22nd Century Group Reports Continued Early Sales Momentum for VLN® Cigarette Products
Rhea-AI Summary
22nd Century Group (Nasdaq: XXII) reported early commercial traction for its FDA-authorized VLN® low nicotine combustible cigarettes. In Q4 2025 the company distributed ~8,800 cartons across ~1,700 new retail outlets, and plans to exceed 5,000 retail points in 2026.
The release cites FDA regulatory developments (Jan 2025 proposed 0.7 mg/g nicotine cap) and reiterates VLN® authorization in Dec 2021 as supporting the company’s market opportunity and distribution expansion.
Positive
- Q4 2025 distribution: ~8,800 cartons across ~1,700 new retail outlets
- 2026 rollout target: plan to exceed 5,000 retail points nationwide
- Regulatory credential: VLN® remains the only FDA-authorized combustible cigarette to reduce nicotine
Negative
- Early scale is limited: 8,800 cartons denotes modest initial volume versus national cigarette market size
- Regulatory uncertainty: proposed FDA nicotine cap (0.7 mg/g) is not finalized and timing remains unclear
Key Figures
Market Reality Check
Peers on Argus
Peer moves are mixed: GNLN -9.59%, ISPR +7.93%, TPB +0.13%, UVV -0.56%, KAVL flat. Combined with scanner data showing both up and down movers, this points to stock-specific dynamics rather than a unified tobacco/cigarettes sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 20 | Prelim 2025 results | Negative | -8.4% | Preliminary 2025 revenue decline and continued net loss highlighted in 8-K. |
| Jan 15 | Year-in-review letter | Positive | +0.8% | CEO letter on VLN® relaunch, restructuring exit, and stronger balance sheet. |
| Jan 12 | Conference participation | Neutral | -6.0% | Announcement of Needham Growth Conference presentation and investor meetings. |
| Jan 06 | MRTP renewal filing | Positive | -4.2% | Filing to renew VLN® MRTP status with supporting low‑nicotine data. |
| Dec 09 | Investor conference | Neutral | -2.7% | Emerging Growth Conference presentation and webcast logistics announcement. |
Recent history shows frequent negative price reactions, including to positive or neutral news, with only one modestly positive response among the last five events.
Over the last few months, 22nd Century has focused on VLN® commercialization, balance sheet repair, and regulatory positioning. On Dec 9, 2025 and Jan 12, 2026, conference participation announcements were followed by modest declines. A Jan 6, 2026 MRTP renewal filing for VLN® also saw a negative move. A positive 2025 year-in-review letter on Jan 15 produced only a small gain, while preliminary 2025 financial results on Feb 20, 2026 prompted another selloff. Today’s operational VLN® update arrives against this backdrop of cautious trading.
Regulatory & Risk Context
An effective Form S-3 from Jun 20, 2025 registers up to 8,588,811 shares for resale tied to prior warrants. These can be exercised on a cashless basis, delivering shares at a zero exercise price. The filing notes potential dilution to EPS and ownership percentages, increased tradable float, and no cash proceeds or liquidity benefit to the company.
Market Pulse Summary
This announcement highlights continued early VLN® sales, with about 8,800 cartons shipped in Q4 2025 and plans to exceed 5,000 retail outlets in 2026. It builds on prior disclosures of FDA authorization in December 2021 and an MRTP framework that supports “95% less nicotine” claims. Against a backdrop of recent revenue declines and losses, investors may watch for sustained sell-through, regulatory developments on the proposed 0.7 mg/g nicotine cap, and how any future share issuances under existing registrations affect per-share metrics.
Key Terms
combustible cigarette medical
modified risk tobacco product (mrtp) regulatory
AI-generated analysis. Not financial advice.
Expansion in 2026 Forecasted to Exceed 5,000 Retail Outlets Nationwide as Consumers Demonstrate Interest in VLN® Brands
VLN® Remains the Only FDA-Authorized Combustible Cigarette Designed to Reduce Nicotine Consumption
MOCKSVILLE, N.C., Feb. 23, 2026 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company focused on reducing the harms of smoking through nicotine reduction, today announced continued early sales momentum for its VLN® low nicotine cigarette products in the U.S. market.
The Company’s proprietary low nicotine technology is designed to serve adult smokers who want to change their smoking habits by significantly reducing nicotine consumption. 22nd Century is focusing on smoker health and wellness by giving smokers an opportunity to control their tobacco consumption, rather than switching them to another highly addictive product like a vape or pouch.
Regulatory Momentum Underscores Significant Market Opportunity
The Company’s progress aligns with accelerating regulatory developments. In January 2025, the U.S. Food and Drug Administration 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 cigarettes sold in the United States to contain minimally addictive or non-addictive levels of nicotine. 22nd Century believes VLN® is uniquely positioned in this evolving regulatory landscape, demonstrating both the scientific and commercial feasibility of very low nicotine cigarettes.
