22nd Century CEO & Chairman Larry Firestone Provides Technology and Regulatory Update Letter to Stockholders
22nd Century Group (Nasdaq: XXII) CEO Larry Firestone provided a comprehensive update on the company's VLN® reduced nicotine tobacco products and regulatory developments. The company announced two major partnerships with Smoker Friendly and Pinnacle for VLN® product distribution, with initial Pinnacle stocking orders shipped in August 2025.
The FDA's proposed Tobacco Product Standard for Nicotine Yield, expected by September 15, 2025, could mandate a 0.7mg/g maximum nicotine content. The company is expanding its VLN® product line to include 100mm cigarettes, international versions, and filtered cigars. Additionally, research is underway exploring potential links between their non-GMO low nicotine tobacco genetics and reduced levels of harmful TSNAs (Tobacco-Specific Nitrosamines).
22nd Century Group (Nasdaq: XXII) — l’amministratore delegato Larry Firestone ha fornito un aggiornamento esaustivo sui prodotti a tabacco a nicotina ridotta VLN® e sulle novità regolatorie. L’azienda ha annunciato due importanti partnership con Smoker Friendly e Pinnacle per la distribuzione dei prodotti VLN®, con i primi ordini di Pinnacle spediti ad agosto 2025.
Lo Standard proposto dalla FDA sul rendimento della nicotina, atteso per il 15 settembre 2025, potrebbe imporre un contenuto massimo di nicotina di 0,7 mg/g. L’azienda sta ampliando la linea VLN® includendo sigarette da 100 mm, versioni per i mercati esteri e sigari filtrati. Inoltre, sono in corso ricerche per verificare potenziali legami tra la genetica del tabacco a basso contenuto di nicotina non OGM e livelli ridotti di dannosi TSNA (nitrosammine specifiche del tabacco).
22nd Century Group (Nasdaq: XXII) — el CEO Larry Firestone ofreció una actualización completa sobre los productos de tabaco de nicotina reducida VLN® y los desarrollos regulatorios. La compañía anunció dos importantes alianzas con Smoker Friendly y Pinnacle para la distribución de productos VLN®, y los primeros pedidos de Pinnacle fueron enviados en agosto de 2025.
La norma propuesta por la FDA sobre el rendimiento de la nicotina, prevista para el 15 de septiembre de 2025, podría establecer un contenido máximo de nicotina de 0,7 mg/g. La empresa está ampliando la línea VLN® para incluir cigarrillos de 100 mm, versiones internacionales y puros filtrados. Además, se investigan posibles vínculos entre la genética de tabaco no transgénico de baja nicotina y niveles reducidos de nocivos TSNA (nitrosaminas específicas del tabaco).
22nd Century Group (Nasdaq: XXII)의 CEO 래리 파이어스톤은 자사 VLN® 저니코틴 담배 제품과 규제 동향에 대한 포괄적인 업데이트를 제공했습니다. 회사는 VLN® 제품 유통을 위해 Smoker Friendly 및 Pinnacle과의 두 건의 주요 파트너십을 발표했으며, Pinnacle의 초기 입고 주문은 2025년 8월에 출하되었습니다.
FDA의 니코틴 산출 관련 제안 규격은 2025년 9월 15일까지 발표될 예정이며, 니코틴 최대 함량을 0.7mg/g로 규정할 수 있습니다. 회사는 VLN® 제품군을 100mm 담배, 해외용 버전 및 필터드 시가를 포함하도록 확대하고 있습니다. 또한 비유전자변형(NON-GMO) 저니코틴 담배 유전형과 유해한 TSNA(담배특이 아질산염) 수치 감소 사이의 잠재적 연관성을 탐구하는 연구도 진행 중입니다.
22nd Century Group (Nasdaq: XXII) — le PDG Larry Firestone a présenté une mise à jour complète sur les produits de tabac à nicotine réduite VLN® et les évolutions réglementaires. La société a annoncé deux partenariats majeurs avec Smoker Friendly et Pinnacle pour la distribution des produits VLN®, les premières commandes de Pinnacle ayant été expédiées en août 2025.
