Category: Smokeless

  • Red Man Rebrands as America’s Best Chew

    Red Man Rebrands as America’s Best Chew

    Photo: Swedish Match

    Swedish Match is rebranding its Red Man chewing tobacco to America’s Best Chew to better align with the company’s contemporary values. The name change comes as the product celebrates its 135th anniversary.

    While the new packaging will reflect the rebrand, the product is the same. According to Swedish Match, consumers can expect the same high-quality chewing tobacco that has been enjoyed by generations, right down to the unmistakable aroma, texture and flavor.

    “Understanding that an essential part of being America’s best means being a leader, Swedish Match worked diligently over the past several months to make changes in response to our heightened awareness and our desire to be more inclusive,” said Joe Ackerman, vice president of marketing at Swedish Match, in a statement. “Consumers and diverse agency partners were selected to participate in the rebranding research. It was critical and valuable for us to gain these insights and recommendations to develop America’s Best Chew packaging.”

    “I applaud the Swedish Match company for retiring the use of ‘Red Man’ as a product name,” said Cherokee Nation Principal Chief Chuck Hoskin, Jr. “Nationally, we are moving away from the use of derogatory terms and depictions of Native Americans as product mascots because representations are stereotypical caricatures, and they do not honor us or reflect how we live and thrive, both as individuals and as unique Tribal Nations today. The announcement to change the brand’s name and imagery gives us hope that more companies, schools and sports teams hear us and that we will continue to make impactful national changes for the betterment of Indian Country.”

    “This decision exemplifies the global awakening of these harmful practices toward Indigenous Peoples and gives us hope that others will follow Swedish Match’s bold and courageous lead,” said Fawn Sharp, president of the National Congress of American Indians.

    “While the phrase ‘America’s Best Chew’ may have gone unnoticed to some, it is an essential part of who we are,” according to Ackerman. “It represents our founder John Pinkerton’s passion and commitment to quality. More importantly, America’s Best Chew was the promise that Pinkerton made 135 years ago when he created the original recipe and innovative flavoring process that we still use today.”

    The transition to the new America’s Best Chew packaging will begin within the next few weeks.

  • Maneson to Lead Sales at Lucy Modern Oral

    Maneson to Lead Sales at Lucy Modern Oral

    Photo: Jakub Jirsák | Dreamstime.com

    Lucy has named Rob Maneson head of sales. Maneson will help the modern oral nicotine startup expand its distribution and retail presence.

    Prior to joining Luci, Maneson held leadership positions at Imperial Brands, including that of senior vice president of sales for Fontem and CEO of JR Cigar. Earlier in the career, Maneson held sales positions at Altria and served as a category manager for tobacco products at RaceTrac Petroleum. He is a graduate of the University of Arizona where he earned a Bachelor of Science degree.

    Additionally, Joe Johnson has been named national accounts director. He will work with major retailers around the country to grow Lucy’s retail presence.

    Johnson comes to Lucy from Sweet Water Brewing Co. where he was vice president of national accounts. Prior to his six-year stint at Sweet Water, he served as category manager, alcohol beverages at RaceTrac Petroleum. Johnson earned his Bachelor of Business Administration at the University of Georgia, majoring in marketing.

    Lucy was founded by former smokers who were dissatisfied with the traditional nicotine options available and set out to develop better alternatives. Its products include Kapsel and Slim nicotine pouches, along with a variety of flavors and nicotine strengths under the Chew + Park brand.

  • The Need for Nuance

    The Need for Nuance

    Photo: Andrey Popov

    It’s time for regulators to stop lumping all tobacco products together as being equally risky.

    By George Gay

    “It’s still difficult for me to understand how the European Commission can claim on the one hand that they want to do everything in their power to fight cancer, including revising tobacco policy, yet on the other hand completely reject the idea of liberalizing regulations for one of the very few products that has shown it can displace cigarettes.”

