FDA Begins Review of VLN MRTP Renewal Applications
The U.S. Food and Drug Administration (FDA) has initiated the scientific review process for the renewal of the Modified Risk Tobacco Product (MRTP) authorization for VLN low-nicotine cigarettes, a product of 22nd Century Group. The current authorization is set to expire in December 2026.
Key Highlights
- FDA initiates review for VLN renewal.
- VLN is the only combustible cigarette with MRTP authorization.
- Authorization set to expire at the end of 2026.TheThe
- FDA simultaneously opens a public comment period.
FDA Formally Accepts VLN Renewal Applications
May 13, 2026. According to the U.S. Food and Drug Administration (FDA). The agency has formally accepted the renewal applications submitted by 22nd Century Group for its VLN King and VLN Menthol King low-nicotine cigarettes as Modified Risk Tobacco Products (MRTP), and has commenced the scientific review process.
VLN Remains the Only Combustible MRTP Cigarette
VLN products first received FDA MRTP authorization in December 2021, becoming the first and currently the only combustible cigarette product in the United States to hold such authorization.
Under the existing FDA authorization, 22nd Century is permitted to market VLN products using claims such as “95% less nicotine,” “Helps reduce your nicotine consumption,” “Greatly reduces your nicotine consumption,” and “Helps you smoke less.”
Current Authorization Expires in 2026
The relevant MRTP authorization is scheduled to expire in December 2026, pending the FDA’s completion of the renewal approval process.
CEO Highlights Importance of Review Process
Larry Firestone, CEO of 22nd Century, stated:
- “The FDA’s acceptance of the VLN MRTP renewal applications and the initiation of the scientific review represent a significant procedural milestone in the renewal process.”
He added that the company will continue to advance through the FDA review process in a manner that is “responsible, transparent, and compliant.”
FDA Opens Public Comment Period
The FDA has now made publicly available a redacted version of the application materials and has simultaneously opened a public comment period, allowing stakeholders to submit data and comments.
22nd Century Emphasizes Scientific Evidence
22nd Century noted that this process further underscores the rigor of the FDA’s regulatory framework for modified risk tobacco products, as well as the importance of maintaining the scientific evidence base supporting VLN.
The company stated that its VLN product platform holds a unique position within the combustible tobacco category and believes that the renewal review is of significant importance to its future harm-reduction strategy.
FDA Standards for Modified Risk Tobacco Products
According to the FDA’s current definition of Modified Risk Tobacco Products (MRTPs). Relevant products must demonstrate that they reduce user exposure risks compared to traditional tobacco products and serve the overall interests of public health.
Clinical Studies Support Low-Nicotine Claims
Publicly available data indicate that the nicotine content in VLN cigarettes is approximately 95% lower than that of traditional cigarettes. Citing multiple independent clinical studies, 22nd Century noted that low-nicotine cigarettes help reduce smoking volume and increase the rate of quit attempts.
Renewal Outcome May Influence Future FDA Policy
Industry observers point out that the outcome of the VLN renewal review could also influence the future direction of the FDA’s policies regarding low-nicotine cigarettes.
The FDA has previously proposed a regulatory concept to advance a national standard for low-nicotine cigarettes; however, the associated rules have not yet been finalized.
