[PPT] - THE PUBLIC HEALTH LAW CENTER 1/22/2020 2 1/22/2020 3 LEGAL PowerPoint Presentation

SLIDE 1

1 1/22/2020

FEDERAL TOBACCO 21 AND THE FDA FLAVOR GUIDANCE

SLIDE 2

THE PUBLIC HEALTH LAW CENTER

1/22/2020 2

SLIDE 3

1/22/2020 3

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LEGAL TECHNICAL ASSISTANCE

1/22/2020 4

Legal Research Policy Development, Implementation, Defense Publications Trainings Direct Representation Lobby

SLIDE 5

RESOURCES

1/22/2020 5

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AGENDA

1/22/2020 6

Youth E-Cigarette Epidemic
FDA Regulation of Tobacco

–Premarket Review –Regulation of Flavors

Federal Tobacco 21
Q&A

SLIDE 7

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 7

Gentzke et al., Vital Signs: Tobacco Product Use Among Middle and High School Students – United States, 2011-2018, 68 MORBIDITY AND MORTALITY WKLY REP 157 (2019)

SLIDE 8

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 8

Gentzke et al., Vital Signs: Tobacco Product Use Among Middle and High School Students – United States, 2011-2018, 68 MORBIDITY AND MORTALITY WKLY REP 157 (2019)

SLIDE 9

0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 9

34.8% 31.2% 28.5% 5.8% 15.3% 7.6% 1.5% 27.5% 19.6%

SLIDE 10

0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 10

28.5% 5.8%

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0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 11

5.8% 15.3% 7.6%

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0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 12

1.5% 27.5%

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0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 13

34.8% 31.2% 28.5% 5.8% 15.3% 7.6% 1.5% 27.5% 19.6%

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 14

$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions)

Market Total

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 15

$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions)

Market Total

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 16

$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions)

Market Total JUUL

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$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 M a r

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Monthly E-Cigarette Sales (in Millions)

Market Total JUUL Reynolds/BAT Altria Imperial/Fontem/Lorillard Logic/JTI NJOY

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 17

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 18

1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000 $- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates)

Market Total JUUL Middle School Users High School Users

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 19

1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000 $- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates)

Market Total JUUL <18 Year-old Users

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 20

1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000 $- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates)

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

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 21

1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000 $- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates)

Market Total JUUL <18 Year-old Users 18-24 Year-old Users 25+

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 22

1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000 $- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates)

Market Total JUUL Youth and Young Adults 25+

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 23

50,000,000

100,000,000 150,000,000 200,000,000 250,000,000 Youth and Young Adults 25+

E-Cigarette Users and Non-Users by Age Group

Users Non-users

SLIDE 24

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 24

50,000,000

100,000,000 150,000,000 200,000,000 250,000,000 Youth and Young Adults 25+

E-Cigarette Users and Non-Users by Age Group

Users Non-users

7.3% 2.6%

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 25

1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000 $- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates)

Market Total JUUL Youth and Young Adults 25+

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YOUTH E-CIGARETTE EPIDEMIC

1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000 $- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates)

Market Total JUUL Youth and Young Adults 25+ 25+ Linear (25+)

1/22/2020 26

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YOUTH E-CIGARETTE EPIDEMIC

1,000,000 2,000,000 3,000,000 4,000,000 5,000,000 6,000,000 7,000,000 $- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions) + Usage by Age Group (Population Estimates)

Market Total JUUL <25 25+ 25+ Linear (25+)

1/22/2020 27

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YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 28

$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

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Monthly E-Cigarette Sales (in Millions)

Market Total JUUL

Deeming rule takes effect (FDA begins regulating JUUL) Pax Labs introduces Juul into U.S. Markets FDA announces new regulatory plan for tobacco products and delays premarket review deadlines JUUL vows to stop using models on social media FDA raids JUUL’s HQ Altria buys a 35% stake in JUUL Juul discontinues some flavors in convenience stores FDA requests marketing documents from JUUL FDA sends Juul a warning letter for unauthorized MRTP Claims First lung injuries reported

