22nd Century Group, Inc. (NYSE American: XXII), a leading
plant-based, biotechnology company that is focused on tobacco harm
reduction, announced today that the U.S. Food and Drug
Administration (FDA) in coordination with the National Institute on
Drug Abuse (NIDA) and others, has submitted an order to 22nd
Century for 3.6 million variable nicotine research cigarettes. The
Company’s research cigarettes will continue to fuel numerous
independent, scientific studies to validate the enormous public
health benefits identified by the FDA and others of implementing a
national standard requiring all cigarettes to contain minimally or
non-addictive levels of nicotine.
The selection of SPECTRUM® cigarettes for use in ongoing
research is not connected to 22nd Century’s Modified Risk Tobacco
(MRTP) application for the Company’s reduced nicotine content VLN®
cigarettes. 22nd Century believes that authorization of the
Company’s MRTP application is imminent, and it plans to launch VLN®
cigarettes within just 90 days of authorization. 22nd Century
continues to maintain a dialogue with the FDA, and the Company
believes the agency is in the final stage of review. At this time,
the Company has no outstanding requests for information from the
FDA, and the Company is confident it has satisfied every FDA
requirement for the agency to make a final decision about our
application.
“Mitch Zeller, director of the CTP at the FDA recently presented
at the Food and Drug Law Institute’s Tobacco and Nicotine Products
Conference and was asked whether the FDA is still considering
moving ahead with the agency’s plan to reduce nicotine content in
cigarettes to non-addictive levels,” said James A. Mish, chief
executive officer of 22nd Century Group. “Zeller confirmed that the
FDA remains ‘absolutely committed to everything that was in that
plan.’ The continuation of studies to validate the role of reduced
nicotine content cigarettes in public health and their potential to
reduce and even eliminate tobacco-related diseases and death
demonstrate the FDA’s continued commitment to tobacco harm
reduction.”
Mish added, “We are proud to partner with public health
researchers and look forward to the next step in the FDA’s plan to
reduce the nicotine content of all cigarettes sold in the U.S. to
minimally or non-addictive levels. 22nd Century remains the leader
in reduced nicotine content tobacco products. We believe when the
FDA mandate ultimately goes into effect, we will be well-positioned
to capitalize on this tremendous opportunity, and we are committed
to licensing our technology to make it possible for every cigarette
manufacturer in the U.S. to comply with the standard.”
Published in 2017, the FDA’s ground-breaking Comprehensive Plan
for Tobacco and Nicotine Regulation aims to set a product standard
for cigarettes that achieves “minimally or non-addictive" levels of
nicotine. Featuring 95 percent less nicotine, the Company’s VLN®
cigarettes, once authorized, would serve as a vanguard for the
FDA’s proposed plan. Importantly, the FDA projects that reducing
nicotine levels in all combustible cigarettes to just 0.5
milligrams of nicotine per gram of tobacco, a level already
achieved by VLN®, would help five million adult smokers quit one
year after implementation, save over eight million American lives
by the end of the century, and protect future generations from
becoming addicted to cigarettes in the first place.
The FDA authorization of VLN® will make 22nd Century the first,
and likely the only, company in the world to ever achieve a MRTP
designation for a combustible cigarette. Once authorized, the
company will rollout VLN® to convenience stores, pharmacies, and
other retail tobacco outlets in the U.S. paired with a compelling
marketing campaign to introduce adult smokers to the world’s lowest
nicotine content cigarette. 22nd Century plans to position VLN® in
the premium price segment of the cigarette market and expects it to
deliver corresponding margins.
With more than 34 million smokers in the U.S. and more than 1
billion smokers worldwide, the FDA’s authorization of 22nd
Century’s MRTP application has the potential to create significant
demand for the Company’s VLN® cigarettes. 22nd Century believes
that achieving just one-quarter of one percent (0.25 percent)
market share with this disruptive product could over time drive the
Company’s market capitalization more than 10 times higher. In
addition, the Company believes that the FDA’s authorization of 22nd
Century’s MRTP will open multiple licensing opportunities for 22nd
Century’s proprietary reduced nicotine technology in the U.S. and
globally.
About SPECTRUM®SPECTRUM®
research cigarettes were developed in collaboration with FDA, NIDA
(a division of the National Institutes of Health (NIH)), the
Centers for Disease Control and Prevention (CDC), and the National
Cancer Institute (NCI). To date, 22nd Century has provided more
than 28 million proprietary SPECTRUM® research cigarettes for
numerous independent scientific studies, funded largely by the FDA,
the National Institutes of Health (NIH), and other U.S. federal
government agencies. The studies, using 22nd Century’s reduced
nicotine content tobacco cigarettes, show that smokers who use the
Company’s products: (i) reduce their nicotine exposure and
dependence, (ii) smoke fewer cigarettes per day, (iii) increase
their number of smoke-free days, and (iv) double their quit
attempts – all with minimal or no evidence of nicotine withdrawal
or compensatory smoking.
About 22nd Century Group, Inc.22nd Century
Group, Inc. (NYSE American: XXII) is a leading plant biotechnology
company focused on technologies that alter the level of nicotine in
tobacco plants and the level of cannabinoids in hemp/cannabis
plants through genetic engineering, gene-editing, and modern plant
breeding. 22nd Century’s primary mission in tobacco is to reduce
the harm caused by smoking through the Company’s proprietary
reduced nicotine content tobacco cigarettes – containing 95% less
nicotine than conventional cigarettes. The Company’s primary
mission in hemp/cannabis is to develop and commercialize
proprietary hemp/cannabis plants with valuable cannabinoid profiles
and desirable agronomic traits.
Learn more at xxiicentury.com, on
Twitter @_xxiicentury and on LinkedIn.
Cautionary Note Regarding
Forward-Looking
StatementsExcept 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 may 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, 2020 and on Quarterly Reports on Form 10-Q.
All information provided in this release is as of the date hereof,
and the Company assumes no obligation to publicly update or revise
any forward-looking statements as a result of new information,
future events, or otherwise, except as required by law.
Communications & Investor Relations Contact:Mei KuoDirector,
Communications & Investor RelationsPhone:
716-300-1221mkuo@xxiicentury.com
22nd Century (AMEX:XXII)
Historical Stock Chart
From Mar 2024 to Apr 2024
22nd Century (AMEX:XXII)
Historical Stock Chart
From Apr 2023 to Apr 2024