La norme proposée par la FDA concernant le rendement en nicotine, attendue pour le 15 septembre 2025, pourrait imposer une teneur maximale en nicotine de 0,7 mg/g. L’entreprise étoffe sa gamme VLN® en ajoutant des cigarettes de 100 mm, des versions internationales et des cigares filtrés. Par ailleurs, des recherches sont en cours pour explorer d’éventuels liens entre la génétique du tabac non-OGM à faible nicotine et des niveaux réduits de TSNA (nitrosamines spécifiques du tabac) nocives.
22nd Century Group (Nasdaq: XXII)-CEO Larry Firestone gab einen umfassenden Bericht zu den VLN®-Nikotinarme-Tabakprodukten des Unternehmens und zu regulatorischen Entwicklungen. Das Unternehmen kündigte zwei bedeutende Partnerschaften mit Smoker Friendly und Pinnacle für den VLN®-Produktvertrieb an; die ersten Bestellungen von Pinnacle wurden im August 2025 versandt.
Der von der FDA vorgeschlagene Standard für Nikotinausstoß, dessen Bekanntgabe bis zum 15. September 2025 erwartet wird, könnte einen maximalen Nikotingehalt von 0,7 mg/g vorschreiben. Das Unternehmen erweitert die VLN®-Produktpalette um 100-mm-Zigaretten, internationale Varianten und gefilterte Zigarren. Außerdem laufen Forschungen, die mögliche Zusammenhänge zwischen der nicht-GVO-basierten Low-Nicotine-Genetik und verringerten Werten der schädlichen TSNA (tabakspezifische Nitrosamine) untersuchen.
- Secured partnerships with two established brands (Smoker Friendly and Pinnacle) for VLN® distribution
- FDA's proposed nicotine regulation aligns with company's VLN® products, validating their technology
- Expanding product line to include 100mm cigarettes, international versions, and filtered cigars
- Holds extensive patent portfolio in low nicotine genetics
- Research indicates potential reduction in harmful TSNAs linked to low nicotine tobacco
- Facing opposition from major tobacco producers regarding FDA's proposed nicotine regulations
- Still working toward profitability
- MRTP renewal application pending by end of year
Insights
22nd Century advances VLN® cigarettes with new partnerships, expanded product lines, and potential FDA regulatory tailwinds, though commercialization challenges remain.
This stockholder letter reveals several significant developments for 22nd Century Group's reduced nicotine cigarette strategy. CEO Larry Firestone highlights two key commercial partnerships with Smoker Friendly and Pinnacle brands, with initial stocking orders already shipped in August. This represents the first meaningful brand adoption of their VLN® technology, validating their business model beyond direct sales.
The most consequential revelation is the upcoming FDA Tobacco Product Standard for Nicotine Yield proposal (September 15, 2025), which would mandate a maximum nicotine content of 0.7mg/g in tobacco products. This proposed rule would fundamentally reshape the $80+ billion U.S. cigarette market and position 22nd Century with a substantial first-mover advantage as the only company with FDA-authorized reduced nicotine products already in commercial production.
The company is expanding its product portfolio to include 100mm cigarettes, filtered cigars, and international versions using their proprietary non-GMO tobacco. Their ongoing R&D suggests a potentially significant discovery - their low nicotine tobacco may contain substantially lower levels of harmful tobacco-specific nitrosamines (TSNAs), particularly the carcinogens NNN and NNK. If verified, this would strengthen their harm reduction claims.
Despite these positive developments, the letter lacks concrete sales figures, market penetration metrics, or financial projections. The emphasis on an FDA mandate that hasn't yet been implemented suggests the company still faces commercialization challenges with their existing products. While their intellectual property position appears strong, the letter contains limited information about competitive threats or consumer adoption rates of their current VLN® products.
MOCKSVILLE, N.C., Aug. 20, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addition, today issued the following letter to stockholders from Larry Firestone, the Chief Executive Officer of 22nd Century Group, Inc.:
A Letter to Our Shareholders
We recently released our second quarter 2025 earnings, along with important corporate updates regarding the ongoing launch and rollout of VLN® products. VLN® cigarettes are the first and only combustible tobacco product purposefully designed to reduce the harms of smoking and authorized by the U.S. Food and Drug Administration.
