1Q21 Investor Update
Q1 DEVELOPMENTS:
SHIFT IN FEDERAL POLICY POSITION
Reduced Nicotine Mandate Now at the Forefront
▪ WSJ reports¹ the Biden Administration is actively considering
moving forward with the ANPRM that will require Big Tobacco to
reduce the amount of nicotine in all combustible cigarettes to be
"minimally or non-addictive"
▪ 22nd Century has the first and only reduced nicotine content
combustible cigarette product authorized for sale
by the FDA
▪ Extensive research - largely funded by U.S. government agencies
- consistently confirms the benefits of a reduced nicotine
mandate for adult smokers
▪ When implemented, FDA's nicotine cap will help 5 million adult
smokers quit within one year and save more than 8 million
American lives by the end of the century²
1.https://www.wsj.com/articles/biden-administration-considering-rule-to-cut-nicotine-in-cigarettes-11618859564
2.https://www.nejm.org/doi/full/10.1056/NEJMsr1714617?query=featured home
Changing Federal Policy Priorities
▪ New administration demonstrating commitment to advancing
critical public health initiatives:
3. Center for Tobacco Products
■
• Xavier Becerra appointed head of Health and Human Services -
long-time advocate of tougher cigarette industry regulation
and reduced nicotine mandate
▪ FDA announced a decision to begin the rulemaking process to
eliminate the use of menthol in highly addictive cigarettes
• Acting FDA Commissioner Janet Woodcock has a strong history
of support for divisional autonomy, including CTP³
CHANGES IN FEDERAL POLICY MAY ACCELERATE MARKET OPPORTUNITIES FOR 22ND CENTURY
22nd Century Group, Inc.
Increasing momentum as 36 states have legalized medical use
and 16 states have legalized recreational use of marijuana
▪ House passed SAFE Act and advanced to Senate; Senate Majority
Leader Schumer (D-NY) proposing wider legalization legislation
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