Washington Post Story Featuring 22nd Century VLN Products Highlights Proposed FDA Reduced Nicotine Content Policy Could Initially Benefit An Estimated 13 Million Smokers
22nd Century Group (NASDAQ: XXII) was featured in a Washington Post article discussing the FDA's proposed policy to mandate reduced nicotine content in cigarettes. The policy, which cleared U.S. Office of Management and Budget review on January 3, 2025, could benefit an estimated 13 million smokers in its first five years.
The company's VLN branded low nicotine cigarettes are the first and only combustible tobacco products with FDA Modified Risk Tobacco Product designation, available in over 5,000 stores nationwide. The products are manufactured using proprietary tobacco strains that can be licensed to other brands, potentially creating a new market category similar to non-alcoholic beverages.
The policy initiative, started in 2017 during the Trump administration, is supported by decades of clinical research using 22nd Century's reduced nicotine content cigarettes, demonstrating that adult smokers can effectively control their smoking habits with these products.
22nd Century Group (NASDAQ: XXII) è stata menzionata in un articolo del Washington Post che discute la proposta della FDA di imporre un contenuto ridotto di nicotina nelle sigarette. La politica, che ha superato la revisione dell'Ufficio di gestione e bilancio degli Stati Uniti il 3 gennaio 2025, potrebbe beneficiare circa 13 milioni di fumatori nei primi cinque anni.
I sigarette a bassa nicotina marchiate VLN dell'azienda sono i primi e unici prodotti di tabacco combustibile con la designazione di prodotto del tabacco a rischio modificato dalla FDA, disponibili in oltre 5.000 negozi in tutto il paese. I prodotti sono fabbricati utilizzando varietà di tabacco proprietarie che possono essere concesse in licenza ad altri marchi, creando potenzialmente una nuova categoria di mercato simile a quella delle bevande analcoliche.
L'iniziativa politica, avviata nel 2017 durante l'amministrazione Trump, è supportata da decenni di ricerca clinica che utilizza le sigarette a contenuto ridotto di nicotina della 22nd Century, dimostrando che i fumatori adulti possono controllare in modo efficace le loro abitudini di fumo con questi prodotti.
22nd Century Group (NASDAQ: XXII) fue mencionado en un artículo de The Washington Post que discute la política propuesta por la FDA para exigir un contenido reducido de nicotina en los cigarrillos. La política, que superó la revisión de la Oficina de Gestión y Presupuesto de EE. UU. el 3 de enero de 2025, podría beneficiar a aproximadamente 13 millones de fumadores en sus primeros cinco años.
Los cigarrillos de bajo contenido de nicotina de la marca VLN de la compañía son los primeros y únicos productos de tabaco combustible con la designación de Producto de Tabaco de Riesgo Modificado por la FDA, disponibles en más de 5,000 tiendas en todo el país. Los productos se fabrican utilizando cepas de tabaco propietarias que pueden ser licenciadas a otras marcas, potencialmente creando una nueva categoría de mercado similar a las bebidas no alcohólicas.
La iniciativa política, iniciada en 2017 durante la administración de Trump, cuenta con el respaldo de décadas de investigación clínica que utiliza los cigarrillos de contenido reducido de nicotina de 22nd Century, demostrando que los fumadores adultos pueden controlar eficazmente sus hábitos de fumar con estos productos.
22nd Century Group (NASDAQ: XXII)는 FDA의 담배 제품의 니코틴 함량 감소 의무화 제안을 다룬 워싱턴 포스트 기사에 등장했습니다. 이 정책은 2025년 1월 3일 미국 관리 및 예산국의 검토를 통과했으며, 첫 5년 동안 약 1,300만 흡연자에게 혜택을 줄 수 있습니다.
회사의 VLN 브랜드 저니코틴 담배는 FDA의 수정 위험 담배 제품 인정을 받은 최초이자 유일한 연소성 담배 제품으로, 전국 5,000개 이상의 상점에서 판매되고 있습니다. 이 제품들은 다른 브랜드에 라이선스가 부여될 수 있는 독점 담배 품종을 사용하여 제조되며, 알콜이 없는 음료와 유사한 새로운 시장 카테고리를 잠재적으로 창출할 수 있습니다.
이 정책 이니셔티브는 2017년 트럼프 행정부에서 시작되었으며, 22nd Century의 저니코틴 담배를 사용한 수십 년의 임상 연구에 의해 지원되어 성인 흡연자들이 이 제품으로 흡연 습관을 효과적으로 조절할 수 있음을 입증합니다.
22nd Century Group (NASDAQ: XXII) a été mentionnée dans un article du Washington Post discutant de la politique proposée par la FDA visant à imposer une teneur réduite en nicotine dans les cigarettes. La politique, qui a passé l'examen du Bureau de gestion et de budget des États-Unis le 3 janvier 2025, pourrait bénéficier à environ 13 millions de fumeurs au cours des cinq premières années.
Les cigarettes à faible nicotine de la marque VLN de l'entreprise sont les premiers et uniques produits de tabac combustibles ayant reçu la désignation de produit du tabac à risque modifié par la FDA, disponibles dans plus de 5 000 magasins à travers le pays. Les produits sont fabriqués en utilisant des variétés de tabac propriétaires qui peuvent être licenciées à d'autres marques, créant potentiellement une nouvelle catégorie de marché similaire à celle des boissons non alcoolisées.
