22nd Century Submits Comments to FDA in Support of Proposed Reduced Nicotine Content Mandate

Proposed FDA Standard Could Avert 4.3 Million Deaths, $600 Billion in Annual Economic Damage Linked to Smoking 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 TobaccoOur 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 95% less nicotine than traditional tobacco plants. Our extensive patent portfolio has been developed to ensure that our high-quality tobacco can be grown commercially at scale. We continue to develop our intellectual property to ensure our ongoing leadership in the tobacco harm reduction movement. Our ProductsWe 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 95% less nicotine compared to traditional cigarettes and have been proven to allow consumers to greatly reduce their nicotine consumption. FDA AuthorizedOur 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 StatementsExcept 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 ContactMatt KrepsInvestor Relations22nd Century Groupinvestorrelations@xxiicentury.com214-597-8200

22nd Century Submits Comments to FDA in Support of Proposed Reduced Nicotine Content Mandate

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