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F EDERAL T OBACCO 21 AND THE FDA F LAVOR G UIDANCE 1/22/2020 1 THE PUBLIC HEALTH LAW CENTER 1/22/2020 2 1/22/2020 3 LEGAL TECHNICAL ASSISTANCE Legal Research Policy Development, Implementation, Defense Publications Trainings Direct

  1. F EDERAL T OBACCO 21 AND THE FDA F LAVOR G UIDANCE 1/22/2020 1

  2. THE PUBLIC HEALTH LAW CENTER 1/22/2020 2

  3. 1/22/2020 3

  4. LEGAL TECHNICAL ASSISTANCE Legal Research Policy Development, Implementation, Defense Publications Trainings Direct Representation Lobby 1/22/2020 4

  5. RESOURCES 1/22/2020 5

  6. AGENDA • Youth E-Cigarette Epidemic • FDA Regulation of Tobacco –Premarket Review –Regulation of Flavors • Federal Tobacco 21 • Q&A 1/22/2020 6

  7. YOUTH E-CIGARETTE EPIDEMIC Gentzke et al., Vital Signs: Tobacco Product Use Among Middle and High School Students – United States, 2011-2018, 68 M ORBIDITY AND M ORTALITY W KLY R EP 157 (2019) 1/22/2020 7

  8. YOUTH E-CIGARETTE EPIDEMIC Gentzke et al., Vital Signs: Tobacco Product Use Among Middle and High School Students – United States, 2011-2018, 68 M ORBIDITY AND M ORTALITY W KLY R EP 157 (2019) 1/22/2020 8

  9. YOUTH E-CIGARETTE EPIDEMIC High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) 40% 40% 34.8% 35% 35% 31.2% 28.5% 30% 30% 27.5% 25% 25% 19.6% 20% 20% 15.3% 15% 15% 10% 10% 7.6% 5.8% 5% 5% 1.5% 0% 0% Any Tobacco Prdouct Any Tobacco Prdouct Cigarettes Cigarettes Cigars Cigars E-cigarettes E-cigarettes 1/22/2020 9

  10. YOUTH E-CIGARETTE EPIDEMIC High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) 40% 40% 35% 35% 28.5% 30% 30% 25% 25% 20% 20% 15% 15% 10% 10% 5.8% 5% 5% 0% 0% Any Tobacco Prdouct Any Tobacco Prdouct Cigarettes Cigarettes Cigars Cigars E-cigarettes E-cigarettes 1/22/2020 10

  11. YOUTH E-CIGARETTE EPIDEMIC High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) 40% 40% 35% 35% 30% 30% 25% 25% 20% 20% 15.3% 15% 15% 10% 10% 7.6% 5.8% 5% 5% 0% 0% Any Tobacco Prdouct Any Tobacco Prdouct Cigarettes Cigarettes Cigars Cigars E-cigarettes E-cigarettes 1/22/2020 11

  12. YOUTH E-CIGARETTE EPIDEMIC High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) 40% 40% 35% 35% 30% 30% 27.5% 25% 25% 20% 20% 15% 15% 10% 10% 5% 5% 1.5% 0% 0% Any Tobacco Prdouct Any Tobacco Prdouct Cigarettes Cigarettes Cigars Cigars E-cigarettes E-cigarettes 1/22/2020 12

  13. YOUTH E-CIGARETTE EPIDEMIC High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019) 40% 40% 34.8% 35% 35% 31.2% 28.5% 30% 30% 27.5% 25% 25% 19.6% 20% 20% 15.3% 15% 15% 10% 10% 7.6% 5.8% 5% 5% 1.5% 0% 0% Any Tobacco Prdouct Any Tobacco Prdouct Cigarettes Cigarettes Cigars Cigars E-cigarettes E-cigarettes 1/22/2020 13

