Author: Staff Writer

  • The Credibility Gap

    The Credibility Gap

    Photo: ia_64

    What tobacco industry scientists wish they could say to physicians and public health researchers about their work

    Cheryl K. Olson

    “I was an ardent antismoker who believed that the tobacco industry was a bunch of evil scientists just working out how they could addict children,” said Justine Shaw Jackson, who is also known as Justine Williamson. Her grandfather, a smoker, died of COPD; her father’s smoking was likely linked to his heart attack and cancer.

    She simply didn’t believe anything that tobacco industry scientists said. “I thought they wanted to make their products even more harmful,” she added.

    So, how did she end up working for Big Tobacco?

    Scientists employed by most industries face predictable concerns about the independence and credibility of their work and even whether they’re “real” scientists. After all, we have a pretty good idea what the Egg Board will be recommending we eat for breakfast. This problem is particularly acute for scientists who work in the tobacco industry.

    Despite their detailed and sophisticated knowledge about harm reduction for smokers, they’re sometimes excluded from professional interactions with nonindustry researchers in which that expertise would be of benefit. The history of Big Tobacco from decades ago has stripped them of their credibility.

    Current employees of tobacco companies are constrained by a combination of government regulations and corporate nondisclosure rules. I spoke with several scientists who had recently left positions at tobacco companies about what they wished they could say to physicians and public health researchers about the work they’d been doing. Some agreed to speak on the record; others agreed to provide background information.

    Twenty years ago, Jackson was finishing her doctorate in genetic technology at Swansea University. British American Tobacco was funding a project in a professor’s laboratory. She met some of their scientists. “These guys were working incredibly hard on understanding what in smoke was causing problems and on reducing the harm of tobacco products,” she added.

    Across the pond in the U.S., Willie McKinney, a toxicologist, had a similar start to his career at Philip Morris USA. He had finished his doctorate in toxicology at the University of North Carolina, met with industry scientists and was impressed with their honest assessment of tobacco’s health effects.

    “They told me that they were out of alignment with society and that their products cause harm,” he said. “That alignment with society means modifying products to be less harmful or selling products that do not cause harm. They can’t make money if they’re shut down. So for 20 years, that was my focus: testing and evaluating potentially reduced-risk products.”

    They both became experts in harm reduction for smokers. Yet because of their association with Big Tobacco, they were frustrated that public health practitioners, medical professionals and government policymakers left researchers like them out of the conversation when it came to helping smokers stay healthier or quit smoking.

    Both recently left industry positions. Jackson is now an executive coach; McKinney formed his own consulting company. (Full disclosure: I’ve worked and written articles with McKinney.)

    One of the concerns I heard from them and others was being unable to respond to the rampant misinformation on the relative risks of nicotine products, especially when that misinformation comes from well-intended government sources or nonprofit organizations. Like epidemiologists facing anti-vax propaganda, industry scientists watch in frustration as facts lose ground to uninformed beliefs and outright lies—information that could interfere with smokers quitting combustible cigarettes.

    I asked them to imagine a long plane flight. Their seatmate, whom they had never met before, is a public health researcher. Upon discovering that they work in the tobacco industry, the public health person starts peppering them with questions. If they could have spoken freely, how would they have responded?

    Why can’t you just stop selling cigarettes? That would solve the problem!

    Unfortunately, it wouldn’t. In an ideal world, there would be no cigarettes. There would be no nicotine. But the world we inhabit includes 1.14 billion smokers.

    This number may startle the seatmate, who probably doesn’t know many current smokers. Smoking is not evenly distributed among the population nowadays. In North America, it’s relatively rare among the highly educated and well-to-do, for example. It’s banned in most workplaces. Anti-smoking ad campaigns have waned. But the deaths continue—nearly 8 million a year. Yet many smokers cannot or will not quit, even with all the available information on how smoking kills. That’s an incredible challenge that won’t respond to simplistic solutions.

    “We know from past experience with prohibition of alcohol and opioids that simply banning something doesn’t work,” noted Jackson.

    In fact, one of the predictable consequences of prohibiting the sale of combustible cigarettes at the commissaries of state and federal prisons has been the growth of a resilient black market. That’s a reflection of how powerful the addiction to nicotine is.

    But combustible cigarettes, the most dangerous of nicotine products, are not the only option for people who are addicted. There’s growing evidence that e-cigarettes work better than nicotine gums or patches at helping people quit smoking.

    But isn’t vaping just as bad?

    Public service campaigns in the U.S. that are meant to keep youth from vaping have stoked fears. National surveys show that more and more people incorrectly view vaping as equal in harm to smoking. Reports of potential benefits get scant attention.

    It’s another example of a moral panic—a widespread and irrational feeling of fear that’s not supported by scientific data. (A moral panic in the 1920s was that motion pictures about gangsters would turn millions of innocent teenagers into hoodlums. We now refer to those films as “classics.”)

    By contrast, health authorities in Europe, such as Public Health England, the Royal College of Physicians and Cancer Research U.K. are taking a different approach than their North American counterparts. They’re educating adult smokers about the relative risks of smoking versus vaping and encouraging them to switch, ideally as a first step toward quitting nicotine altogether. Their experts say that e-cigarettes are about 95 percent less harmful than combustible cigarettes and doubt that vaping leads youth to take up smoking.

    But what about the flavors?

    Some e-cigarette flavors, unfortunately, are attractive to teens. That’s a legitimate concern. We need to have a combination of effective youth vaping prevention programs, buyer age verification protocols, responsible marketing and nicotine addiction treatment programs for those who get hooked.

    But this concern about flavors seems inappropriately focused on vaping. My local grocery store sells stacks of mango-flavored and watermelon-flavored White Claw fizzy alcohol drinks with no visible protest. Yet these types of “alcopops” are highly attractive to underage drinkers and have been linked to dangerously high blood alcohol concentrations.

    Also, banning flavored vapes may do more harm than good when it comes to public health. Grown-ups prefer flavors too. “Evidence shows that flavors are incredibly important for adult smokers to use e-cigarettes to switch with,” Jackson added. “So how do you responsibly market those flavors with age-appropriate adult names? In the U.K. and in Europe, we worry whether the levels of nicotine in these products are high enough for smokers to be able to switch satisfactorily.”

    In other words, adequate nicotine levels may be a critical variable in getting addicted smokers to switch to reduced-harm vaping.

    Can’t we just get rid of the nicotine?

    Not only does the proverbial “man on the street” wrongly point to nicotine as the health danger in smoking; new studies show that most physicians “strongly agree” (also incorrectly) that nicotine directly contributes to cancer and heart disease.

    “Yes, nicotine does have addictive properties; that’s beyond question,” said Jackson. “But it’s all the other stuff. There are 10,000 components in cigarette smoke, and a chunk of them contain the carcinogens and toxicants that do the damage.”

    That’s where harm reduction comes in. If nicotine is not the health danger, how can you improve the health of addicted smokers who don’t (or don’t yet) want to quit? We now have a variety of delivery systems, such as e-cigarettes, heat-not-burn products, pouches and snus that can give smokers the nicotine their brains crave “without all the nasties in the smoke,” as Jackson put it. Ideally, they’ll use those reduced-harm products as a bridge to quitting tobacco and then nicotine completely.

    How can you work for Big Tobacco?

    “I was hired to focus on harm reduction because the people at the company knew that their product caused harm,” said McKinney.

    Today’s industry scientists work under different assumptions than past generations and toward different goals. We know and can openly say that smoking is addictive, dangerous and deadly. From inside, we can work to save lives without being dependent on the vagaries of grant support.

    The flight is coming to an end. The seatbelt light is on. Your seatmate has one final question.

    What can we agree on?

    The development of Covid-19 vaccines has shown what can happen when industry, academia and government work together on solving a critical public health problem. The ongoing threat and lives lost from smoking is similar to that of the pandemic. Imagine what could be achieved with that same level of cooperation and transparency.

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.
  • The Leading Edge

    The Leading Edge

    Photos: Republic Brands

    Building on a formidable heritage, Republic Brands is keen to capitalize on the latest market trends.

    By George Gay

    Here’s a challenge. Try to figure out what “category” was being referred to when, during an interview with Tobacco Reporter in August, a company executive said, “I think it is the most exciting time to be in the category in the U.S.”

    If I didn’t know the answer to this puzzle, I think I would have guessed at something like nicotine pouches. I certainly wouldn’t have gone for a combustible product. But the executive was talking about the roll-your-own category in general, and, in particular, about Republic Brands, which in July changed its name from Republic Tobacco. “It’s rare that you are able to become part of a company like Republic with such great ownership, such iconic global brands and an amazing supply chain in a category that is becoming more and more meaningful in the U.S.,” said Paul Marobella, the former chairman and CEO of Havas Creative in North America who joined Republic as president and chief marketing officer on July 1, having previously acted as a consultant. “And I know that everybody here is really excited about our future. You’re going to see some great new products from us—some innovation. I think people will come to know the Republic Brand name more than they knew Republic Tobacco in the past: We are going to focus more on that. And we’re building a great place to work and a place that really creates iconic brands. That is the spirit here at the moment.”

    Marobella was speaking mainly about the U.S. market, though some of his underlying ideas have wider resonance, which is appropriate given the global reach of Republic. The company, owned by Donald Levin, claims to be the largest RYO company in the world. It has subsidiaries in Canada, continental Europe and the U.K. operating under the name Republic Technologies, seven manufacturing facilities across North America and Europe, and a sales presence in 120 countries.

    But for the moment, the focus is on the U.S. where Marobella has taken on the responsibility for aligning Republic’s brands and brand marketing with specific consumer segments across the U.S. He exudes enthusiasm for this challenge, and it is easy to get swept along by such an experienced brand marketer talking of consumers choosing new pathways through changing cultural environments with products that combine brand heritage with sustainable materials.

    Paul Marobella

    A Growing Market

    But he has a point. If you step back and take a moment to reflect, there is clearly something going on here—in the U.S.—and now. The first thing that should be kept in the background is the size of the U.S. market. This was brought home to me when Marobella mentioned E-Z Wider, one of the most recent brand additions to the Republic portfolio of rolling papers, acquired along with the Joker brand by Levin about three years ago. One of the areas where E-Z Wider has a strong presence comprises the Eastern Seaboard of the U.S., which, the internet tells me, has a population of about 118 million people, slotting it into about 12th position on a list of the most populous nations of the world. The plan is to take E-Z Wider national, as one of the company’s growth and emerging brands.

