Category: Print Edition

  • Leaving No Trace

    Leaving No Trace

    Photo: McAirlaid’s Vliesstoffe

    McAirlaid’s Genia cigarette filters decompose in a matter of weeks rather than years.

    By George Gay

    Some time ago, Rachel Roddy, a food writer specializing in Italian cuisine, wrote in The Guardian newspaper’s Feast magazine that 80 percent of recipes could be improved by omitting the tomatoes usually included. Being a renowned tomato-phobe, I was delighted with this story and set out on a campaign to have the message more widely disseminated and acted upon—a campaign that was met with little success, I’m sorry to say, and that fell by the wayside.

    But I was reminded of Roddy’s piece recently when reading the McAirlaid’s Vliesstoffe’s website, which, at one point, poses an intriguing question: Is it possible to achieve more by omitting something? Of course, I was a convert and knew the answer immediately. Yes. Leave out the tomatoes!

    While answering yes to its own question, McAirlaid’s would not be too happy with my response, I think, because part of its business is focused on food packaging, and tomatoes probably figure in the makeup of that business. But I’m getting ahead of myself. This piece mainly concerns another aspect of the company’s business: cigarette filters—specifically, cigarette filters that offer tobacco-smoke taste similar to that provided by cellulose acetate filters but that are manufactured using only pure cellulose, free from bonding agents, and that, therefore, decompose in a matter of weeks rather than years as is the case with cellulose acetate products.

    A Patented Process

    Katja Selle

    McAirlaid’s specializes in manufacturing nonwoven absorption fleeces from pure, nonchlorine-bleached cellulose fibers using only a patented “airlaid” thermo-mechanical process to bond the fibers. In other words, the company omits from its SuperCore fleece the nonabsorbing bonding agents typically used to make fleeces, allowing SuperCore to achieve greater absorption and fluid distribution than is achieved using traditionally bonded fleeces.

    The company, which sells its SuperCore fleece either as a raw material or as finished products, has four production sites in Germany and one in the U.S. Associate Sales Director Katja Selle told me during an email exchange that the company even had its own engineering department with machine design and building capabilities, which allowed it to develop “innovative and unique technologies.” Currently, it operates with five airlaid machines to produce its SuperCore fleece and more than 100 processing machines to service the particular requirements of the various markets with which it is involved and which it designates as food packaging, hygiene, medical, cigarette filters and home and garden.

    And while McAirlaid’s products may rightly be described as environmentally friendly, so, too, can its processes. The company’s cellulose production, which is certified by the Program for the Endorsement of Forest Certification, operates with low carbon dioxide emissions and without the use of freshwater—and therefore without creating wastewater. Production buildings are climate controlled by means of efficient heat recovery systems.

    McAirlaid’s, which now has more than 500 employees and customers in more than 70 countries, was founded in 1997 in Steinfurt, North Rhine-Westphalia, Germany, with production at its Heilbad Heiligenstadt factory starting the following year. It opened its third factory in Virginia, USA, operating as subsidiary, McAirlaid’s Inc., in 2006 and set up a new marketing organization offering Genia cigarette filters in 2017. 2020 saw the start of its first face mask machine.

    The material that makes up Genia cigarette filters was developed by McAirlaid’s and is made from 100 percent EN-13432-certified cellulose produced using the same airlaid technology that is used for producing the company’s other products, though modified to meet the specific needs of the tobacco industry (EN-13432 is an industrial compostability standard). It is offered bleached or unbleached and is said to be available in just about any filter rod specification, including those suitable for heat-not-burn products. Genia filters are already part of tobacco cigarettes, filtered cigarillos and hemp cigarettes that are available in Europe, and, currently, tests and developments are being carried out in conjunction with many small and large manufacturers in the cigarette, cigarillo and roll-your-own segments.

    McAirlaid’s biggest factory, at Berlingerode, Germany

    Ahead of its Time

    Development of these cigarette filters has been a long time coming. The founder of McAirlaid’s, Alexander Maksimow, recognized the littering problem associated with cigarette butts in the 1990s, at a time when, according to Selle, the market wasn’t ready to accept a change to more sustainable products. Once started, development took several years but was accelerated with the arrival of McAirlaid’s own rod-making machine, which allows it to manufacture efficiently at one of its German factories sample rods for testing by prospective adopters of Genia filters. This is important because Genia filters are always custom made for individual cigarette manufacturers after a joint development process aimed at identifying the most appropriate product to replace a cellulose acetate filter.

    And things are likely to move much quicker in the future. The major filter producers are said now to have similar machines that run equally well as the one developed by McAirlaid’s, and the company has worked with filter-rod-machine builders to optimize the use of airlaid materials through their machines. Additionally, Selle said, McAirlaid’s airlaid material was being manufactured into filter rods and sold by global filter producers.

    Selling Genia filter rods could be seen as pushing at an open door. These filters are price competitive and closely mimic the cellulose acetate products they are replacing, in respect of both their smoke-modifying and taste retention characteristics. But perhaps the major selling point is the fact that while carelessly discarded traditional cellulose acetate cigarette filters take up to 15 years to break down, Genia cigarette filters are biodegradable and compostable and break down within a few weeks of being discarded. Of course, McAirlaid’s emphasizes that the best option would be for smokers not to carelessly discard cigarette butts, but we are where we are, and a note on the company’s website indicates that, annually, carelessly discarded butts would fill up to 253,000 cargo containers. The number of containers that would be needed to house the butts carelessly discarded over the years that cellulose acetate filters have been widely used does not bear thinking about.

    The construction of the Genia material is important from the point of view that it does not contribute to the ever-growing problem caused by micro-plastics being released into the environment. And it is important from the point of view that cigarette manufacturers need to comply with plastics reduction regulations in certain jurisdictions—regulations that are bound to become more widespread. At the same time, the material’s ability to break down quickly is important because it reduces the risk of butts being swallowed by water-dwelling or land-dwelling creatures. And it is important from the point of view of aesthetics, given that cigarette butts have long been an eyesore for many people, though one that seems to be reducing with the reduction in smoking in at least many Western cities.

    Opportunities Ahead

    With these advantages in mind, I asked Selle whether she thought there would be good opportunities for McAirlaid’s to grow its cigarette filters business in the future even though cigarette consumption overall might go down. She started by saying that her company was currently experiencing, especially in Europe, increased demand for sustainable alternatives to cellulose acetate, something that was being driven by various factors, one of which stemmed from a new European Commission regulation, the Single-Use Plastic Directive, which was put in place in July last year. Under the provisions of this directive, there was a package-marking requirement for products that included filters containing plastic of any kind, a designation that encompassed cellulose acetate filters but not Genia airlaid filters. In addition, there was the Extended Producer Responsibility policy, which levied a littering tax on, among any number of products, cigarette filters containing plastic. Again, Genia was exempt from the requirements of this policy. At the same time, McAirlaid’s was seeing an increased demand by consumers for sustainable products, so it was likely that demand would keep increasing.

    In the U.S., the situation was different, Selle added. There, the Food and Drug Administration regulated the tobacco products sector, so moves toward the use of sustainable cigarette filters would first require the FDA to accept their use. This would come either through changes to their rules or through tobacco manufacturers agreeing to submit new cigarettes with sustainable filters through the premarket tobacco product application route. Consequently, McAirlaid’s was encouraging any U.S. tobacco company wishing to develop new products to consider a trial using Genia filters. For one thing, emerging initiatives, such as California’s proposed single-use plastic regulations, were likely to increase the momentum toward more sustainable materials.

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.
  • A Curious Case

    A Curious Case

    Photo: steheap

    The U.S. Food and Drug Administration’s marketing denial order for Juul may have been a political decision.

    By Stefanie Rossel

    In June, long-simmering criticism of the way the U.S. Food and Drug Administration is handling premarket tobacco product applications (PMTAs) culminated in a public uproar. “The whole regulatory process is becoming surreal now,” wrote Clive Bates, an independent public health and sustainability advocate, on his blog The Counterfactual. Bates was referring to the agency’s June 23 marketing denial orders (MDO) for all currently marketed Juul Labs products in the United States and compared them to the FDA’s previous marketing authorization of 22nd Century’s low-nicotine combustible cigarette. “No one could make a vape product even remotely as toxic as a cigarette,” Bates stated, “but guess which one got the green light.”

    In its press release, the FDA said that Juul’s applications lacked “sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data, the agency claimed. The problems of genotoxity and potentially harmful chemicals leaching from Juul’s propriety e-liquid pods had not been adequately addressed in the applications, according to the FDA, thus precluding the agency from completing a full toxicological risk assessment of the products.

    However, the agency admitted that to date it had not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. A further reason for the MDO, the FDA wrote in a statement, was that there was “no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device.”

    Michel Mital, acting director of the FDA’s Center for Tobacco Products, said that the agency was tasked with ensuring that tobacco products sold in the U.S. met the standard set by the law but that responsibility to demonstrate that a product meets those standards was with the manufacturer. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” she said. “However, the company did not provide that evidence and instead left us with significant questions.”

    The FDA’s Volte-Face

    One day later, Juul Labs requested and was granted an emergency stay of the FDA order by the U.S. Court of Appeals for the D.C. Circuit to give the judges time to evaluate the merits of Juul’s appeal. In its court filing challenging the FDA ruling, the company called the FDA’s order “extraordinary,” “discriminatory” and “unlawful” and said that it would suffer significant irreparable harm without a stay.

    The agency, Juul Labs claimed, had overlooked more than 6,000 pages of data in the applications on the aerosols that users inhale. The company, which argued that it has helped 2 million adult smokers quit traditional cigarettes, also suggested that the FDA’s decision was influenced by political pressure—through letters and at hearings, the company said in its filing, members of Congress pressed FDA officials to commit that Juul products would not be authorized. Furthermore, the manufacturer questioned the agency’s handling of the MDO announcement, which had been leaked to the media before it was officially announced.

    On July 5, the FDA backed down and temporarily halted its ban on Juul Labs products while the manufacturer appeals the agency’s decision. The agency said it had determined that there were scientific issues unique to the Juul application that warranted additional review. The FDA stressed that its suspension did not mean rescission of the MDO. While the stay technically doesn’t allow Juul to continue selling its products, the FDA later explicitly stated, for the first time, that it did not intend to take enforcement action against the Juul products subject to the MDO.

    Different Treatment

    The removal of Juul products from the U.S. market would have far-reaching implications. The company had experienced a fairy-tale rise from a small business to U.S. market leader of the vape category. It was said to have revived the stagnating U.S. vape market and became so popular that the term “Juuling” became almost synonymous with “vaping.” Coming in a sleek design and with a nicotine salt-based pod system, Juul products were easy to use and able to satisfy the nicotine cravings that smokers previously satisfied with cigarettes. At the height of its success, Juul Labs accounted for more than 80 percent of U.S. nicotine vape sales. In 2018, it sold a 35 percent stake to Altria. If its products were to exit the market, smokers seeking to switch as well as vapers would be left with a mere handful of FDA-approved, but decidedly less popular, vape products.

