- Aligned with FDA and Biden Administration Important Initiative to Limit Nicotine Content in Cigarettes and Ban Menthol
- VLN® Reduced Nicotine Content Cigarettes Are Designed Specifically to “Help You Smoke Less” and Reduce Exposure to Activities Known to Cause Cancer
- Exceptional Pilot Results in Chicago Lead to Expanding VLN® Points of Sale in Chicago and State of Illinois
BUFFALO, N.Y., Sept. 13, 2022 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, today announced that it is engaged to power President Biden’s plan to reduce the death rate from cancer by at least 50% over the next 25 years. The Company’s VLN® King and VLN® Menthol King 95% reduced nicotine content cigarettes are the first and only combustible cigarette designed specifically to “Help You Smoke Less”, which the U.S. Food and Drug Administration (FDA) requires to be printed right on the packaging. 22nd Century is expanding VLN® points of sale in Chicago and the State of Illinois after seeing exceptional pilot results in Chicagoland. Distribution will begin in September through various channels via retail and distribution partnerships.
Under Biden’s initiative, the FDA has taken aggressive actions aimed at curtailing smoking, in particular the Agency’s pursuit to limit the amount of nicotine and ban menthol-flavored cigarettes. Every year, nearly 500,000 Americans die from smoking-related diseases. Smoking is the leading cause of cancer deaths, with more than 160,000 people perishing every year from cancers directly attributed to tobacco. Although nicotine itself is not the direct cause of most smoking-related diseases, addiction to nicotine in tobacco is the proximate cause of smoking related diseases including cancer. Thus, the magnitude of public health harm that is caused by tobacco is inextricably linked to its addictive nature.
“It is well understood that addiction to nicotine is the primary driver of smoking, leading to smoking related diseases such as cancer. Rather than just another nicotine replacement therapy, 22nd Century’s VLN® cigarettes take a disruptive approach to help people smoke less by reducing the nicotine content to levels the FDA considers non-addictive. Numerous clinical studies sponsored by federal health agencies demonstrate that adult smokers can successfully smoke less and improve their health situation by using reduced nicotine cigarettes to first break the nicotine addiction cycle. By smoking less, adult smokers can reduce their exposure to activities known to cause cancer,” said James A. Mish, chief executive officer of 22nd Century Group.
FDA Commissioner Robert M. Califf explained at a conference last week that the Agency’s proposal to reduce nicotine content in cigarettes is based on nicotine’s extremely high addictive potential. He was quoted saying, “I think it’s every bit as strong as the opioid addiction.”
“Cancer doesn’t discriminate between red or blue, it doesn’t care if you’re a Republican or a Democrat,” said President Biden during his Moonshot Speech Monday afternoon. “Beating cancer is something we can do together and that’s why I’m here today.”
Biden’s Cancer Moonshot Initiative will bring together departments and agencies, including the National Institutes of Health (NIH), and the FDA, to address cancer on multiple fronts. These are the same government agencies that have funded numerous independent scientific studies demonstrating the benefits of using reduced nicotine content tobacco cigarettes. 22nd Century’s VLN® King and VLN® Menthol King cigarettes were engineered to contain 95% less nicotine than conventional cigarettes and is the only combustible product that is in line with the FDA’s proposed nicotine cap. VLN® cigarettes smoke, smell, and taste like conventional cigarettes and are the only cigarettes in the world not designed to create or sustain nicotine addiction purposefully designed to “Help You Smoke Less”.
FDA’s reduced nicotine mandate has the potential to help more than 5 million people quit smoking within the first year of implementation, prevent more than 33 million people from not becoming regular smokers, and prevent more than 8 million fewer people dying from tobacco-related illnesses, including cancer. The Agency also asserts that a proposed menthol ban is expected to have enormous health benefits for the nearly 20 million current smokers of menthol cigarettes. 22nd Century expects VLN® Menthol King reduced nicotine cigarettes to be exempted from FDA’s menthol ban under procedures detailed in FDA’s proposed rule announced April 28, 2022.
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, 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. 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 1, 2022, and in the Company’s Quarterly Report filed on August 9, 2022. 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
22nd Century Group, Inc.
Director, Communications & Investor Relations
mkuo@xxiicentury.com
Darrow Associates Investor Relations
Matt Kreps
T: 214-597-8200
mkreps@darrowir.com
