UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): January 4, 2016
_________________
22nd
Century Group, Inc.
(Exact
Name of Registrant as Specified in Charter)
Nevada |
001-36338 |
98-0468420 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer
Identification No.) |
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9530 Main Street
Clarence, New York
(Address of Principal Executive Office) |
14031
(Zip Code) |
Registrant’s telephone number, including
area code: (716) 270-1523 |
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01 Regulation FD Disclosure.
On January 4, 2016,
22nd Century Group, Inc. (the “Company”) issued a press release announcing that it had submitted a Modified Risk Tobacco
Product application to the U.S. Food and Drug Administration (FDA). A copy of the press release is furnished as Exhibit 99.1 herewith
and is incorporated herein by reference.
Item 9.01(d): Financial Statements and
Exhibits.
Exhibit 99.1 -- Press
Release, dated January 4, 2016.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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22nd Century Group, Inc. |
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/s/ Thomas L. James |
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Date: January 4, 2016 |
Thomas L. James |
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Vice President, General Counsel & Secretary |
Exhibit 99.1
22nd Century Files Modified Risk Tobacco
Product Application with the FDA for World’s Lowest Nicotine Tobacco Cigarettes
Proprietary “Very Low Nicotine”
Cigarettes Drastically Reduce Smokers’ Exposure to Nicotine
January 4, 2016
Clarence, New York – 22nd Century Group, Inc. (NYSE MKT:
XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced
today that on December 31, 2015, the Company’s wholly owned subsidiary, Goodrich Tobacco Company, submitted a Modified Risk
Tobacco Product (MRTP) application to the U.S. Food and Drug Administration (FDA) seeking a reduced exposure order so that 22nd
Century’s “BRAND A” Very Low Nicotine (VLN) cigarettes may be introduced into commerce in the United States.
The application to the FDA requests that BRAND A packaging and marketing be allowed to disclose to consumers that the Company’s
proprietary Very Low Nicotine cigarettes reduce smokers’ exposure to nicotine.
The World’s Lowest Nicotine Tobacco Cigarettes
BRAND A cigarettes contain less than 0.6 mg nicotine per cigarette
and less than 0.05 mg nicotine yield per cigarette. In each case, this represents a reduction of at least 95% less nicotine relative
to “Big Tobacco” cigarette brands, including Marlboro®, Camel®, Newport®, and American Spirit®. With
more than 200 patents relating to the genes in the tobacco plant responsible for nicotine production, 22nd Century is the only
company in the world capable of producing virtually nicotine-free tobacco. Without any artificial extraction or chemical processes,
22nd Century’s BRAND A cigarettes are made with the Company’s proprietary VLN tobacco that is grown on independently-owned
farms in the United States. The finished cigarettes have the taste and sensory characteristics of conventional cigarettes, but
contain only trace amounts of nicotine so that smokers’ exposure to nicotine is drastically reduced.
Under Section 911 of the federal Food, Drug, and Cosmetic Act,
a tobacco product may not be introduced for commerce in the United States if the label or advertising represents that the tobacco
product contains a reduced level of a substance or a reduced exposure to a substance unless given specific approval to do so by
the FDA.
“The scientific testing conducted in support of our submission
to the FDA shows conclusively that BRAND A, as compared to conventional tobacco cigarettes, provides smokers with drastically reduced
exposure to nicotine,” explained Henry Sicignano, III, President and Chief Executive Officer of 22nd Century Group. “We
believe that the public health implications of a virtually nicotine-free tobacco cigarette are enormous and 22nd Century is excited
about the prospect of introducing BRAND A into the U.S. market.”
It has been well established that cigarette smoking is toxic
and poses health risks to smokers. Cigarette smoking is a complex behavior that is sustained primarily by the pharmacological properties
of nicotine. Accordingly, many public health officials believe it is a critically important health need to provide consumers with
a product that reduces exposure to nicotine. This fact echoes former U.S. FDA Commissioner Dr. David Kessler’s recommendation
that “the FDA should quickly move to reduce nicotine levels in cigarettes to non-addictive levels… It is the ultimate
harm reduction strategy.”
Unlike so-called “light” or “ultra-light”
cigarettes (which terms are now banned by the FDA from labeling and marketing in the United States), 22nd Century’s proprietary
BRAND A cigarettes are designed to deliver greatly reduced ratios of nicotine to other smoke components. The Company’s application
to the FDA provides a comprehensive overview of the many independent clinical trials that have found that smoking 22nd Century’s
VLN cigarettes delivers the sensory and behavioral experience associated with conventional cigarettes while providing only minimal
exposure to the most addictive component of tobacco.
Most recently, in October 2015, The New England
Journal of Medicine published a landmark clinical study N Engl J
Med 2015; 373:1340-1349 led by the Center for the Evaluation of Nicotine in Cigarettes. The
double-blind, parallel, randomized clinical trial by Donny et al involved 840 smokers at ten locations who were
randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational
cigarettes. The researchers concluded that:
As compared with cigarettes of conventional
nicotine content, 22nd Century’s proprietary Very Low Nicotine cigarettes were “associated with reductions in smoking,
nicotine exposure, and nicotine dependence, with minimal evidence of nicotine withdrawal, compensatory smoking, or serious adverse
events.”
“The current study by Donny and colleagues adds to a
growing literature supporting the feasibility and potential benefits of a national nicotine reduction policy…” explained
public health policy reform advocates, Drs. Michael Fiore and Timothy Baker in a companion article (Fiore)
in the same issue of The New England Journal of Medicine. “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.”
The available scientific literature shows that smoking 22nd
Century’s VLN cigarettes results in reduced nicotine exposure with minimal compensatory smoking behavior and no greater exposure
to harmful or potentially harmful toxicants, particularly when exposure is maintained for longer than one week. Similarly the prolonged
use of VLN cigarettes seems to result in a decrease in dependence.
“It is the goal of the U.S. Department of Health and Human
Services, as outlined in the program Healthy People 2010, to reduce cigarette smoking in the United States to 12% by the year 2020,”
explained Gregg M. Gellman, 22nd Century’s Director of Regulatory Affairs. “Based on the scientific rationale and clinical
data referenced in our application to the FDA, we believe 22nd Century’s proprietary Very Low Nicotine cigarettes could be
an invaluable tool in helping to drastically reduce smokers’ exposure to nicotine and thereby greatly reducing cravings for,
and consumption of, cigarettes.”
With approximately 277 billion cigarettes manufactured in the
U.S. in 2014 – representing more than $80 billion in sales – the cigarette market in the United States remains enormous.
At present, however, the United States is completely devoid of any “reduced exposure cigarette” option. If 22nd Century’s
application to the FDA is successful, the Company’s VLN cigarettes will offer millions of American smokers a distinct reduced
exposure product choice.
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 cannabis plants
through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd
Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around
the world. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”),
the world’s second largest tobacco company. Visit www.xxiicentury.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, 2014, filed on February 5, 2015, 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.
Contacts
Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com
or
Redington, Inc.
Tom Redington, 203-222-7399
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