Tag: Modern Oral

  • 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.

  • 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.

  • Pouches Scrutinized

    Pouches Scrutinized

    Photo: ir1ska

    Scientists at Georgetown University’s Lombardi Comprehensive Cancer Center have synthesized evidence from 62 studies related to the use of oral nicotine pouches to better understand their potential impact on public health. The findings have been published in Nicotine and Tobacco Research.

    Oral nicotine pouches are rapidly increasing in popularity. While they may present a less harmful nicotine alternative for cigarette users, there is considerable concern about them becoming a new form of nicotine dependence, especially in youth who don’t use tobacco or nicotine,” said the study’s corresponding author, Nargiz Travis, in a statement.

    The investigator’s analysis was based on 45 academic and 17 industry-funded studies, mostly from the U.S. Sales of the products have been concentrated in Scandinavia and the U.S., mainly because of the established smokeless tobacco market in these regions.

    In the U.S., the researchers found, based on nationally representative surveys, that through 2023, oral nicotine pouches were currently used by 1.5 percent of all youth while lifetime use by young people was under 2.5 percent.

    In terms of awareness of the products, between 35 percent and 42 percent of U.S. adolescents and young adults have heard of oral nicotine pouches, and 9 percent to 21 percent of tobacco-naive (nontobacco users) youth surveyed were not opposed to trying them. U.S. adult usage estimates varied widely across surveys; in 2023, 0.8 percent to 3 percent of Americans currently used the products while 3 percent to 16 percent used them at some point in time. In view of rising nicotine pouch sales trends in 2024, their use in the U.S. population has likely increased.

    Because oral nicotine pouches do not contain tobacco leaves, they are often marketed as tobacco-free, but we found that descriptor may confuse the understanding of the source of nicotine and may be associated with the perception that they are not as harmful as other tobacco products.

    Nargiz Travis, project director for the Center for the Assessment of Tobacco Regulations at Georgetown Lombardi

    The investigators’ findings suggest fewer harmful chemical compounds are present in the pouches and occur at lower levels than in cigarettes and smokeless tobacco, with the exception of formaldehyde. However, an analysis of 37 oral nicotine pouches of different brands, nicotine strengths and flavors yielded a wide range of total nicotine content from 0.89 mg to 6.73 mg per pouch.

    “Because oral nicotine pouches do not contain tobacco leaves, they are often marketed as tobacco-free, but we found that descriptor may confuse the understanding of the source of nicotine and may be associated with the perception that they are not as harmful as other tobacco products,” says Travis.

    “In the U.S., oral nicotine pouches are currently neither authorized by the FDA for marketing as a modified-risk product nor approved as a cessation product. It is important to know that nicotine is an addictive chemical with harmful health effects, regardless of whether it is synthetic, meaning tobacco-free, or derived from tobacco.

    One of the studies included in the authors’ analysis was a U.S. survey of young adults 18 years to 34 years of age, many of whom used cigarettes and e-cigarettes. The survey found that among those who had tried nicotine pouches, curiosity about the product (28 percent), flavors (26 percent) and the ability to use in places where other tobacco products are prohibited (26 percent) were among the main reasons for trying the pouches. The availability of flavors (31 percent) was the main motive for use in another U.S. sample of adult current nicotine pouch users.

    Leading brands of the products are currently owned by major tobacco companies. The authors note that a substantial investment in marketing by the companies suggests that oral nicotine pouches are becoming increasingly important to the tobacco industry.

    “As more evidence on oral nicotine patches becomes available, and more importantly, more independent studies become published, it will be essential to conduct further analyses comparing the findings of industry versus non-industry sponsored research and critically assess the quality and risk of bias of such studies,” said Travis.

  • Health Canada Recalls Zyn Pouches

    Health Canada Recalls Zyn Pouches

    Image: Swedish Match/ HstrongART

    Health Canada recalled eight types of Zyn nicotine pouches on June 12, saying they were sold without market authorization, reports Global News.

    They affected variants are flavored apple mint, bellini, black cherry, citrus, cool mint, espresso, original and spearmint. The pouches had 1.5 or three milligrams of nicotine in them.

    Philip Morris International, which manufactures Zyn products, said it does not sell in Canada and applauds Health Canada for taking action.

    “The products at issue are being sold by unauthorized parties,” a spokesperson for PMI’s Rothmans Benson & Hedges affiliate was quoted as saying by the Global News.