  14. YOUTH E-CIGARETTE EPIDEMIC Monthly E-Cigarette Sales (in Millions) $450.00 $400.00 $350.00 $300.00 $250.00 $200.00 $150.00 $100.00 $50.00 $- 3 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - v r y l p v r y l p v r y l p v r y l p v r y l p v r y l p n n n n n n a u a u a u a u a u a u o a o a o a o a o a o a a e a e a e a e a e a e J J J J J J N M M N M M N M M N M M N M M N M M J S J S J S J S J S J S Market Total 1/22/2020 14

  15. YOUTH E-CIGARETTE EPIDEMIC Monthly E-Cigarette Sales (in Millions) $450.00 $400.00 $350.00 $300.00 $250.00 $200.00 $150.00 $100.00 $50.00 $- 3 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - v r y l p v r y l p v r y l p v r y l p v r y l p v r y l p n n n n n n a u a u a u a u a u a u o a o a o a o a o a o a a e a e a e a e a e a e J J J J J J N M M N M M N M M N M M N M M N M M J S J S J S J S J S J S Market Total 1/22/2020 15

  16. YOUTH E-CIGARETTE EPIDEMIC Monthly E-Cigarette Sales (in Millions) $450.00 $400.00 $350.00 $300.00 $250.00 $200.00 $150.00 $100.00 $50.00 $- 3 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - v r y l p v r y l p v r y l p v r y l p v r y l p v r y l p n n n n n n a u a u a u a u a u a u o a o a o a o a o a o a a e a e a e a e a e a e J J J J J J N M M N M M N M M N M M N M M N M M J S J S J S J S J S J S Market Total JUUL 1/22/2020 16

  17. YOUTH E-CIGARETTE EPIDEMIC Monthly E-Cigarette Sales (in Millions) $450.00 $400.00 $350.00 $300.00 $250.00 $200.00 $150.00 $100.00 $50.00 $- 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - r y l p v r y l p v r y l p v r y l p v r y l p n n n n a u a u a u a u a u a o a o a o a o a e a e a e a e a e J J J J J M M N M M N M M N M M N M M S J S J S J S J S Market Total JUUL Reynolds/BAT Altria Imperial/Fontem/Lorillard Logic/JTI NJOY 1/22/2020 17

  18. YOUTH E-CIGARETTE EPIDEMIC Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates) $450.00 7,000,000 $400.00 6,000,000 $350.00 $300.00 5,000,000 $250.00 4,000,000 $200.00 3,000,000 $150.00 2,000,000 $100.00 1,000,000 $50.00 $- 0 3 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - v r y l p v r y l p v r y l p v r y l p v r y l p v r y l p n n n n n n a u a u a u a u a u a u o a o a o a o a o a o a a e a e a e a e a e a e J J J J J J N M M N M M N M M N M M N M M N M M J S J S J S J S J S J S Market Total JUUL Middle School Users High School Users 1/22/2020 18

  19. YOUTH E-CIGARETTE EPIDEMIC Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates) $450.00 7,000,000 $400.00 6,000,000 $350.00 $300.00 5,000,000 $250.00 4,000,000 $200.00 3,000,000 $150.00 2,000,000 $100.00 1,000,000 $50.00 $- 0 3 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - v r y l p v r y l p v r y l p v r y l p v r y l p v r y l p n n n n n n a u a u a u a u a u a u o a o a o a o a o a o a a e a e a e a e a e a e J J J J J J N M M N M M N M M N M M N M M N M M J S J S J S J S J S J S Market Total JUUL <18 Year-old Users 1/22/2020 19

  20. YOUTH E-CIGARETTE EPIDEMIC Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates) $450.00 7,000,000 $400.00 6,000,000 $350.00 $300.00 5,000,000 $250.00 4,000,000 $200.00 3,000,000 $150.00 2,000,000 $100.00 1,000,000 $50.00 $- 0 3 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - v r y l p v r y l p v r y l p v r y l p v r y l p v r y l p n n n n n n a u a u a u a u a u a u o a o a o a o a o a o a a e a e a e a e a e a e J J J J J J N M M N M M N M M N M M N M M N M M J S J S J S J S J S J S Market Total JUUL <18 Year-old Users 18-24 Year-old Users 25-44 Year-old Users 45-64 Year-old Users 65+ Year-Old Users 1/22/2020 20

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