22nd Century Receives Order for 3.6 Million SPECTRUM® U.S. Government Research Cigarettes
August 21 2018 - 10:40AM
Business Wire
Very Low Nicotine Content will eliminate all
cigarettes’ ability to create and sustain addiction
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company focused on tobacco harm reduction and Very
Low Nicotine tobacco, announced today that the National Institute
on Drug Abuse (NIDA), the U.S. Food and Drug Administration (FDA),
and public health researchers have requested a new, significant
quantity of 22nd Century’s proprietary SPECTRUM® research
cigarettes. In coordination with NIDA, FDA, and others, RTI
International has submitted an order to 22nd Century for 3.6
million SPECTRUM® research cigarettes.
RTI’s newest SPECTRUM® order comes on the heels of the close of
the FDA’s public comment period for the FDA’s Advanced Notice of
Proposed Rulemaking (ANPRM) to establish a rule that will require
that all cigarettes sold in the United States contain only
minimally or non-addictive levels of nicotine. While the FDA is
pressing ahead with its rule-making process, 22nd Century is
simultaneously advancing its historic Modified Risk Tobacco Product
(MRTP) application for the Company’s proprietary “BRAND A” Very Low
Nicotine Content (VLNC) cigarettes. 22nd Century will file its MRTP
application before the end of this year.
Progress on the FDA’s planned reduced
nicotine mandate mirrors the work 22nd Century has undertaken to
create a Very Low Nicotine Cigarette product standard that will
forever change the U.S. tobacco industry. Very Low Nicotine Content
will eliminate all cigarettes’ ability to create and sustain
addiction.
With 95% less nicotine than the tobacco contained in the
conventional cigarettes sold by Altria (MO), Reynolds American, a
subsidiary of British American Tobacco (BATS.L), and the other “Big
Tobacco” companies, 22nd Century’s VLNC cigarettes may become the
first combustible cigarettes authorized by the FDA as Modified Risk
Tobacco Products.
Independent scientists are currently leading more than two dozen
active clinical studies using 22nd Century’s proprietary SPECTRUM®
research cigarettes. Following the completion of numerous clinical
studies that have examined the broad application of VLNC cigarettes
to smokers (Donny, et al., Hatsukami, et al., Mercincavage, et
al.), researchers are investigating the application and effect of
VLNC cigarettes on more narrow, vulnerable groups in society,
including adolescents, those diagnosed with ADHD, patients with
mood and anxiety disorders, smokers with schizophrenia, and others.
The data collected from these independent studies will add to the
deep body of knowledge gained from already completed clinical
studies on the impact of VLNC cigarettes on public health.
“22nd Century’s proprietary SPECTRUM® research cigarettes have
been, and continue to be, the linchpin of the scientific support
for both the FDA’s efforts to dramatically reduce nicotine in
cigarettes and for 22nd Century’s own MRTP application for VLNC
cigarettes,” explained Henry Sicignano III, President and Chief
Executive Officer of 22nd Century Group. “VLN™ SPECTRUM® cigarettes
are now widely recognized by public health advocates as the
archetype of all cigarettes to come… And 22nd Century’s
offer to license our proprietary tobacco technology to all
interested companies means VLN™ cigarettes may soon be available –
worldwide – to smokers who wish to sever their addiction to
cigarettes.”
About SPECTRUM®
22nd Century developed SPECTRUM® in partnership with independent
researchers and officials from the National Institute on Drug Abuse
(NIDA), the U.S. Food and Drug Administration (FDA), the National
Cancer Institute (NCI), and the Centers for Disease Control and
Prevention (CDC). The main SPECTRUM® product line, uniquely
produced by 22nd Century, consists of a series of cigarette styles
that vary nicotine yields over a 50-fold range – from very low (97%
less nicotine than tobacco contained in conventional cigarette
brands) to relatively high nicotine yields. SPECTRUM® features 24
styles, in both regular and menthol versions, with 8 different
levels of nicotine.
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/20180821005452/en/
22nd Century GroupJames Vail, Director of
Communications716-270-1523jvail@xxiicentury.com
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