    Importantly, too, there are signs that within the huge U.S. market—the total population is about 328 million—the RYO sector is growing. Hard data on the sector is more difficult to come by than is that on factory-made cigarettes, for instance, but Marobella said Republic was seeing growth both in the incidence of people rolling their own and making their own with papers, cones and tubes. The cone sector, which Republic entered about three years ago, was particularly vibrant, he said, before adding that bamboo cones and bamboo papers were “flying off the shelves.” At the same time, indirect evidence for such growth is being provided, too, by an increase in new competitors and new brands entering the market and by what Marobella described as the excitement currently evident in the segment at trade shows.

    Another important point to keep in mind is that, whereas the market for factory-made cigarettes, which are locked in with tobacco, has nowhere else to go, the market for RYO and make-your-own accessories, such as rolling papers, cones and tubes, while heavily underpinned by tobacco consumption, is expanding beyond tobacco. Marobella is careful to emphasize that Republic wants its products to be used only with legal materials, naming tobacco, hemp, CBD and herbal products generally. But there is no getting away from the fact that smoking marijuana is becoming legal in parts of the U.S. and is already so north of the border, across Canada. And Marobella conceded that, in respect of marijuana, U.S. federal legalization would be great for “the RYO category in which Republic’s brands play such an important part.”

    What I wrote above about factory-made cigarettes having nowhere else to go might be taken to suggest that the manufacturers of factory-made cigarettes also have nowhere they can go beyond tobacco. But such a suggestion would be misleading. Leading manufacturers in this field are making huge efforts to move away from combustible tobacco toward all manner of new-generation products, and, given their initial success is maintained, it is conceivable their departure will leave behind a considerable vacuum, part of which could be filled by RYO products—initially tobacco based, but later, perhaps, underpinned by other smoking materials.

    And on top of these marketing opportunities for RYO brands, you can add emerging retail possibilities, such as ecommerce. Marobella told me that new highly innovative delivery services were coming on line in the U.S.: services such as GoPuff, which will deliver to your house in 25 minutes or less. Despite its name, GoPuff delivers a huge array of products that happens to include a wide range of tobacco and nicotine goods from charcoal heaters for hookahs to rolling papers to e-liquids. “You have consumption lounges being legalized in certain cities,” added Marobella. “Las Vegas is one where you will be able to consume herbal products on-premise. You have subscription delivery boxes in which papers and cones are sometimes included.”

    Bamboo papers and cones have been flying off the shelves, according to Republic Brands.

    A diverse consumer base

    Marobella added, however, that while more and more routes were being opened to the consumer and while it was important for Republic to keep abreast of these new opportunities, the company’s core business was with, and would remain with, distributors, wholesalers, convenience stores, c-gas stations and smoke shops.

    I guess that, to a certain extent at least, the route to the consumer needs to be allied with the type of consumer you are aiming at. So who are these consumers? Well, the traditional RYO consumer is still a male manual worker who likes to roll tobacco and smoke without having to take out a loan, and that is unlikely to change greatly soon. But, partly because of new opportunities provided by herbal materials, more women are entering the RYO category, and, in fact, some estimates have women accounting for nearly 40 percent of the RYO market attributed to herbal material use. In part, too, the RYO category has opened itself up to new entrants with products such as cones that don’t require people to be skilled in the art of rolling. And then there is the question of cultural changes. “I think that in the U.S., people are seeking to find moments to themselves, they are seeking to relax, seeking to enjoy the little things in life more and more because of what is happening in our world,” said Marobella. “And through our research, we have seen that people use our products to help them relax.”

    The JOB brand is said to be about creativity.

    Of course, to satisfy the needs of a diverse consumer base, you need a wide-ranging portfolio of products, and Republic seems to have just that. The company was started in 1969 by Levin, who at that time owned one of the most famous smoke and head shops in the U.S., Adams Apple in Chicago, and a smoking accessories business operating under the same name. He no longer owns the shop but still owns the brand name, which is used for the company’s ecommerce business selling on Amazon, and which appeared as recently as August in a TMA trademark report relating to RYO-related and MYO-related products. Since those early days, Levin has been acquiring and building a formidable brand portfolio, which includes OCB, said to be one of the largest global brands and one that is the company’s all-natural brand, carrying the tag line “One with Nature.” OCB, like many rolling-paper brands, comes in a dizzying number of versions, but Marobella says it is probably the company’s most expansive. “We have a whole line of different sizes, fibers, some that are made of flax, some that are made of wood pulp,” he said. “OCB has organic hemp, bamboo; we have a virgin unbleached paper and cones as well.”

    While OCB is about being one with nature, the JOB brand, which has been in existence since 1838, is said to be about creativity—you’ve almost certainly seen the fine print posters—and cultural relevance while E-Z Wider, apparently named after the film, Easy Rider, is Republic’s outlaw or rebel brand.

    It is not possible to list all the brands and, especially, all the product styles within each brand, but I should point out that, despite such a large existing portfolio, as is mentioned at the start of this piece, there is more to come. Marobella wasn’t going to be drawn on specifics, but he did say that, across Republic’s portfolio, there would be more products made of organic hemp, which, by the way, is sourced from Champagne, France, from the same soils that produce fine champagnes. “You’ll start to see some unique sizes of products, such as cones; you’ll start to see some brands that are targeted at very specific demographics and consumer segments in the U.S.,” he said. “You might see some different colors of papers, some different patterns of papers that would appeal to a different 21+ demographic in the U.S., maybe a female demographic. There is a lot of innovation that is happening. We want to be on the leading edge of that.”

    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.
  • The Time is Now

    The Time is Now

    David O’Reilly (Photo: BAT)

    Making tobacco harm reduction a reality has never been more important.

    Never has tobacco harm reduction been more important than in the wake of the Covid-19 pandemic. Public health bodies are now, more than ever, focusing on broader health issues and how they can optimize outcomes while also making the most of their resources. Minimizing the negative public health impact caused by smoking cigarettes continues to be a major challenge that many are trying to tackle, with some countries, such as the U.K., setting themselves ambitious targets to eliminate cigarettes entirely. The real question is, how can they effectively deliver on this goal? 

    We know from experience, such as the U.S. prohibition of alcohol, that simply banning popular consumer products does not work. Based on the evidence, we believe that the most effective way to tackle this issue is through tobacco harm reduction. Policies that are bold, progressive, forward-looking and, most importantly, backed up by robust scientific evidence must be created and embedded into society.

    The reality is that people continue to smoke despite awareness of the adverse health risks associated with doing so. These are smokers who would benefit from greater access to alternative products that can effectively deliver nicotine and provide an enjoyable and, importantly, reduced-risk alternative to smoking.* It is this group of people for whom effective tobacco harm reduction policy matters most.

    BAT is steadfast in its position that the best thing people can do to protect their health is to not start smoking or to quit smoking. We encourage those who would otherwise continue to smoke to switch completely to a scientifically substantiated, reduced-risk alternative. Products that contain nicotine but do not involve combustion (the burning of tobacco at up to 900 degrees Celsius) emit far fewer and lower levels of toxicants compared to conventional cigarettes and have the potential to be significantly less harmful to health.

    The availability of scientifically substantiated, less risky products such as vapor products, tobacco-heating products and modern oral products are crucial to effective tobacco harm reduction. Product regulations should recognize the role these alternatives can play in harm reduction by ensuring that high quality product standards are enforced, that consumers have access to information to make informed choices and, critically, that underage use is prevented.

    Smokers who wish to continue using nicotine via these less risky alternatives should not be punished by regulations and legislation that deprives them of information and denies them access to these products—a system that does not recognize the rigorous scientific process that goes into developing these reduced-risk products.*

    This view is shared by many within the public health community, including Public Health England. However, there are some organizations and public health bodies that disagree with the concept of tobacco harm reduction. Often, this is because the available reduced-risk alternatives are not entirely risk free, which BAT acknowledges. That doesn’t mean that consumers should be denied the choice to make use of alternative products that reduce the risk of harm versus continuing to smoke.

    At BAT, we support regulation that is founded on scientific evidence that can effectively reduce the projected health impact of smoking around the world. Tobacco harm reduction underpins our clear purpose to build “A Better Tomorrow” by reducing the health impact of our business. We have been clear for many years that our business needs to be built on outstanding products, informed consumer choice and a drive toward a reduced-risk portfolio, which is underpinned by world-class science. We are doing this by providing consumers who would otherwise continue to smoke cigarettes with a range of less risky ways of consuming tobacco and nicotine.*

    We recently conducted a long-term randomized, controlled trial of our tobacco-heating product, Glo, which lends credibility to the harm reduction potential of the entire category of high-quality tobacco-heating products. Surely, even our detractors can see the benefit in this landmark new clinical study showing that the health risks of cigarette smoking may be reduced in smokers who completely switch to using tobacco-heating products.

    We advocate for a collaborative, multi-stakeholder approach to advance tobacco harm reduction. We want to see meaningful change in the development of tobacco and nicotine policy. Industry, government, scientists, regulators and governing bodies must put their differences aside and come together in order to create effective tobacco harm reduction policy and provide better alternatives for those who would otherwise continue to smoke. This is not something that can be tackled by one group alone. Engagement, dialogue and communication among all parties is what is required in the development of effective policy. By adopting a more inclusive stakeholder approach to tackling tobacco harm reduction, we can make progress much more quickly.

    We have a goal of 50 million consumers of our reduced-risk noncombustible products by 2030. Every one of these individuals matters. So, to me, this is 50 million reasons why tobacco harm reduction matters and 50 million reasons to believe in “A Better Tomorrow.”

    * Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk-free and are addictive.

    David O’Reilly is director of scientific research at BAT.
  • Chew on This

    Chew on This

    Photo: Swedish Match

    How sensibly will modern oral nicotine products be regulated in the future?

    By Stefanie Rossel

    Is history repeating itself? The parallels between the development of the vaping sector and that of modern oral nicotine are striking: Quick consumer adoption leads to phenomenal category growth rates. The promising, still-unregulated market lures myriad players and creates an unmanageable number of brands. Leading tobacco manufacturers seek to get their slice of the cake, often by strategic acquisitions. Despite evidence pointing at the reduced harm potential of the product compared to combustible cigarettes, tobacco control activists raise the alarm, urging regulators to crack down. The Wild West, gold-rush atmosphere is then abruptly curbed by the introduction of often-misguided restrictions and even product bans.

