
22nd Century Files Renewal for VLNÂŪ MRTP â Only FDAâAuthorized Combustible Tobacco Product That Helps Smokers Smoke Less
âĒBy ADMIN
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22nd Century Group, Inc. (Nasdaq: XXII) has filed a renewal application with the U.S. Food and Drug Administration (FDA) for its Modified Risk Tobacco Product (MRTP) status for VLNÂŪ reduced nicotine content cigarettes, the company announced on January 6, 2026. VLNÂŪ products are the first and still the only **combustible cigarettes authorized by the FDA** to carry claims such as â95% less nicotineâ and âhelps you smoke less,â based on extensive independent clinical research.
The VLNÂŪ cigarettes contain approximately 95% less nicotine than traditional cigarettes and are supported by data showing reduced smoking and increased quit attempts among users. A 2024 marketplace study with over 400 participants showed a 40% drop in daily cigarette consumption over a 12âweek period when smokers used VLNÂŪ products.
Originally authorized in December 2021 for five years, the MRTP designation for VLNÂŪ is set to expire in December 2026, prompting todayâs renewal filing. VLNÂŪ branded products are now offered by a growing number of cigarette brands, providing adult smokers with alternatives featuring significantly lower nicotine levels.
22nd Centuryâs CEO, Larry Firestone, emphasized that the VLNÂŪ program supports smokersâ health and wellness by helping them reduce their nicotine consumption without abandoning combustion altogether. The company expects the FDA to support the renewal, noting VLNÂŪ products already meet proposed lowânicotine guidelines issued in January 2025, although these guidelines are not yet final.
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