Category: Also in TR

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.

September 1, 2022
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.

September 1, 2022
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.

September 1, 2022
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.

August 1, 2022
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.).

August 1, 2022
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.

August 1, 2022
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.

August 1, 2022
All in the Paper

Photo: RTI

Republic Technologies strengthens its lead in the world of RYO and MYO.
By Stefanie Rossel
While a niche compared to the global combustible cigarette market, the roll-your-own products category continues to grow steadily. Trouve360 Reports valued the global RYO products market at $8.72 billion in 2021 and projects it to reach $10.67 billion by 2028, reflecting a compound annual growth rate of 2.9 percent. The Covid-19 pandemic has boosted the sector, according to Santiago Sanchez, executive president of Republic Technologies International (RTI), a leading supplier of smoking accessories probably best known for its JOB, Zig-Zag and OCB rolling paper brands. “Sales increased a lot in 2020–2021 due to the stocking situation and increasing demand,” he says. “Some retailers overstocked. Now we have a kind of stabilization, which started early this year for our company. Sales have stabilized at a higher level than before Covid.”
The RYO category also benefits from its unique position in the tobacco industry. “If you look at the U.K., for example, where vaping has become very popular, you will notice that the RYO market has not been shrinking because of people switching to vape products,” says Sanchez. “Whilst we have lost some customers to vaping, we have won new customers who have downtraded from highly taxed factory-made cigarettes.”
Due to continuing tax increases for cigarettes, Sanchez expects more smokers to switch to more affordable RYO and make-your-own products. Production planning, however, has become more difficult for his company: “Currently, the situation is very dynamic due to inflation and the energy crisis following the Russian war against Ukraine and due to stockpiling; you don’t know what will happen tomorrow,” says Sanchez.
RTI boasts the largest paper booklet factory in the world. It is located at the company’s headquarters in Perpignan in the south of France and has an output of 1.2 billion booklets annually.
The company is also present in Barcelona, Spain, where it moved to a new, larger site last year. Here, RTI manufactures filter tubes for Spain, Portugal, France and Italy. With its two tube maker machines, the factory has a capacity of 4 billion tubes a year. With five filter maker machines, the plant also supplies 15 billion filters as a base for the tubes as well as for sale as bagged filters.
With Austria-based Altesse, RTI has a third production facility in Europe that manufactures tubes and filters for Central Europe; Germany is the main market for tubes in Europe. Top Tubes in Montreal, Canada, supplies the North American market with filter tubes. A plant in North Carolina produces RYO and MYO products as well as pipe tobaccos for the United States, where the RTI operates under the name Republic Brands. Furthermore, five distribution companies in the U.S., Canada, France, the U.K. and Germany are affiliated with RTI.

Controlled Process
Santiago Sanchez
The company sells to 110 countries worldwide and is vertically integrated. Most of the paper it processes is produced by its sister company Papeteries du Leman, which is associated with the privately held Republic Technologies Group. “From cigarette paper to the final product, everything comes from one company,” Sanchez emphasizes. “We also have close ties with the people growing the plants for the raw materials of our products, for example the farmers in Champagne who grow hemp for our hemp papers.”
RTI has total control of the process, according to Sanchez. To help reduce greenhouse gases, the company tries to source its materials locally as much as possible. “Except for the Arabic gum that is imported from Africa and the bamboo that we source from China, all raw materials and machinery come from within 500 km of our Perpignan site,” says Sanchez.
Operating in a comparatively small segment of the tobacco industry, RTI does not have available as vast of an array of ready-made manufacturing equipment as the large cigarette companies do. Instead, the smoking accessories supplier has an R&D department with a team of engineers and technicians who design all machinery, which is then custom built. Maximized automation and flexibility are key requirements of the equipment as RTI produces many different paper specifications based not only on cellulose but also on textile fibers such as hemp, flax, bamboo and rice. Traceability is another consideration. Each bobbin is marked with a matrix code so that the paper can be traced back to the machine and even the canal on which it was manufactured. As one measure to protect its products from being counterfeited, RTI embosses its papers with watermarks.
Counterfeiting is a big issue in the RYO category, according to Sanchez, who observes this threat especially for RTI’s OCB brand, with fakes coming mostly from China. The company says it relentlessly pursues counterfeiters. In March this year, it won a significant legal victory in the U.S. when a jury found that a Georgia-based wholesaler had willfully sold and distributed counterfeit rolling paper products under Republic Brands’ TOP and JOB trademarks. Republic Brands and its affiliates were awarded $11 million in damages from the counterfeiting wholesaler and its owner.