    It is at these crossroads where modern oral nicotine currently finds itself. The category, still a niche, has grown impressively in the five years since Swedish Match introduced Zyn, the first product of its kind. Market analysts are outdoing each other in their forecasts. 360Research Reports expects the category to increase to $32.77 billion in 2026 from $2.38 billion in 2020. Five key global players jointly hold a 77 percent share of the world market, according to Precision Reports. With 66 percent, Europe is the largest market, followed by North America and Asia-Pacific with more than 30 percent each, the company states.

    Competition in the market has rapidly heated up. Research and Markets notes the launch of 27 new brands of nicotine pouches in 2020. By now, all major tobacco companies and several smaller players are represented in the category. To cater to the increased demand, many of them had to step up production capacities, among them British American Tobacco, which in September 2020 built a new plant in Hungary that is dedicated to the production of nicotine pouches for export markets.

    The most recent company to enter the segment is Philip Morris International. In an investor presentation in February 2021, then-CEO Andre Calantzopoulos announced the development of a respective product through a “combination of partnerships and internal development.” In May, PMI acquired Danish family business AG Snus, a manufacturer of nicotine pouches. The deal was followed by PMI’s takeover of Danish firm Fertin Pharma on July 1, a company specializing in nicotine-replacement therapy (NRT) type products such as gums, pouches, liquefiable tablets and other solid oral systems for the delivery of active ingredients, including nicotine.

    Less Harmful Than Snus

    Nicotine pouches or “modern oral,” as manufacturers have termed the novel segment, are considered a subcategory of the smokeless tobacco segment. They are an evolution of traditional Swedish snus, a pasteurized oral tobacco that is available as loose products or in pouches and has been consumed in the Nordic country for 200 years. Unlike snus, however, modern oral nicotine contains no tobacco. In some brands, the nicotine used is not even derived from tobacco but produced synthetically. The nicotine pouches are white, pre-portioned little bags comprising nicotine applied to a carrier material, such as food-grade fillers. They come in a variety of flavors and nicotine strengths and even as nicotine-free variants. Like snus, they are discreet and spit-free and can be disposed of in household trash after use.

    For years, Sweden has had the lowest smoking rate in the European Union. According to Statista, the share of daily smokers in the country stood at 7 percent in 2019 (if the rate were to drop below 5 percent, Sweden would be considered “smoke-free” by some definitions). This compares to an average smoking prevalence of 23 percent throughout the EU. Sweden’s low smoking incidence is largely attributed to snus, which is used by 1 million Swedes. Decades of scientific research have confirmed the product’s efficiency as a smoking cessation tool. Snus use is estimated to be about 90 percent to 95 percent safer than smoking combustible cigarettes, which puts the product on par with e-cigarettes on the continuum of risk scale. A 2020 survey conducted by the European Tobacco Harm Reduction Advocates found that 43.3 percent of Swedish ex-smokers had used snus and/or nicotine pouches to quit smoking whereas more than 31 percent of current European smokers would be interested in trying snus if it was legalized.

    However, snus sales have been banned in the EU since 1992 except in Sweden, which negotiated an exemption from the ban when it became part of the trading bloc in 1995. The EU prohibition has survived two lawsuits, and few expect it to be lifted in the foreseeable future. Modern oral products, which offer non-Swedish EU users an alternative to snus, may rank even lower than snus on the risk continuum, according to a recent BAT study published in Drug and Chemical Toxicology. The research found that the company’s nicotine pouches had a toxicant profile comparable to that of NRTs, which are currently considered the least risky of all nicotine products.

    In a Gray Zone

    Given the EU’s attitude toward tobacco harm reduction, such an acknowledgement appears unlikely, however. Because modern oral products don’t contain tobacco, they cannot be regulated under the current EU Tobacco Products Directive (TPD); their status will be reconsidered during in the next TPD revision.

    In Germany, this has recently led to confusion over the legality of nicotine pouches. Several courts at the federal level have ruled that modern oral products are to be classified as foodstuff. As such, they would have to meet the requirements of European food legislation, which does not permit nicotine as food, food ingredient, food additive or flavor. Furthermore, food must not be hazardous to consumers’ health, according to the legislation. However, toxicological studies have shown that the nicotine dose that is taken up even by moderate users of modern oral is linked to health damage, courts argued. The rulings led to local sales bans. Due to this legal uncertainty, BAT in July 2021 suspended sales of its Velo nicotine pouches in Germany. The company called for legislation to set advertising standards for tobacco-free nicotine pouches and to limit nicotine concentration to 20 mg/mL.

    In the absence of EU legislation, several countries have tried to regulate nicotine pouches at the national level. In May, the Czech Republic amended its food and tobacco products act, obliging manufacturers, importers, retailers and distributors of nicotine pouches to ensure that these products meet the requirements for the composition, appearance, quality and characteristics stipulated by the decree of the Ministry of Health under similar conditions as those for e-cigarettes. In addition, they will have to inform the ministry, on a regular basis, on the nicotine pouches that they intend to launch on the EU/European Economic Area market. Manufacturers will also have to collect information on the suspected adverse effects of these products on human health. Tobacco-free nicotine pouches that do not comply with the amendment and that were produced or marketed before May 12, 2021, will have to come off the market in 2022.

    Italy, where nicotine pouches are considered consumer products, will reportedly consider modern oral products when it revises its anti-smoking law by the end of the year. Estonia’s parliament announced in July that it might relax its snus regulations to help reduce smoking.

    The U.K., no longer an EU member and therefore not bound to the common market’s regulation, is expected to follow Sweden’s example. To achieve its goal of a smoke-free society by 2030, the British government is presently shaping a tobacco control plan, which may very well include stronger promotion of cigarette alternatives, such as heated-tobacco products and nicotine pouches.

    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.
  • No Exaggeration

    No Exaggeration

    Photo: asayenka

    The future of tobacco machinery in a rapidly changing market for nicotine products

    By George Gay

    According to the Oxford Dictionary of Humorous Quotations, on June 2, 1890, the New York Journal ran what was to become one of most famous quips by Mark Twain: The report of my death was an exaggeration. The quote is perhaps more often rendered as “Reports of my death have been greatly exaggerated,” and, in this form especially, it could be applied to the tobacco industry. With the word “my” substituted with “the tobacco industry’s,” the quote could have been run in the New York Journal and other U.S. or European newspapers any time during the past 50 years because, while the tobacco industry has suffered a number of well-publicized setbacks, it has always recovered.

    No one can deny, however, that while sales of traditional cigarettes might be increasing slightly in a few markets and holding firm in others, in many, they are falling or even plummeting. Certainly, the long-term, worldwide trend seems to be down, and it is difficult to imagine any future scenarios in which tobacco smoking will be given a boost.

    This, of course, raises questions about where the machinery sector—and here and elsewhere in this piece I’m writing about making and packing machines for traditional cigarettes—is headed. It would seem reasonable to assume that it will decline in line with the market for cigarettes. But things might not be quite as simple as this, partly because there are divisions within this sector.

    Ask around and you will no doubt be told any number of reasons why the tobacco industry has managed to survive in the face of the moral outrage aimed at its existence by the people with the power to put it out of existence, but one of the most important reasons is that it has demonstrated flexibility where necessary, though sometimes reluctantly and, therefore, belatedly.

    There was, about 30 years ago, a sense that machinery suppliers, especially those based in Europe, were working themselves out of a job because, as increases in sales of cigarettes outside China slowed, machinery speeds were being ramped up—at times hugely. And at roughly the same time, technology transfer deals were being made with engineering companies in China.

    In part, though, there was something of a separation between overall cigarette consumption and machine capacities. The very fastest machines became relevant mostly to what were known as long-run brands, the most internationally in-demand products, the sorts that major cigarette manufacturers wanted to focus on and wanted increasing numbers of consumers to focus on while the manufacture of lesser brands was left in the hands of slower—though mostly not slow—machinery.

    On the surface, such a separation was based on the competing claims about machine flexibility. Those supplying slower machinery claimed their equipment was better for manufacturing other than long-run brands because technicians could make the size and other changes needed when switching from the manufacture of one type of cigarette to another more quickly than was the case with faster machinery. And even if changes took the same length of time on the two types of machines, they said, it was more inefficient to have a fast machine sitting idle while lengthy changes were made to it than to have a slower one sitting idle.

    Partly in response to this, perhaps, the suppliers of the fastest machinery made well-publicized efforts to make their equipment more flexible. But this response was more likely to have been caused mostly by competitive issues, supplier to supplier, I think. After all, those that supplied the faster machines offered also slower—though not the slowest—equipment, either directly or, as time went by, through acquired specialized suppliers.

    Of course, there is more to the machinery capacity arguments than cigarette production numbers; it also concerns investment costs. For many years now, we have been used to seeing the major international cigarette manufacturers swallow smaller companies, and, in recent times, seeing those manufacturers consolidate their product portfolios, all of which, I guess, has tipped the scales toward high-capacity machinery.

    New-Generation Products

    But what about the future? I guess it is not beyond the bounds of possibility that, having perhaps taken their eyes off the traditional cigarette ball somewhat, the major cigarette manufacturers have left the door open to startups, at least in those countries where it is possible to start a cigarette manufacturing business from scratch. After all, they have stopped manufacturing some of their shorter run brands and are in the process of converting former cigarette factories to manufacture new-generation products. Clearly, if this door is left ajar, part of the focus might start to switch to smaller manufacturers and, therefore, to lower capacity machinery, including secondhand machinery.

    Such thoughts were brought to the surface again recently when, according to a report in the Guardian newspaper, Philip Morris International’s CEO, Jacek Olczak, called on the U.K. government to ban cigarettes within the next 10 years. Olczak apparently said PMI could “see the world without cigarettes … and actually, the sooner it happens, the better for everyone.” Olczak said, “Give [people] a choice of smoke-free alternatives … with the right regulation and information, it can happen 10 years from now in some countries. You can solve the problem once and forever.”

    I don’t know why Olczak picked on the U.K., but it might have been partly because the country has already seen a fairly dramatic fall in cigarette consumption, because it has taken a generally progressive attitude toward lower risk alternatives to combustible cigarettes and because the country is in a state of transition in respect of tobacco and nicotine as it reviews its tobacco and related products regulations after having left the EU and left behind the necessity to comply with that institution’s Tobacco Products Directive (TPD).

    Looked at like this, the U.K. could become an experiment in tobacco harm reduction (THR), were the government to make such a bold move. And this is not altogether unthinkable even for a semi-detached libertarian regime as is now in power. But the real question is: What would be the conclusion of such an experiment? Would the U.K. become, as those supporting the principles of THR might have it, a tobacco smoke-free heaven in which former smokers were satisfied with the new, less risky nicotine-delivery products, cancer rates plummeted and the economy boomed as improvements in health, productivity and social cohesion provided huge dividends?

