A Cigarette to Help Californians Smoke Less: 22nd Century Group, Inc. Launches Reduced Nicotine VLN® King Cigarettes in California, VLN Will Be Sold at #1 U.S. Convenience Store Chain and Other Responsible Retail Locations

SACRAMENTO, Calif., July 17, 2023 (GLOBE NEWSWIRE) — Biotech company 22nd Century Group, Inc. (NASDAQ: XXII) this week launched VLN^® King cigarettes, the first-ever reduced nicotine combustible cigarette, in the California market. Starting July 17^th, VLN^® cigarettes contain a staggering 95% less nicotine than conventional cigarettes and will be conveniently available in California at more than 275 sites of the number one convenience store in the US, in addition to numerous other convenience stores across California. VLN^® King cigarettes have made history by receiving U.S. Food & Drug Administration (FDA) approval as a modified risk tobacco product (MRTP).

“We see our VLN^® product offering Californians who smoke a tremendous new option because VLN^® cigarettes are specifically designed to help smokers smoke less, increase their number of smoke-free days, and reduce their nicotine exposure and dependence,” said John Miller, 22nd Century Group President, Tobacco Division. “Our goal with VLN^® is to meet California consumers where they are with a combustible product that helps people smoke less.”

In the FDA press release announcing the VLN^® MRTP authorization, Mitch Zeller, J.D., former FDA Director for the Center for Tobacco Products, said, “Our mission is to find ways to stop tobacco-related disease and death. We know that three out of four adult smokers want to quit and the data on these products show that they can help addicted adult smokers transition away from highly addictive combusted cigarettes. Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”

According to recent data from the California Department of Public Health, approximately 6.2% of adult Californians are tobacco cigarettes users, which translates to an estimated 2.4 million adults still consuming high-nicotine cigarettes in the state. Remarkably, research indicates that nearly 70% of smokers want to quit smoking or smoke less – and 22nd Century Group, Inc.’s VLN^® cigarettes are intended to support individuals achieve success on their journey to a smoke-free life.

Research conducted in 2018¹ highlighted the significant benefits experienced by smokers who transitioned to reduced nicotine content cigarettes. The study revealed that over a period of 20 weeks, smokers were able to reduce their daily cigarette consumption by 50%, leading to an increased number of smoke-free days and quit attempts. Additionally, participants reported a noticeable decrease in cravings and fewer withdrawal symptoms during the transition.

“VLN^® cigarettes are clinically proven to help adult smokers smoke less and cut back on their nicotine intake,” said Calvin Treat, 22nd Century Group, Inc., Chief Scientific Officer. “The scientific body of research supports the efficacy of VLN^® cigarettes as a smoking reduction tool, and this is a significant advance in smoking reduction technology available to consumers. We know that U.S. regulators and policymakers are seeking to create a nicotine cap for cigarettes, and VLN^® is leading the charge on making a reduced nicotine combustible option a reality.”

VLN^® King cigarettes will soon be available at designated convenience store locations across California, starting on July 17, 2023.

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 priority 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 reduced the first and only FDA Modified Risk Tobacco Product (MRTP) authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis, and hop plants, 22^nd 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 www.xxiicentury.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 9, 2023. 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

¹ Hatsukami DK, Luo X, Jensen JA, et al. Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure: A Randomized Clinical Trial. JAMA. 2018;320(9):880–891. doi:10.1001/jama.2018.11473