22nd Century Reports on New Responses to the FDAs Nicotine Reduction Plan

22nd Century Group, Inc. (NYSE American: XXII),
a plant biotechnology company that is a leader in tobacco harm reduction
and Very Low Nicotine tobacco, today highlights two important
submissions to the U.S. Food and Drug Administration (FDA). Altogether,
nine separate researchers authored these particular submissions in
response to the FDA’s Advance Notice of Proposed Rulemaking (ANPRM)
to require that nicotine levels in combustible cigarettes be lowered to
minimally or non-addictive levels. 22nd Century’s proprietary VLN™
tobacco cigarettes were used by the FDA in formulating the Agency’s plan
to dramatically reduce the nicotine content of cigarettes. 22nd Century
is the only company in the world now growing multiple varieties of Very
Low Nicotine flue-cured and burley tobacco varieties to satisfy the
FDA’s planned mandate that will reduce drastically the nicotine levels
of all cigarettes sold in the United States.

The open comment period for the FDA’s ANPRM on a nicotine product
standard for cigarettes ends July 16, 2018. To date, major medical
associations, government agencies, tobacco insiders, and the public at
large have submitted nearly 5,000
public comments to the FDA.

Noted scientific researchers Neal Benowitz, M.D., Eric Donny, Ph.D.,
Kathryn Edwards, Ph.D., Dorothy Hatsukami, Ph.D., Tracy Smith, Ph.D.,
and Clifford Watson, Ph.D. coauthored
a letter from the University of California – San Francisco (UCSF)
that identified a “minimally addictive” nicotine content for cigarettes
as follows:

“The amount of nicotine needed to make cigarettes minimally addictive
appears to be 0.4 to 0.5 mg nicotine per gram of tobacco in the tobacco
rod. This represents a reduction of nicotine content of 95% or more
compared to currently available commercial cigarettes.”

22nd Century’s SPECTRUM® Very Low Nicotine research cigarettes contain
less than 0.5 mg nicotine per gram of tobacco – exactly the level
specified in the UCSF submission. The above-noted researchers also
conclusively refuted claims that Very Low Nicotine cigarettes could
cause smokers to increase their smoking:

“Effectively compensating to maintain nicotine exposure is virtually
impossible when switching to cigarettes with minimally addictive
nicotine content.”

In another recent
submission to the FDA regarding the FDA’s ANPRM to limit
dramatically the nicotine content of cigarettes, noted scientific
researchers Megan Piper, Ph.D., David Drobes, Ph.D., and Natalie Walker,
Ph.D. address the issues of smoking dependence and smoking abstinence
when smokers switch exclusively to Very Low Nicotine content cigarettes.
Citing a number of scientific studies investigating nicotine dependence,
these researchers explain:

“…there is direct evidence that smoking reduced nicotine cigarettes
is associated with reduced dependence (both self-reported dependence and
dependence related criteria such as withdrawal, cravings) and ultimately
smoking abstinence.”

In conclusion, Drs. Piper, Drobes, and Walker cite scientific clinical
evidence to show that an immediate switch to Very Low Nicotine content
cigarettes results in:

“1) a reduction in validated dependence measures…; 2) a reduction in
cigarettes smoked; 3) a reduction in biomarkers of nicotine exposure;
and 4) a reduction in withdrawal symptoms”

“The scientists responsible for many of the independent clinical trials
using 22nd Century’s proprietary VLN™ cigarettes continue to refute the
objections raised to the FDA’s nicotine reduction plan and hasten the
road to final implementation of the life-saving mandate,” explained
Henry Sicignano, III, President and Chief Executive Officer of 22nd
Century Group. “When the FDA’s plan is enacted, 22nd Century’s Very Low
Nicotine tobacco varieties could form the foundation for, quite
literally, ALL tobacco cigarettes sold in the United States.”

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 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, 2017, filed on March 7,
2018, 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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