22nd Century Provides Corporate Update On Its VLN庐 MRTP Renewal Process 鈥� The First and Only Combustible Tobacco Product Authorized by the FDA Specifically to Help Smokers Smoke Less
22nd Century Group (Nasdaq: XXII) provided an update on the Modified Risk Tobacco Product (MRTP) renewal process for its VLN庐 reduced nicotine content products. VLN庐 is the first and only FDA-authorized combustible cigarette containing 95% less nicotine than conventional cigarettes, with renewal due in December 2026.
The company's VLN庐 products, originally authorized in December 2021, have demonstrated through extensive clinical research their ability to reduce smoking rates, increase quit attempts, and lower nicotine consumption. The product line is expanding with more brands using VLN庐 tobacco, meeting FDA's proposed low nicotine mandate issued in January 2025.
22nd Century Group (Nasdaq: XXII) ha fornito un aggiornamento sul processo di rinnovo della certificazione come Prodotto del Tabacco a Rischio Modificato (MRTP) per i suoi prodotti VLN庐 a contenuto ridotto di nicotina. VLN庐 猫 la prima e unica sigaretta combustibile autorizzata dalla FDA che contiene il 95% di nicotina in meno rispetto alle sigarette tradizionali, con il rinnovo previsto per dicembre 2026.
I prodotti VLN庐 dell'azienda, inizialmente autorizzati a dicembre 2021, hanno dimostrato tramite ampie ricerche cliniche la loro capacit脿 di ridurre il consumo di sigarette, aumentare i tentativi di cessazione e abbassare l'assunzione di nicotina. La gamma di prodotti si sta ampliando con pi霉 marchi che utilizzano tabacco VLN庐, in linea con il mandato proposto dalla FDA per basse quantit脿 di nicotina, previsto per gennaio 2025.
22nd Century Group (Nasdaq: XXII) proporcion贸 una actualizaci贸n sobre el proceso de renovaci贸n del Producto de Tabaco de Riesgo Modificado (MRTP) para sus productos VLN庐 con contenido reducido de nicotina. VLN庐 es el primer y 煤nico cigarrillo combustible autorizado por la FDA que contiene que los cigarrillos convencionales, con renovaci贸n prevista para diciembre de 2026.
Los productos VLN庐 de la compa帽铆a, autorizados originalmente en diciembre de 2021, han demostrado mediante extensas investigaciones cl铆nicas su capacidad para reducir las tasas de consumo de tabaco, aumentar los intentos de dejar de fumar y disminuir la ingesta de nicotina. La l铆nea de productos se est谩 expandiendo con m谩s marcas que utilizan tabaco VLN庐, cumpliendo con el mandato propuesto por la FDA para bajos niveles de nicotina, previsto para enero de 2025.
22nd Century Group (雮橃姢雼�: XXII)电� VLN庐 鞝�雼堨綌韹� 頃湢 鞝滍拡鞐� 雽�頃� 靾橃爼 鞙勴棙 雼措鞍 鞝滍拡(MRTP) 臧膘嫚 鞝堨皑鞐� 甏�頃� 鞐呺嵃鞚错姼毳� 鞝滉车頄堨姷雼堧嫟. VLN庐电� 旮办〈 雼措鞍鞐� 牍勴暣 雼堨綌韹� 頃焿鞚� 95% 鞝侅潃 FDA 鞀轨澑 斓滌磮鞚挫瀽 鞙犾澕頃� 臧�鞐办劚 雼措鞍搿�, 臧膘嫚鞚� 2026雲� 12鞗� 鞓堨爼鞛呺媹雼�.
