Workflow
FDA Publishes Proposed New Tobacco Product Standard for Nicotine Yield, Citing VLN from 22nd Century as the Only Combustible Cigarette That Complies with the New Standard
XXII22nd Century (XXII) Newsfilter·2025-01-15 16:37

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].