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 disponibilit脿 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 猫 stata strumentale nella ricerca e nello sviluppo che supportano questa politica, che 猫 avanzata attraverso pi霉 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 disposici贸n a apoyar el est谩ndar propuesto por la FDA que exige un contenido reducido de nicotina en los cigarrillos. La propuesta, 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, tiene como objetivo reducir dr谩sticamente 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 煤nicos cigarrillos de contenido reducido de nicotina autorizados por la FDA en el mercado. El CEO Larry Firestone enfatiza el potencial impacto significativo de la pol铆tica en la salud p煤blica y en la reducci贸n del da帽o por fumar.
22nd Century Group ha sido fundamental en la investigaci贸n y desarrollo que apoya esta pol铆tica, que ha avanzado a trav茅s de m煤ltiples administraciones desde 2009. La empresa planea lanzar m谩s productos de contenido reducido de nicotina bajo otras marcas y tiene como objetivo expandir la distribuci贸n y conciencia de los cigarrillos de baja nicotina como una categor铆a de mercado distinta.
22nd Century Group (NASDAQ: XXII)電 FDA臧 鞝滌晥頃 雼措鞍 鞝滍拡 響滌鞚 歆鞗愴暊 欷牍勱皜 霅橃棃雼り碃 氚滍憸頄堨姷雼堧嫟. 鞚 響滌鞚 2025雲 1鞗 3鞚 氙戈淡 甏毽 鞓堨偘甑潣 瓴韱犽ゼ 韱店臣頄堨溂氅, 雼措鞍鞚 雼堨綌韹 頃焿鞚 雽韽 欷勳澊電 瓴冹潉 氇╉憸搿 頃橁碃 鞛堨姷雼堧嫟.
须岇偓鞚 VLN 靸來憸 鞝雼堨綌韹 雼措鞍電 鞚 鞚措媹靺旐嫲敫岇檧 鞚检箻頃橂┌, 鞁滌灔鞐愳劀 FDA鞚 鞀轨澑鞚 氚涭潃 斓滌磮鞚挫瀽 鞙犾澕頃 鞝雼堨綌韹 頃焿 雼措鞍鞛呺媹雼. CEO 霝橂Μ 韺岇澊鞏挫姢韱れ潃 鞚 鞝曥眳鞚 瓿店车 瓯搓皶瓿 頋§棸 頂柬暣 臧愳唽鞐 氙胳範 靾 鞛堧姅 欷戨寑頃 鞓來枼鞚 臧曥“頃╇媹雼.
22nd Century Group鞚 2009雲 鞚错泟 鞐煬 甏毽棎 瓯胳硱 氚滌爠頃 鞓 鞚 鞝曥眳鞚 霋冯皼旃晿電 鞐瓣惮 氚 臧滊皽鞐 欷戩殧頃 鞐暊鞚 頃挫檾鞀惦媹雼. 鞚 須岇偓電 雼るジ 敫岆灉霌 鞎勲灅鞐愳劀 於旉皜 鞝雼堨綌韹 鞝滍拡鞚 於滌嫓頃 瓿勴殟鞚措┌, 鞝雼堨綌韹 雼措鞍毳 霃呺霅 鞁滌灔 旃错厡瓿犽Μ搿滌劀 雿 雱愲Μ 氚瓣笁頃橁碃 鞚胳霃勲ゼ 雴掛澊電 瓴冹潉 氇╉憸搿 頃橁碃 鞛堨姷雼堧嫟.
22nd Century Group (NASDAQ: XXII) annonce sa volont茅 de soutenir la norme propos茅e par la FDA sur les produits du tabac imposant une r茅duction de la teneur en nicotine dans les cigarettes. La proposition, qui a 茅t茅 approuv茅e par le Bureau de gestion et du budget des 脡tats-Unis le 3 janvier 2025, vise 脿 r茅duire de mani猫re drastique les niveaux de nicotine dans les cigarettes.
Les cigarettes 脿 faible teneur en nicotine de la marque VLN de l鈥檈ntreprise s鈥檌nscrivent dans cette initiative, 茅tant les premi猫res et uniques cigarettes 脿 teneur r茅duite en nicotine autoris茅es par la FDA sur le march茅. Le PDG Larry Firestone souligne l'impact potentiel significatif de cette politique sur la sant茅 publique et la r茅duction des dommages caus茅s par le tabagisme.
Le 22nd Century Group a jou茅 un r么le cl茅 dans la recherche et le d茅veloppement soutenant cette politique, qui s'est d茅velopp茅e au fil de plusieurs administrations depuis 2009. L'entreprise pr茅voit de lancer d'autres produits 脿 teneur r茅duite en nicotine sous d'autres marques et vise 脿 茅largir la distribution et la sensibilisation aux cigarettes 脿 faible teneur en nicotine comme une cat茅gorie de march茅 distincte.
22nd Century Group (NASDAQ: XXII) k眉ndigt seine Bereitschaft an, den von der FDA vorgeschlagenen Standard f眉r Tabakprodukte zu unterst眉tzen, der eine reduzierte Nikotinkonzentration in Zigaretten vorschreibt. Der Vorschlag, der am 3. Januar 2025 die Pr眉fung des U.S. Office of Management and Budget bestanden hat, zielt darauf ab, die Nikotinwerte in Zigaretten drastisch zu senken.
Die VLN-Marke f眉r 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 枚ffentliche Gesundheit und die Verringerung des Rauchenschadens.
Die 22nd Century Group war ma脽geblich an der Forschung und Entwicklung beteiligt, die diese Politik unterst眉tzt, die seit 2009 眉ber mehrere Regierungen hinweg vorangetrieben wurde. Das Unternehmen plant die Einf眉hrung weiterer Produkte mit reduziertem Nikotinkgehalt unter anderen Marken und hat zum Ziel, die Verbreitung und das Bewusstsein f眉r Niedrignikotinzigaretten als eine eigenst盲ndige 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鈥檚 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鈥檚 VLN branded low nicotine cigarettes.
鈥淥MB 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,鈥 said Larry Firestone, Chief Executive Officer of 22nd Century Group. 鈥淭he 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.鈥
鈥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庐 蹿辞辞迟辫谤颈苍迟.鈥
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 , on聽, and on .
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
When did the FDA's reduced nicotine content proposal clear OMB review for XXII?
What is 22nd Century Group's (XXII) role in the FDA's nicotine reduction initiative?
What are XXII's expansion plans for VLN cigarettes?
How long has the FDA's reduced nicotine policy been in development affecting XXII?
