Tag: Modern Oral

  • Unpacking the Pouch

    Unpacking the Pouch

    Photo courtesy of Broughton

    How we can better understand the toxicological risk of nicotine in modern oral and other nicotine products

    By Libby Clarke

    Nicotine may be acutely toxic via all routes of exposure if the dose is high enough, but determining the true extent of its toxicity is challenging because of the variation in data. In 2014, Bernd Mayer highlighted the discrepancy between the generally accepted lethal dose of nicotine and documented cases of nicotine intoxication. Examining these accidental oral ingestion case studies gives us another data point for consideration when determining nicotine toxicity.

    In this article, Libby Clarke, managing consultant for toxicology at contract research organization (CRO) and scientific consultancy Broughton, explains how manufacturers can understand the true impact of oral pouches and other nicotine-based products.

    The U.S. Centers for Disease Control and Prevention and the National Institute for Occupational Safety and Health, along with other sources, report an estimated lethal dose of around 60 mg when nicotine is ingested orally. While broadly accepted by the Food and Drug Administration and other regulatory bodies, this value is derived from a series of self-experiments conducted by two individuals in the 19th century, where non-fatal adverse effects were reported.

    Mayer estimated that a dose of 60 mg of nicotine would give rise to a plasma concentration of approximately 0.18 mg per liter based on 20 percent oral bioavailability and assuming linear kinetics. Cases of fatal nicotine intoxication cited by Mayer suggest a much higher lethal nicotine blood concentration of approximately 2 mg per liter, corresponding to 4 mg per liter in plasma. Many existing case studies include data on accidental ingestion in children and infants, where the lethal dose is likely lower, as with nicotine naive adults.

    There is a significant disparity in the levels of nicotine that individuals can tolerate and a broad range in the upper level of nicotine that nonsmokers can consume without experiencing adverse effects. Research indicates that tolerance increases with repeated use of nicotine products, but the speed at which tolerance grows depends on the frequency of nicotine use, the amount absorbed systemically and individual genetics.

    Research Challenges

    Understanding nicotine toxicity is essential for determining the likelihood of adverse effects associated with certain products and concentrations, but research is limited. It is unethical to test nicotine toxicity in nonsmokers, and light or nondaily nicotine users are likely to have a lower tolerance, putting them at a higher risk of experiencing adverse effects such as dizziness, nausea and vomiting. On the other hand, established smokers have upregulated receptors in the brain, meaning many more nicotine receptors are available to bind nicotine than in nonsmokers. Therefore, the higher levels of nicotine that produce adverse reactions in nonsmokers are often required to satisfy the cravings of regular smokers.

    The wide range in tolerance among adult nicotine users makes it challenging for manufacturers to define a threshold for nicotine toxicity in their products. Meanwhile, attempting to extrapolate findings from children to adults is not recommended due to differences in metabolic capacity, which increases as people grow. There is also a vast difference in metabolic efficiency, even among adults, which limits extrapolation.

    Understanding the Effects of Nicotine

    One option is for manufacturers to review case studies, conduct postmarket surveillance (PMS) on the incidence of reported adverse effects and use surveys to understand consumer use and the subjective effectiveness of nicotine delivery. For example, Massen et al. (2020) evaluated case studies reporting the clinical symptoms and outcomes associated with accidental or intentional ingestion of nicotine-containing e-liquids, which are limited to 20 mg per milliliter in the EU. Gerdinique C. Maessen et al. reported that the highest nicotine plasma concentration in the surviving group was 0.8 mg per liter. In comparison, the lowest plasma concentration in the patients who did not survive was 1.6 mg per liter.

    Another approach is working with a CRO that can conduct dissolution, aerosol characterization for inhaled products and pharmacokinetic studies to inform on the nicotine levels being delivered to users. CROs can also conduct behavioral studies under controlled conditions to understand the use patterns for certain products and what products and strengths are used across population samples.

