22nd Century’s Pre-Market Tobacco Application for VLN™ Cigarettes Advances with Completed FDA Inspection
April 30 2019 - 9:50AM
Business Wire
FDA Inspection is an important milestone for
22nd Century’s VLN™ Cigarettes
22nd Century Group, Inc. (NYSE American:XXII), a plant
biotechnology company that is a world leader in tobacco harm
reduction, Very Low Nicotine Content tobacco, and hemp/cannabis
research, announced today that last week the U.S. Food and Drug
Administration (FDA) conducted a comprehensive inspection of the
Company’s manufacturing facility in North Carolina as a part of the
FDA’s review of 22nd Century’s Pre-Market Tobacco (PMT) application
for the Company’s VLN™ cigarettes. 22nd Century’s proposed VLN™
cigarettes are made with the Company’s proprietary Very Low
Nicotine Content (VLNC) tobacco.
In December of 2018, the Company submitted Modified Risk Tobacco
Product (MRTP) and related PMT applications to the FDA for the
Company’s VLNC cigarettes. Together, these important applications
seek the FDA’s authorization to commercialize the Company’s VLN™
cigarettes and to communicate to consumers that VLN™ cigarettes
contain at least 95% less nicotine as compared to the 100 leading
cigarette brands in the United States.
The FDA’s inspection was a highly anticipated component of the
third phase of the FDA’s four phase review process for the PMT
application. The FDA’s stated goal for the inspection was “to
verify the information and data contained in the [PMT]
application.” As such, the FDA inspectors witnessed production of
22nd Century’s proprietary VLN™ cigarettes. In addition, FDA
inspectors reviewed 22nd Century’s raw material receiving and
storage procedures, quality control processes, manufacturing
equipment and systems, tobacco processing methods, and
finished-products analyses procedures.
Concurrent with the FDA’s review process for 22nd Century’s MRTP
and PMT applications, the FDA is pursuing a proposed rule that,
when finalized and effective, would limit the amount of nicotine in
all cigarettes sold in the United States to
“minimally-addictive or non-addictive levels.” Officials from the
FDA have previously indicated a “minimally-addictive or
non-addictive” level of nicotine in cigarettes could be achieved at
approximately 0.3 to 0.7 mg nicotine per gram of tobacco. The World
Health Organization (WHO) has similarly recommended that all member
nations adopt “a [tobacco] policy of limiting the sale of
cigarettes to brands with a nicotine content that is not sufficient
to lead to the development and/or maintenance of addiction.”
Importantly, in its published report, Global Nicotine Reduction
Strategy, the WHO referred specifically to 22nd Century and to the
Company’s proprietary VLNC tobacco.
22nd Century’s proposed VLN™ cigarettes – with a target
concentration of 0.5 mg nicotine per gram tobacco – fall squarely
within the nicotine range that public health officials anticipate
will be mandated by the FDA, and that will simultaneously enable
the WHO to advance its global nicotine reduction agenda. For these
reasons, when 22nd Century’s proprietary VLNC cigarettes achieve
MRTP status, they could serve as a powerful tool and precedent in
support of the FDA’s broader national nicotine reduction
mandate.
“Our extraordinary VLN™ cigarettes contain at least 95% less
nicotine than any of the 100 leading cigarette brands in the U.S.,”
explained Henry Sicignano III, President and Chief Executive
Officer of 22nd Century Group. “The FDA’s inspection of our
manufacturing facility is another important milestone in the FDA
review process that we expect will ultimately result in VLN™
cigarettes becoming the world’s first FDA-approved MRTP combustible
tobacco cigarettes.”
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/cannabis strains for
important new medicines and agricultural crops. Visit
www.xxiicentury.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, 2018, filed on March 6, 2019,
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/20190430005551/en/
22nd Century GroupJames Vail, Director of
Communications716-270-1523jvail@xxiicentury.com
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