    In a letter to investors, the financial services company Morgan Stanley wrote that a Juul MDO would create opportunities for other reduced-risk products that have already received PMTA approval, most notably BAT, which recently overtook Juul as the leading U.S. vape manufacturer through its Vuse brands with a market share of more than 33 percent. In recent months, the FDA has authorized several vape products for marketing in the U.S. market, among them Njoy and Logic variants.

    While tobacco control activists welcomed the FDA’s decision, vaping advocates were shocked, and the events following the MDO sparked much speculation. The agency treated Juul’s application very different from those submitted by competing vaping companies, according to critics. Following its normal process, the FDA should have sought answers to its “significant questions” about Juul’s application through a deficiency letter. Instead, the FDA simply banned Juul’s products. Also, the agency did not rescind its MDO for Juul as it had done for other companies after admitting potential errors. In addition, the FDA in its MDO held Juul responsible for third-party or counterfeit Juul products—a task that belongs to the regulator. 

    Punishing Past Mistakes

    “It looks like the FDA searched for a pretext for denying Juul’s products, and this is the best they could come up with,” wrote Bates. The MDO seems to be designed to punish Juul for past mistakes. When the company entered the U.S. market in 2015, its early ad campaigns were heavily criticized for targeting youth.

    Critics held the company single-handedly responsible for triggering a youth vaping “epidemic.” By the time Altria purchased a stake in Juul, the e-cigarette manufacturer was facing a sea of lawsuits. Around 2,000 cases have been filed against the company, by cities, counties, school districts and states, claiming that Juul purposefully addicted teenagers to its products with high-level nicotine pods.

    Although youth vaping, which was never high on a daily basis among youth who have never smoked, has been declining since 2019 and vaping adolescents have turned to other, mostly disposable products such as Puff Bar, Juul Labs continues to bear the blame for youth vaping in the popular imagination.

    Over the past years, the company has gone out of its way to please anti-vaping advocates—perhaps mistakenly, according to critics. Instead of challenging the misinformation spread by its opponents, Juul removed its flavored pods from the market before the law required this.

    FDA Processes Questioned

    While the MDO decision surprised many, the FDA’s subsequent administrative stay later made the story only more curious. Almost immediately querying a decision that the FDA had taken two years to reach appeared odd at best. Experts assumed the FDA realized that its arguments were weak and wouldn’t stand up to a legal challenge. The withdrawal leaves the agency with two options: issuing a new, amended MDO or admitting that it has erred, releasing a full rescission and putting Juul back in scientific review.

    In an interview with Filter, Bates said the PMTA process was “wide open to abuse” as the agency can set arbitrary standards for what it considers acceptable.

    In mid-July, the American Vapor Manufacturers Association (AVMA) asked the U.S. Department of Health and Human Services inspector general to investigate whether the FDA’s MDOs were driven by political pressure. “Manufacturers are routinely meeting the PMTA requirements to scientifically demonstrate how their products are appropriate for the protection of public health,” wrote AVMA President Amanda Wheeler. “Despite compliance, the agency isn’t approving the vape products sought by adults who want to quit smoking. The Office of Inspector General should open the door and hold the FDA accountable to its standards.”

    In recent months, the FDA has faced increasing public and congressional scrutiny not only over its regulation of novel nicotine products but also for its role in a shortage of infant formula. On July 19, FDA Commissioner Robert Califf announced an external review of the agency’s offices on food safety and tobacco regulation.

    The agency has tasked the Reagan-Udall Foundation with an assessment of the resources, procedures and organization of the offices on food and tobacco as well as parts of the Office of Regulatory Affairs, the division that conducts inspections. Whether the measure will improve Juul’s odds remains to be seen. The initial evaluation of the reviewing process was scheduled to be completed within 60 days.

     

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • A True Transformation

    A True Transformation

    Photo: BAT

    To BAT, “A Better Tomorrow” is more than a catchy slogan.

    By Stefanie Rossel

    Flora Okereke

    Flora Okereke is head of global regulatory insights and foresights at BAT, responsible for the analysis and forecasting of international regulatory developments on behalf of the company’s 180-plus markets. She has previously held several senior country, regional and global roles at BAT, including legal, corporate and regulatory affairs director for West Africa; head of regulatory affairs for Africa, the Middle East and Eastern Europe; global head of regulatory strategy and engagement; and senior director of government affairs and international policy at Reynolds American Incorporated Services, a subsidiary of R.J. Reynolds Tobacco based in Washington, D.C. She is an advocate of evidence-based regulation. Okereke was called to the Bar of England and Wales (Middle Temple) and later admitted as a solicitor by the Law Society. Tobacco Reporter caught up with Okereke to discuss her views on the remarkable transformations taking place at BAT and throughout the tobacco industry.

    Tobacco Reporter: It has been some years since BAT set out on its transformation journey from a single-category company to a multi-category player. In March 2020, it announced its new corporate purpose: to build a better tomorrow, with the aim to reduce the health impact of its business through offering a greater choice of reduced-risk products. You have been with BAT for more than 20 years—can you please describe how working for BAT has changed since the transformation process started?

    Okereke: I’ve had the great fortune of working in most parts of our business over the years across every region of the globe. Given the long history and focus on combustibles, the transformation since we launched our first e-cigarette in 2013 is nothing short of miraculous. We have seen the emergence of a multitude of products that are giving adult consumers compelling choices as an alternative to combustibles. And this is a very good thing. Recognizing the strong potential of these new products to reduce the risk in comparison to continued smoking, our CEO invited everyone in our organization in 2020 to embark on a transformation journey to reduce the health impact of our business. The goal of this transformation journey is what we call “A Better Tomorrow.”

    Being part of this transformation has engaged employees across the business like never before. There’s a real rise in energy and a renewed commitment and sense of pride amongst our employees as we work together to reduce the health impact of our business.

    During the recent Global Forum on Nicotine, you participated in a panel debating whether the industry’s transformation is a myth or reality. Being inside a company during the transformation process, what do you think?

    The transformation is real, and we are making tangible change. We are laser-focused on providing adult consumers with a wide range of less risky* products. We are making significantly increased investments year-on-year in reduced-risk products—in 2021 alone, we invested £496 million [$602.73 million]. We are proactively communicating with our adult consumers, encouraging them to switch through over 1 billion inserts to date and over 136 peer-reviewed scientific publications on product manufacturing safety and performance standards of our products.

    In parallel, we are expanding availability of reduced-risk products, which are in 57 countries to date, 20 of which have the highest smoking prevalence. We are actively engaging regulators and public health and governments advocating for a regulatory and fiscal framework that recognizes the important role of tobacco harm reduction and is designed to incentivize adult smokers who would otherwise continue to smoke to switch.

    We aim to switch 50 million adult smokers to reduced-risk products by 2030. E-cigarettes were only invented in 2003, by a Chinese pharmacist, so when we see the level of progress BAT is making in this area, I think we are doing pretty well.

    How can we verify that tobacco companies are really transforming?

    For BAT, “A Better Tomorrow” is a world where smokers who would otherwise choose to continue to smoke have the option to switch to less risky alternatives to combustible tobacco. But A Better Tomorrow also represents a renewed commitment by BAT to improve society for all those that are sharing the road in our transformation journey—we are measuring ourselves against the expectations of our customers, our employees, our shareholders, our government partners and the public.

    We are setting clear and ambitious goals, measuring ourselves and sharing progress with all of our stakeholders. And we are making significant progress in support of those goals.

    We have set a goal of 50 million consumers of our noncombustible products by 2030. Today, over 20 million adult consumers have chosen to use our many reduced-risk products, with 14.6 percent of group revenue delivered by noncombustible products.

    We also aim to achieve at least £5 billion in New Category revenues by 2025. In a few short years, we have built a £2 billion New Category revenue business, and we are confident of more than doubling this to reach our revenue target by 2025.

    In your panel presentation, you said that the core of the change was the transformation of BAT’s portfolio, but behind it, this meant that smokers are encouraged to switch and that BAT is therefore doing something for society. While this is working quite well in the developed world, what can tobacco companies do to repeat this success in low-income countries?

    BAT’s reduced-risk products are available in 57 countries to date—something we are truly proud of. We are rolling these out as fast and as responsibly as we can, including in low-income countries.

    It is important to remember that we are not alone in our transformation journey—our governments in low-[income] and middle-income countries have an especially crucial role to play. Progressive, evidence-based regulatory measures will help encourage smokers to transition to reduced-risk products. We believe governments in low-[income] and middle-income countries can introduce three types of regulation to accelerate the transition of smokers from combustibles to reduced-risk products. These include regulations and policies that enable and encourage companies to innovate and bring new products to market, permit clear communications with consumers about the relative risks of products and incentivize consumers to switch from combustibles to reduced-risk* alternatives.

    Regulations should allow flavors that adults enjoy, ensure high enough levels of nicotine to satisfy adult smokers, and where products are taxed, acknowledge the reduced-risk profile of products like e-cigarettes, oral nicotine pouches and tobacco-heating products compared to combustibles. To realize the benefit of tobacco harm reduction, the products must remain affordable.

    What does the transformation process mean for BAT’s company culture?

    My earliest impression when I first joined BAT was how diverse it is, which gave rise to our motto, “Strength in Diversity.” For a company with over 52,000 employees based in over 175 countries with multiple languages and time zones, the advent of the “A Better Tomorrow” vision has been a global rallying cry that has motivated and organized our people around a common purpose to transform our business and benefit society.

    The “A Better Tomorrow” purpose has affected our culture positively in many meaningful ways. [For example], 72 percent of new senior management hires are from outside the tobacco industry, and 39 percent of women [work] in management roles. [There are] employee initiatives supported by management to drive and reward new ideas that generate solutions; [and the company has] a comprehensive environmental program addressing factory waste, emissions, plastic and litter.

    Most notably, there has been a shift in who our people are and how they expect the business to operate. As we make progress in our transformation, I have personally noted our people taking more pride in our organization and raising their expectations for the company in the way we deliver our commitments. This is making BAT a better company and improving our contribution to society.

    Increased focus on complex novel nicotine-delivery systems requires a different composition of staff, i.e., an increasing share of scientists also coming from other industries. How far have these new arrivals impacted on the internal spirit and atmosphere at BAT?

    Probably the biggest change I’ve noticed is the diverse types of profiles now applying to join BAT. We have moved from a company selling a product based on agriculture to a high-tech and innovation-focused company. This requires all kinds of expertise that is new—[as mentioned], 72 percent of new senior management hires are now from outside of the tobacco industry. These new hires are bringing new perspectives and capabilities to drive our business transformation.

    I believe this shift in hiring will only strengthen our culture and DNA while at the same time propelling us all toward our “A Better Tomorrow” goals.