    When developing oral pouches, manufacturers must adhere to the regulatory guidelines that are starting to be brought in by some markets. The rate at which nicotine transfers from the pouch across the buccal membrane is one of the main factors associated with users experiencing adverse effects, so manufacturers should consider a range of nicotine strengths. Dissolution studies and clinical studies may provide useful data to inform nicotine exposure from pouches, and case studies and PMS may also provide valuable insights. Working with a CRO that can conduct such studies is an effective way of understanding a product’s safety profile and form part of a manufacturer’s product stewardship and duty of care responsibilities.

    Libby Clarke is managing consultant for toxicology at Broughton, a global scientific consultancy-based CRO across industries in pharmaceuticals, next-generation nicotine-delivery products and cannabinoids.
  • TACJA launches nicotine pouches in Europe

    TACJA launches nicotine pouches in Europe

    TACJA has launched nicotine pouches in the United Kingdom, Switzerland and Sweden.

    The products offer eight flavors in two taste series—Mellow and Frozen—and nicotine concentrations of 20 mg/g, 18 mg/g and 12 mg/g. According to TACJA, the products contain pharmaceutical-grade ingredients and comply with the European Union Good Manufacturing Practice.

    “We are thrilled to introduce TACJA, offering a diverse range of flavors and a delightful sensory presence,” said Charles An of TACJA in a statement. “Our nicotine pouches are designed to provide users with moments of quality and unconstraint,” he added.

  • Health Canada Licenses Nicotine Pouch

    Health Canada Licenses Nicotine Pouch

    Photo: Andrii

    Health Canada has granted Nicoventures Trading permission to sell Zonnic, a nicotine pouch that can help adult smokers quit smoking by delivering nicotine to the body. The product will be distributed in Canada exclusively by BAT subsidiary Imperial Tobacco Canada (ITCAN).

    “This is a first for Canada. No other nicotine pouch has received Health Canada’s authorization. Zonnic will give smokers a new option to help them quit smoking,” said ITCAN President and CEO Frank Silva, President in a statement.

    “We all agree, smoking is the cause of serious diseases, and we are committed to reducing the health impact of our business. The addition of Zonnic to our product portfolio is the next step in this journey.’’

    Zonnic, which temporarily relieves cravings and nicotine withdrawal symptoms, is licensed as a Natural Health Product and has been authorized for sale by Health Canada for use as a form of Nicotine Replacement Therapy (NRT). Zonnic contains no tobacco.

    As part of its license application, Nicoventures provided all information required by Health Canada, including a pharmacokinetics study that assessed the bioavailability of nicotine in Zonnic in comparison to other commercially available NRTs. The study showed that Zonnic nicotine pouches effectively deliver nicotine, and are comparable to other commercial brands.

    “Canada has a golden opportunity to achieve its reducing smoking rates below 5 percent by 2035. We just have to look at Sweden to see how it can be done. Sweden is about to become the first smoke free country,” said Silva. “This is being achieved by embracing new, less harmful nicotine products and creating a policy environment which encourages smokers to move away from smoking. With Canadian smoking rates at an all-time low, we believe that Zonnic can reduce rates even further, and help Canada get the same results as Sweden.”

    ‘’I am immensely proud to add Zonnic to our product portfolio that hit the shelves this week in convenience stores and later this year in pharmacies. Offering a range of less harmful products to smoking will benefit our adult consumers and society as a whole,’’ concluded Silva.

  • Premier to Distribute NIC-S Pouches

    Premier to Distribute NIC-S Pouches

    Photo: Premier Manufacturing/Enorama Pharma

    Premier Manufacturing, a subsidiary of U.S. Tobacco Cooperative, and Enorama Pharma have entered into an exclusive distribution agreement regarding the sale of NIC-S, tobacco-free white snus, for the U.S. market.

    “The growth and sales potential in tobacco free nicotine pouch market is growing exponentially”, said Premier Manufacturing Sales Director Steve Lucas. “We wanted to offer our customers and their consumers a broader range of products and NIC-S is a great partner to achieve this”, said Lucas.

    “We at Enorama are very pleased to have entered into this distribution agreement with Premier Manufacturing and we look forward to a long and close collaboration. We are convinced that Premier Manufacturing, its extensive sales organization and a wide contact network, will be a valuable partner for Enorama’s expansion in the American market.” said CEO Annette Agerskov.

