22nd Century Stands Ready to Support the Adoption of FDA Proposed Tobacco Product Standard to Mandate Reduced Nicotine Content in Cigarettes with its VLN Cigarettes
22nd Century Group (NASDAQ: XXII) announces its readiness to support the FDA's proposed tobacco product standard mandating reduced nicotine content in cigarettes. The proposal, which cleared review by the U.S. Office of Management and Budget on January 3, 2025, aims to drastically reduce nicotine levels in cigarettes.
The company's VLN branded low nicotine cigarettes align with this initiative, being the first and only FDA-authorized reduced nicotine content cigarettes in the market. CEO Larry Firestone emphasizes the policy's potential significant impact on public health and smoking harm reduction.
22nd Century Group has been instrumental in research and development supporting this policy, which has progressed across multiple administrations since 2009. The company plans to launch additional reduced nicotine content products under other brand labels and aims to expand the distribution and awareness of low nicotine cigarettes as a distinct market category.
22nd Century Group (NASDAQ: XXII) annuncia la sua disponibilità a supportare il standard proposto dalla FDA sui prodotti del tabacco, che richiede una riduzione del contenuto di nicotina nelle sigarette. La proposta, che ha superato la revisione da parte dell'Ufficio di Gestione e Bilancio degli Stati Uniti il 3 gennaio 2025, mira a ridurre drasticamente i livelli di nicotina nelle sigarette.
Le sigarette a bassa nicotina a marchio VLN dell'azienda si allineano a questa iniziativa, essendo le prime e uniche sigarette a contenuto ridotto di nicotina autorizzate dalla FDA sul mercato. Il CEO Larry Firestone sottolinea il potenziale impatto significativo della politica sulla salute pubblica e sulla riduzione del danno del fumo.
22nd Century Group è stata strumentale nella ricerca e nello sviluppo che supportano questa politica, che è avanzata attraverso più amministrazioni dal 2009. L'azienda pianifica di lanciare ulteriori prodotti a contenuto ridotto di nicotina sotto altri marchi e mira ad espandere la distribuzione e la consapevolezza delle sigarette a bassa nicotina come una categoria di mercato distinta.
22nd Century Group (NASDAQ: XXII) anuncia su disposición a apoyar el estándar propuesto por la FDA que exige un contenido reducido de nicotina en los cigarrillos. La propuesta, que superó la revisión de la Oficina de Gestión y Presupuesto de EE.UU. el 3 de enero de 2025, tiene como objetivo reducir drásticamente los niveles de nicotina en los cigarrillos.
Los cigarrillos de baja nicotina de marca VLN de la empresa se alinean con esta iniciativa, siendo los primeros y únicos cigarrillos de contenido reducido de nicotina autorizados por la FDA en el mercado. El CEO Larry Firestone enfatiza el potencial impacto significativo de la política en la salud pública y en la reducción del daño por fumar.
22nd Century Group ha sido fundamental en la investigación y desarrollo que apoya esta política, que ha avanzado a través de múltiples administraciones desde 2009. La empresa planea lanzar más productos de contenido reducido de nicotina bajo otras marcas y tiene como objetivo expandir la distribución y conciencia de los cigarrillos de baja nicotina como una categoría de mercado distinta.
22nd Century Group (NASDAQ: XXII)는 FDA가 제안한 담배 제품 표준을 지원할 준비가 되었다고 발표했습니다. 이 표준은 2025년 1월 3일 미국 관리 예산국의 검토를 통과했으며, 담배의 니코틴 함량을 대폭 줄이는 것을 목표로 하고 있습니다.
회사의 VLN 상표 저니코틴 담배는 이 이니셔티브와 일치하며, 시장에서 FDA의 승인을 받은 최초이자 유일한 저니코틴 함량 담배입니다. CEO 래리 파이어스톤은 이 정책이 공공 건강과 흡연 피해 감소에 미칠 수 있는 중대한 영향을 강조합니다.
22nd Century Group은 2009년 이후 여러 관리에 걸쳐 발전해 온 이 정책을 뒷받침하는 연구 및 개발에 중요한 역할을 해왔습니다. 이 회사는 다른 브랜드 아래에서 추가 저니코틴 제품을 출시할 계획이며, 저니코틴 담배를 독립된 시장 카테고리로서 더 널리 배급하고 인지도를 높이는 것을 목표로 하고 있습니다.
22nd Century Group (NASDAQ: XXII) annonce sa volonté de soutenir la norme proposée par la FDA sur les produits du tabac imposant une réduction de la teneur en nicotine dans les cigarettes. La proposition, qui a été approuvée par le Bureau de gestion et du budget des États-Unis le 3 janvier 2025, vise à réduire de manière drastique les niveaux de nicotine dans les cigarettes.
Les cigarettes à faible teneur en nicotine de la marque VLN de l’entreprise s’inscrivent dans cette initiative, étant les premières et uniques cigarettes à teneur réduite en nicotine autorisées par la FDA sur le marché. Le PDG Larry Firestone souligne l'impact potentiel significatif de cette politique sur la santé publique et la réduction des dommages causés par le tabagisme.