     

    *BAT use the terms “less risky,” and “reduced risk” based on the weight of evidence and assuming a complete switch from cigarette smoking. The company is keen to stress that these products are not risk-free and that they are addictive. BAT says that its products sold in the U.S., including Vuse, Velo, Grizzly, Kodiak and Camel Snus, are subject to Food and Drug Administration regulation and that it will make no reduced-risk claims regarding these products without FDA clearance.

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • The Review Reviewed

    The Review Reviewed

    Photo: Marc

    The recent U.K. Khan review contains a number of wrong-headed statements that need to be challenged.

    By George Gay

    To my way of thinking, there is little of value in the U.K. government-commissioned review by Javed Khan into government policies aimed at reducing the incidence of tobacco smoking in England to 5 percent or lower by 2030. The review, Making Smoking Obsolete, which was published on June 9, was apparently supposed to also reflect on government policies aimed at countering health inequalities within England, part of its “leveling up” agenda. But while there is little of value in the review, it is worth reading because it contains any number of wrong-headed statements that need to be challenged, one of which seems aimed at propping up the hypocrisy that—in England and many other places—regards tobacco smoking as bad but alcohol consumption as good.

    In Part 2 of his review, in which Khan addresses the idea of prevention, of stopping people from taking up smoking in the first place, he says, in part, “I have considered various options for raising the age of sale. Should the government raise it from the current age of 18 to 21 in one go? Why not jump to 25? Will this be the ‘nanny state’ or ‘big government’ in action? How would this sit alongside the legal age to buy alcohol, to get married, to vote? Note, none of the others are likely to kill you!”

    Literally speaking, this is true. Buying alcohol is highly unlikely to kill you. But consuming it, now that’s another thing entirely. According to Alcohol Change U.K., “[a]lcohol misuse is the biggest risk factor for death, ill health and disability among 15[-year-olds to] 49-year-olds in the U.K. and the fifth biggest risk factor across all ages.”

    Of course, Khan, and other anti-tobacco, pro-alcohol operatives, would say that while tobacco smoking is a risk factor for death, ill health and disability when smokers consume cigarettes as they are intended to be consumed, it is only when alcohol is misused that it negatively affects health and leads to lethal consequences. But this, of course, is pure head-in-the-sand hokum. The U.K. National Health Service website is unequivocal in stating, “[t]here’s no completely safe level of drinking.”

    “It’s recommended to drink no more than 14 units of alcohol a week, spread across three days or more,” the website states. “That’s around six medium (175 ml) glasses of wine, or six pints of four percent beer. There’s no completely safe level of drinking, but sticking within these guidelines lowers your risk of harming your health. Try using Alcohol Change U.K.’s unit calculator to work out how many units you drink.”

    What the website doesn’t tell you is that, by its intoxicating nature, alcohol consumption does not lend itself to rational analysis of how much you have drunk or should continue to drink on any particular occasion. By design, it fuddles the brain and disguises misuse as having a good time. How many times are we told that cigarettes are designed to addict consumers and keep them smoking? But we are rarely told that alcohol is much the same—that alcohol by its nature is such that the more you drink, the more you feel like drinking more.

    It is ironic, I think, that Khan chose to make his statement about alcohol in a review that was commissioned by a government department because, within a month of the review’s publication, the prime minister, Boris Johnson, had been forced to resign over his failure to act decisively when one of his whips—a person, it is worth noting, with the responsibility, in part, of ensuring the smooth running of parliamentary business—was allegedly involved in alcohol-fueled inappropriate behavior. Of course, it wasn’t only this alcohol-fueled incident that brought Johnson down. He had started tottering previously when he was involved in alcohol-fueled events in Downing Street during a time when, because of a Covid lockdown, such events had been declared by his government to be illegal.

    Given this, it might have been expected that questions would have been raised about drinking alcohol, especially about the apparently numerous subsidized bars that the Palace of Westminster boasts. But no—there was hardly a murmur. And this speaks to the foreword with which Khan opens his review. “Most people don’t see smoking as a problem anymore,” reads his first sentence, to which the obvious rejoinder is: and clearly few people see drinking as a problem even when its use is prominent in bringing down a prime minister.

    In the next sentence of his foreword, Khan makes the point that the nation has moved on from smoking, which tends to indicate that he believes that smokers are not part of the nation but outcasts, an idea he seems to endorse when he seeks in his review to have smoking, and by association, smokers, “denormalized.” But it’s his third sentence that I really like. “It’s no longer common for living room ceilings to be stained yellow from chain-smoking in front of the TV,” he remarks, without adding, “but the carpets are still stained with the vomit spewed out by drunks downing buckets of alcohol on top of cheap takeaways.”

    A Blind Spot

    I have no problem with alcohol consumption. But what is beyond my comprehension is how some people are able to condemn outright the problems caused by tobacco smoking while turning a blind eye to the much wider-ranging problems created by drinking alcohol. I think sometimes these people would sooner be the victim of passive drinking—of being knocked down by a drunk driver or assaulted by a drunk in the street—than being the victim of passive smoking—of being annoyed by the smell of burning tobacco.

    As well as comparing tobacco smoking with alcohol consumption, Khan cannot resist an equally risky diversion toward Covid 19, suggesting, I think, that smoking presents a potential risk greater than that of viruses. “Tobacco manufacturers make lethal products, which have killed 8 million people in the U.K. over the last 50 years,” he writes. “That’s more than 400 people a day and far more than Covid-19.”

    I assume that what is meant here is that the average number of daily deaths from smoking is greater than the average number of daily deaths caused by Covid-19, which seems like an odd comparison to make without adding caveats. Smoking tobacco is a lifestyle choice while contracting Covid-19, unless you’re really strange, is not.

    One clue here is to be found in the fact that tobacco consumption raises huge amounts of revenue while Covid-19 just consumes revenue. Smokers die from smoking-related diseases, if they do, after 40–50 years of smoking while those who have contracted Covid-19 die, if they do, within days, weeks or months, so the years “lost” to smoking will generally be fewer than the years “lost” to Covid-19.

    Additionally, we now know pretty much what happens when people smoke, but there is no agreement yet even on how to calculate the number of deaths caused by Covid-19, and the future of those who have had Covid-19 and survived is still being mapped out. There is simply no way that tobacco smoking threatens to destroy the human race, but the same cannot be said about viruses, antimicrobial resistance and environmental breakdown. It is time to introduce a sense of proportion—to get a grip.

    More of the Same

    Two of the major problems with the Khan review are that it contains little that is new and that it is mostly about scaling up those things that haven’t worked in the past. In addition, it seems to take no notice of the problems that England is facing at the moment, though this is perhaps down to the brief Khan was handed. Khan wants cigarette taxes to be increased by 30 percent, something he recognizes will cause the further impoverishment of some of the most financially vulnerable people in the country.

    And, in an admission that this tax hike will prove a bonanza for those involved in the illegal trade in cigarettes, he wants a further, faster crackdown by the police and the courts on those involved in this trade. But what is the point of making such recommendations in a country where six police forces are in special measures, where one of those forces, London’s Metropolitan Police, has, as I understand it, lost the confidence and support of the public and is no longer able to police by consent, and where the courts, already with huge backlogs of cases, are the subject of strikes?

    Khan seems to accept that the 12-year austerity program imposed by successive conservative governments has “skinned to the bone” smoking interventions. “The results of disinvestment are stark,” he writes. “Since 2010, the number of people using stop-smoking services reporting a successful quit attempt has fallen by 72 percent. From 380,000 people then to 105,000 now.” But he doesn’t seem to appreciate that the police and the courts have also been starved of funds to the point where they are unable to function as they should.

    Inconsistencies

    Khan’s review has many uncompleted comparisons, inconsistencies and oddities, such as when he speaks of “illicit enforcement” when presumably he means law enforcement activities against those involved in illegal activities. And he says at one point that he wants to put out of business the criminal gangs behind the illegal trade in cigarettes, seemingly having failed to notice that the government for which he is producing the review is also something of a criminal gang that has shown itself willing to break national and international law to get its own way.

    Despite his claiming to be interested in the dissemination of accurate information, Khan seems to also be blind to the fact that, in England, cigarette packs are covered with graphic health warnings that amount to falsehoods in the absence of proper explanations about what proportion of smokers suffers from the particular medical complaints depicted, what proportion of smokers suffers from those complaints to the extent depicted and what proportion of nonsmokers suffers from these conditions.

    Some bottles of alcohol, on the other hand, come in what I would describe as colors likely to appeal to young children, especially girls aged four to seven, and with labels depicting sophisticated young people having a good time. There are no graphic warnings on these bottles showing diseased livers and brains and none showing bodies mangled in car wrecks or with faces disfigured by broken glass. And yet, Khan wants to go further in the case of cigarettes. With no room for maneuver on the pack, he wants to attack the cigarettes themselves with more misleading warnings. He wants to choke any enjoyment out of consuming cigarettes, even in the case of committed smokers.

    Interestingly, one of his ideas is to mandate that cigarette paper should be colored brown or green, without, I assume, having carried out any experiments into whether the coloring agents would add to the toxicity of those cigarettes. Presumably, he picked brown and green because his personal view is that these colors are unattractive. Of course, here he feeds into the great myopia of our government and our age. The government doesn’t like green either. It’s an embarrassment that daily reminds them of how it, along with most governments around the world, is failing in respect of the environment. What the government seems to have overlooked, however, is that this failure means that it doesn’t need to worry about making smoking obsolete. Destroy the environment and you make smoking obsolete. Dead people don’t smoke.

    Countering the Myths?

    As suggested above, Khan often mentions the need for the dissemination of accurate information to counter the myths around smoking and vaping, but what he is talking about is information based on a version of reality concocted by people who make their living out of opposing the consumption of tobacco and will retire on comfortable pensions having failed to achieve that which they purportedly set out to do. Most of these antis have probably never smoked and probably have never lived in financial poverty the way that many smokers do, partly because of the oh-it’s-in-your-best-interests tax hikes that the antis have recommended to governments greedy for revenue. The antis probably never question whether people living in abject poverty actually want the extra five years of life without adequate food, shelter and heating that giving up smoking may or may not impose on them. And the antis will probably live their lives without ever questioning whether their drinking, opioid or cocaine habits might make what they are up to a tad hypocritical.

    Although Khan claims to be interested in accurate information, he perpetuates the myth that it is somehow bad for your health to sit outside a pub or restaurant drinking if there is a smoker on the horizon, while failing to point out that, if you are 49 years of age or younger, you are more likely to be harmed by your drink than by a whiff of tobacco smoke. And he fails to warn that, if you are worried about your health, it is not the tiny puffs of visible tobacco smoke that should concern you the most but the invisible, ubiquitous air pollution, the inhalation of which, worldwide, kills more people than the consumption of primary and secondary tobacco smoke.

