FDA Publishes Proposed New Tobacco Product Standard for Nicotine Yield, Citing VLN from 22nd Century as the Only Combustible Cigarette That Complies with the New Standard
22nd Century Group (NASDAQ: XXII) welcomes FDA's proposed new Tobacco Product Standard that would set a maximum nicotine content of 0.7 mg per gram of tobacco in cigarettes. The company's VLN products, currently available in over 5,000 stores nationwide, are the only FDA-authorized reduced nicotine cigarettes that already comply with this standard.
The FDA projects that by 2100, approximately 48 million youth and young adults would avoid starting smoking due to this regulation. The standard would take effect two years after final approval. VLN cigarettes contain 95% less nicotine than conventional cigarettes, positioning 22nd Century Group advantageously as the only current manufacturer meeting the proposed requirements.
22nd Century Group (NASDAQ: XXII) accoglie la proposta della FDA per un nuovo Standard sui Prodotti del Tabacco che stabilirebbe un contenuto massimo di nicotina di 0,7 mg per grammo di tabacco nelle sigarette. I prodotti VLN dell'azienda, attualmente disponibili in oltre 5.000 negozi a livello nazionale, sono le uniche sigarette a nicotina ridotta autorizzate dalla FDA che già rispettano questo standard.
La FDA prevede che entro il 2100 circa 48 milioni di giovani e giovani adulti eviteranno di iniziare a fumare grazie a questa regolamentazione. Lo standard entrerà in vigore due anni dopo l'approvazione finale. Le sigarette VLN contengono il 95% in meno di nicotina rispetto alle sigarette convenzionali, posizionando favorevolmente la 22nd Century Group come l'unico produttore attualmente in grado di soddisfare i requisiti proposti.
22nd Century Group (NASDAQ: XXII) da la bienvenida a la propuesta de la FDA para un nuevo Estándar de Productos de Tabaco que establecería un contenido máximo de nicotina de 0,7 mg por gramo de tabaco en los cigarrillos. Los productos VLN de la empresa, actualmente disponibles en más de 5,000 tiendas en todo el país, son los únicos cigarrillos autorizados por la FDA que ya cumplen con este estándar de nicotina reducida.
La FDA proyecta que, para el 2100, aproximadamente 48 millones de jóvenes y adultos jóvenes evitarían empezar a fumar debido a esta regulación. El estándar entrará en vigor dos años después de la aprobación final. Los cigarrillos VLN contienen un 95% menos de nicotina que los cigarrillos convencionales, posicionando a la 22nd Century Group de manera ventajosa como el único fabricante actual que cumple con los requisitos propuestos.
22nd Century Group (NASDAQ: XXII)는 FDA가 제안한 새로운 담배 제품 기준을 환영합니다. 이 기준은 담배의 그램당 최대 니코틴 함량을 0.7mg으로 설정할 것입니다. 현재 5,000개 이상의 매장에서 판매되고 있는 회사의 VLN 제품은 이미 이 기준을 준수하는 FDA 승인 니코틴 감소 담배의 유일한 제품입니다.
FDA는 2100년까지 약 4,800만 명의 청소년 및 젊은 성인이 이 규정 덕분에 흡연을 시작하지 않을 것으로 예상하고 있습니다. 이 기준은 최종 승인 이후 2년 후에 시행될 것입니다. VLN 담배는 일반 담배보다 95% 적은 니코틴을 포함하고 있어 22nd Century Group이 제안된 요건을 충족하는 유일한 현재 제조업체로서 유리한 위치를 차지하고 있습니다.
22nd Century Group (NASDAQ: XXII) accueille la proposition de la FDA concernant une nouvelle norme pour les produits du tabac qui établirait une teneur maximale en nicotine de 0,7 mg par gramme de tabac dans les cigarettes. Les produits VLN de l'entreprise, actuellement disponibles dans plus de 5 000 magasins à l'échelle nationale, sont les seules cigarettes à faible teneur en nicotine autorisées par la FDA qui respectent déjà cette norme.
La FDA prévoit qu'en 2100, environ 48 millions de jeunes et de jeunes adultes éviteront de commencer à fumer grâce à cette réglementation. La norme entrera en vigueur deux ans après l'approbation finale. Les cigarettes VLN contiennent 95 % de nicotine en moins que les cigarettes classiques, positionnant ainsi 22nd Century Group de manière avantageuse comme le seul fabricant actuel répondant aux exigences proposées.
