VLN Commercial Launches Confirm Viability of the FDA’s Proposed Reduced Nicotine Mandate
22nd Century Group (Nasdaq: XXII) is gaining traction with its VLN® reduced nicotine content cigarettes as multiple tobacco brands partner to expand product availability. The company's proprietary tobacco contains 95% less nicotine than conventional cigarettes, meeting the FDA's proposed standard of 0.7 mg nicotine per gram of tobacco.
The FDA's January 2025 proposed Tobacco Product Standard aims to reduce smoking-related harm by limiting nicotine content in cigarettes. VLN® products, averaging 0.5 mg per gram, are currently the only FDA-authorized combustible cigarettes meeting this standard. The FDA projects this initiative could prevent approximately 48 million youth and young adults from starting smoking by 2100.
New partnerships including Smoker Friendly VLN® and Pinnacle VLN® demonstrate growing industry adoption ahead of the standard's implementation, expected two years after final approval.
22nd Century Group (Nasdaq: XXII) sta guadagnando terreno con le sue sigarette VLN® a contenuto ridotto di nicotina, grazie a diverse collaborazioni con marchi del tabacco per ampliare la disponibilità del prodotto. Il tabacco proprietario dell'azienda contiene il 95% di nicotina in meno rispetto alle sigarette tradizionali, rispettando lo standard proposto dalla FDA di 0,7 mg di nicotina per grammo di tabacco.
Lo standard proposto dalla FDA a gennaio 2025 mira a ridurre i danni legati al fumo limitando il contenuto di nicotina nelle sigarette. I prodotti VLN®, con una media di 0,5 mg per grammo, sono attualmente le uniche sigarette combustibili autorizzate dalla FDA a rispettare questo standard. La FDA stima che questa iniziativa potrebbe prevenire l'inizio del fumo in circa 48 milioni di giovani e giovani adulti entro il 2100.
Nuove collaborazioni, tra cui Smoker Friendly VLN® e Pinnacle VLN®, mostrano una crescente adozione da parte dell'industria in vista dell'entrata in vigore dello standard, prevista due anni dopo l'approvazione definitiva.
22nd Century Group (Nasdaq: XXII) está ganando impulso con sus cigarrillos VLN® de contenido reducido de nicotina, gracias a múltiples asociaciones con marcas de tabaco para ampliar la disponibilidad del producto. El tabaco patentado de la compañía contiene un 95% menos de nicotina que los cigarrillos convencionales, cumpliendo con el estándar propuesto por la FDA de 0,7 mg de nicotina por gramo de tabaco.
El estándar propuesto por la FDA en enero de 2025 tiene como objetivo reducir los daños relacionados con el tabaquismo limitando el contenido de nicotina en los cigarrillos. Los productos VLN®, con un promedio de 0,5 mg por gramo, son actualmente los únicos cigarrillos combustibles autorizados por la FDA que cumplen con este estándar. La FDA proyecta que esta iniciativa podría evitar que aproximadamente 48 millones de jóvenes y adultos jóvenes comiencen a fumar para el año 2100.
Nuevas asociaciones, incluyendo Smoker Friendly VLN® y Pinnacle VLN®, demuestran una creciente adopción en la industria antes de la implementación del estándar, prevista dos años después de la aprobación final.
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22nd Century Group (Nasdaq : XXII) gagne en popularité avec ses cigarettes VLN® à teneur réduite en nicotine, alors que plusieurs marques de tabac s'associent pour élargir la disponibilité du produit. Le tabac propriétaire de l'entreprise contient 95 % de nicotine en moins que les cigarettes conventionnelles, respectant la norme proposée par la FDA de 0,7 mg de nicotine par gramme de tabac.
La norme proposée par la FDA en janvier 2025 vise à réduire les méfaits liés au tabagisme en limitant la teneur en nicotine des cigarettes. Les produits VLN®, avec une moyenne de 0,5 mg par gramme, sont actuellement les seuls cigarettes combustibles autorisées par la FDA à respecter cette norme. La FDA prévoit que cette initiative pourrait empêcher environ 48 millions de jeunes et jeunes adultes de commencer à fumer d'ici 2100.
De nouveaux partenariats, dont Smoker Friendly VLN® et Pinnacle VLN®, témoignent d'une adoption croissante par l'industrie avant la mise en œuvre de la norme, attendue deux ans après l'approbation finale.
22nd Century Group (Nasdaq: XXII) gewinnt mit seinen VLN®-Zigaretten mit reduziertem Nikotingehalt an Bedeutung, da mehrere Tabakmarken Partnerschaften eingehen, um die Produktverfügbarkeit zu erweitern. Der firmeneigene Tabak enthält 95 % weniger Nikotin als herkömmliche Zigaretten und erfüllt den von der FDA vorgeschlagenen Standard von 0,7 mg Nikotin pro Gramm Tabak.
Der von der FDA im Januar 2025 vorgeschlagene Tabakproduktstandard zielt darauf ab, durch Begrenzung des Nikotingehalts in Zigaretten rauchbedingte Schäden zu reduzieren. VLN®-Produkte mit durchschnittlich 0,5 mg pro Gramm sind derzeit die einzigen von der FDA zugelassenen brennbaren Zigaretten, die diesen Standard erfüllen. Die FDA schätzt, dass diese Initiative etwa 48 Millionen Jugendliche und junge Erwachsene bis zum Jahr 2100 daran hindern könnte, mit dem Rauchen zu beginnen.
