Conference Presentation
VLNⓇ Path to Commercialization
The FDA Pathway to MRTP Commercial Readiness
Submit Premarket Tobacco Product Application (PMTA) to the FDA
December 4, 2018
✓
Submit Modified Risk Tobacco Product Application (MRTPA) to the FDA
May 17, 2019
✓
The FDA accepted and filed MRTPA for substantive scientific review
July 19, 2019
PMTA authorized by the FDA
December 17, 2019
"Authorizing these reduced nicotine products for sale
in the U.S. is appropriate for the protection of public
health" - The FDA press release on 12/17/19
MRTPA public comment period close
May 18, 2020
MRTP Authorization by the FDA
IN "FINAL ACTION" STAGE
*These advertisements were submitted to the FDA as an exhibit to the Company's MRTP application for VLN.
●
✓
The FDA's Tobacco Products Scientific Advisory Committee (TPSAC) review of MRTPA
February 14, 2020
Go-to-Market Strategy
After the FDA authorizes 22nd Century's MRTP application, VLNⓇ
will be registered with each state to enable national
commercialization
• 22nd Century will initially launch VLN® though a targeted pilot
rollout program across select U.S. geographies
• 22nd Century manufactures its reduced nicotine content cigarettes
in a 62,000 sq. ft. manufacturing facility, which also contract
manufactures third-party brands
Contains 95% less
nicotine than
conventional cigarettes*
VLN VLN
95% LESS NICOTINE
Helps dace your
cumption
VLN
Nicotine is addictive, Less nicolare
does NOT mean safer. All cigaretten
can cause disease and death.
95% LESS NICOTINE
If you smoke, consider VLN™
VLN™ smells, burns, and tastes like
a conventional cigarette, but greatly
reduces your nicotine consumption
Learn more at
vincigarettes.com
95% LESS NICOTINE
nicotine consump
*
VLN
Helps reduce
nicotine
consumption
SURGEON GENERAL'S WARNING: Cigarette
Smoke Contains Carbon Monoxide.
22nd Century Group, Inc.
MAKE THE
SWITCH
to
95%
Less
Nicotine
REAL TOBACCO
VLN smells, burns, and tastes like a
conventional cigarette, but greatly reduces
your nicotine consumption
For the nearest retailer,
visit vincigarettes.com/stores
or call: 800-225-1838 ext. 221
% LESS NICOTINE
VLN
Nicotie is addictive as nicotina does NOT safer A ciganes can cause disease and death
SURGEON GENERAL'S WARNING:
Cigarette Smoke Contains Carbon Monoxide.
Smells, burns, and
tastes like a
conventional cigarette
*
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