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22nd Century Group, Inc. (Nasdaq: XXII), a tobacco harm reduction company focused on reduced nicotine innovation, said the U.S. Food and Drug Administration has filed for scientific review two Modified Risk Tobacco Product (MRTP) renewal applications for the company’s VLN® King and VLN® Menthol King combusted, filtered cigarettes. The company said the FDA filing is an important step in the regulatory process to continue marketing the 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 authorized as MRTPs. The company said the existing orders are set to expire in December 2026 unless renewed, and that the current review process is intended to support continued modified risk marketing status beyond that date.
“We are pleased that the FDA has filed our VLN MRTP renewal applications for scientific review, an important procedural step in the renewal process for the first and only combustible cigarettes authorized as modified risk tobacco products,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. He said the company remains focused on working through the FDA review process “responsibly, transparently and in full compliance” as it advances its reduced-nicotine platform for adult smokers.
Under the existing FDA orders, 22nd Century said it 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 the claims are accompanied by the statement “Helps you smoke less.”
In connection with the renewal process, the company said the FDA has begun releasing redacted application materials for public access and opened a docket for public comment. 22nd Century said the process enables stakeholders to submit data and feedback as part of the scientific review, and that it underscores the rigor of the FDA’s modified risk framework and the importance of maintaining a robust evidence base for its VLN® franchise.
In the 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 said its renewal submission was supported by additional marketplace data, including a 2024 study involving more than 400 participants. The company said the study demonstrated a 40% reduction in daily cigarette consumption over 12 weeks among smokers using VLN® cigarettes.
The company said the release does not announce renewal approval, and it said no assurance can be given regarding the outcome of the FDA’s review.
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