Perhaps one of the most exciting updates in that report was the early adoption of our VLN® approach by two well-established partner brands, Smoker Friendly and Pinnacle, with more expected to follow. The initial Pinnacle VLN® stocking orders were shipped in August, bringing reduced nicotine content options to even more smokers looking for new ways to reduce their smoking habit.
In addition to accelerating growth and achieving profitability, we are also driving important initiatives in the technology and regulatory landscape. I want to share more on those efforts and how they will help us to maintain and expand our industry leading position in the very low nicotine plant genetics and bioscience space.
FDA Proposed Rule – September 15, 2025
The FDA’s proposed new Tobacco Product Standard for Nicotine Yield could be the most groundbreaking and effective new tobacco regulation in a generation. Designed specifically to curb the nicotine addiction that keeps smokers smoking, the proposed 0.7mg/g maximum nicotine content standard is based on extensive clinical documentation that incorporated real-world testing of actual products produced by 22nd Century.
The VLN® products cited by the FDA to back this groundbreaking standard show that the rule is fully viable and commercially feasible across brands and form factors to make this crucial public health mandate a priority and a reality.
The proposed mandate has already received strong support from public health advocates who understand that taking nicotine out of tobacco is critical to reduction of smoking. We will support the proposed mandate with our own formal comment submission as well. Not surprisingly, comments from major tobacco producers have focused mostly on decrying the loss of addictive levels of nicotine in products that fuel their profits, even at the expense of lives and immense societal costs.
But we aren’t waiting. Smokers can buy an increasing array of VLN® products right now, proving that a reduced nicotine future is not just possible, it’s desirable to retail chains selling tobacco products.
With two partner brands announced and more in discussion, it is no longer debated whether a VLN® based future is possible – it is clear with our help, tobacco-based products can fully transition to a reduced nicotine version under any and every brand.
Next Gen VLN® Products
We recognize that VLN® products need to be available in brands and forms that consumers recognize and are willing to choose. Our goal is to meet tobacco users where they are most comfortable, offer a familiar branded product minus the addictive levels of nicotine, and help them stop the cycle of nicotine dependence.
To that end, we have also announced projects to bring VLN® products to market as 100mm cigarettes, plus international versions of combustible products tailored to the consumer preferences of those markets. We are also engaged in the production and testing of filtered cigar products using proprietary non-GMO VLN® reduced nicotine content tobacco and non-GMO VLN® based homogenized tobacco leaf (HTL) sheet. VLN® based filtered cigar products are designed specifically to ensure compliance with the FDA’s proposed low nicotine rule described above.
The new form factors will be supported by the continued submission of PMTA and MRTP filings with the FDA, as well as our MRTP renewal application that we will submit near the end of this year.
Further Research and Development Initiatives
We are investigating a potential link between our non-GMO low nicotine tobacco genetics and substantially lower levels of harmful TSNAs. TSNAs are Tobacco-Specific Nitrosamines, which are a group of potent carcinogens. The area of focus in our research is what appears to be a link between a reduction in nicotine in our low nicotine tobacco and a reduction of two of the most harmful TSNAs called NNN and NNK.
Expand and Secure Our IP Portfolio
Our extensive patent portfolio in low nicotine genetics firmly cements us as the leader in low nicotine tobacco. Our intellectual property is a cornered resource that sets us apart from every tobacco company in the world. But our mission goes well beyond what we have today. We continue to invest in the next generation of technology that will help us to further enhance our leadership in tobacco harm reduction. This includes ongoing plant genetics research into additional tobacco varietals, enhanced disease resistance, and product technologies that can improve our products, reduce our environmental footprint or bring innovation to our customers.
2025 and Beyond: The Tobacco Harm Reduction Movement
This is an exciting time for our Company, and I thank you for being a valued shareholder as we continue on this journey. Our mission is both noble and important - low nicotine technology and products that have the capability to dramatically improve public health and the welfare of smokers worldwide – hopefully even save lives.
Larry Firestone
Chief Executive Officer
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 non-GMO 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 Quarterly Reports on Form 10-Q on May 13, 2025 and August 14, 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
What partnerships did 22nd Century Group (XXII) announce for VLN® products in 2025?
What is the FDA's proposed nicotine content standard for tobacco products in 2025?
What new VLN® products is 22nd Century Group (XXII) developing?
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When will 22nd Century Group (XXII) submit its MRTP renewal application?
