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22nd Century Group Announces First Production of VLN® Cigarettes for Retail Sale

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22nd Century Group (Nasdaq: XXII) announced the production of the first cartons of VLN® King and VLN® Menthol King Cigarettes for retail sale, marking a significant milestone for the company. The VLN® cigarettes contain 95% less nicotine than leading brands and have received FDA MRTP designation. CEO James A. Mish emphasized the importance of this product in aiding adult smokers to reduce nicotine dependency. The company is also expanding its manufacturing capabilities to support a national launch after the pilot program.

Positive
  • Production of VLN® King and VLN® Menthol King Cigarettes has commenced, marking a significant product launch.
  • VLN® is the first cigarette with FDA MRTP designation aimed at reducing nicotine addiction.
  • Potential to capture market share in the $80 billion U.S. tobacco products market.
Negative
  • None.

BUFFALO, N.Y., Jan. 26, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and improving health and wellness through modern plant science, today announced production of the first cartons of VLN® King and VLN® Menthol King Cigarettes destined for retail sale as part of the Company’s pilot program.

“We are incredibly excited to hit this milestone moment as the first cartons of VLN® that will be sold to adult smokers rolled off the line at our North Carolina manufacturing facility,” said James A. Mish, Chief Executive Officer. “We are eager to get this disruptive new product into the hands of adult smokers looking to change their relationship with highly-addictive nicotine products. Since receiving the first and only FDA MRTP designation for a combustible cigarette on December 23, we have moved swiftly to prepare the launch of our VLN® 95% reduced nicotine content cigarettes. Among the many activities to date, our first market has been confirmed, our initial retail partner selected and the packaging updated to reflect the FDA’s added claim of ‘Helps You Smoke Less.’”

“Production of VLN® for commercial sale is now underway at 22nd Century’s in-house manufacturing facilities,” said Nathan Schmitt, Director of Operations & Supply Chain. “With a long history of producing reduced nicotine content research cigarettes as well as contract manufacturing for other brands, we were well prepared to commence manufacturing quickly upon receiving VLN®’s historic MRTP authorization. We are also making additional capital investments into our facilities to support expanded production volumes as we ready for national launch following the pilot launch program.”

VLN® is the first cigarette in the world that is not designed to create or sustain nicotine addiction. VLN® smokes, smells, and tastes like a conventional cigarette, but uses 22nd Century Group’s proprietary tobacco to deliver America’s lowest nicotine content cigarette with 95% less nicotine than America’s leading brands.

VLN® King and VLN® Menthol King are the only FDA authorized reduced nicotine content combustible cigarettes in the U.S. tobacco products market, estimated at approximately $80 billion in size.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. The Company received the first and only FDA MRTP authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.

Learn more at xxiicentury.com, on Twitter @_xxiicentury, and on LinkedIn.

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. 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. 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 11, 2021. 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:
Mei Kuo
Director, Communications & Investor Relations
22nd Century Group, Inc.
(716) 300-1221
mkuo@xxiicentury.com 


FAQ

What is the significance of the production of VLN® King and VLN® Menthol King Cigarettes for XXII?

The production signifies a major milestone for XXII, as it introduces the first FDA-authorized reduced nicotine cigarettes for retail sale.

When did XXII receive FDA MRTP designation for their cigarettes?

XXII received FDA MRTP designation on December 23, 2021.

What is the nicotine content of VLN® cigarettes compared to leading brands?

VLN® cigarettes contain 95% less nicotine than America's leading brands.

What is the market potential for VLN® cigarettes?

The U.S. tobacco products market is estimated at approximately $80 billion.

22nd Century Group Inc.

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