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AGENDA

1/22/2020 29

Youth E-Cigarette Epidemic
FDA Regulation of Tobacco

–Premarket Review –Regulation of Flavors

Federal Tobacco 21
Q&A

SLIDE 30

1/22/2020 30

FDA Regulation Enforcement Date Minimum sales age of 18 (age verification under 27) August 8, 2016 Prohibition on vending machines in facilities where youth may enter August 8, 2016 Prohibition on free samples August 8, 2016 Manufacturer registration and submission of product lists October 30, 2017 Submission of ingredient lists May 8, 2018 Warning labels required on packages and advertisements August 10, 2018

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FDA REGULATION

1/22/2020 31

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No “new tobacco product” can be sold without marketing authorization

from the FDA. – “new tobacco product” first sold after 2/15/07 – “grandfathered product” available for sale on 2/15/07

All currently marketed e-cigarettes are “new tobacco products.” (not

sold on 2/15/07)

All e-cigarettes require marketing authorization from the FDA in order

to be sold.

FDA REGULATION

1/22/2020 32

SLIDE 33

In 2009, FDA was given authority to regulate cigarettes, smokeless

tobacco, RYO & cigarette tobacco.

For all other tobacco products, FDA must “deem” them (with a

rulemaking).

The FDA cannot accept marketing applications for e-cigarettes until

they have been deemed.

FDA REGULATION

1/22/2020 33

SLIDE 34

Once the FDA has regulatory authority, all e-cigarettes require

affirmative marketing authorization from the FDA before they can be sold.

The FDA cannot accept marketing applications for e-cigarettes until

they have regulatory authority.

FDA REGULATION

1/22/2020 34

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Marketing with affirmative order

FDA REGULATION

1/22/2020 35

Continued marketing without application

2016 Final Deeming Rule (Deadlines for E-cigarettes)

8/8/2018 8/8/2022 8/8/2019 Continued marketing with application

Today

8/8/2016

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FDA REGULATION

1/22/2020 36

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Marketing with affirmative order

FDA REGULATION

1/22/2020 37

Continued marketing without application

2016 Final Deeming Rule (Deadlines for E-cigarettes) 2017 Regulatory Plan (Deadlines for E-cigarettes)

8/8/2022 8/8/2018 8/8/2018 8/8/2022 8/8/2019 8/8/2019 Continued marketing with application

Today

8/8/2016 8/8/2016

SLIDE 38

FDA REGULATION

1/22/2020 38

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Marketing with affirmative order

FDA REGULATION

1/22/2020 39

Continued marketing without application

2016 Final Deeming Rule (Deadlines for E-cigarettes) 2017 Regulatory Plan (Deadlines for E-cigarettes) 2019 Judicial Order from AAP v. FDA (Deadlines for E-cigarettes)

8/8/2022 8/8/2018 8/8/2018 8/8/2022 5/12/2021 8/8/2016 5/12/2020 8/8/2022 8/8/2019 8/8/2019 Continued marketing with application

Today

8/8/2016 8/8/2016

SLIDE 40

AGENDA

1/22/2020 40

Youth E-Cigarette Epidemic
FDA Regulation of Tobacco

–Premarket Review –Regulation of Flavors

Federal Tobacco 21
Q&A

SLIDE 41

Draft Guidance – 3/8/19
Comment Period Ends – 4/30/19
White House Announcement – 9/11/19
Final Guidance to OMB – 10/25/19
Final Guidance Clears OMB – 11/4/19
White House Meeting – 11/22/19
Final Guidance Published – 1/7/20

