22nd Century Submits Comments to FDA in Support of Proposed Reduced Nicotine Content Mandate
22nd Century Group (Nasdaq: XXII) has submitted public comments supporting the FDA's proposed mandate to reduce nicotine content in cigarettes and certain combusted tobacco products. The company's submission highlights that their Very Low Nicotine Content (VLNC) technology could transform the industry within two years.
According to FDA's model, the proposed rule could prevent 48 million youth and young adults from starting smoking and avert 1.8 million tobacco-related deaths by 2060. The company's VLN® cigarettes, containing 95% less nicotine than traditional cigarettes, are currently the only FDA-authorized low nicotine combustible cigarettes in the U.S.
The initiative has received support from over 75 health care professional organizations, including the American Medical Association and American College of Cardiology, while facing opposition from major tobacco producers.
22nd Century Group (Nasdaq: XXII) ha presentato commenti pubblici a sostegno della proposta della FDA volta a ridurre il contenuto di nicotina nelle sigarette e in alcuni prodotti del tabacco combusti. La sottomissione dell'azienda evidenzia che la loro tecnologia a contenuto di nicotina molto basso (VLNC) potrebbe trasformare l'industria entro due anni.
Secondo il modello della FDA, la regola proposta potrebbe impedire 48 milioni di giovani e giovani adulti di iniziare a fumare e far evitare 1,8 milioni di decessi legati al tabacco entro il 2060. Le sigarette VLN® dell'azienda, contenenti il 95% in meno di nicotina rispetto alle sigarette tradizionali, sono attualmente le uniche sigarette combustibili a bassa nicotina autorizzate dalla FDA negli Stati Uniti.
L'iniziativa ha ricevuto il supporto di oltre 75 organizzazioni di professionisti sanitari, tra cui la American Medical Association e l'American College of Cardiology, pur affrontando l'opposizione dei principali produttori di tabacco.
22nd Century Group (Nasdaq: XXII) ha presentado comentarios públicos en apoyo de la propuesta de la FDA para establecer un mandato que reduzca el contenido de nicotina en los cigarrillos y en ciertos productos de tabaco combustibles. La presentación de la empresa destaca que su tecnología de contenido de nicotina muy bajo (VLNC) podría transformar la industria en dos años.
Según el modelo de la FDA, la regla propuesta podría prevenir 48 millones de jóvenes y adultos jóvenes de empezar a fumar y evitar 1,8 millones de muertes relacionadas con el tabaco para 2060. Los cigarrillos VLN® de la empresa, que contienen un 95% menos de nicotina que los cigarrillos tradicionales, son actualmente los únicos cigarrillos combustibles de baja nicotina autorizados por la FDA en Estados Unidos.
La iniciativa ha recibido el apoyo de más de 75 organizaciones de profesionales de la salud, incluyendo la American Medical Association y la American College of Cardiology, mientras enfrenta la oposición de los principales productores de tabaco.
22nd Century Group (나스닥: XXII)가 FDA의 담배 및 특정 연소 담배의 니코틴 함량 감소를 의무화하자는 제안에 대한 공공 의견을 제출했습니다. 회사의 제출은 매우 낮은 니코틴 함량(VLNC) 기술이 2년 내에 산업을 변화시킬 수 있다고 강조합니다.
FDA의 모델에 따르면 제안 규칙은 청소년과 젊은 성인 4800만 명이 흡연을 시작하지 않도록 하고 2060년까지 흡연으로 인한 사망을 180만 명 줄일 수 있습니다. 회사의 VLN® 담배는 전통적 담배보다 니코틴이 95% 적은 담배로, 현재 미국에서 FDA가 승인한 유일한 저니코팅 연소 담배입니다.
이 이니셔티브는 American Medical Association과 American College of Cardiology를 포함한 75개 이상 보건 전문가 단체의 지지를 받았으며, 주요 담배 제조사들의 반대에 직면해 있습니다.
22nd Century Group (Nasdaq: XXII) a soumis des commentaires publics soutenant l mandataire proposé par la FDA visant à réduire la teneur en nicotine dans les cigarettes et certains produits du tabac combustibles. La soumission de l'entreprise souligne que leur technologie à faible teneur en nicotine (VLNC) pourrait transformer l'industrie en deux ans.
Selon le modèle de la FDA, la règle proposée pourrait empêcher 48 millions de jeunes et de jeunes adultes de commencer à fumer et éviter 1,8 million de décès liés au tabac d'ici 2060. Les cigarettes VLN® de l'entreprise, contenant 95 % de nicotine en moins que les cigarettes traditionnelles, sont actuellement les seules cigarettes combustibles à faible nicotine autorisées par la FDA aux États-Unis.
Cette initiative a reçu le soutien de plus de 75 organisations de professionnels de la santé, notamment l'American Medical Association et l'American College of Cardiology, tout en faisant face à l'opposition des grands producteurs de tabac.
