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Tag: 22nd Century

  • 22nd Century Expands VLN to 140 C-Stores in Illinois

    22nd Century Expands VLN to 140 C-Stores in Illinois

    22nd Century Group, Inc. announced the launch of its VLN reduced-nicotine content cigarettes with 140 Circle K locations in Illinois, marking another step in the company’s nationwide rollout. The products, designed to contain 95% less nicotine, are now authorized for sale in 45 states, with approvals in the remaining five expected soon.

    Chief Executive Officer Larry Firestone said the expansion returns the brand to its first launch market. “We know there are VLN smokers who will appreciate the new branding and product rollout in Illinois,” Firestone said. “Once we achieve authorization and distribution in all 50 states, we will demonstrate the large-scale feasibility of our VLN low-nicotine products and alignment with the FDA’s new low-nicotine mandate.”

  • 22nd Century Group Backs FDA’s Proposed Reduced Nicotine Standard

    22nd Century Group Backs FDA’s Proposed Reduced Nicotine Standard

    22nd Century Group, Inc. submitted public comments in support of the U.S. FDA’s proposed rule to mandate very low nicotine levels in cigarettes and other combusted tobacco products. CEO Larry Firestone said the evidence shows such a standard could save millions of lives and transform the market within two years, with the company’s VLNC technology already proven to deliver consumer-acceptable products.

    22nd Century criticized Big Tobacco’s stance as contradictory, arguing that support for a reduced nicotine mandate would align with industry claims of pursuing a “smoke-free future.” The company pledged to continue backing the rule, calling it a landmark public health measure.

    “The evidence is overwhelming that a reduced nicotine yield standard for combusted tobacco products has the potential to save millions of lives and trillions of dollars cumulatively in the U.S. alone,” said Firestone. “From both a public health and commercial standpoint, the only barrier left to the most transformative public health policy of a generation is the willingness to move forward with this mandate.”

  • 22nd Century Settles $9.5M Insurance Claim, Eyes 2026 Profitability

    22nd Century Settles $9.5M Insurance Claim, Eyes 2026 Profitability

    22nd Century Group, Inc. announced it reached a settlement with its insurers for $9.5 million in cash to resolve all business interruption claims related to a fire at the company’s Grass Valley facility in November 2022. The insurers are required to remit the payment within 45 days of the agreement’s effective date.

    “We are very excited to close this chapter and finally settle with our insurance carrier for the full amount we targeted,” CEO Larry Firestone said. “Additionally, because the company is now debt free, this marks a major transition from survival capital to growth capital.”

    The company highlighted that over the past 22 months it has addressed legacy financial challenges, cleaning up its balance sheet. With these matters resolved, 22nd Century Group plans to focus on expanding distribution for its VLN and partner VLN products and is targeting profitability in 2026.

  • 22nd Century Touts VLN Growth, FDA Regs in Shareholder Letter

    22nd Century Touts VLN Growth, FDA Regs in Shareholder Letter

    22nd Century Group, Inc. is doubling down on its push for very low nicotine (VLN) products, highlighting new partnerships, regulatory momentum, and expanded product development in a shareholder letter released yesterday (August 19). CEO Larry Firestone said the company’s VLN cigarettes, the first FDA-authorized combustible products designed to reduce smoking harms, are gaining traction through stocking orders with Smoker Friendly and Pinnacle, with more partners expected.

    A looming FDA proposal, set for September 15, could mandate a cap of 0.7 mg/g nicotine yield in cigarettes, a standard built on 22nd Century’s own clinical trials. Firestone said the move “could be the most groundbreaking and effective tobacco regulation in a generation.”

    Beyond cigarettes, 22nd Century is developing VLN filtered cigars, 100mm formats, and international variants, supported by ongoing FDA filings. The company is also studying whether its low-nicotine genetics reduce cancer-causing TSNAs.

    With a growing IP portfolio in plant genetics, the company said it is aiming to cement its position as the leader in tobacco harm reduction. Firestone framed the mission as both business and public health: “Our technology and products have the capability to dramatically improve public health and the welfare of smokers worldwide – hopefully even save lives.”

