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) 猫 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 variet脿 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, 猫 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 art铆culo de The Washington Post que discute la pol铆tica propuesta por la FDA para exigir un contenido reducido de nicotina en los cigarrillos. La pol铆tica, que super贸 la revisi贸n de la Oficina de Gesti贸n y Presupuesto de EE. UU. el 3 de enero de 2025, podr铆a beneficiar a aproximadamente 13 millones de fumadores en sus primeros cinco a帽os.
Los cigarrillos de bajo contenido de nicotina de la marca VLN de la compa帽铆a son los primeros y 煤nicos productos de tabaco combustible con la designaci贸n de Producto de Tabaco de Riesgo Modificado por la FDA, disponibles en m谩s de 5,000 tiendas en todo el pa铆s. Los productos se fabrican utilizando cepas de tabaco propietarias que pueden ser licenciadas a otras marcas, potencialmente creando una nueva categor铆a de mercado similar a las bebidas no alcoh贸licas.
La iniciativa pol铆tica, iniciada en 2017 durante la administraci贸n de Trump, cuenta con el respaldo de d茅cadas de investigaci贸n cl铆nica que utiliza los cigarrillos de contenido reducido de nicotina de 22nd Century, demostrando que los fumadores adultos pueden controlar eficazmente sus h谩bitos de fumar con estos productos.
22nd Century Group (NASDAQ: XXII)電 FDA鞚 雼措鞍 鞝滍拡鞚 雼堨綌韹 頃焿 臧愳唽 鞚橂頇 鞝滌晥鞚 雼る， 鞗岇嫳韯 韽姢韸 旮办偓鞐 霌膘灔頄堨姷雼堧嫟. 鞚 鞝曥眳鞚 2025雲 1鞗 3鞚 氙戈淡 甏毽 氚 鞓堨偘甑潣 瓴韱犽ゼ 韱店臣頄堨溂氅, 觳 5雲 霃欖晥 鞎 1,300毵 頋§棸鞛愳棎瓴 順滍儩鞚 欷 靾 鞛堨姷雼堧嫟.
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鞚 鞝曥眳 鞚措媹靺旐嫲敫岆姅 2017雲 韸鸽熂頂 頄夓爼攵鞐愳劀 鞁滌瀾霅橃棃鞙茧┌, 22nd Century鞚 鞝雼堨綌韹 雼措鞍毳 靷毄頃 靾橃嫮 雲勳潣 鞛勳儊 鞐瓣惮鞐 鞚橅暣 歆鞗愲悩鞏 靹膘澑 頋§棸鞛愲摛鞚 鞚 鞝滍拡鞙茧 頋§棸 鞀店磤鞚 須臣鞝侅溂搿 臁办爤頃 靾 鞛堨潓鞚 鞛呾頃╇媹雼.
22nd Century Group (NASDAQ: XXII) a 茅t茅 mentionn茅e dans un article du Washington Post discutant de la politique propos茅e par la FDA visant 脿 imposer une teneur r茅duite en nicotine dans les cigarettes. La politique, qui a pass茅 l'examen du Bureau de gestion et de budget des 脡tats-Unis le 3 janvier 2025, pourrait b茅n茅ficier 脿 environ 13 millions de fumeurs au cours des cinq premi猫res ann茅es.
Les cigarettes 脿 faible nicotine de la marque VLN de l'entreprise sont les premiers et uniques produits de tabac combustibles ayant re莽u la d茅signation de produit du tabac 脿 risque modifi茅 par la FDA, disponibles dans plus de 5 000 magasins 脿 travers le pays. Les produits sont fabriqu茅s en utilisant des vari茅t茅s de tabac propri茅taires qui peuvent 锚tre licenci茅es 脿 d'autres marques, cr茅ant potentiellement une nouvelle cat茅gorie de march茅 similaire 脿 celle des boissons non alcoolis茅es.