R&D is Key
At its headquarters, RTI has a dedicated laboratory that checks the ingredients and raw materials of the company’s products for regulatory compliance. It also analyzes competitors’ products and fake versions of its own trademarks. The lab is equipped to measure all paper characteristics, such as opacity, tensile strength, porosity or thickness.
R&D is a must for RTI because of legislation, the move toward more environmentally friendly production and other factors, says Sanchez. “Regulation makes work highly complicated. Being delivered to 110 markets, our products have to comply with all the different regulations, health warnings and even plain packaging requirements, as is the case in Israel,” he says.
RTI’s lab also provides vaping machines and related testing equipment. The company diversified into the vape category in 2014 and has since been selling e-liquids under the E-CG brand. In October 2020, the company acquired French liquid manufacturer Innovative – So Good to expand the scope of its business. Today, RTI is one of the leaders in the French vape market, where its liquids are exclusively sold through tobacconists. All liquids are created at the Perpignan site.
One of the advantages of rolling papers is that they can be made with naturally occurring fibers and without calcium carbonate and citrate as combustion additives, as is the case with factory-made cigarettes.
In June 2019, the EU Single-Use Plastics Directive entered into force. Since then, all tobacco products with filters and filters marketed for use in combination with tobacco products in the common market must carry a label that states that the products contain plastic.
Presently, the RTI’s R&D team develops many products that are more environmentally friendly. RTI has launched a line of biodegradable filters that are made with paper. Touch and filter properties are virtually the same as those of cellulose acetate (CA) filters, explains Sanchez. “It’s the result of a two-year development,” he says. “Technically, it replicates CA. Tests have shown that smoking experience is the same, and from a physical point of view, pressure drop equals that in a CA filter. We are the only ones offering this kind of biodegradable filter for RYO. The paper is the key; it is made from cellulose and viscose. Only few paper manufacturers are capable of producing this.”
RTI also markets its biodegradable filters in some of its tube products. Environmentally friendly filters today account for 20 percent of the company’s turnover from filters.

New Base Materials
Regarding rolling papers, the company has a wide range of products in its portfolio. RTI claims to be the only company selling cigarette papers that contain real rice fibers. “Rice fibers are quite fragile; they tend to break too often on high-speed machines,” says Sanchez. “So many manufacturers stopped making it. We developed a rice paper in 2021 with a mixed blend consisting of 50 percent rice and 50 percent hemp and adopted our manufacturing process to handle the product.” Rice paper is one of the original cigarette paper types; it burns more evenly and reportedly gives more of a natural taste, so many consumers still want it. The rice that RTI processes in its paper comes from the French Camargue region.
In 2021, RTI also introduced Roor rolling papers with CBD-infused gum, which are distributed in markets where CBD is legal, such as the U.K. and Germany. “Due to Covid, the product has been launched only recently, but it’s doing particularly well in Germany. We also offer variants with rice, organic hemp and unbleached papers,” says Sanchez.
OCB Bamboo is another newcomer from RTI. “We have developed a full range of bamboo papers, which we are now planning to sell worldwide,” Sanchez says. “OCB Bamboo has been a big success in the U.S. Bamboo is good for the environment; it grows fast and needs no fertilizers. We are trying to find an alternative source to China, for instance, in the Philippines.”

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

August 1, 2022
Tools Of The Trade

Photo: JTI

At a summer event in London, JTI showcases some of the devices that may help England achieve its smoke-free ambitions.
By George Gay
In his U.K. government-commissioned review, “Making Smoking Obsolete” [in England], Javed Khan said he had seen no evidence of a plan by industry to move toward meeting the ultimatum “for industry to make smoking obsolete,” which was included in the government’s 2019 prevention green paper. I’m not certain what is meant by “industry” here, but assuming it means partly or exclusively the tobacco industry, and perhaps the nicotine industry, this statement seems extraordinary. After all, one of Khan’s reviews, “Critical Interventions,” recommends promoting as effective tools to encourage smokers to quit their habit some of the products that, for well over a decade, the tobacco and nicotine industries have been developing, making available and promoting insofar as they have been allowed to do so.
The independent e-cigarette industry has arisen almost solely for the purpose of converting as many smokers to vapers as possible—to making smoking obsolete, if you like. That is its raison d’etre. Of course, a purist might complain that individual vaping industry firms also want to make a profit, but making a reasonable profit provides funding for new developments and, more generally, makes the world go round.
So perhaps the government’s ultimatum was aimed only at the tobacco industry. But even in this case, it seems somewhat uncharitable not to give recognition to the enormous investments and efforts that have been made by tobacco companies in developing what I am comfortable calling lower risk products and, especially, in the scientific validation of their products’ lower risk credentials. And this is not to mention that, as far as I am aware, it was individual tobacco companies that first started to apply the concept of “harm reduction” to tobacco/nicotine consumption and that, in the U.K., first suggested setting a target date for ending smoking: 2027.
If my memory serves me correctly, the emergence of the tobacco harm reduction principle predated the arrival of vaping products and was based on snus, a product that is without doubt one of the least risky tobacco products of all but one that, inexplicably, was and is banned in the U.K. and one that Khan believes should remain banned. And it is worth mentioning that the country might conceivably have been well on the way to meeting the 2027 target if the government had been more ambitious and reacted more positively in 2017, when the target was suggested, largely based on the use of heated-tobacco products (HTPs). Certainly, I think the U.K. would have been in a better place if e-cigarette companies had been allowed to advertise the consumption of their vaping products as being 95 percent less risky than the consumption of combustible cigarettes, a figure that, to its credit, the government had long accepted.