22nd Century Group (NASDAQ: XXII) begrüßt den Vorschlag der FDA für einen neuen Tabakproduktstandard, der einen maximalen Nikotingehalt von 0,7 mg pro Gramm Tabak in Zigaretten festlegen würde. Die VLN Produkte des Unternehmens, die derzeit in über 5.000 Geschäften im ganzen Land erhältlich sind, sind die einzigen FDA-zugelassenen Zigaretten mit reduziertem Nikotingehalt, die bereits diesem Standard entsprechen.
Die FDA prognostiziert, dass bis 2100 etwa 48 Millionen Jugendliche und junge Erwachsene aufgrund dieser Regelung davon abgehalten werden, mit dem Rauchen zu beginnen. Der Standard wird zwei Jahre nach der endgültigen Genehmigung in Kraft treten. VLN-Zigaretten enthalten 95% weniger Nikotin als herkömmliche Zigaretten und positionieren die 22nd Century Group vorteilhaft als den einzigen aktuellen Hersteller, der die vorgeschlagenen Anforderungen erfüllt.
- Only manufacturer with FDA-authorized reduced nicotine cigarettes meeting new standard
- Established distribution network with presence in 5,000+ stores
- First-mover advantage in potentially mandatory reduced nicotine market
- Products contain 95% less nicotine than conventional cigarettes
- Two-year implementation period could allow competitors to develop competing products
- Regulation still in proposal phase, not yet finalized
Insights
The FDA's proposed tobacco product standard represents a landmark regulatory shift in tobacco control. The 0.7 mg nicotine per gram limit effectively creates a new product category that currently has only one compliant product - 22nd Century's VLN cigarettes. This regulatory moat provides XXII with a significant first-mover advantage in what could become a mandated standard within two years.
The FDA's citation of VLN in the proposed rule and the explicit recognition of its 95
This regulatory development could fundamentally reshape the $80 billion U.S. cigarette market. With XXII's current presence in 5,000 stores and being the only FDA-authorized reduced nicotine cigarette, they are positioned to potentially capture significant market share. The FDA's projection of preventing 48 million new smokers by 2100 indicates the massive scale of market transformation ahead.
For context, imagine a scenario where every cigarette manufacturer must either license XXII's technology or develop alternative solutions within two years. This could trigger substantial valuation changes for a company currently valued at just
The FDA's proposed standard marks a pivotal shift in tobacco control policy. Historical data shows that reducing nicotine content to very low levels significantly decreases addiction potential while maintaining product familiarity for current smokers seeking to quit. The explicit mention of VLN's success in current markets provides real-world evidence supporting the feasibility of this standard.
The projected health impact - preventing 48 million youth and young adults from starting smoking by 2100 - represents an unprecedented public health intervention. For XXII, this positions them not just as a commercial entity but as a key facilitator of one of the most significant public health initiatives in recent history.
New FDA Rule Cites Extensive Research Using 22nd Century Manufactured Products and Specifically Cites 22nd Century VLN Sales Activity
Proposed Standard Designates VLNC as a New Product Category, 22nd Century Ready to Manufacture as Needed to Quickly Expand Commercialization and Distribution
FDA Expects Proposed Product Standard Would Significantly Reduce the Morbidity and Mortality Caused by Smoking
MOCKSVILLE, N.C., Jan. 15, 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 heralded the publication of a proposed new Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products by the U.S. Food and Drug Administration.
The new proposed standard would set a maximum nicotine content of 0.7 mg nicotine per gram of tobacco in cigarettes and certain other combusted tobacco products and take effect in two years from final approval. 22nd Century’s VLN products – the only combustible cigarettes authorized by the FDA as a reduced nicotine content product – already comply with this standard and are available in more than 5,000 stores across the country.
“After 26 years of commitment to nicotine harm reduction, the FDA is now clearing the path for commercial adoption of our very important VLN reduced nicotine content tobacco products in what could be the most game-changing public health policy of a generation,” said Larry Firestone, Chief Executive Officer of 22nd Century Group.
Highlights from the more than 330 pages in the proposed rule include:
- The Food and Drug Administration is proposing a tobacco product standard that would regulate nicotine yield by establishing a maximum nicotine level in cigarettes and certain other combusted tobacco products.
- FDA is proposing this action to reduce the addictiveness of these products, thus giving people who are addicted and wish to quit the ability to do so more easily.
- FDA expects that this proposed product standard would significantly reduce 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.
The FDA’s press release today announcing the rule includes the following statement from FDA Commissioner Robert M. Califf, M.D.: “Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease. 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.”
The proposed rule specifically highlights 22nd Century’s VLN product as authorized for marketing and sale by the FDA. VLN cigarettes are currently being marketed and sold to consumers in select U.S. markets as cigarettes with 95 percent less nicotine than conventional cigarettes.
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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