    Khan seems to be certain of a couple of things. One is that longevity is a goal that should be embraced by everybody—or, in the case of those who refuse to do so, embraced on their behalf. “The single most important thing you [my emphasis] can do to improve someone’s [my emphasis] physical health, mental health and to get them to live a longer life is to help them to give up smoking,” he writes. Of course, a curious reader of the review might be pardoned for asking who is this you, and who is this someone? Well let me give you my best attempt at definitions. You comprise all the good, financially well-off people bulging at the seams with the right stuff that they are just bursting to share with someone while someone comprises the bad people who are lacking the right stuff and need to be guided onto the true path by you.

    There seems to be no hint in the Khan review that rational arguments could be put forward for tobacco smoking. There’s no hint that smokers might have independent minds with which they have examined the facts and with which they have decided they want to continue with their habit. In fact, this idea is borne out in one sentence of the review that I found especially instructive. “For example, many people wrongly think smoking relieves their stress, but the science shows us that it is quitting that reduces anxiety and depression,” Khan wrote. Wrongly think! What towering scientific arrogance! The idea here is that through the use of some gadgetry, scientists working in a field that is as yet little understood can experience an emotion in a way that it is being experienced by an individual independent of the scientists—only more accurately. It reminds me of the old joke that I read again somewhere quite recently in which two behavioral scientists meet in the street and one says to the other, “You’re fine, how am I?”

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.
  • Listening to Nicotine Users

    Listening to Nicotine Users

    Photo: G. Lombardo

    A GTNF panel puts “forgotten smokers” in the spotlight.

    Cheryl K. Olson

    Skip Murray used to be one of the forgotten smokers. “I think people that have a life like my background are invisible to the people who have more influence in the world,” she says. “I hate to use class terms, but lower class.” Heavy drinking and mental illness ran in her family. Her memories include events psychologists would call “adverse childhood experiences.” 

    When Murray started smoking at age 10, no one paid any mind. Today, in her sixties, she gets her nicotine from a vaping device. She and her son (who suffered a heart attack at age 29) both used vapor products to quit cigarettes.

    People who smoke find that their needs and views are routinely neglected by policymakers, physicians and other potential sources of support. Research shows that cigarette use is increasingly concentrated in what public health people describe as “vulnerable populations.” Some lack resources or homes, are challenged by physical or mental illnesses or are incarcerated. None want to be lectured to or labeled.

    On Sept. 28, the Global Tobacco and Nicotine Forum (GTNF) will literally put a spotlight on these issues in a plenary event on “forgotten smokers.” Panelists will share personal experiences and research on ways to raise empathy and visibility for people who smoke and ideas to spread the benefits of harm reduction more equitably. They include Alex Clark, CEO of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA); Will Godfrey, founding editor-in-chief of the Filter news site and executive director of the Influence Foundation; Skip Murray, a Minnesota-based vaping advocate and former vape shop owner; and Brent Taylor, senior director of consumer and marketplace insights at Altria. I will moderate the panel.

    Who’s Still Smoking?

    In 1965, 42 percent of adult Americans smoked. According to the U.S. Centers for Disease Control and Prevention (CDC), as of 2020, just 12.5 percent, or 25 of every 200 adults, were smoking. Sounds great! But with population growth, the absolute number is still huge: Almost 31 million adults use combustible cigarettes. The plummet in smoking rates has slowed to a crawl because the easy wins are over.

    No job, or a poverty-level income. No high school diploma. Serious psychological distress. Disabilities that limit daily activities. Heavy alcohol use. Data from hundreds of thousands of people interviewed for the CDC’s National Health Interview Survey from 2008 to 2017 found that the more of those socioeconomic and health-related disadvantages you face, the more likely you are to start smoking and the less likely you are to quit. The majority of people who quit smoking during that period had zero or one disadvantage. 

    Sixteen million Americans live with a smoking-related disease, says the CDC. And the fallout is concentrated among those who can least afford it. Those who lack health insurance or use Medicaid are more than twice as likely as those with private insurance to smoke.

    Before Covid-19 shutdowns and media-driven fears about vaping safety shuttered her business, Murray and her adult son sold e-liquids and vaping equipment to low-income and disabled nicotine users. “If you make $60,000 a year, you can afford not to smoke if you don’t want to,” she says. “But when you’re surviving on 20 grand a year or less, on a Social Security or disability check—if we don’t keep vaping affordable, and cheaper than smoking, people will smoke.”

    The Case of People in Custody

    A good example of the link between compounded disadvantages and smoking is found in jails and prisons. People in custody smoke at roughly four times the rate of those “outside,” and most have a history of other substance use. Historically, cigarettes fill multiple important roles in these settings. According to a World Health Organization report, “Tobacco use is completely entangled in prison life where it helps to cope with boredom, deprivation or stress, relieve anxiety and tension and function as a source of pleasure or monetary value in an environment without currency.” 

    Researching the plight of those held in officially “smoke-free” prisons was eye-opening to me. One recently incarcerated person we interviewed described watching guards spit out chewing tobacco that was quickly scraped up by prisoners to re-chew or to save for later smoking. “That’s how desperate some of these guys are,” he said. “Tobacco in jail is basically air.”

    Another said, “People in jail crave tobacco. They want to relieve stress, and that’s a stress-reliever. I actually thought, when they took tobacco away, I thought there were going to be riots.” When cigarettes were banned in his facility, e-cigarettes were introduced. “Now, if they take this [vaping] away, there might be riots,” he said.

    Vaping has been introduced with great success as an alternative to smoking in Scotland’s prisons and in some U.S. facilities (with vapes specially designed for safety and trackability). My public health colleagues often think of e-cigarettes exclusively as a health risk to teenagers. I’ve found that talking about vaping in the context of the traumas and needs of people in custody reframes the issue. At the GTNF, Godfrey will say more about this vulnerable population as well as the links between harm reduction for tobacco and for other substances.

    Nicotine and Mental Health

    Murray has been open about her lifelong mental health struggles and how she perceived the effects of nicotine on her brain. “When I stole my grandpa’s cigarette and snuck it behind his barn, from day one, I liked smoking,” she says. “It wasn’t icky to me. I felt better.”

    When she finally sought professional help decades later, after attempts to quit nicotine led to suicidal thoughts, Murray received multiple diagnoses. After initially struggling with shame—“You hear stigmatizing things your whole life that you just accept as true”—she went public on social media with her story. “It was amazing how many people went, ‘Oh my God, me too,’” she says. “And amazing how many say they are self-medicating with nicotine.” 

    She finds relief from symptoms of attention-deficit/hyperactivity disorder through mindfulness practices and vaping nicotine. “And it helps me sleep. For most people, nicotine is a stimulant, but for people with ADHD, it has the opposite effect.” Many laboratory and real-world studies support the self-medication hypothesis for a range of mental health disorders, from depression to ADHD to schizophrenia.

    Understanding the Harm Reduction Journey

    New approaches are needed to help forgotten smokers who can’t or don’t want to quit nicotine find lower-risk options that work for them. An obvious next step is to stop blaming and start listening.

    “We need to make sure that we bring the voice of the adult tobacco consumer into the center of the discussion about tobacco harm reduction,” says Taylor. “We need to spend time getting to know the individuals, what this means to them and what it can mean if they are successful in their harm reduction journey.”

    At the GTNF, he’ll share insights from a recent deep dive into the daily lives of smokers trying to reduce their health risks, called the 21 Project. Named for the popular notion that it takes 21 days to change a habit, the Altria project recruited 21 smokers interested in making a change. Armed with information about the array of reduced-harm recreational nicotine products available, these individuals spent three weeks testing alternatives to cigarettes on their own. Researchers documented their stories of the day-by-day transition.

    “You can review numbers and bar charts, but what you never get from them is the heart and feelings of the adult tobacco consumer,” says Taylor. “How do you take the experience of moving from cigarettes to smoke-free alternatives and bring it to life so that everyone can feel and understand what that’s like?”

    Taylor is himself a former smoker who now uses alternative products. “Hearing the stories of people who smoked and switched to smoke-free alternatives was powerful and really emotional,” he says.

    He says the 21 Project taught invaluable lessons to his organization about how to support and empower people in making changes. “We learned a ton; to hear firsthand people’s challenges and successes and what would sustain them on their transition journey was critically important.”

    Adding to that perspective will be Clark of CASAA, which has long worked to highlight the issues facing nicotine consumers. Clark would like to do away with the victim narrative that casts people who smoke as dupes swayed by peer pressure and advertising.

    “Even with a growing awareness of the need to address issues of health, racial and economic equity, the legacy of stigma embedded in anti-smoking policies is leaving millions of people behind,” he says. “The overweighted focus on predatory marketing as the driver of youth tobacco use is ultimately dismissive of more powerful underlying factors contributing to any substance use.”

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Associates. She spent 15 years on the faculty of Harvard Medical School.
  • All Eyes on Harm Reduction

    All Eyes on Harm Reduction

    Photo: Borgwaldt KC

    Suppliers of instrumentation and lab services are focusing on novel nicotine products.

    By Stefanie Rossel

    Two things are for sure: Instrumentation and lab service suppliers don’t have any time to be idle. And a look at their most recent innovations conveys a good idea about where the nicotine industry is heading.

    Two years ago, instrumentation manufacturers and providers of laboratory services were busy supporting makers of electronic nicotine-delivery systems (ENDS) with their submissions for premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration.

    “It certainly has been an interesting two years for ENDS manufacturers,” says Chris Allen, chief executive officer of Broughton, a U.K.-based contract research organization helping companies with delivering full-service regulatory projects.

    Chris Allen

    “In the last few weeks, there have been marketing denial orders (MDOs) for multiple Myblu and Juul products as well as three high-profile manufacturers being awarded marketing orders for their products. Broughton is thrilled to have played a significant part in the granting of some of these marketing orders, and we expect more to come soon.

    “With these five separate PMTA decisions, the FDA has given the industry an indication of where the bar is set for gaining a marketing order. It also gives additional insight into its evaluation process as the rationale behind the Myblu and Juul MDOs were very different. Although not everyone benefited from these decisions directly, they have given manufacturers new confidence to move forward with product development and future business roadmap decisions.”

    Nicotine companies are now considering new PMTA applications, modified-risk tobacco product (MRTP) applications and marketing authorization applications for products under European Medicines Agency regulation. “The industry isn’t losing its appetite or ambition for innovation and new product development,” says Allen. The PMTA process is now firmly established as one of the costs of selling next-generation nicotine products in the U.S., and manufacturers have adapted to this and are moving forward.”

    In addition to full-service solutions, Allen observes a significant interest in Broughton’s standalone services, such as toxicological assessments and laboratory services, many of which are in support of preparing for or responding to PMTA deficiencies. “Unfortunately, many companies have been provided with a substandard service for their PMTAs. Now [that] we have understood the bar for gaining approval, many companies are requesting us to provide extra evidence to submit before their applications enter into substantive review.”

