Tag: Modern Oral

  • 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.”

  • 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.

  • Finland Aims for Pouch Regulation Like Tobacco

    Finland Aims for Pouch Regulation Like Tobacco

    Photo: ir1ska

    The government of Finland wants to bring nicotine pouches under tobacco laws so that it can more effectively discourage consumption, reports YLE.

    Among other measures, it wants to curb pouch nicotine levels to 20 milligrams per gram of product. In addition, the government wants to prohibit the online sales of nicotine pouches and limit the range of flavors, in an effort to reduce the products’ appeal to young people.

    Under the proposals, retailers selling pouches would need to obtain a license, while importers would face restrictions.

    The stated aim of the proposed legal reform is to prevent health risks and the use of oral nicotine among young people.

    The widespread availability of strong nicotine pouches in Finland has reportedly reduced the smuggling of oral tobacco products from neighboring Sweden.

  • Show Them the Numbers

    Show Them the Numbers

    By Neil McKeganey and Andrea Patton

    To prevent nicotine pouches from being legislated out of the market, manufacturers must demonstrate the extent to which they are benefiting adult smokers, and quantify underage usage.

    By Neil McKeganey and Andrea Patton

    As tobacco companies seek to market lower harm alternatives to combustible cigarettes, there is one issue that is seriously undermining those efforts—youth use of their products. If you were in any doubt as to the scale of the threat that youth use of tobacco products represents for manufacturers, think Juul, Puff Bar, Elf Bar and disposable e-cigarettes in general. And now, critics of the tobacco industry have a new product in their sight. Fresh from their success in calling for the banning of disposable e-cigarettes, they are shifting attention to nicotine pouches with an increasingly familiar playbook of media alarm, political pronouncements and regulatory action.

    The widest-selling nicotine pouch product in the U.S. is Philip Morris International’s Zyn, which grew in sales from 126 million units in 2019 to 808 million units by March 2022 (Majmundar et al. 2022). Accounting for 58 percent of the U.S. nicotine pouch market, Zyn has become a key part of PMI’s next-generation nicotine product range. It is also a product that has not had to work hard to find its critics.

    Zyn is “a pouch packed with problems,” according to Senator Chuck Schumer. “These nicotine pouches seem to lock their sights on young kids—teenagers, and even lower—and then use the social media to hook them,” the senator said. Alongside Schumer’s dire warnings of a future in which young Americans are increasingly dependent on oral nicotine products, there has been a torrent of media articles casting Zyn as a major new threat to U.S. youth. In a New York Times article published at the start of the year, Emily Dreyfuss opened parents’ eyes to a world of “Zynfluencers”—social media personalities assiduously promoting oral nicotine products such as Zyn to their followers. Dreyfuss has called for age-gated advertising restrictions to limit young peoples’ exposure to “Zynfluencer” activities.

    In contrast to the often hysterical tone of the media reporting on underage use of nicotine pouches, the National Youth Tobacco Survey (NYTS) estimated that in 2023, 1.5 percent of U.S. middle school and high school students had used oral nicotine pouches in the past 30 days. Likewise, the 2023 Tobacco Product Prevalence Study (TPPS) undertaken by the Centre for Substance Use Research (CSUR) in Scotland estimated that 1.7 percent of 13-year-olds to 20-year-olds in the U.S. had used a nicotine pouch in the past 30 days.

    While the NYTS data relates to the category of oral nicotine pouch use, rather than Zyn in particular, the TPPS also quantifies the prevalence of underage use of Zyn and other tobacco products and devices, with 0.5 percent of 13-year-olds to 20-year-olds in the U.S. reporting past-30-day use of Zyn. Neither the NYTS nor the TPPS are detecting epidemic levels of oral nicotine pouch use among young people in the U.S. TPPS estimates show further that Zyn use is infrequent, with 70.8 percent of underage past-30-day pouch users reporting use on between one day and five days of the past 30 days.

    If most U.S. Zyn sales, and subsequent use, are among those aged over 21, the possibility exists that these products may be helping adult smokers to switch from combustible to noncombustible tobacco products. Despite this, the U.S. Truth Initiative has called for a nationwide ban of Zyn.  

