22nd Century to File Second FDA PMTA for 100mm VLN® to Target Half of $82B Market
22nd Century Group completed prototyping for its 100mm VLN® reduced nicotine cigarette and plans a second FDA PMTA after authorizing its 84mm VLN king size product. Operation 100 targets roughly half of the $82 billion U.S. cigarette market while expanding its PMTA portfolio and licensing strategy for diverse combustible formats.
1. Product Development for 100mm VLN®
Under Operation 100, 22nd Century’s R&D team completed prototyping and initial analytical evaluations for a 100mm VLN® reduced nicotine cigarette, leveraging proprietary non-GMO tobacco technology engineered to reduce nicotine by 95%.
2. Regulatory Strategy and PMTA Expansion
Building on its exclusive FDA authorization for the 84mm VLN® king size product, the company is preparing a second PMTA submission for the 100mm format and plans multiple additional filings across diverse combustible tobacco products.
3. Market Targeting and Licensing Growth
The 100mm VLN® initiative aims to capture roughly half of the $82 billion U.S. cigarette market, while an expanded PMTA portfolio and licensing strategy will enable other tobacco firms to offer compliant low-nicotine products under their own brands.