Core Viewpoint - The FDA has proposed a new Tobacco Product Standard that aims to significantly reduce nicotine levels in cigarettes and certain combusted tobacco products, which could lead to a decrease in smoking-related morbidity and mortality. 22nd Century Group's VLN products are highlighted as compliant with this new standard, positioning the company for potential growth in commercialization and distribution [1][2][6]. Group 1: FDA Proposed Standard - The proposed standard sets a maximum nicotine content of 0.7 mg per gram of tobacco in cigarettes and certain other combusted tobacco products, expected to take effect two years after final approval [2]. - The FDA anticipates that this standard could prevent approximately 48 million youth and young adults from initiating smoking by the year 2100 [6]. Group 2: 22nd Century Group's Position - 22nd Century Group's VLN products are the only combustible cigarettes authorized by the FDA as reduced nicotine content products, currently available in over 5,000 stores across the U.S. [2][3]. - The company has been committed to nicotine harm reduction for 26 years, and the FDA's proposal is seen as a significant opportunity for commercial adoption of its VLN products [3]. Group 3: Product and Manufacturing Capabilities - VLN cigarettes contain 95% less nicotine than traditional cigarettes and have been proven to reduce overall nicotine consumption [5]. - The company operates a 60,000 square foot manufacturing facility in Mocksville, North Carolina, capable of producing over 45 million cartons of combusted tobacco products annually, with room for expansion [7]. Group 4: Technological Innovation - 22nd Century Group utilizes patented technologies to create proprietary reduced nicotine tobacco blends, ensuring they have the only low nicotine combustible cigarette in the U.S. and critical international markets [8].

Core Viewpoint - The FDA has proposed a new Tobacco Product Standard that aims to significantly reduce nicotine levels in cigarettes, which could lead to a decrease in smoking-related morbidity and mortality, with 22nd Century's VLN products positioned to benefit from this regulation [1][6]. Group 1: FDA Proposed Standard - The proposed standard sets a maximum nicotine content of 0.7 mg per gram of tobacco in cigarettes and certain combusted tobacco products, expected to take effect in two years after final approval [2]. - The FDA anticipates that this standard could prevent approximately 48 million youth and young adults from initiating smoking by the year 2100 [6]. Group 2: 22nd Century's Position - 22nd Century's VLN products are the only combustible cigarettes authorized by the FDA as reduced nicotine content products, already compliant with the new standard and available in over 5,000 stores nationwide [2][3]. - The company emphasizes its commitment to nicotine harm reduction, providing smokers with a choice to control their nicotine consumption through products that contain 95% less nicotine than traditional cigarettes [5][8]. Group 3: Industry Impact - The FDA's proposal is seen as a potential game-changer in public health policy, aiming to reduce the burden of tobacco-related diseases and save lives [3][6]. - The proposed rule is expected to facilitate the commercial adoption of reduced nicotine products, which could lead to a significant shift in the tobacco industry landscape [3][4].

Industry Trends and Market Opportunity - The FDA estimates that 13 million smokers could benefit from reduced nicotine cigarette policies in the first five years, highlighting a significant public health opportunity [1] - The reduced nicotine cigarette market mirrors the growth of non-alcoholic beer and spirits, as consumers seek alternatives to traditional products [1] - The FDA's policy proposal to mandate reduced nicotine content in cigarettes has cleared review by the U.S. Office of Management and Budget, indicating regulatory progress [3] Company Overview and Product Innovation - 22nd Century Group is a pioneer in nicotine harm reduction, offering VLN cigarettes with 95% less nicotine than traditional cigarettes [2] - The company's proprietary technology regulates nicotine biosynthesis in tobacco plants, enabling full flavor and high yield with significantly reduced nicotine content [2][6] - VLN cigarettes are the only FDA-authorized combustible tobacco products under the Modified Risk Tobacco Product designation, available in over 5,000 stores nationwide [7] Manufacturing and Expansion Capabilities - The company operates a 60,000 square foot manufacturing facility in Mocksville, North Carolina, with an annual production capacity of over 45 million cartons of combusted tobacco products [2] - The facility has additional space for expansion, supporting future growth in production [2] Regulatory and Policy Developments - The reduced nicotine cigarette policy, initiated during the Trump administration, has gained momentum under the Biden administration, reflecting bipartisan support for smoking harm reduction [7] - 22nd Century Group's VLN products have demonstrated commercial viability and effectiveness in controlling nicotine intake, countering skepticism from major tobacco companies [1][7] Market Positioning and Competitive Advantage - The company's extensive patent portfolio ensures it is the sole provider of low nicotine combustible cigarettes in the U.S. and key international markets [6] - 22nd Century Group collaborates with retailers to stock VLN products and other reduced nicotine cigarette brands, creating a new market category [1]

