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Business Upturn
11 hours ago
- Health
- Business Upturn
22nd Century Applauds the American Academy of Family Physicians Comments and Support of the FDA's Proposed Reduced Nicotine Mandate to Reduce Smoking, Transform Public Health, Save Lives and Reduce Health Costs
22nd Century VLN ® products are the only combustible cigarettes authorized by the FDA as a reduced nicotine content product that comply with the FDA proposed rule MOCKSVILLE, N.C., July 29, 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 commented on responses provided to the U.S. Food and Drug Administration to date as part of its open comment period on the proposed new Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products . 'In the United States, smoking causes more than 480,000 deaths and costs over $600 billion annually and reduces life expectancy by 10 years. The US government and our federal courts have issued countless warnings concerning nicotine, the effects of nicotine addiction, and the harms caused by smoking since the early 1950's. Implementation of the proposed FDA standard, which would require that all combusted tobacco products sold in the U.S. contain less than 0.7mg of nicotine per gram of tobacco, would directly combat the public health issues resulting from nicotine and nicotine dependence, as outlined by the American Academy of Family Physicians,' said Larry Firestone, Chief Executive Officer of 22nd Century Group. Comments published from the American Academy of Family Physicians (AAFP), which represents more than 128,300 family physicians and medical students across the country, recommend the FDA finalize the proposed mandate as the new standard, including: Establishing a maximum nicotine yield of 0.7 milligrams per gram of total tobacco in cigarettes and other combusted tobacco products Extending the standard to other forms of nicotine consumption, such as e-cigarettes and vapes, as a means to protect children and support quitting. It's letter states: 'Establishing a maximum nicotine yield is a vital step towards curbing nationwide tobacco dependence.' The full comment submission can be read on the AAFP webpage found here . 'The commercial launch of our low nicotine VLN® products which include partner brand products such as Smoker Friendly VLN® and Pinnacle VLN®, demonstrate the commercial viability for cigarettes which are already compliant with the new standard. If licensed from, or produced by 22nd Century, VLN® products can be quickly produced, marketed and sold under the wide array of brands in the tobacco industry,' said Larry Firestone, Chief Executive Officer of 22nd Century Group. 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 in the form of a combustible cigarette that helps them take control of their nicotine consumption. VLN® cigarettes have 95% less nicotine than the traditional cigarette and have been proven to allow consumers to greatly reduce their nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers in the form that they are used to, the option to take control of their nicotine consumption and make informed and more productive choices, including the choice to avoid addictive levels of nicotine altogether. Our proprietary non-GMO 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 95% less nicotine. Our extensive patent portfolio has been developed to ensure we have the only low nicotine combustible cigarette in the United States and critical international markets. VLN® is a registered trademark of 22nd Century Limited LLC. Learn more at , on X (formerly Twitter) , on LinkedIn , and on YouTube . Learn more about VLN® at 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 Report on Form 10-Q 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 ContactMatt KrepsInvestor Relations22nd Century Group [email protected] 214-597-8200
Business Insider
18-07-2025
- Business
- Business Insider
Why Is 22nd Century Stock (XXII) Up 85% Today?
22nd Century (XXII) stock rocketed higher on Thursday after the tobacco company announced new partnerships for its low-nicotine cigarettes. The company has teamed up with Smoker Friendly and Pinnacle for the sale of its unique cigarettes, which are designed to reduce the harmful effects of smoking normal cigarettes. This includes weaning smokers off normal cigarettes and helping them stop smoking. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. To go along with this, 22nd Century cigarettes are compliant with the U.S. Food and Drug Administration's proposed new Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products. 22nd Century CEO Larry Firestone said, '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.' 22nd Century Stock Movement Today XXII stock was up 86.035% in pre-market trading on Thursday, following a 3.58% drop yesterday. The stock has also fallen 96.25% year to date and 99.83% over the past 12 months. Today's rally came with heavy trading, as some 10 million shares changed hands, compared to a three-month daily average of about 94,000 units. Is 22nd Century Stock a Buy, Sell, or Hold? Turning to Wall Street, coverage of 22nd Century is lacking. Luckily, TipRanks' AI analyst Spark has it covered. Spark rates XXII stock a Neutral (44) with a $5 price target, suggesting a potential 9.17% upside for the shares. It cites 'weak financial performance and bearish technical indicators' as reasons for this stance.
