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  • 22nd Century Group Expands VLN Cigarette Sales Across U.S.

    22nd Century Group Expands VLN Cigarette Sales Across U.S.

    22nd Century Group announced a major expansion of its reduced-nicotine VLN cigarette products, with state authorizations now covering up to 41 states. The company’s VLN Gold and Green are currently approved in 41 states, while new products like VLN Red, Smoker Friendly VLN, and Pinnacle VLN are entering 20 or more markets in 2025.

    CEO Larry Firestone said the approvals clear the way for VLN and partner brands to launch in more than 2,000 retail outlets by the second half of 2025.

    “Our products are the only combustible cigarettes that meet the FDA’s reduced-nicotine criteria,” Firestone said. “These commercial launches and our readiness once we receive state approval to scale availability to all 50 states for the entire U.S. cigarette market continues to demonstrate that there need not be any commercial barriers to adopting this FDA policy, which could be the most impactful health decision in a generation.”

    The move comes as the FDA considers a national low-nicotine mandate. VLN cigarettes, which contain 95% less nicotine than conventional brands, are the only combustible products that meet the FDA’s proposed standards.

  • 22nd Century Advances FDA Renewal for VLN

    22nd Century Advances FDA Renewal for VLN

    22nd Century Group, Inc. announced that it is proceeding with the Modified Risk Tobacco Product (MRTP) renewal process for VLN, its flagship line of reduced-nicotine content cigarettes.

    First authorized by the FDA in December 2021, VLN remains the only combustible cigarette with MRTP designation, permitted to market key reduced-harm claims such as “95% less nicotine” and “Helps you smoke less.” The renewal, due in December 2026, comes as the company expands its VLN portfolio through partnerships and patented low-nicotine plant varieties.

    “Our MRTP authorization for VLN cigarettes stands apart as one of the most unique and innovative tools in the tobacco industry, leading the fight in Tobacco Harm Reduction to reduce the health harms of smoking,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “Our VLN cigarette is the only product that meets the FDA’s guideline for low nicotine based on its proposed low-nicotine mandate issued in January 2025.

    “While the FDA’s mandate has not yet become a final ruling, we expect that the FDA will fully support our MRTP renewal for VLN.”

  • 22nd Century Targets Q4 to Have 100mm VLN to FDA

    22nd Century Targets Q4 to Have 100mm VLN to FDA

    22nd Century Group, Inc. announced “Operation 100,” a new initiative to develop a 100mm version of its VLN reduced-nicotine cigarettes, targeting FDA submission by Q4 2025. The product will complement the company’s existing 84mm king-size VLN cigarettes, the only FDA-authorized combustible cigarettes with reduced nicotine content.

    VLN cigarettes contain 95% less nicotine and are designed to help smokers reduce consumption and dependence. CEO Larry Firestone emphasized that offering VLN in familiar formats increases adoption and aligns with smokers’ preferences.

    If approved, the new 100mm VLN products would be sold under both the company’s own brand and partner labels such as Smoker Friendly and Pinnacle, expanding reach to the nearly 50% of U.S. smokers who prefer 100mm cigarettes.

  • 22nd Century Announces Major Pinnacle Brand Expansion

    22nd Century Announces Major Pinnacle Brand Expansion

    22nd Century Group, Inc. expanded its Pinnacle product agreement with a “top-5 convenience store chain,” launching four new SKUs—two of which are low-nicotine VLN cigarettes (Gold and Menthol). These products will be available in 1,700 stores across 27 states, with sales starting late summer to early fall 2025, pending state approvals.

    Additionally, two Pinnacle moist snuff flavors (straight and wintergreen) will roll out in the second half of 2025. 22nd Century will handle manufacturing, distribution, and tax compliance, with VLN products made using their proprietary low-nicotine tobacco. This deal also opens the door for future expansion to other retail and c-store chains.

    “We are very excited to launch our second partner VLN product and branded moist snuff products, leveraging the well-known Pinnacle brand sold at one of the largest convenience store chains in the U.S.,” said Larry Firestone, 22nd Century Group Chief Executive Officer. “Pinnacle’s conventional cigarette and cigarillo products have built a strong sales track record with consumers, owing to extensive marketing and awareness directed by the chain and a compelling value proposition for adult smokers. We believe Pinnacle-branded products in the VLN and moist snuff categories can see similar success with customers at this c-store chain’s more than 1,700 stores.”

