22nd Century Advances FDA Review for Renewal of VLN Cigarettes' Modified Risk Status

Event summary

  • FDA has filed for scientific review the MRTP renewal applications for 22nd Century's VLN® King and VLN® Menthol King cigarettes.
  • Original MRTP orders for these products, granted in December 2021, are set to expire in December 2026.
  • 22nd Century claims a 2024 study showed a 40% reduction in daily cigarette consumption among smokers using VLN® cigarettes over 12 weeks.
  • FDA has opened a docket for public comment on the renewal applications.

The big picture

22nd Century's VLN® cigarettes are the first and only combustible cigarettes authorized as Modified Risk Tobacco Products (MRTPs) by the FDA. The renewal of this status is strategically important as it allows the company to market these products with specific reduced-exposure nicotine claims. The outcome of this review will influence 22nd Century's ability to maintain its leadership in the tobacco harm reduction movement and could impact the broader combustible tobacco market.

What we're watching

Regulatory Outcome
Whether the FDA will renew the MRTP status for VLN® cigarettes, which would allow continued marketing with reduced-exposure nicotine claims.
Market Differentiation
How 22nd Century will leverage the VLN® platform's unique positioning in the combustible tobacco category if the renewal is approved.
Public Feedback
The impact of public comments on the FDA's review process and the strength of the evidence base supporting the VLN® franchise.