Company to Pursue Additional PMTA Submissions, Building on Its Status as the Only Holder of an FDA-Authorized Low Nicotine Combustible Cigarette Branded as VLN® Products
Expanded PMTA Portfolio and Licensing Strategy Designed to Address Wider Consumer Preference and Unlock Further Retail Penetration Opportunities
MOCKSVILLE, N.C., April 07, 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 an update on the advancement of a 100mm VLN® reduced nicotine content cigarette.
The Company’s proprietary reduced 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.
Previously announced as “Operation 100” in 2025, the Company’s research and development team has completed product prototyping and initial analytical evaluations required for advancing to the next phase of regulatory submissions. 22nd Century Group believes that introducing a 100mm VLN® reduced nicotine content cigarette — alongside its existing authorized 84mm king size VLN® products — will expand access to reduced nicotine alternatives in the familiar form factors preferred by adult smokers.
Notably, 22nd Century Group currently holds the only FDA-issued Premarket Tobacco Product Application (PMTA) authorization for a combustible reduced nicotine content cigarette, its VLN® king size products. Building on this foundation, the Company is preparing a second PMTA application for authorization from the FDA for its new 100mm VLN® cigarette. Management believes its prior PMTA experience, scientific data package, and regulatory engagement have positioned the Company to efficiently advance the 100mm submission process.
The Company is also advancing its long-term strategic initiative to grow its unique product portfolio through the submission of multiple PMTAs across a broad range of combustible products. This initiative is designed to support diverse tobacco blends and components, a variety of product sizes, and multiple product formats, including filtered cigars. By building a robust portfolio of new tobacco product authorizations from the FDA spanning these categories, the Company intends to create a flexible and scalable platform that can accommodate evolving market preferences and regulatory requirements. All current and any newly authorized combustible tobacco products within this expanded portfolio will be available for licensing. This will provide other tobacco companies with compliant, ready-to-market product pathways and reinforcing the Company’s position as a leader in regulatory-driven innovation within the combustible tobacco segment.
“Our attitude at 22nd Century is that it would be preferable if the FDA did not need to impose a mandate on low-nicotine cigarettes. Instead, we believe progress can be achieved by continuing to expand our presence in the tobacco retail market with our own brands and licensed partner brands, allowing consumers across the U.S. and eventually around the world to access VLN® products through normal market choice.
We are open to licensing our low-nicotine technology more broadly within the industry, which we believe could significantly accelerate efforts to reduce smoking-related harm in a relatively short period of time.
We envision a future where virtually any brand a consumer chooses could offer a VLN® SKU on the shelf, similar to what we have already accomplished with Pinnacle VLN® and Smoker Friendly VLN®. Today, we believe we offer a compelling solution for adult smokers who value the ritual of lighting up and relaxing with a cigarette, while seeking a reduced-nicotine alternative.” stated Larry Firestone, Chief Executive Officer of 22nd Century Group.
The Company continues to explore additional smoking harm reduction initiatives. VLN® products currently in the market remain the only FDA-authorized combustible cigarettes that align with the FDA’s proposed mandate for reduced nicotine cigarettes. In addition, the Company has received consistent feedback from both consumers and retail partners indicating meaningful demand for a 100mm VLN® product offering, reinforcing management’s belief that expanding into this format represents both a public health opportunity and a compelling market-driven initiative.
Any new tobacco product resulting from our ongoing research and development initiatives, including Operation 100, will require FDA authorization prior to commercialization. The Company intends to provide ongoing updates as regulatory milestones are achieved.
FDA Authorization and Scientific Foundation
22nd Century 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 and Nicotine Reduction Movements 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.
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 expectations regarding regulatory enforcement, including our ability to receive authorization or approval for new products, and (ii) 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 26, 2026. 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