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

Rhea-AI Summary

22nd Century Group (Nasdaq: XXII) has announced "Operation 100," an initiative to develop a 100mm version of their VLN® reduced nicotine content cigarettes. The company plans to submit this new product for FDA approval in Q4 2025.

The 100mm format targets approximately half of the U.S. smoking market and will complement their existing FDA-authorized 84mm king size VLN® cigarettes. The product will be available under the VLN® brand and through partner brands like Smoker Friendly and Pinnacle.

Clinical studies have demonstrated that 22nd Century's proprietary reduced nicotine tobacco helps lower cigarette consumption, increases quit attempts, and reduces cigarette dependence without compensatory smoking behaviors.

Positive

• First and only holder of Modified Risk Tobacco Authorization for combustible cigarettes
• Expansion to 100mm format targets approximately 50% of U.S. smoking market
• Clinical studies demonstrate reduced smoking behavior and increased quit attempts
• Product complies with proposed FDA mandate for low nicotine cigarettes
• Multiple distribution channels through VLN® brand and partner brands

Negative

• FDA approval for 100mm version not yet secured
• Product still promotes smoking despite reduced nicotine
• Significant regulatory hurdles and timeline to approval

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 22^nd 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 22^nd 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 Contact
Matt Kreps
Investor Relations
22nd Century Group
mkreps@xxiicentury.com
214-597-8200

FAQ

When will 22nd Century Group (XXII) launch their 100mm VLN® cigarettes?

22nd Century Group plans to submit the 100mm VLN® cigarettes for FDA approval in Q4 2025. The actual launch date will depend on FDA authorization timeline.

What are the key benefits of 22nd Century Group's (XXII) VLN® cigarettes according to clinical studies?

Clinical studies show VLN® cigarettes lead to reduced cigarette consumption, increased quit attempts, reduced cigarette dependence, and no compensatory smoking behaviors.

How much of the U.S. market could 22nd Century's (XXII) new 100mm VLN® cigarettes reach?

The 100mm cigarette format represents approximately 50% of the U.S. smoking market, significantly expanding VLN®'s potential reach.

Which brands will offer 22nd Century's (XXII) 100mm VLN® cigarettes?

The 100mm VLN® cigarettes will be available under the VLN® brand and through partner brands including Smoker Friendly and Pinnacle.

What regulatory approvals does 22nd Century Group (XXII) currently have for VLN® cigarettes?

22nd Century Group holds the first and only Modified Risk Tobacco Authorization from the FDA for a combustible cigarette with their current 84mm VLN® products.