    Focus on Reduced-Risk Products

    Joost Elvers

    Reduced-risk product (RRP) testing continues to be at the core of instrumentation suppliers’ business. “The industry as well as governmental organizations still have a strong focus on new-generation products like e-cigarettes and heated-tobacco products (HTPs),” notes Joost Elvers, group leader of key account management at Borgwaldt KC, a German manufacturer of quality control instruments and devices that is part of the Hauni group of companies, which also includes metrology specialist Sodim. “New product designs combined with upcoming further regulations and standardizations will continuously require close support,” says Joost. “Besides, the combustible product category experienced a focus revival with the opening of markets to cannabis and hemp products. We are therefore strengthening our portfolio of quality control equipment for the different product categories as well as our broad range of emissions testing devices. Furthermore, with the reduction of Covid-19 measures in companies and countries, our team of service engineers has increased its service activities again to support our customers on site in addition to the remote services that have been introduced over the last 2.5 years.”

    U.K.-based Cerulean is focusing on three tobacco-related areas, according to Ian Tindall, head of innovation and marketing.

    “The first is supporting companies within the ever-expanding heated-tobacco product market,” he says. “This still requires a lot of specialist equipment to generate information needed in support of MRTP applications as well as other product development activities.

    “Also, with increasing amounts of products coming to full-scale production, we are finding routine quality assurance equipment is definitely an area we see as expanding. Partly, we are addressing this need by working with our sister company G.D in providing closed-loop control for makers and combiners and partly, it is rolling out and deploying our X-ray equipment to monitor combiner output.

    “A second area we are really excited about is in producing routine test equipment for modern oral products as we see this as a rapidly growing area where quality assurance can be automated and improved. We launched a product, the Orion, just for this market, and we have received almost overwhelming positive feedback from companies.

    “The final area is in supplying test equipment for the safe regulation of legal recreational cannabis use in the United States. We have rapidly found that this is not another cigarette-type application, and we are learning alongside clients how to ensure the safety and compliance to regulation of these now legal products.”

    While the Orion is currently one of Cerulean’s most sought-after products, Tindall has detected another trend, which he finds difficult to describe. “It’s the service that starts with a customer saying, ‘I want to measure something, but I am not quite sure what,’” says Tindall. “The service is about working with customers to develop test and measurement equipment for new-to-the-world products that have no background of tests to ensure conformance.”

    While Cerulean’s commitment to customer confidentiality prevents Tindall from elaborating on current projects, he cites the example of a customer who wants to prevent burst capsules from wetting tipping paper. “We might come up with a way to measure the radial and longitudinal positioning of the capsule in the filter, which prevents liquid getting too close to the outside tipping paper,” he says.

    New Testing for New Products

    Cerulean’s Orion

    Cerulean’s Orion, the first automated snus test station to enter the market, is but one example of an array of innovations for testing novel nicotine products. Currently, the Orion measures the weight, length and width of the pouch along with the tensile strength of the pouch seams as well as extension against load.

    “We will, before the end of Q3, deploy extra measurements in the form of longitudinal pouch seam position and overlap, pouch transverse seam size and pouch moisture,” says Tindall. “We are listening to the customer base and expect to be adding further enhancements in the future once we have really established what is important to our customers, including the potential for auto-sampling and feedback to a maker to reduce reject rates. We expect Orion to follow the trajectory of most of our products in that it will be developed and enhanced as our customers’ needs change.” The Orion can be used for all types of modern oral pouches as long as the size fits in the maximum and minimum dimensions allowed and the pouches follow a rectilinear format.

    Sodim recently introduced a test station dedicated to the testing of HTP consumables. “HTP and RRP confront us with many challenges, such as different format compatibility and new measurement request,” says Christine Camilleri, director of sales and marketing at Sodim.

    “This, combined with sustainability, guides our development team toward instruments [that are] fully scalable, responding to the needs of this market as regards to quick product changes. All our test stations are compatible with HTP products of any size. Multiple diameter measurements on filter rods are an example.”

    From Borgwaldt comes the LM1E DtL, a new vaping machine that provides direct-to-lung testing. ISO 20768 requires aerosol to fill the mouth before entering the lung, which is commonly named mouth-to-lung vaping.

    Consumers, however, tend to vape different products differently. Borgwaldt KC developed the LM1E-DtL based on the draft development standard of CEN/TC437. “This vaping machine fulfills the requirements of an additional vaping regimen considering inhalation from an electronic cigarette directly into the lung,” explains Elvers. “As you can easily imagine, the emissions composition differs from that generated under the ISO 20768 process and therefore reflects the consumer exposition much better.”

    Design Support 

    The industry’s focus on RRPs is reflected in the demand for lab services too. With nicotine pouches, one of the most rapidly growing segments within the reduced-risk category, Broughton is seeing much interest in its consulting and testing services. “There are some interesting innovations around oral pouch materials, so our feeling is that the scope for oral pouches will grow beyond nicotine. The products are covered by the PMTA process within the U.S., so we have been busy providing support for these applications. Within the EU, any work performed is typically to support product development and/or due diligence. As per the ENDS analysis, the focus is placed upon nicotine content and HPHCS [harmful and potentially harmful constituents]. However, automated (flow-through) dissolution analysis is widely used to support the R&D process.”

    Broughton is also offering development services for next-generation products as well as for cannabinoids, another big theme in the sector. The company already has a medicinal cannabis and CDB business. For novel nicotine products, it has launched a division that helps customers design their products in a way that increases the chance of regulatory approval, for example by ensuring that development decisions taken early in a project support the later stages of a planned regulatory submission or go-to-market strategy.

    “This could be early development material or ingredient selection to expedite extractables and leachable studies or ensuring product designs are suitable for mass-market manufacturing scale-up,” says Allen. “Our services are completely scalable to the needs of the client so we can help with one stage of product realization or work as an extension of an in-house development team all through the product lifecycle. We created the service in response to requests from existing clients, so we know there is a demand for this sort of expert advice and consultancy.”

    As far as trends are concerned, Allen sees growth in the diversity of nicotine-delivery systems. “There are more heated-tobacco products, more modern oral nicotine pouch manufacturers plus innovations like water-based vape devices and new heating mechanisms,” he says. “Disposable vape devices are also growing in popularity, and there are some exciting innovations around device material selection, especially focused on improving the recyclability of products, which we predict will be very important in the future. At Broughton, we work with a wide variety of ENDS manufacturers of different sizes and backgrounds. We are seeing a lot of new technology coming from regions like the Middle East, India and Indonesia in addition to where you’d expect it to come from, such as the USA and China. It really is a very dynamic industry with lots of new players looking to bring something different and differentiated to the market.”

    Greener Measurements

    While flexibility plays an important role in novel-products testing equipment, Borgwaldt KC and Sodim have also noticed growing demand for sustainability. “We can currently see two trends gaining momentum within our customer base. One is for sure the change in available product portfolios of some of our customer groups; the other is the realization of sustainability targets in the instruments environment,” explains Elvers.

    “We therefore spend many efforts in making flexible emissions testing solutions for combustible cigarettes and cigars as well as for the new electronic product segment of ENDS. The successful launch of the 10-port vaping machine NGX10 and its continuous modularization with further add-ons shows us the high demand for such a modern and ENDS-dedicated solution on the market. Besides this, the trend of rethinking life cycles of instruments and how they can be converted for new demands to save resources made us create our ‘lifetime extension’ program in which we update older instruments with the newest measuring technology by fully building upon existing infrastructure and reusing or refurbishing existing parts for a more sustainable outcome.”

    Camilleri notes that customers are moving to “green” products, such as hemp and cannabis. “On physical parameters, they are aiming to get fast measuring solutions in a quickly changing market,” she says. “Specific developments become the norm compared to standard solutions in the past. We orientate our products on super flexible instruments adapted to different market environments and production allowing long-term evolution of test stations, including the possibility to upgrade them to cater to new product trends. Our products can have several lives in different segments of the industry, reducing the impact on the environment.”

    Christine Camilleri

    Testing Without Standards

    As more countries legalize cannabis, instrumentation makers detect new opportunities—even though testing standards are not yet in place. “Weight is currently the most important parameter, but we also see a new interest to measure the same physical parameters as in conventional cigarettes to improve the quality of the products and reduce cost generated by waste,” says Camilleri, whose company has adapted its Sodiline and Sodiqube test stations to cannabis testing.

    Borgwaldt and Sodim are active in the raw material and emissions testing segments of cannabis products. “Combined with the experience gained with production machines of our sister companies Garbuio and Hauni, we established ourselves as a main contact point for raw material and production control as well as emissions testing for cannabis products,” says Elvers.

    Borgwaldt has developed an electrostatic precipitation trap, HV1, which is used to trap emissions for the analysis of metals. Being a phytoextracting plant, cannabis collects and saves metals from the soil so that these elements will be released during the smoking and consumption process. “This smoking and vaping machine-independent solution can be used as a flexible add-on for the emission control of metals of cannabis products,” says Elvers.

    Cerulean also has an electrostatic precipitator trap upgrade kit in its portfolio. The company has been working with Kaycha Labs in Denver, Colorado, USA, to overcome some of the problems inherent in the Colorado state requirement for emissions testing for metals, and it has published several white papers describing some of the changes required to allow a vaping machine to work with highly viscous cannabis oils. “This work supports the multiple machines we have sold to legal operations in the United States and hopefully demonstrates our commitment to this new industry,” says Tindall.  He hopes that a set of practical conditions and analysis standard operating procedures can be adopted by the cannabis industry that provide a basis for comparisons from state to state.

    Agility is Key

     Regarding future requirements for testing equipment and lab services, Sodim and Borgwaldt KC say agility will be key. “Demands change within months, [and] products appear and disappear on the markets in a short period of time, therefore we as a supplier of quality control and emissions testing equipment have to keep up and even overtake these market demands and show our ability to react fastest to new market challenges,” says Camilleri, speaking for both companies.

    “Also, digital solutions within the instruments business are expected to play a bigger role in the future. This can be related to the use of data being generated by measurement equipment or the combination and common usage of such data by the measuring instrument and the manufacturing systems. Even the partial replacement of physical measurements by a digital process is something to be considered as a future requirement.”

    “My personal view is that we have probably hit, or are near to hitting, an innovation ceiling for vaping products,” predicts Tindall. “HTPs are still in a growth phase, and there will be other entrants beyond the big players currently in the market. There will be novel HTPs for sure over the coming five years.”

    Tindall expects quality assessment and quality control for physical tests to transition from the laboratory to the production floor. “This means we need to have robustness and simplicity of operation in the forefront of our equipment design,” he says. “Especially if, as I expect, HTP manufacture is increasingly accompanied by more stringent traceability [requirements] as HTPs become even more highly regulated than combustible cigarettes. This will make current good manufacturing practice a baseline requirement that our equipment would need to support. Moreover, the interconnectedness of manufacturing processes and data retrieval becomes a fundamental of design and not just an afterthought.”

    The recreational cannabis market, he says, will continue to spread. “This will mean that belatedly, there will be regulation of emissions, requiring new vaping equipment.”

