22nd Century Group Inc. (NASDAQ: XXII) announced it has completed product prototyping and initial analytical evaluations for a 100mm VLN reduced nicotine content cigarette, preparing to submit a second Premarket Tobacco Product Application (PMTA) to the FDA.

The company currently holds the only FDA-issued PMTA authorization for a combustible reduced nicotine content cigarette with its existing 84mm king size VLN products. The new 100mm format aims to address consumer and retail partner demand for additional product options.

22nd Century's VLN cigarettes contain 95% less nicotine than traditional cigarettes and received FDA authorization in December 2021. The FDA authorized claims include "95% less nicotine," "Helps reduce your nicotine consumption," "Greatly reduces your nicotine consumption," and "Helps you smoke less."

The company is developing a broader strategic initiative to submit multiple PMTAs across various combustible products, including different tobacco blends, product sizes, and formats such as filtered cigars. All authorized products within this expanded portfolio will be available for licensing to other tobacco companies.

"We are open to licensing our low-nicotine technology more broadly within the industry, which we believe could significantly accelerate efforts to reduce smoking-related harm in a relatively short period of time," stated Larry Firestone, Chief Executive Officer.

The company's proprietary reduced nicotine tobacco plants were developed using patented technologies that regulate alkaloid biosynthesis activities. Any new tobacco product from ongoing research and development initiatives will require FDA authorization prior to commercialization.

22nd Century indicated it will provide updates as regulatory milestones are achieved for the 100mm VLN product development.