Business Upturn
18-07-2025
- Business
- Business Upturn
22nd Century Reports Expanded State Authorization Progress to Sell VLN®, Partner VLN® and Conventional Products
State Authorizations Mean Even More Adult Smokers Will Be Able to Purchase VLN ® , Partner VLN ® , Smoker Friendly and Pinnacle Products MOCKSVILLE, N.C., July 17, 2025 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), today announced a significant increase in state authorizations for the sale of its growing portfolio of both proprietary and contract manufactured products. The increase in state authorizations enables new sales activity and new product launches for 22nd Century's proprietary VLN® reduced nicotine content cigarettes, a growing list of partner VLN® brands, a diverse and expanded range of Smoker Friendly products and a growing number of Pinnacle® products sold at a top 5 C-Store chain in the U.S. 'The most recent state authorizations will open even more new markets as we drive toward approval to sell VLN® based products in all 50 states. Additionally, this demonstrates to the FDA that VLN® based products can be available on a nationwide basis by the close of its proposed Low Nicotine Mandate comment period in mid-September. Our VLN® and partner VLN® products are the only combustible cigarettes that fit within the confines of the FDA's mandate as originally issued by the first Trump administration in 2018 and reissued in January 2025,' said Larry Firestone, Chief Executive Officer of 22nd Century Group. 'We already have partner VLN® retailers accounting for over 2,000 outlets progressing through implementation to begin shipping in the second half of 2025 and expect more ahead.' Key state authorizations to date now include the following brands. Additional state authorizations are pending and expected in the second half of 2025, supporting the launch of these products in further new markets. Products marked with an * represent new introductions to the market and retailers in 2025: VLN ® Gold and Green – 41 States Gold and Green – 41 States *VLN ® Red – 21 States Red – 21 States *Smoker Friendly VLN ® – 20 States – 20 States *Pinnacle ® VLN ® – 20 States VLN – 20 States Smoker Friendly – 45 States *Smoker Friendly Black Label – 27 States Pinnacle® – 37 States The growing list of state approvals expands the market opportunity for additional partner brands to launch their own private label VLN® products in large and untapped markets across the country. 'With more than 272,000 U.S. retail outlets that sell tobacco products across the country, 22nd Century and its partners have a tremendous untapped market opportunity for both our VLN® and conventional products in the US, and we have begun to look internationally with VLN® as well,' said Firestone. 22nd Century is the only tobacco products company that has for 27 years led the tobacco harm reduction movement 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 that contains 95% less nicotine than tobacco used in highly addictive conventional cigarettes. Decades of peer reviewed studies have shown that the level of nicotine content in 22nd Century's products can reduce both the rate of smoking and the health harms of smoking. 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 in the form of a combustible cigarette that helps them take control of their nicotine consumption . VLN® cigarettes have 95% less nicotine than the traditional cigarette and have been proven to allow consumers to greatly reduce their nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers in the form that they are used to, the option to take control of their nicotine consumption and make informed and more productive choices, including the choice to avoid addictive levels of nicotine altogether. 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 95% less nicotine. Our extensive patent portfolio has been developed to ensure we have the only low nicotine combustible cigarette in the United States and critical international markets. VLN® is a registered trademark of 22nd Century Limited LLC. Learn more at on X (formerly Twitter), on LinkedIn, and on YouTube. Learn more about VLN® at 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 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 ContactMatt KrepsInvestor Relations22nd Century Group [email protected] 214-597-8200
Business Upturn
17-07-2025
- Business
- Business Upturn
VLN Commercial Launches Confirm Viability of the FDA's Proposed Reduced Nicotine Mandate
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 95% less nicotine than tobacco used in highly addictive conventional cigarettes. Decades of peer reviewed studies have shown that the level of nicotine content in 22nd Century's products can reduce both the rate of smoking and the health harms of smoking. 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 Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products, 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 22nd Century's comment letter at that time, 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 FDA's January 15, 2025 press release 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 95% less nicotine than the traditional cigarette and have been proven to allow consumers to greatly reduce their nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers the option to take control of their nicotine consumption and make informed and more productive choices, including the choice to avoid addictive levels of nicotine altogether. 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 95% less nicotine. Our extensive patent portfolio has been developed to ensure we have the only low nicotine combustible cigarette in the United States and critical international markets. VLN® is a registered trademark of 22nd Century Limited LLC. Learn more at on X (formerly Twitter), on LinkedIn, and on YouTube. Learn more about VLN® at 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 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 ContactMatt KrepsInvestor Relations22nd Century Group [email protected] 214-597-8200
Business Upturn
19-05-2025
- Business
- Business Upturn
22nd Century to Present at the Emerging Growth Conference on May 21, 2025
MOCKSVILLE, N.C., May 19, 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, (the 'Company') is pleased to announce that Larry Firestone, Chief Executive Officer, will present a brief corporate update at the Emerging Growth Conference on Wednesday, May 21, 2025, at 12:00 pm Eastern Time. Mr. Firestone will provide updates to recent company advancements and may subsequently open the floor for questions. Questions may be submitted in advance to [email protected]. Investors can register in advance to attend the conference and receive any updates at: If attendees are not able to join the event live on the day of the conference, an archived webcast will also be made available on and on the Emerging Growth YouTube Channel, 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 95% less nicotine than the traditional cigarette and have been proven to greatly reduce nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers the option to take control of their nicotine consumption and make informed and more productive choices, including the choice to avoid addictive levels of nicotine altogether. 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 95% less nicotine. Our extensive patent portfolio has been developed to ensure we have the only low nicotine combustible cigarette in the United States and critical international markets. VLN® is a registered trademark of 22nd Century Limited LLC. Learn more at on X (formerly Twitter), on LinkedIn, and on YouTube. Learn more about VLN® at Investor Relations & Media ContactMatt KrepsInvestor Relations22nd Century Group [email protected] 214-597-8200
