FDA summarizes the compelling science
supporting its plan to dramatically reduce nicotine in
cigarettes
22nd Century Group, Inc. (NYSE American: XXII), a plant
biotechnology company focused on tobacco harm reduction and Very
Low Nicotine tobacco, announced today that on October 11, 2018, Dr.
Lynn Hull, Lead Pharmacologist at the United States Food and Drug
Administration (FDA) Center for Tobacco Products, held a webcast
highlighting and summarizing the published science supporting the
FDA’s efforts to dramatically reduce nicotine in all cigarettes
sold in the United States. Entitled “Science to Inform a Tobacco
Product Standard for the Level of Nicotine in Combusted
Cigarettes,” Dr. Hull’s presentation featured prominently many
independent clinical trials conducted with 22nd Century’s Very Low
Nicotine Content (VLNC) SPECTRUM® research cigarettes.
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22nd Century’s SPECTRUM cigarettes are
featured prominently in the FDA’s summary of science supporting a
VLNC cigarette mandate.
Dr. Hull contrasted VLNC cigarettes with so-called “light”
cigarettes by clarifying that VLNC cigarettes contain minimally or
non-addictive levels of nicotine as compared to traditional “light”
cigarettes that contain just as much nicotine as traditional
cigarettes.
Though Big Tobacco companies waged massive marketing campaigns,
for decades, to persuade smokers that so-called “light” or “smooth”
cigarettes contain less nicotine, this simply is not true. Major
national cigarette brands that historically advertised “low
nicotine,” “light,” “ultra-light” or “smooth” styles were referring
to the smoking machine-measured nicotine yield of cigarettes
– not the nicotine content of the tobacco in the
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” by smoking more cigarettes when using low
nicotine yield cigarettes and do not actually achieve reduced
nicotine intake.
In discussing “light” cigarettes, Dr. Hull remarked: “They are
designed to appear ’light’ to the user, but can deliver as much
nicotine as traditional cigarettes. These products have no
benefit to public health.” (emphasis added)
For precisely this reason, the FDA banned the terms “light,”
“ultra-light,” “low tar” and other terms from use with respect to
combustible cigarettes so that Big Tobacco companies could no
longer mislead consumers.
In contrast to the highly addictive tobacco cigarettes marketed
by Big Tobacco companies, 22nd Century’s proprietary VLN TM tobacco
and technology make possible tobacco cigarettes with a nicotine
content of just 0.4mg/g, which is more than 95% less nicotine than
conventional cigarettes (conventional cigarettes contain
approximately 20 mg nicotine per gram of tobacco). The World Health
Organization (WHO) Study Group on Tobacco Product Regulation, the
FDA’s March 2018 Advanced Notice of Proposed Rulemaking, and highly
respected, independent scientists across the United States have all
pointed to tobacco with a nicotine content at or about 0.4mg/g as
being “minimally or non-addictive.”
In her FDA webcast presentation, Dr. Hull also discussed the
consistent scientific findings of numerous independent clinical
studies that were conducted with VLNC cigarettes. In an overview of
the compelling science supporting the FDA’s planned mandate that
all cigarettes sold in the United States contain only minimally or
non-addictive levels of nicotine, Dr. Hull presented the powerful
benefits of VLNC cigarettes:
“Findings suggest that VLNC Cigarettes:
- Do not increase the number of
cigarettes [smoked] per day
- May decrease dependence
- May increase quit attempts
- Have lower addiction potential than NNC
[Normal Nicotine Content] cigarettes
- May reduce exposure to nicotine and
other Harmful and Potentially Harmful Constituents (HPHCs)
- Either do not result in differences in
how people smoke, or result in changes associated with reductions
in tobacco smoker exposure (e.g., lower total puff volume)
- Can suppress craving and
withdrawal
- Have not been found to increase adverse
effects in smokers with symptoms of mental health disorders”
Dr. Hull continued her presentation with references to the
special report by Dr. Benjamin Apelberg, et al: “Potential Public
Health Effects of Reducing Nicotine Levels in Cigarettes in the
United States,” published in the March 2018 issue of The New
England Journal of Medicine. Dr. Apelberg’s Population Health Model
uses empirical evidence and expert opinion to predict the results
of implementing the FDA’s proposed new rule to require that all
cigarettes sold in the United States contain only minimally or
non-addictive levels of nicotine. Dr. Hull discussed the compelling
conclusions reached by Dr. Apelberg’s team that are based on
implementation of the FDA’s plan in the year 2020:
1) 5 million people would quit smoking in the
first year, 13 million people would quit smoking in 5 years, and 33
million people would quit smoking or not become addicted to smoking
by the year 2100
2) 8 million tobacco-attributable deaths
would be prevented by 2100
3) 134 million life-years would be gained by
2100
Dr. Hull concluded: “It is FDA’s belief that rendering
cigarettes minimally addictive by reducing their nicotine content
could help current users quit and prevent future users from
becoming addicted and escalating to regular use.”
“As evidenced by Dr. Hull’s October 11, 2018 webcast, the FDA is
continuing to build systematically the regulatory framework
necessary to implement a sweeping reduction of nicotine in
combustible cigarettes,” explained Henry Sicignano III, President
and Chief Executive Officer of 22nd Century Group. “The benefits of
Very Low Nicotine Content cigarettes are compelling and impossible
to ignore. Under the FDA’s nicotine reduction mandate, we look
forward to providing our extraordinary products to every smoker in
America.”
About SPECTRUM® Research Cigarettes
22nd Century developed SPECTRUM® research cigarettes in
partnership with independent researchers and officials from the
National Institute on Drug Abuse (NIDA), the U.S. Food and Drug
Administration (FDA), the National Cancer Institute (NCI), and the
Centers for Disease Control and Prevention (CDC). The main
SPECTRUM® product line, uniquely produced by 22nd Century from its
proprietary Very Low Nicotine tobacco plants, consists of a series
of cigarette styles that vary nicotine contents from very low (more
than 95% less nicotine than tobacco contained in conventional
cigarette brands) to relatively high nicotine contents. SPECTRUM®
features 24 styles, in both regular and menthol versions, with 8
different levels of nicotine.
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
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/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, 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/20181012005274/en/
22nd Century GroupJames Vail, Director of
Communications716-270-1523jvail@xxiicentury.com
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