XXII 22nd Century Group Inc.

22nd Century Group (Nasdaq: XXII) Expects VLN® Menthol King Reduced Nicotine Cigarettes To Be Exempted From FDA’s Proposed Ban on Menthol Cigarettes

22nd Century Group (Nasdaq: XXII) Expects VLN® Menthol King Reduced Nicotine Cigarettes To Be Exempted From FDA’s Proposed Ban on Menthol Cigarettes

  • Exemption Would Leave 22nd Century’s VLN® Product as the Only Menthol Cigarette on the Market
  • VLN® Menthol King Reduced Nicotine Cigarettes Are Solution To Help Current Menthol Smokers Smoke Less and Transition Away From Highly Addictive Nicotine Cigarettes
  • VLN® Cigarettes Contain 95% Less Nicotine Than Conventional Cigarettes
  • FDA Continues To Demonstrate Commitment to Its Comprehensive Plan Requiring Reduced Nicotine Content in All Cigarettes

BUFFALO, N.Y., April 29, 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 its support of FDA’s plan to ban menthol in all cigarettes and that the Company 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.

“We commend the FDA for taking action to reduce tobacco-related disease and death and advance health equity. Today’s proposed menthol ban is expected to have enormous health benefits for the nearly 18.6 million current smokers of menthol cigarettes – including the millions of African-Americans who are disproportionally harmed by these products,” said James A. Mish, chief executive officer of 22nd Century Group.

“Our VLN® Menthol King reduced nicotine cigarettes are an unmatched tool for helping adult menthol smokers find an off-ramp from nicotine addiction. 22nd Century will continue to support FDA in its public health mission by providing the only alternative on the marketplace today that approaches the problem by removing the addictive element from combustible cigarettes. We fully anticipate an even more favorable regulatory environment as the FDA continues to proceed with the Agency’s Comprehensive Plan, which includes banning menthol and requiring all cigarettes to be ‘minimally or non-addictive.’ 22nd Century’s VLN® King and VLN® Menthol King are the cornerstone of FDA’s public health mission for tobacco,” continued Mish.

The FDA authorized 22nd Century’s MRTP for VLN® reduced nicotine content cigarette products on December 23, 2021. In its press release announcing that decision, the FDA acknowledged its menthol plans, stating, “In reaching today’s determination [authorizing the MRTP applications for VLN®], the FDA considered both the current legal status of menthol cigarettes and the available science demonstrating that these particular products are 'appropriate for the protection of public health' and could help addicted cigarette smokers reduce their nicotine consumption and the number of cigarettes they smoke per day.”

In its announcement today, the FDA reiterated the importance that reduced nicotine menthol cigarettes could play in a marketplace where menthol cigarettes are banned, and it laid out a process through which such products could be exempted from the proposed product standard. The FDA has also maintained, including in its media call today, the importance of its continued work towards requiring all combustible cigarettes to be made non-addictive, a feat already achieved with 22nd Century’s proprietary VLN® tobacco and MRTP products.

John Pritchard, Vice President of Regulatory Science for 22nd Century added, “Removing menthol from highly addictive cigarettes is a crucial public health step by the FDA, and we welcome today’s announcement. At the same time, we recognize, as the FDA has, that many adults who continue to smoke highly addictive cigarettes after the implementation of a final FDA rule will need access to suitably regulated alternative products. Our VLN® products, including our recently authorized MRTP VLN® Menthol King is an example of such a product, and we have already and will continue to represent our views to FDA on the importance of MRTP products in achieving FDA’s public health mission.”

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. The Company launched VLN, the first cigarette that “Helps You Smoke Less,” in the Chicago metro area in April 2022.

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. Menthol cigarettes make up nearly 40% of the U.S. cigarette market.

About 22nd Century Group, Inc.

22nd Century Group, Inc. (Nasdaq: ) 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  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 , on , on , and on .

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

 

Darrow Associates Investor Relations

Matt Kreps

T: 214-597-8200

 

A photo accompanying this announcement is available at



EN
29/04/2022

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on 22nd Century Group Inc.

 PRESS RELEASE

22nd Century Group (Nasdaq: XXII) Reports Business Highlights and Fina...

22nd Century Group (Nasdaq: XXII) Reports Business Highlights and Financial Results for the Second Quarter 2022 Strong Chicago Pilot Exceeded Expectations, Accelerates VLN® Expansion in ColoradoAccretive GVB Biopharma Acquisition Doubles Corporate Revenue and Expands Market Leading Hemp/Cannabis CapabilitiesSecond Quarter Net Sales $14.5 Million, Up 73% from the Second Quarter 2021Strengthened Balance Sheet with $35 Million Above-Market Equity Offering to Support Accelerated VLN® Expansion BUFFALO, N.Y., Aug. 09, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: ), a leading agr...

 PRESS RELEASE

22nd Century Group (Nasdaq: XXII) to Announce Second Quarter 2022 Resu...

22nd Century Group (Nasdaq: XXII) to Announce Second Quarter 2022 Results on August 9, 2022 BUFFALO, N.Y., July 27, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: ), a leading agricultural biotechnology company dedicated to improving human health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, will host a live webcast on Tuesday, August 9, 2022, at 10:00 AM ET to discuss its 2022 second quarter results, which are to be reported in a press release at 6:00 AM ET the same day. During the webcast, James A. Mish, chief executive officer; John Mi...

 PRESS RELEASE

22nd Century Group (Nasdaq: XXII) Strengthens Balance Sheet to Acceler...

22nd Century Group (Nasdaq: XXII) Strengthens Balance Sheet to Accelerate the Expansion of VLN Launch Announces $35 Million Above Market FinancingBolsters Company’s Position with Ongoing Strategic Discussions BUFFALO, N.Y., July 21, 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, announced that it has entered into definitive agreements with several institutional investors for the purchase and sale of 17,073,...

 PRESS RELEASE

22nd Century Announces $35 Million Registered Direct Offering Priced A...

22nd Century Announces $35 Million Registered Direct Offering Priced Above Market under Nasdaq Rules BUFFALO, N.Y., July 21, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (Nasdaq: XXII), leading agricultural biotechnology company dedicated to improving human health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, today announced that it has entered into definitive agreements with institutional investors for the purchase and sale of 17,073,175 shares of its common stock at a purchase price of $2.05 per share in a registered direct offering priced abov...

 PRESS RELEASE

22nd Century Group (Nasdaq: XXII) Supports Federal Proposal to Require...

22nd Century Group (Nasdaq: XXII) Supports Federal Proposal to Require Less Nicotine in All U.S. Cigarettes FDA’s Proposed Rule Draws on Research That Supports Reduced Nicotine Content Cigarettes Are Less Addictive22nd Century Group’s FDA MRTP Authorized 95% Reduced Nicotine Cigarette Products Is Already Available to Meet Proposed Policy to Reduce Nicotine in All CigarettesVLN® 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 bi...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch