FDA begins scientific review of 22nd Century's VLN cigarette MRTP renewal applications.

22nd Century Group has submitted renewal applications to the FDA for its VLN King and VLN Menthol King cigarettes, the first combusted cigarettes authorized as Modified Risk Tobacco Products (MRTP). The FDA has filed these applications for scientific review, a key step to maintain the products' modified risk marketing status beyond their current expiration in December 2026. VLN cigarettes contain 95% less nicotine than conventional cigarettes, aiming to reduce nicotine exposure and dependence. The review process includes public access to application materials and stakeholder feedback, reflecting the FDA's rigorous evaluation framework. The outcome and timing of the renewal remain uncertain as the FDA conducts its independent assessment.