    Or would it conclude, as those opposed to THR might have it, with a nation, most of whose youngsters were hooked on nicotine and committing crimes to obtain the money necessary to buy the black market cigarettes onto which they had moved during their summer breaks abroad—a nation with worsening health, productivity and social cohesion?

    Given scenario one, the medium-term to long-term outlook for cigarette machinery suppliers would be bleak because even the best efforts of the World Health Organization and its allies would not be able to hold the tide of countries wanting to take advantage of similar THR dividends. But given scenario two, cigarette machinery suppliers could end up on a roll given that what had appeared to be the only truly viable route out of smoking had been shown to be fatally flawed.

    Of course, it is unlikely, I think, that Olczak believes the U.K. government would ban cigarette smoking within 10 years, but I wouldn’t rule out that he is banking on his plan B being taken seriously: “Give [people] a choice of smoke-free alternatives … with the right regulation and information …”

    This would, of itself, be a valuable experiment, especially if cigarette smokers were also provided with the right, or rather truthful, information and if the information provided to both smokers and vapers included accurate information about the environmental impacts of traditional cigarettes and lower risk products. After all, it is going to be challenging to enjoy a smoke or a vape if your house has been blown away and you are standing up to your neck in water that is being evaporated by the heat dome that has appeared overhead.

    So what is the likely outcome? I think we will see a U.K. scenario that sits somewhere between one and two above. The art of politics is compromise, which, depending on your point of view, means satisfying everybody or nobody. In other words, there will be significant but modest changes in the U.K. that will bring about a welcome boost to the conversion of smokers to less risky products.

    Looking further afield, the U.K. example might have some effect on those countries orbiting at the greatest distance from the WHO, while those in closer orbits will continue to try to rebut the ideas of THR. The result will be that cigarette smoking worldwide will continue to fall for the next 10 years, much as it has in the past, and the requirement for cigarette machinery will fall with it, perhaps with demand tilting toward medium-speed equipment. I think there is simply too much inertia in the market, largely held in place by the opposition to THR inherent in positions taken up by the WHO and its allies, for there to be any sudden, major changes. For one thing, it has to be remembered that while the U.K. might have shaken off the shackles of the TPD, it is still tied to the WHO’s Framework Convention on Tobacco Control and the way that treaty is interpreted by the parties to it.

    One last point: If the U.K. government does decide to ban cigarettes during the next 10 years, it would be consistent and fair for it to also ban alcohol. In fact, it would be hypocrisy not to do so. Alcohol consumption takes a far greater toll on U.K. society than tobacco consumption, and, with the number of smokers falling and the number of drinkers increasing, the damage caused by alcohol is only going to increase relative to that of tobacco.

    Sodim’s Synergies

    Eric Favre

    In communicating earlier this year about a story published in the August issue of Tobacco Reporter, Eric Favre described as synergistic the relationship between the instrument company of which he is managing director, Sodim, and Hauni, the machinery supplier. He made his remark in reply to a question about what advantages had accrued after the acquisition some years ago of Sodim by Hauni.

    Favre made the point, also, that this synergy, this coordination if you like, extended to customers and potential customers. There were, for example, advantages to be had for a customer in acquiring, for instance, a cigarette maker and a quality control (QC) test station as a single package—advantages such as those to do with technology and logistics. And by the same token, Favre added, during an R&D project, a customer could take advantage not only of the machinery expertise and support available from Hauni but also of the quality assurance (QA) and QC oversight of Sodim.

    The idea of such synergies did not make it into the August story but, this, the September issue, provides an opportunity to take the idea further because it is looking at making and packing.

    Tobacco Reporter: Given that Hauni making machinery would, in the normal course of things, be delivered with QA/QC equipment included, what, specifically, can Sodim add to a cigarette manufacturer’s standards armory?

    Eric Favre: Sodim adds the capacity of automatic sampling, a hands-free system that picks a cigarette from the mass flow and delivers it into the hopper of a Sodim test station: a SodiQube or a station from the Sodiline family. The data generated by the test station is then fed back to the maker, which, where necessary, uses it automatically to adjust its settings and thereby keep each cigarette produced very close to the target weight, diameter and dense end position. It is, in fact, a “police camera” that fine tunes the monitoring of the maker.

    What can Sodim offer in the way of additional QA and QC equipment in respect of cigarette packing?

    In the packing area, Sodim can offer a nondestructive pack seal tester that has the advantage of allowing all boxes that are correctly sealed to be returned to the product flow. Currently, this system is manual, and it would be ideal if it were developed so that it sampled automatically. Such automatic sampling would require complex developments, however, and might not be viable economically.

    In respect of making and packing, what can Sodim offer to manufacturers of other tobacco and nicotine products, such as tobacco-heated products (THP) and snus?

    Sodim test stations are suitable for measuring THP weights and diameters, though not dense-end positions. And the nondestructive pack-seal tester is suitable for testing THP and snus packs.

    Are Sodim’s instruments used mainly by major manufacturers, or do smaller manufacturers also use them?

    Sodim equipment is used by any type or size of manufacturer, from small and family-owned businesses to international groups.

    Is it true to say there are certain measurements, such as those that have to do with complying with regulations, that all manufacturers must make, though these will differ from country to country, while others are optional because they provide data for internal use, perhaps for improving efficiencies and reducing waste, etc.?

    This is correct. In the case of traditional cigarettes, Sodim’s very accurate and specialized equipment is needed to meet both the demands of regulations and internal standards of quality control. But for THPs, which do not generate smoke, our equipment is used more for internal QC reasons because there are fewer specific regulations in respect of these products than is the case with traditional cigarettes.

    How does Sodim or a manufacturer running Sodim instruments ensure they are giving the correct readings? Do they need regular servicing and replacement after a given lifetime?

    Sodim instruments will give the correct readings provided that the end users—mainly manufacturers but also laboratories—calibrate these devices regularly. And to allow users to calibrate their instruments, Sodim’s ISO 17025-accredited laboratory regularly delivers calibrated standards to the users. In addition, regular servicing is strongly advised and in most cases is carried out by Sodim at customers’ sites. –G.G.

    A Veteran’s View: Challenging Times Ahead

    Chris Crawley

    In another main story accompanying this sidebar, I question how much longer traditional cigarettes, and therefore the machinery that makes and packs them, will be around. My conclusion is that they will be around for quite some time, even though their demise is perhaps being brought into sharper focus right now.

    That is my stab at predicting the future, but what is happening right now? In an email exchange, I asked Chris Crawley of Axiom Select, who has been observing and working widely in the tobacco industry for many years, whether he believed that demand for traditional cigarette making and packing machinery was currently strong, average or weak. “I believe the market for new secondary (making and packing) machinery—with almost all the multinationals—is soft globally as traditional cigarette markets mature and volumes decline,” Crawley wrote. “If there’s a bright spot, it is probably Asia, but this, too, has its ups and downs.”

    And if Asia is a bright spot, for whom is it a bright spot? Crawley pointed out that the large EU-based machinery producers were finding emerging competition in Asia where labor and materials were often lower. There was an ongoing argument that said the quality of machinery built in Asia was not as good as that built in Europe, but while those putting forward this argument might be correct in some instances, any quality gap was certainly narrowing. And, at the same time, the cost and, therefore, the machinery price gap could be considerable.

    Crawley said he expected these trends to continue as mature cigarette markets slowly contracted, particularly in North America and Europe. But again, there is a bright spot. “Nevertheless, there is a highly competitive market—mostly price driven—for used/refurbished machinery from some of the larger independent cigarette producers,” said Crawley.

    That is all well and good, but isn’t the competitiveness of this market in part down to the fact that supply has been choked off in recent years? “It has been general policy, with the multinational producers, not to resell or trade their surplus machinery,” Crawley acknowledged. “Nevertheless, not all play by the same rules all over the world. Consequently, there is a good amount of used machinery available if one cares to search. This trend, also, is expected to continue.”

    At this point, I couldn’t help asking a question that has often occurred to me in my more fanciful moments. If I decided I wanted to start a modest cigarette manufacturing plant in the EU, what would be my best options in respect of machinery and equipment, assuming that I had a modest budget—whatever that might be—but what I thought was a winning brand name? “A modest startup can still find good used machinery at competitive prices,” said Crawley. “For example, a Molins Mk9 with a Hauni MaxS tipper is a good medium-speed complex with high efficiency/productivity. Spares and expertise are also available. And from this mid-point, you can go up or down in price and type of machinery.

    “For the last 30 years, machinery development has focused on higher speed machinery, and, while there are huge benefits to achieving greater speeds from the same machinery footprint, those speed increases often come with the sacrifice of flexibility. Machinery flexibility lags profoundly and there is little development in this sector. Changing machinery configurations for different lengths, diameters and tipping, etc., remains difficult, time consuming and costly.”

    Finally, Crawley turned his gaze on the future. “Affluent and highly profitable cigarette markets still abound, but they are increasingly finding their volumes shrinking and competition increasing,” he said. “In the longer term, challenging times are ahead for both machinery and cigarette producers.” –G.G.

    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.
  • Uncharted Territory

    Uncharted Territory

    Photo: JHVEPhoto

    The FDA’s review process of PMTA applications won’t be completed by the Sept. 9 deadline.

    By Stefanie Rossel

    Regulation of novel tobacco products can be a tedious and sometimes overwhelming process, as current developments in the United States show. Almost a year after the court-ordered deadline for manufacturers to hand in premarket tobacco product applications (PMTAs) for their products and only a few days before the grace period for unapproved products to stay on the market ends, the U.S. Food and Drug Administration sits on a mountain of more than 2 million applications for “deemed new tobacco products.”

    In 2019, a Maryland district court judge had ordered the FDA’s Center for Tobacco Products (CTP) to set a new and earlier PMTA deadline for electronic nicotine-delivery systems (ENDS), which was finally laid down for Sept. 9, 2020. The court order provided for a one-year period during which time such products might remain on the market pending FDA review. After Sept. 9, 2021, the FDA will be allowed to grant further extensions on a case-by-case basis for “good cause,” but no general extra time.

    If a negative action is taken by the FDA on the application prior to Sept. 9, 2021, the product must be removed from the market or will risk FDA enforcement. If the FDA issues a positive order on a product, it will be listed on the positive marketing orders page and can continue to be marketed, according to the terms specified in the order letter. At the time of writing, however, most applications, each consisting of hundreds or even thousands of pages of scientific data, still needed to be reviewed. In May 2021, the agency published a long-awaited list of vapor companies that had submitted PMTAs by the Sept. 9, 2020, deadline. The publication of the list is believed to signal the start of enforcement.

