Tag: Modern Oral

  • Prague to Regulate Pouches Like Tobacco

    Prague to Regulate Pouches Like Tobacco

    Photo: Andrii

    The Czech Ministry of Health is preparing rules that would treat nicotine pouches as tobacco products, according to a Radio Prague international report.

    Nicotine pouches are currently unregulated in the Czech Republic. “We are aware of the problems this causes,” said Ministry of Health spokesman Ondřej Jakob. “We are working on a decree that would determine the properties, the labelling and the regulation of the product. We are also working on an amendment to the current legislation.”

    According to Jakob, the new decree could come into force within a few months.

    Health activists have expressed concern about the growing popularity of nicotine pouches, especially among young people, in the Czech Republic. According to Marek Lžičař, an addictologist at St. Anne’s University Hospital in Brno, children can develop an addiction in just a few weeks. 

    “The risk of addiction is huge for anyone, both for children and adults, and it shouldn’t be downplayed,” he said. “It is definitely risky behavior that could be a gateway to the use of other tobacco products. It could also lead to the use of softer or harder drugs.” 

    Experts attribute the growing use of addictive substances among children to the long social isolation caused by the Covid-19 pandemic.

  • Streamline Launches ‘Fruit-Forward’ Pouches

    Streamline Launches ‘Fruit-Forward’ Pouches

    Photo: The Streamline Group

    The Streamline Group has launched Juice Head pouches, the latest addition to its line of premium, fruit-flavored nicotine products.

    Featured in 6 mg and 12 mg tobacco-free nicotine strengths, Juice Head pouches are available in five premium, fruit first, mint second flavors: blueberry lemon mint, watermelon strawberry mint, mango strawberry mint, peach pineapple mint and raspberry lemonade mint.

    Juice Head pouches are thin, white pouches that are made with Zero Tobacco Nicotine—a trademarked synthetic nicotine brand—and are available in 20-pouch cans and 5-can sleeves.

    Compared to other nicotine pouches currently on the market, which are mainly offered in a variety of mint or mint with light fruit flavors, Juice Head pouches offer adult users a unique “fruit first, mint second,” rich flavor experience that’s on par with the brand’s world-renowned e-liquid flavors, according to the company.

    “As the needs of our customers continue to evolve, we are proud to introduce a new product that’s unlike any other currently on the market and offers discreet, convenient, smoke-free, and tobacco-free nicotine satisfaction for adults around the world,” said Patrick Mulcahy, CEO and co-founder of the Streamline Group, in a statement.

    “With the launch of Juice Head pouches, we plan to not only expand our product offering for our existing global customer base but to also introduce the Juice Head brand to an entirely new demographic of consumers, retailers and distributors that we had previously been unable to reach.

    Juice Head is manufactured and distributed by Streamline Group, which is based out of Huntington Beach, California, USA.

  • Cerulean Debuts Snus Test Station

    Cerulean Debuts Snus Test Station

    Photo: Cerulean

    Cerulean has launched Orion, the world’s first automated test station for snus.

    The Orion can handle oral pouches of all commercially available size formats, including mini, large, maxi and slim.

    The instrument measures pouch weight, length, width, end seam width, longitudinal seam overlap width and pouch tensile strength. According to Cerulean, the Orion requires only a few minutes to configure and perform the test. The instrument is equipped with an intuitive user interface that provides key information, graphical representation of process capability and stores the data in a network accessible SQL database. A powerful vision system takes images of both sides of every pouch that are used to measure the pouch dimensions, seams width and longitudinal seam position.

    The Orion test station reduces the number of operators per line and provides fast, consistent and repeatable users’ independent testing process with real time visualization of the test results, configurable report generators and readily available connectivity to LIMS and MES systems.

    According to Cerulean, the Orion saves operator time and improves quality through independent, fast, consistent and repeatable testing of pouches. With a real time visualization of test results and configurable report generation, the Cerulean test station guarantees that the production process is always in control.