    NIC-S is available in a wide range of options allowing the consumer to tailor their nicotine intake. “With three different nicotine strengths—3 mg, 6 mg and 9 mg—and several flavors such as wintergreen, mint, orange, berry, cinnamon and flavor free; consumers will be sure to find a favorite style—or two,” said Lucas.

    “Everyone at Premier Manufacturing is excited about the opportunity to partner with Enorama Pharma to supply our customers with a superior quality premium tobacco-free white pouch that will satisfy the growing number of consumers entering this exciting category,” said U.S. Tobacco Cooperative Senior Vice President Russ Mancuso.

    Premier Manufacturing will be doing a full marketing campaign promoting NIC-S that will include point-of-sale materials, print and digital ad campaigns, display fixtures and various websites. Product will be available via Premier’s distribution network throughout the U.S. in the coming months.

  • Steve McGeough to Lead Übbs

    Steve McGeough to Lead Übbs

    Photo: Übbs

    Nicotine pouch manufacturer Übbs has appointed Steve McGeough as general manager.

    Previously head of retail at British American Tobacco, Steve brings considerable experience from within the nicotine space. During his time at BAT, McGeough transformed the retail and direct-to-consumer experience, boosting sales by 20 percent. In addition, McGeough led the launch of BAT’s Vuse and Velo brands across the U.K., underpinned by a global offline subscription proposition.

    Prior to BAT, McGeough was retail director for Tesco Mobile where he helped to achieve double-digit revenue growth and enhance customer satisfaction.

    As general manager for Übbs, Steve will drive distribution, accelerate the brand’s online presence, build awareness and focus on responsible growth.

    “With over 25 years’ experience across retail, start-ups and product-led businesses, including significant time in the nicotine industry, Steve brings an impressive blend of experience that means he is perfectly positioned to help propel Übbs forward,” says Nigel Hardy director of Übbs parent company, RV Kharma.

    “His experience at British American Tobacco working within the next generation products division where he achieved impressive sales growth and launched nicotine pouch products across the U.K. is a great grounding for what’s to come with Übbs.

    “Steve shares our unwavering commitment to excellence, sustainability and ethical practices. We look forward to him taking the reins as we continue to grow.”

    Founded in the U.K. in 2022, Übbs’ pouches are manufactured to global pharma standards in India.

  • Seeking Substitutes

    Seeking Substitutes

    Dholakia Tobacco is offering Indian smokeless tobacco products that are less hazardous than the country’s most commonly used varieties. Photos: Dholakia Tobacco

    Modern oral nicotine products could help Indian consumers abandon deadly local smokeless tobacco products.

    By Stefanie Rossel

    When it comes to tobacco, India holds several records: It is the world’s second-largest consumer, third-largest producer and fifth-largest exporter. Its consumption pattern is also remarkable. According to the 2016–2017 Global Adult Tobacco Survey, 266.8 million adult Indians—28.6 percent of the country’s population—use tobacco in some form.

    However, with 199.4 million consumers, the most used tobacco product is smokeless (SLT). Only 99.5 million Indians consume tobacco by smoking it. Of these, only 37.5 million smoke cigarettes. Most smokers prefer bidis—cheap, unfiltered cigarettes made of tobacco flakes wrapped in a tendu or temburni leaf that are even more hazardous to health than factory-made cigarettes.

    India has the world’s largest number of SLT users. Unfortunately, the type of SLT that prevails here does not reside on the low end of the risk continuum like other smokeless products such as Swedish snus do. A pasteurized oral tobacco with limited negative health effects, snus has helped Sweden achieve the world’s lowest smoking prevalence. Indian SLTs, by contrasts, are considered “uniquely deadly” by experts.

    Indian SLTs come in a large variety. The most commonly used variants are khaini, a mixture of tobacco and lime, and gutkha, which comprises tobacco, slaked lime, paraffin wax as well as catechu, an extract of acacia trees and crushed areca (betel) nut. Other local forms of SLTs contain mixtures of betel quid or paan masala. All are highly addictive and full of carcinogens. In addition to the typical ingredients, they can be laced with thousands of chemicals. Available for a few rupees, these SLTs are affordable for low-income groups. Like bidis, they are predominantly consumed in rural areas, where almost 70 percent of the country’s population lives. SLTs are responsible for an estimated 350,000 premature deaths annually in India.

