StockNews.AI
XXII
StockNews.AI
54 days

22nd Century Announces Operation 100 – A 100mm VLN® Cigarette Designed to Reach Even More Adult Smokers Who Want to Reduce Their Nicotine Consumption

1. 22nd Century Group advances 100mm VLN® cigarette for FDA review by Q4 2025. 2. The 100mm size targets half the U.S. smoking population for nicotine reduction. 3. Clinical studies show reduced smoking behaviors with VLN® low nicotine products. 4. 22nd Century is the only company with FDA authorization for reduced risk cigarettes. 5. Expansion is supported by 45 million cartons annual production capacity in NC.

9m saved
Insight
Article

FAQ

Why Bullish?

The FDA submission represents a significant growth opportunity. Historical precedents show approval leads to stock price spikes.

How important is it?

Success in FDA submissions can lead to increased sales and market share, making the news impactful.

Why Long Term?

Successful FDA submission may enhance product offerings and revenue streams over time.

Related Companies

PMMOBTI
100mm Cigarettes Comprise Approximately Half the U.S. Market, Giving Even More Smokers a Familiar Choice as They Seek Ways to Change Their Smoking Behavior First FDA Submission Planned for Q4 2025 MOCKSVILLE, N.C.,, June 26, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that is leading the fight against nicotine by offering smokers a choice about their nicotine consumption, today announced the advancement of a 100mm VLN® reduced nicotine content cigarette. The first of many exciting new research and development initiatives, dubbed “Operation 100,” the program targets an FDA submission for the new 100mm VLN® product by Q4 2025, joining the family of existing FDA authorized 84mm king size VLN® reduced nicotine content cigarettes in the fight against nicotine and the resulting harms of smoking. The 100mm combustible cigarette product, if authorized, would be available in both VLN® branded products and through 22nd Century’s partner branded VLN® products, such as Smoker Friendly, Pinnacle and others. "Independent clinical studies have shown that offering reduced nicotine content products in familiar form factors already used by smokers is effective in reducing smoking behaviors – a fact that has been proven in real life by our VLN® products already on the market," stated Larry Firestone, 22nd Century Group Chief Executive Officer. "By adding a 100mm VLN® cigarette, which is preferred by approximately half the U.S. smoking population, we can reach even more customers who want to benefit from VLN® products and take control of their nicotine consumption.” 22nd Century’s proprietary reduced nicotine content tobacco has been extensively studied in independent clinical studies including those reviewed by the U.S. Food and Drug Administration as part of its decision to grant the first and only Modified Risk Tobacco Authorization to a combustible cigarette – VLN® from 22nd Century. Findings from these independent clinical studies include: Smokers lower their cigarette consumption when using cigarettes containing 22nd Century's patented low nicotine tobacco.There is an increased number of quit attempts when using cigarettes containing 22nd Century's patented low nicotine tobacco.Smokers do not engage in compensatory smoking when using cigarettes containing 22nd Century’s patented low nicotine tobacco.Biomarkers of nicotine exposure are reduced in individuals smoking cigarettes made from 22nd Century’s patented low nicotine tobacco compared to normal nicotine content cigarettes.Cigarette dependence is reduced when using cigarettes containing 22nd Century’s patented low nicotine tobacco. Said Firestone. “Nicotine is a highly addictive substance. While stopping smoking and nicotine consumption entirely is always the best approach from a health perspective, decades of health data tells us that we need to offer a wide variety of approaches for smokers to achieve their health goals. We are developing a lane for smoking harm reduction solely centered around our VLN ® products. Cigarettes containing 22nd Century’s patented low nicotine tobacco products have been shown to help smokers reduce their smoking behaviors, and we hope to reach even more smokers by making this innovative product available in the styles, brands and form factors smokers prefer.” “We continue to explore additional smoking harm reduction avenues and our VLN ® products which are now in the market are the only FDA authorized combustible cigarette that complies with the most recent proposed FDA mandate for low nicotine cigarettes.” About 22nd Century Group, Inc. 22nd Century Group is the pioneering nicotine harm reduction company in the tobacco industry enabling smokers to take control of their nicotine consumption.  We created our flagship product, the VLN® cigarette, to give traditional cigarette smokers an authentic and familiar alternative that helps them take control of their nicotine consumption. VLN® cigarettes have 95% less nicotine than the traditional cigarette and have been proven to allow consumers to greatly reduce their nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers the option to take control of their nicotine consumption and make informed and more productive choices, including the choice to avoid addictive levels of nicotine altogether.  Our wholly owned subsidiaries include a leading cigarette manufacturer that produces all VLN® products and provides turnkey contract manufacturing for other tobacco brands both domestically and internationally. The 60,000 square foot facility in Mocksville, North Carolina has the capacity to produce more than 45 million cartons of combustible tobacco products annually with additional space for expansion.  Our proprietary reduced nicotine tobacco blends are made possible by comprehensive and patented technologies that regulate nicotine biosynthesis activities in the tobacco plant, resulting in full flavor and high yield with 95% less nicotine. Our extensive patent portfolio has been developed to ensure we have the only low nicotine combustible cigarette in the United States and critical international markets. 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, (iii) our financial and operating performance and (iv) our expectations for our business interruption insurance claim. 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 in the Company’s Quarterly Report filed on May 13, 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 ContactMatt KrepsInvestor Relations22nd Century Groupmkreps@xxiicentury.com214-597-8200

Related News