Top Takeaways:
- Renewal filed: 22nd Century submitted its MRTP renewal application to keep VLN cigarettes on the market beyond 2026.
- Regulatory outlier: VLN remains the only FDA-authorized combustible cigarette with reduced-risk claims.
- Policy relevance: The product already meets the FDA’s proposed low-nicotine cigarette standard issued in 2025.
22nd Century Group has filed a renewal application with the U.S. Food and Drug Administration to extend its Modified Risk Tobacco Product (MRTP) authorization for VLN reduced-nicotine cigarettes, the company said. The filing is required before the December 2026 expiration of the original five-year authorization granted in December 2021.
VLN cigarettes remain the only combustible cigarette product authorized by the FDA to make modified-risk claims based on reduced nicotine content. Under its existing MRTP order, 22nd Century may state that VLN contains “95% less nicotine” and that the products help reduce nicotine consumption and smoking frequency.
The FDA’s decision was based on a substantial body of independent clinical research showing that lowering nicotine levels can reduce cigarette consumption and increase quit attempts without compensatory smoking.
The renewal submission comes amid federal regulators’ continued interest in nicotine reduction as a core tobacco control strategy. In January 2025, the FDA issued a proposed product standard that would require very low nicotine levels in cigarettes.
While that rulemaking process is ongoing, VLN cigarettes already meet the proposed nicotine threshold, making the product one of the few commercially available options aligned with the agency’s long-term policy direction.
According to the company, additional marketplace data since the original authorization further support VLN’s public health impact. A 2024 study of more than 400 adult smokers found that participants using VLN cigarettes reduced their daily cigarette consumption by roughly 40% over 12 weeks. The company said those findings were included in the renewal package submitted to the FDA.
22nd Century said the renewal is part of its broader effort to expand access to reduced-nicotine combustible products through partnerships with additional cigarette brands, offering adult smokers alternatives that align with existing smoking behaviors while reducing nicotine exposure.
The FDA will review the application as part of its MRTP renewal process, which assesses whether the products continue to meet the statutory “appropriate for the protection of public health” standard.
