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

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
[email protected]
214-597-8200

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