22nd Century Announces Operation 100 – A 100mm VLN® Cigarette Designed to Reach Even More Adult Smokers Who Want to Reduce Their Nicotine Consumption
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.
22nd Century Group (Nasdaq: XXII) ha annunciato "Operazione 100", un'iniziativa per sviluppare una versione da 100 mm delle loro sigarette VLN® a contenuto ridotto di nicotina. L'azienda prevede di sottoporre questo nuovo prodotto all'approvazione della FDA nel quarto trimestre del 2025.
Il formato da 100 mm mira a coprire circa la metà del mercato statunitense delle sigarette e andrà a integrare le sigarette VLN® king size da 84 mm già autorizzate dalla FDA. Il prodotto sarà disponibile sotto il marchio VLN® e tramite marchi partner come Smoker Friendly e Pinnacle.
Studi clinici hanno dimostrato che il tabacco a nicotina ridotta proprietario di 22nd Century aiuta a ridurre il consumo di sigarette, aumenta i tentativi di smettere e diminuisce la dipendenza senza comportamenti compensatori di fumo.
22nd Century Group (Nasdaq: XXII) ha anunciado "Operación 100", una iniciativa para desarrollar una versión de 100 mm de sus cigarrillos VLN® con contenido reducido de nicotina. La empresa planea presentar este nuevo producto para la aprobación de la FDA en el cuarto trimestre de 2025.
El formato de 100 mm apunta a aproximadamente la mitad del mercado estadounidense de fumadores y complementará sus cigarrillos VLN® king size de 84 mm ya autorizados por la FDA. El producto estará disponible bajo la marca VLN® y a través de marcas asociadas como Smoker Friendly y Pinnacle.
Los estudios clínicos han demostrado que el tabaco con nicotina reducida patentado por 22nd Century ayuda a disminuir el consumo de cigarrillos, aumenta los intentos de dejar de fumar y reduce la dependencia sin comportamientos compensatorios de fumar.
22nd Century Group (나스닥: XXII)는 니코틴 함량이 줄어든 VLN® 담배의 100mm 버전 개발을 위한 "작전 100"을 발표했습니다. 회사는 이 신제품을 2025년 4분기에 FDA 승인을 위해 제출할 계획입니다.
100mm 포맷은 미국 흡연 시장의 약 절반을 목표로 하며, 기존에 FDA 승인을 받은 84mm 킹사이즈 VLN® 담배를 보완할 예정입니다. 이 제품은 VLN® 브랜드와 Smoker Friendly, Pinnacle 같은 파트너 브랜드를 통해 제공될 것입니다.
임상 연구 결과에 따르면 22nd Century의 독자적인 니코틴 저감 담배는 담배 소비를 줄이고 금연 시도를 늘리며 보상적 흡연 행동 없이 담배 의존도를 감소시키는 데 도움이 됩니다.
22nd Century Group (Nasdaq : XXII) a annoncé "Opération 100", une initiative visant à développer une version 100 mm de leurs cigarettes VLN® à teneur réduite en nicotine. La société prévoit de soumettre ce nouveau produit à l'approbation de la FDA au 4e trimestre 2025.
Le format 100 mm cible environ la moitié du marché américain du tabac et viendra compléter leurs cigarettes VLN® king size de 84 mm déjà autorisées par la FDA. Le produit sera disponible sous la marque VLN® ainsi que via des marques partenaires telles que Smoker Friendly et Pinnacle.
Des études cliniques ont démontré que le tabac à teneur réduite en nicotine propriétaire de 22nd Century aide à diminuer la consommation de cigarettes, augmente les tentatives d'arrêt et réduit la dépendance sans comportements compensatoires liés au tabagisme.
22nd Century Group (Nasdaq: XXII) hat "Operation 100" angekündigt, eine Initiative zur Entwicklung einer 100 mm Version ihrer VLN® Zigaretten mit reduziertem Nikotingehalt. Das Unternehmen plant, dieses neue Produkt im vierten Quartal 2025 zur FDA-Zulassung einzureichen.
Das 100-mm-Format zielt auf etwa die Hälfte des US-amerikanischen Zigarettenmarkts ab und ergänzt die bereits von der FDA genehmigten 84 mm King-Size VLN® Zigaretten. Das Produkt wird unter der Marke VLN® sowie über Partner-Marken wie Smoker Friendly und Pinnacle erhältlich sein.
Klinische Studien haben gezeigt, dass der proprietäre Tabak mit reduziertem Nikotingehalt von 22nd Century den Zigarettenkonsum senkt, die Rauchstopp-Versuche erhöht und die Abhängigkeit ohne kompensatorisches Rauchverhalten verringert.
- 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
- FDA approval for 100mm version not yet secured
- Product still promotes smoking despite reduced nicotine
- Significant regulatory hurdles and timeline to approval
Insights
XXII's 100mm VLN cigarette launch targets half the US market, potentially doubling their reduced-nicotine product reach by Q4 2025.
22nd Century Group is strategically expanding their reduced nicotine cigarette portfolio with a 100mm version of their VLN® product. This targets approximately half the U.S. smoking market that prefers longer cigarettes – a significant untapped opportunity for their FDA-authorized reduced nicotine technology.
The company's FDA submission timeline for Q4 2025 establishes a clear regulatory pathway for this product extension. What's noteworthy is that this isn't just about adding another size variant – it's about doubling their potential market reach with a product that already has proven clinical benefits and regulatory advantages.
The existing VLN® cigarettes are the only combustible cigarettes with Modified Risk Tobacco Authorization from the FDA, giving 22nd Century a unique market position. Their proprietary reduced nicotine tobacco has demonstrated multiple benefits in clinical studies: decreased cigarette consumption, increased quit attempts, reduced cigarette dependence, and no compensatory smoking behaviors.
By expanding their form factors to match consumer preferences, 22nd Century is applying a classic consumer products strategy to the tobacco harm reduction space. This move should enable their reduced nicotine technology to reach smokers who would otherwise be unlikely to try their existing king-size products.
The multi-brand strategy mentioned (VLN®, Smoker Friendly, Pinnacle) indicates they're pursuing both proprietary branding and partner distribution channels, maximizing potential market penetration. This approach could accelerate adoption of their reduced nicotine products across different market segments.
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
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
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
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