  • 22nd Century & Smoker Friendly Expand Partnership

    22nd Century & Smoker Friendly Expand Partnership

    22nd Century Group, Inc. and Smoker Friendly have signed a new five-year agreement to expand their collaboration. The deal includes manufacturing 11 existing Smoker Friendly cigarette brands and launching eight new premium products. These additions aim to strengthen Smoker Friendly’s market position by tapping into the growing demand for natural tobacco products.

    The agreement deepens a decade-long partnership between the two companies and secures a significant production volume for 22nd Century’s North Carolina manufacturing facility. The new premium Smoker Friendly brands are expected to occupy a higher-tier market segment, broadening Smoker Friendly’s customer base and increasing sales opportunities for both companies.

    A key aspect of the partnership is the potential introduction of reduced nicotine content products, which align with 22nd Century’s VLN line of non-addictive cigarettes. These products, designed to help smokers control their nicotine intake, represent a growing category in the tobacco market. The companies plan to expand their collaboration further, integrating additional products like filtered cigars and companion VLN brands.

    “Our next focus will be to expand the range of products covered under this agreement as well as our projects currently underway to add VLN companion brands that will help to build out a new category of reduced nicotine content products, creating greater visibility and sales reach for products that use our proprietary tobacco strains containing 95% less nicotine – a level considered to be non-addictive and shown in clinical studies to reduce smoking activity among adult smokers,” said Keelan Gallagher, Vice President Operations at Smoker Friendly.

  • VLN Relaunch in Korea

    VLN Relaunch in Korea

    Image: Tobacco Reporter archive

    22nd Century Group announced a new agreement for full-scale commercial rollout of its VLN reduced-nicotine content cigarettes in South Korea. The new agreement with 22nd Century’s local partner, Nico-Tech Korea Inc., follows an initial test launch conducted in 2022 that identified product updates needed to align with local South Korean cigarette characteristics and appeal to the specific preferences of adult smokers in Korea.

    “South Korea is a unique market characterized by high smoking rates and a corresponding high commitment from its government to reduce the harms of smoking,” said Larry Firestone, chairman and CEO, in a statement. “Based on the pilot launch in 2022, we made key product modifications to better align with specific characteristics of combusted cigarettes preferred by South Korea’s adult smokers. We have made those changes and are now ready to fully enter the market with VLN export shipments to South Korea anticipated to begin later this year.

    “This relaunch with our original partner, Nico-Tech, demonstrates their commitment to smoking harm reduction and making VLN products a key part of the South Korean market through the diverse array of local retail channels they serve. We are working with Nico-Tech to plan a full launch event for the fall of 2024, including on-site support.”

    South Korea represents an estimated $1.6 billion tobacco market and was the first international market to commence sales of VLN reduced-nicotine content cigarettes. While tobacco product use has declined since signing into law the 1995 National Health Promotion Act and subsequent government actions, the prevalence of smoking remains high in certain segments of the South Korean population. It is estimated that one in three adult men in South Korea are smokers, and an estimated 6 percent of adult women smoke.

    Nico-Tech will be responsible for all local marketing activities to generate consumer demand and awareness in South Korea. The new agreement includes minimum order quantities to support the initial stocking and restocking needs of the planned South Korean distribution.

  • 22nd Century Increases VLN Availability

    22nd Century Increases VLN Availability

    22nd Century Group’s VLN reduced-nicotine content cigarettes are now available at more than 1,200 drug store locations across Texas, Florida, Illinois, North Carolina and Georgia. With this most recent addition, VLN is available in more than 4,000 stores across 16 states compared with approximately 1,100 stores on July 1.

    “We are excited to launch the first drug store chain selling our FDA [Food and Drug Administration]-authorized VLN tobacco harm reduction products, adding 1,200 stores across five key state markets to our growing roster of convenience store points of sale,” said John Miller, interim CEO of 22nd Century Group, in a statement. “VLN offers a new, clinically researched solution helping adult smokers reduce their smoking rate and the associated harms of smoking over time.”