Coincidentally, a range of U.K.-market, lower risk products was on display during Japan Tobacco International U.K.’s summer event held at the Mandarin Oriental Hotel in London on July 13, one of which was launched in 2019 and another of which was launched in 2020—so, in line with the government’s ultimatum, though not necessarily in response to it. There were three products in all—a vaping device, an HTP and a nicotine pouch—so, at the very least, JTI U.K. must be given credit for having made a huge effort, if not toward making smoking obsolete per se but toward providing as far as it can the tools and encouragement for smokers to switch to less harmful products. It is, after all, beyond the power of a single company to “make” smoking obsolete; only the government has the power to come close to doing that and, no doubt for good reasons, it has chosen not to do so.
The summer event, dubbed “Innovating for Tomorrow,” was attended by about 300 people, including those representing trade and retail partners, community investment partners, agencies, think tanks and the media. About 20 politicians from across the political spectrum were also scheduled to attend, though whether they all tore themselves away from the Conservative Party’s leadership hustings in Westminster I don’t know. Given this attendance and an abundance of fine drinks and delicious food, it is not surprising that the evening was devoted, aside from two short speeches—by Charlie Cunningham-Reid, U.K. corporate affairs and communications vice president for JTI U.K., and Gemma Bateson, U.K. sales director—to relaxed discussions around and away from the product displays. On what was for England a hot day, the venue, with its two large, airy rooms and pleasant garden overlooking Hyde Park, lent itself to such discussions.

One of the products on display was Logic Compact (more information on the products displayed is available at www.jti.com/europe/united-kingdom), a closed-tank e-cigarette that is used with pods of e-liquid available in a range of flavors. At the display stand for these products, much was made of the high level of testing that was carried out on the devices and e-liquids. And, interestingly, a figure from the Office of National Statistics that was on display had it that about 3.3 million people in the U.K. used e-cigarettes, which was something of a testament to the effort that had been made by the vaping and tobacco industries to deliver smoking obsolescence.
The most recent JTI U.K. reduced-risk product to be made available on the U.K. market and that was on display at the summer event was Ploom, an HTP launched in 2020. Ploom is said to offer an authentic smokeless tobacco experience delivered through the action of an innovative heating technology that causes no combustion and no burning and therefore produces no smoke or tar. Consumers have already embraced e-cigarettes, and the government has largely accepted them, so JTI U.K. will be hoping to see the same level of acceptance for HTPs. These products are certainly likely to appeal to consumers on price, especially those used to paying around £9 ($10.77) for a pack of cigarettes. After an initial outlay of about £45 on a device, consumers pay about £4.50 for a pack of 20 EVO tobacco sticks, which come in a range of flavors and strengths.
Meanwhile, JTI U.K.’s Nordic Spirit nicotine pouches, which were launched in the U.K. in 2019 and are available in a range of flavors and strengths, are said to comprise a discreet product that can be used at any time since, on consumption, they produce no smoke or vapor and contain no tobacco. Here is a product, I think, that indicates the length JTI U.K. has gone to cut the use of combustible products. When it launched Nordic Spirit, the company could have had little idea how the product was going to be received because there was little knowledge about such products among U.K. consumers, who, after all, had not been allowed to buy snus, a cousin of the nicotine pouch. Surprisingly, perhaps, but encouragingly, participants at the London event were told that sales growth had been good, which is perhaps an indication of the importance of choice in offering alternative products to smokers, who too often are treated as if they comprised one homogeneous group with one set of likes and aspirations.
The news about the growing interest in nicotine pouches must be good, too, for the environment. This is a pared-back product that must have a low negative impact on the environment, a feature that we are all discovering is hugely important. I have to say, too, that during conversations around the display stands, I heard of the initiatives being undertaken by JTI U.K. to ensure that when alternative devices are no longer operable, they are disposed of properly. There is probably some way to go in regard to this, but you have to say that these efforts are likely to be some way ahead of those of the government. As I am writing this piece, of the five people still standing for the leadership of the Conservative Party and therefore to become the next prime minister, only one was unequivocally backing the government’s net-zero emissions by 2050 target.
It’s worth noting that a small pamphlet, “JTI U.K. at a Glance,” that was made available to participants at the summer event indicated that JTI is still committed, throughout its global operations, to net-zero greenhouse gas emissions by 2050.

