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22nd Century Provides Corporate Update On Its VLN® MRTP Renewal Process � The First and Only Combustible Tobacco Product Authorized by the FDA Specifically to Help Smokers Smoke Less

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22nd Century Group (Nasdaq: XXII) provided an update on the Modified Risk Tobacco Product (MRTP) renewal process for its VLN® reduced nicotine content products. VLN® 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® 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® 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® a contenuto ridotto di nicotina. VLN® è 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® dell'azienda, inizialmente autorizzati a dicembre 2021, hanno dimostrato tramite ampie ricerche cliniche la loro capacità 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 più marchi che utilizzano tabacco VLN®, in linea con il mandato proposto dalla FDA per basse quantità di nicotina, previsto per gennaio 2025.

22nd Century Group (Nasdaq: XXII) proporcionó una actualización sobre el proceso de renovación del Producto de Tabaco de Riesgo Modificado (MRTP) para sus productos VLN® con contenido reducido de nicotina. VLN® es el primer y único cigarrillo combustible autorizado por la FDA que contiene que los cigarrillos convencionales, con renovación prevista para diciembre de 2026.

Los productos VLN® de la compañía, autorizados originalmente en diciembre de 2021, han demostrado mediante extensas investigaciones clínicas su capacidad para reducir las tasas de consumo de tabaco, aumentar los intentos de dejar de fumar y disminuir la ingesta de nicotina. La línea de productos se está expandiendo con más marcas que utilizan tabaco VLN®, cumpliendo con el mandato propuesto por la FDA para bajos niveles de nicotina, previsto para enero de 2025.

22nd Century Group (나스�: XXII)VLN® 저니코� 함유 제품� 대� 수정 위험 담배 제품(MRTP) 갱신 절차� 관� 업데이트� 제공했습니다. VLN®� 기존 담배� 비해 니코� 함량� 95% 적은 FDA 승인 최초이자 유일� 가연성 담배�, 갱신은 2026� 12� 예정입니�.

회사� VLN® 제품은 2021� 12월에 최초 승인되었으며, 광범위한 임상 연구� 통해 흡연� 감소, 금연 시도 증가, 니코� 섭취 감소 효과� 입증했습니다. VLN® 담배� 사용하 브랜드가 늘어나면� 제품 라인� 확장 중이�, 이 2025� 1월에 제안� FDA� 저니코� 규정� 부합합니다.

22nd Century Group (Nasdaq : XXII) a fourni une mise à jour sur le processus de renouvellement de l'autorisation du Produit du Tabac à Risque Modifié (MRTP) pour ses produits VLN® à teneur réduite en nicotine. VLN® est la première et unique cigarette combustible autorisée par la FDA contenant 95 % de nicotine en moins que les cigarettes conventionnelles, avec un renouvellement prévu pour décembre 2026.

Les produits VLN® de la société, initialement autorisés en décembre 2021, ont démontré à travers de nombreuses recherches cliniques leur capacité à réduire les taux de consommation de tabac, augmenter les tentatives d'arrêt et diminuer la consommation de nicotine. La gamme de produits s'élargit avec davantage de marques utilisant du tabac VLN®, répondant au mandat proposé 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) für seine VLN® Produkte mit reduziertem Nikotingehalt. VLN® ist die erste und einzige von der FDA zugelassene brennbare Zigarette mit 95 % weniger Nikotin als herkömmliche Zigaretten, die Erneuerung ist für Dezember 2026 geplant.

Die VLN® Produkte des Unternehmens, ursprünglich im Dezember 2021 genehmigt, haben durch umfangreiche klinische Studien ihre Fähigkeit gezeigt, das Rauchverhalten zu reduzieren, die Rauchstoppversuche zu erhöhen und den Nikotinkonsum zu senken. Die Produktlinie wird erweitert, indem mehr Marken VLN®-Tabak verwenden und somit dem von der FDA vorgeschlagenen Niedrignikotin-Mandat ab Januar 2025 entsprechen.

Positive
  • None.
Negative
  • 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® 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® 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® products contain 95% less nicotine than conventional cigarettes, positioning them uniquely in the tobacco harm reduction landscape. What's particularly noteworthy is the expanding portfolio of brands under the VLN® umbrella, indicating potential for market penetration growth through diversification of low-nicotine alternatives.

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® 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 � including helping smokers reduce consumption and increase quit attempts � provides scientific credibility to their unique value proposition in an industry facing increasing regulatory pressure.

Extensive Clinical Data Continues to Demonstrate VLN® Reduced Nicotine Content Tobacco Helps Reduce Smoking and Increase Quit Attempts

Growing List of VLN® 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® 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® tobacco containing 95% less nicotine than conventional, highly addictive cigarettes. Decades of independent clinical research studies and an extensive list of peer reviewed publications that were included as part of the FDA’s MRTP authorization process have demonstrated that smoking VLN® reduced nicotine content cigarettes lowers the amount of addictive nicotine consumed, can reduce the rate of smoking, increase quit attempts by smokers and reduce the health harms of smoking. Based on independent clinical research studies included in the original MRTP decision, FDA authorized VLN® claims include:

  • 95% less nicotine�
  • “Helps reduce your nicotine consumption�
  • “Greatly reduces your nicotine consumption�
  • “Helps you smoke less�

“Our MRTP authorization for VLN® 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’s 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,� said Larry Firestone, Chief Executive Officer of 22nd Century Group. “With a growing list of brands, products and patented tobacco plant varieties under the VLN® 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.�

“Additionally, Our VLN® cigarette is the only product that meets the FDA’s guideline for low nicotine based on its proposed low nicotine mandate issued in January 2025.� Said Firestone. “While the FDA’s mandate has not yet become a final ruling, we expect that the FDA will fully support our MRTP renewal for VLN®.�

The renewal process is part of 22nd Century’s ongoing R&D programs that continue to advance reduced nicotine content in tobacco and support the introduction of additional VLN® 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® 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 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 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�, on�, on�, and on�.

Learn more about VLN® a�.

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 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® cigarettes compared to conventional cigarettes?

VLN® cigarettes contain 95% less nicotine than conventional cigarettes, making them a non-addictive alternative.

When does 22nd Century Group's MRTP authorization for VLN® expire?

The MRTP authorization, originally granted in December 2021, is due for renewal in December 2026.

How does VLN® help reduce smoking according to clinical studies?

Clinical studies show that VLN® helps reduce nicotine consumption, lower smoking rates, and increase quit attempts among smokers.

Does XXII's VLN® meet the FDA's new low nicotine mandate requirements?

Yes, VLN® is currently the only product that meets the FDA's guidelines for low nicotine based on their proposed mandate issued in January 2025.

When was VLN® first authorized by the FDA as a Modified Risk Tobacco Product?

VLN® received its initial FDA MRTP authorization in December 2021, becoming the first and only authorized reduced nicotine combustible cigarette.
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