FDA Remains Firmly Committed to Nicotine Reduction in Cigarettes
January 31 2018 - 03:41PM
Business Wire
American Heart Association, American Lung
Association, and others endorse FDA’s plan Reduced nicotine tobacco
and less harmful alternatives both eminently feasible
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company focused on tobacco harm reduction, reports
recent activity relevant to the nicotine reduction mandate planned
by the US Food and Drug Administration (FDA) .
In July 2017, FDA Commissioner Scott Gottlieb, M.D., announced
the FDA’s plan to limit nicotine in cigarettes to minimally or
non-addictive levels. In his announcement, Dr. Gottlieb explained
that if nicotine – long known as the primary addictive component of
cigarettes – were reduced, smokers would lose their addiction to
cigarettes and would then be free to choose when and how often to
smoke. An equally important component in FDA’s announced plan is to
provide current smokers who are unable or unwilling to quit using
nicotine with other, less harmful means to obtain it.
Prominent health advocacy associations have endorsed FDA’s plan
to dramatically reduce nicotine in cigarettes to minimally
addictive or non-addictive levels and to provide “demonstrably less
hazardous” (non-combustible) products for the subset of smokers who
are unable or unwilling to quit. On October 13, 2017, the heads of
the Cancer Action Network, American Heart Association, American
Lung Association, Campaign for Tobacco-Free Kids and the Truth
Initiative co-authored a letter to Dr. Gottlieb and the FDA urging
the agency to enact a nicotine mandate as promptly as possible: “We
support the objective of reducing the level of nicotine in
cigarettes to render them minimally or non-addictive… It is
critical that FDA begin action promptly, and set a firm deadline
for completing, a Final Rule to reduce the levels of nicotine in
cigarettes.”
On January 23, 2018, The National Academies of Sciences,
Engineering, and Medicine (NASEM) published an independent report
evaluating the available scientific evidence addressing the short-
and long-term health effects related to the use of electronic
nicotine delivery systems (ENDS), such as e-cigarettes. While the
NASEM report raised some concerns, the authors found conclusive
evidence that switching exclusively to e-cigarettes “reduces users’
exposure to numerous toxicants and carcinogens present in
combustible tobacco cigarettes.” The report also found substantial
evidence that “nicotine intake from e-cigarette devices among
experienced adult users can be comparable to that from combustible
tobacco cigarettes.” These two conclusions strengthen support for
the FDA’s proposed standard to: 1) reduce the nicotine content in
cigarettes, and 2) provide current cigarette smokers who will not
quit nicotine, with less harmful means to obtain it.
In a statement on the FDA’s website, Dr. Gottlieb said, “the
report finds that current smokers who completely switch to
e-cigarettes may see improved short-term health outcomes.”
Responding to comments on the NASEM report that were posted on
Twitter, Dr. Gottlieb made it clear that approved ENDS products are
only part of the FDA plan, “We are pursuing a market where we use
the product standard to render combustible cigs minimally or
non-addictive.”
On January 25, 2018, Dr. Gottlieb continued to trumpet the FDA’s
plan in a speech at the World Economic Conference in Davos,
Switzerland. Stating that the smoking rate in the United States is
too high, Dr. Gottlieb explained “we wish to reduce it greatly
through our proposal to reduce nicotine in combustible cigarettes
to minimally/non-addictive levels.”
“22nd Century’s Very Low Nicotine tobacco technology
demonstrates that the FDA’s plan to dramatically reduce nicotine in
cigarettes is technologically feasible,” explained James E.
Swauger, PhD, Senior Vice President of Science and Regulatory
Affairs for 22nd Century Group. “The letter to the FDA from public
health associations, together with the NASEM report on
e-cigarettes, highlight the growing public and scientific consensus
that the FDA’s planned nicotine reduction mandate is timely,
practical, and urgently needed.”
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 hemp/cannabis plants. 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/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
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version on businesswire.com: http://www.businesswire.com/news/home/20180131006193/en/
22nd Century GroupJames Vail, 716-270-1523Director of
Communicationsjvail@xxiicentury.com
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