Neue Partnerschaften, darunter Smoker Friendly VLN® und Pinnacle VLN®, zeigen eine wachsende Branchenakzeptanz vor der Umsetzung des Standards, die zwei Jahre nach der endgültigen Genehmigung erwartet wird.
- VLN® is the only FDA-authorized combustible cigarette product meeting the new nicotine standard
- Multiple tobacco brands partnering to expand VLN® product availability
- Company's proprietary tobacco achieves 95% nicotine reduction compared to conventional cigarettes
- Positioned to scale availability to all 50 states upon state approval
- Two-year implementation timeline from final approval before standard takes effect
- Still requires individual state approvals for nationwide distribution
Insights
22nd Century's VLN cigarettes gaining commercial adoption ahead of FDA's proposed nicotine reduction mandate, positioning company for significant growth.
The press release highlights a pivotal development for 22nd Century Group as multiple tobacco brands are now adopting its proprietary VLN® reduced nicotine content cigarettes, including branded versions like Smoker Friendly VLN® and Pinnacle VLN®. This market traction directly validates the commercial viability of the FDA's proposed nicotine reduction mandate announced in January 2025, which would limit cigarettes to 0.7 mg of nicotine per gram of tobacco � a standard 22nd Century's products already meet at 0.5 mg per gram.
What makes this particularly significant is the regulatory timing � 22nd Century positions itself as the only company currently authorized to produce cigarettes meeting this proposed standard. The FDA's proposed rule would take effect two years after final approval, creating a substantial first-mover advantage for 22nd Century. The company has effectively demonstrated through these partnerships that implementation barriers are minimal, countering a key industry objection to such regulation.
The FDA's population health modeling projects that approximately 48 million youth and young adults would avoid initiating smoking by 2100 as a result of this standard. Importantly, 22nd Century's earlier recommendations from 2018 appear to have directly influenced the current proposed rule, including the specific nicotine threshold and feasibility assessments.
This development represents a potential inflection point for the company, as it transitions from regulatory preparation to commercial execution, with plans to scale to all 50 states pending state approvals. The timing aligns with increasing regulatory pressure on nicotine products, positioning 22nd Century to potentially capture significant market share if the FDA mandate proceeds as proposed.
Multiple Tobacco Brands Partnering with 22nd Century to Expand Availability and Awareness of VLN Based Reduced Nicotine Content Products
Manufactured in the USA, VLN Products from 22nd Century Provide Clinically Proven Solution to Reduce the Rate and Harms of Smoking
MOCKSVILLE, N.C., July 16, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), the only tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addiction is creating a new pathway to reducing the rate of smoking and related health harms through increasing adoption of its VLN® reduced nicotine content cigarette products by additional brands. Our products incorporate proprietary and patented tobacco having
The recently announced partner VLN® initiatives, such as Smoker Friendly VLN®, Pinnacle VLN®, reflect a growing commitment by tobacco brands to accelerate compliance with the U.S. Food and Drug Administration’s proposed new , which is intended to curb the harms of smoking.
“The FDA recognizes that nicotine is a highly addictive substance and that to achieve true tobacco harm reduction, nicotine consumption must be addressed. The FDA’s new product standard proposed in January is one of many factors that are driving early commercial interest in our VLN reduced nicotine content tobacco products. We are excited to see our customer’s brands adding VLN cigarettes to their lineup. This will enhance market availability of VLN cigarettes and offer customers a Tobacco Harm Reduction product that will give the smoker a choice to control their nicotine consumption,� said Larry Firestone, Chief Executive Officer of 22nd Century Group. “These commercial launches and our readiness once we receive state approval to scale availability to all 50 states for the entire U.S. cigarette market continues to demonstrate that there need not be any commercial barriers to adopting this FDA policy, which could be the most impactful health decision in a generation.�
Formally announced in January 2025, the proposed standard sets a maximum nicotine content of 0.7 mg of nicotine per gram of tobacco in cigarettes and certain other combusted tobacco products, taking effect two years from final approval. VLN® based products from 22nd Century are the only combustible cigarette products authorized by the FDA to meet the standard, at an average of 0.5 mg per gram, and the only product that offers consumers a choice about their nicotine consumption.
On implementation of the FDA proposal, people who are addicted and wish to alter their dependency or even quit could have the ability to do so more easily, significantly reducing the morbidity and mortality caused by smoking. Based on FDA’s population health model, by the year 2100, in the United States, approximately 48 million youth and young adults who would have otherwise initiated smoking would not start as a result of the proposed product standard.
22nd Century is monitoring comment submissions under the proposed rule and intends to make its own submission before the comment period closes.
This activity follows the 2018 rule making process, which ultimately incorporated many of the suggestions, independent clinical research studies and feasibility data from , including:
- A proposed standard of not more than 0.7mg/g of nicotine content, based on 22nd Century’s recommendation of an average of 0.5mg/g,
- The fact that our patented low nicotine content tobacco leaf contained in our VLN Products that already meets the standard can be readily sourced in enough quantity to meet demand for reduced nicotine content cigarette products, and
- The fact the reduced nicotine content tobacco is an effective way to reduce the rate and harms of smoking, as documented by dozens of peer reviewed and published independent clinical studies using research cigarettes manufactured by 22nd Century
The announcing the rule includes the following statement from the former FDA Commissioner Robert M. Califf, M.D.: “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products. This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money. I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward.�
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 proprietary reduced nicotine tobacco blends are made possible by comprehensive and patented technologies and tobacco plants 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 , on , on , and on .
Learn more about VLN®.
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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 in the Company’s Quarterly Reports filed on May 13, 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
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