22nd Century Files FDA Renewal for VLN King MRTP Claims Beyond 2026
22nd Century Group has filed FDA MRTP renewal applications for its VLN King and VLN Menthol King cigarettes, originally authorized in December 2021 as the first combusted MRTPs, to secure their “95% less nicotine” claims past the December 2026 expiration. FDA has released redacted materials and opened a comment docket.
1. Renewal Applications Filed
On May 12, 2026, 22nd Century Group submitted two MRTP renewal applications covering its VLN King and VLN Menthol King combusted cigarettes. This filing seeks to extend the FDA’s authorization of modified risk claims, including “95% less nicotine,” beyond the current December 2026 expiration.
2. Background on VLN MRTP Authorization
VLN King and VLN Menthol King were granted original MRTP exposure modification orders in December 2021, marking them as the first combusted cigarettes authorized for modified risk marketing. Under these orders, the products may advertise reduced-exposure nicotine claims provided they include the statement “Helps you smoke less.”
3. FDA Review and Public Comment Process
The FDA has begun releasing redacted sections of the renewal applications for public examination and opened a docket for stakeholder submissions of data and feedback. This procedural step aims to ensure transparency and rigorous scientific review of the VLN platform.
4. Supporting Data and Commercial Implications
The renewal submissions are backed by a 2024 study involving over 400 participants, which showed a 40% reduction in daily cigarette consumption over 12 weeks among VLN users. This evidence is intended to bolster both the regulatory and commercial case for maintaining modified risk labeling for the VLN franchise.