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Tag: VLN

  • FDA Files MRTP Renewal for Two 22nd Century Products

    FDA Files MRTP Renewal for Two 22nd Century Products

    Today (May 12), FDA filed two modified risk tobacco product (MRTP) renewal applications for scientific review for 22nd Century Group Inc. products VLN King and VLN Menthol King. Both products are combusted, filtered cigarettes that contain a reduced amount of nicotine compared to typical commercial cigarettes.

    The renewal follows MRTP orders first granted in 2021, which are set to expire in December 2026, requiring FDA reauthorization for continued marketing with reduced-risk claims. The agency has begun releasing redacted application materials for public access and has opened a docket for public comment, allowing stakeholders to submit data and feedback as part of the review process.

  • 22nd Century Reports $4.1M in Revenue as it Focuses on Future

    22nd Century Reports $4.1M in Revenue as it Focuses on Future

    22nd Century Group reported first-quarter 2026 revenue of $4.1 million, with a continued focus on expanding its reduced-nicotine VLN cigarette portfolio and distribution footprint. The company said it is gaining traction with adult smokers, with products now available in more than 2,000 stores across 20 states and targeting over 5,000 retail locations by the end of 2026.

    The company is positioning its proprietary low-nicotine technology as aligned with potential future FDA standards, while pursuing a broader product pipeline across cigarettes, filtered cigars and other formats. Despite ongoing net losses, 22nd Century said it is prioritizing distribution growth, regulatory engagement, and margin improvement, with plans to expand licensing opportunities and advance multiple PMTA submissions to support long-term growth.

  • 22nd Century Expands Low-Nicotine Research with NC State

    22nd Century Expands Low-Nicotine Research with NC State

    22nd Century Group entered a testing services agreement with North Carolina State University to validate new low-nicotine tobacco varieties designed to improve yield and leaf quality while maintaining reduced nicotine levels, the company said. The research will evaluate genetic traits, crop performance, and commercial scalability as the company looks to strengthen its supply chain.

    The initiative builds on 22nd Century’s proprietary reduced-nicotine platform, which underpins its FDA-authorized VLN cigarette products. The company said the collaboration is aimed at supporting long-term production efficiency and aligning with evolving regulatory focus on nicotine reduction.

  • 22nd Century to File New PMTA for 100mm VLN

    22nd Century to File New PMTA for 100mm VLN

    22nd Century Group, Inc. said it will submit an additional premarket tobacco product application to the U.S. Food and Drug Administration for a new 100mm version of its VLN reduced-nicotine cigarette, building on its status as “the only company with FDA authorization for a low-nicotine combustible product.” The company’s existing 84mm king-size VLN cigarettes received PMTA authorization in 2021.

    The new product, developed under its “Operation 100” initiative, is designed to offer adult smokers a familiar format while significantly lowering nicotine intake. 22nd Century said expanding into the 100mm size responds to retailer and consumer feedback and could widen access to reduced-nicotine alternatives without requiring smokers to switch to non-combustible products.

    Beyond the single submission, the company outlined plans to pursue multiple PMTAs across different combustible formats, blends, and sizes, including filtered cigars, creating a broader portfolio that can be licensed to other tobacco companies. Management said this strategy is intended to accelerate retail penetration of VLN products and to position the company as a provider of regulatory pathways for reduced-nicotine tobacco offerings.

  • 22nd Century Reports Momentum for VLN Products

    22nd Century Reports Momentum for VLN Products

    22nd Century Group touted early sales momentum for its VLN low-nicotine cigarettes, distributing approximately 8,800 cartons to about 1,700 new retail outlets nationwide in the fourth quarter of 2025, with initial sell-through data indicating growing adoption across its 22nd Century VLN, Pinnacle VLN, and Smoker Friendly VLN brands. The company said expanding retail placement across convenience stores, wholesalers, and independent chains supports its plan to exceed 5,000 points of distribution in 2026.

    22nd Century positioned its progress alongside regulatory developments, including a January 2025 proposed rule by the U.S. Food and Drug Administration to cap nicotine levels in cigarettes at 0.7 mg per gram of tobacco, and broader global support for nicotine reduction under the World Health Organization Framework Convention on Tobacco Control.

  • 22nd Century Files PMTA Renewal

    22nd Century Files PMTA Renewal

    22nd Century Group, Inc. announced it has filed a renewal application with the U.S. Food and Drug Administration for its Modified Risk Tobacco Product authorization covering VLN reduced nicotine content cigarettes. The original authorization, granted in December 2021, expires in December 2026.

    22nd Century says VLN remains the first and only combustible cigarette authorized by the FDA to reduce the health harms of smoking, with approved claims including “95% less nicotine” and statements that it helps reduce nicotine consumption and smoking frequency. The company cited decades of independent clinical research supporting VLN products, including evidence that lowering nicotine content reduces smoking rates and increases quit attempts. Company CEO Larry Firestone said the renewal builds on FDA recognition that reducing nicotine directly can alter smoking behavior and improve public health outcomes, adding that VLN products align with the FDA’s proposed low-nicotine standard issued in January 2025.

  • 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 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.