Key Points
- FDA begins VLN renewal review;
- VLN remains only combustible MRTP cigarette;
- Current authorization expires in 2026;
- Public comment process now open.
2Firsts
May 13, 2026
According to the U.S. Food and Drug Administration (FDA), the agency has formally accepted for scientific review renewal applications submitted by 22nd Century Group, Inc. (NASDAQ: XXII) for its VLN King and VLN Menthol King reduced-nicotine cigarettes under the Modified Risk Tobacco Product (MRTP) pathway.
VLN products were originally granted MRTP authorization in December 2021, becoming the first — and currently the only — combustible cigarettes authorized by the FDA as modified-risk tobacco products.
Under existing FDA orders, 22nd Century is authorized to market VLN products using claims including “95% less nicotine,” “Helps reduce your nicotine consumption,” “Greatly reduces your nicotine consumption,” and “Helps you smoke less.”
The current MRTP authorizations are scheduled to expire in December 2026 unless renewed by the FDA.
22nd Century CEO Larry Firestone said:
“The FDA’s acceptance of our VLN MRTP renewal applications for scientific review marks an important procedural step in the renewal process.”
He said the company remains committed to working through the FDA review process “responsibly, transparently and in full compliance.”
The FDA has released redacted application materials and opened a public comment docket, allowing stakeholders to submit data and feedback during the review process.
22nd Century said the process demonstrates the rigor of the FDA’s modified-risk regulatory framework and the importance of maintaining a robust scientific evidence base for VLN products.
The company said VLN remains uniquely positioned within the combustible tobacco category and described the renewal process as strategically important to its harm-reduction strategy.
Under the FDA’s MRTP framework, products must demonstrate that they reduce exposure risks compared with conventional tobacco products and benefit public health overall.
Public information shows VLN cigarettes contain approximately 95% less nicotine than conventional cigarettes. 22nd Century cited independent clinical studies indicating reduced-nicotine cigarettes may help lower smoking rates and increase quit attempts.
Industry observers say the renewal outcome could also influence future FDA policy related to reduced-nicotine cigarettes.
The FDA has previously proposed a nationwide low-nicotine cigarette standard, though the rule has not yet been finalized.
(Cover Image:22nd Century Group rings the Nasdaq Closing Bell on Aug 16, 2022, marking the successful launch of its reduced-nicotine tobacco products| Image source: Linkedin)
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