    The above is a quote attributed to the Swedish member of the European Parliament, Sara Skyttedal, as part of a Snusforumet story published on Nov. 19. Skyttedal is clearly frustrated and angry with the commission, and, according to my interpretation of the story, her frustration comes down in part to the fact that while the commission says it wants to reduce the incidence of smoking throughout the EU to the low level at which it stands in Sweden, it is not willing to remove the ban on snus, the product that has largely displaced cigarettes in Sweden but that, for inexplicable reasons, is banned in the EU with the exception of Sweden.

    I feel certain Skyttedal is merely making a point: She doesn’t really believe there is a logical conflict in the commission’s position. The apparent conflict is easily resolved by pointing out that while the commission might say it wants to do everything in its power to fight cancer, that is not the case. In fact, this becomes clear later in the story when, talking about the connection between Sweden’s low level of tobacco-related cancers relative to those in the rest of the EU and the fact that Sweden is the only country in the EU where snus is legally available, Skyttedal says the commission sees the connection but is not willing to act on it.

    I hate to state the obvious, but I would guess that one of the commission’s hang-ups has to do with tobacco. It can tolerate the idea that nicotine in the form of nicotine-replacement therapy products or even vaping products should be allowed to replace tobacco products, but it cannot bear the idea that tobacco products might be allowed to substitute tobacco products. Tobacco has pariah status; nicotine is somewhere lower on the continuum of the unacceptable.

    Let me provide an example. In November, my newspaper ran a story about how, because of the goods transport chaos afflicting the U.K. post-Brexit, there might be a shortage of alcohol this Christmas. This was seen as a negative because, apparently, we cannot celebrate this Christian festival without being off our heads, and despite the fact that such a shortage would probably result in fewer family fights, stomach-pumping hospital visits, drunk driving and all that entails, assaults on hospital accident and emergency staff and even deaths, since alcohol kills.

    Imagine, however, if the story had been about a shortage of tobacco at Christmas. This would have been presented as a positive, though it would have caused a number of negative outcomes and almost no positive results, with the exception that a few people might have discovered they were able to quit their habit.

    Language Matters

    But I digress. Let me return to Skyttedal’s original complaint about the commission’s failure to follow through on its aim to do everything in its power. There are certain categories of phrases that immediately flash warning signs to the effect that what is being said should be taken with a pinch of salt, and one such category comprises those with superlatives. Just think of the phrases “nobody wants to see …” and “everyone agrees that ….” You hear and see such phrases used all the time, but it doesn’t take more than a second’s thought to realize they cannot be correct. It is almost impossible to imagine an instance when nobody or everybody was in favor of something. So when somebody tells you they are doing “everything in their power” to bring about a certain result, you know it’s time to look somewhere else for help.

    Language matters, and, to my way of thinking, one of the problems that people who champion tobacco harm reduction have helped to create is down to the fact that they have been too willing to accept and parrot some of the extreme language and figures used by those people also involved in tobacco control but who are opposed to harm reduction. For instance, there has been a willingness to go along with claims of nicotine addictiveness that are clearly unsupportable, even though some health professionals keep this pot simmering by telling smokers they cannot give up nicotine without the support of … yup, there’s a surprise, health professionals.

    Probably the ultimate superlative is “smoking kills,” which has become so ingrained that you are mocked if you say you don’t agree with it, but the truth of the matter is that a certain percentage of smokers die of smoking-related diseases, mostly after a long and possibly enjoyable history of smoking. The other smokers die of something else—perhaps of injuries caused by a drunk driver. And, I hate to be downbeat, nonsmokers die too, perhaps of “tobacco-related diseases,” though ones caused by pollution. If they didn’t die, the world would become full up, and the gene pool would lose its vigor.

    OK, some will argue the smoking problem is not only about death but about the physical and economic costs of smokers living with medical conditions linked to their habit. But we are all prisoners of the choices we make. I doubt there are many people who reach the age of 50 without carrying some physical ailment linked to something they did when they were young. Some footballers die at relatively young ages having suffered from dementia attributable to their playing football, but few would claim playing football kills. Rather, we try to change the rules of the game and the equipment used to prevent brain damage—we employ harm reduction techniques.

