FDA Acknowledges Receipt of 22nd Century’s Very Low Nicotine Modified Risk Tobacco Product Application
March 31 2016 - 10:37AM
Business Wire
Company intends to offer American smokers
the first and only reduced exposure product choice
22nd Century Group, Inc. (NYSE MKT: XXII), a plant
biotechnology company that is a leader in tobacco harm reduction,
announced today that in a communication received by the Company,
the Food and Drug Administration (FDA) has formally acknowledged
receipt of the Company’s Modified Risk Tobacco Product (MRTP)
application for BRAND A Very Low Nicotine tobacco cigarettes.
22nd Century’s BRAND A tobacco cigarettes contain less than 0.6
mg nicotine per cigarette and less than 0.05 mg nicotine yield per
cigarette – a reduction in nicotine of at least 95% as compared to
conventional cigarettes. 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 growing
virtually nicotine-free tobacco. Though Very Low Nicotine
cigarettes have the taste and sensory characteristics of
conventional cigarettes, smokers’ exposure to nicotine is
drastically reduced.
As a part of its review process, the FDA has assigned the
following Submission Tracking Numbers (STN) to 22nd Century’s
historic MRTP application: MR0000047 and MR0000048. Though not yet
publicly linked on FDA’s website, these tracking numbers will
remain with the Company’s MRTP application throughout the FDA’s
review and authorization process. After 22nd Century redacts all
confidential information from its MRTP application, the document
will be released to the public on FDA’s website at www.fda.gov
According to FDA guidance literature, the MRTP application
process results in a “Final Review and Action” by FDA within the
360 days of the receipt of an application that contains the
information required by Section 911 of the FD&C Act.
“The feedback received to date from the FDA on our MRTP
application for BRAND A is as expected,” explained Gregg Gellman,
Director of Business Development and Regulatory Affairs at 22nd
Century Group. “22nd Century is committed to providing the FDA with
any and all empirical data needed to support a marketing order for
the Company’s novel Very Low Nicotine product. It is our intention
to work collaboratively with FDA in order for 22nd Century to be
allowed to offer millions of American smokers the first and only
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 and
www.magiccigarettes.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, 2015, filed on February 18, 2016,
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: http://www.businesswire.com/news/home/20160331005925/en/
Investor Relations:IRTH CommunicationsAndrew Haag,
866-976-4784xxii@irthcommunications.comorRedington, Inc.Tom
Redington, 203-222-7399
22nd Century (AMEX:XXII)
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