L'initiative politique, lancée en 2017 sous l'administration Trump, est soutenue par des décennies de recherche clinique utilisant les cigarettes à teneur réduite en nicotine de 22nd Century, démontrant que les fumeurs adultes peuvent contrôler efficacement leurs habitudes de consommation avec ces produits.
22nd Century Group (NASDAQ: XXII) wurde in einem Artikel der Washington Post erwähnt, der die von der FDA vorgeschlagene Richtlinie zur Festlegung eines reduzierten Nikotingehalts in Zigaretten thematisiert. Die Richtlinie, die am 3. Januar 2025 die Überprüfung des US-Büros für Management und Haushalt bestanden hat, könnte in den ersten fünf Jahren schätzungsweise 13 Millionen Raucher zugutekommen.
Die VLN-Marke der nikotinarmen Zigaretten des Unternehmens sind die ersten und einzigen brennbaren Tabakprodukte mit der von der FDA genehmigten Risikomodifikation. Diese Produkte sind in über 5.000 Geschäften landesweit erhältlich. Sie werden aus proprietären Tabaksorten hergestellt, die anderen Marken lizenziert werden können, was potenziell eine neue Marktategorie ähnlich wie alkoholfreie Getränke schaffen könnte.
Die politische Initiative, die 2017 während der Trump-Administration begann, wird von jahrzehntelanger klinischer Forschung unterstützt, die die Zigaretten mit reduziertem Nikotingehalt der 22nd Century verwendet, und zeigt, dass erwachsene Raucher ihre Rauchergewohnheiten mit diesen Produkten effektiv kontrollieren können.
- First and only FDA-authorized reduced nicotine cigarettes in the market
- Present in over 5,000 stores across the country
- Potential to license proprietary tobacco strains to other brands
- FDA policy implementation could benefit 13 million smokers
- Cleared important regulatory hurdle with OMB review
- Faces competition from larger tobacco companies ('David-and-Goliath' situation)
- Success depends on pending FDA policy implementation
- Potential resistance from major tobacco companies questioning policy viability
Insights
The FDA's proposed reduced nicotine mandate represents a landmark shift in tobacco regulation with substantial market implications. The policy's progression through OMB review signals serious momentum, despite the upcoming administration change. The estimated impact on 13 million smokers in the first five years demonstrates the policy's massive public health potential.
XXII's strategic positioning as the only FDA-authorized provider of reduced nicotine cigarettes creates a significant first-mover advantage. The company's 5,000+ store presence and manufacturing capabilities position it to capture substantial market share when the mandate takes effect. The parallel to the growing non-alcoholic beverage market suggests a viable commercial model for reduced nicotine products.
This development could fundamentally restructure the $80 billion U.S. cigarette market. XXII's proprietary tobacco strains and manufacturing infrastructure give it a important technical advantage over major tobacco companies that currently lack reduced nicotine capabilities. The company's ability to license its technology to other manufacturers could create multiple revenue streams through both direct sales and licensing fees.
However, XXII's relatively small market cap of
VLN Reduced Nicotine Content Cigarettes from 22nd Century Is the Only Authorized Combustible Solution to Support the FDA’s War on Smoking
MOCKSVILLE, N.C., Jan. 14, 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, was featured today in a Washington Post news story (https://www.washingtonpost.com/health/2025/01/14/cigarettes-low-nicotine-regulation-biden/) addressing new federal policy activities that could reduce the health harms of smoking. The article focuses on a recent U.S. Food and Drug Administration policy proposal to mandate reduced nicotine content in cigarettes, which recently cleared review by the U.S. Office of Management and Budget on January 3, 2025.
“While we are in the final days of the Biden administration, this policy – which may be the most ambitious and impactful smoking harm reduction policy in a generation – was originally jumpstarted in 2017 during the first Trump administration by then FDA Commissioner Scott Gottlieb, a major proponent of smoking harm reduction,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “We are excited to see federal policy continue to progress even as we continue to roll out the first reduced nicotine cigarettes commercially across the U.S., demonstrating that adult smokers who want this product can use it effectively to control their nicotine intake.”
The proposal is based on decades of clinical research underpinned by reduced nicotine content cigarettes manufactured by 22nd Century showing that adult smokers can control their smoking when using a reduced nicotine content cigarette in place of conventional nicotine cigarettes currently sold by the major tobacco companies. 22nd Century’s VLN branded low nicotine cigarettes are the first and only combustible tobacco products to receive authorization by the FDA under its Modified Risk Tobacco Product designation and available at more than 5,000 stores across the country.
“While this may be a David-and-Goliath story, we are quickly moving ahead with an increasing number of retailers who are interested in not only putting our VLN products on the shelf, but also stocking their own or other brands of reduced nicotine cigarettes that we can manufacture or license using our proprietary tobacco strains, creating a new category in the market. Using VLN products mirrors the growing non-alcoholic beer and spirits segments in adult beverage as consumers seek alternatives to traditional products in those categories.”
“The FDA originally estimated in the first five years alone that 13 million smokers could benefit under this policy, a tremendous figure for public health across the country. Big Tobacco has tried to question whether this policy could be achieved on a commercial basis or suggest contraband cigarettes would be a major issue. 22nd Century has demonstrated that not only is this policy commercially viable, it is also effective at the primary goal – controlling nicotine intake and cutting smoking activity,” said Firestone.
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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