    Considering the large volumes of PMTAs submitted, though, it is improbable that the FDA will be able to process all submissions before manufacturers are required to withdraw their products from the market. In June, the U.S. Small Businesses Administration (SBA), a federal agency that represents small businesses to the various branches of government, urged the FDA to ask the Maryland district court judge to allow the agency to extend the deadline until September 2022. Most small ENDS manufacturers, the SBA argued, did not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. It said that once the FDA ordered small ENDS manufacturers’ products removed from the market, those small businesses would close permanently. The SBA also pressed the FDA to end its current practice of processing PMTAs in order of manufacturer market share.

    On August 4, Swisher International filed a motion for an emergency preliminary injunction against the CTP for threatening enforcement against products without PMTAs or substantial equivalence approval authorized. The cigar manufacturer, whose cigars are also in the FDA’s premarket-review process with authorization pending, called the FDA’s process “half baked” and accused the agency of creating chaos.

    Individual instead of standardized

    Jonathan Fell

    Consumer staples specialist Jon Fell, partner at Ash Park Capital, thinks it’s unlikely that the FDA will grant a blanket extra year extension. “The FDA has regularly stressed that it has discretion to defer enforcement action on a case-by-case basis, although it’s very hard to know what that will actually mean for the—presumably quite large number—of products which the FDA still hasn’t had time to review by September. I suspect that they will have to defer enforcement against products whose PMTAs have been accepted for review and aren’t obviously deficient, otherwise they’ll face more legal challenges.”

    The agency has repeatedly issued warning letters to manufacturers and retailers to remove unauthorized products from the market, most recently in late July. “The FDA will continue to prioritize enforcement against companies that market ENDS without the required authorization and that haven’t submitted a premarket application to the agency—especially those products with a likelihood of youth use or initiation,” the agency said on its website.

    In contrast to the EU, which with the Tobacco Products Directive (TPD) created a regulatory framework that sets the legislative standards for nicotine strengths, ingredients, labeling, health warnings and other issues for ENDS, the U.S. opted for an individual approach at product regulation. In its recent application report of the TPD, the European Commission stated that the directive’s restrictions on additives in e-liquids, such as vitamins, likely was the reason why the EU was spared the EVALI (e-cigarette or vaping associated lung injury) that raged through the U.S. in 2019.

    “There are very few pros to the way FDA is regulating e-cigarettes in the U.S.,” says Fell. “About the only one I can think of is that having a product explicitly authorized to be marketed in the U.S. might help build consumer confidence in these products after various health scare stories, including the EVALI crisis. But that is at the cost of an enormously complicated and expensive regulatory process that really adds very little value and is a substantial barrier to innovation. I think it would have been far more effective to define a set of standards that e-cigarettes have to meet and then take enforcement action against any products on the market which don’t meet those standards.”

    IQOS on hold

    But it’s not always the FDA’s long-winded processes that prevent manufacturers from marketing their novel tobacco products. Altria subsidiary Philip Morris USA suspended sales of its IQOS heated-tobacco product (HTP) after the U.S. International Trade Commission (ITC) in late July 2021 had found that PM USA had infringed on two patents owned by British American Tobacco subsidiary Reynolds American Inc. (RAI). RAI, which sued PMI USA last year before the ITC and in federal court in Virginia, claims that IQOS violates its patents over the device’s heating blade and alleges PMI was using a former version of the current technology of its own HTP Glo.

    RAI was seeking to have an import ban into the U.S. imposed on IQOS devices and consumables unless PMI licensed the technology from it. The ITC judge’s findings are subject to review by the full commission, with the investigation scheduled to be completed by Sept. 15. In the Virginia case, Altria responded with its own patent-infringement claims and a separate suit in May. The company also filed petitions with the U.S. Patent and Trademark Office, challenging the legality of several RAI patents, inclusive of three investigated in the ITC court case.

    IQOS had been introduced in U.S. test markets, including Atlanta, Georgia, Richmond, Virginia, and metropolitan areas in North Carolina after the FDA had granted the product PMTA authorization in April 2019. IQOS was the first next-generation inhalable product to be authorized as a modified-risk product in July 2020. Its U.S. expansion is now on hold.

    “I hope that the two-way patent battles between PMI and BAT will be settled in a grown-up way before long,” says Fell. “It’s not a good look for an industry trying to make the case for harm reduction to be squabbling in this way, particularly if it results in consumer choice being restricted, by products being taken off the market or not rolled out as fast as they otherwise might. Robust competition ought to be a potent mechanism for encouraging more innovation and shifts in consumer behavior.”

    Another development with uncertain impact on the cause of tobacco harm reduction is Juul Lab’s recent funding of a scientific publication. According to The New York Times, the vaping company spent almost $60,000 to fund the entire May/June issue of The American Journal of Health Behavior to help establish Juul as a smoking cessation tool. Juul Labs has submitted a PMTA to the FDA for its Juul products.

    In the past, scientific articles on reduced-risk products sponsored by tobacco or ENDS manufacturers repeatedly had difficulties being accepted by renowned scientific journals. “Perhaps optimistically, I think if the tobacco harm reduction concept continues to take a broader hold, then over the medium to longer term, excluding research sponsored by tobacco or nicotine companies from academic journals will not be tenable,” says Fell.

    “It will come to be seen as what it is: an anti-scientific and unjustifiable attempt at censorship, rooted in a view of the industry which is at least a couple of decades out of date. Perhaps this is the other silver lining of FDA regulation: the FDA has to engage with industry science and recognize its integrity, and over time the influence of that might spread. Ultimately, the FDA’s decision on Juul’s PMTA will have to come down to rigorous science and hard data, whatever attempts are made to sway the agency’s hand via the emotive arguments of campaigning organizations.”

    FDA Refuses to File Substantial Share of PMTA Applications

    On Aug. 9, the U.S. Food and Drug Administration issued a “refuse to file” (RTF) letter to JD Nova Group. The letter notified the company that the premarket tobacco product applications (PMTAs) it submitted for approximately 4.5 million of its products do not meet the filing requirements for a new tobacco product seeking a marketing order.

    As a result of this RTF action, JD Nova Group must remove approximately 4.5 million products from the market or risk enforcement action by FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.

    The FDA’s action affects a significant share of PMTAs under review. The agency has received applications for more 6.5 million products from over 500 companies.

    According to the FDA, JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate environmental assessment. Under FDA’s regulations implementing the National Environmental Policy Act, an environmental assessment must be prepared for each proposed authorization.

    This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020, deadline are still moving through the review process, according to the FDA.

    The list of affected products is available at https://bit.ly/3fP6cZj.

  • Innovation as a Driver

    Innovation as a Driver

    Photo: Celanese

    Even in challenging times, filter and tow suppliers find new business opportunities in innovative nicotine products.

    By Stefanie Rossel

    Over the past years, manufacturers of acetate filter tow and cigarette filters have come to learn how to best cope with challenges. The continuous decline in global cigarette consumption since 2013, which also resulted in lower demand for tow and filters, has been one such issue.

    Hyunyoung Park

    In 2020, tobacco companies sold 5.06 trillion cigarettes worldwide, representing a decline of 3.7 percent compared to 2019, according to Euromonitor. Increasing restrictions on tobacco products as well as the rise of reduced-risk alternatives contributed to this development. “Philip Morris International’s conventional cigarette-free world mission is a big challenge to filter makers,” notes Hyunyoung Park, sales and business development manager at Taeyoung Industry Corp. of South Korea, a supplier of mono, dual and triple filters to multinational cigarette manufacturers.

    The year 2020 added more trials for the tobacco industry, most notably the Covid-19 pandemic. At the ITGA’s Issues Day in November 2020, Shane MacGuill, Euromonitor’s senior head of tobacco research, said he expected combustible cigarette volume to decline further in the next five years, aided by a pandemic that left many governments scrambling to refill their coffers.

    Harald Bruggeman

    For the time being, the most tangible effect of the pandemic for suppliers of acetate tow is logistic in nature, says Harald Bruggeman, vice president of commercial acetate tow at Celanese in the U.S. “A challenge for the entire industry is that the global liner market remains tight with lower performance and higher freight rates that continue to climb,” he says. “To ensure supply chain security, Celanese has a global warehouse network and healthy inventory levels.”

    Bruggeman notes that pandemic-related travel restrictions continue to impact business. To provide best possible service, he explains, Celanese provides remote sales and technical customer support by offering video conferences, online training, webinars, web-based software for item selection, filter and cigarette design calculations and RealWear devices, such as hands-free, voice activated, head-mounted tablets, for remote assistance.

    The pandemic follows a period during which tow manufacturers were busy preparing for tighter regulation. In February 2018, the European Commission published the classification of titanium dioxide (TiO2), a delustering agent that had been used in paints and varnish, plastics, paper, printing inks and many other applications for about 100 years, as a suspicious carcinogen for inhalation. Although many scientific studies show that TiO2 does not cause cancer in humans, the classification will take effect Oct. 1, 2021. “The filter tow manufacturers are transitioning to acetate tow without added TiO2, which increases complexity in manufacturing, portfolio and supply chain,” Bruggeman says. “Celanese has completed all necessary preparations for the commercial production of acetate tow without added TiO2 at both manufacturing sites, i.e., Narrows, Virginia, USA, and Lanaken, Belgium.”

    Jens Ebinghaus

    Jens Ebinghaus, CEO of Swiss-based acetate tow manufacturer Cerdia, formerly Rhodia Acetow, stresses the positive side of this challenge. In November 2018, the company launched DE-Tow, a tow made of cellulose acetate that is free from TiO2. “Most of our customers have already switched to TiO2-free filter tow while others still use tow with TiO2,” he says. “Supplying both customer groups adds complexity to the manufacturing process and creates opportunities to the most flexible suppliers.” In 2019, Cerdia’s Freiburg, Germany, plant committed to invest close to $100 to strengthen its competitiveness, to foster the growing market share of specialty filters produced in Freiburg and to focus on product innovation as well as diversification.

    Taeyoung Industry Corp. is developing filters with non-acetate tow and studying alternatives to conventional filter material.