    In line with its national health policy, India aims to reduce the number of tobacco users by 30 percent by 2025. The country closely adheres to the World Health Organization’s abolitionist guidelines, but its tobacco control measures are often contradictory. Attempts to curb tobacco use have remained limited to tax hikes on cigarettes rather than bidis and a ban on e-cigarettes and heated-tobacco products. In 2012, all states banned the manufacture, sale and distribution—but not the public use—of pre-packaged gutkha under laws that defined the product as a food. Some states extended this ban to other oral tobacco products, such as paan masala. Enforcement of these bans has been weak, however.

    In an interview with The Free Press Journal, Kiran Melkote of AHER, a harm reduction group, outlined the reasons for India’s ineffective tobacco control policy. “Many arms of the government work at cross purposes and implement policies that even on paper are in direct conflict with the WHO Framework Convention on Tobacco Control. The health ministry tries to implement awareness campaigns and maintain zero industry contact norms for its employees while the commerce ministry provides loans and support for tobacco cultivation and the finance ministry bans e-cigarettes and incentivizes bidi manufacturers. All of them generally ignore oral tobacco. The answer therefore lies in understanding that the strategies used in the developed world where the predominant form of tobacco is the cigarette may not really impact tobacco use in India. Here we have a larger population with different problems and an admitted inability to implement existing laws.”

    The success of modern oral products in Pakistan is welcome proof that they can replace the deadlier local oral tobacco.

    Samrat Chowdhery, director of the Council for Harm Reduced Alternatives

    Potential Solution

    Perhaps a look across the border might be useful. India’s neighbor Pakistan has a tobacco consumption profile similar to that of India. An estimated 10 million people use SLT, which represents more than 40 percent of the country’s total tobacco market. Recently, Pakistan has seen a remarkable development: In December, BAT announced that its modern oral nicotine brand Velo had achieved a monthly volume of more than 40 million pouches in the country, making it BAT’s third-largest market for nicotine pouches. Modern oral nicotine products consist of pre-portioned bags comprising nicotine applied to a carrier material. They are considered to be a more advanced, cleaner version of Swedish snus.

    Could Pakistan’s experience in substituting hazardous SLT products with less harmful varieties serve as a blueprint for India? “The tobacco use patterns in both nations are similar,” says Samrat Chowdhery, director of the Council for Harm Reduced Alternatives, referring to the high share of oral tobacco use. “Nicotine pouches have not been sold on scale before in the South Asian region, hence their substitution potential for the region’s tobacco users, especially the SLT users, was not known. Their success in Pakistan is welcome proof that they can replace the deadlier local oral tobacco—though whether that is indeed happening needs to be better understood.”

    Nihar Dholakia, director of next-generation products at Dholakia Tobacco, an SLT company based in Gujarat, India, has been closely monitoring the rise of the modern oral category in Pakistan. “Given that both Pakistan and India have a similar culture of using SLT products, we believe that the success of nicotine pouches in Pakistan could be replicated in India but on a much larger scale.”

    In light of the Indian government’s abolitionist strategy and the competitive structure of the local SLT segment, in which two leading companies jointly hold around 40 percent of the market, less hazardous oral products in India could encounter major hurdles, according to Chowdhery. “Nicotine pouches and snus could face opposition from the SLT lobby unless they can be made to see the business potential,” he says. “It would be a major setback if the government banned safer oral nicotine products too.”

    Issues are also likely to come up in terms of cultural heritage and consumer education. “Tobacco use, especially oral, has long been part of India’s cultural milieu, just like alcohol is in western nations,” says Chowdhery. “SLT is also available for cheap, and varieties vary across regions. While the social stigma around smoking is beginning to develop, none exists for oral products as there is no secondary harm. Educating users can be challenging given the number of users, with different cultural norms and languages such that it is difficult to design communications.”