    “RBH works with law enforcement to stop illicit trade and we are supportive of government efforts on this front.”

    Health Canada has approved only one nicotine pouch for sale—Imperial Tobacco Canada’s Zonnic brand.  

    The introduction of nicotine pouches in Canada has run into opposition from health activists.

    Experts say these products are appealing to children, who face the risk of becoming addicted to nicotine.

    In March, Health Minister Mark Holland said that he was “seeking authority” to restrict such products “so they are solely for the purposes of cessation.”

     

  • FDA Accepts Application for CLEW Pouches

    FDA Accepts Application for CLEW Pouches

    Image: Nevcore Innovations

    The U.S. Food and Drug Administration has accepted a premarket tobacco product application for Nevcore Innovations’ CLEW modern oral nicotine pouches.

    According to the manufacturer, CLEW pouches are manufactured in state-of-the-art cGMP- and HAACP-certified facilities that comply with strict quality protocols and ensure products meet the highest safety standards.

    “At the core of CLEW lies our unwavering commitment to delivering an unparalleled experience, by blending cutting-edge technology with the finest ingredients,” said Nevcore Innovations’ founder and chairman, Nutesh Singla, in a statement.

    “Crafted with precision and passion, CLEW nicotine pouches are formulated at the top laboratories in the USA and contain pharmaceutical-grade nicotine and carefully selected flavorings, ensuring a gratifying sensation with every use.”

    “CLEW nicotine pouches herald a new era in nicotine indulgence, and we are confident they will set the new global benchmark for white nicotine pouches the world over,” said Nevcore Innovations’ global CEO, Waqas Khan.

    “We have listened to the needs and desires of consumers and have developed a product that not only meets but exceeds their expectations and are confident that they will play a significant role in global harm reduction efforts. With CLEW, we are reimagining what it means to enjoy nicotine, providing a solution that is both convenient and satisfying.”

    CLEW nicotine pouches will be available in flavors such as mint, fruit and tobacco, and in strengths of 3 mg, 5 mg, 6 mg, 9 mg, 10 mg, 12 mg, 15 mg and 20 mg.

  • Controlled Kick

    Controlled Kick

    TJP Lab’s oral nicotine factory in Pickering, Ontario, features high-speed pouch filling equipment and sophisticated technology to ensure consumer safety and product efficacy.

    TJP Labs’ novel nicotine particulate significantly speeds up nicotine delivery.

    By Stefanie Rossel

    David Richmond-Peck | Photos: TJP Labs

    More than two decades after the debut of the first commercial e-cigarettes, delivering consumers the right degree of nicotine—the “perfect kick”—remains a challenge for manufacturers of reduced-risk products.

    To solve this issue, Canada-based TJP Labs has developed a novel nicotine particulate, for which it filed for patent protection in April 2024. The new technology dramatically increases the speed of nicotine release compared to polacrilex, a resin complex commonly used in nicotine-replacement therapy (NRT) products, and other forms of nicotine that presently exist in recreational products, according to David Richmond-Peck, chief relationship officer at TJP Labs.

    “Our technology allows for control and extreme flexibility in terms of the finished product’s nicotine release profile,” he says. “It is quite versatile and can be used with different forms of nicotine—whether it’s tobacco-derived, synthetic, a prodrug or an analog. This inclusivity helps with its applicability across a wide range of products. Quite notably, the development can aid in addressing concerns with tobacco-specific nitrosamines, which are minimal or absent, especially in synthetic forms. Further, our innovative development has the potential to provide an enhanced consumer experience by providing a faster and more efficient nicotine release, aiming to provide a more satisfying and potentially safer alternative.”

    According to TJP Labs, the nicotine particulate offers versatile particulate size customization, ranging from ultra-fine to several hundred microns, for precise product design as well as precision-targeted binding. “When utilized in combination with other features, our technology allows us specific customization capability to tailor products for faster or more controlled release, addressing various consumer needs and improving efficacy. Such control can lead to cost-effective production and better overall product performance, enhancing the success rates of smoking cessation efforts or providing more enjoyable recreational options.”

    The product can also be used with a broad spectrum of core materials, including porous or nonporous, biodegradable and various organic compounds, notes Richmond-Peck. This enhances the company’s ability to innovate and tailor nicotine-delivery products. “This versatility means products can be designed to mimic the nicotine uptake of combustible tobacco more closely, potentially improving their effectiveness as smoking cessation aids or recreational alternatives,” he says. “The flexibility in core material choice allows for innovations that can help to meet diverse consumer preferences and regulatory requirements.”