L'initiative politique, lanc茅e en 2017 sous l'administration Trump, est soutenue par des d茅cennies de recherche clinique utilisant les cigarettes 脿 teneur r茅duite en nicotine de 22nd Century, d茅montrant que les fumeurs adultes peuvent contr么ler efficacement leurs habitudes de consommation avec ces produits.
22nd Century Group (NASDAQ: XXII) wurde in einem Artikel der Washington Post erw盲hnt, der die von der FDA vorgeschlagene Richtlinie zur Festlegung eines reduzierten Nikotingehalts in Zigaretten thematisiert. Die Richtlinie, die am 3. Januar 2025 die 脺berpr眉fung des US-B眉ros f眉r Management und Haushalt bestanden hat, k枚nnte in den ersten f眉nf Jahren sch盲tzungsweise 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 眉ber 5.000 Gesch盲ften landesweit erh盲ltlich. Sie werden aus propriet盲ren Tabaksorten hergestellt, die anderen Marken lizenziert werden k枚nnen, was potenziell eine neue Marktategorie 盲hnlich wie alkoholfreie Getr盲nke schaffen k枚nnte.
Die politische Initiative, die 2017 w盲hrend der Trump-Administration begann, wird von jahrzehntelanger klinischer Forschung unterst眉tzt, die die Zigaretten mit reduziertem Nikotingehalt der 22nd Century verwendet, und zeigt, dass erwachsene Raucher ihre Rauchergewohnheiten mit diesen Produkten effektiv kontrollieren k枚nnen.
- 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鈥檚 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聽 () 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.
鈥淲hile we are in the final days of the Biden administration, this policy 鈥 which may be the most ambitious and impactful smoking harm reduction policy in a generation 鈥 was originally jumpstarted in 2017 during the first Trump administration by then FDA Commissioner Scott Gottlieb, a major proponent of smoking harm reduction,鈥 said Larry Firestone, Chief Executive Officer of 22nd Century Group. 鈥淲e 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.鈥
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鈥檚 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.
鈥淲hile 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.鈥
鈥淭he 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 鈥 controlling nicotine intake and cutting smoking activity,鈥 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.聽
We created our flagship product, the VLN庐 cigarette, to give traditional cigarette smokers an authentic and familiar alternative that helps them take control of their nicotine consumption. VLN庐 cigarettes have
Our wholly owned subsidiaries include a leading cigarette manufacturer that produces all VLN庐 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.聽
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庐 and Helps You Smoke Less庐 are registered trademarks of 22nd Century Limited LLC.
Learn more at聽, on聽, on聽, and on聽.
Learn more about VLN庐听补迟听.
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 鈥渁nticipate,鈥 鈥渂elieve,鈥 鈥渃onsider,鈥 鈥渃ontinue,鈥 鈥渃ould,鈥 鈥渆stimate,鈥 鈥渆xpect,鈥 鈥渆xplore,鈥 鈥渇oresee,鈥 鈥済oal,鈥 鈥済uidance,鈥 鈥渋ntend,鈥 鈥渓ikely,鈥 鈥渕ay,鈥 鈥減lan,鈥 鈥減otential,鈥 鈥減redict,鈥 鈥減reliminary,鈥 鈥減robable,鈥 鈥減roject,鈥 鈥減romising,鈥 鈥渟eek,鈥 鈥渟hould,鈥 鈥渨ill,鈥 鈥渨ould,鈥 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 鈥淩isk Factors鈥 in the Company鈥檚 Annual Report on Form 10-K filed on March 28, 2024, and in the Company鈥檚 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
214-597-8200
FAQ
What is the potential market impact of FDA's reduced nicotine policy for XXII?
How many stores currently sell XXII's VLN cigarettes?
When did the FDA's reduced nicotine content proposal clear OMB review?
What regulatory approval does XXII have for its VLN cigarettes?
How does XXII plan to expand its reduced nicotine cigarette business?
