• Recent FDA Action Advances Policy Proposal That Originated During First Trump Administration and Continued to Progress Under Biden Administration

Mocksville, North Carolina--(Newsfile Corp. - December 12, 2024) - 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 announced that it applauds action by the U.S. Food and Drug Administration to advance its long-standing proposal mandating a drastic reduction in the amount of nicotine in cigarettes, a cornerstone goal of public health experts seeking to reduce the harms of smoking.

"We are excited to see definitive action by the FDA intended to advance its scientifically backed reduced nicotine content mandate for cigarette products, a non-partisan proposal that actually began moving forward during the first Trump administration and continued its progress during the Biden administration," said Larry Firestone, Chief Executive Officer of 22nd Century Group.

"22nd Century has played a pivotal role in this effort following 26 years of research and product development as a key supplier for reduced nicotine content research cigarettes used in the numerous federally funded studies to generate a massive body of scientific evidence in support of this policy. 22nd Century also has the first and only FDA authorized reduced nicotine content cigarette designed specifically to reduce the harms of smoking."

"VLN reduced nicotine content cigarettes from 22nd Century, which are available in thousands of stores across the country, have shown that this product can be an important tool for adult smokers seeking to control their nicotine intake. We are now in the process of launching additional products, including VLN^® SKUs within key customer brand families, as part of our drive to expand the distribution of reduced nicotine content cigarettes manufactured by 22nd Century. Adding VLN^® within other brand families is a straightforward way to reduce our time to market, increase consumer awareness and expand the VLN^® footprint.

"With still almost half a million premature deaths in the U.S. attributed to smoking each year, we fully support the FDA in advocating for the significant potential harm reduction that could come from a reduced nicotine content cigarette mandate."

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® 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.

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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 28, 2024, and in the Company's Quarterly Reports filed on May 15, 2024 and August 13, 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.