    The particulate can be utilized in both NRT products and recreational nicotine products. “This includes applications in gums, patches and lozenges, especially in modern oral nicotine pouches, where controlled nicotine release is crucial,” says Richmond-Peck. “Our technology is designed to enhance both the efficacy and consumer satisfaction of these products, making them viable alternatives to traditional smoking products.”

    Pouches with Potential

    Other advantages include efficient raw material use, allowing for nicotine loading several orders of magnitude over polacrilex, and optimization for organic and inorganic forms, including biodegradable resins, according to TJP Labs. The technology is designed for seamless integration, enabling easy incorporation into nicotine pouch formats and related products.

    A wholly owned subsidiary of Kik Ass Products, TJP Labs is a full-service, global contract manufacturer of next-generation products, specializing in modern oral buccal delivery pouch manufacturing. It is also a newcomer to the industry. In 2021, it began developing innovative pouched products for energy and nutraceutical uses. In September that year, it opened Canada’s first modern oral nicotine contract manufacturing facility for oral nicotine pouches in Pickering, Ontario. Spread over a rapidly expanding campus, the plant features high-speed pouch filling, in-line photography, check weighers and integrated finished product metal detectors to ensure high standards of consumer safety and product efficacy.

    “We are currently expanding our production capabilities, aiming to achieve an impressive output of over 100 million retail units annually by mid-2025,” says Richmond-Peck. “As market dynamics evolve, we plan to double this capacity to 200 million retail units by 2026. Our operations extend beyond manufacturing to include robust research and development efforts, all driven by our commitment to advancing harm reduction.”

    In addition to contract manufacturing for international brands, TJP Labs has also launched its own brand, L!X nicotine pouches, which was first marketed by its subsidiary L!X Innovations. In early 2022, TJP submitted a premarket tobacco product application to the U.S. Food and Drug Administration for L!X nicotine pouches.

    In June 2023, Imperial Brands acquired 14 L!X pouch variants for an initial consideration of £65 million ($81.57 million) and an additional deferred sum based on sales volumes over five years. The deal is meant to enable Imperial’s U.S. operation, ITG Brands, to expand its next-generation product offerings in the United States. Following further consumer testing, ITG Brands launched the range in the U.S. under the brand name Zone in the first quarter of 2024, with TJP Labs continuing to manufacture the pouches under contract.

    “Our primary focus in the nicotine industry has consistently been on harm reduction,” says Richmond-Peck. “Although we started as a manufacturing company, we have broadened our capabilities to include research and development. In 2023, we facilitated Imperial Brands’ entry into the U.S. market by selling them our range of nicotine pouch products and serving as their contract manufacturer. We retained the global rights to our L!X pouches outside the U.S. and are actively seeking market opportunities and partnerships in additional territories. Currently, our development efforts are concentrated on providing consumers with innovative pouched products that incorporate energy and other nutraceutical ingredients.”

    To TJP Labs, modern oral pouches are an innovative delivery system with the potential to deliver various active ingredients, with applications ranging from pharmaceutical to recreational use. “In 2021, we began to develop a separate category of energy products for adult consumers. These products are now market-ready and slated to launch later this year,” says Richmond-Peck.

    For its new nicotine particulate, TJP Labs anticipates to receive initial evaluation data by the end of the second quarter this year. Next steps will involve exploring partnerships or licensing opportunities to leverage the technology effectively for harm reduction, according to Richmond-Peck. “Depending on the product application, regulatory approvals will be necessary, such as certifications from medical agencies for NRT products or FDA approval for recreational nicotine products in the U.S. Our objective will be to sell or license the intellectual property to the party that can most effectively contribute to global harm reduction.”

    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.
  • Icelandic Snuff Sales Hurt By Pouches

    Icelandic Snuff Sales Hurt By Pouches

    Photo: Burtsc

    Rising sales of nicotine pouches are depressing demand for snuff in Iceland, reports Iceland Review, citing comments made by State Alcohol and Tobacco Co. Director Sveinn Víkingur Arnason.

    Iceland began producing snuff in 1941, and consumption peaked in 2019, when 46 tons were produced and sold domestically. Since then, the trend has been steadily downwards, with only 10 tons of snuff tobacco sold in 2023.

    While snuff is intended for nasal use, surveys have shown that it has been used predominantly orally in Iceland, which prohibits the sale and production of chewing tobacco.

