22nd Century Reports on New Responses to the FDA’s Nicotine Reduction Plan
July 11 2018 - 9:35AM
Business Wire
Scientists highlight reduced consumption;
refute claims of compensation; support an immediate reduction in
nicotine level
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company that is a leader in tobacco harm reduction
and Very Low Nicotine tobacco, today highlights two important
submissions to the U.S. Food and Drug Administration (FDA).
Altogether, nine separate researchers authored these particular
submissions in response to the FDA’s Advance Notice of Proposed
Rulemaking (ANPRM) to require that nicotine levels in combustible
cigarettes be lowered to minimally or non-addictive levels. 22nd
Century’s proprietary VLN™ tobacco cigarettes were used by the FDA
in formulating the Agency’s plan to dramatically reduce the
nicotine content of cigarettes. 22nd Century is the only company in
the world now growing multiple varieties of Very Low Nicotine
flue-cured and burley tobacco varieties to satisfy the FDA’s
planned mandate that will reduce drastically the nicotine levels of
all cigarettes sold in the United States.
The open comment period for the FDA’s ANPRM on a nicotine
product standard for cigarettes ends July 16, 2018. To date, major
medical associations, government agencies, tobacco insiders, and
the public at large have submitted nearly 5,000 public comments to
the FDA.
Noted scientific researchers Neal Benowitz, M.D., Eric Donny,
Ph.D., Kathryn Edwards, Ph.D., Dorothy Hatsukami, Ph.D., Tracy
Smith, Ph.D., and Clifford Watson, Ph.D. coauthored a letter from
the University of California – San Francisco (UCSF) that identified
a “minimally addictive” nicotine content for cigarettes as
follows:
"The amount of nicotine needed to make
cigarettes minimally addictive appears to be 0.4 to 0.5 mg nicotine
per gram of tobacco in the tobacco rod. This represents a reduction
of nicotine content of 95% or more compared to currently available
commercial cigarettes."
22nd Century’s SPECTRUM® Very Low Nicotine research cigarettes
contain less than 0.5 mg nicotine per gram of tobacco – exactly the
level specified in the UCSF submission. The above-noted researchers
also conclusively refuted claims that Very Low Nicotine cigarettes
could cause smokers to increase their smoking:
“Effectively compensating to maintain
nicotine exposure is virtually impossible when switching to
cigarettes with minimally addictive nicotine content."
In another recent submission to the FDA regarding the FDA’s
ANPRM to limit dramatically the nicotine content of cigarettes,
noted scientific researchers Megan Piper, Ph.D., David Drobes,
Ph.D., and Natalie Walker, Ph.D. address the issues of smoking
dependence and smoking abstinence when smokers switch exclusively
to Very Low Nicotine content cigarettes. Citing a number of
scientific studies investigating nicotine dependence, these
researchers explain:
“…there is direct evidence that smoking
reduced nicotine cigarettes is associated with reduced dependence
(both self-reported dependence and dependence related criteria such
as withdrawal, cravings) and ultimately smoking abstinence.”
In conclusion, Drs. Piper, Drobes, and Walker cite scientific
clinical evidence to show that an immediate switch to Very Low
Nicotine content cigarettes results in:
“1) a reduction in validated dependence
measures…; 2) a reduction in cigarettes smoked; 3) a reduction in
biomarkers of nicotine exposure; and 4) a reduction in withdrawal
symptoms”
“The scientists responsible for many of the independent clinical
trials using 22nd Century’s proprietary VLN™ cigarettes continue to
refute the objections raised to the FDA’s nicotine reduction plan
and hasten the road to final implementation of the life-saving
mandate,” explained Henry Sicignano, III, President and Chief
Executive Officer of 22nd Century Group. “When the FDA’s plan is
enacted, 22nd Century’s Very Low Nicotine tobacco varieties could
form the foundation for, quite literally, ALL tobacco cigarettes
sold in the United States.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on
technology which allows it to increase or decrease the level of
nicotine in tobacco plants and the level of cannabinoids in
hemp/cannabis plants through genetic engineering and plant
breeding. The Company’s primary mission in tobacco is to reduce the
harm caused by smoking. The Company’s primary mission in
hemp/cannabis is to develop proprietary hemp strains for important
new medicines and agricultural crops. Visit www.xxiicentury.com and
www.botanicalgenetics.com for more information.
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, 2017, filed on March 7, 2018,
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: https://www.businesswire.com/news/home/20180711005194/en/
22nd Century GroupJames Vail, 716-270-1523Director of
Communicationsjvail@xxiicentury.com
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