    “In India, the avenues available for broadly educating consumers about THR and more specifically finessing that message to SLT users may be very limited,” says Dholakia. “The process seems to be largely organic, with consumers themselves becoming aware of the harmful effects and seeking alternatives. This often involved researching THR and exploring a range of reduced-risk products available. Online resources and word of mouth play a significant role in the education process. However, to make a more substantial impact, we require greater consumer advocacy as well as government initiatives to generally raise awareness.”

    We believe that the success of nicotine pouches in Pakistan could be replicated in India—but on a much larger scale.

    Nihar Dholakia, director of next-generation products at Dholakia Tobacco

    Treading New Paths

    Despite the government’s reluctance to admit safer substitutes, not all is lost for THR in India. Dholakia and other manufacturers are beginning to look at snus and nicotine pouches. With the Paz brand, his business recently launched the first Swedish-style tobacco snus brands in India. “In fact, we operate India’s first online platform for snus,” says Dholakia. “However, we face regulatory challenges, such as the requirements of an 85 percent pictorial warning of product packaging, high taxes and restrictions on advertisement and promotion. Nevertheless, despite these obstacles, we have observed a growing trend among consumers who are actively seeking reduced-risk products as a better alternative.”

    Dholakia Tobacco caters primarily to the premium SLT category. “However, considering the fact that India has over 220 million smokeless tobacco users who lack access to harm-reduced alternatives, we aspire to make our products more accessible and available to any SLT user. Therefore, we are determined to expand our reach to a broader audience in the domestic market as well through the right forms of direct-to-consumer education and word-of-mouth product awareness.”

    Indian consumers have responded positively to Dholakia’s snus products, particularly after switching from traditional chewing tobacco, cigarettes or khaini. “Many customers have reported experiencing a positive change firsthand, indicating their acceptance and awareness of the harm-reduced properties of snus products,” says Dholakia. “These are some of our future ambassadors for risk-reduced products, who will quite naturally be out there to talk with other consumers about their experiences with these new products.”

    The company also manufactures a filtered khaini brand, which has become popular in many Indian states recently. Filtered khaini is a modern version of khaini chewing tobacco that resembles western-style, portion pouch-packed snus but has a significantly different toxicological profile. “Traditional filter khaini available on the market is not less harmful than regular khaini,” clarifies Dholakia. “In fact, it can be thought of as a pulverized moist version of khaini packed in an oral pouch.”

    Dholakia’s filtered khaini brand is not the same, he insists. “The filter tobacco products we offer are different in composition when compared to traditional filter khaini and commercially available products in India currently. It can be said it is less harmful than other filter products due to the use of low-impact base ingredients, the type of quality tobacco and the novel processes as well as our advanced approach to product integrity and testing infrastructure. As far as affordability and availability is concerned, these filter products are comparable to regular chewing tobacco and khaini products. They are available in a few states and are perceived by khaini consumers as a more sophisticated version of a mainstay khaini product.”

    Dholakia Tobacco has also ventured into modern oral nicotine pouches. It was the first company in India to venture into this category. “As pioneers of modern oral nicotine pouches from India, our products are currently available only in the global markets we cater to and have not yet been launched domestically,” Dholakia says.

    “However, we are considering and working toward introducing them in India as we firmly believe that they can have a positive impact on public health in the country. We are confident that Indian consumers are ready for such a product. Accessibility, awareness, the right information, a fair regulatory framework and quality control are key factors that need to be addressed for the category. Given that India is in dire need of multiple harm-reduced products, we are committed to making them available in India.”

    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.
  • Netherlands to Ban Nicotine Pouches

    Netherlands to Ban Nicotine Pouches

    Photo: Andrii

    The Netherlands will ban the sale of nicotine pouches and expand the rules for tobacco to cover all other types of tobacco-free nicotine products, the government announced on April 21.

    Currently, Dutch law permits sales of nicotine pouches only if they contain less than 0.035 grammes of nicotine.

    The new rules will also prohibit the use of nicotine pouches and other tobacco-free nicotine products in places where smoking is not allowed.