    In the face of such calls, it will be inadequate for the industry to stress that these products are intended solely for adult smokers as an alternative to combustibles. The problem facing PMI and other oral nicotine product manufacturers is how to respond to claims of widespread use of their products by young people.

    There are two things that companies must do if they are to stand any chance of keeping their products on the market. The first is to show the extent to which these products are benefiting adults who smoke. The data required here involves showing the impact of an oral nicotine product such as Zyn on an adult smoker’s ability to completely switch away from smoking or to substantially reduce their use of combustible cigarettes over a six-month to 12-month period.

    Secondly, companies must quantify the extent to which their oral nicotine products are indeed being used by those below age 21. The CSUR’s Tobacco Product Prevalence Study is the only national probability-based study that collects data on a range of individual tobacco products among both adults and youth within the U.S. and provides timely estimates of use. As such, it can help manufacturers present important data to regulators on the actual extent of youth use of their products.

    Unless the industry assembles the evidence with which to respond to political and media commentators’ calls to ban oral nicotine products, these companies are going to face an increasingly difficult future. The calls to ban oral nicotine products, in the absence of data showing how widely specific products and devices are being used by youth, provides an indication of just how influential a coordinated campaign against a specific product or category of products can be. It is ironic that many of those calling for such bans, no doubt motivated by a commitment to public health, find themselves advocating for legislation that will narrow rather than expand the routes out of smoking.

  • PMI Sued Over Zyn

    PMI Sued Over Zyn

    Photo: PMI

    In the first major legal challenge to oral nicotine pouches, a consumer has sued Philip Morris International over its popular Zyn brand, saying the product is addictive and harmful to young people, reports BNN Bloomberg.

    The plaintiff, Bailey Wolters, alleges addiction and dental issues as a result of his Zyn use. The lawsuit says that the pouches deliver more nicotine than cigarettes, and that PMI benefits from “Zynfluencers” who promote the brand on social media.

    The suit, which is seeking class-action status, also names as a defendant Swedish Match, which made the pouches before PMI bought it for $16 billion in 2022.

    According to the plaintiff, the companies failed to warn consumers about the risk of addiction and other harmful effects like cognitive issues, cardiovascular injuries, gastrointestinal problems and gum disease.

    PMI insists its pouches are intended only for existing users of nicotine products.

    The case was brought by Schlesinger Law Offices, whose initial lawsuit against Juul Labs investors including Altria Group expanded into thousands of legal actions and led to Altria’s eventual settlement of $235 million.

  • Health Groups Urge Pouch Prescriptions

    Health Groups Urge Pouch Prescriptions

    Photo: DW labs

    Leading health organizations are urging Canadian lawmakers to crack down on flavored nicotine products and make nicotine pouches available upon prescription only.

    In a full-page ad in The Hill Times, Action on Smoking and Health, the Canadian Cancer Society, the Canadian Lung Association, the Quebec Coalition for Tobacco Control, Heart and Stroke, and Physicians for a Smoke-Free Canada assert that flavors play a key role in attracting kids to nicotine products and call on the federal government to ban flavors, including mint and menthol, in e-cigarettes.

    The ad also calls for action to protect minors against the sale and promotion of nicotine pouches by making them a prescription-only product. Under the current federal rules, nicotine pouches authorized under the Natural Health Products Regulation can be legally sold to minors in convenience stores and promoted on television, billboards and social media, including by means of lifestyle advertising.

    “Several additional options are available to the health minister, like temporarily suspending the sale of nicotine products, which would also allow federal, provincial and territorial authorities to strengthen relevant laws and regulations. For example, nicotine pouches could be subject to many of [the] same provisions regarding promotion that apply to tobacco and vaping products,” said Cynthia Callard, executive director of Physicians for a Smoke-Free Canada, in a statement.

    The ad is in part a response to the success of Imperial Tobacco Canada’s Zonnic pouches, which Health Canada approved for sale in 2023. The health groups rebuffed the company’s insistence that its pouches are intended for adult smokers who want to quit. “Unlike other manufacturers of nicotine-replacement therapies, this company deliberately chose to distribute its product through convenience stores and promote them with lifestyle messaging and images of young adults,” said Flory Doucas, co-director and spokesperson of the Quebec Coalition for Tobacco Control.