22nd Century Reports Expanded State Authorization Progress to Sell VLN®, Partner VLN® and Conventional Products
22nd Century Group (Nasdaq: XXII) announced significant progress in state authorizations for its tobacco product portfolio. The company has secured approval to sell its VLN® reduced nicotine content cigarettes in up to 41 states, along with expanded authorizations for partner brands and conventional products.
The company's flagship VLN® products contain 95% less nicotine than conventional cigarettes and are the only combustible cigarettes that comply with the FDA's proposed Low Nicotine Mandate. 22nd Century has secured partnerships with retailers representing over 2,000 outlets for implementation in the second half of 2025.
The expanded state authorizations cover multiple product lines including VLN® Gold and Green (41 states), VLN® Red (21 states), Smoker Friendly VLN® (20 states), Pinnacle® VLN® (20 states), and various conventional products across different states.
22nd Century Group (Nasdaq: XXII) ha annunciato progressi significativi nelle autorizzazioni statali per il suo portafoglio di prodotti a base di tabacco. L'azienda ha ottenuto l'approvazione per la vendita delle sue sigarette VLN® a contenuto ridotto di nicotina in fino a 41 stati, insieme a autorizzazioni ampliate per i marchi partner e i prodotti convenzionali.
I prodotti di punta dell'azienda, le VLN®, contengono il 95% di nicotina in meno rispetto alle sigarette tradizionali e sono le uniche sigarette combustibili conformi al mandato proposto dalla FDA per la riduzione della nicotina. 22nd Century ha stretto partnership con rivenditori che rappresentano oltre 2.000 punti vendita per l'implementazione nella seconda metà del 2025.
Le autorizzazioni statali estese coprono diverse linee di prodotto, tra cui VLN® Gold e Green (41 stati), VLN® Red (21 stati), Smoker Friendly VLN® (20 stati), Pinnacle® VLN® (20 stati) e vari prodotti convenzionali in diversi stati.
22nd Century Group (Nasdaq: XXII) anunció avances significativos en las autorizaciones estatales para su cartera de productos de tabaco. La compañía ha obtenido la aprobación para vender sus cigarrillos VLN® con contenido reducido de nicotina en hasta 41 estados, junto con autorizaciones ampliadas para marcas asociadas y productos convencionales.
Los productos principales de la empresa, VLN®, contienen un 95% menos de nicotina que los cigarrillos convencionales y son los únicos cigarrillos combustibles que cumplen con el mandato propuesto por la FDA para reducir la nicotina. 22nd Century ha establecido asociaciones con minoristas que representan más de 2,000 puntos de venta para su implementación en la segunda mitad de 2025.
Las autorizaciones estatales ampliadas cubren varias líneas de productos, incluyendo VLN® Gold y Green (41 estados), VLN® Red (21 estados), Smoker Friendly VLN® (20 estados), Pinnacle® VLN® (20 estados) y varios productos convencionales en diferentes estados.
22nd Century Group (나스닥: XXII)는 담배 제품 포트폴리오에 대한 주 정부 승인에서 중요한 진전을 발표했습니다. 회사는 최대 41개 주에서 VLN® 저니코틴 함유 담배 판매 승인을 확보했으며, 파트너 브랜드 및 기존 제품에 대한 승인도 확대했습니다.
회사의 주력 제품인 VLN® 제품은 기존 담배보다 니코틴 함량이 95% 적으며, FDA가 제안한 저니코틴 규제에 부합하는 유일한 가연성 담배입니다. 22nd Century는 2025년 하반기 도입을 위해 2,000개 이상의 판매점을 대표하는 소매업체들과 파트너십을 체결했습니다.
확대된 주 정부 승인은 VLN® Gold 및 Green (41개 주), VLN® Red (21개 주), Smoker Friendly VLN® (20개 주), Pinnacle® VLN® (20개 주) 및 다양한 기존 제품 라인을 포함합니다.
22nd Century Group (Nasdaq : XXII) a annoncé des progrès significatifs dans les autorisations étatiques pour son portefeuille de produits du tabac. L'entreprise a obtenu l'approbation pour vendre ses cigarettes VLN® à teneur réduite en nicotine dans jusqu'à 41 États, ainsi que des autorisations élargies pour les marques partenaires et les produits conventionnels.
Les produits phares de la société, les VLN®, contiennent 95 % de nicotine en moins que les cigarettes conventionnelles et sont les seules cigarettes combustibles conformes au mandat proposé par la FDA sur la nicotine faible. 22nd Century a établi des partenariats avec des détaillants représentant plus de 2 000 points de vente pour une mise en œuvre au second semestre 2025.
Les autorisations étatiques étendues couvrent plusieurs gammes de produits, notamment VLN® Gold et Green (41 États), VLN® Red (21 États), Smoker Friendly VLN® (20 États), Pinnacle® VLN® (20 États) et divers produits conventionnels dans différents États.
22nd Century Group (Nasdaq: XXII) hat bedeutende Fortschritte bei den staatlichen Genehmigungen für sein Tabakproduktportfolio erzielt. Das Unternehmen hat die Zulassung erhalten, seine VLN® Zigaretten mit reduziertem Nikotingehalt in bis zu 41 Bundesstaaten zu verkaufen, sowie erweiterte Genehmigungen für Partner-Marken und konventionelle Produkte.
