22nd Century CEO & Chairman Larry Firestone Provides Technology and Regulatory Update Letter to Stockholders
MOCKSVILLE, N.C., Aug. 20, 2025 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NASDAQ:XXII), a tobacco products company that has for 27 years led and continues to lead the fight against the harms of smoking driven by nicotine addition, today issued the following letter to stockholders from Larry Firestone, the Chief Executive Officer of 22nd Century Group, Inc.:
A Letter to Our Shareholders
We recently released our second quarter 2025 earnings, along with important corporate updates regarding the ongoing launch and rollout of VLN® products. VLN® cigarettes are the first and only combustible tobacco product purposefully designed to reduce the harms of smoking and authorized by the U.S. Food and Drug Administration.
Perhaps one of the most exciting updates in that report was the early adoption of our VLN® approach by two well-established partner brands, Smoker Friendly and Pinnacle, with more expected to follow. The initial Pinnacle VLN® stocking orders were shipped in August, bringing reduced nicotine content options to even more smokers looking for new ways to reduce their smoking habit.
In addition to accelerating growth and achieving profitability, we are also driving important initiatives in the technology and regulatory landscape. I want to share more on those efforts and how they will help us to maintain and expand our industry leading position in the very low nicotine plant genetics and bioscience space.
FDA Proposed Rule – September 15, 2025
The FDA's proposed new Tobacco Product Standard for Nicotine Yield could be the most groundbreaking and effective new tobacco regulation in a generation. Designed specifically to curb the nicotine addiction that keeps smokers smoking, the proposed 0.7mg/g maximum nicotine content standard is based on extensive clinical documentation that incorporated real-world testing of actual products produced by 22nd Century.
The VLN® products cited by the FDA to back this groundbreaking standard show that the rule is fully viable and commercially feasible across brands and form factors to make this crucial public health mandate a priority and a reality.
The proposed mandate has already received strong support from public health advocates who understand that taking nicotine out of tobacco is critical to reduction of smoking. We will support the proposed mandate with our own formal comment submission as well. Not surprisingly, comments from major tobacco producers have focused mostly on decrying the loss of addictive levels of nicotine in products that fuel their profits, even at the expense of lives and immense societal costs.
But we aren't waiting. Smokers can buy an increasing array of VLN® products right now, proving that a reduced nicotine future is not just possible, it's desirable to retail chains selling tobacco products.
With two partner brands announced and more in discussion, it is no longer debated whether a VLN® based future is possible – it is clear with our help, tobacco-based products can fully transition to a reduced nicotine version under any and every brand.
Next Gen VLN® Products
We recognize that VLN® products need to be available in brands and forms that consumers recognize and are willing to choose. Our goal is to meet tobacco users where they are most comfortable, offer a familiar branded product minus the addictive levels of nicotine, and help them stop the cycle of nicotine dependence.
To that end, we have also announced projects to bring VLN® products to market as 100mm cigarettes, plus international versions of combustible products tailored to the consumer preferences of those markets. We are also engaged in the production and testing of filtered cigar products using proprietary non-GMO VLN® reduced nicotine content tobacco and non-GMO VLN® based homogenized tobacco leaf (HTL) sheet. VLN® based filtered cigar products are designed specifically to ensure compliance with the FDA's proposed low nicotine rule described above.
The new form factors will be supported by the continued submission of PMTA and MRTP filings with the FDA, as well as our MRTP renewal application that we will submit near the end of this year.
Further Research and Development Initiatives
We are investigating a potential link between our non-GMO low nicotine tobacco genetics and substantially lower levels of harmful TSNAs. TSNAs are Tobacco-Specific Nitrosamines, which are a group of potent carcinogens. The area of focus in our research is what appears to be a link between a reduction in nicotine in our low nicotine tobacco and a reduction of two of the most harmful TSNAs called NNN and NNK.
Expand and Secure Our IP Portfolio
Our extensive patent portfolio in low nicotine genetics firmly cements us as the leader in low nicotine tobacco. Our intellectual property is a cornered resource that sets us apart from every tobacco company in the world. But our mission goes well beyond what we have today. We continue to invest in the next generation of technology that will help us to further enhance our leadership in tobacco harm reduction. This includes ongoing plant genetics research into additional tobacco varietals, enhanced disease resistance, and product technologies that can improve our products, reduce our environmental footprint or bring innovation to our customers.
2025 and Beyond: The Tobacco Harm Reduction Movement
This is an exciting time for our Company, and I thank you for being a valued shareholder as we continue on this journey. Our mission is both noble and important - low nicotine technology and products that have the capability to dramatically improve public health and the welfare of smokers worldwide – hopefully even save lives.
Larry Firestone
Chief Executive Officer
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 non-GMO 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 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 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 Contact
Matt Kreps
Investor Relations
22nd Century Group
[email protected]
214-597-8200