Le 22nd Century Group a joué un rôle clé dans la recherche et le développement soutenant cette politique, qui s'est développée au fil de plusieurs administrations depuis 2009. L'entreprise prévoit de lancer d'autres produits à teneur réduite en nicotine sous d'autres marques et vise à élargir la distribution et la sensibilisation aux cigarettes à faible teneur en nicotine comme une catégorie de marché distincte.
22nd Century Group (NASDAQ: XXII) kündigt seine Bereitschaft an, den von der FDA vorgeschlagenen Standard für Tabakprodukte zu unterstützen, der eine reduzierte Nikotinkonzentration in Zigaretten vorschreibt. Der Vorschlag, der am 3. Januar 2025 die Prüfung des U.S. Office of Management and Budget bestanden hat, zielt darauf ab, die Nikotinwerte in Zigaretten drastisch zu senken.
Die VLN-Marke für Niedrignikotinzigaretten des Unternehmens steht im Einklang mit dieser Initiative und ist die erste und einzige von der FDA zugelassene Zigarettenmarke mit reduziertem Nikotinkgehalt auf dem Markt. CEO Larry Firestone betont die potenziell erheblichen Auswirkungen dieser Politik auf die öffentliche Gesundheit und die Verringerung des Rauchenschadens.
Die 22nd Century Group war maßgeblich an der Forschung und Entwicklung beteiligt, die diese Politik unterstützt, die seit 2009 über mehrere Regierungen hinweg vorangetrieben wurde. Das Unternehmen plant die Einführung weiterer Produkte mit reduziertem Nikotinkgehalt unter anderen Marken und hat zum Ziel, die Verbreitung und das Bewusstsein für Niedrignikotinzigaretten als eine eigenständige Markt-kategorie zu erweitern.
- First and only company with FDA-authorized reduced nicotine content cigarettes
- Strategic positioning to benefit from potential FDA mandate on reduced nicotine
- Plans for expansion with additional reduced nicotine products under new brands
- None.
Insights
The FDA's proposal to mandate reduced nicotine content in cigarettes represents a watershed moment in tobacco regulation. The Office of Management and Budget (OMB) clearance signals the final stage before potential implementation, marking the most substantial regulatory shift in U.S. tobacco control since the 1960s. XXII's VLN cigarettes, being the only FDA-authorized reduced nicotine product, positions the company for a potential monopolistic advantage in a market that could be federally mandated.
The regulatory framework would effectively require all cigarette manufacturers to meet reduced nicotine standards, potentially forcing them to either license XXII's technology or exit the traditional cigarette market. This creates a significant first-mover advantage for XXII, particularly given their existing FDA authorization and commercial infrastructure. However, implementation challenges, potential legal challenges from major tobacco companies and the timeline for industry-wide adoption remain critical considerations.
With a market cap of just
- Direct sales of VLN branded products
- Licensing agreements with major tobacco companies
- Contract manufacturing opportunities
The company's ability to scale production and meet potential industry-wide demand will be crucial. Their strategy to launch additional reduced nicotine products under other brand labels suggests preparation for market expansion, though execution risks and capital requirements for scaling operations remain key considerations.
FDA Reduced Nicotine Content Proposal Indicated to Have Completed OMB Review as of January 3, 2025
FDA Spokesperson Indicates Policy Could Be Among Most Impactful Population-Level Actions in the History of U.S. Tobacco Product Regulation
MOCKSVILLE, N.C., Jan. 13, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco products company that is leading the fight against nicotine and believes smokers should have a choice about their nicotine consumption, today announced that it stands ready to support the U.S. Food and Drug Administration’s proposed tobacco product standard to mandate reduced nicotine content in cigarettes, which is indicated to have cleared review by the U.S. Office of Management and Budget on January 3, 2025. The proposal is part of a long-standing effort by the FDA to mandate a drastic reduction in the amount of nicotine in cigarettes, a cornerstone goal of public health experts seeking to reduce the harms of smoking and very much in concert with 22nd Century’s VLN branded low nicotine cigarettes.
“OMB clearance marks a major step in moving this policy forward, and we are excited to see further definitive action by the federal government toward making this scientifically backed, non-partisan smoking harm reduction policy a reality,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “The FDA has openly stated that this could be the most impactful action for the improvement of public health in reducing the widespread and clearly documented harms of smoking.”
“22nd Century has played a pivotal role in the research, development and numerous federally funded clinical studies underpinning this policy, which has been advanced across multiple administrations since 2009, including action under the first Trump administration. We are also the first and only Company to bring an FDA authorized reduced nicotine content cigarette designed specifically to reduce the harms of smoking to market through the commercial launch of our VLN reduced nicotine content cigarettes. We are now working to launch additional products, including additional reduced nicotine content products using our tobacco but under other brand labels and give greater awareness to low nicotine cigarettes as a separate category in the market. This is a key component as part of our drive to expand the distribution of reduced nicotine content cigarettes manufactured by 22nd Century, increase consumer awareness and expand the VLN® footprint.”
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 combusted 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® and Helps You Smoke Less® are registered trademarks 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 28, 2024, and in the Company’s Quarterly Reports filed on May 15, 2024, August 13, 2024, and November 11, 2024. 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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