    Perhaps it’s time to reconsider what we mean by “smokeless.” After all, some tobaccos are cured using artificial heat—in some cases by burning wood fuel and contributing to deforestation. (Photo: phanasitti)

    Distortion is a Problem

    On the question of parroting figures, take the annual death toll attributed to tobacco-related diseases. Over the years, it has been increased a number of times, usually in lots of one million, so it now stands at the nicely rounded figure of 8 million. At the same time, the World Health Organization, which has ownership of this figure, has been claiming success in its efforts to prevent the deaths attributed to tobacco. But even given the world’s population has been increasing, it cannot be the case that the figure for tobacco-related deaths keeps leapfrogging this supposed success.

    Why is this important? Because by exaggerating the problems caused by tobacco, some sections of tobacco control have been allowed to distort the picture to such an extent that it becomes difficult to sell the idea of tobacco harm reduction. When tobacco is depicted as being “deadly”—a superlative you often see applied to this product—and that depiction is not challenged, it becomes too counterintuitive even for the uncommitted to imagine that the problem caused by tobacco can be significantly reduced by another tobacco product such as snus. Additionally, because too many people have, for a quiet life, gone along with the U.S. Food and Drug Administration’s airy-fairy idea that e-cigarettes can be “deemed” “tobacco” products, the use of even vaping products as tobacco harm reduction agents can be challenged easily by those who wish to do so.

    What we need is honesty. For instance, we need to stop lumping all combustibles together as if the consumption of cigarettes, cigars or pipe tobacco is equally risky. This cannot be the case, especially at a population level. And we have to do the same in respect of smokeless products. For instance, what do we mean by “smokeless”? Are we talking only of the consumption of the final product? Perhaps it’s time we checked out whether some of the tobaccos used in some “smokeless” products are cured using artificial heat—in some cases by burning wood fuel and contributing to deforestation.

    It has become fashionable to talk of both individual and population risk, so, in this context, is it OK to reduce the harm caused to individuals by tobacco consumption if the production of the less risky items involves damaging the environment and, by extension, threatening the health of tobacco and nontobacco users alike?

    This is a massively complex question, the answer to which would mean a descent into not altogether helpful relativities. One thing seems clear to me, however. If you drew up a continuum of environmental risk caused by tobacco and nicotine products, you would wind up with a picture somewhat different to the continuum of individual consumer risk caused by tobacco and nicotine products, which we are more used to seeing. But one thing would remain pretty much the same. Smokeless products, such as nicotine pouches, snus and chewing tobacco, would be the stand-out products when it comes to reduced environmental risks. What would change, I think, is that the divisions between combustibles in respect of environmental risks would widen appreciably, and vaping products, which are smokeless, while scoring well on the individual consumer risk continuum might well end up in free fall on the environmental risk continuum, something that needs to be addressed.

    I’ve seen it said that there should be one set of rules for combustible products and another set of rules for noncombustible products. I think the rules need to be more nuanced than that.

  • Uniquely Deadly

    Uniquely Deadly

    A street vendor offers smokeless tobacco in Kolkata. (Photo: Taco Tuinstra)

    India’s crackdown on its dangerous smokeless tobaccos in the wake of Covid-19 should be complemented by a more coherent harm reduction strategy.

    By Stefanie Rossel

    The Covid-19 pandemic presented an opportunity for India to intensify its fight against the consumption of local smokeless tobaccos. On April 15, 2020, the government banned the sale of tobacco products, including chewing tobacco, the most widely used form of tobacco in India, as a measure to slow the spread of the coronavirus. Chewing smokeless tobacco products, which in India typically contain areca (betel) nut, increase the production of saliva and create a strong urge to spit—an undesirable habit during a pandemic.

    As in Sweden, smokeless tobacco is significantly more popular than combustible tobacco in India. According to a 2020 analysis, nearly 199.4 million Indian adults consume smokeless tobacco regularly, which is more than twice the number of smokers. This makes it the country with the largest number of smokeless tobacco users. However, unlike Sweden’s snus, which ranks at the bottom of the continuum of risk, Indian smokeless tobaccos are quite risky. Public health experts describe them as “uniquely deadly.”

