FDA plan to reduce nicotine in cigarettes to
non-addictive levels “could save more lives than any other act of a
governmental agency in all of human history.”
68% of surveyed adults in the United States
believe government should mandate that all cigarettes have very
low, non-addictive levels of nicotine.
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company that is focused on tobacco harm reduction,
announced today that a growing number of independent scientists
specializing in tobacco harm reduction are publicly proclaiming
that the FDA’s recently announced plan to reduce nicotine to
non-addictive levels in cigarettes will drastically improve public
health. Noted experts have proclaimed that Very Low Nicotine
cigarettes will “end the combustible tobacco epidemic” and “could
save more lives than any other act of a governmental agency in all
of human history.”
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 is
capable of growing tobacco with nicotine levels of just 0.4mg per
gram of tobacco – a 95% reduction in nicotine.
The vast majority of public health advocates, tobacco control
experts, and scientists have widely embraced the FDA’s proposed
nicotine policy. In fact, outside of “Big Tobacco” companies, few
critics of the nicotine reduction plan have emerged and the FDA has
now strongly affirmed its regulatory authority for cigarette
product standards. On August 16, 2017, Scott Gottlieb, M.D., the
Commissioner of the FDA and Mitchell Zeller, J.D., the Director of
FDA’s Center for Tobacco Products, released an article entitled, “A
Nicotine-Focused Framework of Public Health.” Published in The New
England Journal of Medicine (NEJM), the article spells out the
FDA’s regulatory authority for mandating non-addictive levels of
nicotine in combustible cigarettes. Gottlieb and Zeller point to
the 2009 Tobacco Control Act that authorizes the FDA to establish
tobacco product standards that are appropriate for the protection
of public health. The NEJM article states, the agency has “clear
authority” [emphasis added] to reduce nicotine levels. On the
issue of compensatory smoking, the authors state that, “FDA will be
led by the science” and they reference several independent clinical
studies that suggest minimum compensation when smokers use 22nd
Century’s proprietary Very Low Nicotine research cigarettes.
Gottlieb and Zeller reference a recent 6-week study by Donny, et
al. that showed that “cigarettes with lower nicotine content
reduced nicotine exposure and dependence, as well as the number of
cigarettes smoked, as compared with cigarettes with standard
nicotine levels.” [emphasis added]
In their concluding paragraph, Commissioner Gottlieb and
Director Zeller highlight the ultimate goal of a nicotine mandate:
“The public health benefits of implementing a nicotine-reduction
policy for combustible cigarettes could be enormous: we would
expect smoking-related morbidity and premature mortality to
decrease considerably.”
Dr. Benowitz, Commissioner Gottlieb and Director Zeller are not
alone in their determination to regulate nicotine. In a May 2017
survey conducted by Harris Poll online, 68% of more than 2,000
adults across the United States voiced support for government to
mandate that all cigarettes have very low, non-addictive levels of
nicotine. A similar percentage of surveyed adults in Japan
(73%), Australia (77%), Canada (76%) and the United Kingdom (76%)
also agreed that their governments should mandate very low,
non-addictive levels of nicotine for cigarettes.
On August 22, 2017, Stanford professor, Robert N. Proctor,
Ph.D., authored an editorial published in Tobacco Control entitled,
“FDA’s new plan to reduce the nicotine in cigarettes to
sub-addictive levels could be a game-changer.” Professor Proctor
reasons that limiting cigarettes to non-addictive levels of
nicotine is a moral imperative when he asserts: “Smokers would be
able to start or quit at will, without suffering the robbery of
choice that defines addiction.” The Tobacco Control editorial
argues, convincingly, that the new FDA plan “could save more
lives than any other act of a government agency in all of human
history. The magnitude of the harms is that great. We
hear a lot about tobacco endgames: this one could be a
game-changer.” [emphasis added]
In recognition and acceptance of this inevitable, upcoming
paradigm shift in the combustible tobacco market, the Chief
Executive Officer of Philip Morris International (PMI), Andre
Calatzopoulos, stated in an article published by Reuters on August
22, 2017 and entitled “Philip Morris International CEO Cheers U.S.
FDA Tobacco Proposal,” that PMI was actually “extremely encouraged”
by the FDA’s recent proposal to lower nicotine levels in cigarettes
and called it “one of the best articulated positions in many years”
that does not require “litigation or anything of this nature.”
“More than $100 Million of independent research has demonstrated
that 22nd Century’s proprietary Very Low Nicotine tobacco could
save many millions of lives and will prevent future generations of
young people from becoming addicted to cigarettes,” explained Henry
Sicignano, III, President and Chief Executive Officer of 22nd
Century Group. “22nd Century’s technology is proven. The FDA plan
is already feasible. The time to implement a mandate of Very Low
Nicotine tobacco in all combustible cigarettes sold in the United
States has arrived.”
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company focused on genetic
engineering and plant breeding which allows the increase or
decrease of the level of nicotine in tobacco plants and the level
of cannabinoids in cannabis plants. The Company’s primary mission
in tobacco is to reduce the harm caused by smoking. The Company’s
primary mission in cannabis is to develop proprietary hemp/cannabis
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, 2016, filed on March 8, 2017,
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170823005257/en/
22nd Century Group, Inc.James Vail,
716-270-1523jvail@xxiicentury.com
22nd Century (AMEX:XXII)
Historical Stock Chart
From Aug 2024 to Sep 2024
22nd Century (AMEX:XXII)
Historical Stock Chart
From Sep 2023 to Sep 2024