FDA filing covers renewal applications for VLN ® King and VLN ® Menthol King, the first combusted cigarettes authorized as Modified Risk Tobacco Products, as 22nd Century advances its regulatory pathway for continued modified risk marketing status

MOCKSVILLE, N.C., May 12, 2026 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a tobacco harm reduction company focused on reduced nicotine innovation, today highlighted that the U.S. Food and Drug Administration has filed for scientific review two Modified Risk Tobacco Product, or MRTP, renewal applications for the Company’s VLN ® King and VLN ® Menthol King combusted, filtered cigarettes. The FDA filing marks an important step in the regulatory process for the continued marketing of these products with authorized modified risk claims.

VLN ® King and VLN ® Menthol King were originally granted MRTP exposure modification orders by the FDA in December 2021, making them the first combusted cigarettes ever authorized as MRTPs. Those orders are set to expire in December 2026 unless renewed, and the current review process is intended to support continued modified risk marketing status beyond that date.

“We are pleased that the FDA has filed our VLN ® MRTP renewal applications for scientific review, an important procedural step in the renewal process for the first and only combustible cigarettes authorized as modified risk tobacco products,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “We believe this development reflects the strength of the scientific and regulatory foundation supporting VLN ® , and we remain focused on working through the FDA review process responsibly, transparently and in full compliance with all applicable requirements as we continue advancing our reduced-nicotine platform for adult smokers.”

Under the existing FDA orders, 22nd Century is authorized to market VLN ® King and VLN ® Menthol King with specific reduced-exposure nicotine claims, including “95% less nicotine,” “Helps reduce your nicotine consumption,” and “…Greatly reduces your nicotine consumption,” provided those claims are accompanied by the statement “Helps you smoke less.” The Company believes the continued review of these products is strategically important because VLN ® remains a uniquely differentiated product platform within the combustible tobacco category.

In connection with the renewal process, the FDA has begun releasing redacted application materials for public access and opened a docket for public comment, enabling stakeholders to submit data and feedback as part of the scientific review. 22nd Century believes this process further underscores the rigor of the FDA’s modified risk framework and the significance of maintaining a robust evidence base for its VLN ® franchise.

In its original MRTP review, the FDA found that nicotine levels in the tobacco and mainstream smoke of VLN cigarettes are at least 95% lower than the majority of marketed and market-leading conventional cigarette brands. The agency also stated that consumers who exclusively use cigarettes with the same or similarly reduced nicotine content as VLN cigarettes could reduce their nicotine exposure by approximately 95%, and that use of these products is reasonably likely to reduce nicotine dependence.

22nd Century previously announced that its renewal submission was supported by additional marketplace data, including a 2024 study involving more than 400 participants, which the Company said demonstrated a 40% reduction in daily cigarette consumption over 12 weeks among smokers using VLN ® cigarettes. The Company believes this data strengthens the long-term commercial and regulatory case for the VLN ® platform, although the outcome and timing of the FDA’s renewal review remain subject to the agency’s independent evaluation.

This release does not announce renewal approval, and no assurance can be given regarding the outcome of the FDA’s review. The original publication can be found on the FDA website here: https://www.fda.gov/tobacco-products/advertising-and-promotion/22nd-century-group-inc-modified-risk-tobacco-product-mrtp-applications?utm_campaign=ctp-mrtp&utm_content=landingpage&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms

About 22nd Century Group, Inc.

22nd Century Group is pioneering the Tobacco Harm Reduction and Nicotine Reduction Movements 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 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 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 95% less nicotine compared to traditional cigarettes and have been proven to allow consumers to greatly reduce their nicotine consumption.

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 expectations regarding regulatory enforcement, including our ability to receive authorization or approval for new products, and (ii) our financial and operating performance. 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 26, 2026. 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