22nd Century Files VLN® MRTP Renewal – Only Combustible Tobacco Product Authorized by the FDA Specifically to Help Smokers Smoke Less

Rhea-AI Summary

22nd Century Group (Nasdaq: XXII) filed a Modified Risk Tobacco Product (MRTP) renewal on Jan 6, 2026 for its VLN® reduced nicotine combustible cigarettes, the only combustible cigarette authorized by the FDA to make low‑nicotine and "helps you smoke less" claims.

Key factual points: VLN® tobacco contains 95% less nicotine; a 2024 marketplace study reported a 40% reduction in daily smoking over 12 weeks; original FDA authorization was issued in Dec 2021 for five years, with renewal due Dec 2026.

Positive

• 95% less nicotine in VLN tobacco
• 2024 study: 40% daily consumption reduction over 12 weeks
• Only combustible cigarette FDA-authorized for MRTP claims

Negative

• MRTP renewal is a filed application, not yet renewed
• FDA's low‑nicotine mandate is not a final ruling
• Original authorization expires in Dec 2026 (timeline risk)

Key Figures

U.S. smokers 28.8 million Estimated number of smokers in the United States cited in release

Smoking healthcare costs $600 billion annually Healthcare-related costs from tobacco harm in the United States

Nicotine reduction 95% less nicotine VLN® reduced nicotine content vs conventional cigarettes per FDA-authorized claim

Marketplace study size 400+ participants 2024 marketplace study using 95% reduced nicotine VLN® cigarettes

Study duration 12 weeks Period over which smokers’ daily consumption was tracked in 2024 study

Smoking reduction 40% reduction Decrease in daily cigarette consumption over 12 weeks in 2024 study

MRTP authorization term 5 years Original VLN® combustible authorization from December 2021 to December 2026

FDA low nicotine guideline Issued January 2025 Proposed low nicotine mandate that VLN® products are stated to meet

Market Reality Check

$0.9270 Last Close

Volume Volume 175,106 is near its 20-day average of 173,562 shares ahead of this MRTP renewal filing. normal

Technical Price 0.9653 was trading below the 200-day MA of 8.86 before this news.

Peers on Argus

Pre-news, XXII was up 9.69% while peers were mixed: KAVL (+1.13%), ISPR (+0.35%), UVV (+0.86%) higher, GNLN (-0.6%) and TPB (-1.67%) lower, pointing to a stock-specific move rather than a broad tobacco sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 09	Investor conference	Neutral	-2.7%	CEO scheduled to present at Emerging Growth Virtual Investor Conference.
Oct 28	Insurance settlement	Positive	-0.7%	Received <b>$9.5 million</b> cash from business interruption insurance settlement.
Oct 23	VLN rollout update	Positive	+3.4%	VLN® launch at ~<b>140</b> Circle K stores in Illinois and expansion to <b>45</b> states.
Oct 21	Earnings notice	Neutral	-1.9%	Announcement of Q3 2025 results release date and webcast details.
Sep 30	Policy support	Positive	+3.7%	Support for FDA reduced nicotine mandate highlighting VLNC tech’s public health impact.

Pattern Detected

Recent positive VLN- and policy-related headlines have sometimes seen mixed price reactions, with both aligned and divergent moves around regulatory and commercialization updates.

Recent Company History

Over the last few months, XXII has focused updates on its VLN® reduced-nicotine platform and regulatory landscape. On Sep 30, 2025, it highlighted support for FDA’s reduced nicotine mandate and the potential to avert 1.8 million deaths. Commercial rollout progressed with a Circle K launch across about 140 locations and authorizations in 45 states. The company also secured a $9.5 million insurance settlement and maintained investor outreach via conferences and earnings calls. Today’s MRTP renewal filing extends this ongoing regulatory and harm-reduction narrative.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-06-20

An effective Form S-3 shelf filed on June 20, 2025 registers up to 8,588,811 resale shares tied to prior warrants, all via cashless exercise. The company receives no cash from these exercises or subsequent resales, but tradable float can increase and existing holders may face ownership and EPS dilution without any liquidity benefit to the issuer.

Market Pulse Summary

This announcement highlights 22nd Century’s MRTP renewal filing for VLN®—described as the only combustible cigarette authorized by the FDA specifically to help smokers smoke less—and reinforces clinical data such as a 40% reduction in daily consumption over 12 weeks in a 400+-participant study. In context with prior efforts to expand VLN® distribution and support FDA’s reduced nicotine mandate, key items to watch include the timing and outcome of the renewal decision and how the company manages dilution from existing registered resale shares.

