FDA filing covers renewal applications for VLN® King and VLN® Menthol King, the first combusted cigarettes authorized as Modified Risk Tobacco Products, as 22nd Century advances its regulatory pathway for

FDA filing covers renewal applications for VLN® King and VLN® Menthol King, the first combusted cigarettes authorized as Modified Risk Tobacco Products, as 22nd Century advances its regulatory pathway for continued modified risk marketing status

MOCKSVILLE, N.C., May 12, 2026 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), a tobacco harm reduction company focused on reduced nicotine innovation, today highlighted that the U.S. Food and Drug Administration has filed for scientific review two Modified Risk Tobacco Product, or MRTP, renewal applications for the Company's VLN® King and VLN® Menthol King combusted, filtered cigarettes. The FDA filing marks an important step in the regulatory process for the continued marketing of these products with authorized modified risk claims.

VLN® King and VLN® Menthol King were originally granted MRTP exposure modification orders by the FDA in December 2021, making them the first combusted cigarettes ever authorized as MRTPs. Those orders are set to expire in December 2026 unless renewed, and the current review process is intended to support continued modified risk marketing status beyond that date.

Under the existing FDA orders, 22nd Century is authorized to market VLN® King and VLN® Menthol King with specific reduced-exposure nicotine claims, including "95% less nicotine," "Helps reduce your nicotine consumption," and "…Greatly reduces your nicotine consumption," provided those claims are accompanied by the statement "Helps you smoke less." The Company believes the continued review of these products is strategically important because VLN® remains a uniquely differentiated product platform within the combustible tobacco category.

In connection with the renewal process, the FDA has begun releasing redacted application materials for public access and opened a docket for public comment, enabling stakeholders to submit data and feedback as part of the scientific review. 22nd Century believes this process further underscores the rigor of the FDA's modified risk framework and the significance of maintaining a robust evidence base for its VLN® franchise.

In its original MRTP review, the FDA found that nicotine levels in the tobacco and mainstream smoke of VLN cigarettes are at least 95% lower than the majority of marketed and market-leading conventional cigarette brands. The agency also stated that consumers who exclusively use cigarettes with the same or similarly reduced nicotine content as VLN cigarettes could reduce their nicotine exposure by approximately 95%, and that use of these products is reasonably likely to reduce nicotine dependence.

22nd Century previously announced that its renewal submission was supported by additional marketplace data, including a 2024 study involving more than 400 participants, which the Company said demonstrated a 40% reduction in daily cigarette consumption over 12 weeks among smokers using VLN® cigarettes. The Company believes this data strengthens the long-term commercial and regulatory case for the VLN® platform, although the outcome and timing of the FDA's renewal review remain subject to the agency's independent evaluation.