Have you seen a change in women working in STEM, and what does that look like?

    Haswell: R&D has some great female role models, and their support and encouragement has been invaluable to me during my career.

    Cheung: I have seen an increase in communication around supporting return from maternity leave and being given the flexibility to be able to work from home when children are ill rather than taking holidays or unpaid leave, which shows progress in this area. Sharing of parental responsibilities has also gained traction with shared parental leave gaining in popularity to enable the father to take part of the traditional maternity leave.

    Hoffmann: I have come from a university (Universite Pierre et Marie Curie in Paris) with a good balance between male and female students across all fields, which from my point of view shows that the interest for science has always been present, no matter the gender. As a result, I don’t think that the increase of women in STEM is a change in women’s career interests but more due to an increase of opportunities given to women in those fields as well as better communication, representation and focus in areas that were historically only represented by men.

    Santos: Out of the four STEM fields, I believe science has a better gender balance than the other areas, and this is probably why I have not faced the same challenges that some women in engineering or technology have. Society still has work to do, and we need to make sure everyone has access to equal opportunities.

    How is the industry helping to normalize and promote women in STEM?

    Cheung: At my level, I don’t think there is a gender bias, however, it’s fair to say there are less women in senior positions than men when you look at big organizations. I think this is the case across many industries, and sometimes women feel the need to park their career progress at a certain point to balance family pressures. BAT supports having a work-life balance, and initiatives like Parents@BAT is a good example of this in action.

    Hanna: When I started in the industry, Susan Cameron had just retired the first time as CEO, and starting your career as a young woman in a company with the first female CEO of a major tobacco company was inspiring. For her to return as CEO a second time, having an executive leadership team with significant female representation and then conduct the third woman-to-woman CEO handover in the history of the Fortune 500 fostered an environment in which women in the workplace could see real opportunity for themselves. That sort of legacy becomes part of your company culture, and so while the industry may have been historically male-centric, my experience has been that there’s a real commitment to implementing company practices which promote equity across the board for all women in the workplace, not just those in STEM professions.

    Hoffmann: I think there is a spotlight on Women in STEM, with regular articles and coverage of women working in those fields. The rise of the movement combined with internet and social media allows for more networking as well. This allows people to have more access to information about different fields of science that would have not been available prior to the Women in STEM movement.

    The representation and diversity within the Women in STEM movement is empowering.

    A focus on women having (or having had) successful careers in STEM is also very inspiring as it allows women of all generations to have great role models. I personally had the chance to attend a university named after Marie Curie, located next to the institute where she conducted her research, and she was definitely an inspiration.

    I didn’t find it difficult to establish a career in the tobacco industry, which is great. I spent some time on a military base as part of my forensic science background. This was my first scientific workplace experience, and it was quite a male-dominated field. As [a] result, being a civilian, a female and with no prior experience, this was impressive and daunting. I was, however, included quite easily in those fields, mainly due to my scientific knowledge and contribution to the projects I was working on, but [I] also think my personality was a huge factor, and I can appreciate that some obstacles can be encountered by other women.

    Santos: BAT has launched and supported many diversity initiatives; Women in STEM is one of many. We are such a multicultural company, and diversity is a key element of our DNA. Specifically on gender, BAT has many initiatives in place in order to promote diversity within the group. I do not think that women in BAT nowadays feel that it is harder to establish a career than in other industries—at least I feel that I have always had the same opportunities as my male colleagues.

     

    Where do you see the biggest gaps in regard to women in STEM? How do you think the industry or companies could help bridge these gaps?

    Cheung: If you have responsibilities at home, you can’t always stay late in the office; however, many people catch up in the evenings at home. In the past, I think this hasn’t always been acknowledged because it’s not seen. However, in the post-Covid world, I think this is changing, and there’s traction to the idea that people can work effectively from home and in the office.

    Santos: I think everyone and every company still has a lot of work to do. But my experience has been very positive, and from the very first day I joined BAT, I looked at the female leaders and immediately thought, “I can be like them one day.” This is a very important point that sometimes we underestimate—the power of a mentor or role model in our careers. One of the greatest things about working at BAT is the welcoming and friendly work environment. The flexibility, medical leave policies, equal maternity and paternity leave, zero tolerance for discrimination and harassment should all be considered as priority to every company in order to retain good employees.

    What are you excited about in the changing industry—either diversity and inclusion related or project/product related?

    Cheung: The pace and thinking of the company have really changed since we have branched out into our new category products and brought in different skill sets to match this change in our product portfolio.

    Hanna: I am excited to be a part of the industry in a time of such rapid transformation—not just in what our workforce may look like but also how we think about our products and ourselves as an industry. Every day presents new challenges and opportunities.

    Hoffmann: I like diversity and collaborative work. I particularly enjoy the different perspectives and points of view it can bring, whether project related, work related or people related.

    Santos: I am certain that we will start seeing more innovations, more advanced products, lots of different options, new formats, colors and flavors.

    Do you have a favorite project that you’ve worked on?

    Haswell: It has been really great to see our science grow and progress over my time at BAT, so one of the achievements I am proud of is the longer-term exposures we have done recently. We believe it’s important to look at the effects of repeated exposure on human lung cells using in vitro methods. It was a complex project with lots of challenges along the way, and being able to take that project from initial concept through the work in the lab and finally seeing the results at the end was something I feel was a great achievement.

    Cheung: We have had our first publication on modern oral products accepted in Food and Chemical Toxicology Journal. This is a new category for the company, and it was exciting to develop the method for assessing this product type.

    Hoffmann: All projects I have worked on are quite dear to my heart, but generally, the ones I have enjoyed most were the ones where I had to collaborate with multiple teams and multiple stakeholders. They often offer the opportunity to combine laboratory work, fundamental science and project management, which are three different aspects of my work. They are quite different, and translating scientific language to business-relevant language is sometimes a bit challenging, but it is something I enjoy.

     

    What advice would you give to someone considering your field of study?

    Haswell: The advice I would give to anyone interested in a career in science is follow your passion and do what you love. For me, being a scientist is a privilege that I don’t take for granted as not everyone gets to do what they love as a career.

    Cheung: If you have an interest in industrial science, go for it. There are lots of opportunities in the industry for both scientific and personal development.

    Hanna: Science is an incredibly dynamic, exciting space to work in. Some days it can be challenging, and like anything else, there will be days when you want to walk away. However, if you stick with it, the days where things come together make it worth the work.

    Hoffmann: My advice would be [to] follow your instinct and believe in yourself. I’m a firm believer that when there’s a will, there’s a way! 

    Santos: Toxicology is an exciting and very challenging field. If you want to work in an area where you can work on lots of different challenges, you should definitely consider toxicology. We use robust science and our expertise. Toxicology is an area where the demand will not stop growing in the coming years, and academia should take the lead in keeping toxicology programs available to young scientists.