22nd Century (US:XXII) Globenewswire·2026-01-06 11:10Core Viewpoint - 22nd Century Group, Inc. is advancing the fight against smoking-related health harms through its VLN reduced nicotine content products, which have been authorized by the FDA as a Modified Risk Tobacco Product [1][4]. Group 1: Product and Market Impact - The VLN reduced nicotine content cigarettes have been shown to lower daily nicotine consumption by 40% over 12 weeks in a study with over 400 participants, indicating their potential to reduce smoking rates and increase quit attempts [2]. - Approximately 28.8 million smokers in the U.S. contribute to over $600 billion in annual healthcare costs related to tobacco harm, highlighting the significant market opportunity for VLN products [2]. - VLN cigarettes contain 95% less nicotine than conventional cigarettes, providing a non-addictive alternative for smokers [3][10]. Group 2: Regulatory and Strategic Developments - The FDA originally authorized VLN combustible cigarettes in December 2021 for a five-year period, with a renewal application filed for December 2026 [3]. - The company is expanding its range of VLN branded products and tobacco plant varieties to offer smokers more low-nicotine alternatives, aligning with the FDA's proposed guidelines for low nicotine [5]. - The renewal process is part of the company's ongoing research and development efforts to advance reduced nicotine content in tobacco and introduce additional VLN products [5]. Group 3: Company Vision and Leadership - The CEO of 22nd Century Group emphasized that the FDA's MRTP authorization for VLN cigarettes represents a forward-thinking approach to reducing smoking-related health harms, focusing on behavioral and social aspects of nicotine addiction [4]. - The company aims to empower smokers to take control of their nicotine consumption through its innovative VLN products, positioning itself as a leader in the tobacco harm reduction movement [8][9].