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

August 1, 2022
Smart Sachets

Photos: Amplicon

Amplicon presents the first pouch with controlled nicotine release.
By Stefanie Rossel
All nicotine pouch brands presently on the market use a form of cellulose as a carrier material. Powdered cellulose is drenched in a mixture of pharmaceutical grade nicotine, flavors and a pH alignment to bring the product’s pH to the optimum level for nicotine uptake. Although the blend is moistened with polyglycol or glycerol, the pouches are slightly dry. This leads to the user feeling the nicotine effect and perceiving the taste within a few seconds after placing a pouch behind the lip. For some users, the sudden intense nicotine hit is too much—they react physically; sometimes they even get sick. Cellulose has another downside: During consumption, it may dissolve into a slimy lump in the consumer’s mouth, thereby quickly losing its flavor.
Release of pouch nicotine is controlled mainly by the solubility of the nicotine, which means the size of the pouches also determines the release profile. In nontraditional snus markets, users prefer small pouches. These, however, release nicotine and flavor in a very short time.

Hakan Engqvist

A Swedish consumer products company set out to solve these issues. In June, Amplicon presented its Freee nicotine pouches, which it describes as the next generation of oral nicotine. While from the outside the pouches look like those already on the market, they are filled with a powder made of bioceramics. Under the microscope, bioceramic granules look like Swiss cheese, having a porous inner structure. The bioceramics used for the pouches belong to a family of chemically bonded ceramics. The substances can be found in nature. For example, hydroxyapatite, a bioceramic generated in the body by biomineralization, forms the basis of the hard matter of all mammals. For the past 40 years, bioceramics have been used clinically for hard tissue replacement.
Amplicon’s Freee bioceramic platform also contains water, bulk and the active ingredients nicotine and flavor, which bind to that platform. Substance release takes place through diffusion and dissolution. This allows for a more constant, controlled release of nicotine and flavor and better absorption by the human body. The company uses nicotine salt in its pouches. Water-soluble flavors integrate best with the material, but oil-based flavors can be used as well.
The technology allows manufacturers to produce pouches that are small but pack the punch of much larger products, says Amplicon founder Hakan Engqvist, who is also a professor in materials science at Uppsala University. “Our technology enables customized nicotine-delivery and a much-improved nicotine and flavor experience, and it allows for pH stability over time. It also maintains the consistency of the pouch better. Feedback from consumer tests has been positive.”
Current pouch products, he explains, also have an issue with shelf life because their pH levels are less stable than they are in bioceramics.

Tomas Hammargren

Intelligence Inside
The new pouch technology stems from pharmaceutical research. “We have been and are still working on an opioid-based pain relief formulation,” says Engqvist. “Through different routes, we started to work with solid vape to load nicotine into the ceramics and thereby reduce the use of e-liquid and instead just have a tablet. Controlled release of nicotine from pouches then became the next development, quite natural in a snus country such as Sweden.”
Engqvist has lots of experience with bioceramics. Amplicon’s parent company, Emplicure, which he also co-founded, combines biomaterials with existing pharmaceutical substances to deliver drugs precisely and safely. Its controlled-release technology targets unmet medical needs, especially in opioid-based pain relief where its formulations offer not only improved therapy with less discomfort but also reduce the risk of opioid abuse, according to the company.
Its patented bioceramic platforms are based on tunable nanostructures that enable the distribution of active substances in bioceramic materials. The active substance is then released to achieve the desired effect by controlled diffusion. The release and dosage of the active substances can be tuned by adjusting the size of the pores, the choice of biomaterial and the excipients.
Amplicon was established to leverage Emplicure’s technology in the nicotine market. In June, the company filed for a trademark registration for Freee nicotine pouches at the European Intellectual Property Office. The company presently manufactures the pouches in-house at pilot scale but says it is able to scale up production from laboratory volumes to commercial volumes. Control over the making of the ceramic powder will stay with Amplicon, which has received a lot of interest in its technology from both established distributors and pouch manufacturers, says Tomas Hammargren, chairman of Amplicon.
The product is scheduled to hit the market by mid-2023. Initial target markets will include both new, “non-pouch” geographies, such as Europe, Japan and Korea, and existing pouch markets, according to Hammargren. “To reach all important markets, such as Southern Europe or Asia, a pouch product needs to be as small as possible but has to provide a good nicotine and flavor hit, which is difficult to achieve with cellulose,” he says. “It’s hard to imagine an Italian woman putting a big pouch under her lip. The same is true for Asia. Our product is more urban, metropolitan and attractive to female and new users, hence we are confident that it will also be successful in existing oral nicotine markets. It will be the perfect complement for vapers and users of heated-tobacco products in places where smoking and vaping is banned.”

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

August 1, 2022