    The government said it would also end all advertising for tobacco-free nicotine products, a segment that tobacco companies have invested heavily in as move away from combustible products to less harmful cigarette alternatives.

    “The tobacco industry keeps launching new products that make it easy for young people to come into contact with nicotine,” health deputy minister Maarten van Ooijen was quoted as saying by Reuters.

    “This is bad, because nicotine is addictive and harmful. That’s why I’m glad we will now treat these products the same as tobacco products,” he said.

  • Fighting the Dip Mentality

    Fighting the Dip Mentality

    Photo: Andrey Popov

    What will it take for women who smoke to consider smokeless?

    By Cheryl K. Olson

    When Brittney Niquette first tried smokeless tobacco two years ago, it was from a sense of obligation. She runs customer support for Lucy Goods, a maker of nicotine pouches, gums and lozenges.

    “I like to know what our products taste like, so that I have a genuine opinion and feedback to give customers,” she explains. “They’re just not marketed to women. So I honestly didn’t know what a nicotine pouch was. I was thinking tobacco, like, brown in a pouch.”

    Niquette started smoking at 15, repeatedly quitting and restarting. She now uses tobacco-free pouches every day. “My favorite is the berry citrus. And I like espresso flavor with coffee in the morning.”

    In Scandinavian countries, widespread use of smokeless tobacco products has driven smoking rates to astonishing lows. In his recent article “Can alternative nicotine put the final nail in the smoking coffin?,” Karl Fagerstrom writes, “The availability and use of snus has contributed to Sweden’s record-low prevalence of smoking and the lowest level of tobacco-related mortality among men in Europe. This phenomenon is sometimes referred to as the ‘Swedish experience.’”

    Public health modeling that factors in that experience and the low-harm chemical constituents of modern products suggest that a huge number of deaths could be averted if more people switched, as Niquette did, from cigarettes to smokeless. But so far, most of those switching, even to the newest smokeless alternatives, have been men.

    “Of all adult smokers, about 45 percent are women, and 55 percent are men,” says Allison Bolyard, vice president for innovative nicotine products strategy at Altria. “But if you look at lifetime smokers who have successfully switched, only about one-third are women. We see a big opportunity in providing alternatives for women that they can enjoy and can be successful in switching, because they’re falling behind.”

    In recent behavioral studies on smokeless products that I’ve conducted for industry, women described negative stereotypes about smokeless users. One said, “You kinda have to fight the dip mentality. Marketing needs to be classy and discreet. Not a country boy dip and spit.”

    What innovations and approaches might get women who don’t want to quit nicotine to consider a smokeless alternative? To better understand this, I talked with people in industry working to provide appealing options for women. I also collaborated with the Consumer Advocates for Smoke-Free Alternatives Association (CASAA) on a survey of its female members about their smokeless tobacco perceptions and experiences.

    Deadly Misperceptions

    Surveys consistently find that smokeless products are wrongly seen as more risky than e-cigarettes and often as more risky than smoking. A recent analysis of the nationally representative Population Assessment of Tobacco and Health Study found that a higher percentage of Americans believe smokeless tobacco products are more harmful than cigarettes than believe the (actual) reverse to be true. What’s more, “the study demonstrates that harm perceptions not only predict future product uptake in nonproduct users but also predict continued product use among existing users.” 

    Unfortunately, these misperceptions are even more widespread among women. Previous research found that among people in the U.S. and Canada who smoke, women were significantly less likely than men to agree with a statement that some types of smokeless tobacco are less harmful than cigarettes.

    Daunting Barriers

    Along with exaggerated fears of health risks, there are psychological and practical barriers to female interest in smokeless products. (More on these below.) One is outdated perceptions of smokeless products. Discreet modern products, such as tobacco-free nicotine pouches, do not involve what one CASAA member labeled “the nasty habit of spitting out the juice.” As Niquette’s story above implies, these small, white pouches bear little resemblance to the stereotype of a wet, brown wad of chew.

    Another barrier is the unfamiliar mode of delivery. Bolyard previously oversaw Altria’s On! tobacco-free nicotine pouch line. She notes that users of traditional moist smokeless tobacco (MST) are about 95 percent male: “As opposed to men, women who smoke cigarettes aren’t used to putting, and parking, a product in their mouth.”