22nd Century Group (Nasdaq: XXII) hat öffentliche Stellungnahmen eingereicht, die die vorgeschlagene Verpflichtung der FDA unterstützen, den Nicotinspiegel in Zigaretten und bestimmten combustierten Tabakprodukten zu senken. Die Einreichung des Unternehmens hebt hervor, dass ihre Very Low Nicotine Content (VLNC) Technologie die Branche innerhalb von zwei Jahren transformieren könnte.
Nach dem Modell der FDA könnte die vorgeschlagene Regel 48 Millionen Jugendliche und junge Erwachsene davon abhalten, mit dem Rauchen zu beginnen, und bis 2060 1,8 Millionen tabakbedingte Todesfälle verhindern. Die VLN®-Zigaretten des Unternehmens, die 95% weniger Nikotin enthalten als herkömmliche Zigaretten, sind derzeit die einzigen von der FDA genehmigten schadstoffarmen brennbaren Zigaretten in den USA.
Die Initiative hat Unterstützung von über 75 Gesundheitsberuf-Organisationen erhalten, darunter die American Medical Association und das American College of Cardiology, steht jedoch der Opposition großer Tabakhersteller gegenüber.
شركة 22nd Century Group (ناسداك: XXII) قدمت تعليقات عامة تدعم المقترح الذي فرضه FDA لتقليل محتوى النيكوتين في السجائر وبعض منتجات التبغ المحترقة. تسلط مساهمة الشركة الضوء على أن تقنيتهم VLNC (محتوى النيكوتين منخفض جدًا) يمكن أن تحوّل الصناعة في غضون عامين.
وفق نموذج FDA، يمكن أن تمنع القاعدة المقترحة 48 مليون من الشباب والشباب البالغين من بدء التدخين وتجنب 1.8 مليون وفاة مرتبطة بالتبغ بحلول 2060. سجائر VLN® من الشركة، التي تحتوي على نِسبة نِيكوتين أقل بنسبة 95٪ من السجائر التقليدية، هي حالياً السجائر المحترقة ذات النيكوتين المنخفضة الوحيدة المعتمدة من FDA في الولايات المتحدة.
مبادرة حظيت بدعم أكثر من 75 جمعية مهنية صحية، بما فيها الجمعية الطبية الأمريكية وكلية القلب الأمريكية، في حين تواجه معارضة من كبار منتجي التبغ.
22nd Century Group（纳斯达克：XXII） 已提交公开意见，支持 FDA 提议的要求，降低香烟及部分燃烧性烟草产品中的尼古丁含量。公司提交指出他们的极低尼古丁含量（VLNC）技术在两年内即可改变行业。
根据 FDA 的模型，拟议规则可能使 4800 万名青少年及年轻人避免开始吸烟，并在2060年前避免 180 万例烟草相关死亡。公司的 VLN® 香烟的尼古丁含量比传统香烟少 95%，是目前美国唯一经 FDA 授权的低尼古丁燃烧烟草香烟。
该倡议已得到超过 75 个卫生专业组织 的支持，包括美国医学会和美国心脏病学会，同时也面临主要烟草生产商的反对。
- Company's VLNC technology could transform the industry within 2 years
- VLN® cigarettes contain 95% less nicotine than traditional cigarettes
- Only FDA-authorized low nicotine combustible cigarette in the U.S.
- Strong support from 75+ healthcare organizations
- Potential to prevent 48 million youth from starting smoking
- Opposition from major tobacco producers could delay implementation
- Potential emergence of illicit trade in high nicotine cigarettes
- Economic disruption risks in tobacco industry
Insights
22nd Century stands to benefit substantially from FDA's proposed nicotine reduction mandate, potentially transforming their business position in just two years.
This FDA proposal represents a potential watershed moment for the tobacco industry and particularly for 22nd Century Group. The proposed mandate would limit nicotine in combustible tobacco products to non-addictive levels - precisely the market 22nd Century has been preparing for with their proprietary Very Low Nicotine Content (VLNC) technology.
The company's VLN® cigarettes contain 95% less nicotine than traditional cigarettes and are the only FDA-authorized low nicotine combustible cigarettes in the US market. This gives 22nd Century a significant first-mover advantage in what could become the new regulatory standard.
What makes this development particularly significant is the scale of potential impact. The FDA's population health model projects this rule would prevent approximately 48 million youth from initiating smoking and avert 1.8 million tobacco-related deaths by 2060. The company suggests the industry could transform to an entirely reduced nicotine product base in as little as two years.
The stark contrast between 22nd Century's position and major tobacco companies is noteworthy. While traditional tobacco giants oppose the regulation (despite public messaging about harm reduction), 22nd Century is positioned as the solution provider. Their non-GMO reduced nicotine tobacco plants developed through patented technologies can be grown commercially at scale.
