Category: Smokeless

  • Cigarette Alternatives Gain Ground in Europe

    Cigarette Alternatives Gain Ground in Europe

    Photo: Tobacco Reporter archive

    Cigarette sales declined across Western Europe in 2023, but increased slightly at a regional level due to the strong growth in Turkey, where illicit trade was falling and the smoking population was growing, according to a new report published by Research and Markets.

    Sales of next-generation products continue to grow in Western Europe, with even an upcoming ban on disposable vapes in the U.K., their biggest regional market, not expected to significantly impact this trend, with Italy remaining the leading market for heated tobacco products regionally.

    Rising prices, due to the global inflationary environment and ongoing tax hikes, increasing health awareness and competition from next-generation products is resulting in declining unit volume sales of cigarettes across most of Western Europe, with little likelihood of this changing over the forecast period.

    Although slower than in the two previous years, closed-system single-use vaping products were still recording growth in the U.K. in 2023. However, with concerns about the throwaway nature of disposable vapes as well as their attraction to underage smokers, the U.K. government announced a ban on these products from early 2025, which force industry players to shift their focus toward open and other closed vaping products.

    The nicotine pouches category is expected to see strong growth over the forecast period. Sweden will continue to be the leading country market in Western Europe, but Finland is expected to take over from Denmark as the second biggest in the region over 2023-2028. This is due to the Finnish authorities deregulating the sale of these products in mid-2023.

    Heated tobacco products will be accounting for just over half of overall smokeless tobacco, e-vapor products and heated tobacco sales at the end of the forecast period, having recorded further growth in the coming years. Philip Morris International continues to drive the development of the category, rolling out its new IQOS Iluma devices and Terea sticks across the region, with the other tobacco giants also present with devices like Ploom (Japan Tobacco International), Glo (British American Tobacco) or Pulze (Imperial Brands).

  • Accorto Joins Institute for Novel Nicotine

    Accorto Joins Institute for Novel Nicotine

    Accorto Regulatory Solutions has joined the Global Institute for Novel Nicotine (GINN), an organization dedicated to advancing tobacco harm reduction through supporting the research and development of non-vaporized tobacco alternatives for adult smokers. The GINN also promotes compliance standards, focusing on youth access prevention, responsible marketing and product quality.

    Accorto Chief Scientific Officer Vince Angelico will join the GINN’s science and standards committee, which helps shape regulatory recommendations for the industry.

    “Becoming a member of GINN is a pivotal move in our ongoing commitment to advancing public health through robust, evidence-based regulation,” said Accorto Regulatory Solutions CEO Tom Beaudet in a statement. “GINN’s dedication to upholding industry integrity and prioritizing consumer safety mirrors our own values. We are eager to collaborate with fellow members to drive impactful progress in the tobacco harm reduction space.”

    Through this collaboration, Accorto Regulatory Solutions aims to contribute to the development of comprehensive, science-driven regulations that will enhance public health outcomes and promote responsible industry practices. Additionally, Accorto says it is dedicated to helping GINN members with novel, science-backed reduced-risk products fortify their regulatory applications, enabling these products to reach the market.

    “Accorto Regulatory Solutions joining GINN marks a significant step forward in our shared mission to advance tobacco harm reduction through evidence-based regulation,” said GINN Director Shem Baldeosingh. “Accorto’s deep expertise in regulatory compliance and their commitment to public health align perfectly with GINN’s core values. We are particularly excited about Dr. Vince Angelico’s involvement in our science and standards committee, as it will further enhance our ability to develop comprehensive, science-driven regulatory frameworks that support the safe and responsible marketing of reduced-risk nicotine products.”

  • Canada to Crack Down on Pouches

    Canada to Crack Down on Pouches

    Photo: JHVEPhoto

    Nicotine pouches may be sold in Canada only by individuals working under the supervision of a pharmacist, under a new ministerial order targeting “new and emerging” nicotine-replacement therapies (NRTs). Sellers will also be required to store nicotine pouches behind the pharmacy counter.

    In addition, the new rules prohibit youth-appealing advertising or promotion and sales of nicotine pouches with flavors other than mint or menthol.

