22nd Century Meets with FDA on Modified Risk Tobacco Product Application for World’s Lowest Nicotine Tobacco Cigarettes

CLARENCE, N.Y.–(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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