Key Points
- 22nd Century distributed approximately 8,800 cartons of VLN® cigarettes across 1,700 new U.S. retail outlets in Q4 2025.
- The company plans to exceed 5,000 retail points of distribution nationwide in 2026.
- VLN® remains the only FDA-authorized combustible cigarette permitted to make reduced nicotine consumption claims.
- The FDA’s proposed 0.7 mg/g nicotine cap could reshape the U.S. cigarette market if finalized.
- The company continues to report financial losses and faces liquidity and distress risks despite early sales growth.
2Firsts, February 24, 2026
According to Globe Newswire/TheFly/GuruFocus，22nd Century Group, Inc. reported continued early sales momentum for its VLN® very low nicotine cigarettes in the U.S. market, highlighting expanding retail penetration and regulatory developments that could reshape the combustible cigarette category.
In the fourth quarter of 2025, the company distributed approximately 8,800 cartons of VLN® cigarettes across about 1,700 new retail outlets nationwide. The company stated that initial sell-through data from participating retailers indicates early consumer adoption among adult smokers, with purchases occurring across all three VLN® brand variants: 22nd Century VLN®, Pinnacle VLN®, and Smoker Friendly VLN®.
Chief Executive Officer Larry Firestone described the distribution phase as an “ignition” point, signaling the beginning of broader commercial rollout. The company plans to expand distribution to more than 5,000 retail points in 2026 by adding large convenience chains, national and regional wholesalers, and independent retailers.
VLN® cigarettes were authorized by the U.S. Food and Drug Administration in December 2021 under the Modified Risk Tobacco Product (MRTP) framework. They remain the only combustible cigarettes permitted to market claims such as “95% less nicotine” and “helps reduce your nicotine consumption.”
The company’s technology is based on proprietary non-GMO reduced nicotine tobacco plants developed through plant biotechnology to lower alkaloid biosynthesis, resulting in tobacco containing approximately 95% less nicotine than conventional varieties.
Regulatory momentum may influence the product’s future market position. In January 2025, the FDA issued a proposed rule to mandate a maximum nicotine level of 0.7 milligrams per gram of tobacco in combustible cigarettes. If finalized, the rule would require minimally addictive nicotine levels in all cigarettes sold in the U.S. The proposal remains under review, and implementation timing is uncertain.
Despite the reported commercial traction, financial disclosures indicate ongoing challenges. The company reported revenue of approximately $7.8 million and negative operating margins exceeding 100%. Its Altman Z-score places it in the financial distress category, suggesting elevated bankruptcy risk. Institutional ownership remains limited, while insider ownership is comparatively high.
The company derives most of its revenue from its tobacco segment, which includes commercialization of VLN® cigarettes and research cigarettes under the SPECTRUM brand.
While early distribution signals progress, scaling adoption nationally and navigating regulatory uncertainties remain key factors in determining the company’s long-term commercial viability.
（Source: 22nd Century Group official website）