Core Viewpoint - The FDA's proposal to mandate reduced nicotine content in cigarettes has cleared the OMB review, which could significantly impact public health by reducing smoking-related harms [1][2]. Group 1: FDA Proposal and Company Position - The FDA's proposed tobacco product standard aims for a drastic reduction in nicotine levels in cigarettes, aligning with public health goals and the mission of 22nd Century Group [1][2]. - 22nd Century Group supports the FDA's initiative and emphasizes its role in research and development of reduced nicotine products, including the VLN brand [2][3]. Group 2: Product and Market Strategy - The VLN cigarette contains 95% less nicotine than traditional cigarettes, providing smokers with a familiar alternative that helps control nicotine consumption [3]. - The company plans to expand its product line with additional reduced nicotine content products and increase consumer awareness of low nicotine cigarettes as a distinct market category [2][3]. Group 3: Company Overview - 22nd Century Group is a pioneering company in nicotine harm reduction, with a manufacturing facility in Mocksville, North Carolina, capable of producing over 45 million cartons of tobacco products annually [3]. - The company holds a comprehensive patent portfolio that ensures it is the only provider of low nicotine combustible cigarettes in the U.S. and key international markets [3].

Agreement covers 11 existing brands, supports launch 8 additional premium brands with Smoker Friendly retail and dealer locations Creates foundation to launch additional reduced nicotine content brands in 2025 MOCKSVILLE, N.C., Jan. 07, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have a choice about their nicotine consumption, today announced the completion of a new license and manufacturi ...

Mocksville, North Carolina--(Newsfile Corp. - December 13, 2024) - 22nd Century Group, Inc. (NASDAQ: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have a choice about their nicotine consumption, today announced that it will effect a reverse stock split of its outstanding shares of common stock, par value $0.00001 per share (the "Common Stock"), at a ratio of 1-for-135, to be effective as of December 17, 2024. The reverse stock split is intended for ...

22nd Century Applauds FDA Proposal to Mandate Reduced Nicotine Content in CigarettesRecent FDA Action Advances Policy Proposal That Originated During First Trump Administration and Continued to Progress Under Biden AdministrationDecember 12, 2024 11:31 AM EST | Source: 22nd Century GroupMocksville, North Carolina--(Newsfile Corp. - December 12, 2024) - 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period From ________ to ________ Commission File Number: 001-36338 22nd Century Group, Inc. (Exact name of registrant as specified in its charter) Nevada 98-04684 ...

Exhibit 99.1 22nd Century Group Reports Third Quarter 2024 Financial Results Remains on Path to Cash Positive Operations in Q1 2025 Commencing Growth Strategy Leveraging Both Internal and External Brand Assets Across Multiple Categories MOCKSVILLE, N.C., November 12, 2024 — 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine dependence and believes smokers should have a choice about their nicotine consumption, today announced results for the third q ...

22nd Century Group Reports Third Quarter 2024 Financial ResultsRemains on Path to Cash Positive Operations in Q1 2025November 12, 2024 6:00 AM EST | Source: 22nd Century GroupCommencing Growth Strategy Leveraging Both Internal and External Brand Assets Across Multiple CategoriesMocksville, North Carolina--(Newsfile Corp. - November 12, 2024) - 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine dependence and believes smokers should ha ...