1Q21 Investor Update
VLNⓇ IS IN FINAL STAGES OF REVIEW WITH THE FDA
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*For descriptive purposes only. Final trade dress
subject to the FDA review and authorization.
VLN
Nicotine is addictive
Lesnicutine does NOT
sa Al cigaretes can cause
de and death
Obtaining both PMTA & MRTP designation
is critical to the success of VLNⓇ.
Premarket Tobacco Product
Application (PMTA)
"Authorizing these reduced nicotine
products for sale in the U.S. is appropriate
for the protection of public health"
- FDA press release on 12/1/19
FDA is in the final stages of the review process; no
outstanding requests for information
from the FDA
Modified Risk Tobacco Product
Application (MRTPA)
22nd Century Group, Inc.
MRTP authorization will allow 22nd
Century VLNⓇ to carry headline claim of
"95% less nicotine" on packaging,
distinguishing the product from
conventional cigarettes
Working with legal advisers, regulatory consultants, and
government affairs specialists to highlight the public health
importance of MRTP application
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