22nd Century’s Very Low Nicotine Cigarettes Significantly Reduce Withdrawal and Craving Symptoms in Vulnerable Population Groups

“When nicotine content is set very low… dependence decreases,
smoking rates decrease, and people are better able to quit if they
choose to do so.” – Dr. Stephen T. Higgins, University
of Vermont Center on Tobacco Regulatory Science

CLARENCE, N.Y.–(BUSINESS WIRE)–22nd Century Group, Inc. (NYSE MKT:XXII),
a leader in tobacco harm reduction, announced today that scientists from
the University of Vermont Center on Tobacco Regulatory Science, Brown
University, Johns Hopkins University, and Southern Illinois University published
online in the October 2016 issue of Psychopharmacology a new
independent clinical study which concluded that, even among vulnerable
populations, 22nd Century’s Very Low Nicotine tobacco cigarettes
significantly reduce nicotine withdrawal and craving symptoms. Dr.
Stephen T. Higgins, et al., conducted the study, which examined
the effects of Very Low Nicotine cigarettes on economically
disadvantaged women, opioid-dependent individuals, and individuals with
affective disorders.

The FDA Center for Tobacco Products (CTP) partners with other public
health agencies to conduct research that drives tobacco regulatory
action based on the best available science. At the onset of his clinical
study, Dr. Higgins discussed the objectives for his trial in an FDA
sponsored Tobacco
Regulatory Science in Action video. In the video, Dr. Higgins
explains that “when nicotine content is set very low… dependence
decreases, smoking rates decrease, and people are better able to quit if
they choose to do so.” Characterizing the results of previous trials
with Very Low Nicotine cigarettes as “promising,” Dr. Higgins states
clearly: “we have to make cigarettes less addictive.”

The Higgins study, which exclusively used 22nd Century’s SPECTRUM®
research cigarettes as provided by the National institute on Drug Abuse
(NIDA), examined the potential impacts of enacting a national policy to
lower the nicotine content of cigarettes to a level not capable of
sustaining addiction. The study scientists note that “there is now an
abundance of evidence that very low nicotine content cigarettes provide
smokers with significant relief [from withdrawal symptoms].”

Fifteen scientific papers from independent clinical studies have already
demonstrated a host of desirable outcomes for the broader U.S. smoking
population, including: reduced smoking, reduced nicotine exposure,
reduced nicotine dependence, increased abstinence, reduced exposure to
toxicants and few adverse events with little evidence of
withdrawal-related discomfort or safety concerns. Independent
scientists widely agree that 22nd Century’s proprietary Very Low
Nicotine cigarettes drastically reduce smokers’ exposure to
nicotine and do not result in compensatory smoking. In contrast,
“light” cigarettes (as previously labeled and marketed by “Big Tobacco”
companies like Altria Group, Inc. (NYSE: MO)
and Reynolds American, Inc. (NYSE: RAI)),
merely reduce machine-smoking nicotine yields by diluting the smoke
rather than by reducing the nicotine content of the tobacco itself.
Accordingly, “light” cigarettes made by Big Tobacco companies can result
in compensatory smoking and actually lead to increased exposure to
toxicants.

The paper by Dr. Higgins, et al. adds to the substantial number
of previous clinical trials that support the use of 22nd Century’s Very
Low Nicotine cigarettes with a nicotine content of 0.4mg/g. Dr. Higgins
reports that this 95-97% reduction in nicotine versus conventional
tobacco has “the greatest likelihood” of falling below a nicotine
dependence threshold. Only 22nd Century can grow tobacco plants with
such minute nicotine content.

“22nd Century’s Very Low Nicotine cigarettes have proven beneficial for
every examined smoker population, from the broad U.S. smoking population
to subsets that include smokers suffering from schizophrenia, heavy
consumers of alcohol, and now even the most vulnerable groups among us,”
noted Henry Sicignano, III, President and Chief Executive Officer at
22nd Century Group. “Under the Tobacco Control Act of 2009, the FDA has
the regulatory authority to mandate that all U.S. cigarette
manufacturers offer Very Low Nicotine brand styles so that smokers can
have a non-addictive choice. I understand why Altria might be
hesitant to embrace the idea of Very Low Nicotine Marlboro® cigarettes…
but I can no longer imagine why public health officials would hesitate.”

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.

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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
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future results, levels of activity or performance. You should not place
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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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or
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