FDA REGULATION

1/22/2020 41

SLIDE 42

FDA REGULATION

1/22/2020 42

Tobacco, Mint & Menthol

Fewer Restrictions

Other Flavors

More Restrictions

SLIDE 43

FDA REGULATION

1/22/2020 43

Tobacco, Mint & Menthol

Allowed to remain on

the market Other Flavors

Removed from the

market (temporarily) Cartridge-based E-Cigarettes

SLIDE 44

FDA REGULATION

1/22/2020 44

Tobacco, Mint & Menthol

Allowed to remain on

the market Other Flavors

Removed from the

market (temporarily) Cartridge-based E-Cigarettes

SLIDE 45

FDA REGULATION

1/22/2020 45

0% 10% 20% 30% 40% 50% 60% 70% 80% 2016 2017 2018 2019

High School E-Cigarette Flavor Preference

Fruit Menthol or Mint Candy Alcoholic drink Chocolate Clove/spice Other flavor

Cullen et al., E-Cigarette Use Among Youth in the United States, 2019, 322 JAMA 2095 (2019)

SLIDE 46

FDA REGULATION

1/22/2020 46

0% 10% 20% 30% 40% 50% 60% 70% 80% 2016 2017 2018 2019

High School E-Cigarette Flavor Preference (NYTS)

Fruit Menthol or Mint Candy Alcoholic drink Chocolate Clove/spice Other flavor 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% 8th Grade 10th Grade 12th Grade

Flavor Used Most Often by Grade Level (MTF)

Mint Menthol Cucumber Fruit Mango Other

Cullen et al., E-Cigarette Use Among Youth in the United States, 2019, 322 JAMA 2095 (2019) Leventhal et al., Flavors of E-Cigarettes Used by Youths in the United States, 2019, 322 JAMA 2132 (2019)

SLIDE 47

$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

v
1

3 J a n

1

4 M a r

1

4 M a y

1

4 J u l

1

4 S e p

1

4 N

v
1

4 J a n

1

5 M a r

1

5 M a y

1

5 J u l

1

5 S e p

1

5 N

v
1

5 J a n

1

6 M a r

1

6 M a y

1

6 J u l

1

6 S e p

1

6 N

v
1

6 J a n

1

7 M a r

1

7 M a y

1

7 J u l

1

7 S e p

1

7 N

v
1

7 J a n

1

8 M a r

1

8 M a y

1

8 J u l

1

8 S e p

1

8 N

v
1

8 J a n

1

9 M a r

1

9 M a y

1

9 J u l

1

9 S e p

1

9

Monthly E-Cigarette Sales (in Millions)

Market Total JUUL

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 47

Retail & Juul’s Website

Classic Tobacco Mint Menthol Virginia Tobacco Crème Cucumber Fruit Mango

SLIDE 48

$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

v
1

3 J a n

1

4 M a r

1

4 M a y

1

4 J u l

1

4 S e p

1

4 N

v
1

4 J a n

1

5 M a r

1

5 M a y

1

5 J u l

1

5 S e p

1

5 N

v
1

5 J a n

1

6 M a r

1

6 M a y

1

6 J u l

1

6 S e p

1

6 N

v
1

6 J a n

1

7 M a r

1

7 M a y

1

7 J u l

1

7 S e p

1

7 N

v
1

7 J a n

1

8 M a r

1

8 M a y

1

8 J u l

1

8 S e p

1

8 N

v
1

8 J a n

1

9 M a r

1

9 M a y

1

9 J u l

1

9 S e p

1

9

Monthly E-Cigarette Sales (in Millions)

Market Total JUUL

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 48

Retail & Juul’s Website

Classic Tobacco Mint Menthol Virginia Tobacco

Juul’s Website Only

Crème Cucumber Fruit Mango

SLIDE 49

$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 $400.00 $450.00 N

v
1

3 J a n

1

4 M a r

1

4 M a y

1

4 J u l

1

4 S e p

1

4 N

v
1

4 J a n

1

5 M a r

1

5 M a y

1

5 J u l

1

5 S e p

1

5 N

v
1

5 J a n

1

6 M a r

1

6 M a y

1

6 J u l

1

6 S e p

1

6 N

v
1

6 J a n

1

7 M a r

1

7 M a y

1

7 J u l

1

7 S e p

1

7 N

v
1

7 J a n

1

8 M a r

1

8 M a y

1

8 J u l

1

8 S e p

1

8 N

v
1

8 J a n

1

9 M a r

1

9 M a y

1

9 J u l

1

9 S e p

1

9

Monthly E-Cigarette Sales (in Millions)