Key Terms

modified risk tobacco product regulatory

"announced the filing of its Modified Risk Tobacco Product renewal application"

A modified risk tobacco product is a tobacco or nicotine product that is marketed with claims it reduces health risks or exposure to harmful substances compared with other tobacco products; such claims are typically subject to regulatory review and approval. For investors, this matters because approved modified-risk status can change consumer demand, legal exposure, labeling requirements and market access—similar to how a government-backed “low-risk” label can alter a product’s sales and liability profile.

mrtp regulatory

"included in the original MRTP decision, FDA authorized VLN® claims"

An MRTP (Modified Risk Tobacco Product) is an official U.S. regulatory designation for a tobacco or nicotine product that a regulator has reviewed and allowed to be marketed as posing lower health risks or reduced exposure to harmful substances. Think of it like an official “lower-risk” label: investors watch MRTP decisions closely because they can open or restrict market access, change legal and marketing rights, and materially affect a product’s sales and a company’s valuation.

clinical research medical

"Based on the extensive independent clinical research studies included"

Clinical research is the process of testing medical treatments, procedures, devices or diagnostics in people to determine whether they are safe, effective and beneficial. Think of it like testing a new gadget in controlled steps with increasing numbers of users to prove it works and identify risks. For investors, outcomes and timelines from these studies drive regulatory approval, market potential, and the value and risk of healthcare companies.

peer reviewed medical

"an extensive list of peer reviewed publications reviewed as part of the FDA’s MRTP"

Peer reviewed means a study, report or paper has been evaluated by independent experts in the same field before publication; think of it as a professional second opinion that checks methods, reasoning and conclusions. For investors, peer review increases confidence that the claims are scrutinized and less likely to be errors or biased, so findings cited in company disclosures or product claims carry more credibility when they are peer reviewed.

non-gmo technical

"Our proprietary non-GMO reduced nicotine tobacco plants were developed"

Non-GMO means a product or ingredient was produced without genetic modification techniques — the plant or organism’s DNA has not been intentionally altered in a laboratory. Investors care because non-GMO labeling can affect consumer demand, price premiums, shelf access and supply-chain cost; think of it like an organic or “no added hormones” label that can open certain markets, change margins, and create reputational risk or advantage for companies.

alkaloid biosynthesis medical

"technologies that regulate alkaloid biosynthesis activities resulting in a tobacco plant"

Alkaloid biosynthesis is the set of natural chemical steps inside plants, fungi or microbes that build alkaloids — a class of nitrogen-containing molecules that include many medicines, stimulants and defensive toxins. For investors, controlling or scaling these pathways is like improving a factory assembly line: it affects how much of a valuable compound can be produced, the cost and consistency of supply, intellectual property and regulatory or safety risks.

combustible cigarette technical

"the only low nicotine combustible cigarette authorized by the FDA"

A combustible cigarette is a hand-held tobacco product that delivers nicotine by burning plant material and inhaling the resulting smoke; think of it like a tiny controlled fire whose smoke is the product users inhale. It matters to investors because these products face steady declines in consumer demand, rising taxes, stiff regulation, health-related legal risks and competition from non-burning alternatives, all of which can materially affect sales, costs and long-term profitability for companies in the tobacco sector.

nicotine addiction medical

"harms of smoking driven by nicotine addiction, today announced the filing"

An ongoing medical condition in which a person repeatedly seeks and uses nicotine products despite harmful consequences, driven by chemical changes in the brain that create strong cravings and withdrawal symptoms when use stops. For investors, nicotine addiction matters because it shapes demand for cigarettes, vaping, nicotine replacement therapies, and cessation products, and influences regulatory risk, public perception, and long-term sales—similar to how customer dependence on a popular service can make revenue stable but also attract scrutiny and potential disruption.

AI-generated analysis. Not financial advice.

VLN^® Reduced Nicotine Content Tobacco Reduces Smoking and Increases Quit Attempts Per Clinical Data

Multiple VLN^® Based Cigarette Brands Expand Availability and Reach of Non-Addictive Alternative in the Fight Against The Harms of Smoking

MOCKSVILLE, N.C., Jan. 06, 2026 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that has for 28 years led and continues to lead the fight against the harms of smoking driven by nicotine addiction, today announced the filing of its Modified Risk Tobacco Product renewal application for its innovative VLN^® reduced nicotine content products, the first and still the only combustible cigarette authorized by the U.S. Food and Drug Administration specifically to reduce the health harms of smoking.