    Manufacturers will be required to print a front-of-package nicotine addiction warning as well as a clear indication of the intended use as a smoking cessation aid for adults trying to quit smoking. They must also submit mock-ups of labels and packages for all new or amended NRT licenses to ensure no youth appeal.

    The new restrictions will take force Aug. 28, 2024, though there will be a six-month transition period for the provisions on advertising and labeling. Established smoking cessation aids, such as nicotine gums, lozenges, sprays and inhalers, will continue to be available in a wide range of retail locations, with a variety of flavors.

    “Stronger measures are needed to protect youth from the harmful effects of nicotine and stop dependency before it starts,” said Minister of Health Mark Holland in a statement. “The action our government is taking will keep these products available for adults who need them to quit smoking while making sure they don’t get into the hands of youth for recreational use.”

    Public health advocates welcomed Health Canada’s announcement. “These new measures put an end to the easy access young people have had to a very addictive substance,” said Rob Cunningham, senior policy analyst with the Canadian Cancer Society, in a statement. “These restrictions will help protect youth from tobacco industry marketing and from nicotine addiction. We must avoid a repeat of the experience that has seen a dramatic increase in youth vaping.”

    Imperial Tobacco Canada (ITCAN), which makes the popular Zonnic nicotine pouches, warned that the ministerial order would derail efforts to reduce smoking rates.

    “The Minister of Health is making smoking cessation products more difficult to buy for adults who smoke and who want to quit,” said ITCAN Vice President of Corporate and Regulatory Affairs Eric Gagnon in a statement. “It goes against all logic for a country that wants to reduce smoking rates to target products that actually help people quit.”

    According to ITCAN, Zonnic is quickly becoming the leading smoking cessation aid product in locations where it’s sold. The company claims to have received testimonials suggesting that consumers have stopped or reduced smoking by using Zonnic.

    Canada regulates NRTs as drugs under the Food and Drugs Act. All NRTs must be approved by Health Canada and carry an approved health claim to be legally sold in Canada. Health Canada authorized sales of Zonnic in October 2023.

  • Altria Worried About Illicit Pouches

    Altria Worried About Illicit Pouches

    Photo: Tobacco Reporter archive

    Altria Group is worried about growing illicit sales of modern oral products in the United States, reports Reuters. The company has shared data on illegal nicotine pouches with the U.S. Food and Drug Administration.

    “This illicit market echoes the beginning of the illicit e-vapor market several years ago,” Altria CEO William Gifford told analysts during a financial update. “We believe it is critical that the FDA acts decisively to regain control of the oral nicotine pouch category to prevent another widespread illicit market from taking hold,” he added.

    Altria said it had identified more than 350 unique illegal nicotine pouches on sale, with new brands launching every month.

    Gifford said Altria had also observed an increase in illicit cigarettes, one survey of discarded packs in California finding that some 25 percent were non-U.S. brands, mostly originating from duty-free channels or China.

    Last month, Philip Morris International said it had observed sales of its nicotine pouches intended for the Scandinavian market on sale in the United States.

    Recently, British American Tobacco’s CEO expressed concern about the continued lack of enforcement against unauthorized single-use vapes in the U.S., which makes it difficult for authorized brands to compete in that market.

  • Air Global Launches R&D Facility in Dubai

    Air Global Launches R&D Facility in Dubai

    Photos: Air Global

    Advanced Inhalation Rituals (AIR Global) has launched a new research, design and development (RDD) lab in Dubai.

    Backed by an AED100 million ($27.23 million) investment, the facility will be used to develop and hire tech talent, drive innovation in the shisha industry and speed up the development of new products.

    The global hub will develop new inhalation products that build on the success of OOKA, a charcoal-free, pod-based shisha device, which, according to AIR Global, provides a cleaner alternative.

    OOKA currently delivers approximately 30 percent of AIR Global’s revenue in the United Arab Emirates region.

    The lab will boast newly designed laboratories and deliver purpose-built workshops; new products are in early phases of testing and intended for launch in 2025.

