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].
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