Based on the extensive independent clinical research studies included in the original MRTP decision, FDA authorized VLN^® claims include:

• “95% less nicotine”
• “Helps reduce your nicotine consumption”
• “Greatly reduces your nicotine consumption”
• “Helps you smoke less”
  
  

In the United States, there are approximately 28.8 million smokers, and the resulting tobacco harm generates over $600 billion annually in healthcare related costs in the United States. Smoking VLN^® reduced nicotine content cigarettes lowers the amount of addictive nicotine consumed. Decades of independent clinical research studies and an extensive list of peer reviewed publications reviewed as part of the FDA’s MRTP authorization process documented that this simple change can reduce the rate of smoking, increase quit attempts by smokers and reduce the health harms of smoking. The 2024 marketplace studyⁱ, including 400+ participants and 95% reduced nicotine VLN^® cigarettes, demonstrated that smokers reduced daily consumption over 12 weeks by 40%, adding further evidence of the potential impact of VLN^® combustible products.

VLN^® combustible cigarettes were originally authorized in December 2021 for five years, with renewal due in December 2026. Now a growing list of cigarette brands are carrying VLN^® branded products to offer smokers an alternative product containing 95% less nicotine than conventional, highly addictive cigarettes. In doing so, these partner brands are propagating a new tool in the fight against the pervasive health harms of smoking.

“With smoker health and wellness as a top priority, the MRTP authorization for VLN^® cigarettes was one of the most forward-thinking decisions by the FDA in the tobacco industry, launching an innovative tool in the fight to reduce the health harms of smoking. Nicotine is a highly addictive substance, and most smoking reduction strategies simply try to replace the source of nicotine while disregarding the critically important behavioral and social elements of addiction. The FDA’s clinically documented affirmation that our VLN^® reduced nicotine content tobacco products can positively alter smoking behaviors, leading to more quit attempts and improved public health outcomes, opened an entirely new approach to fighting the harms of smoking,” said Larry Firestone, Chief Executive Officer of 22nd Century Group.

“We now have a growing list of brands, products and tobacco plant varieties under the VLN^® umbrella to give smokers as many low nicotine alternatives as possible, meeting them where they are today in the comfort of their current habit, with products and price points they can readily adopt. Additionally, VLN^® tobacco products are the only products that meet the FDA’s proposed guideline for low nicotine based on its low nicotine mandate issued in January 2025,” said Firestone. “While the FDA’s mandate has not yet become a final ruling, we expect that the FDA will fully support our MRTP renewal for VLN^®.”

The renewal process is part of 22nd Century’s ongoing R&D programs that continue to advance reduced nicotine content in tobacco and support the introduction of additional VLN^® based products. The VLN^® line of low nicotine products allow tobacco users to focus on health and wellness by smoking less, rather than being strategically transitioned into the growing number of new nicotine delivery products that are designed by Big Tobacco to create and sustain nicotine addiction.

About 22^nd 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 95% less nicotine than traditional tobacco plants. Our extensive patent portfolio has been developed to ensure that our high-quality tobacco can be grown commercially at scale. We continue to develop our intellectual property to ensure our ongoing leadership in the tobacco harm reduction movement. 

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 95% less nicotine compared to traditional cigarettes and have been proven to allow consumers to greatly reduce their nicotine consumption. 

FDA Authorized 

Our VLN^® cigarette is the only low nicotine combustible cigarette authorized by the FDA in the United States.

VLN^® is a registered trademark 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

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ⁱ https://pubmed.ncbi.nlm.nih.gov/38911348/ Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial

FAQ

What did 22nd Century (XXII) file on Jan 6, 2026 regarding VLN®?

22nd Century filed a Modified Risk Tobacco Product renewal for VLN® reduced nicotine combustible cigarettes.

How much lower is nicotine in VLN® cigarettes compared with regular cigarettes?

VLN® tobacco contains 95% less nicotine than traditional tobacco plants, per the company.

What smoking reduction was reported in the 2024 VLN® marketplace study?

The 2024 study reported smokers cut daily consumption by 40% over 12 weeks when using 95% reduced nicotine VLN® cigarettes.

Is VLN® the only combustible product authorized by the FDA for MRTP claims?

Yes; VLN® is described as the only combustible cigarette authorized by the FDA to make specific reduced‑nicotine and smoking‑reduction claims.

When does the original FDA MRTP authorization for VLN® expire?

The original authorization was issued in Dec 2021 for five years, with renewal due in Dec 2026.

Does the FDA's low‑nicotine mandate already apply to VLN® products?

The company says VLN® meets the FDA's proposed low‑nicotine guideline, but the mandate is not yet a final ruling.