    Toward Increased Sustainability

    While the pandemic is far from over, this summer brought about new challenges for the sector: On July 3, 2021, more parts of the European Union’s Single-Use Plastics Directive (SUPD) entered into force, banning the sale of items such as plates, cutlery, straws and cotton bud sticks made of plastic as well as food containers and expanded polystyrene cups. The directive was drafted to fight marine pollution. Although cigarette filters are among the 10 single-use plastic products most often found on Europe’s beaches and seas, representing as much as 60 percent of all waste items, they are not among the prohibited products. Worldwide, around 98 percent of cigarette filters are made of cellulose acetate, a bio-based polymer that biodegrades over several months to several years, depending on the conditions of the environment where it has been discarded.

    Instead of the originally discussed consumption reduction targets for filter cigarettes, the European Parliament reached a provisional agreement stating that “the huge environmental impact caused by post-consumption waste of tobacco products with filters, discarded directly into the environment, needs to be reduced. Innovation and product development are expected to provide viable alternatives to filters containing plastic, and this development needs to be accelerated.” Through the introduction of extended producer responsibility (EPR), a reinforced application of “the polluter pays” principle, the provisional agreement seeks to further encourage innovation leading to the development of sustainable alternatives to tobacco product filters containing plastic.

    More specifically, the directive will require producers to cover the costs of consumer awareness-raising measures and EPR schemes tackling the clean up of litter and its subsequent transport and treatment, the costs of data gathering and reporting, and the costs of collection of waste of tobacco filters discarded in public collection systems. EU member states have until Dec. 5, 2023, to set up ERP schemes for tobacco filters that contain plastic, but to date, there is no available guidance for member states as to how such EPR schemes should be implemented. As of July 3, all packaging of tobacco products with filters are required to be marked with a pictogram warning against littering.

    “The most burning concern at the moment is the impact of the SUPD—how to deal with the directive and product solutions that are compatible with the criteria it sets out,” says Ebinghaus. “The role that biodegradability of filters and tow will play in the future depends heavily on littering regulations. Cellulose acetate is based on wood pulp, a renewable raw material. With Cerdia DE-Tow, we have already created a product that is characterized by certified rapid biodegradability. We are convinced that this topic will continue to accompany us in the future and are glad that we can already offer a future-proof solution to our customers.”

    “The criteria for biodegradability under the SUP directive are not expected to be established by the EU until 2027,” notes Bruggeman. “The EC is concerned about potential misleading claims around biodegradability of filters as it could likely have an inverse effect on littering behavior. Certifications of biodegradability alone do not resolve the fundamental problem of reducing the impact of ‘littering’—thus, the measures called for in the EU SUP directive remain as important and necessary to be adopted, i.e., contribute to awareness-raising EPR, including cleanup, collection and waste treatment, and labeling requirements for cigarette packs.”

    SK Low

    Seeking the Gold Standard

    Filter manufacturers are also busy trying to meet changing requirements for an expanding environmentally friendly products market. Taeyoung’s R&D department is working on filter development with non-acetate tow and is carrying out studies on the replacement of conventional filter material. Seng Keong Low (SK), global marketing manager at specialty filter manufacturer Essentra, explains that the greatest challenge now is to find the perfect substitute for cellulose acetate filters—“a gold standard, so to speak. While we have commercially launched paper-based filters from our ECO range, we also acknowledge that there are certain tradeoffs when using these alternative materials. That is why Essentra Filters continues to learn, innovate and improve upon these products to achieve that gold standard.” He relates that his company has several intermediary products within its portfolio of products, such as BiTech, which mixes cellulose acetate and paper, thus increasing the biodegradability of the product.

    Sustainability issues aside, filter designers continue to seek innovative solutions beyond the usual range. Filter and tow makers observe an ongoing shift toward slim and superslim formats while capsule filters remain popular. “Outside of the EU, flavors continue to play a role in driving consumer demand, especially in countries like China, Japan and Korea,” says SK.

    While cigarette consumption will likely continue to decrease, heated-tobacco products (HTPs) are creating new opportunities for filter and tow manufacturers. Like conventional cigarettes, HTP consumables require a—highly complex—filter. Cellulose acetate tow is found in vape products too; it can be used in e-cigarettes to prevent leakage of e-liquids. “We see great opportunities and great potential in developing and producing a broader spectrum of specialty items for more specific new-generation products and in the advancement, refinement and expansion of the [HTP] segment,” says Ebinghaus.

    “We observe continuous innovation and product launches in the strong growing HTP market, e.g., PMI’s IQOS Iluma, BAT’s Glo Hyper plus, JT’s Ploom X or KT&G’s Lil Solid 2.0,” echoes Bruggeman. “Celanese partners with the major players in the HTP segment for the development of new filters for heated-tobacco sticks.”

    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.
  • Thank You!

    Thank You!

    The 2021 GTNF would have been impossible without the support of these generous sponsors.

    TR Staff Report

    Founded in 2009 and headquartered in Shenzhen, China, ALD Group Limited is an innovation-driven enterprise specializing in a full range of next-generation products, including electronic nicotine-delivery systems, CBD vaporizers and heated-tobacco devices. As one of the leading vape manufacturers, ALD is capitalizing on years of R&D know-how and manufacturing experience to provide global one-stop service. With a powerful intellectual property system, high-quality assurance, fast delivery service and a strong commitment to social responsibility, ALD serves worldwide clients with the most cutting-edge products.

    Alliance One International is a tobacco leaf supplier that offers customers high-quality leaf they can trust. With more than 145 years of agricultural experience and customers in approximately 90 countries, Alliance One International purchases tobacco from a network of more than 300,000 farmers worldwide to produce products that are sustainable and traceable.

    Altria’s tobacco companies have a long history of leading the industry. Today, adult tobacco consumers are increasingly seeking new options, including those that reduce risk, and their preferences are evolving rapidly. Altria’s vision by 2030 is to responsibly lead the transition of adult smokers to a smoke-free future. To that end, it will work within the framework that government, public health and regulatory bodies have established to communicate about reduced-harm choices. And for any tobacco consumer who wants to quit, Altria offers access to a breadth of information from experts on how to do so successfully. The actions the company is taking will create a different Altria—and a different landscape that the company believes will benefit today’s adult tobacco consumers.

    Barrettine Environmental Health has worked with the tobacco industry to develop a combined insect monitoring trap that functions as an early warning detection system for both tobacco beetles and tobacco moths. The MoBe Combo trap is an all-in-one hygiene control system for use during tobacco storage, shipment, processing and manufacture.

    When using the MoBe Combo Mk. 2, there is only one trap to check, which can significantly reduce both product and labor cost. Since the launch of the MoBe Combo trap, the company has introduced several enhancements.

    The tobacco beetle is often seen as the most significant tobacco pest; however, tobacco moth infestations can also contribute to significant damage to stored tobacco as well as processed and finished stock. With climate control used in many areas of tobacco processing sites, both species have the potential to thrive in all regions of the world. The MoBe Combo trap is effective in monitoring both species or either of the species in isolation.

    BAT is a leading consumer-centric, multi-category consumer goods company that provides tobacco and nicotine products to millions of adult consumers around the world. Its purpose is to build “a better tomorrow.” It will achieve this by reducing the health impact of its business through a multi-category portfolio of noncombustible products tailored to meet the preferences of adult consumers.

    BAT is investing in building a portfolio of reduced-risk tobacco and nicotine products*† alongside its traditional tobacco business—including vapor products, tobacco-heating products and modern oral products, which are collectively termed New Categories, as well as traditional oral products.

    BAT’s ambition is to increasingly transition revenues from combustible products to its New Category products over time. The company employs more than 55,000 people, operates in more than 180 markets and has 79 owned manufacturing facilities in countries around the world. In 2020, the BAT Group generated revenue of £25.8 billion and profit from operations of £10 billion.

    BMJ is the world’s No. 1 partner for specialty paper and packaging materials in the cigarette industry. BMJ produces cigarette paper, plugwrap paper, base tipping paper and printed tipping paper with standard weights of 18 grams to 40 grams per square meter. As a printing packaging company, BMJ represents high-quality packaging utilizing both rotogravure and offset.

    Boegli-Gravures designs, develops and manufactures state-of-the-art embossing tools and solutions for an exacting worldwide clientele. The company’s combination of artistic vision and engineering excellence has brought it recognition as a world leader in high-precision embossing and as an original equipment manufacturer supplier. The secret of Boegli-Gravures’ success lies in the company’s vision and passion for innovation.

    Broughton is a privately owned global contract research organization (CRO) offering fully integrated end-to-end services to deliver U.S. premarket tobacco product applications, EU medicinal product applications and EU Tobacco Products Directive notifications for next-generation nicotine products. Our business culture is to continue to invest in new science and innovations aligned with global regulatory requirements. By partnering with Broughton, clients will know they have access to some of the most experienced consultants in the world with deep industry knowledge combined with regulatory compliant CRO laboratory facilities. Broughton is committed to supporting clients in their development of safer nicotine products.

    CNT is the world’s largest supplier of highly purified nicotine to the pharmaceutical and next-generation products (NGP) industries. With pure nicotine and nicotine polacrilex resin manufacturing capabilities in Switzerland and Northern Ireland, CNT offers 100 percent contingency in supply of these key products. In addition, CNT has now developed an array of new nicotine-containing formulations for use in a broad spectrum of NGP applications, including modern oral (pouch) products. CNT is actively developing new product categories in its “beyond nicotine” strategy, utilizing its knowledge learned in nicotine to explore additional active substances of interest to our customers. CNT is one of the world’s leading suppliers of sustainably produced tobacco leaf.

    Headquartered in Austria, Delfort is a global leader in tailor-made specialty papers. In addition to thin print paper, release base paper, food packaging paper and electrical applications paper, the company manufactures a complete portfolio of top-quality cigarette paper, plugwrap paper, tipping base paper and printed papers. By utilizing pure and certified raw materials with the most advanced equipment, Delfort ensures that its products meet the most stringent quality requirements.

    FEELM is a high-end atomization technology brand belonging to SMOORE, a world leader in atomization. Focused on cutting-edge atomization technology research, FEELM specializes in the development and manufacturing of high-quality atomization devices driven by the FEELM ceramic coil.

    As the research engine of the global electronic atomization industry, FEELM delivers premium experience. Ever since the successful development of the FEELM black ceramic coil in 2016, FEELM has a significant impact on the research and manufacturing of closed vaping products, changing the whole competitive landscape.

    FEELM won a Golden Leaf Award at GTNF 2018, the China Patent Excellence Award and the iF Design Award 2020. Vaping devices loaded with FEELM atomizer have been exported to Europe, America, East Asia, Africa, Oceania and many other countries and regions. Its accumulated sales volume has surpassed 3 billion pieces, becoming more and more popular among worldwide consumers.