    With more than 1 billion adult smokers in the world—a number that is still increasing—Allen expects demand for testing to support regulatory submissions to increase over time, with a demand for more sensitive testing criteria, more in-depth analysis of test data and great insight from real-world evidence based on human factor studies over longer time periods.

    “Remember, this is still a very young industry, so continuing to collect data is going to be essential to underpin belief in reduced-risk products and their contribution to tobacco harm reduction,” he says.

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • Nicotine And The Weirdness Of Harm

    Nicotine And The Weirdness Of Harm

    Photo: artefacti

    The availability of nicotine with minimal harm justifies a complete rethink of our approach to this legal recreational drug.

    By Clive Bates

    Whisper it quietly, but people use nicotine for a reason. Nicotine has psychoactive effects that provide functional benefits and pleasurable sensations to its users. Neal Benowitz, a global authority on nicotine, writing in the U.S. Annual Review of Pharmacology and Toxicology in 2009, summarized the effects: “In humans, nicotine from tobacco induces stimulation and pleasure and reduces stress and anxiety. Smokers come to use nicotine to modulate their level of arousal and for mood control in daily life. Smoking may improve concentration, reaction time and performance of certain tasks.”

    Writing in the journal Nicotine & Tobacco Research in 2018, the neuroscientist Paul Newhouse described the cognitive benefits of nicotine: “Cognitive improvement is one of the best-established therapeutic effects of nicotinic stimulation. Nicotine improves performance on attentionally and cognitively demanding vigilance tasks and response inhibition performance, suggesting that nicotine may act to optimize attention/response mechanisms as well as enhancing working memory in humans.”

    With such characteristics, one is tempted to ask why nicotine has so few users. It turns out this is a serious question with some interesting implications. The answer is that nicotine use is strongly associated with the harms of smoking and an addiction so powerful that former U.S. Surgeon General C. Everett Koop compared it to heroin or cocaine. The iron grip of nicotine addiction keeps people smoking even though they are well aware of the lethal consequences.

    Nicotine seems to provide valuable benefits for people whose lives are difficult and stressful, those prone to anxiety or distraction or those who just enjoy the strange mixture of its stimulating and calming effects. Perhaps that could mean most of us? At one point, it did. In the decades before the health implications of smoking were widely understood, smoking prevalence was very high. In the United Kingdom in 1948–1952, smoking prevalence was about 80 percent for men and 40 percent for women. That compares to a combined total of around 14 percent today. But the overwhelming driver of this decline has been intense concern about harm to health and the introduction of policies to reduce these harms by making smoking less appealing, more expensive and more difficult to do. But maybe our concerted public health efforts to reduce disease and death caused by smoking deterred people who would otherwise have benefited from or enjoyed the mood-regulating and cognitive benefits of nicotine had it been available in safer forms.

    So, here is the interesting question. What if nicotine use is no longer all that harmful? What if the real problem was always the inhalation of toxic smoke while trying to consume nicotine for its benefits? As early as 1991, the leading medical journal The Lancet reflected on how the nicotine landscape might look after the year 2000: “There is no compelling objection to the recreational and even addictive use of nicotine provided it is not shown to be physically, psychologically or socially harmful to the user or to others.”

    In my view, we have reached the position where smoke-free nicotine products, such as e-cigarettes, heated tobacco, smokeless tobacco or nicotine pouches, can provide nicotine at acceptably low risk. By acceptably low risk, I don’t mean perfect safety, but within society’s normal risk appetites for consumption and other recreational activities. If continuing innovation in the design of the products ultimately leads to smoking cigarettes becoming obsolete, then the vast burden of smoking-related disease will decline and fade away.

    So why is there so much opposition to low-risk nicotine products? Why do so much effort and money go into trying to demonstrate that these products are harmful? I call this the weirdness of harm, and it takes several forms.

    First, perhaps good science shows these products are very harmful and should be treated no differently than cigarettes? We can rule out this explanation quite easily. The toxicants found in users’ blood, saliva and urine are far fewer, and the levels are far lower than in smokers. Credible data show a range of benefits in switching from smoking to smoke-free products, and there is little convincing evidence to suggest material risks at present. We might be concerned about currently unknown long-term effects, but these are more likely to be trivial than severe and may be tackled if and when they emerge, which they haven’t so far. Yet the ferocity of the backlash against safer products goes far beyond doubts about safety or concern for the welfare of consumers. It looks more like a reaction to a threat.

    Second, much safer products pose an existential threat to a powerful interest group. As a profession, tobacco control exists only because of a need to control severe harm to health. A significant part of the professional tobacco control field could ultimately be rendered irrelevant and unemployed by safer forms of nicotine. The whole edifice of careers, grants, university departments, journals, conferences, advocacy campaigns and the personal prestige of anti-tobacco warriors has harm as its foundation. Otherwise, it becomes the equivalent of “coffee control,” which barely exists. That creates strong, perverse incentives to find (or fabricate) harms to sustain the profession. That conflict of interest is large and pervasive, yet it is paradoxically invisible and never acknowledged or discussed. But for many, it means good news is unwelcome, and bad news is good news. Take, for example, the muted reactions to the recent sharp decline in U.S. teen smoking compared to the apparent enthusiasm that has greeted the long list of (unfounded) scares about nicotine vaping, such as e-cigarette or vaping use-associated lung injury, popcorn lung and seizures.

    Third, without harm, the case for a nicotine-free society falls apart. Harm is the primary reason for abstinence from nicotine. Gallus and colleagues found that about 80 percent of smokers quit because they currently experience harm, expect harm in the future, have taken a doctor’s advice about harm or worry about harming others. Only 2.8 percent mentioned “loss of pleasure or desire to smoke.” But if the products are no longer harmful, where does that leave those who feel we should aspire to be a “nicotine-free society”? That goal likely arises from a mixture of motives: a loathing of the tobacco industry and a sense that “harm reduction” is an unfair escape from its inevitable destruction, an instinctive disgust about the drug choices of others or just the stoical sentiment that if people can be abstemious, they should be. Harm has always been the trump card of the proponents of a nicotine-free society, but their case is greatly diminished if it rests mainly on moral instincts.

    Fourth, it is possible that nicotine use will increase without the deterrent effect of harm. This arises from a basic but unsettling economic argument. The underlying demand for nicotine was once very high but has been suppressed by harm to the user and related policies. The harms of smoking are part of the overall nonmonetary costs (health, stigma, welfare) of using nicotine to the individual. Low-risk products and proportionate regulation will reduce or eliminate these costs. All other things being equal, lower costs mean that nicotine use should increase. Many will be uncomfortable with the prospect of nicotine use rising after years of sustained decline. But we should recall that the effort to reduce nicotine use was driven by the harms of smoking not by opposition to the effects of nicotine as a drug. If we successfully address the public health goal, these smoking-related deterrence effects will no longer apply.

    Fifth, harm is integral to the definition of addiction. The casual and sloppy use of the word addiction is pervasive in public health. It is always worth asking what is meant by “addiction.” In the formal Addiction Ontology, serious harm is integral to the definition of addiction: “A mental disposition toward repeated episodes of abnormally high levels of motivation to engage in a behavior, acquired as a result of engaging in the behavior, where the behavior results in risk or occurrence of serious net harm” (emphasis added).

    The inclusion of serious net harm in the definition of addiction is intended “to limit the class to things that merit a treatment and public health response.” A similar reference to harm is also included in other definitions, such as those of the U.S. National Institute on Drug Abuse and the American Psychiatric Association. So, it could be argued that without the associated harm from exposure to smoke, nicotine would no longer be classified as addictive and would simply join the short but growing list of psychoactive chemicals people enjoy and society accepts, like caffeine, alcohol and increasingly, cannabinoids. C. Everett Koop’s 1988 comparison of nicotine to heroin was a powerfully provocative statement, but in the context of safer nicotine products and the U.S. opioid epidemic, the comparison is not convincing.

    The emerging range of smoke-free consumer tobacco and nicotine products means much more than tobacco harm reduction or an elegant way to help smokers quit. The availability of nicotine with minimal harm justifies a complete rethink of our approach to this legal recreational drug.

    Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
  • Generational Change

    Generational Change

    Photo: Universal

    Human rights and the environment are at the core of Universal’s social and sustainability goals.

    By Timothy S. Donahue

    There are numerous moving pieces in the sustainability puzzle. Many global enterprises now see environment, social and governance (ESG) programs and sustainability issues as urgent business matters. Strong corporations realize that managing ESG programs effectively enables the company to build trust and long-term value in an ever-changing business environment.

    According to experts, sustainability, as a part of a company’s ESG standards, must be a corporate strategy and is critical for a business to stay competitive.

    Being an agricultural company, Universal Corp., the world’s largest supplier of leaf tobacco, must be ultra-aware of the impacts of environmental issues such as climate change and the social supply chain risks that it encounters. Universal understands the need to adapt to survive. It has been a lesson learned throughout the company’s long history.

    Founded in the late 1800s, Universal incorporated in 1918 and was listed on the New York Stock Exchange in 1927. The company has survived the stock market crash of 1929, two world wars and two pandemics.

    Early on, Universal’s environmental programs were traditionally focused on reducing carbon dioxide emissions centered around efficiency and cost savings. Today, those early efforts have evolved into a variety of policies and practices that are designed to enhance the resilience of Universal’s infrastructure and its supply chains.

    This is now referred to as ESG, the corporate governance and investment framework. Sustainability is the relationship between a company and the environment. ESG encompasses a set of standards for Universal’s socially conscious investors to screen potential investments, including sustainability.

    According to Airton Hentschke, senior vice president and chief operating officer for Universal, the company considers a science-based and evidence-based approach to its sustainability practices. Universal is concerned about climate change and how it will impact its footprint in the future.

    “We have set emissions targets that were approved by the Science-Based Target Initiative, and we are in the process of formalizing our approach to reduce emissions. We are looking into the future for pathways to net-zero emissions,” he explains. “Engagement throughout the supply chain has made the most impact in reducing emissions. Engagement allows us to align expectations from our customers through to our farmers and supply chain partners.”

    Hentschke says that the evidence is clear that Universal must contribute to emission reductions to build sustainability and support a thriving planet. “Universal relies on the communities we operate within and attempts to address the root causes of social and environmental issues in these communities,” says Hentschke. “We believe in being a responsible and sustainable corporate citizen and will continue to implement practices with the intention of benefitting our diverse global stakeholders.”

    Challenges lie ahead. Universal operates throughout the world and impacts thousands of people every day. The company operates in more than 30 countries, employing a multicultural and multinational workforce. Universal’s global operations face unique challenges in each of their operating environments related to local social dynamics and traditions, according to Karen Hall, director of sustainability at Universal. She says that ESG is a collection of numerous programs, such as Universal’s corporate human rights policy, which extends equitable expectations to all its operations and to its suppliers.

    “We support our local teams so that they can focus on their communities and supply chain and address risks and opportunities as they arise. One example is in Brazil where we needed a larger workforce than the adjacent community could fulfill, so we contracted buses to bring workers from rural regions to our operation,” Hall explains. “A risk and opportunity were addressed here. The risk was a labor shortage, and the opportunity was to engage and employ a rural workforce that would not have had access to these jobs without our support.”