This announcement signals that 22nd Century has positioned itself ahead of potential regulation that aligns perfectly with their business model. If implemented, this mandate could rapidly accelerate demand for their proprietary tobacco technology and products, potentially transforming them from a smaller player to a critical industry partner or competitor.
Proposed FDA Standard Could Avert 4.3 Million Deaths,
VLNC Products Could Fully Supplant Conventional Highly Addictive Combusted Products in as Little as Two Years
MOCKSVILLE, N.C., Sept. 30, 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, today announced submission of public comments in support of the proposed “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products,” 90 Fed. Reg. 5032 (Jan. 16, 2025) (“Proposed Rule”) by the U.S. Food & Drug Administration (“FDA”). The complete submission is available online at https://downloads.regulations.gov/FDA-2024-N-5471-4171/attachment_1.pdf.
In its submission, the Company noted the clear and consistent acknowledgement among medical professionals, researchers and even industry leaders that nicotine, the highly addictive substance in conventional tobacco products, is and always has been the driver of every harm and cost of cigarette smoking. The development and FDA authorization of Very Low Nicotine Content (VLNC) tobacco now makes it entirely feasible to produce conventionally flavored and consumer-acceptable combusted tobacco products that deliver a customary cigarette smoking experience with greatly reduced nicotine levels that comply with the proposed standard.
“The evidence is overwhelming that a reduced nicotine yield standard for combusted tobacco products has the potential to save millions of lives and trillions of dollars cumulatively in the U.S. alone,” said Larry Firestone, Chief Executive Officer. “Our success in commercializing reduced nicotine content cigarettes under a growing number of brands demonstrates that these products can readily succeed in the marketplace and reduce smoking rates. In as little as two years, this mandate and 22nd Century’s tobacco technology could transform the industry to an entirely reduced nicotine product base. From both a public health and commercial standpoint, the only barrier left to the most transformative public health policy of a generation is the willingness to move forward with this mandate.”
Based on the FDA’s population health model, adopting the Proposed Rule will prevent smoking initiation by approximately 48 million youth and young adults in the United States and avert 1.8 million tobacco-related deaths by 2060. The benefits of limiting nicotine in combusted tobacco products to non-addictive or minimally addictive levels are clinically documented and include significantly reduced cigarette-per-day consumption, reduced dependance on tobacco, increased smoke-free days and cessation attempts, and reduced initiation of tobacco use by youth and young adults. These science-based results, accumulated over more than 20 years, are consistent and conclusive.
22nd Century was joined in its endorsement of the Proposed Rule by more than 75 health care professional organizations and public health advocacy groups, including the American Medical Association, American Academy of Family Physicians, American College of Cardiology, and the American Association for Cancer Research. Those organizations observed in their own commentary that the proposed standard is urgently needed and that scientific evidence in support of the standard is abundant and undeniable. Some even argued that the Proposed Rule does not go far enough, but should be extended to limit nicotine content in recently developed Heated Tobacco Products (HTPs), which the major tobacco producers are positioning to replace combusted cigarettes in coming years.
The most strident opponents of the proposed reduced nicotine standard were major legacy tobacco producers, warning variously of economic disruption, illicit trade in high nicotine cigarettes, and loss of personal freedom to engage in self-destructive and societally costly behaviors. “Big Tobacco’s combative rhetoric and vehement opposition to the Proposed Rule is predictable given the tens of billions in profits it earns from sales of its addictive cigarettes,” said Firestone. “At the same time, this opposition seems to be at odds with the stated goal of these companies to transition cigarette smokers to even more profitable HTP and alternative nicotine delivery products. If Big Tobacco companies truly believed in concepts such as ‘Tobacco Harm Reduction’ and a ‘Smoke-Free Future,’ they would be working in support of the Proposed Rule rather than doing everything in their power to undermine it.”
The Company gives its full support for the Proposed Rule, which has the potential to save millions of lives and remedy trillions of dollars in economic imbalance caused by addiction to conventional high nicotine tobacco products. In the event the FDA determines to extend the comment period for the Proposed Rule, we expect to provide additional commentary addressing misinformation submitted in opposition to the Rule.
About 22nd Century Group, Inc.
22nd Century Group is pioneering the tobacco harm reduction movement by enabling smokers to take control of their nicotine consumption.
Our Technology is Tobacco
Our proprietary non-GMO reduced nicotine tobacco plants were developed using our patented technologies that regulate alkaloid biosynthesis activities resulting in a tobacco plant that contains
Our Products
We created our flagship product, the VLN® cigarette using our low nicotine tobacco, to give traditional cigarette smokers an authentic and familiar alternative in the form of a combustible cigarette that helps them take control of their nicotine consumption. VLN® cigarettes have
FDA Authorized
Our VLN® cigarette is the only low nicotine combustible cigarette authorized by the FDA in the United States.
VLN® is a registered trademark 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 20, 2025 and Quarterly Reports on Form 10-Q on May 13, 2025 and August 14, 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
investorrelations@xxiicentury.com
214-597-8200
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