National Conference on “Tobacco Regulatory Science” to Address FDA’s New Comprehensive Plan for Nicotine Regulation
October 03 2017 - 9:50AM
Business Wire
22nd Century’s Very Low Nicotine cigarettes
will be featured in key panel discussions.
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company that is focused on tobacco harm reduction,
announced today that the Vermont Center on Behavior and Health’s
5th Annual Conference will focus on Tobacco Regulatory Science and
will include the prodigious science surrounding 22nd Century’s Very
Low Nicotine tobacco cigarettes. This national conference will take
place on October 5-6, 2017 in Burlington, Vermont and will feature,
as its keynote speaker, Mitch Zeller, J.D., Director of the U.S.
Food and Drug Administration Center for Tobacco Products. Director
Zeller’s address comes on the heels of FDA Commissioner Dr. Scott
Gottlieb’s July 28th announcement that the FDA is planning to
reduce nicotine content in cigarettes to non-addictive levels. In
his address to open the conference, Director Zeller will expand
upon “FDA’s New Comprehensive Plan for Nicotine Regulation.”
This Tobacco Regulatory Science conference gathers together many
of the world’s foremost scientific experts on the important
behavioral impacts of Very Low Nicotine tobacco cigarettes.
Chairing the panel on Very Low Nicotine Content Cigarettes is Neal
Benowitz, M.D., Core Director and Investigator, University of
California, San Francisco (UCSF) Tobacco Center of Regulatory
Science. Dr. Benowitz recently authored a paper: “Comprehensive
Nicotine Regulation to End the Combustible Tobacco Epidemic” where
he states that an FDA-mandated 95% reduction in nicotine content
would “make it impossible to compensate by smoking cigarettes more
intensively or smoking more per day.”
Eric C. Donny, Ph.D., Co-Director, Center for the Evaluation of
Nicotine in Cigarettes; Professor of Physiology & Pharmacology,
Baptist Cancer Center, Wake Forest, will address the “Main Effects
and Moderators of the Impact of Nicotine Content on Smoking Rate
and Nicotine Dependence.” Dr. Donny’s landmark 840-patient, Phase
III study, Randomized Trial of Reduced-Nicotine Standards for
Cigarettes, was published in the New England Journal of Medicine
and used exclusively 22nd Century’s SPECTRUM® research
cigarettes.
Dorothy K. Hatsukami, Ph.D., Co-Director, Center for the
Evaluation of Nicotine in Cigarettes, Professor of Psychiatry and
Director of the Tobacco Research Programs, University of Minnesota,
will address “Approaches to Reducing Nicotine in Cigarettes” at
this conference. Together, Dr. Hatsukami and Dr. Donny are leading
the Phase III study, Strategies for Reducing Nicotine Content in
Cigarettes, which features 1,250 participants and uses 22nd
Century’s SPECTRUM research cigarettes. This important study
compares two different approaches to help smokers lose their
addiction to nicotine: (A) an immediate reduction in nicotine
content in cigarettes to non-addictive levels, or (B) a gradual
reduction in nicotine content in cigarettes to non-addictive
levels. The results of this study are expected imminently; whatever
the outcome, 22nd Century will be the “winner” since the various
research cigarettes used in both arms of this study were provided
by 22nd Century.
Stephen T. Higgins, Ph.D., Director, University of Vermont
Tobacco Center of Regulatory Science, will discuss the results of
his recently published study “Addiction Potential of Cigarettes
with Reduced Nicotine Content in Populations with Psychiatric
Disorders and Other Vulnerabilities to Tobacco Addiction.” As a
part of this study, Professor Higgins, et al. provided participants
with 22nd Century’s SPECTRUM research cigarettes. The lowest
nicotine level (0.4mg/g) represents a 95% reduction in nicotine as
compared to the nicotine level in conventional cigarettes.
Professor Higgins, et al. note that “the 0.4mg/g dose most
consistently and robustly differed from the [conventional nicotine]
control dose.” Only 22nd Century is capable of growing tobacco with
a 95% reduction in nicotine.
“We are proud that 22nd Century’s proprietary Very Low Nicotine
cigarettes can help all smokers – even vulnerable population
groups,” explained Henry Sicignano III, President and CEO of 22nd
Century Group. “By mandating that all cigarettes sold in the United
States contain only minimally or non-addictive levels of nicotine,
the FDA will be taking a giant step in preventing a future
generation from becoming addicted to combustible cigarettes. This
is a massively important initiative.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on genetic
engineering and plant breeding which allows the increase or
decrease of the level of nicotine in tobacco plants and the level
of cannabinoids in cannabis plants. The Company’s primary mission
in tobacco is to reduce the harm caused by smoking. The Company’s
primary mission in cannabis is to develop proprietary hemp/cannabis
strains for important new medicines and agricultural crops. Visit
www.xxiicentury.com and www.botanicalgenetics.com for more
information.
About the Vermont Center on Behavior and
Health
The Vermont Center on Behavior and Health (VCBH) is an
interdisciplinary research center committed to investigating
relationships between lifestyle patterns and the risk for chronic
disease. VCBH is a part of the University of Vermont and The Robert
Larner, M.D. College of Medicine.
Cautionary Note Regarding Forward-Looking Statements: This press
release contains forward-looking information, including all
statements that are not statements of historical fact regarding the
intent, belief or current expectations of 22nd Century Group, Inc.,
its directors or its officers with respect to the contents of this
press release, including but not limited to our future revenue
expectations. The words “may,” “would,” “will,” “expect,”
“estimate,” “anticipate,” “believe,” “intend” and similar
expressions and variations thereof are intended to identify
forward-looking statements. We cannot guarantee future results,
levels of activity or performance. You should not place undue
reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should
be considered with any written or oral forward-looking statements
that we may issue in the future. Except as required by applicable
law, including the securities laws of the United States, we do not
intend to update any of the forward-looking statements to conform
these statements to reflect actual results, later events or
circumstances, or to reflect the occurrence of unanticipated
events. You should carefully review and consider the various
disclosures made by us in our annual report on Form 10-K for the
fiscal year ended December 31, 2016, filed on March 8, 2017,
including the section entitled “Risk Factors,” and our other
reports filed with the U.S. Securities and Exchange Commission
which attempt to advise interested parties of the risks and factors
that may affect our business, financial condition, results of
operation and cash flows. If one or more of these risks or
uncertainties materialize, or if the underlying assumptions prove
incorrect, our actual results may vary materially from those
expected or projected.
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version on businesswire.com: http://www.businesswire.com/news/home/20171003005925/en/
22nd Century GroupJames Vail, 716-270-1523Director of
Communicationsjvail@xxiicentury.com
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