22nd Century Group (Nasdaq: XXII) Supports Federal Proposal to Require Less Nicotine in All U.S. Cigarettes

Rhea-AI Summary

22nd Century Group (Nasdaq: XXII) announces the pilot sales of VLN® cigarettes, which feature 95% reduced nicotine content, aligning with the FDA's proposed rule to reduce nicotine in all cigarettes. The pilot program, conducted in Circle K Stores in the Chicago area, shows strong interest among adult smokers seeking to manage their nicotine consumption. The FDA has granted Modified Risk Tobacco Product (MRTP) authorization, allowing VLN® to be marketed with claims such as 'Helps You Smoke Less'. The company aims for a national launch to assist the 70% of smokers who wish to quit.

Positive

• VLN® cigarettes are the first and only products authorized by the FDA for reduced nicotine content, helping smokers consume less nicotine.
• Pilot sales indicate strong interest from adult smokers in the Chicago area, potentially leading to a successful national launch.
• FDA MRTP designation enhances the product's marketability and consumer acceptance.

Negative

• None.

• FDA’s Proposed Rule Draws on Research That Supports Reduced Nicotine Content Cigarettes Are Less Addictive
• 22nd Century Group’s FDA MRTP Authorized 95% Reduced Nicotine Cigarette Products Is Already Available to Meet Proposed Policy to Reduce Nicotine in All Cigarettes
• VLN^® Pilot Sales Across Circle K Stores in the Chicago Area Showing Strong Interest from Adult Smokers
  

BUFFALO, N.Y., June 22, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company dedicated to improving human health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, is now selling the first and only 95% reduced nicotine content cigarette compliant with the renewed federal policy initiative to require all cigarettes sold in the U.S. be made minimally or non-addictive.

“We are delighted by today’s announcement from the Biden Administration, which is great news for adults who smoke and for 22nd Century Group,” said John Miller, president of 22nd Century’s tobacco programs. “The FDA requiring tobacco companies to reduce the nicotine content in all cigarettes sold in the United States has long been seen as the most powerful tool in the fight to reduce smoking and its grave health effects on citizens.”

“We are excited to pilot sales of the first and only cigarette designed specifically not to create and sustain addiction, but to instead reduce the hold of cigarette addiction on adult smokers,” said Miller. “The facts clearly demonstrate that the overwhelming majority of smokers want to quit, but few are able to do so, even after repeated attempts with current smoking cessation therapies or alternative nicotine products. VLN^® from 22nd Century offers a new approach in this fight – a tobacco cigarette that actually helps adult smokers reduce their nicotine consumption and smoke less. We are hopeful that many will also go on to quit their habit of smoking highly addictive cigarettes entirely.”

VLN^® King and VLN^® Menthol King 95% reduced nicotine content cigarettes from 22nd Century are the first and only cigarettes to secure the U.S. Food and Drug Administration’s Modified Risk Tobacco Product (MRTP) designation. Moreover, the FDA requires 22nd Century to also include “Helps You Smoke Less” on product packaging and advertising to further communicate to adult smokers the unique product attributes.

Both of 22nd Century Group’s reduced nicotine content products are being sold in a pilot program in the greater Chicagoland area through the nation’s second largest C-store chain, Circle K Stores. Pilot sales have indicated that there is a strong interest in a cigarette to help smokers smoke less as they seek to take control of their smoking habit.

Upon completion of the pilot program, VLN^® products are expected to advance to a national launch, making them available to more than 30 million adults who currently smoke highly addictive cigarettes in the U.S. Of those smokers, it is estimated that 70% want to quit. Each year, more than half of smokers make an attempt to quit, but the Centers for Disease Control and Prevention (CDC) data indicates only 7% succeed, regardless of the method they use. VLN^® reduced nicotine content cigarettes provide an additional tool to help smokers break their habit.

The MRTP designation and associated claims granted to 22nd Century’s VLN^® products were based on extensive, independent research showing that 22nd Century’s reduced nicotine content tobacco cigarettes smoke and taste like a conventional cigarettes, while containing 95% less nicotine. At that greatly reduced nicotine level, the clinical data and extensive federally-sponsored research show that 22nd Century’s products help smokers to smoke less, providing a new and innovative approach in the fight to reduce smoking in the U.S. Cigarette addiction continues to claim the lives of nearly half a million Americans each year.

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 other valuable agronomic traits.

Learn more at xxiicentury.com, on Twitter, on LinkedIn, and on YouTube.

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
22nd Century Group, Inc.
Director, Communications & Investor Relations
T: 716-300-1221
mkuo@xxiicentury.com

Darrow Associates Investor Relations
Matt Kreps
T: 214-597-8200
mkreps@darrowir.com 

FAQ

What does the FDA's proposed rule entail for nicotine content in cigarettes?

The FDA's proposed rule aims to require all cigarettes sold in the U.S. to have minimal or non-addictive nicotine levels.

How does VLN® from 22nd Century Group help smokers?

VLN® cigarettes contain 95% less nicotine, assisting smokers in reducing consumption and potentially quitting altogether.

Where are VLN® cigarettes currently available?

VLN® cigarettes are currently being sold in a pilot program at Circle K Stores in the Chicago area.

What is the significance of the MRTP designation for XXII?

The MRTP designation allows 22nd Century Group to market VLN® cigarettes with claims that they help smokers smoke less, which enhances their appeal.

What percentage of smokers want to quit, according to the press release?

The press release states that approximately 70% of smokers want to quit their habit.