22nd Century Group, Inc. said it will submit an additional premarket tobacco product application to the U.S. Food and Drug Administration for a new 100mm version of its VLN reduced-nicotine cigarette, building on its status as “the only company with FDA authorization for a low-nicotine combustible product.” The company’s existing 84mm king-size VLN cigarettes received PMTA authorization in 2021.
The new product, developed under its “Operation 100” initiative, is designed to offer adult smokers a familiar format while significantly lowering nicotine intake. 22nd Century said expanding into the 100mm size responds to retailer and consumer feedback and could widen access to reduced-nicotine alternatives without requiring smokers to switch to non-combustible products.
Beyond the single submission, the company outlined plans to pursue multiple PMTAs across different combustible formats, blends, and sizes, including filtered cigars, creating a broader portfolio that can be licensed to other tobacco companies. Management said this strategy is intended to accelerate retail penetration of VLN products and to position the company as a provider of regulatory pathways for reduced-nicotine tobacco offerings.