    “I have always drawn personal inspiration in my career from the power of technology—to create entirely new industries, disrupt existing sectors and develop products that no one else has thought of,” said AIR Global Chief Product Officer Paul Dawson.

    “And it’s this exact mindset and ethos that we will achieve through the RDD Lab. With an aspirational team from around the world and cutting-edge technology at our fingertips, we’ll be creating new prototypes and combining them with our existing range of products to fundamentally change how people experience shisha. It’s an exciting time to be part of such a talented team that will drive forward innovation.”

    The RDD Lab will employ 26 people and 19 different nationalities, with equal numbers of men and women in its workforce.

    “The business is embarking on the next phase in its growth journey at an incredibly exciting time, where consumers are showing appetite for more eco-conscious, reduced-risk shisha experiences. The RDD lab will not only create new products that put sustainability, science and technology at the forefront but enable us to break ground into new global regions,” said Chief Legal and Corporate Officer Ronan Barry.

    “The recent launch of OOKA in Germany, a significant shisha market, was a milestone moment for us as we aspire to bring new inhalation experiences to a European market. The launch of this lab gives us even more momentum to build on as we expand our product range and presence globally.”

  • Asia Pacific Urged to Permit Oral Nicotine

    Asia Pacific Urged to Permit Oral Nicotine

    Photo: Tobacco Reporter archive

    The Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) is urging governments across the Asia Pacific region to follow New Zealand’s lead and allow the sale of oral nicotine products as part of a comprehensive tobacco harm reduction strategy.

    New Zealand’s government recently agreed in principle to permit the sale of reduced-harm smokeless tobacco and oral nicotine products, such as Swedish snus and nicotine pouches. This progressive policy aligns with mounting evidence that these products can play a crucial role in reducing smoking rates and improving public health outcomes.

    “New Zealand’s approach demonstrates how embracing tobacco harm reduction can accelerate progress towards smoke-free goals,” said Nancy Loucas, executive coordinator of CAPHRA. “Their smoking rates have plummeted to historic lows, proving that pragmatic policies focused on harm reduction work.

    “Recent data from New Zealand shows daily smoking rates have dropped to just 6.8 percent, down from 16.4 percent in 2011/2012. This remarkable decline coincides with the country’s adoption of progressive vaping regulations and openness to other reduced-risk nicotine products.”

     According to Loucas, scientific evidence increasingly supports the harm reduction potential of oral nicotine products. She cited a study published in the Harm Reduction Journal, which found that snus use in Sweden has led to “substantially lower rates of smoking-related disease” compared to other European countries. Loucas also referenced research from the U.K.’s Royal College of Physicians, which concluded that nicotine products are “unlikely to exceed 5% of the harm from smoking tobacco.”

    “Asia Pacific nations have an opportunity to dramatically improve public health by allowing and properly regulating these products,” Loucas said. “Continuing to ban safer alternatives while deadly cigarettes remain widely available is counterproductive and harmful to public health.

    “CAPHRA emphasizes that regulations should ensure product quality and safety while making these alternatives accessible to adult smokers looking to quit. The organization calls for a balanced approach that protects youth while helping millions of current smokers transition away from combustible tobacco.  

    “We urge policymakers across the region to objectively review the evidence and engage with consumers and experts in tobacco harm reduction,” said Loucas. “It’s time to move beyond outdated ‘quit or die’ approaches and embrace the full range of tools available to end the smoking epidemic.”

  • PMI to Expand Zyn Production

    PMI to Expand Zyn Production

    Photo: PMI

    Philip Morris International will invest $600 million in in a factory in Aurora, Colorado, USA, to help meet U.S. consumers’ ferocious appetite for the company’s Zyn nicotine pouches. The factory is poised to begin operations by the end of next year with regular production starting in 2026.

    “PMI and its U.S. affiliates are accelerating their mission to move adults who smoke away from cigarettes in the U.S. by investing in new U.S. manufacturing capacity to meet the increasing demand for nicotine options that are scientifically substantiated as better alternatives,” said PMI Americas President and U.S. CEO Stacey Kennedy in a statement.

