
22nd Century Files Renewal for VLN® MRTP — Only FDA‑Authorized Combustible Tobacco Product That Helps Smokers Smoke Less
•By 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 VLN® reduced nicotine content cigarettes, the company announced on January 6, 2026. VLN® products are the first and still the only **combustible cigarettes authorized by the FDA** to carry claims such as “95% less nicotine” and “helps you smoke less,” based on extensive independent clinical research.
The VLN® 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 12‑week period when smokers used VLN® products.
Originally authorized in December 2021 for five years, the MRTP designation for VLN® is set to expire in December 2026, prompting today’s renewal filing. VLN® branded products are now offered by a growing number of cigarette brands, providing adult smokers with alternatives featuring significantly lower nicotine levels.
22nd Century’s CEO, Larry Firestone, emphasized that the VLN® program supports smokers’ health and wellness by helping them reduce their nicotine consumption without abandoning combustion altogether. The company expects the FDA to support the renewal, noting VLN® products already meet proposed low‑nicotine guidelines issued in January 2025, although these guidelines are not yet final.
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