22nd Century Group, Inc. announced that it is proceeding with the Modified Risk Tobacco Product (MRTP) renewal process for VLN, its flagship line of reduced-nicotine content cigarettes.
First authorized by the FDA in December 2021, VLN remains the only combustible cigarette with MRTP designation, permitted to market key reduced-harm claims such as “95% less nicotine” and “Helps you smoke less.” The renewal, due in December 2026, comes as the company expands its VLN portfolio through partnerships and patented low-nicotine plant varieties.
“Our MRTP authorization for VLN cigarettes stands apart as one of the most unique and innovative tools in the tobacco industry, leading the fight in Tobacco Harm Reduction to reduce the health harms of smoking,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “Our VLN cigarette is the only product that meets the FDA’s guideline for low nicotine based on its proposed low-nicotine mandate issued in January 2025.
“While the FDA’s mandate has not yet become a final ruling, we expect that the FDA will fully support our MRTP renewal for VLN.”