    The decline in snuff sales has been driven in part by the growing popularity of nicotine pouches, which at ISK40 ($0.29) per gram are significantly cheaper than snuff. Snuff tobacco sold by the State Alcohol and Tobacco Co. sells for around ISK80 per gram.

    The main reason for this price difference is the fact that nicotine pouches and snuff tobacco fall under different tax schedules.

    Arnason said he expects the downward trend in snuff sales to continue.

  • ITCAN Launches Zonnic Awareness Campaign

    ITCAN Launches Zonnic Awareness Campaign

    Photo: mtsaride

    Imperial Tobacco Canada (ITCAN) launched a public awareness campaign about its Zonnic nicotine pouches. The company says it aims to dispel myths and prove accurate, science-based information about nicotine-replacement therapies (NRT) and Zonnic’s potential role in reducing smoking in Canada.

    “Our new Zonnic campaign fact-checks what’s being said about Zonnic nicotine pouches and reflects our dedication to harm reduction and our commitment to help reduce smoking rates in Canada,” said ITCAN President and CEO Frank Silva in a statement.

    Since Zonnic’s launch in October, anti-tobacco lobby groups and the Federal Minister of Health have targeted ITCAN with accusations and inaccuracies, according to the company.

    “Our intentions are clear; we want to help smokers who want to quit smoking, period,” said Silva. “This starts by distributing new and innovative options and by keeping these products available to adult smokers while ensuring that minors don’t have access to any kind of nicotine products, including NRTs. Our position is that all forms of NRT should require proof of age before purchase and be stored at retail in a way that is inaccessible to minors.

    “We have tried to meet with Minister Holland. Our door is always open, but he has not returned our calls. We are more than open to a fair discussion, based on facts, to keep NRTs accessible to adult smokers while keeping nicotine products out of the hands of youth. Working together, we can achieve your ministry’s goal, a goal that we share.”

  • Patent Filed for Pouch Technology

    Patent Filed for Pouch Technology

    Photo: ir1ska

    TJP Labs has filed for patent protection of a novel nicotine particulate that dramatically increases the speed of nicotine release.

    According to the company, the new technology releases nicotine significantly faster than polacrilex, a resin complex commonly used in nicotine replacement therapy products.

    Other features of the nicotine particulate include:

    • Versatile particulate size customization; from ultra-fine to several hundred microns for precise product design.
    • Precision-targeted binding, which improves nicotine release rate, which enhances effectiveness.
    • Broad spectrum of adaptable core materials, which expands product versatility and application possibilities.
    • Efficient raw material use, allowing for nicotine loading several orders of magnitude over Polacrilex.
    • Eco-friendly and versatile composition. The product is optimized for organic and inorganic forms, including biodegradable resins, enabling diverse, innovative applications.
    • Streamlined manufacturing, which accelerates product development.
    • Seamless integration: The technology is designed for easy incorporation into nicotine pouch formats and related products.

    “This landmark initiative powerfully showcases TJP Labs’ commitment to redefining nicotine consumption through innovation,” said TJP Labs Chief Relationship Officer David Richmond-Peck in a statement. “With other innovations in our pipeline, safeguarding our intellectual property remains integral to our strategy, matching our innovative efforts with consumers’ evolving preferences.”

    TJP Labs anticipates initial evaluation data for these particulates to be available toward the end of the second quarter of 2024

    TJP Labs is a wholly owned subsidiary of KIK ASS Products, a full-service contract manufacturer of next-generation products focusing on modern oral nicotine.

  • Luxembourg to Tax Vapes and Pouches

    Luxembourg to Tax Vapes and Pouches

    Photo: Trevor Parker Photo

    Luxembourg will start taxing e-cigarettes and nicotine pouches in October, reports RTL Today.

    Slated to take effect Oct. 1, the measures are part of a Grand Ducal regulation currently in the process of being drafted. Under this provision, e-liquids will be taxed at €120 ($129.82) per liter while nicotine pouches will incur a tax of €22 per kilo.

    Minister of Health Martine Deprez and Minister of Finance Gilles Roth disclosed this information in response to an inquiry by Member of Parliament Sven Clement of the Pirate Party.

    Luxembourg also plans to start targeting next-generation products through its anti-smoking program. Lawmakers are also mulling price increases for tobacco products, which remain considerably less expensive in Luxembourg than in neighboring countries.