22nd Century Group’s FDA Advisory Committee Meeting for Reduced Nicotine Content Cigarettes Brings New Standard for the Tob...
February 11 2020 - 1:30PM
Business Wire
22nd Century Group seeks Modified Risk Tobacco
Product marketing authorization for its VLN® and VLN® Menthol
Reduced Nicotine Tobacco Products
22nd Century Group, Inc. (NYSE American: XXII)—a plant
biotechnology company that is a leader in tobacco harm reduction,
reduced nicotine tobacco, and hemp/cannabis plant research—will
present the Company’s Modified Risk Tobacco Product (MRTP)
application for its reduced nicotine content cigarettes to the U.S.
Food and Drug Administration’s Tobacco Product Scientific Advisory
Committee (FDA TPSAC) on Friday, February 14, 2020. This meeting
will be the first TPSAC meeting to review a combustible tobacco
product application, and the first time it has reviewed a modified
exposure claim application.
Committee experts from across public health and medicine will
hear from 22nd Century Group and the FDA about 22nd Century’s MRTP
application and will then discuss specific areas of interest to the
FDA. The Company’s MRTP applications seek a reduced exposure
marketing authorization from the FDA to allow 22nd Century’s
reduced nicotine content cigarettes to be marketed under the brand
name “VLN®” with pack and advertising claims stating that the
cigarettes contain “95% Less Nicotine” than conventional tobacco
cigarettes, as well as related claims.
Mike Zercher, President of 22nd Century Group, explained: “The
presentation of our MRTP application to the FDA’s Scientific
Advisory Committee is yet another milestone in the Company’s
mission to make available reduced nicotine content products to
adult smokers.” Zercher continued: “22nd Century is poised to
significantly disrupt the $100 billion U.S. tobacco industry. Our
research shows VLN® strongly appeals to adult smokers, and
importantly from a public health perspective, former and never
smokers have little interest in the product.”
John Pritchard, Vice President of Regulatory Science for 22nd
Century Group, who will lead the Company’s presentation to TPSAC,
explained: “Over recent years, 22nd Century has invested millions
of dollars and countless hours to create and submit comprehensive,
science-based applications to FDA for these first-of-their-kind
tobacco products. These applications are supported by well over
$100 million of independent clinical research conducted at leading
institutions and major universities in the United States and
elsewhere.
“Late last year, we secured an FDA authorization for our
Moonlight® and Moonlight® Menthol brand of reduced nicotine content
cigarettes by meeting the PMTA regulatory requirements,” continued
Pritchard. “This week, we look forward to presenting an overview of
our modified exposure claim application to the FDA’s scientific
advisory committee. We believe that all adult smokers have the
right to know that our VLN® products have 95% less nicotine than
conventional cigarettes; an authorization under the MRTP regulatory
pathway will enable this. Moreover, receiving an FDA authorization
for VLN® will further advance FDA’s stated goal of achieving a
reduced nicotine product standard for all cigarettes sold in the
United States, which would be truly game-changing for public
health.”
22nd Century’s reduced nicotine cigarettes enable smokers to
experience the same taste and smell as they would smoking
conventional cigarettes but with minimal exposure to nicotine. The
FDA’s own assessment of its plan to regulate nicotine to levels
already achieved in VLN® would lead to 5 million additional adult
smokers quitting one year after implementation with over 8 million
American lives saved by the end of this century.
The public is invited to attend the Tobacco Product Scientific
Advisory Committee meeting in Building 31 at the FDA White Oak
Campus (Silver Spring, MD). The meeting also will be webcast.
Meeting details can be found on the FDA’s website at
https://www.fda.gov/advisory-committees/tobacco-products-scientific-advisory-committee/2020-tpsac-meeting-materials-and-information#agenda
About 22nd Century Group, Inc.
22nd Century Group is a plant biotechnology company focused on
technologies that allow it to regulate the level of nicotine in
tobacco plants and the level of cannabinoids in hemp/cannabis
plants through genetic engineering and modern plant breeding. The
Company’s primary mission in tobacco is to reduce the harm caused
by smoking by bringing to market reduced nicotine content
cigarettes with 95% less nicotine than conventional cigarettes. The
Company’s primary mission in hemp/cannabis is to develop
proprietary hemp/cannabis plants with unique cannabinoid profiles
and desirable agronomic traits. Visit https://xxiicentury.com for
more information.
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version on businesswire.com: https://www.businesswire.com/news/home/20200211005908/en/
Press: Jon Lindsay Phillips RLM PR 22C@rlmpr.com
+1-646-828-8566
Investor Relations: 22nd Century Group
InvestorRelations@xxiicentury.com +1-716-270-1523
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