Market Overview

Washington Examiner Publishes Public Policy Article by 22nd Century's James Vail and Juan Sanchez Tamburrino, Ph.D.


Tobacco Asia article puts tobacco executives on notice

22nd Century Group, Inc. (NYSE American: XXII),
a plant biotechnology company focused on tobacco harm reduction and Very
Low Nicotine tobacco, announced today that The Washington Examiner
published an op-ed
by James Vail, Director of Communications, and Juan Sanchez
Tamburrino, Ph.D. Vice President of Research and Development, at 22nd

The article calls for the U.S. Congress, tobacco control advocates, and
the American people "to ensure that the FDA's nicotine reduction plan
quickly becomes reality." Dr. Scott Gottlieb, Commissioner of the U.S.
Food and Drug Association (FDA), has stated that the FDA's efforts to
lower nicotine in cigarettes will be based on science. Since 2011 the
National Institutes of Health (NIH), in cooperation with the FDA, has
funded dozens of important clinical studies employing 22nd Century's
Very Low Nicotine Content (VLNC) cigarettes. The results of these
numerous clinical studies provide independent scientific support for the
FDA's planned rule to require that all cigarettes sold in the United
States contain only minimally or non-addictive levels of nicotine.
Citing the many completed clinical studies using VLNC cigarettes, the
article succinctly and concisely summarizes the important results:

have found
that VLNC cigarettes reduce cravings, reduce
consumption of cigarettes, and increase quit attempts. Further, the
benefits of VLNC cigarettes appear to
to adolescents
, nondaily
, and vulnerable
population groups
, including those with psychiatric disorders
and opioid dependence."

An often-repeated but erroneous objection to the FDA's planned nicotine
reduction mandate is that VLNC cigarettes will lead to "compensation" – i.e.
cigarettes with minimally or non-addictive levels of nicotine will drive
smokers to consume more cigarettes. Vail and Tamburrino conclusively
address this misconception by citing the work of preeminent independent
tobacco scientists:

, et al. recently coauthored a letter to the FDA that
emphatically closed the door on the myth that smokers might smoke more
if cigarettes were minimally or non-addictive:
compensating to maintain nicotine exposure is virtually impossible when
switching to cigarettes with minimally addictive nicotine content

(emphasis added)

In responding to the FDA's Advanced Notice of Proposed Rulemaking
(ANPRM) for a mandate that will require that all cigarettes sold in the
United States contain only minimally or non-addictive levels of
nicotine, twelve
prominent United States Senators
urged the FDA to set an aggressive
deadline for rulemaking and implementation of a reduced nicotine
standard, proclaiming "the FDA can help save millions of lives and
positively impact public health for generations to come."

Separately, in an article published in Tobacco
on July 26, 2018, author Thomas Schmid gives voice to the
likely fears of many tobacco insiders when he writes:

"The question on many tobacco firm executives' minds around the world
also is whether the FDA rule is going to have a domino effect.
Historically, many countries – particularly in Europe – have regularly
felt compelled to follow suit with their own corresponding rules
whenever FDA had enacted an important new regulation."

Indeed, conventional tobacco control methods may have reached their
limits. Australian smokers endure the world's most aggressive tobacco
control laws, including a ban on all marketing, mandated plain white
packaging, a prohibition on store displays, and the highest taxes in the
world. A pack of cigarettes in Australia costs more than USD $20. Yet,
from the years 2013 to 2016, the smoking
in Australia remained virtually unchanged.

"The FDA's plan to limit nicotine in cigarettes is moving forward
rapidly in the United States; at the same time, the World Health
Organization is advocating for equally bold nicotine reduction measures
around the world," explained Henry Sicignano III, President and Chief
Executive Officer of 22nd Century Group. "With continued pressure from
lawmakers, the FDA, public health advocates, and the public at large,
smokers everywhere may soon be free from the addictive power of

About the Washington Examiner

The Washington Examiner provides news, investigative reporting,
commentary and analysis focused on Washington, D.C. with a monthly
circulation of 40,000 print and 4 million unique online viewers.

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
for more information.

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press release contains forward-looking information, including all
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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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