Proprietary “Very Low Nicotine” Cigarettes
Drastically Reduce Smokers’ Exposure to Nicotine
22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology
company that is a leader in tobacco harm reduction, announced today
that on December 31, 2015, the Company’s wholly owned subsidiary,
Goodrich Tobacco Company, submitted a Modified Risk Tobacco Product
(MRTP) application to the U.S. Food and Drug Administration (FDA)
seeking a reduced exposure order so that 22nd Century’s “BRAND A”
Very Low Nicotine (VLN) cigarettes may be introduced into commerce
in the United States. The application to the FDA requests that
BRAND A packaging and marketing be allowed to disclose to consumers
that the Company’s proprietary Very Low Nicotine cigarettes reduce
smokers’ exposure to nicotine.
The World’s Lowest Nicotine Tobacco Cigarettes
BRAND A cigarettes contain less than 0.6 mg nicotine per
cigarette and less than 0.05 mg nicotine yield per cigarette. In
each case, this represents a reduction of at least 95% less
nicotine relative to “Big Tobacco” cigarette brands, including
Marlboro®, Camel®, Newport®, and American Spirit®. With more than
200 patents relating to the genes in the tobacco plant responsible
for nicotine production, 22nd Century is the only company in the
world capable of producing virtually nicotine-free tobacco. Without
any artificial extraction or chemical processes, 22nd Century’s
BRAND A cigarettes are made with the Company’s proprietary VLN
tobacco that is grown on independently-owned farms in the United
States. The finished cigarettes have the taste and sensory
characteristics of conventional cigarettes, but contain only trace
amounts of nicotine so that smokers’ exposure to nicotine is
drastically reduced.
Under Section 911 of the federal Food, Drug, and Cosmetic Act, a
tobacco product may not be introduced for commerce in the United
States if the label or advertising represents that the tobacco
product contains a reduced level of a substance or a reduced
exposure to a substance unless given specific approval to do so by
the FDA.
“The scientific testing conducted in support of our submission
to the FDA shows conclusively that BRAND A, as compared to
conventional tobacco cigarettes, provides smokers with drastically
reduced exposure to nicotine,” explained Henry Sicignano, III,
President and Chief Executive Officer of 22nd Century Group. “We
believe that the public health implications of a virtually
nicotine-free tobacco cigarette are enormous and 22nd Century is
excited about the prospect of introducing BRAND A into the U.S.
market.”
It has been well established that cigarette smoking is toxic and
poses health risks to smokers. Cigarette smoking is a complex
behavior that is sustained primarily by the pharmacological
properties of nicotine. Accordingly, many public health officials
believe it is a critically important health need to provide
consumers with a product that reduces exposure to nicotine. This
fact 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.”
Unlike so-called “light” or “ultra-light” cigarettes (which
terms are now banned by the FDA from labeling and marketing in the
United States), 22nd Century’s proprietary BRAND A cigarettes are
designed to deliver greatly reduced ratios of nicotine to other
smoke components. The Company’s application to the FDA provides a
comprehensive overview of the many independent clinical trials that
have found that smoking 22nd Century’s VLN cigarettes delivers the
sensory and behavioral experience associated with conventional
cigarettes while providing only minimal exposure to the most
addictive component of tobacco.
Most recently, in October 2015, The New England Journal of
Medicine published a landmark clinical study N Engl J
Med 2015; 373:1340-1349 led by the Center for the Evaluation
of Nicotine in Cigarettes. The double-blind, parallel, randomized
clinical trial by Donny et al involved 840 smokers at ten locations
who were randomly assigned to smoke for 6 weeks either their usual
brand of cigarettes or one of six types of investigational
cigarettes. The researchers concluded that:
As compared with cigarettes of
conventional nicotine content, 22nd Century’s proprietary Very Low
Nicotine cigarettes were “associated with reductions in smoking,
nicotine exposure, and nicotine dependence, with minimal evidence
of nicotine withdrawal, compensatory smoking, or serious adverse
events.”
“The current study by Donny and colleagues adds to a growing
literature supporting the feasibility and potential benefits of a
national nicotine reduction policy…” explained public health policy
reform advocates, Drs. Michael Fiore and Timothy Baker in a
companion article (Fiore) in the same issue of The New England
Journal of Medicine. “Reducing the nicotine content of combustible
tobacco to levels that will not sustain dependence seems to us to
be the most promising regulatory policy option for preventing [at
least] 20 million premature deaths.”
The available scientific literature shows that smoking 22nd
Century’s VLN cigarettes results in reduced nicotine exposure with
minimal compensatory smoking behavior and no greater exposure to
harmful or potentially harmful toxicants, particularly when
exposure is maintained for longer than one week. Similarly the
prolonged use of VLN cigarettes seems to result in a decrease in
dependence.
“It is the goal of the U.S. Department of Health and Human
Services, as outlined in the program Healthy People 2010, to reduce
cigarette smoking in the United States to 12% by the year 2020,”
explained Gregg M. Gellman, 22nd Century’s Director of Regulatory
Affairs. “Based on the scientific rationale and clinical data
referenced in our application to the FDA, we believe 22nd Century’s
proprietary Very Low Nicotine cigarettes could be an invaluable
tool in helping to drastically reduce smokers’ exposure to nicotine
and thereby greatly reducing cravings for, and consumption of,
cigarettes.”
With approximately 277 billion cigarettes manufactured in the
U.S. in 2014 – representing more than $80 billion in sales – the
cigarette market in the United States remains enormous. At present,
however, the United States is completely devoid of any “reduced
exposure cigarette” option. If 22nd Century’s application to the
FDA is successful, the Company’s VLN cigarettes will offer millions
of American smokers a distinct reduced exposure product choice.
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. The Company’s strong IP position led to a licensing
agreement with British American Tobacco (“BAT”), the world’s second
largest tobacco company. Visit www.xxiicentury.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, 2014, filed on February 5, 2015,
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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version on businesswire.com: http://www.businesswire.com/news/home/20160104005880/en/
Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
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