    The Foundation for a Smoke-Free World is an independent, U.S. nonprofit private organization that was formed in 2017 to reduce the 8 million annual deaths caused by tobacco use and address the consequences of reduced demand for tobacco farmers. The Foundation’s mission to end smoking in this generation is supported through three core pillars: Health, Science, and Technology; Agriculture and Livelihoods; and Industry Transformation. To achieve its mission on a truly global scale, the Foundation strives to identify and address the unique needs of the developing world as they relate to tobacco cessation and harm reduction. The Foundation is led by Derek Yach, a global health expert and anti-smoking advocate for more than 30 years.

    Funded by annual gifts from PMI Global Services, the Foundation is independent from PMI and operates in a manner that ensures its independence from the influence of any commercial entity. Under the Foundation’s pledge agreement with PMI and bylaws, PMI and the tobacco industry are precluded from having any control or influence over how the Foundation spends its funds or focuses its activities.

    Founded in the mid-1980s, Hall Analytical is a globally respected analytical laboratory based in Manchester, U.K., which specializes in complex trace analytical chemistry.

    The company’s mission is to deliver innovative and high-quality analytical expertise to strengthen its clients’ ability to improve product safety and reduce harm to patients and consumers. To that end, Hall Analytical partners with clients in the pharmaceutical, biopharmaceutical, medical device and consumer sectors to ensure their products are safe and compliant with appropriate regulatory frameworks.

    To support the nicotine reduced-risk product industry, Hall Analytical offers clients a wealth of experience in the analysis of vapor products and heated-tobacco products, supporting their core strategic objective to deliver less harmful, smoke-free alternatives for nicotine consumers.

    Imperial Brands is a global consumer organization and the world’s fourth-largest international tobacco company. Its products include JPS, West and Davidoff cigarettes, Rizla rolling papers and the vapor brand Blu. Imperial Brands operates in 120 markets, including the U.S. where its ITG Brands subsidiary offers a broad portfolio of cigarette and mass market cigar brands, including Winston and Backwoods.

    Driven by insights and data, Imperial seeks to meet the expectations of adult smokers by putting the consumer at the center of everything it does. It is also refining its ways of working and its culture to foster a strong challenger mindset among its 27,000 employees worldwide.

    Imperial is focused on leveraging its tobacco assets in its five priority markets and on building a successful and sustainable next-generation product (NGP) business. This year, it has refocused its NGP strategy behind heated-tobacco and oral nicotine opportunities in Europe and in selective market opportunities in vapor.

    Japan Tobacco International is a leading international tobacco and vaping company, with headquarters in Geneva, Switzerland. JTI began 22 years ago when Japan Tobacco acquired the non-U.S. operations of R.J. Reynolds. Since then, its international workforce of over 40,000 employees has driven two decades of growth. JTI owns some of the world’s best-known brands, including Winston, the No. 2 global cigarette brand, and Camel. Other major international brands are Mevius and LD. The company’s portfolio brings together the rich heritage of traditional tobacco as well as the latest technical and scientific innovation in reduced-risk products.

    Juul Labs’ mission is to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use and combat underage usage of its products. The company believes that vapor products can offer adult smokers an alternative to combustible cigarettes and, in so doing, reduce the harm associated with tobacco. Nicotine is addictive and can potentially be harmful. It would be best if no one used any nicotine product. Anyone who smokes should quit. Adult smokers who have not successfully quit should completely switch to potentially less harmful alternative nicotine products. Juul Labs does not want any non-nicotine users, especially those underage, to try its products, as they exist only to transition adult smokers away from combustible cigarettes. Juul products are not intended to be used for smoking cessation or other therapeutic purposes.

    Kure operates more than 130 retail locations across the United States and several more in Europe. The company is a recognized leader in the vape industry. Kure’s e-liquid line and bar offers custom, bespoke liquids made with the highest quality ingredients to cater to the tastes of every guest. Its tailored in-store service is designed to provide the best support possible to transition from smoking to vaping. Kure offers the latest and greatest hardware to ensure its guests receive only the best.

    Kure has submitted its thorough premarket tobacco product applications to the U.S. Food and Drug Administration. These applications detail the high standards the company adheres to in all aspects of its business. Moreover, Kure takes its responsibility to its guests and the community it serves seriously and has thus designed and implemented measures to ensure its products never end up in the hands of minors. Kure uses tools such as electronic point-of-service age verification software, secret shopper programs and extensive employee training programs to keep this commitment.

    Philip Morris International is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes as well as smoke-free products, associated electronic devices and accessories and other nicotine-containing products in markets outside the U.S.

    In addition, PMI ships versions of its IQOS Platform 1 device and consumables to Altria Group for sale under license in the U.S., where these products have received marketing authorizations from the Food and Drug Administration under the

    premarket tobacco product application pathway; the FDA has also authorized the marketing of a version of IQOS and its consumables as a modified-risk tobacco product, finding that an exposure modification order for these products is appropriate to promote the public health.

    PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements.

    PMI’s smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of June 30, 2021, PMI’s smoke-free products are available for sale in 67 markets in key cities or nationwide. PMI estimates that approximately 14.7 million adults around the world have already switched to IQOS and stopped smoking. For more information, please visit www.pmi.com and www.pmiscience.com.

    Quartz Business Media is the owner and organizer of the largest network of tobacco-related exhibitions and conferences in the world. These include the market-leading series of World Tobacco events, WT Middle East, TABEXPO and World Shisha Dubai.

    Founded in January 2018, Relx is Asia’s leading e-cigarette brand. Relx’s mission is to empower adult smokers through technology, product and science ethically. Relx independently develops its e-cigarette products at its CNAS-standard R&D center and continues to make significant investments in R&D, e-liquid testing and new product development to deliver the best possible experience to its adult users. To protect minors from accessing e-cigarette products, Relx developed the guardian program, a companywide initiative that stretches from product development to sales and marketing, leveraging cutting-edge facial recognition technologies, GPS data and cloud technologies. The company has attracted global talent from Uber, Proctor and Gamble, Huawei, Beats and L’Oreal.

    Reynolds American Inc. (RAI) is an indirect, wholly owned subsidiary of BAT and is the parent company of R.J. Reynolds Tobacco Co., American Snuff Co., Santa Fe Natural Tobacco Co., R.J. Reynolds Vapor Co. and Modoral Brands. RAI’s vision is to build “A Better Tomorrow” by reducing the health impact of its business through offering a greater choice of innovative products for adult tobacco consumers.

    SMOORE is a global leader in offering vaping technology solutions, including manufacturing vaping devices and vaping components for heat-not-burn products on an ODM basis, with advanced R&D technology, a strong manufacturing capacity, wide-spectrum product portfolio and a diverse customer base. According to Frost & Sullivan, SMOORE is the world’s largest vaping device manufacturer in terms of revenue, accounting for 18.9 percent of the total global market in 2020.

    Through its innovative and pioneering vaping technology solutions, SMOORE operates two principal business segments: research, design and manufacturing of closed system vaping devices and vaping components for leading global tobacco companies and independent vaping companies; and research, design, manufacturing and sale of self-branded open system vaping devices, or APV, for retail clients.

    SMOORE owns a series of tech brands, including FEELM, CCELL and METEX, and the product brand Vaporesso.

    SWM is a leading global provider of highly engineered papers, films, nets and nonwovens for a variety of applications and industries. As an expert in manufacturing materials made from fibers, resin and polymers, the company provides critical components that enhance the performance of their end products.

    The company’s engineered papers group has been serving the tobacco industry for decades with highly technical papers and reconstituted tobacco leaf. SWM continues to innovate, with a special focus on heat-not-burn products, using its advanced paper and reconstitution technologies to meet the demands of this emerging product category. SWM’s versatility and portfolio are designed to deliver satisfaction while meeting stringent specifications.

    In recent years, SWM has diversified to include films, nets and nonwovens offered through its advanced materials and structures (AMS) segment. The AMS platform serves a variety of industries with the same focus on technical expertise, operational excellence and customer collaboration that have long been SWM’s hallmark traits.

    SWM and its subsidiaries manufacture on four continents, conduct business in over 90 countries and employ approximately 5,000 people worldwide.

    Founded in 1975, Tobacco Technology Inc. (TTI) exclusively develops and manufactures customized flavors, including casings, for the global tobacco industry: cigarettes, cigars, water pipe, snuff, snus, chew, kretek, roll-your-own, pipe, hemp and dissolvables. TTI also offers consulting services to facilitate flavor, process and product development.

    E-LiquiTech (ELT), a TTI subsidiary established in 2016, is dedicated to the development and manufacture of the highest quality e-liquids in addition to offering both bottle and cartomizer filling services. ELT is also the exclusive global distributor to the tobacco industry for Zanoprima, a research-driven, innovation-led life sciences company, offering SyNic high-purity synthetic (S)-nicotine in pure, bitartrate and polacrilex resin form.

    TTI Flavors, TTI’s subsidiary in Assisi, Italy, will start production of flavors, casings and e-liquids in the fall of 2021 to offer faster delivery to the company’s customers in Europe, the Middle East, Africa and Russia.

    Turning Point Brands continues to grow and evolve to meet changing consumer preferences. Along with a tobacco portfolio that features iconic, historic brands, such as Zig-Zag and Stoker’s, the company has expanded into the vapor and tobacco alternative segments with innovative brands such as VaporBeast, VaporFi and Marley. A highly effective sales force and distribution network ensure that consumers, retailers, partners and shareholders benefit from these products.

    For over 100 years, Universal Corp. has been finding innovative solutions to serve its customers and meet their agri-products needs. The company built a global presence, solidified long-term relationships with customers and suppliers, adapted to changing agricultural practices, embraced state-of-the-art technology—and emerged as the recognized industry leader.

    Today, Universal Corp. is a global business-to-business agri-products supplier to consumer product manufacturers, operating in over 30 countries on five continents, that sources and processes leaf tobacco and plant-based ingredients. Tobacco has been the company’s principal focus since its founding in 1918, and Universal Corp. is the leading global leaf tobacco supplier. Through its plant-based ingredients platform, Universal provides a variety of value-added manufacturing processes to produce high-quality specialty vegetable-based and fruit-based ingredients for the food and beverage end markets.

    Universal Corp. has a long history of operating with integrity, honesty and a focus on quality. It is a vital link in the leaf tobacco supply chain, providing expertise in working with large numbers of farmers, efficiently selling various qualities of leaf to a broad global customer base, adapting to meet evolving customer needs and delivering products that meet stringent quality and regulatory specifications.