    There is a wide variety of chewing tobacco available in India. The most commonly used products are khaini, a mixture of tobacco and lime used by 11.2 percent of adults, and gutkha, which consists of tobacco, slaked lime, paraffin wax, catechu (an extract of acacia trees) and crushed areca (betel) nut, and is consumed by 6.8 percent adults. Other smokeless tobaccos use mixtures of betel quid and paan masala.

    What all these types of tobacco have in common is that they are highly addictive and full of carcinogens. In addition to the typical ingredients, these products can be laced with thousands of chemicals. The products are said to have both stimulant and relaxing effects; some are sold as mouth fresheners. Available for a few rupees, they are also affordable for poor people.

    The consumption of smokeless tobacco was above the national average of 21.4 percent in 13 Indian states, with prevalence ranging from 23.5 percent in Bihar to 48.5 percent in the Tripura, according to the 2016–2017 Global Adult Tobacco Survey (GATS).

    Smokeless tobacco consumption is responsible for India’s high rate of oral cancer. With 141.2 million male users compared to 58.2 million female users, consumption of smokeless tobacco is predominantly a male habit. However, three-fifths of the deaths attributable to smokeless tobacco use occur among women. In contrast to smoking, which is generally considered a taboo for women, smokeless tobacco consumption is more socially acceptable. As smokeless tobacco is deeply entrenched in the region’s culture, it tends to pass from one generation to the next. Children as young as 10 years old have been found to regularly use smokeless tobacco.

    Samrat Chowdhery, who leads consumer advocacy for tobacco harm reduction in India and is the past president of the International Network of Nicotine Consumer Organizations, estimates that smokeless tobacco is responsible for 350,000 premature deaths annually in India. “Though this mortality rate is lower than from combustible tobacco, it is still quite high,” he says. “The main reason for this is that Indian/southeastern smokeless tobacco products are handmade or made in poor hygienic conditions, which allows for impurities to creep in. There is no attempt to control or reduce tobacco-specific nitrosamines; the use of slaked lime adds another cancerous component; there is no licensing, standards or quality control; and finally toxic additives, such as nicotine sulphate and flavoring agents, are added to tobacco products.”

    Samrat Chowhery

    Ineffective Ban

    India has been targeting smokeless tobacco as it aims to reduce the number of tobacco users by 30 percent by 2025. In 2012, states started banning the manufacture, sale and distribution—but not consumption—of pre-packaged gutkha under laws governing food, which may not contain tobacco. Some states extended this ban to other tobacco-containing oral products, such as paan masala.

    Enforcement, however, has been patchy. A 2014 World Health Organization study found that 15 percent of respondents continued to purchase prepackaged gutkha. According to a 2018 YouTube feature by The Print, many street vendors in Delhi were unaware of the ban, and police were not taking action.

    A large-scale household survey in Delhi in 2016 revealed that a mere 18.84 percent of gutkha users attempted to quit after the ban, although 97.5 percent of respondents believed tobacco to be harmful or very harmful. Only 2.4 percent successfully quit, the report found. Gutkha, a white-to-brownish granular flavored product, turns saliva bright red, and is usually spat onto a wall or on the ground, causing red stains that are hard to remove. It typically comes in colorful sachets. Following the ban, manufacturers started selling gutkha and tobacco in separate packs. In Delhi, 84.1 percent of pre-ban gutkha users switched to these twin sachets, the household survey found. Many switched from single-dose to multi-dose sachets or to khaini.

    In March 2015, legislators prohibited all smokeless tobacco products including twin packs. Violators risk prison sentences or fines of up to INR25,000 ($336.39).

    “The reporting of the so-called bans is usually skewed by the need to showcase them to their peers from the global tobacco control community,” says R. N. Sharan, retired professor of biochemistry, molecular biology and genetics at North-Eastern Hill University in Shillong, India. “Thus, at global and national forums on tobacco control, India’s attempts to ban risky smokeless tobacco products are often given a high profile and kudos showered on the involved public health advocates as well as policymakers. However, the proof is in the pudding. The bans have been cleverly, and sadly, circumvented by manufacturers, retailers and common ones. On the ground, prohibition seems to have, once again, failed.”