Market Total JUUL

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 49

Retail & Juul’s Website

Classic Tobacco Mint Menthol Virginia Tobacco

Juul’s Website Only

Crème Cucumber Fruit Mango

NYTS & MTF

SLIDE 50

FDA REGULATION

1/22/2020 50

0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 8th Grade 10th Grade 12th Grade

Flavor Most Often Used (Youths Using Juul <20 Days)

Classic Tobacco Mint Menthol Virginia Tobacco Crème Cucumber Fruit Mango Other 0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 8th Grade 10th Grade 12th Grade

Flavor Most Often Used (Youths Using Juul ≥20 Days)

Classic Tobacco Mint Menthol Virginia Tobacco Crème Cucumber Fruit Mango Other

Leventhal et al., Flavors of E-Cigarettes Used by Youths in the United States, 2019, 322 JAMA 2132 (2019)

SLIDE 51

FDA REGULATION

1/22/2020 51

0% 10% 20% 30% 40% 50% 60% 70% 8th Grade 10th Grade 12th Grade

Flavors Most Often Used (Youths Using Juul <20 Days)

Classic Tobacco, Mint, Menthol & Virginia Tobacco Crème, Cucumber, Fruit, Mango 0% 10% 20% 30% 40% 50% 60% 70% 8th Grade 10th Grade 12th Grade

Flavors Most Often Used (Youths Using Juul ≥20 Days)

Classic Tobacco, Mint, Menthol & Virginia Tobacco Crème, Cucumber, Fruit, Mango

Leventhal et al., Flavors of E-Cigarettes Used by Youths in the United States, 2019, 322 JAMA 2132 (2019)

SLIDE 52

FDA REGULATION

1/22/2020 52 The picture can't be displayed. The picture can't be displayed.

SLIDE 53

FDA REGULATION

1/22/2020 53 The picture can't be displayed. The picture can't be displayed.

FRESH MENTHOL

SLIDE 54

FDA REGULATION

1/22/2020 54

SLIDE 55

FDA REGULATION

1/22/2020 55

Tobacco, Mint & Menthol

Allowed to remain on

the market Other Flavors

Removed from the

market (temporarily) Cartridge-based E-Cigarettes

SLIDE 56

FDA REGULATION

1/22/2020 56

ENDS – “deliver aerosolized e-liquid when

inhaled”

SLIDE 57

FDA REGULATION

1/22/2020 57

ENDS – “deliver aerosolized e-liquid when

inhaled”

Cartridge-based ENDS – “type of ENDS”

“involves a cartridge or pod that holds liquid that is to be aerosolized”

SLIDE 58

FDA REGULATION

1/22/2020 58

ENDS – “deliver aerosolized e-liquid when

inhaled”

Cartridge-based ENDS – “type of ENDS”

“involves a cartridge or pod that holds liquid that is to be aerosolized”

Cartridge or pod – “designed to fit within or
perate as part of an ENDS”

SLIDE 59

FDA REGULATION

1/22/2020 59

Exempt from Final Guidance:

– Tank/Mod systems

SLIDE 60

FDA REGULATION

1/22/2020 60

Exempt from Final Guidance:

– Tank/Mod systems – Disposables

SLIDE 61

FDA REGULATION

1/22/2020 61

SLIDE 62

FDA REGULATION

1/22/2020 62

SLIDE 63

0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

0% 5% 10% 15% 20% 25% 30% 35% 40% Any Tobacco Prdouct Cigarettes Cigars E-cigarettes