    Going forward, Universal will build on its history by seeking opportunities in both tobacco and plant-based ingredients to leverage both its assets and expertise. The company will continue its commitment to leadership in setting industry standards, operating with transparency, providing products that are responsibly sourced and investing in and strengthening the communities where it operates.

    Zinwi Biotech was founded with the desire to offer the “nature flavor” e-liquid product to its clients. The company is sensitive to new trends. When nicsalt appeared as a game changer, Zinwi became one of the first suppliers with its own formula to meet the market needs.

    The merging of cutting-edge technology and boundless creativity, in turn, generates innovative flavoring solutions that serve 400-plus customers worldwide, resulting in a significant share on nicsalt juice used for electronic nicotine-delivery systems.

    With heavy investment in R&D, Zinwi in the future won’t limit itself as an e-liquid or nicsalt manufacturer but will also provide flavoring technologies that enrich food, healthcare and medicine products and other products that will help take humans’ lives to the next health level. Visit the company’s website

    * Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk-free and are addictive.† BAT products as sold in the U.S., including Vuse, Velo, Grizzly, Kodiak and Camel Snus, are subject to FDA regulation, and no reduced-risk claims will be made as to these products without agency clearance.

  • A Hard Sell

    A Hard Sell

    Photo: Sergii Figurnyi

    The EU continues to view harm reduction with suspicion.

    By Stefanie Rossel

    The European Commission’s 2021 application report on the EU Tobacco Products Directive (TPD), which was published on May 20, 2021, had been highly anticipated as its objective was to clarify which parts of the TPD the commission deemed necessary to amend.

    Considering the Commission’s goal to create a “tobacco-free generation” by 2040, where less than 5 percent of EU citizens use tobacco, tobacco harm reduction (THR) advocates had been hoping the report would reconsider its opposition to their cherished concept.  

    TPD Article 28 required the Commission to review the directive in the light of scientific and technical developments five years after the legislation had entered into force. It was obliged to pay special attention to e-cigarettes.

    The application report would also guide the EU position toward safer nicotine products at the upcoming Conference of the Parties (COP9) of the World Health Organization Framework Convention on Tobacco Control (FCTC). As COP9 had to be postponed to November 2021 due to the Covid-19 pandemic, the commission found itself in the unusual situation that its stance might point the way for COP9 rather than the other way around.

    In the event, the Commission preferred to be the well-behaved pupil, mirroring the WHO’s hostile stance toward THR and what has been termed the organization’s war on nicotine. “As scientific consensus has yet to be reached, the precautionary principle prevails and the TPD takes a careful approach in regulating these products,” the application report states. “The WHO further concluded that no firm evidence exists on the safety of e-cigarettes, but there is increasing evidence of harm.”

    That the commission was unwilling to consider the relative risks of alternative nicotine products compared to that of combustible cigarettes already became clear when the EU Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released its preliminary opinion in 2020. Critics called the report “fundamentally flawed,” having, among other things, effectively ignored scientific literature published after April 2019, most of which supports the argument that vaping actively helps facilitate THR. Mandated to focus only on health impacts of e-cigarettes compared to nonsmoking, the SCHEER’s final opinion leaves the users of vape products without guidance and clear information about the level of risk of these products compared to traditional cigarettes, as scientists wrote in a letter to the EU Commissioner of Health and Food Safety, Stella Kyriakides.

    Disregarding ample feedback from the scientific community and other stakeholders, the final opinion turned out to be a nearly verbatim version of the preliminary opinion. “The SCHEER opinion underlined [the] health consequences [of e-cigarettes] and the important role they play in smoking initiation,” its authors stated. “This opinion supports the careful and precautionary approach taken so far. However, it should be explored whether some provisions could be further developed or clarified, such as tank size or labeling requirements; use of flavors; use of nicotine-free liquids; and advertising provisions. Insofar as e-cigarettes are smoking cessation aids, their regulation should follow the pharmaceutical legislation.”

    Damian Sweeney, a partner in the European Tobacco Harm Reduction Advocates (ETHRA), an advocacy group formed by consumers, says that the EU misuses the precautionary principle to justify imposing harsher regulations. “This could mean flavor bans and restrictions on open systems, which would severely limit the appeal of vaping and would be extremely detrimental to public health,” he says. “The danger is that they will throttle the one game-changing measure that really does seem to be working and could scale up dramatically and quickly with the right regulatory, fiscal and communications environments.”

    Learning from others

    Altogether, the application report is positive about the TPD, claiming it has put in place comprehensive EU tobacco control policy rules, “notably through enlarged combined health warnings, a track-and- trace system, a ban on characterizing flavors, the creation of an ingredients database and the regulation of electronic cigarettes.” Most importantly, the Commission states that the TPD has overachieved its aim to reduce tobacco consumption among those aged 15 and over by 2 percent within five years of its transposition. Smoking prevalence across the EU, the report says, had declined from 26 percent in 2014 to 23 percent in 2020. “Of course, it didn’t attribute any of this to the rise of low-risk alternatives, even though that has had an obvious effect,” says Sweeney. “While any reduction in smoking is to be welcomed, we think that the gains in smoking cessation could have been far greater were it not for the excessive restrictions which the TPD imposes on vaping products, such as nicotine and volume limits or marketing restrictions. A positive effect of the TPD is that it has prevented member states from banning vaping outright.”

    According to Sweeney, declines in smoking prevalence accelerate where safer nicotine products are widely available, accessible and affordable. “The EU data shows that Sweden has almost reached smoke-free status, with a smoking prevalence of just 7 percent,” he says. “This is the lowest smoking prevalence in the EU by a significant margin and it’s largely thanks to the use of snus. The U.K., where tobacco harm reduction is widely supported and promoted by public health, experienced the sharpest decline in smoking prevalence since 2006 (minus 21 percentage points). Ireland has one of the highest rates of adult vaping in the EU, which led to a 6 percent fall in smoking prevalence in three years—a drop which was unheard of before vaping became popular.”

    Despite the U.K.’s departure from the EU, Sweeney says the country will continue to play an important role in tobacco control policy at the international level. “The U.K. is a world leader in tobacco harm reduction, with a smoking prevalence 9 percent lower than the EU average, so they are clearly doing something right that the rest of the EU can learn from. Researchers from the U.K. are still involved in pan-European tobacco control initiatives and the high-quality research and experience they bring will be invaluable in informing future policy.”

    While the EU Parliament lost important voices for tobacco harm reduction with the departure of Britain, Sweeney believes the move creates opportunities as well. “Leaving the EU means that the U.K. is now in a position to diverge from the TPD; to remove the arbitrary restrictions on vaping products, which are a barrier to switching; and to lift the ban on snus. The main consumer organization in the U.K., the New Nicotine Alliance, has put forward proposals that would take advantage of Brexit to help the government meet its ambitious smoke-free 2030 target. If the government adopted these proposals, it would set an example for the EU by showing what could be achieved with a comprehensive approach to tobacco harm reduction.”

    Proof, not anecdotes

    To achieve an EU smoking incidence of less than 5 percent by 2040, the application report urges improvements in TPD enforcement at the national level and better consideration of new market developments, such as novel tobacco products.

    The 5 percent goal is at the heart of the EU’s Beating Cancer Plan (BCP), which the EU presented in February this year (see “Beating Harm Reduction,” Tobacco Reporter, April 2021). The BCP identified tobacco as the top avoidable key risk factor. However, this plan, too, failed to distinguish between combustible and noncombustible products. It did not recognize low-risk alternatives, such as vape products and smokeless tobacco, as substitutes for the more harmful combustible products.

    The European Parliament’s BECA committee drew similar conclusions. Its draft report, presented for discussion on July 15, calls for an increase in minimum excise duties for all tobacco products and a ban on flavorings in all tobacco products. At press time, it remained unclear whether these requirements would apply to safer nicotine products. “Taken literally in EU law, this would apply to heated-tobacco products and smokeless tobacco, including snus,” says Sweeney. “Most countries have cigarette taxes that are above the minimum, so this would tend to close the gap between very dangerous and much safer products and therefore reduce switching and increase smoking compared to not doing it,” he explains.

    “However, several countries have moved to increase taxes on vaping products, most notably Germany. So, we may see this language evolve. The danger is that we will see the fiscal incentive to switch weakened and more smoking as a result. The MEPs need to realize that taxation has direct consequences for behavior and therefore for health,” says Sweeney.

    Ahead of the July meeting, ETHRA had written to all BECA members to outline the important role THR can play in achieving the goal of reducing cancer in Europe. Judging from members’ reactions to the draft report presentation, Sweeney is cautiously optimistic. “THR is facing a difficult future in Europe, there can be no doubt about that, but I don’t think it’s the end—far from it. Ultimately, political opinions don’t change the lived experience or underlying science. There is support for THR within the European Parliament and several MEPs have asked very important parliamentary questions on the role harm reduction can and should play in the Cancer Plan. […] So, some MEPs clearly do understand the concept and importance of harm reduction strategies.”

    According to Sweeney, the fact that the science of THR and the lived experience of consumers of safer nicotine products have been largely ignored should be used as a rallying call to consumers and advocates alike. “We need to contact our elected representatives to share our experiences and let them know that harm reduction will be key to successfully preventing cancer. As consumers who have successfully quit smoking using safer nicotine products, we are not anecdotes, we are proof that THR works. There are millions of us, and we shouldn’t be ignored.”

    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.
  • Firms Eye Synthetics After FDA Rejections

    Firms Eye Synthetics After FDA Rejections

    Photo: Martinmark | Dreamstime.com

    Vapor Salon will be switching to synthetic nicotine, the company wrote in a public Facebook post dated Aug. 26.

    The post was published on the same day that the U.S. Food and Drug Administration denied some 55,000 marketing applications by Vapor Salon and two other companies on the ground that they “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by well-documented, alarming levels of youth use of such products,” according to an FDA press release.

    “VaporSalon is switching to TOBACCO FREE NICOTINE on Friday, 8/27/2021,” the Facebook post reads. “The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement, which takes full effect on Sept. 9, 2021, with needing an approved PMTA, or your product can no longer be sold. There has been 0 approved PMTA’s for anything ENDS related to date.”

    According to Filter, more manufacturers have begun looking at the possibility of synthetic nicotine as a way to avoid having to comply with FDA regulations.

    The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”

    Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that, in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as a tobacco product or push for synthetic nicotine to be regulated like any other drug.

    Because synthetic nicotine is more expensive than the natural variety, a switch would likely result in higher prices for consumers. Vapor Salon indicated that many of its redesigned products will now have “an upcharge,” according to Filter.