    A third barrier is fear of being associated with negative stereotypes of smokeless tobacco users. In my previous research, smokeless users were perceived as being mostly men, “biker guys and baseball players.” There were mentions of “gross people” with brown or black teeth.

    Based on this, women were reluctant to be observed using smokeless. One said, “Folks were noticing it [the round pouch tin] in my pocket and expecting me to spit somewhere.”

    Unfamiliar, uncomfortable mouth sensations are a fourth barrier that may turn off women. In the CASAA survey, a number of women referred to “burn” or irritation as a reason for stopping smokeless use or avoiding certain brands.

    “The familiar stinging/burning sensation on the gum when trying either snus or nicotine pouches is a huge deterrent to switch to smokeless oral products, especially for women,” says Bengt Wiberg, a Swedish economist turned snus advocate and innovator. His startup company, Sting Free, markets nicotine pouches with a patented shield technology that provides flavor and nicotine sans discomfort. “I think the U.S. expression ‘You only have one chance to make a first impression’ applies very much to this issue,” he says.

    Wiberg also notes that today’s smaller, slimmer pouch products fit more comfortably in women’s mouths. Niquette seconded this, saying, “I could be talking to somebody, and you won’t know I have one in.”

    Bolyard noted that Altria’s On! product was designed to minimize some of these barriers. The can is a square shape instead of an MST-like circle and includes 20 small pouches to match the typical cigarette pack size.  

    Unexpected Benefits

    As women get better acquainted with smokeless products, they may discover unexpected benefits over other nicotine-delivery methods. Niquette appreciates the hands-free convenience of smokeless tobacco. “Women do so much stuff: We’re busy people—we cook, clean, raise kids. Sometimes your hands are full,” she points out. “So vaping or smoking is not an option.”

    “I have three computer screens; I’m typing all day,” she adds. “And I don’t have to break. I can just grab a pouch out of the can, put [it] in my mouth and keep going.”

    To ease the transition, Niquette suggests that women start with a smokeless alternative that comes in flavors they enjoy in other products, such as fruity or minty gum.

    “Not Messy or Gross Like I Thought They Would Be”

    Here is a selection of comments from 260 female members of the Consumer Advocates for Smoke-Free Alternatives Association on what makes women who smoke decide to try or reject smokeless tobacco products.

    We defined “smokeless tobacco” as including nicotine pouches, snus, dip and chew. However, we learned that unfamiliarity with these products extends to the terminology. One wrote, “I’m confused; I thought vaping was smokeless tobacco?”

    What would make women consider a smokeless product? The most common response was “nothing.” This included variations such as “threat of death,” “a million dollars,” or less hyperbolically, “a vaping ban.” However, a few respondents were open-minded: “I have no idea what it is, but this email was enough to have me interested. I currently vape.”

    Factors listed that might make smokeless products appealing included: not having to spit, smaller size, “a bigger spectrum of flavors,” “cleaner,” “nonstaining” and “not noticeable to others.”

    Few who had tried traditional moist smokeless tobacco found it appealing. One said, “It was convenient, and there was no annoying smoke, but it irritated my mouth a bit, and I worried about my teeth or developing cancer.” “The smell and the taste [were] overpowering, the ‘juice’ burned my mouth, spitting was gross, but swallowing was even worse,” said another.

    But tobacco-free pouches, and to a lesser extent snus, found some favor. A user of both said they are “not messy or gross like I thought they would be and are advertised in the media.” Reasons for trying these products among those who use(d) them include not being able to smoke or vape at work or while traveling; wanting to quit vaping (“to give my lungs a break”), ease of access (“Vaping products became less available online … pouches were available at our convenience store”), ease of use, and curiosity.

    Other positive comments included “Liked that it was discreet and just nicotine”; “It works just as well as the smoking of something, and it’s easy to just spit it out when you have enough”; “Use to get through the day at work without having to take a break. I liked how they curb cravings; the flavors and the size of the pouch makes it easy to be discreet”; and “Can do them anywhere. Try these pouches!! No smoke, but satisfaction given.”