    Facing the Issues

    Experience makes a difference. The Universal team is skilled at identifying risks and opportunities in communities where it contracts tobacco. Its farmers are the most important segment of Universal’s supply chain operations. Universal is involved in the Sustainable Tobacco Program (STP), an industry-wide initiative jointly developed by tobacco manufacturers and experts to assure standards in agricultural practices as well as environmental management and key social and human rights matters.

    In 2020, the STP made changes to better address eight core issues: governance, crop, climate change, human and labor rights, livelihoods, natural habitat, soil health and water.

    Universal has been supportive of the STP from the program’s inception. Lea Scott, vice president of agronomy for Universal, said the STP provides an alignment across the tobacco industry under a cohesive set of standards and best practices.

    “It’s positive for all stakeholders from investors to smallholder farmers. The new program has several strengths, including aligning common goals and focusing on continuous improvement,” says Scott. “With any new program, we are working through implementation with the aim of continued improvement and transparency.”

    Prior to 2020, Universal took a risk-based approach to addressing issues in its operations and supply chain. The company would implement programs that addressed mainly key risks in particular regions. Its Agricultural Labor Practices (ALP) program, for example, sets global expectations, such as no child labor, fair worker renumeration and no forced labor in the tobacco supply chain.

    “In regions where a specific risk has been identified by our farmer monitoring, we tailor programs to address these risks. In the United States and Europe, for instance, we have worker interview programs to engage farm workers and monitor their treatment while in other regions we have child labor programs that focus on removing identified root causes of child labor,” says Scott. “The new STP in 2020, along with ALP, better highlights Universal’s efforts and the commitment we put into addressing the identified risks. It has also reinforced the unity and commitment within the industry to addressing human rights violations in the tobacco supply chain.”

    Child labor is a major concern for Universal. Seventy percent of child labor is estimated to occur in agriculture, mainly taking place in family subsistence and commercial farming. While there have been significant advances made in tackling child labor, in recent years the progress has slowed and has been uneven across regions. According to the United Nations, the number of children in child labor has declined by an estimated 19 million since 2000.

    Universal is committed to an industry that works in unity and alignment on human rights issues, including child labor, according to Hentschke. Universal, along with other major transnational tobacco companies, has been involved with the Eliminating Child Labour in Tobacco-Growing Foundation (ECLT), a Swiss-based nonprofit organization dedicated to eliminating child labor since its inception in 2000.

    The ECLT focuses on regions where child labor is at higher risk for occurrence and where local stakeholders are willing to engage in programs, explained Hall. The ECLT functions as a link between industry and local stakeholders like government and nongovernmental organizations so that programs are designed in sustainable and impactful ways.

    “Universal believes that children should grow and have access to educational opportunities that are not impacted by labor requirements at home,” says Hall. “While technology has been beneficial in understanding the extent of child labor, understanding root causes does more to benefit children and reduce the risk. When we understand why children work at a young age in various regions, we can address the underlying cause. For example, in Africa, we found that mothers and children in some areas had to walk a long distance for access to clean water.

    “Based on a geographic information system analysis of existing boreholes and water access, we drilled and repaired boreholes to increase water accessibility. Technology helped reduce the risk of child labor, but the root cause needed to be identified for the appropriate technology to be implemented.”

    Being Transparent

    Universal has a variety of projects all over the world that reinforce its commitments to environmental, social and financial sustainability. Hall says programs and projects are most effective when they engage a variety of stakeholders and address motivators of an identified risk or issue.

    “Effective programs not only mitigate the issue but also educate, have strong community participation and contribution and are the basis of sustainable change and improvement,” she says. “Programs with these characteristics have the potential to result in real cultural change.”

    Another example of Universal’s unique commitments is its Village Savings and Loan (VSLA) project in Malawi. In this program, Universal subsidiary Limbe Leaf Tobacco Company works with an NGO to bring financial literacy to the region’s growing areas. The program focuses on teaching women how to manage money and how to invest. The VSLA addresses several social issues, including women’s empowerment, child labor and farm livelihood.

    Words mean little in sustainability and other ESG goals. Without openness in failures and successes, the impact of any efforts is greatly reduced. Hall says that the key to managing ESG issues effectively is transparency. Universal uses the services of an outside law firm to conduct an independent benchmark assessment of its various compliance policies.

    Scott adds that Universal’s operational and supply chain practices are routinely assessed, and its global operations work together to provide the data and resources used by third-party groups and stakeholders to verify the company’s practices. STP has also been a great resource to highlight the adequacy of Universal’s programs.

    “While the tobacco industry continues to effectively work together, we are increasingly utilizing third-party assessments. For example, we are engaging NGOs to conduct Human Rights Impact Assessments to support our social programs,” Scott says. “We will utilize the results from these assessments to refine our programs and further improve our local actions as well as share this feedback with other regions in our supply chain.”

    Hall says that, internally, Universal believes its ESG and sustainability goals are aligned with global best practices and meet stakeholder expectations; however, the company is always looking forward. She said that preparing for the unexpected is a necessity to ensure that in 2050, the goals that Universal is creating now will come to fruition.

    “It might be costly now, but what’s the cost really going to be like in the future? And how much do we invest in people right now and [in] social programs right now?” Hall asks. “But how far will that investment take us if we don’t also do what we need to as an industry to reduce our climate impacts?”

    Universal will continue to adapt to changing expectations and conditions. It is difficult to predict what will change, but if the current climate situation does not improve, Hall says the world will continue to see increasing changes to global weather patterns. Universal intends to be mindful of these changes and will use data and resources to adjust its operational programs and practices as needed.

    Hall adds that the company will also build resilience through continued variety in development, agricultural practices and communications with Universal’s grower base. Farmers, Hall says, are the most important link in Universal’s supply chain, and the environment is the major concern for them.

    “We will need to monitor the environmental and social situations in our supply chain and continue to have diverse global sourcing to mitigate any future unforeseen issues that may arise. We will take the lessons learned from the past century—especially the last decade—and apply them to the future,” says Hall. “No supply chain will be perfect, but Universal intends to have programs and practices in place that help us manage and mitigate risk to the benefit of our all of our stakeholders and global customers.”

    Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.
  • In The Crossfire

    In The Crossfire

    Photo: Tabakprom

    Russia’s invasion of Ukraine has wreaked havoc on the regional tobacco market.

    By Vladislav Vorotnikov

    Russia’s invasion of Ukraine has wreaked havoc on the tobacco industry in the post-Soviet area, prompting the world’s largest cigarette companies to shut down Ukrainian factories and curtail investments and marketing activity in Russia. The current crisis is also likely to provoke a dramatic rise in the illegal segment of the tobacco market in this part of the world.

    Since the beginning of the conflict, BAT, Japan Tobacco International and Philip Morris International faced mounting public pressure to sever their ties with Russia.

    On March 23, Ukrainian Finance Minister Serhiy Marchenko appealed to Western tobacco companies to stop doing business in Russia. Marchenko wrote in a statement posted on his Facebook page that all cigarette manufacturers had pledged to suspend new investments, while BAT considered transferring business to a third party. However, he added, those steps were clearly not enough.

    “My conviction is that there can be no compromises and smoothing alternatives,” Marchenko wrote.

    Since Feb. 24, more than 1,000 multinational businesses have said they’re curtailing, suspending or severing ties to Russia compared to only the few hundred that abandoned South Africa over Apartheid,  research conducted by the Yale School of Management showed. The Russian government responded to the mass exodus of Western brands by threatening foreign firms leaving the country with forced nationalization of their production assets.

    On May 16, Russia went through with its threats and nationalized a major factory that belonged to French car maker Renault, sending a clear signal to all Western companies that curtailing operations in the current conditions would come at a heavy cost since it would mean losing their production capacities.

    The Russian authorities are keen to avoid a shortage of cigarettes on the domestic market as it would spark social unrest, something the country had already seen during the final days of the Soviet Union.

    “In 1990, a shortage of cigarettes led to massive strikes and even to plant and factory shutdowns,” said Ekaterina Pozdeeva, an analyst of the Moscow-based think tank Finam. “In Moscow, more than 100 cases of riots over tobacco were registered. The workers demanded at least two packs per hand. The USSR was forced to buy $300 million worth of cigarettes from the USA.”

    On the other hand, over the past 25 years, Western tobacco companies invested roughly $5 billion in the Russian tobacco industry, Pozdeeva said. Losing this money would be quite painful, so most companies opted for transferring their businesses to local market players.

    For instance, BAT has transferred business management to its Russian distributor and partner, SNS Group, which plans to maintain the same level of production and supplies. Philip Morris International also said it considered options for restructuring and transferring assets but has not yet made any concrete decisions.

    Imperial Brands said in a statement on April 21 that it had transferred its business in Russia, including its Volgograd factory, to local investors and would write off €225 million ($294 million) of its tobacco assets in the country. Japan Tobacco International also suggested that it would change the Russian owner of its local business.

    With annual sales ranging between 200 million and 230 million cigarettes, Russia is among the world’s largest tobacco markets. In 2020, the value of the Russian cigarette market was estimated at RUR1.4 trillion ($23 billion), bringing RUR600 billion of taxes to the federal budget, the Russian federal statistical service Rosstat estimated.

    Biting Sanctions

    The Russian cigarette industry, however, is likely to feel the sting of sanctions as all tobacco and almost all raw materials are imported to the country, according to Maxim Korolev, head of the Russian Tobacco informational agency, adding that it is not clear whether import replacement in this field is even possible.

    “On the one hand, paper-based aluminium foil supplied by a Russian company, after several years of quality improvement, has become widely used by many Russian tobacco factories,” Korolev said. “On the other, the domestically produced polypropylene film has not reached the required quality level in terms of some key parameters, and none of the tobacco companies uses it.

    “Factories also use domestic corrugated cardboard for master cases, but we do not make coated cardboard for the cigarette packs,” he said, adding that fast import replacement is not anticipated in this field.

    On top of that, Russia experiences problems with leaf tobacco imports. Over the past few months, Russian businesses complained about a lack of tobacco for homemade cigarettes.

    Igor Moiseev, chairman of the Pogar Cigarette and Cigar Factory, commented that the supply disruptions are primarily attributed to logistics issues. Moiseev said that before the Russia-Ukraine crisis, Germany, Denmark and the Netherlands were the main suppliers of tobacco for homemade products, and most tobacco was delivered by road through Belarus.

    “Today, even with an advance payment, no one can guarantee that the cargo will be delivered [from Europe to Russia],” Moiseev said. “Difficulties in making wire transfers also affect import. And the majority of suppliers operating in this segment of the tobacco market are small[-sized] and medium-sized companies with limited resources.”

