USFDAMay 12, 2026, 01:52 PM
22nd Century Group: FDA Files VLN® MRTP Renewal Applications
AI Summary
22nd Century Group announced that the U.S. Food and Drug Administration (FDA) has filed for scientific review two Modified Risk Tobacco Product (MRTP) renewal applications for its VLN® King and VLN® Menthol King combusted cigarettes. This is a critical procedural step for the continued marketing of these products with authorized modified risk claims beyond their December 2026 expiration. The company believes this development reflects the strength of the scientific and regulatory foundation supporting VLN®, citing a 2024 study demonstrating a 40% reduction in daily cigarette consumption among users.
Key Highlights
- FDA filed Modified Risk Tobacco Product (MRTP) renewal applications for 22nd Century Group's VLN® King and VLN® Menthol King cigarettes.
- The renewal aims to continue modified risk marketing status beyond the December 2026 expiration.
- VLN® King and VLN® Menthol King were the first combusted cigarettes authorized as MRTPs in December 2021.
- The products are authorized to be marketed with claims like "95% less nicotine" and "Helps reduce your nicotine consumption."
- Renewal submission is supported by a 2024 study showing a 40% reduction in daily cigarette consumption among VLN® users.
- FDA previously found VLN® nicotine levels are at least 95% lower than conventional cigarettes.
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