Company to Pursue Additional PMTA Submissions, Building on Its Status as the Only Holder of an FDA-Authorized Low Nicotine Combustible Cigarette Branded as VLN® Products
Expanded PMTA Portfolio and Licensing Strategy Designed to Address Wider Consumer Preference and Unlock Further Retail Penetration Opportunities
MOCKSVILLE, N.C., April 07, 2026 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), a tobacco products company focused on reducing the harms of smoking through nicotine reduction, today announced an update on the advancement of a 100mm VLN® reduced nicotine content cigarette.
The Company's proprietary reduced nicotine technology is designed to serve adult smokers who want to change their smoking habits by significantly reducing nicotine consumption. 22nd Century is focusing on smoker health and wellness by giving smokers an opportunity to control their tobacco consumption, rather than switching them to another highly addictive product like a vape or pouch.
Previously announced as "Operation 100" in 2025, the Company's research and development team has completed product prototyping and initial analytical evaluations required for advancing to the next phase of regulatory submissions. 22nd Century Group believes that introducing a 100mm VLN® reduced nicotine content cigarette — alongside its existing authorized 84mm king size VLN® products — will expand access to reduced nicotine alternatives in the familiar form factors preferred by adult smokers.
Notably, 22nd Century Group currently holds the only FDA-issued Premarket Tobacco Product Application (PMTA) authorization for a combustible reduced nicotine content cigarette, its VLN® king size products. Building on this foundation, the Company is preparing a second PMTA application for authorization from the FDA for its new 100mm VLN® cigarette. Management believes its prior PMTA experience, scientific data package, and regulatory engagement have positioned the Company to efficiently advance the 100mm submission process.
The Company is also advancing its long-term strategic initiative to grow its unique product portfolio through the submission of multiple PMTAs across a broad range of combustible products. This initiative is designed to support diverse tobacco blends and components, a variety of product sizes, and multiple product formats, including filtered cigars. By building a robust portfolio of new tobacco product authorizations from the FDA spanning these categories, the Company intends to create a flexible and scalable platform that can accommodate evolving market preferences and regulatory requirements. All current and any newly authorized combustible tobacco products within this expanded portfolio will be available for licensing. This will provide other tobacco companies with compliant, ready-to-market product pathways and reinforcing the Company's position as a leader in regulatory-driven innovation within the combustible tobacco segment.
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