  • Maneson to Lead Sales at Lucy Modern Oral

    Maneson to Lead Sales at Lucy Modern Oral

    Photo: Jakub Jirsák | Dreamstime.com

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

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

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

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

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

  • Lexaria Demonstrates Rapid Nicotine Delivery

    Lexaria Demonstrates Rapid Nicotine Delivery

    Image: Zerbor

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

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

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

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

  • New Nicotine Pouch Hits Market

    New Nicotine Pouch Hits Market

    Photo: V&YOU

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

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

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

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

  • Kaival Restarts Pouch Production

    Kaival Restarts Pouch Production

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

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

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

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

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

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

  • BAT: Modern Oral Comparable to NRT

    BAT: Modern Oral Comparable to NRT

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

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

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

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

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

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

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

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

  • Out of the Bag

    Out of the Bag

    Photo: RAI

    Regulators are trying to catch up with the rapid growth of nicotine pouches.

    By Stefanie Rossel

    It’s a niche within a niche, but it’s growing quickly. An analysis published by 360marketupdates values the global market for nicotine pouches at $619.9 million and projects it to reach $12.97 billion by 2026. This translates into a whopping compound annual growth rate of 53.8 percent.

    The novel products have been rapidly adopted throughout Scandinavia and central and eastern Europe, according to Research and Markets. Nicotine pouches are the younger and “cleaner” siblings of Swedish snus, a pasteurized oral tobacco that has been around for some 200 years. Both products are discrete; consumers place them between their upper lip and gum where the nicotine and taste are then released. Snus and nicotine pouches are spit-free. After use, the pouch is disposed of in household trash.

    Unlike snus, however, nicotine pouches don’t contain tobacco; they are white, pre-portioned bags composed of nicotine applied to a carrier material, such as food-grade fillers. They come in a variety of nicotine strengths and flavors, including mint, coffee and fruit. There are even nicotine-free variants. Like snus, nicotine pouches offer considerable potential for tobacco harm reduction because consumption does not involve combustion. 

    With 9 percent of men and 11 percent of women using cigarettes in 2018, Sweden has by far the lowest smoking rate in the European Union (EU). This enviable situation is widely attributed to the popularity of snus in that country. Decades of scientific research have confirmed the product’s efficiency as a smoking-cessation tool. A study published in the Harm Reduction Journal in November 2019 called snus “a compelling harm reduction alternative to cigarettes.” Using snus is estimated to be between 90 percent and 95 percent safer than smoking cigarettes, which puts the product on par with e-cigarettes on the continuum of risk scale.

    Nevertheless, snus sales have been prohibited throughout the EU since 1992. (When Sweden became part of the EU in 1995, it negotiated an exemption from the ban.) Switzerland, a non-EU member, lifted its ban on snus last year. Following two unsuccessful legal challenges, the EU ban was again endorsed by the European Court of Justice in 2018.

    In recent years, international tobacco companies have started including snus in their portfolios either by purchasing existing players or by developing their own products. And then they started developing the nicotine pouch. By now, all leading global tobacco firms are represented in the category, and nicotine pouches have been eating into the share of traditional snus. In the first quarter of 2020, nicotine pouches accounted for 6.7 percent of Sweden’s snus market, up from 3.2 percent in 2019, according to Swedish Match. In Norway, a non-EU member with a snus tradition, pouches today account for 25.8 percent of the snus market, up from 15.3 percent in 2018.

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    All present

    Competition in the pouch segment has heated up significantly, and manufacturers are increasing production capacity for their “modern oral” products.

    It all started with the introduction of Zyn by Swedish Match, the world’s largest producer of snus in Sweden and a significant player in the U.S. market for smokeless products. In the first quarter of 2020, Zyn was sold in 13 countries outside of the U.S. and Scandinavia, including many EU member states, such as Austria, Croatia, Denmark, Germany, the U.K. and the Czech Republic.

    Growth of Zyn has been so strong that Swedish Match CEO Lars Dahlgren spoke of a “transformational year” for the company, saying that the product had been the key driver of the company’s U.S. smoke-free sales in 2019. In the first quarter of 2020, Swedish Match sold almost 70 million cans of Zyn in the U.S., up from roughly 18 million cans in the same period a year earlier. Swedish Match also filed a premarket tobacco product application (PMTA) with the U.S. Food and Drug Administration (FDA).

    Demand for Zyn has been so strong that Swedish Match announced expansions of its U.S. production facility twice in short succession. Scheduled for completion in 2020, the fourth phase of expansion will increase capacity to more than 200 million cans per year.