    R. N. Sharan

    Expanded Authorities

    With the advent of the pandemic in India, the government cracked down on tobacco. After the first reports that smoking might increase the risk of severe Covid-19, many Indians attempted to switch from cigarettes to smokeless tobacco. According to Statista, about 77 percent of smokers aged between 25 years old and 39 years old tried to transition to smokeless tobacco.

    In addition to the government’s national directive on Covid-19 management, states and union territories received new powers under the Epidemic Disease Act, the Disaster Management Act and the Indian Penal Code to prohibit use of smokeless tobacco and spitting in public places.

    By May 2020, up to 28 states and union territories had implemented various restrictions linked to smokeless tobacco, according to the Observer Research Foundation. The study’s authors concluded that the jurisdictions were right to act. Despite the country being a signatory to the WHO Framework Convention on Tobacco Control (FCTC), many of the treaty’s recommended policies, such as graphic health warnings on packs and advertising bans, tend to be circumvented by smokeless tobacco products.

    The bans, all of which are outside FCTC policy, strengthened during the pandemic and appeared to have been more uniformly rolled out across the country, giving additional powers to states, the authors stated, but the amendment of some policies within a short span of time was likely to have caused confusion. At the time of writing, several states had extended the bans on smokeless tobacco manufacture, sale and distribution for another year.

    Sharan says there are a number of reasons why the ban on chewing tobacco hasn’t shown the desired results so far. “India’s capabilities for technical analysis of smokeless products are not yet fully up and running, despite significant investment over the years,” he says. “Enforcement on the ground is also a big issue, further complicated by (a) the governance structure where primarily the central government legislates while the responsibility of their implementations remains essentially vested in the state or provincial governments, and (b) a complex web of vested interests.”

    In fact, says Sharan, the Covid-19 pandemic may have made the situation worse. The regulatory apparatus in India has been and continues to be under severe stress from the pandemic, and they can only focus on so many things at one time. This is in sharp contrast to the Food and Drug Administration in the U.S. and the Trading Standards Authority in the U.K., which are well funded, adequately resourced to police the regulated products in the market and empowered to identify prohibited products or pull out noncompliant products from the market and suitably punish the erring vendors/manufacturers if required.

    “It is to be noted that the FDA’s Center for Tobacco Products is funded from fees paid by the industry they regulate, thus ensuring a fair and level marketplace. I am not aware of the existence of any such mechanism in India. In this context, India could be a winner if it chose to learn some lessons from the rest of the world.”

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    Desperately Needed: Harm Reduction

    India closely adheres to the WHO’s abolitionist stance, as evidenced by the country’s 2019 ban on vape products. “My understanding is there is a general denial of harm reduction approaches among governmental stakeholders,” Chowdhery says. “I am not sure, though, how the bans are evaluated or if there is a mechanism for that, though I do keep hearing about smuggling of these goods going up through everyday reports of seizures.

    “My view is that such bans, if not accompanied by meaningful cessation support in the form of in-person counselling centers and affordable, subsidized nicotine-replacement products or substitution products, such as nicotine pouches and snus, for those who can’t or don’t want to quit, along with strong enforcement, will lead to creation of black markets, which end up increasing population-level harm through proliferation of unregulated, substandard products.”

    Sudhanshu Patwardhan, U.K.-based medical doctor and tobacco cessation expert, looked exactly at these issues in a paper, “New Nicotine Pouch Category: A Tobacco Harm Reduction Tool?” which he published with Swedish Scientist Karl Fagerstrom in October 2021.

    “India’s latest GATS [Global Adult Tobacco Survey] data shows that nearly 200 million people continue to use risky forms of oral tobacco,” he says. “With no meaningful cessation support available, nor any affordable and appealing safer nicotine alternatives, consumers are struggling to give up their risky tobacco habit. Frankly, it is naive to expect governments to embrace tobacco harm reduction at face value.

    “The ban on e-cigarettes was partly fueled by irresponsible behavior from multinational companies and international experts’ lack of understanding of the Indian policymaking milieu and worsened by nicotine illiteracy among Indian policymakers and their influencers, such as healthcare professionals. A lot of work needs to be done in India and globally to enable and empower healthcare professionals by disentangling in their minds nicotine’s addictive properties from smoked as well as smokeless tobacco products’ carcinogenic and other harmful properties.

