Biotech

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 the World Health Organization (WHO) Study Group on Tobacco Product Regulation (TobReg) has recommended “a policy of limiting the sale of cigarettes to brands with a nicotine content that is not sufficient …

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 the World Health Organization (WHO)
Study Group on Tobacco Product Regulation (TobReg) has recommended “a
policy of limiting the sale of cigarettes to brands with a nicotine
content that is not sufficient to lead to the development and/or
maintenance of addiction
.” (WHO
Global Nicotine Reduction Strategy
)

The WHO report states: “No specific amount of nicotine has yet been
identified as the absolute threshold for addiction; however, it is
likely to be equal to or possibly less than 0.4 mg/g of dry cigarette
tobacco filler
.” 22nd Century is the only company in the world
capable of producing combustible tobacco cigarettes at this very low
level of nicotine – without any artificial extraction or chemical
processes.
Reflecting on independent clinical studies, the WHO report explains that
government-mandated nicotine reduction strategies utilizing Very Low
Nicotine cigarettes could “decrease the acquisition of smoking and
progression to addiction among experimenters, limit the number of
cigarettes smoked by some proportion of addicted smokers and both
increase the number of addicted smokers who stop smoking and reduce the
number of those who relapse.”
22nd Century’s proprietary Very Low Nicotine SPECTRUM®, MAGIC®, and
BRAND A cigarettes have the taste and sensory characteristics of
conventional cigarettes, but contain approximately 95% less nicotine
than conventional cigarettes made by Altria Group, Inc. (NYSE: MO)
and Reynolds American, Inc. (NYSE: RAI),
including Marlboro®, Newport®, Camel®, and American Spirit®.
Reduced nicotine “yield” cigarettes first developed and marketed by “Big
Tobacco” companies in the 1970’s as “light,” and “low tar” (terms now
banned by the FDA from labeling and marketing in the United States),
deliver doses of nicotine that are actually comparable to full-flavored
conventional cigarettes and, in fact, extend the prevalence of
addiction
. In stark comparison, 22nd Century’s Very Low Nicotine
cigarettes drastically reduce smokers’ exposure to nicotine. A growing
body of scientific evidence – including the ground breaking clinical
trial by Donny
et al
. that was funded by
the FDA and published in The New England Journal of Medicine
demonstrates that 22nd Century’s proprietary Very Low Nicotine
cigarettes do not sustain addiction. Further, the use of
22nd Century’s Very Low Nicotine cigarettes has been shown to decrease
daily cigarette consumption, as well as nicotine and toxicant exposure.
As demonstrated by the WHO report, many public health officials believe
it is a critically important health need to provide consumers with a
product that reduces exposure to nicotine. This point echoes former
U.S. FDA Commissioner Dr. David Kessler’s recommendation that “the
FDA should quickly move to reduce nicotine levels in cigarettes to
non-addictive levels… It is the ultimate harm reduction strategy.”

“22nd Century is the only company in the world that can make cigarettes
containing naturally grown tobacco with nicotine at the non-addictive
levels recommended by the WHO and former U.S. FDA Commissioner Dr. David
Kessler,” explained Henry Sicignano, III, President and Chief Executive
Officer of 22nd Century Group. “We welcome the opportunity to
collaborate with public health officials and scientists around the world
to test and implement the important recommendations made by the World
Health Organization Study Group on Tobacco Product Regulation.”
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
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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