Food and Drug Law Institute Publishes Public Policy Article by 22nd Century’s Dr. James Swauger
23 April 2018 - 10:58PM
Business Wire
Stakeholders in public health – and the
tobacco industry – will support the FDA’s bold nicotine reduction
plan
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 Food and Drug Law
Institute (FDLI) has published an article by Dr. James Swauger,
Senior Vice President of Science and Regulatory Affairs at 22nd
Century. In this matter-of-fact public policy analysis, Dr. Swauger
points out that since it is universally accepted that nicotine is
the primary addictive component of cigarettes, the tobacco industry
and public health officials should logically support the nicotine
reduction plan proposed by the U.S. Food and Drug Administration
(FDA).
In the article, Dr. Swauger points to the FDA’s focus on
nicotine as the “common ground that both sides can stand upon to
begin civil, truly productive conversations.” Quoting Stanford
Professor Robert N. Proctor, Ph.D., Dr. Swauger argues that the
benefits of “minimally or non-addictive” cigarettes are the
foundation of the FDA’s plan: “Smokers would be able to start or
quit at will, without suffering the robbery of choice that defines
addiction.”
Dr. Swauger describes Very Low Nicotine Content (VLNC)
cigarettes as “well-studied by a diverse group of scientists.”
Since 2011, the FDA, the National Institute on Drug Abuse (NIDA), a
department of the National Institutes of Health (NIH), and other
U.S. federal government agencies have invested more than $100
million in independent clinical studies utilizing 22nd Century’s
proprietary VLNC cigarettes, with such studies being conducted by
scientists at many well-known locations, including the Mayo Clinic,
the MD Anderson Cancer Center at the University of Texas, the Johns
Hopkins University, Duke University, the University of Pittsburgh,
the University of Minnesota, the University of Vermont, the
University of California, and others. Since 2011, 22nd Century has
provided more than 24 million SPECTRUM® research cigarettes
containing the Company’s VLNC tobaccos for use in these independent
clinical studies. The results of these clinical studies have been
published in peer-reviewed articles and reflect the independent
scientific support for the planned mandate by the FDA that all
combustible cigarettes sold in the United States contain only
minimally or non-addictive levels of nicotine.
The FDA’s nicotine reduction plan enjoys broad public support.
Dr. Swauger cites three survey-based research articles, each
published in 2018 and conducted even before the FDA announced its
intention to regulate nicotine. The first article found that 71% of
respondents thought the FDA “should reduce nicotine in cigarettes.”
Another article reported that 63% of smokers would “support a law
that reduced the amount of nicotine in cigarettes and tobacco.” And
the third article found that 68% of adults in the U.S. agreed that
“government should mandate that all cigarettes have very low,
non-addictive levels of nicotine.”
Dr. Swauger also cites an editorial in the October 2015 edition
of The New England Journal of Medicine in which Drs. Michael Fiore
and Timothy Baker wrote that “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.”
Sadly, this will be the last article penned by Dr. Swauger. Dr.
Swauger passed away suddenly on Thursday, April 19, 2018.
“Jim Swauger was an important part of the 22nd Century team… and
a good friend as well. Our thoughts and prayers are with Jim’s
family,” explained Henry Sicignano III, President and Chief
Executive Officer of 22nd Century Group. “Jim Swauger was focused
on realizing the potential of Very Low Nicotine cigarettes to
greatly reduce the harm caused by smoking. And though Jim will be
sorely missed, our team of industry-leading researchers and tobacco
harm reduction experts will press forward, seamlessly, in 22nd
Century’s campaign to deliver our Company’s remarkable Very Low
Nicotine products to the smoking public.”
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/20180423005468/en/
22nd Century GroupJames Vail, 716-270-1523Director of
Communicationsjvail@xxiicentury.com
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