Globally, nicotine reduction is also supported under the WHO Framework Convention on Tobacco Control, developed under the auspices of the World Health Organization. The FCTC recognizes product regulations, including nicotine reduction to minimally addictive levels—as a key strategy for reducing tobacco dependence and supporting cessation. Together, these developments reinforce what 22nd Century has long advanced: reducing nicotine content is central to addressing addiction itself.
Early Commercial Traction and Expanding Retail Footprint
In the fourth quarter of 2025, approximately 8,800 cartons of VLN® low nicotine combustible cigarettes were distributed across approximately 1,700 new retail outlets nationwide. Initial sell-through data from participating retailers indicates encouraging early consumer adoption, with adult smokers now purchasing VLN® products across all three brand presentations: 22nd Century VLN®, Pinnacle VLN®, and Smoker Friendly VLN®.
Smokers seeking greater control over nicotine intake are beginning to incorporate VLN® products into their smoking journey, validating the Company’s belief that a large, underserved segment of adult smokers is looking for meaningful alternatives.
Expanding distribution across multiple classes of trade is central to unlocking this opportunity. By securing placement with large convenience store retailers, national and regional wholesalers, and independent chains, 22nd Century is broadening access, increasing visibility, and strengthening replenishment cycles. This diversified distribution strategy is designed to accelerate awareness, trial, and sustained adoption as retail points of distribution expand.
“We have achieved ignition. Following our initial distribution phase, smokers are now purchasing our VLN® combustible cigarettes across all markets,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “Early adoption validates years of scientific investment and positions us at the forefront of a potentially transformative shift in the tobacco industry. At the same time, we are seeing growing international interest—from markets exploring tobacco harm reduction policies to potential partners interested in our proprietary very low nicotine tobacco leaf.”
Firestone continued, “This is a long-term opportunity. As we continue to demonstrate sustained smoker adoption of VLN® products, we expect to expand our retail footprint. We plan to grow to more than 5,000 points or more of distribution in 2026 by continuing to add new retail partners across all classes of trade and have significantly advanced sales discussion with partners we anticipate adopting VLN® branded products over the upcoming months. We remain committed to addressing nicotine addiction itself and making our reduced-nicotine products broadly available to adult consumers.”
“As regulatory bodies in the United States and around the world increasingly consider nicotine reduction as a cornerstone of tobacco control policy, we believe we are uniquely positioned at the intersection of science, regulation, and consumer demand. By combining proprietary plant biotechnology, FDA-authorized claims, and expanding retail distribution, the Company aims to play a leading role in accelerating the transition toward minimally addictive combustible cigarettes and supporting adult smokers seeking meaningful change.” concluded Firestone.
FDA Authorization and Scientific Foundation
VLN® low nicotine combustible cigarettes were authorized in December 2021, making them the first and still the only combustible cigarettes authorized by the U.S. Food and Drug Administration specifically to help reduce nicotine consumption.
Decades of independent clinical research and peer-reviewed studies—evaluated as part of the FDA’s Modified Risk Tobacco Product (MRTP) authorization process—demonstrated that reducing nicotine content can decrease nicotine intake, increase quit attempts, and reduce overall exposure to nicotine.
FDA-authorized VLN® claims include:
- “
95% less nicotine” - “Helps reduce your nicotine consumption”
- “Greatly reduces your nicotine consumption”
- “Helps you smoke less”
About 22nd Century Group, Inc.
22nd Century Group is pioneering the Tobacco Harm Reduction Movement by enabling smokers to take control of their nicotine consumption.
Our Technology is Tobacco
Our proprietary non-GMO reduced nicotine tobacco plants were developed using our patented technologies that regulate alkaloid biosynthesis activities resulting in a tobacco plant that contains
Our Products
We created our flagship product, the VLN® cigarette using our low nicotine tobacco, to give traditional cigarette smokers an authentic and familiar alternative in the form of a combustible cigarette that helps them take control of their nicotine consumption. VLN® cigarettes have
VLN® and Helps You Smoke Less® are registered trademarks of 22nd Century Limited LLC.
Learn more at xxiicentury.com, on X (formerly Twitter), on LinkedIn, and on YouTube.
Learn more about VLN® at tryvln.com.
Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements, including but not limited to our full year business outlook. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Forward-looking statements include, but are not limited to, statements regarding (i) our cost reduction initiatives, (ii) our expectations regarding regulatory enforcement, including our ability to receive an exemption from new regulations, and (iii) our financial and operating performance. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 20, 2025 and Quarterly Reports on Form 10-Q on May 13, 2025, August 14, 2025, and November 4, 2025. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.
Investor Relations & Media Contact
Matt Kreps
Investor Relations
22nd Century Group
investorrelations@xxiicentury.com
214-597-8200
FAQ
How many VLN® cartons did 22nd Century (XXII) distribute in Q4 2025?
What is 22nd Century's (XXII) 2026 retail distribution target for VLN® products?
Is VLN® authorized by the FDA and why does that matter for XXII (Nasdaq: XXII)?
How has consumer adoption of VLN® brands been described by 22nd Century (XXII)?
What regulatory development does 22nd Century cite that could affect the cigarette market?
What are the near-term commercial risks for XXII related to VLN® expansion?