    Korolev said that Imperial Tobacco was forced to stop the operation of its factory in Russia due to a lack of tobacco, estimating that other market players may have stocks of tobacco large enough to maintain operation for up to six months. On the other hand, Korolev added, most tobacco for cigarette production is imported into Russia from South American and African countries that have not publicly supported Western sanctions against the country, so there are good chances that the supply disruptions could eventually be sorted out.

    Oleg Barvin, a spokesperson for BAT, confirmed to the Russian newspaper Kommersant that all market participants experienced logistics problems with delivering tobacco and other raw materials for cigarette production to Russia. Barvin added that despite these challenges, the company ensured uninterrupted production and distribution of products.

    On the other hand, the sanctions are not expected to impact the Russian e-cigarette market. As explained by Kirill Plokhikh, director of the business faculty at Synergy University, Russia imports most e-cigarettes from China. Plokhikh added that some share of nicotine-containing liquids for vapes was supplied to Russia from Western countries, but in this segment, too, buyers could swiftly shift to Chinese suppliers.

    Tobacco Industry Bounces Back in Ukraine

    The Russian invasion forced all Ukrainian cigarette makers to pull the plug on operations, but several have already relaunched production, with some even eyeing restoring production performance to the pre-war level.

    Galina Vorobieva, director of Imperial Tobacco Production Ukraine, said that despite fears voiced by Western officials since October 2021 about the upcoming Russian invasion, nobody in Ukraine took it seriously.

    “Although we assumed such a course of events, we did not believe until the very end that it [the Russian invasion] could happen,” said Vorobieva. “We had a plan on how to act in the event of a real threat to the enterprise and personnel. And it is very good that we had it. In the early morning [of Feb. 24], we turned off the equipment, asked people to hop on buses and took them home.”

    Imperial Tobacco considered moving its Ukrainian factory to Western parts of Ukraine even though it would take at least six months to relocate equipment.

    “When we realized that the situation had become more or less controllable, we decided to resume production. It was not an easy decision because we understand that there are still risks,” Vorobieva said, estimating that the factory was out of service for 46 days.

    With much of Ukraine’s tobacco production offline, demand is met primarily by imports from the European Union, according to the Ukrainian tobacco association Ukrtabak.

    Illegal Market Flourishes

    The current crisis promises to dramatically boost the size of the illegal cigarette market in the region. A quarter of Russians have already switched to illegal cigarettes, a survey conducted by the analytical agency Ipsos in April showed. In early April, nearly 25 percent of respondents admitted buying illegal tobacco products, 8 percent more than in mid-March.

    Not only consumers and retailers suffer from illegal products. From 2016 to mid-2021, the federal budget “lost” almost RUR300 billion in tax revenues due to illegal tobacco products, the Russian Accounts Chamber calculated.

    The Moscow-based think tank Kantar TNS Russia estimated that the share of the illegal sector grew tenfold, from 1.1 percent to 10.7 percent, recently. In 2021, the share of illegal tobacco products on the market reached at least 11.5 percent, according to a study by the government’s National Scientific Competence Center.

    The main supplier of illegal tobacco products to Russia is Belarus. Before the adoption of the first Russian anti-tobacco law, Belarus produced 15 billion cigarettes a year with a population of 10 million. Today, the population remains about the same, but cigarette production has grown to 35 billion sticks.

  • Hear, Hear!

    Hear, Hear!

    Photo: Bertie Watson

    Participants in the Forest Summer Lunch event lament the continuing assaults on personal choice and personal responsibility.

    By George Gay

    And … (slight pause for effect) … the Golden Nanny Award goes to … (rustling of envelope) … Javed Khan!

    Yes, during a ceremony that brought to a close the Forest Summer Lunch and Awards* at the Boisdale of Belgravia restaurant in London on July 5, Khan was recognized for his contribution to the nanny state. The event, which was co-hosted by Forest (Freedom Organization for the Right to Enjoy Tobacco, for the uninitiated) and Ranald Macdonald, managing director of Boisdale Restaurants, was attended by about 60 guests, who included friends of Forest, broadcasters, journalists, parliamentarians and think tank representatives.

    Khan, however, was not in attendance, though he had been invited, so the award, presented by Forest Director Simon Clark, was collected by the editor of the Nanny State Index, Christopher Snowdon, who, unfortunately, was unable to guarantee that it would reach its intended recipient.

    Khan’s absence was a pity because he had been a shoo-in for the award after the publication of his report, Making Smoking Obsolete, which was published June 9 as an independent review into the U.K. government’s smoke-free 2030 policies. The review had been commissioned by then Secretary of State for Health and Social Care Sajid Javid, apparently to help inform the government’s policies aimed at countering health inequalities within England, which are part of its “leveling up” agenda.

    A story on MedPage Today described the Khan review as providing “cutting-edge recommendations with the aim of achieving a ‘smoke-free 2030,’” but to my way of thinking, the review is confusing, blinkered, paternalistic and spiteful in its calls for the further degrading of cigarettes and their packaging and the further impoverishment of smokers. But perhaps worst of all, it is devoid of new ideas, so its general theme is to suggest the way forward through the inflation of the failed policies of the past.

    But perhaps none of this matters. Within three hours of Khan’s award being announced, though, I should emphasize, unconnected with the announcement, Sajid Javid resigned from the front bench in what was to become a government meltdown that, over a couple of days, saw the resignation of almost 60 ministers and culminated in that of the prime minister, Boris Johnson. The ruling Conservative Party is deeply divided, and what happens in respect of the review’s recommendations could well depend partly on who the party picks as its new leader and, therefore, the new prime minister. It should be pointed out, however, that it is unlikely the result of the leadership contest will provide good news for smokers—just varying degrees of bad news.

    Speaking during an after-lunch Q&A session conducted by Mark Littlewood, the director general of the Institute of Economic Affairs, Clark said he was opposed to targets such as the smoke-free 2030 goal. Forest had no problem with the falling smoking rates of the past 50 years. Society had changed, he said. People now knew about the health risks associated with smoking, and many were choosing to switch to products that were less risky than cigarettes. But Forest believed that decisions about quitting smoking should be made on the basis of choice and personal responsibility. It was against people being forced or coerced into giving up smoking, which was a possibility given that the “ludicrous” smoke-free 2030 target could not be achieved on a voluntary basis. If the Khan review was accepted, smokers were going to be coerced into quitting through a range of measures, including the extension of smoking bans from inside hospitality venues to outside those venues, and by pushing up taxes, which would force even more people into poverty.

    In addition, Clark expressed concern that even if the government achieved its target, those opposed to tobacco would not be satisfied. At the moment, many of them said that vaping was a good alternative to smoking, but their long-term goal was not smoke-free—it was tobacco-free and nicotine-free. “These people will never stop, and we have to stand up to them,” he said to loud applause from guests who listened to Clark throughout with respect, interspersed with whoops of delight and cries of “hear, hear!”

    Turning to what he described as Khan’s “so-called independent review,” Clark pointed out that the acknowledgements made in one of its appendices comprised a who’s who of tobacco control. Forest tried to engage with Khan during the review period, but it wasn’t clear whether he had even read its submission because the only response it received was a note saying that, under article 5.3 of the World Health Organization Framework Convention on Tobacco Control, he couldn’t engage with Forest. It was rather pathetic, Clark said, when somebody who was supposed to be conducting an independent review would not engage with representatives of an important stakeholder. Why would you conduct a review if you were not prepared to engage with that important group of people? Such a stance suggested that Khan had no interest in the views of the people who comprised this group, no interest in why they smoked or why they enjoyed smoking and no interest in why they didn’t want to quit.

    Khan, Clark said, had made about 14 recommendations, but it was interesting that, given that it was an independent review, he hadn’t come up with a single original idea. The ideas were all copied from New Zealand, Canada, the U.S. and elsewhere. And they included some bizarre ideas, such as changing the color of cigarettes to dirty green. This was an attempt to take cigarette sticks down the same path as cigarette packaging, which had been turned into “plain packaging.” There was no evidence that plain packaging had made any difference whatsoever to smoking rates, so the idea that smokers were going to give up simply because the color of their cigarettes had been changed was nonsense.

    Currently, cigarette packs carry huge warnings, so everybody is aware that there are serious health risks associated with smoking, but now Khan wants “smoking kills” written on the side of cigarettes. How far was this going to go? Clark mused. This latest review showed how desperate the anti-smoking lobby had become. “We’ve had enough education, we’ve had enough regulation, we’ve had enough legislation; just let it go,” he said.

    It would seem that the public, too, has had enough. Last week, said Clark, on the 15th anniversary of the smoking ban, Forest had carried out a poll in which it asked 2,000 people what the government’s priorities should be, and, of the 10 options given, the top three were tackling the rising cost of energy and gas, tackling rising inflation and improving the health service. Some of the issues that people thought the government should treat as moderately important were helping businesses recover from the impact of the pandemic, addressing care for the elderly and tackling the housing shortage. The topics that were deemed the least important were tackling smoking, tackling the misuse of alcohol, tackling obesity and tackling climate change.

    In fact, the previous paragraph should probably have opened with, “It would seem that the public, too, has for a long time had enough.” Clark said that Forest had been running annual polls for many years, and it had always turned out that people did not consider tackling smoking to be an important priority for this or any other government. “It was time governments started listening,” he said.

    Finally, Clark, who has been at Forest since 1999, was asked what the future held given that the percentage of British people who smoked had dropped from about 40 in 1979, when Forest was formed, to about 14 now. From the Forest point of view, he said, he wasn’t looking forward very far. He didn’t know where we were going to be in 15–25 years, though he believed there would still be a substantial number of people smoking.

    But Clark said that for him, Forest had never been just about smoking, a point that is hinted at in the first two words of the organization’s full name, Freedom Organization for the Right to Enjoy Tobacco, and that is underlined by the guestlists of Forest events, which comprise mostly people who can be described loosely as libertarians, some of whom are smokers. “It’s always been about personal choice and personal responsibility,” he said. “They are the principles that we have been fighting for, and those principles don’t age. And that is why I think there will always be a role for a group like Forest, even if it has to change its name in the future because there are so few actual tobacco smokers. It’s all about choice and personal responsibility, and we need to put those issues, those principles, higher up on the political agenda because in recent decades, politicians seem to have forgotten about them.”

    *Special presentations were made during the awards ceremony to Liz Barber and Pat Nurse, described as two Forest supporters who previously had remained unsung heroes.

    The first award of the afternoon went to the semi-retired Daily Mail columnist Tom Utley, who was painted as a smoker of heroic proportions and who was said to be described by Wikipedia as having made a career out of opposing wokery. Second up was Will Lloyd, the commissioning editor of Britain’s Unheard online magazine, who collected an award on behalf of David Hockney, described as arguably Britain’s greatest living artist and, despite the best efforts of Utley, unarguably its greatest smoker.

    Then, after Snowdon had stood in for Khan, a special award was made to Ranald Macdonald for his longstanding but hitherto officially unrecognized support of Forest, which, over the years, had included hosting numerous events at Boisdale venues.

    George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.