    “Nicotine-replacement therapy is on the WHO’s model essential medicines list and also on India’s essential medicines list. As I and globally renowned nicotine dependence expert Dr. Fagerstrom argue in our paper in the Nicotine and Tobacco Research Journal, ‘there is a great challenge and opportunity in India to bring affordable nicotine pouches that are responsibly manufactured and marketed only to adult tobacco users. It would be important to ensure that adult users’ access and affordability are not compromised by the regulatory regime and the behaviors of profit-maximizing manufacturers.’”

  • Lexaria Demonstrates Rapid Nicotine Delivery

    Lexaria Demonstrates Rapid Nicotine Delivery

    Image: Zerbor

    Lexaria Bioscience Corp.’s DehydraTECH nicotine pouch delivered nicotine up to 20 times faster than a generic nicotine benzoate pouch during a study conducted on dogs, the company reported.

     The analysis, conducted in collaboration with an independent testing laboratory, evaluated nicotine benzoate and polacrilex plasma levels in 40 anesthetized male beagle dogs, comparing Lexaria’s recently developed, advanced DehydraTECH 2.0 nicotine formulation to concentration-matched controls. The dogs’ blood samples were taken every few minutes over the course of two hours.

     “The results from the study showed that the generic nicotine benzoate pouch required about 45 minutes to reach its peak delivery rate. In comparison, the DehydraTECH-nicotine benzoate pouch reached peak delivery rates at both eight minutes and again at 30 minutes. It was further noted that in just four minutes after the pouch was placed in the mouth, the DehydraTECH-nicotine had reached a higher delivery level than the generic achieved at any point during the study,” reads a recent article.

     “Our technology was ten to twenty times faster in delivering comparable levels of nicotine into [the] bloodstream than the peak of the concentration-matched controls and went on to far exceed their total delivery, which should provide much greater consumer satisfaction,” said Chris Bunka, Lexaria CEO, in a statement.

  • New Nicotine Pouch Hits Market

    New Nicotine Pouch Hits Market

    Photo: V&YOU

    V&YOU has launched a new Boost+ nicotine pouch that offers “a bold and bright burst of flavor balanced with a powerfully refreshing kick,” according to the company.

    “We’re incredibly excited to share this product with our fans,” says V&YOU co-founder Markus Bonke. “Boost+ is simply one of the best nicotine pouches we’ve ever made. The flavor combos, the nicotine content and flavors—even the can itself has been improved to deliver the ultimate in consumer satisfaction, not to mention the first-ever child-safe packaging.”

    “Our customers demanded a stronger nicotine pouch, and we’ve really delivered here,” says V&YOU co-founder Titus Wouda Kuipers. “With 15 mg of Swiss-made nicotine per pouch combined with our fantastic delivery system, this is for pure fans who love the nicotine sensation without the hang-ups of smoking, vaping or snus.” 

    Boost+ comes in a professional looking can with a beautiful metallic finish that matches style with substance, according to V&YOU.

  • Dalli to Face Charges in Snus Bribery Scandal

    Dalli to Face Charges in Snus Bribery Scandal

    Photo: highwaystarz

    Former European Commissioner John Dalli will face charges as part of a tobacco bribery scandal that resulted in his resignation from the commission in 2012, reports the Times of Malta.

    Dalli’s aide Silvio Zammit allegedly tried to obtain a €60 million ($71.17 million) bribe from Swedish Match to reverse the EU ban on snus (the company rejected the offer as improper and reported it to the European Commission). Dalli was the European commissioner for health at the time, in charge of managing reforms to the EU’s tobacco rules. Zammit was charged in December 2012 for trading influence and complicity in the request.

    Dalli, however, escaped charges, returning to Malta only after the newly elected Labour government removed Police Commissioner John Rizzo from his job.

    Rizzo has always maintained that Dalli, too, had a case to answer to.

