22nd Century’s Pre-Market Tobacco Application for VLN™ Cigarettes Advances with Completed FDA Inspection

FDA Inspection is an important milestone for 22nd Century’s VLN™

WILLIAMSVILLE, N.Y.–(BUSINESS WIRE)–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)

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

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.


22nd Century Group
James Vail, Director of Communications

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