FDA Provides Positive and Encouraging Feedback for 22nd Century’s Very Low Nicotine MRTPA Filings

CLARENCE, N.Y.–(BUSINESS WIRE)– 22nd Century Group, Inc. (NYSE MKT:XXII),
a plant biotechnology company that is focused on reducing the harm
caused by smoking, today announced that the U.S. Food and Drug
Administration (FDA) has provided the Company with helpful and positive
feedback on the Company’s combined Modified Risk Tobacco Product
Applications (MRTPAs) and Premarket Tobacco Product Applications (PMTAs)
for 22nd Century’s “BRAND A” Very Low Nicotine tobacco cigarettes.

On December 31, 2015, the Company’s wholly owned subsidiary, Goodrich
Tobacco Company, submitted MRTPAs and PMTAs to the FDA seeking a reduced
exposure order for 22nd Century’s “BRAND A” Very Low Nicotine
cigarettes. More specifically, the Company requested in its MRTPAs
permission from the FDA to be able to state, as truthful and accurate in
BRAND A packaging and marketing, that the Company’s proprietary Very Low
Nicotine cigarettes reduce smokers’ exposure to nicotine.

With less than 0.6 mg nicotine per cigarette and less than 0.05 mg
nicotine yield per cigarette, BRAND A cigarettes are the world’s lowest
nicotine tobacco cigarettes. Relative to “Big Tobacco” cigarette brands,
including Marlboro®, Camel®, Newport®, and American Spirit®, BRAND A
contains 95% less nicotine. Unlike so-called “light” or “ultra-light”
cigarettes (which terms are now banned by the FDA from labeling and
marketing in the United States), 22nd Century’s proprietary BRAND A
cigarettes are designed to deliver greatly reduced ratios of nicotine to
other smoke components.

The Company is very pleased with the productive and encouraging
communication it received from the FDA. Though the Company is only
requesting an MRTP marketing order that will allow 22nd Century to
disclose that BRAND A reduces smokers’ exposure to nicotine, the FDA has
requested more information related to the independent clinical studies
on the Company’s Very Low Nicotine tobacco that focused on smoking
cessation and harm reduction objectives.

Further, though the Company’s MRTPAs and PMTAs for BRAND A included a
comprehensive overview of many independent clinical trials that have
found that smoking 22nd Century’s Very Low Nicotine cigarettes delivers
the sensory and behavioral experience associated with conventional
cigarettes while providing only minimal exposure to the most addictive
component of tobacco, the FDA expressed interest in receiving additional
documents pertaining to research findings and statistical analyses
related to the focus group studies that were conducted in support of the
Company’s BRAND A applications.

In response to the FDA’s requests, and in conjunction with additional
clarifying guidance, the Company has withdrawn its existing filings in
order to file even more expansive and robust MRTPAs and PMTAs for BRAND
A that will include additional scientific data and information from
already completed clinical studies on the Company’s Very Low Nicotine
tobacco cigarettes, in addition to smoking cessation research. In order
to help further expedite the FDA review process, the Company also
intends to bifurcate its application into separate PMTAs and MRTPAs for
BRAND A to enjoy the benefit of the FDA’s shorter review timing for
PMTAs as compared to MRTPAs.

As 22nd Century expands upon its discussion and interactions with the
FDA’s Center for Tobacco Products (CTP) on the Company’s MRTPAs and
PMTAs for its BRAND A Very Low Nicotine over-the-counter product, the
Company is also continuing to separately work with the FDA’s Center for
Drug Evaluation and Research (CDER) with respect to the Company’s
previously-filed New Drug Application (NDA) for 22nd Century’s proposed
“X-22” prescription-based smoking cessation product. Thus, 22nd Century
is advancing two distinct products – one a proposed reduced exposure
combustible cigarette, the other a proposed pharmaceutical smoking
cessation aid – with different parts of the FDA.

“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. “To address this critically
important issue, we look forward to collaborating with the FDA in 2017
on both BRAND A and on X-22 in order to provide consumers access to 22nd
Century’s remarkable Very Low Nicotine products.”

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 cannabis plants through genetic
engineering and plant breeding. The Company’s primary mission is to
reduce the harm caused by smoking. 22nd Century currently owns or
exclusively controls more than 200 issued patents and more than 50
pending patent applications around the world. 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, 2015, filed on February 18,
2016, 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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