須岇偓鞚� VLN庐 鞝滍拡鞚� 2021雲� 12鞗旍棎 斓滌磮 鞀轨澑霅橃棃鞙茧┌, 甏戨矓鞙勴暅 鞛勳儊 鞐瓣惮毳� 韱淀暣 頋§棸鞙� 臧愳唽, 旮堨棸 鞁滊弰 歃濌皜, 雼堨綌韹� 靹法 臧愳唽 須臣毳� 鞛呾頄堨姷雼堧嫟. VLN庐 雼措鞍毳� 靷毄頃樀鐢 敫岆灉霌滉皜 電橃柎雮橂┐靹� 鞝滍拡 霛检澑鞚� 頇曥灔 欷戩澊氅�, 鞚吹鐢 2025雲� 1鞗旍棎 鞝滌晥霅� FDA鞚� 鞝�雼堨綌韹� 攴滌爼鞐� 攵�頃╉暕雼堧嫟.
22nd Century Group (Nasdaq : XXII) a fourni une mise 脿 jour sur le processus de renouvellement de l'autorisation du Produit du Tabac 脿 Risque Modifi茅 (MRTP) pour ses produits VLN庐 脿 teneur r茅duite en nicotine. VLN庐 est la premi猫re et unique cigarette combustible autoris茅e par la FDA contenant 95 % de nicotine en moins que les cigarettes conventionnelles, avec un renouvellement pr茅vu pour d茅cembre 2026.
Les produits VLN庐 de la soci茅t茅, initialement autoris茅s en d茅cembre 2021, ont d茅montr茅 脿 travers de nombreuses recherches cliniques leur capacit茅 脿 r茅duire les taux de consommation de tabac, augmenter les tentatives d'arr锚t et diminuer la consommation de nicotine. La gamme de produits s'茅largit avec davantage de marques utilisant du tabac VLN庐, r茅pondant au mandat propos茅 par la FDA pour une faible teneur en nicotine, qui entrera en vigueur en janvier 2025.
22nd Century Group (Nasdaq: XXII) gab ein Update zum Erneuerungsprozess des Modified Risk Tobacco Product (MRTP) f眉r seine VLN庐 Produkte mit reduziertem Nikotingehalt. VLN庐 ist die erste und einzige von der FDA zugelassene brennbare Zigarette mit 95 % weniger Nikotin als herk枚mmliche Zigaretten, die Erneuerung ist f眉r Dezember 2026 geplant.
Die VLN庐 Produkte des Unternehmens, urspr眉nglich im Dezember 2021 genehmigt, haben durch umfangreiche klinische Studien ihre F盲higkeit gezeigt, das Rauchverhalten zu reduzieren, die Rauchstoppversuche zu erh枚hen und den Nikotinkonsum zu senken. Die Produktlinie wird erweitert, indem mehr Marken VLN庐-Tabak verwenden und somit dem von der FDA vorgeschlagenen Niedrignikotin-Mandat ab Januar 2025 entsprechen.
- None.
- MRTP authorization requires renewal by December 2026
- FDA's low nicotine mandate still not finalized
- Product still involves combustible tobacco with associated health risks
Insights
22nd Century's VLN庐 authorization renewal preparation highlights its unique position in tobacco harm reduction with FDA-backed reduced nicotine products.
22nd Century Group's update on its Modified Risk Tobacco Product (MRTP) renewal process underscores the strategic importance of its VLN庐 reduced nicotine cigarettes. As the only FDA-authorized combustible tobacco product designed specifically to help smokers reduce consumption, this represents a significant competitive advantage in the industry.
The company's VLN庐 products contain
The timing of this announcement is strategically relevant given the FDA's proposed low nicotine mandate issued in January 2025. 22nd Century's assertion that VLN庐 is the only product meeting these guidelines suggests a potential first-mover advantage if this mandate becomes finalized regulation. This regulatory alignment could substantially strengthen their market position against larger competitors who would need to reformulate products.
While renewal isn't due until December 2026, this proactive communication signals confidence in the clinical data supporting their claims and preparation for continued regulatory compliance. The extensive research backing their authorized claims 鈥� including helping smokers reduce consumption and increase quit attempts 鈥� provides scientific credibility to their unique value proposition in an industry facing increasing regulatory pressure.