    Women who tried and stopped using pouches gave a variety of reasons. Some missed the “hand-to-mouth action—still wanted to smoke.” Others complained of hiccups, nausea or irritation: “I’m not a big fan of pouches because they burn the inside of my cheeks.” A few mentioned other sources of discomfort, such as “uncomfortable material that hurts my gums/mouth” or too much bulk. There was also just difficulty getting used to this type of product: “Flavors were good, but it was weird having something in my mouth that I wasn’t supposed to be chewing.” Some disliked the taste.

    Because “smokeless” received various interpretations, many women left comments on other nicotine products, including gums, lozenges, tablets or sprays. These received a similar range of positive comments and complaints. This supports the idea that women seeking alternatives to cigarettes may have to try a variety of products and brands to find their fit. As one wrote, “Try it if it will benefit your health and you’re OK with it. To each their own.”

    In short, it’s clear that many women hold strong, perhaps outdated stereotypes of smokeless tobacco. Many will never try it. However, there appears to be an untapped demand for the benefits some women report from modern oral nicotine products: a discreet product to use where no smoke or vapor is allowed or a hands-free product that gives nicotine and flavor without effort. –C.K.O

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
  • Belgium Health Minister Pushes For Pouch Ban

    Belgium Health Minister Pushes For Pouch Ban

    Photo: Liudmila

    The Belgian health minister, Frank Vandenbroucke, has called for a ban on nicotine pouches, citing concerns about youth exposure to tobacco products.

    “Our goal is to prevent our children and young people from smoking,” Vandenbroucke said. “If you are fully committed to a smoke-free generation, you must ensure that young people come into less contact with smoking or anything related to it.”

    Nicotine pouches are popular with youth, according to The Brussels Times, because they are easy to use, like snus, which is banned in the EU except for Sweden, but without the tobacco, and because they are cheaper than other tobacco products. Dutch research has shown that nicotine pouches are addictive and cause harm to the brain.

    “These nicotine pouches, like electronic cigarettes and vaping, can be a steppingstone to smoking at an early age,” Vandenbroucke said. “That is why we are resolutely opting for a ban on them. We are doing this because protecting the health of children and young people is an absolute priority.”

  • Pouch Trade Secrets Dispute Settled

    Pouch Trade Secrets Dispute Settled

    Photo: Andrii

    Kretek International, Modoral and Swedish Match have settled a legal dispute relating to nicotine pouch trade secrets, reports Law360.

    In 2020, Swedish Match alleged that Kretek and its subsidiary Dryft Sciences, as well as Modoral, misappropriated six trade secrets concerning the manufacturing and formulation of nicotine pouches.

    The defendants all denied Swedish Match’s claims and said they don’t owe the company any damages.

    Swedish Match sells nicotine pouch products under the name Zyn based on U.S. Patent No. 9,161,908 and trade secrets that it bought from Swedish nicotine company TillCe. According to Swedish Match, one of TillCe’s affiliates in 2016 breached its agreements with Swedish Match by selling the trade secrets to Kretek, which formed Dryft Sciences to sell products in competition with Swedish Match.

    Kretek then formed Dryft Sciences to sell products that misappropriated Swedish Match’s trade secrets, the complaint states.

    In November 2020, BAT—which owns Modoral’s parent company Reynolds American—bought Dryft Sciences’ nicotine pouch business and its product line.

    After Swedish Match informed BAT that it owned the U.S. patent and other trade secret information, Modoral filed a declaratory judgment action for noninfringement and also sought invalidity of the patent as well as for no misappropriation of Swedish Match’s trade secrets, the complaint states.

    On Jan. 19, U.S. District Judge Stanley Blumenfeld Jr. entered partial judgment in favor of Modoral, finding that Swedish Match couldn’t establish that Modoral’s accused product infringed any of the asserted claims of the patent.

    In their trial briefs filed earlier this month, Modoral and Kretek both argued that Swedish Match can’t sustain its trade secret misappropriation claims because its alleged trade secrets aren’t actually secret.