Die Flaggschiffprodukte des Unternehmens, VLN® enthalten 95 % weniger Nikotin als herkömmliche Zigaretten und sind die einzigen brennbaren Zigaretten, die den von der FDA vorgeschlagenen Low-Nicotine-Mandat erfüllen. 22nd Century hat Partnerschaften mit Einzelhändlern geschlossen, die über 2.000 Verkaufsstellen vertreten, für die Implementierung in der zweiten Hälfte des Jahres 2025.
Die erweiterten staatlichen Genehmigungen umfassen mehrere Produktlinien, darunter VLN® Gold und Green (41 Staaten), VLN® Red (21 Staaten), Smoker Friendly VLN® (20 Staaten), Pinnacle® VLN® (20 Staaten) und verschiedene konventionelle Produkte in unterschiedlichen Staaten.
- None.
- Still pending authorizations in several states
- Implementation of retail partnerships not yet complete
- Market penetration remains limited compared to total 272,000 U.S. retail outlets
Insights
22nd Century's expanded state authorizations boost market access for VLN® products, aligning with FDA's nicotine reduction goals while expanding distribution footprint.
22nd Century Group has achieved a significant expansion in state authorizations for its product portfolio, most notably reaching 41 states for its VLN® Gold and Green reduced nicotine cigarettes. This regulatory progress strategically positions the company within the FDA's proposed Low Nicotine Mandate, which was originally introduced in 2018 and reissued in January 2025. The timing is particularly noteworthy as the comment period for this mandate concludes in September.
The company's flagship VLN® products contain tobacco with 95% less nicotine than conventional cigarettes, making them the only combustible cigarettes currently compatible with the FDA's mandate. This represents a substantial first-mover advantage in a potentially transformative regulatory environment for tobacco.
From a distribution perspective, 22nd Century has secured partnerships that will place their products in over 2,000 retail outlets in the second half of 2025. The broader tobacco retail landscape encompasses approximately 272,000 outlets nationwide, indicating substantial room for growth. The company is also introducing new product variants across multiple states, including VLN® Red and partner-branded versions through Smoker Friendly and Pinnacle®.
The expansion of state authorizations creates dual revenue opportunities: direct sales of proprietary products and licensing opportunities for partner brands developing private-label VLN® products. This two-pronged approach could accelerate market penetration while generating multiple revenue streams from the same underlying technology.
The company's decades of experience in tobacco harm reduction and its proprietary low-nicotine tobacco position it uniquely at the intersection of commercial opportunity and public health objectives, particularly as regulatory momentum builds toward reducing nicotine levels in cigarettes.
State Authorizations Mean Even More Adult Smokers Will Be Able to Purchase VLN®, Partner VLN®, Smoker Friendly and Pinnacle Products
MOCKSVILLE, N.C., July 17, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), today announced a significant increase in state authorizations for the sale of its growing portfolio of both proprietary and contract manufactured products.
The increase in state authorizations enables new sales activity and new product launches for 22nd Century’s proprietary VLN® reduced nicotine content cigarettes, a growing list of partner VLN® brands, a diverse and expanded range of Smoker Friendly products and a growing number of Pinnacle® products sold at a top 5 C-Store chain in the U.S.
“The most recent state authorizations will open even more new markets as we drive toward approval to sell VLN® based products in all 50 states. Additionally, this demonstrates to the FDA that VLN® based products can be available on a nationwide basis by the close of its proposed Low Nicotine Mandate comment period in mid-September. Our VLN® and partner VLN® products are the only combustible cigarettes that fit within the confines of the FDA’s mandate as originally issued by the first Trump administration in 2018 and reissued in January 2025,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “We already have partner VLN® retailers accounting for over 2,000 outlets progressing through implementation to begin shipping in the second half of 2025 and expect more ahead.”
Key state authorizations to date now include the following brands. Additional state authorizations are pending and expected in the second half of 2025, supporting the launch of these products in further new markets. Products marked with an * represent new introductions to the market and retailers in 2025:
- VLN® Gold and Green – 41 States
- *VLN® Red – 21 States
- *Smoker Friendly VLN® – 20 States
- *Pinnacle® VLN® – 20 States
- Smoker Friendly – 45 States
- *Smoker Friendly Black Label – 27 States
- Pinnacle® – 37 States
The growing list of state approvals expands the market opportunity for additional partner brands to launch their own private label VLN® products in large and untapped markets across the country.
“With more than 272,000 U.S. retail outlets that sell tobacco products across the country, 22nd Century and its partners have a tremendous untapped market opportunity for both our VLN® and conventional products in the US, and we have begun to look internationally with VLN® as well,” said Firestone.
22nd Century is the only tobacco products company that has for 27 years led the tobacco harm reduction movement and continues to lead the fight against the harms of smoking driven by nicotine addiction is creating a new pathway to reducing the rate of smoking and related health harms through increasing adoption of its VLN® reduced nicotine content cigarette products by additional brands. Our products incorporate proprietary and patented tobacco that contains
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 in the form of a combustible cigarette that helps them take control of their nicotine consumption. VLN® 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® 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 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
mkreps@xxiicentury.com
214-597-8200
FAQ
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