Extensive Clinical Data Continues to Demonstrate VLN庐 Reduced Nicotine Content Tobacco Helps Reduce Smoking and Increase Quit Attempts
Growing List of VLN庐 Based Cigarette Brands Bring Non-Addictive Alternatives to the Fight Against Smoking
MOCKSVILLE, N.C., July 10, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addiction today announces a corporate update regarding its Modified Risk Tobacco Product renewal process for its innovative VLN庐 reduced nicotine content products - the first and only combustible cigarette authorized by the U.S. Food and Drug Administration specifically to reduce the health harms of smoking.
Originally authorized in December 2021 and due for renewal in December 2026, a growing list of brands are using VLN庐 tobacco containing
- 鈥�
95% less nicotine鈥� - 鈥淗elps reduce your nicotine consumption鈥�
- 鈥淕reatly reduces your nicotine consumption鈥�
- 鈥淗elps you smoke less鈥�
鈥淥ur MRTP authorization for VLN庐 cigarettes stands apart as one of the most unique and innovative tools in the tobacco industry leading the fight in Tobacco Harm Reduction to reduce the health harms of smoking. Nicotine is a highly addictive substance and the FDA鈥檚 clinically documented affirmation that reducing the nicotine content of combusted tobacco to nonaddictive levels can reduce smoking behaviors, leading to more quit attempts and improved public health outcomes, could be the most important public health decision in decades,鈥� said Larry Firestone, Chief Executive Officer of 22nd Century Group. 鈥淲ith a growing list of brands, products and patented tobacco plant varieties under the VLN庐 umbrella, we intend to give smokers as many low nicotine alternatives as possible to help them control their nicotine intake to potentially use less tobacco and achieve their personal health goals.鈥�
鈥淎dditionally, Our VLN庐 cigarette is the only product that meets the FDA鈥檚 guideline for low nicotine based on its proposed low nicotine mandate issued in January 2025.鈥� Said Firestone. 鈥淲hile the FDA鈥檚 mandate has not yet become a final ruling, we expect that the FDA will fully support our MRTP renewal for VLN庐.鈥�
The renewal process is part of 22nd Century鈥檚 ongoing R&D programs that continue to advance reduced nicotine content in tobacco and support the introduction of additional VLN庐 based products that give tobacco users further health oriented non-addictive alternatives to conventional tobacco products, as well as to new nicotine delivery products that are designed to create and sustain nicotine addiction.
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庐 cigarette, to give traditional cigarette smokers an authentic and familiar alternative that helps them take control of their nicotine consumption. VLN庐 cigarettes have
Our proprietary reduced nicotine tobacco blends are made possible by comprehensive and patented technologies and tobacco plants that regulate nicotine biosynthesis activities in the tobacco plant, resulting in full flavor and high yield with
VLN庐 is a registered trademark of 22nd Century Limited LLC.听
Learn more at鈥�, on鈥�, on鈥�, and on鈥�.听
Learn more about VLN庐鈥痑迟鈥�.
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 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃onsider,鈥� 鈥渃ontinue,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渆xplore,鈥� 鈥渇oresee,鈥� 鈥済oal,鈥� 鈥済uidance,鈥� 鈥渋ntend,鈥� 鈥渓ikely,鈥� 鈥渕ay,鈥� 鈥減lan,鈥� 鈥減otential,鈥� 鈥減redict,鈥� 鈥減reliminary,鈥� 鈥減robable,鈥� 鈥減roject,鈥� 鈥減romising,鈥� 鈥渟eek,鈥� 鈥渟hould,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 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 鈥淩isk Factors鈥� in the Company鈥檚 Annual Report on Form 10-K filed on March 20, 2025, and in the Company鈥檚 Quarterly Reports 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
214-597-8200
FAQ
What is the nicotine reduction percentage in XXII's VLN庐 cigarettes compared to conventional cigarettes?
When does 22nd Century Group's MRTP authorization for VLN庐 expire?
How does VLN庐 help reduce smoking according to clinical studies?
Does XXII's VLN庐 meet the FDA's new low nicotine mandate requirements?
When was VLN庐 first authorized by the FDA as a Modified Risk Tobacco Product?
