FDA Authorizes Clinical Trial for 22nd Century’s BRAND B Low Tar-to-Nicotine Ratio Cigarettes

CLARENCE, N.Y.–(BUSINESS WIRE)– 22nd Century Group, Inc. (NYSE MKT: XXII),
announced today that the U.S. Food and Drug Administration (FDA) has
granted 22nd Century authorization to conduct a clinical trial studying
the Company’s BRAND B, low tar-to-nicotine ratio cigarettes. This
trial is designed to confirm that as smokers make the adjustment to a
higher nicotine cigarette, they take in less smoke because the nicotine
is more readily available. 22nd Century has engaged a Contract Research
Organization with extensive experience in combustible cigarette exposure
studies to conduct the BRAND B trial this summer.

According to the Centers for Disease Control and Prevention (CDC), 32%
of smokers (nearly 12 million) do not wish to quit smoking.
For these smokers, 22nd Century is developing its BRAND B Low
Tar-to-Nicotine ratio cigarettes as a reduced exposure product
candidate. The Company intends to submit a Modified Risk Tobacco Product
(MRTP) application to the FDA for Brand B. Independent surveys
have shown that even though 30-50% of American smokers are not committed
to quitting, 90% of these smokers would be willing to try a potentially
reduced exposure tobacco product. For this reason, 22nd Century believes
the Company’s proprietary BRAND B product has enormous market
potential.

“Our initial clinical trial investigating the effects of BRAND B’s
design-objective – the reduced delivery of smoke components, other than
nicotine – is a measurable step forward in the development of our
Company’s mission,” explained Dr. Michael Moynihan, Vice President of
Research & Development at 22nd Century Group.

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 in tobacco
is to reduce the harm caused by smoking. The Company’s primary mission
in cannabis is to develop proprietary 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.

Image may be NSFW.
Clik here to view.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170501005507/en/