    “We believe Colorado is likeminded in its commitment to innovation, economic opportunity and public health, and we’re eager to work with the state and its talented workforce as we expand our U.S. manufacturing presence.”

    Sales of Zyn jumped 80 percent in the first quarter, leaving PMI struggling to keep up with demand. Retail stores have been experiencing Zyn shortages, with some even limiting the number of cans customers can buy each month.

    Supply was further constrained after the company decided to halt online sales nationwide in June following a subpoena in the District of Columbia asking for information on the sale of flavored pouch products that are banned there.

    PMI is also increasing production of Zyn at its factory in Owensboro, Kentucky. In addition to meeting U.S. demand, the investments will also help create capacity for exports, according to PMI.

    Zyn accounted for more than 70 percent of the $8.6 billion nicotine pouch market in 2023, according to Vaping360. Given the relatively young age of the category, there is little brand loyalty, and analysts believe continued supply constraints may prompt some consumers to defect to other brands.

  • Surprisingly Low Adult Pouch Use: Study

    Surprisingly Low Adult Pouch Use: Study

    Despite a 641 percent increase in sales of nicotine pouches between 2019 and 2022, few U.S. adults use modern oral products, according to a nationally representative study conducted by the Keck School of Medicine of the University of Southern California (USC) and the University of Nebraska Medical Center.

    “The low prevalence of nicotine pouch use in adults surprised us, given the rapid increase in sales,” said study co-author Adam Matthew Leventhal, a professor in the Department of Population and Public Health Sciences at the Keck School of Medicine and executive director of the USC Institute for addiction science, in a statement. “But it’s also possible that the sales are being diverted to adolescents, who were not represented in this survey.”

    The researchers surveyed nicotine pouch use in a nationally representative sample of 39,557 U.S. adults. They found that 2.9 percent of adults had ever used nicotine pouches, with 0.4 percent reporting current use. The majority of adults currently using pouches also currently smoke cigarettes. Additionally, 5.2 percent of those who attempted to quit smoking in the past year and had relapsed back to smoking reported using pouches to help with their cessation efforts.

    One question raised by the findings is whether adults who use nicotine pouches may be using them to “top off” nicotine in situations where they cannot smoke or use other tobacco products, Leventhal said, rather than as a way to quit smoking.

    Based on the study results, Leventhal estimates that of all U.S. adults who currently used nicotine pouches in 2022, about 35 percent had previously smoked cigarettes and 25 percent were currently smoking cigarettes. The remaining 40 percent of adult pouch consumers had never regularly smoked cigarettes and could be at risk for developing nicotine dependence.

    “In summary, we didn’t see a large population of adults using nicotine pouches, and fewer appear to be using them in a fashion that would potentially reduce their harm from smoking cigarettes,” Leventhal said.

  • Swedish Match Presents to FDA on General Snus

    Swedish Match Presents to FDA on General Snus

    Image: Tobacco Reporter archive

    Experts from Swedish Match USA, an affiliate of Philip Morris International, presented to the Tobacco Products Scientific Advisory Committee on June 26, 2024, according to a PMI press release. The committee, comprising independent scientific researchers, provides regulatory guidance to the U.S. Food and Drug Administration’s Center for Tobacco Products.

    The half-day meeting was part of the FDA’s review of Swedish Match’s request to continue marketing General Snus products in the U.S. as modified-risk tobacco products (MRTPs) and to expand permitted use of the reduced-risk claim to reach, and transition, more legal-age smokers away from cigarettes.

    Initially granted by the FDA in October 2019, Swedish Match can communicate to legal-age consumers that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” Currently, that message is accessible only on the General Snus website.

    Swedish Match presented to the committee real-world evidence showing the claim is delivering on its promise to reduce harm to individual tobacco users and benefit the health of the population and should be renewed.

    In its renewal submission, Swedish Match is seeking to expand use to additional lawful marketing channels, such as point-of-sale display and direct mail to age-verified consumers.

    “As FDA’s Center for Tobacco Products Director Brian King said when unveiling its new five-year strategic plan, this is a critical moment in the history of tobacco product regulation,” Gerry Roerty, general counsel for Swedish Match, said to committee members. The center’s mission is to make smoking-related disease and death a part of America’s past, and “today, together, we can meaningfully advance that goal,” Roerty told committee members.