  • 22nd Century Group Posts Q2 Results, Expands VLN Distribution

    22nd Century Group Posts Q2 Results, Expands VLN Distribution

    22nd Century Group reported second-quarter 2025 revenues of $4.1 million, down from $6 million in the first quarter, with a net loss holding steady at $3.3 million. Operating loss widened to $3 million, while adjusted EBITDA loss came in at $2.6 million. The company reduced its debt by an additional $1 million, bringing total debt down to $3.8 million.

    CEO Larry Firestone highlighted the momentum behind the company’s FDA-authorized VLN reduced-nicotine cigarettes, which now have authorization for sale in 44 states. Partner brands, including Pinnacle VLN, are expanding distribution, with nearly 1,000 stores across 12 states expected to begin selling the product September 1. The company is also advancing new SKUs, including Pinnacle moist snuff, and preparing an FDA submission for a new 100mm VLN cigarette by year-end.

    Despite financial challenges, Firestone emphasized that 22nd Century is entering a “profitable growth phase” built on its proprietary low-nicotine tobacco technology. He said VLN® products are positioned to align with the FDA’s proposed nicotine standards, giving the company a first-mover advantage in the harm reduction market.

  • 22nd Century Group Announces Reduced-Nicotine Cigarette Launch

    22nd Century Group Announces Reduced-Nicotine Cigarette Launch

    22nd Century Group, Inc. announced the first shipments of its new Pinnacle VLN Gold and Pinnacle VLN Menthol reduced-nicotine content cigarettes will be available September 1 at nearly 1,000 convenience store locations across 12 states.

    Company CEO Larry Firestone said Pinnacle’s conventional cigarettes have built strong customer loyalty, and the new VLN line offers smokers a choice to significantly reduce nicotine intake—about a 95% reduction compared to traditional cigarettes.

    The company plans to expand the Pinnacle VLN range into more states and stores while continuing to supply other Pinnacle products, including conventional cigarettes, cigarillos, and moist snuff. Firestone emphasized 22nd Century’s commitment to lead the tobacco harm reduction movement by increasing access to these reduced-nicotine products.

  • 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 Sees 50% Jump from Q4 2024 to Q1 2025

    22nd Century Sees 50% Jump from Q4 2024 to Q1 2025

    22nd Century Group, Inc. today (May 13) announced results for the first quarter, ended March 31, and provided an update on recent business highlights. Compared to the fourth quarter 2024, first quarter 2025 saw net revenues increase from $4 million to $6 million and gross profit losses declined from $1.3 million to $600,000. Operating expenses decreased from $2.8 million to $2 million, the lowest quarterly amount since company restructuring began in 2023, and operating losses decreased from $4.1 million to $2.6 million.

    “Our first quarter results demonstrate the positive trends we expect to build on in 2025 as we secure new opportunities to drive volume across our VLN, core CMO and filtered cigar businesses, with a particular emphasis on leveraging both our own and customer driven campaigns for partner branded products,” said Larry Firestone, CEO of 22nd Century Group. “We are excited about the upcoming launch of now two partner-branded VLN products, both for chains with substantial retail store counts, bringing additional partner-supported marketing and outreach activity to grow sales volumes in the VLN category. We are moving ahead on these and other opportunities ahead as we continue to execute our growth strategy in 2025.”

    View the full financial report here.

  • 22nd Century Further Reduces Debt by $1M

    22nd Century Further Reduces Debt by $1M

    22nd Century Group, Inc. today (May 7) announced that repaid an additional $1 million in debt to its senior lender. The company’s total debt principal outstanding now stands at approximately $3.9 million.

    “Our debt reduction progress has been outstanding and total debt principal is now less than $4 million, as compared with approximately $20 million of total debt obligations when I joined the company in December 2023,” said Larry Firestone, CEO of 22nd Century Group. “We are on our way to becoming debt-free, which will allow us to focus our resources on growth opportunities we see across our contract manufacturing business, as well as reduced nicotine content and branded products.”

    22nd Century will report its complete first quarter results on May 13 with a conference call the same day.

  • 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.