    His successor as police commissioner, Peter Paul Zammit, decided there was not enough proof to bring charges against the former EU commissioner.

    Contacted by Times of Malta, Dalli said the charges were part of a deal struck between current Police Commissioner Angelo Gafa and former Olaf head Giovanni Kessler, who led the EU Anti-Fraud Office’s investigation in 2012.

    Dalli will appear in court in Malta on Sept. 17. He said the charges were part of a “campaign” against him. “This is another fraud,” he told the Times of Malta.

    In February, Dalli lost his final appeal before the EU high court against a lower court ruling that dismissed the politician’s claim for €1 million in damages stemming from his resignation over the scandal.

    Denying knowledge of the bribe, Dalli claimed that he was illegally forced from his post.

  • 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.

  • Kaival Restarts Pouch Production

    Kaival Restarts Pouch Production

    Kaival Brands Innovations Group is restarting production of its Bidi Pouch ahead of an anticipated September launch.

    The Bidi Pouch rollout had been delayed because of Covid-related manufacturing and supply chain constraints. Due to these complications and to prevent future bottlenecks, the company decided to move manufacturing in-house. One of the few pouch products on the market formulated without the Swedish Match formula, the Bidi Pouch provides a proprietary tobacco-free nicotine formulation packed in a convenient plastic can, according to Kaival Brands.

    “I am pleased to confirm that we expect to take delivery of the pouch manufacturing machines to our warehouse the end of August and anticipate beginning production in September with our first run expected to yield up to 500,000 cans,” said Niraj Patel, founder and CEO of Kaival Brands and Bidi Vapor, in a statement.

    “We are excited to launch distribution of the Bidi Pouch and have been working behind the scenes during Covid-based delays to secure initial distribution. To that extent, we are proud to announce that 8,000 points of distribution have been secured and are ready to receive our product,” said Eric Mosser, chief operating officer of Kaival Brands.

    The company believes that the nicotine pouch category represents a significant market opportunity. The category has witnessed significant growth recently, with New York-based Nielsen reporting an increase in unit sales of 59.9 percent in U.S. convenience stores over the 52-week period ended June 19, 2021.

    This growth is expected to continue as evidenced by publicly available material from MarketResearch.com in which it indicated that the global nicotine pouches market is expected to reach $32.8 billion by the end of 2026, with an expected compound annual growth rate of 54.9 percent through 2026.

  • BAT: Modern Oral Comparable to NRT

    BAT: Modern Oral Comparable to NRT

    New research published today indicates that BAT’s modern oral products in the form of tobacco-free nicotine pouches have a toxicant profile that is comparable to nicotine-replacement therapies (NRTs) and much lower than traditional oral snus, a category of products that when used as the sole nicotine product is already established as a reduced-risk product compared with cigarettes.

    The study, published in Drug and Chemical Toxicology, analyzed four variants of one of BAT’s modern oral nicotine pouch products Lyft+, three snus products, and two different NRT products in a lozenge and a gum format. Each of these products was tested for a range of known harmful and potentially harmful constituents.

    The results showed that the modern oral products had a comparable toxicant profile to NRTs, which are currently considered to be the least risky of all nicotine products. The study also estimated that users of the studied modern oral products are likely to be exposed to far fewer and significantly lower levels of toxicants than those who use snus.

    According to BAT, the findings suggest that modern oral products, such as Lyft and Velo, should be placed close to NRTs at the lowest exposure end of the nicotine product toxicant delivery continuum.

    “These results add to the growing body of evidence to support the reduced-risk potential of modern oral products compared to continuing to smoke,” said Aaron Williams, head of science and R&D, in a statement.

    These results add to the growing body of evidence to support the reduced-risk potential of modern oral products compared to continuing to smoke.

    “They provide important new evidence to support the role of modern oral products in tobacco harm reduction by demonstrating that they have far fewer and much lower levels of toxicants compared with cigarette smoke and even compared with Swedish-style snus, which is already well established as a reduced-risk product when used as the sole nicotine product.

    “This means smokers looking for an alternative nicotine product have another alternative offering greatly reduced exposure to toxicants that comes in an oral format that some may find convenient and easy to use.”