    Swedish Match’s competitors have not been idle. By acquiring an 80 percent stake in the global business of Burger Soehne, Altria in June 2019 became the owner of the On! nicotine pouch brand. Altria will provide global distribution for On!, which currently is available at retail outlets in the U.S., Canada, Sweden and Japan as well as globally through the company’s online shop. On! comes in seven flavors, including coffee, berry and citrus, and five different nicotine strengths. In May 2020, Altria submitted a PMTA for 35 On! products to the FDA.

    British American Tobacco (BAT) is represented in the nicotine pouch market through its Lyft brand, which it sells in the U.K., Sweden and Kenya. Going forward, BAT plans to market all its modern oral products under the name Velo—the brand under which BAT subsidiary Reynolds American Inc. (RAI) has been marketing its nicotine pouch product in the U.S. since June 2019.

    To cater to the anticipated increase in demand, BAT in September 2020 built a nicotine pouch factory in Hungary. The investment, estimated at more than HUF7.5 billion ($24.3 million), the investment aims to boost production to more than 1 billion nicotine pouches in 2020, a figure that is expected to triple next year. Initially equipped with one line for the manufacture of nicotine pouches, the factory is supposed to receive a further five production lines by the end of this year. Its output is destined mainly for European markets, including Germany, Austria and the Nordic countries. The Hungarian factory is supposed to become one of BAT’s global hubs for the manufacturing of oral products.

    In June last year, Japan Tobacco International (JTI) entered the race with Nordic Spirit, nicotine pouches that were developed in Sweden and sold in Switzerland and Sweden and online. Upon the launch, the company had said it intends to significantly increase distribution across various trade channels in the near term. Nordic Spirit is currently available in four flavors, including mint and bergamot wild berry.

    Imperial Brands is present in the modern oral nicotine market with Zone X, Killa, BLCK and Pablo, among other products. With a high nicotine content of 50 mg per gram, Pablo is the “strongest” nicotine pouch in the market. Usually, nicotine content in the novel products vary between 2 mg and 24 mg per gram.

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    Product regulation

    In the U.S., tobacco-free nicotine pouches are required to carry the warning “This product contains nicotine. Nicotine is an addictive chemical,” and may be sold only to consumers over 21 years of age. Entry barriers are low compared to those for other tobacco products, but the product is subject to FDA regulation all the same. By contrast, the market for nicotine pouches in the EU currently operates in a regulatory vacuum. Containing no tobacco, the products are not covered by the EU Tobacco Product Directive (TPD2) nor do they belong to any other regulated product category. Unlike tobacco products, they may be advertised on television, radio and billboards throughout the common market.

    Christofer Fjellner, who served as a member of the European Parliament from 2004 to 2019, expects new regulation to be adopted in all important markets in the coming years. In a report published in April 2020, he writes that Sweden and Norway will likely be the first countries to enact regulations for nicotine pouches—a development that could also influence how other European governments will shape legislation. For the time being, Sweden has decided that nicotine pouches are not a food product thereby indirectly approving the product to be placed on the market.

    The country has started defining and categorizing nicotine pouches; its government has tasked a special commissioner with proposing new regulation. Meanwhile, Austria’s chemical authority is referring to the EU’s classification, labeling and packaging regulation, demanding that all nicotine-laced product carry health warning texts and symbols.

    The World Health Organization has yet to take up the topic of nicotine pouches, according to Fjellner. He expects to receive an indication of how the European Commission views nicotine pouches in the implementation report for TPD3, scheduled for May 2021.

    “How the EU chooses to regulate nicotine pouches is influenced by at least three factors,” he says. “Whether EU member states call on the EU to ban nicotine pouches, due to concern about the use of the product in member states—which was the reason for EU ban on snus—whether there are already specific product regulations or national bans in individual member states that new European legislation may be in conflict with, and the number of users of nicotine pouches, and thus a public opinion critical to a new restrictive legislation or ban.”

    The latter, he adds, was one of the reasons e-cigarettes were not banned in the 2014 TPD revision. The way the EU regulated e-cigarettes in 2014, Fjellner says, could be an indicator of how it will likely deal with nicotine pouches, which would indicate a focus on warning texts and the introduction of a maximum nicotine level. For advocates of tobacco harm reduction, such an approach would be preferable over an outright ban.