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 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 .

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
[email protected]
214-597-8200