FDA Acknowledges Receipt of 22nd Century’s Very Low Nicotine Modified Risk Tobacco Product Application

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 in a communication received by the
Company, the Food and Drug Administration (FDA) has formally
acknowledged receipt of the Company’s Modified Risk Tobacco Product
(MRTP) application for BRAND A Very Low Nicotine tobacco
cigarettes.

22nd Century’s BRAND A tobacco cigarettes contain less than 0.6
mg nicotine per cigarette and less than 0.05 mg nicotine yield per
cigarette – a reduction in nicotine of at least 95% as compared to
conventional cigarettes. With more than 200 patents relating to the
genes in the tobacco plant responsible for nicotine production, 22nd
Century is the only company in the world capable of growing virtually
nicotine-free tobacco. Though Very Low Nicotine cigarettes have the
taste and sensory characteristics of conventional cigarettes, smokers’
exposure to nicotine is drastically reduced.

As a part of its review process, the FDA has assigned the following
Submission Tracking Numbers (STN) to 22nd Century’s historic MRTP
application: MR0000047 and MR0000048. Though not yet publicly linked on
FDA’s website, these tracking numbers will remain with the Company’s
MRTP application throughout the FDA’s review and authorization process.
After 22nd Century redacts all confidential information from its MRTP
application, the document will be released to the public on FDA’s
website at www.fda.gov

According to FDA guidance literature, the MRTP application process
results in a “Final Review and Action” by FDA within the 360 days of the
receipt of an application that contains the information required by
Section 911 of the FD&C Act.

“The feedback received to date from the FDA on our MRTP application for BRAND
A is as expected,” explained Gregg Gellman, Director of Business
Development and Regulatory Affairs at 22nd Century Group. “22nd Century
is committed to providing the FDA with any and all empirical data needed
to support a marketing order for the Company’s novel Very Low Nicotine
product. It is our intention to work collaboratively with FDA in order
for 22nd Century to be allowed to offer millions of American smokers the
first and only reduced exposure product choice.”

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. The Company’s strong IP
position led to a licensing agreement with British American Tobacco
(“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com
and www.magiccigarettes.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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