High School Tobacco Product Usage Rates (NYTS 1999, 2000, 2002, 2004, 2006, 2009, 2011-2019)

YOUTH E-CIGARETTE EPIDEMIC

1/22/2020 63

5.8% 15.3% 7.6%

SLIDE 64

FDA REGULATION

1/22/2020 64

Flavored (other than Tobacco and Menthol) Cartridge-based E-Cigarettes

8/8/2016 5/12/2021 5/12/2020 8/8/2022 Marketing with affirmative order Continued marketing without application Continued marketing with application

Today

8/8/2016 8/8/2022

All Other E-Cigarettes, Cigars, Waterpipe Tobacco & Pipe Tobacco

2/6/2020

SLIDE 65

AGENDA

1/22/2020 65

Youth E-Cigarette Epidemic
FDA Regulation of Tobacco

–Premarket Review –Regulation of Flavors

Federal Tobacco 21
Q&A

SLIDE 66

1/22/2020 66

12/20/19 – Bill Signed/Law Effective
6/17/20 – Final Rule Due
9/15/20 – Latest Possible Effective

Date

FEDERAL T21

SLIDE 67

1/22/2020 67

12/20/19 – Bill Signed/Law Effective
6/17/20 – Final Rule Due
9/15/20 – Latest Possible

Effective Date

FEDERAL T21

SLIDE 68

FEDERAL T21

1/22/2020 68

SLIDE 69

FEDERAL T21

1/22/2020 69

Scenario: Retailer sells tobacco product to a 22-year-

ld

Outcome: . . . . Federal Law = Not Violated State Law = Not Violated

Background: Federal MLSA = 21, State MLSA = 18

Scenario: Retailer sells tobacco product to a 17-year-

ld

Outcome: . . . . Federal Law = Violated State Law = Violated

SLIDE 70

FEDERAL T21

1/22/2020 70

Scenario: Retailer sells tobacco product to a 20-year-

ld

: . . . .

Background: Federal MLSA = 21, State MLSA = 18

SLIDE 71

FEDERAL T21

1/22/2020 71

Scenario: Retailer sells tobacco product to a 20-year-

ld

Outcome: . . . .

Background: Federal MLSA = 21, State MLSA = 18

Federal Law = Violated State Law = Not Violated

SLIDE 72

FEDERAL T21

1/22/2020 72

Scenario: Retailer sells tobacco product to a 20-year-

ld

Outcome: . . . .

Background: Federal MLSA = 21, State MLSA = 18

Federal Law = Violated State Law = Not Violated

Background: Federal MLSA = 21, State MLSA = 21 with military exemption

Scenario: Retailer sells tobacco product to a 20-year-

ld with military ID

Outcome: . . . . Federal Law = Violated State Law = Not Violated

SLIDE 73

1/22/2020 73

Governments can

raise the MLSA to 21

Easier for those trying

to comply

Easier for those trying

to enforce

No need to wait

FEDERAL T21

SLIDE 74

State preemption of T21 local
rdinances

– Careful evaluation – May open conversation to eliminating preemption

Tribal Communities

1/22/2020 74

FEDERAL T21

Photo credit: Canli Coalition, exhibit for CDC

SLIDE 75

1/22/2020 75

FEDERAL T21

Penalties

– Same as before – Change in age for decoy buyer

FDA’s current fee schedule

available on website

SLIDE 76

1/22/2020 76

FEDERAL T21

SLIDE 77

1/22/2020 77

FEDERAL T21

https://www.fda.gov/tobacco-products/compliance- enforcement-training/report-potential-tobacco- product-violation

SLIDE 78

AGENDA

1/22/2020 78

Youth E-Cigarette Epidemic
FDA Regulation of Tobacco

–Premarket Review –Regulation of Flavors

Federal Tobacco 21
Q&A

SLIDE 79

CONTACT US

1/22/2020 79