    “VLN users continue to report an overwhelmingly positive experience in our market research, and most say it has helped them reduce consumption of their regular cigarette brand,” said Miller. “Research with VLN users indicates that while most nonprescription methods of quitting or reducing smoking are strongly disliked, more than 75 percent of VLN users say they like their experience with the product. As a result of using VLN, 80 percent of adult consumers report a reduction in usage of their regular brand, and many want to share their positive experience with other adult smokers.”

    VLN is the first and only FDA-authorized combustible cigarette labeled as a tobacco harm reduction product.

  • VLN Launched in California

    VLN Launched in California

    Image: Tobacco Reporter archive

    22nd Century Group launched VLN King cigarettes in the California market. Starting July 17, VLN cigarettes will be available in California at more than 275 sites of the No. 1 convenience store in the U.S. in addition to numerous other convenience stores across California.

    “We see our VLN product offering Californians who smoke a tremendous new option because VLN cigarettes are specifically designed to help smokers smoke less, increase their number of smoke-free days and reduce their nicotine exposure and dependence,” said John Miller, 22nd Century Group president of the tobacco division, in a statement. “Our goal with VLN is to meet California consumers where they are with a combustible product that helps people smoke less.”

  • 22nd Century Produces Homogenized Leaf

    22nd Century Produces Homogenized Leaf

    Image: Tobacco Reporter archive

    22nd Century Group has successfully produced homogenized tobacco leaf (HTL) sheet using VLN reduced-nicotine content tobacco, demonstrating a reduced-nicotine content pathway for additional large markets, such as heat-not-burn products, and as the binder or wrapper for machine-made cigars.

    “It’s time for the industry to offer adult smokers a true alternative to highly addictive nicotine products in every format,” said John Miller, president of tobacco products for the company, in a statement. “HTL is critical to the fast-growing heat-not-burn product category, where a VLN 95 percent reduced-nicotine content HTL would be a compelling alternative to the nicotine-laden tobaccos commonly used in these products. HTL is also commonly used as the binder and wrapper in the high-volume cigar market due to its greater mechanical resistance and uniformity as compared to whole tobacco leaves.”

    “Conventional tobacco products still seek to create and sustain nicotine addiction to generate sales,” said James A. Mish, CEO. “Even alternatives to conventional smoking products, such as vaping and e-cigarettes, perpetuate sales through nicotine addiction rather than giving consumers a real choice. 22nd Century wants to provide a true alternative that allows users to take control of their consumption habit once and for all by breaking the chains of nicotine addiction.”

    VLN HTL sheet product could be manufactured and sold as a raw material input or produced under license for companies interested in offering reduced-nicotine content and nonaddictive products.

  • VLN Debuts in “Four Corners” States

    VLN Debuts in “Four Corners” States

    Photo: 22nd Century Group

    22nd Century Group is launching its VLN reduced-nicotine content in the “Four Corners” states—Arizona, Utah and New Mexico. The company will leverage both existing partners and new distribution networks. VLN was previously introduced in Colorado and Illinois.

    “With the addition of three more states, we are moving ahead with our plans to rapidly make our innovative products available to a much larger portion of the adult smoker population in the United States,” said John J. Miller, president of 22nd Century’s tobacco business, in a statement.

    “This is a massive market in need of new solutions to help adult smokers smoke less. Every 1 percent share of the U.S. market equates to approximately $800 million in sales at the register, which is about $500 million in revenue to a premium cigarette manufacturer.

    “These four states will demonstrate our scalable and repeatable state launch blueprint for VLN, which we are now leveraging to rapidly put our product in front of an ever-growing population of adult smokers looking for a way to smoke less.

    “Additionally, we have the benefit of favorable MRTP excise tax structures for tobacco products sold in Utah and New Mexico, similar to the beneficial programs in Colorado, that can assist us in getting the word out to adults who can benefit from our products.

    22nd Century Group’s proprietary VLN cigarettes smoke, smell and taste like a cigarette but contain approximately 95 percent less nicotine than conventional cigarettes, a level shown to be nonaddictive, according to 22nd Century Group.