22nd Century Meets with FDA on Modified Risk Tobacco Product Application for World’s Lowest Nicotine Tobacco Cigarettes
June 16 2017 - 09:25AM
Business Wire
22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology
company that is a leader in tobacco harm reduction, announced today
that the Company and its wholly-owned subsidiary, Goodrich Tobacco
Company, held yesterday a very encouraging and productive meeting
with the Office of Science of the Center for Tobacco Products (CTP)
of the U.S. Food and Drug Administration (FDA). Based on written
feedback received ahead of the meeting, and on the positive
exchange between Goodrich and the FDA at the meeting itself, the
Company will now move forward with a significantly expanded
Modified Risk Tobacco Product (MRTP) application with the CTP/FDA
for the Company’s BRAND A Very Low Nicotine (VLN) cigarettes.
The World’s Lowest Nicotine Tobacco Cigarettes
BRAND A VLN cigarettes contain less than 0.6 mg nicotine per
cigarette and less than 0.05mg nicotine yield per cigarette. In
each case, this represents a reduction of at least 95% less
nicotine relative to “Big Tobacco” cigarette brands, including
Marlboro®, Camel®, Newport®, and American Spirit®. The Company’s
MRTP application to the CTP/FDA will request that BRAND A packaging
and marketing be allowed to disclose to consumers that the
Company’s proprietary Very Low Nicotine cigarettes reduce smokers’
exposure to nicotine.
22nd Century is the only company in the world capable of growing
virtually nicotine-free tobacco. Without any artificial extraction
or chemical processes, 22nd Century’s BRAND A cigarettes are made
with the Company’s proprietary VLN tobacco that is grown on
independently-owned farms in the United States. 22nd Century’s
finished Very Low Nicotine cigarettes have the taste and sensory
characteristics of conventional cigarettes, but contain only trace
amounts of nicotine so smokers’ exposure to nicotine is drastically
reduced.
“We are extremely pleased with the frank and collaborative
dialogue that occurred in yesterday’s meeting,” explained Gregg M.
Gellman, 22nd Century’s Director of Regulatory Affairs. “FDA’s
written and in-person feedback – combined with the ongoing
discussions we plan to have with the FDA in the coming weeks and
months – will help 22nd Century prepare and submit comprehensive
and robust MRTP application for BRAND A Very Low Nicotine
cigarettes.”
“The World Health Organization has recommended ‘mandated
reductions in nicotine to minimally addictive levels.’
Unfortunately, at present, smokers in the United States do not have
a Very Low Nicotine cigarette option,” explained Henry Sicignano,
III, President and Chief Executive Officer of 22nd Century Group.
“We believe BRAND A VLN cigarettes will prove invaluable in
drastically reducing smokers’ exposure to nicotine. To this end,
22nd Century looks forward to continuing to work closely with the
FDA on this very important public health matter.”
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.
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/20170616005130/en/
22nd Century GroupInvestor Relations:IRTH CommunicationsAndrew
Haag, 866-976-4784xxii@irthcommunications.com
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