22nd Century Announces First Shipments of Pinnacle VLN® Products to Top 5 C-Store Chain Locations Across 12 States

Rhea-AI Summary

22nd Century Group (Nasdaq: XXII) announced the initial shipments of its Pinnacle VLN® Gold and Pinnacle VLN® Menthol reduced nicotine cigarettes. The products will launch on September 1, 2025 across nearly 1,000 locations in 12 states through a top-5 U.S. convenience store chain.

The Pinnacle VLN® cigarettes contain 95% less nicotine compared to traditional cigarettes, meeting the FDA's proposed standard of less than 0.7 mg/g nicotine content. These products are the first and only FDA-authorized combusted cigarettes specifically designed to reduce nicotine intake, supported by extensive clinical research demonstrating their effectiveness in reducing smoking habits.

Positive

• First and only FDA-authorized combusted cigarettes for nicotine reduction
• Expansion to nearly 1,000 locations across 12 states
• Partnership with a top-5 U.S. convenience store chain
• Products comply with FDA's proposed new Tobacco Product Standard
• Strong existing brand loyalty through conventional Pinnacle product lines

Negative

• Initial rollout limited to 12 states
• Dependent on FDA's proposed mandate implementation
• Market acceptance of reduced nicotine products uncertain

Insights

Tobacco Industry Analyst

22nd Century's Pinnacle VLN® reduced-nicotine cigarettes gaining distribution traction with major c-store chain, validating their FDA-compliant tobacco harm reduction strategy.

22nd Century Group (XXII) has secured a significant distribution win for its reduced nicotine cigarettes, with initial shipments of Pinnacle VLN® products heading to nearly 1,000 locations across 12 states at a top-5 US convenience store chain. Sales are expected to launch on September 1, 2025.

This represents the second early adopter partner for the company's VLN® brand, indicating growing retailer acceptance of their reduced nicotine concept. The strategic importance lies in how these products align with the FDA's proposed low nicotine mandate that would require combustible tobacco products to contain less than 0.7 mg/g of nicotine – a standard that VLN® products already meet.

What makes these products unique is their 95% reduction in nicotine compared to traditional cigarettes, using proprietary tobacco. The regulatory advantage is substantial – VLN® products are the first and only combusted cigarettes authorized by the FDA specifically to reduce nicotine intake and affect smoking habits, backed by clinical research.

From a business perspective, this launch expands 22nd Century's existing relationship with this retailer, which already carries their conventional Pinnacle cigarettes, cigarillos, and moist snuff products. The company's strategy to expand VLN® products across multiple brands positions them at the forefront of the tobacco harm reduction movement while potentially creating a competitive advantage should the FDA's proposed nicotine standards be implemented.

Pinnacle VLN^® from 22nd Century Gains 2^nd Early Adopter to Join Popular Pinnacle Branded Conventional Cigarette Products Already Sold at Top-5 U.S. C-Store Chain

MOCKSVILLE, N.C., Aug. 04, 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 the first shipments of its new Pinnacle VLN^® Gold and Pinnacle VLN^® Menthol reduced nicotine content cigarettes into distribution. These initial Pinnacle VLN^® shipments will support a sales launch expected on September 1, 2025 at almost 1,000 locations across 12 states for a top-5 U.S. convenience store chain.

“Pinnacle’s conventional cigarette product lines have been very successful for this c-store chain, establishing strong brand loyalty with customers. We are excited to launch our new Pinnacle VLN^® products, representing our second early adopter partner VLN^® brand, expanding the reach and awareness of this innovative solution designed specifically to give smokers a choice with respect to their nicotine intake with an eye on improving public health,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “This opportunity reinforces the validity of the FDA’s recent proposed low nicotine mandate that would require all combustible tobacco products to be less than 0.7 mg/g. A standard that VLN^® products deliver on. This equates to roughly a 95% reduction in nicotine compared to traditional cigarettes.”

Additional Pinnacle VLN^® states and locations for this c-store chain will continue to be added, plus re-order inventory with the c-store chain’s distributor. Pinnacle VLN^® cigarettes expand the total Pinnacle branded product offerings which include conventional cigarettes, cigarillos and moist snuff, which are all supplied by 22^nd Century.

VLN® products using proprietary tobacco grown with 95% reduced nicotine content are the first and only combusted tobacco products to comply with the FDA’s proposed new Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products.

“VLN^® products from 22nd Century are the first and only combusted cigarette authorized by the U.S. Food and Drug Administration specifically to reduce nicotine intake and therefore affect the smoking habit, backed by extensive clinical research that shows a 95% reduced nicotine cigarette can be an effective way to reduce total smoking,” said Firestone. “Our goal is to expand VLN^® products into as many brands as possible to widen the reach of this important harm reduction product enabling 22nd Century to stay in the forefront of the Tobacco Harm Reduction Movement.”

About 22nd Century Group, Inc.

22nd Century Group is pioneering the nicotine harm reduction movement in the tobacco industry enabling smokers to take control of their nicotine consumption through combustible cigarettes.

We created our flagship product, the VLN^® cigarette, 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 than the traditional cigarette and have been proven to allow consumers to greatly reduce their nicotine consumption. Instead of offering new ways of delivering nicotine to addicted smokers, we offer smokers in the form that they are used to, 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 proprietary non-GMO reduced nicotine tobacco blends are made possible by comprehensive and patented technologies and tobacco plants 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 Report on Form 10-Q filed on May 13, 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
mkreps@xxiicentury.com
214-597-8200

FAQ

What is the nicotine reduction level in 22nd Century's Pinnacle VLN® cigarettes?

Pinnacle VLN® cigarettes contain 95% less nicotine compared to traditional cigarettes, meeting the FDA's proposed standard of less than 0.7 mg/g nicotine content.

When and where will Pinnacle VLN® cigarettes be available?

Pinnacle VLN® cigarettes will launch on September 1, 2025 at nearly 1,000 locations across 12 states through a top-5 U.S. convenience store chain.

What FDA authorization does XXII have for its VLN® products?

VLN® products are the first and only combusted cigarettes authorized by the FDA specifically to reduce nicotine intake and affect smoking habits, backed by clinical research.

What products are included in 22nd Century's Pinnacle brand portfolio?

The Pinnacle brand portfolio includes conventional cigarettes, cigarillos, moist snuff, and now VLN® reduced nicotine cigarettes.

How does Pinnacle VLN® align with FDA regulations?

Pinnacle VLN® products comply with the FDA's proposed Tobacco Product Standard requiring combustible tobacco products to contain less than 0.7 mg/g of nicotine.