    During the meeting, representatives from Swedish Match and committee members discussed a range of scientific, technical and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented evidence and research demonstrating low levels of use by unintended populations.

    General Snus is a smokeless tobacco product, traditionally produced in Sweden, that is nonfermented and air cured. The modified-risk products submitted for renewal include eight General Snus varieties that have been made available in the U.S. for more than a decade: General Snus Original (pouch); General Snus Original (loose); General Snus White (pouch); General Snus Mint (pouch); General Snus Wintergreen (pouch); General Snus Mini Mint (pouch); General Snus Classic Blend (pouch); and General Snus Nordic Mint (pouch).

    “We are understandably proud of our commitment to a cigarette-free America, which is achievable much faster if policy is guided by science,” said Stacey Kennedy, president of the Americas region and CEO of PMI’s U.S. business. “America’s 28 million adult smokers have been bombarded with misinformation about smoke-free products, which can cause confusion and prolong the most harmful form of nicotine consumption—smoking. We look forward to continuing dialogue with the FDA as it continues to consider renewal of this modified-risk authorization.”

    The General Snus products were first authorized as “appropriate for the protection of the public health” through the premarket tobacco product application (PMTA) process in 2015 following a PMTA submission earlier that same year.

    Since then, Swedish Match USA has submitted eight annual reports over as many years, the last four of which were combined with MRTP annual reporting.

  • Altria Submits PMTA for ‘On! Plus’ Pouches

    Altria Submits PMTA for ‘On! Plus’ Pouches

    Image: maurice norbert

    Altria Group has submitted premarket tobacco product applications (PMTAs) to the U.S. Food and Drug Administration for its “On! Plus” oral nicotine pouch products. The PMTAs were submitted by Altria’s wholly owned subsidiary Helix Innovations.

    On! Plus is a spit-free, oral tobacco-derived nicotine (TDN) pouch product made from a proprietary “soft-feel” material to provide a more comfortable product experience. The On! Plus pouch is designed for adults who dip and adult dual users (i.e., adults who smoke and dip).

    According to Altria, On! Plus pouches are seamless and larger than the leading U.S. TDN brands. Similar to the currently marketed On! products, On! Plus packaging features a compartment to responsibly dispose of used product. Helix submitted PMTAs for three distinct On! Plus varieties: tobacco, mint and wintergreen. Each variety comes in three different nicotine strength options.

    “Helix’s submission of the On! Plus applications underscores Altria’s commitment to addressing consumers’ evolving preferences through innovation in potentially reduced risk products. We firmly believe that On! Plus is a transformative product that will meaningfully contribute to Helix’s growth in the U.S. market, upon timely FDA authorization,” said Nick MacPhee, managing director and general manager of Helix in a statement.

    “We’ve long believed in the value of a robust marketplace of authorized smoke-free products for adult tobacco consumers. We believe that these PMTAs demonstrate that responsibly marketed On! Plus pouches can provide a compelling alternative in the marketplace,” said Paige Magness, senior vice president of regulatory affairs, Altria Client Services.

    Upon authorization, Altria expects the products to be distributed by Altria Group Distribution Co.

    Helix currently sells On! nicotine pouches in the U.S. In the first quarter of 2024, On! shipment volume grew 32 percent versus the prior year and the brand achieved a 7.1 percent retail share of the total U.S. oral tobacco category.

    Altria entered the U.S. oral nicotine products market in 2019 after signing a deal with Burger Söhne to acquire an 80 percent ownership stake in some companies that commercialized On! Products, according to The Wall Street Journal. In December 2020 and April 2021, Altria subsidiaries concluded transactions to buy the remaining 20 percent stake of the global on! business for about $250 million.

    Altria’s PMTA announcement comes after Philip Morris International’s Swedish Match North America unit suspended nationwide sales on its U.S. website as local officials in Washington, D.C., investigate whether the company is in compliance with the district’s ban on the sale of flavored products.