FDA Announces Deadline to Submit Comments on 22nd Century Group’s MRTP Application
April 17 2020 - 11:15AM
22nd Century Group, Inc. (NYSE American: XXII) (“22nd Century” or
“the Company”), a leading plant biotechnology company focused on
reduced nicotine content tobacco and hemp/cannabis plant genetics
research and development, announced today that the U.S. Food and
Drug Administration (FDA) has set May 18, 2020 as the deadline for
the submission of public comments on the Company’s Modified Risk
Tobacco Product (MRTP) Application.
22nd Century’s MRTP application seeks
authorization from the FDA to allow the Company to market its
reduced nicotine content cigarettes under the brand name VLN®, with
pack and advertising claims stating that the product contains 95%
less nicotine than conventional tobacco cigarettes, as well as
related claims regarding reduced nicotine exposure.
“We are very pleased with the progress our team
continues to make towards receiving FDA authorization to market our
VLN® reduced nicotine content cigarettes,” said Michael Zercher,
President and Chief Operating Officer of 22nd Century Group. “With
the imminent closing of the public comment period, we are hopeful
that we will receive a positive decision from FDA allowing us to
introduce our reduced nicotine content cigarettes to adult smokers
looking to reduce their exposure to nicotine.”
22nd Century’s reduced nicotine content
cigarettes enable adult smokers to experience the same taste and
smell as conventional cigarettes but with minimal exposure to
nicotine. Numerous independent scientific studies funded by the
National Institutes of Health (NIH) and other U.S. federal
government agencies using the Company’s reduced nicotine content
cigarettes studies show that smokers who use 22nd Century’s reduced
nicotine content cigarettes (i) reduce their nicotine exposure and
dependence, (ii) smoke fewer cigarettes per day, (iii) experience
reduced withdrawal symptoms, (iv) increase their number of
smoke-free days, and (v) double their quit attempts.
The Company believes that bringing its reduced
nicotine content cigarettes to market will be an important
step towards the implementation of the FDA’s proposed plan to
require all cigarettes sold in the U.S. to be made “minimally or
non-addictive.” By limiting the nicotine content of all combustible
cigarettes to just 0.5 milligrams of nicotine per gram of tobacco,
a level already achieved in VLN®, FDA projects that five million
adult smokers would quit one year after implementation and over
eight million American lives would be saved by the end of the
century.
About 22nd Century Group, Inc.
22nd Century Group, Inc. (NYSE AMERICAN: XXII) is a leading plant
biotechnology company focused on technologies that alter the level
of nicotine in tobacco plants and the level of cannabinoids in
hemp/cannabis plants through genetic engineering, gene-editing and
modern plant breeding. The Company’s primary mission in tobacco is
to reduce the harm caused by smoking by bringing its proprietary
reduced nicotine content cigarettes with 95% less nicotine than
conventional cigarettes to adult smokers in the U.S. and
international markets. The Company’s primary mission in
hemp/cannabis is to develop proprietary hemp/cannabis plants with
unique cannabinoid profiles and desirable agronomic traits and to
commercialize those plants through a synergistic portfolio of
strategic partnerships in the hemp/cannabis industry.
Learn more at xxiicentury.com, on
Twitter @_xxiicentury and on LinkedIn.
Mei Kuo
22nd Century Group, Inc.
(716) 300-1221
mkuo@xxiicentury.com
Cory Ziskind
ICR
(646) 277-1232
cory.ziskind@icrinc.com
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