22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural
biotechnology company focused on tobacco harm reduction, reduced
nicotine tobacco, and health and wellness through plant science,
announced today that the Company’s Vice President of Regulatory
Science, John Pritchard, was invited and will participate as a
panelist at the Food and Drug Law Institute (FDLI) Tobacco and
Nicotine Products Regulation and Policy Conference as part of the
event’s session, “Reactor Panel: Assessing the Past, Present, and
Future of the Comprehensive Plan,” on Wednesday,
October
27, 2021, at 11:55 a.m. ET. The session will consider key
points of the U.S. Food and Drug Administration’s (FDA) Center for
Tobacco Products Director, Mitch Zeller’s keynote address, and the
current state of and future directions for FDA’s Comprehensive Plan
for product regulation, in particular the mandate to make all
cigarettes “minimally or non-addictive.”
“We are thrilled that John is representing 22nd
Century Group on this critically important panel to discuss the
FDA’s Comprehensive Plan,” said James A. Mish, chief executive
officer of 22nd Century Group. “Following yesterday’s announcement
by FDA, there are now authorized products in the vape category, the
heated tobacco category, and smokeless tobacco category. The Agency
should now authorize 22nd Century’s modified risk tobacco product
(MRTP) application for our VLN® reduced nicotine content cigarettes
to give adult smokers another alternative to highly addictive
cigarettes.” He added, “Such a move would be a significant step
towards FDA’s proposed standard to reduce the level of nicotine in
all combustible cigarettes sold in the U.S. to ‘minimally or
non-addictive’ levels, the health impact of which would be
generationally significant, with millions of lives saved. VLN®
reduced nicotine content cigarettes and non-combustible nicotine
products are the two pillars of FDA’s harm reduction strategy. VLN®
cigarettes will help adult smokers reduce their exposure to
nicotine, the addictive chemical in tobacco, while those adult
smokers who still desire nicotine, less harmful alternatives are
now available.”
“Set against the backdrop of the pandemic and
other challenges, FDA has nonetheless demonstrated its ongoing
commitment to advance its Comprehensive Plan. For example, in April
of this year, FDA reaffirmed that a product standard for reducing
nicotine in cigarettes remained ‘on the table,’ and the New York
Times reported yesterday that the FDA continues to work on this
critical public health initiative,” said Pritchard. “I am delighted
to have this opportunity to respond to Mitch Zeller’s presentation
later this month and to share our perspective on FDA’s recent and
future actions.”
Joining Pritchard on the panel will be
world-renowned reduced nicotine researcher, Dorothy K. Hatsukami,
Professor, Department of Psychiatry and Behavioral Sciences at the
University of Minnesota Medical School; Desmond Jenson, Lead Senior
Staff Attorney for Federal Regulation, Commercial Tobacco Control
Programs, Public Health Law Center at Mitchell Hamline School of
Law; and Valerie Briggs Solomon, Assistant General Counsel and Vice
President, RAI Service Company.
Public health researchers project that the
enactment of a nicotine cap would help more than five million
people to quit smoking within the first year of implementation,
save more than eight million American lives by the end of the
century, and that more than 134 million life-years would be gained
by 2100. More than 16 million Americans are currently living with
diseases caused by smoking, and with every delay in action, more
people are dying. Introducing a standard nicotine cap could
decrease the chances of future generations becoming addicted to
cigarettes and could make it easier for currently addicted smokers
to quit.
22nd Century Group’s VLN® cigarettes, which
contain 0.5 milligrams of nicotine per gram of tobacco, are the
only combustible tobacco products able to meet the nicotine levels
proposed in the FDA’s Advanced Notice of Proposed Rulemaking for a
tobacco product standard that requires all combustible cigarettes
to contain “minimally or non-addictive” levels of nicotine. The
Company’s menthol and non-menthol reduced nicotine content
cigarettes have already received a Premarket Tobacco Product
Application (PMTA) designation indicating FDA’s decision that they
are “appropriate for the protection of public health.” An MRTP
designation will allow 22nd Century to communicate the key features
of its VLN® King and VLN® Menthol King cigarettes, including the
headline claim of 95% less nicotine. Despite its reduced nicotine
content, VLN® tastes, smells, and smokes like a conventional
cigarette. The Company is fully prepared to launch VLN® in the U.S.
within 90 days of receiving its MRTP authorization. The Company
will continue the launch process for VLN® in countries outside of
the U.S. that do not require MRTP-type approvals. VLN® is expected
to be introduced in the first of these international markets in the
first quarter of 2022.
About 22nd Century Group, Inc.22nd Century
Group, Inc. (Nasdaq: XXII) is a leading agricultural
biotechnology company focused on tobacco harm reduction 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 its 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. 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 @_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
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 KuoDirector, Communications & Investor
Relations22nd Century Group, Inc.(716)
300-1221mkuo@xxiicentury.com
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