22nd Century Committed to Advancing FDA’s Nicotine Mandate
April 25 2018 - 10:29AM
Business Wire
Altria and Reynolds American petition FDA
for 90-day delay in comment period for proposed nicotine reduction
rule
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 Company is committed
to working collaboratively with the U.S. Food and Drug
Administration (FDA) on the FDA’s planned nicotine reduction
mandate despite the fact that, last week, regulations.gov
published requests from Altria Group, Inc. (MO) and Reynolds
American Inc., a subsidiary of British American Tobacco (BTI),
petitioning the FDA for an additional 90-days beyond the original
public comment period that is currently set to end on June 14,
2018.
22nd Century has publicly stated that since it is universally
accepted that nicotine is the primary addictive component of
cigarettes, the tobacco industry and public health officials must
logically support the FDA’s plan to mandate that all cigarettes
sold in the United States contain only “minimally or non-addictive”
levels of nicotine. FDA Commissioner Dr. Scott Gottlieb has built a
strong case for this bold policy: “…we’ll solve the tobacco crisis
by addressing the root issue of tobacco addiction: nicotine…. [We]
could save millions of lives.”
As investors have begun to realize that the FDA is, in fact,
truly committed to its nicotine reduction plan, the share prices
for Altria Group, Philip Morris International (PM), and British
American Tobacco all continue to fall and are substantially lower
today than they were last June before the FDA’s nicotine reduction
plan was publicly announced in July 2017.
Nevertheless, misconceptions continue to abound regarding the
definition of “Very Low Nicotine;” i.e. tobacco with nicotine
content at minimally or
non-addictive levels. Many American smokers erroneously believe
that Big Tobacco companies already offer Very Low Nicotine content
brand styles. This simply is not true. National tobacco brands that
advertised “low nicotine” or “light” styles in the past were
referring to the smoking machine-measured nicotine yield of cigarettes. The FDA, the Federal
Trade Commission (FTC), and the public health community at large
have determined that the yield
method of nicotine measurement is wholly unreliable and gives no
indication of actual nicotine intake because smokers engage in
“compensatory behavior” when using low yield products and do not
actually achieve reduced nicotine intake. For precisely this
reason, the FDA banned the terms “light” and “ultra-light” from
being used with respect to combustible cigarettes so that tobacco
companies could not mislead consumers with these terms.
A better measurement, and one that is advanced in the FDA’s
Advance Notice of Proposed Rulemaking (ANPRM) to lower dramatically
the nicotine level in cigarettes, is the measurement of nicotine
content. The nicotine
content of a cigarette cannot
be modified by smoking behavior.
22nd Century produces proprietary Very Low Nicotine content tobacco cigarettes. 22nd Century's
Very Low Nicotine content
cigarettes have nicotine contents as low as 0.4mg per gram of
tobacco. In contrast, even other manufacturers’ previously
so-called “light” or “ultra-light” cigarettes have nicotine
contents 20-30 times higher at 10-15mg per gram of tobacco.
Dr. Neal Benowitz, a tobacco science expert and a professor at
the University of California, San Francisco School of Medicine,
wrote an article published on August 15, 2017 in the Annals of
Internal Medicine entitled “Comprehensive Nicotine Regulation to
End the Combustible Tobacco Epidemic.” In the perspective article,
Dr. Benowitz states that an FDA-mandated 95% reduction in nicotine
content would “make it
impossible to compensate by smoking cigarettes more intensively or
smoking more per day.” Like many other health experts, Dr. Benowitz
recognizes that compensatory smoking does not occur when the
nicotine content of combustible cigarettes is reduced by 95% as
compared to conventional cigarettes.
22nd Century is the only company in the world that has grown
commercial crops of proprietary tobacco with nicotine levels of
just 0.4mg per gram of tobacco – a 95% reduction in nicotine.
Independent clinical trials using 22nd Century’s proprietary
SPECTRUM research cigarettes have shown that Very Low Nicotine
content cigarettes reduce cravings, reduce consumption of
cigarettes, and increase quit attempts. In fact, the
research done with 22nd Century’s SPECTRUM cigarettes provided the
foundation for the FDA’s plan to mandate that all cigarettes sold
in the United States contain only “minimally or non-addictive”
levels of nicotine.
“It now seems clear that Big Tobacco companies are not willing –
or able – to comply with the FDA’s bold nicotine reduction plan,
despite their prior public statements to the contrary,” explained
Henry Sicignano III, President and Chief Executive Officer of 22nd
Century Group. “On the other hand, 22nd Century continues to grow
proprietary Very Low Nicotine tobacco with 95% less nicotine. And,
in order to save countless lives and in order to prevent millions
of young people from becoming addicted to cigarettes, 22nd Century
is 100% committed to working collaboratively with any and all
tobacco companies that truly wish to address the root issue
of tobacco addiction.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on
technology which allows the Company 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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version on businesswire.com: https://www.businesswire.com/news/home/20180425006047/en/
22nd Century GroupJames Vail, Director of
Communications716-270-1523jvail@xxiicentury.com
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