12/26/2019

THE FDA TOOLS TO TACKLE THEJUUL EPIDEMIC

THE PUBLIC HEALTH LAW CENTER

1/23/2019 2

LEGAL TECHNICAL ASSISTANCE

1/23/2019 3

Legal Research

Policy Development, Implementation, Defense

Publications

Trainings

Direct Representation

Lobby

1/23/2019 4

Photo credit: Sam Bradd https://drawingchange.com/gathering-wisdom-visuals-for-a-healthy-future/

OVERVIEW

1. E-Cigarette Epidemic– No End in Sight– How Did We Get Here?– 2017 Regulatory Plan

2. Premarket Review and Enforcement Discretion

3. JUUL4. FDA Action5. State and Local Regulation

52/26/2019

E-CIGARETTE EPIDEMIC

62/26/2019

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Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18

Monthly E-Cigarette Sales (in Millions)

Market Total JUUL

E-CIGARETTE EPIDEMICNO END IN SIGHT

2/26/2019 7

Nielsen All-Channel Data

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Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18

Monthly E-Cigarette Sales (in Millions)

Market Total JUUL

E-CIGARETTE EPIDEMICNO END IN SIGHT

2/26/2019 8

Nielsen All-Channel Data

13.4%

16.0%

11.3% 11.7%

NYTS Survey Periods

20.8%

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Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18

Monthly E-Cigarette Sales (in Millions)

Market Total JUUL

E-CIGARETTE EPIDEMICNO END IN SIGHT

2/26/2019 9

Nielsen All-Channel Data

13.4%

16.0%

11.3% 11.7%

NYTS Survey Periods

20.8%

E-CIGARETTE EPIDEMICCDC’S CURRENT TOBACCO USE AMONG HIGH SCHOOL STUDENTS

2/26/2019 10

E-CIGARETTE EPIDEMICCDC’S CURRENT TOBACCO USE AMONG HIGH SCHOOL STUDENTS

2/26/2019 11

2018: 20.8%

E-CIGARETTE EPIDEMICCDC’S CURRENT TOBACCO USE AMONG HIGH SCHOOL STUDENTS

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E-CIGARETTE EPIDEMICCDC’S CURRENT TOBACCO USE AMONG HIGH SCHOOL STUDENTS

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AUTHORITY AND THE DEEMING RULEHOW DID WE GET HERE?

142/26/2019

15

Nielsen All-Channel Data

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Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18

Monthly E-Cigarette Sales (in millions)

Market Total JUUL

AUTHORITY AND THE DEEMING RULEHOW DID WE GET HERE?

2/26/2019

Deem

ing Rule

Effective Date

DEEMING RULEWHAT IS ENFORCEMENT DISCRETION?

2/26/2019 16

DEEMING RULEHOW DID WE GET HERE?

17

8/8/20198/8/2016 8/8/2018 8/8/2022

Continued marketing without application Continued marketing with application

Marketing with affirmative order

2/26/2019

2016 Final Deeming Rule (Deadlines for E-cigarettes)

“Freeze Date” Today

FDA TOBACCO & NICOTINE REGULATORY PLAN

182/26/2019

FDA TOBACCO & NICOTINE REGULATORY PLAN

19

2017 Regulatory Plan (Deadlines for E-cigarettes)

8/8/2016 8/8/20228/8/20198/8/2018

8/8/20198/8/2016 8/8/2018 8/8/2022

Continued marketing without application Continued marketing with application

Marketing with affirmative order

2/26/2019

“Freeze Date” Today

2016 Final Deeming Rule (Deadlines for E-cigarettes)

JUUL

202/26/2019

JUUL

2/26/2019 21

8/8/2016 8/8/20228/8/20198/8/2018

Continued marketing without application Continued marketing with application

Marketing with affirmative order

“Freeze Date”

2017 Regulatory Plan (Deadlines for E-cigarettes)

JUUL

2/26/2019 22

8/8/2016 8/8/20228/8/20198/8/2018

“Freeze Date”

6/1/2015JUUL enters the market

Continued marketing without application Continued marketing with application

Marketing with affirmative order

2017 Regulatory Plan (Deadlines for E-cigarettes)

JUUL

2/26/2019 23

8/8/2016 8/8/20228/8/20198/8/20186/1/2015JUUL enters the market 11/2018

Reynolds releases Vuse Alto

2/2018 ITGreleases myBlu

Continued marketing without application Continued marketing with application

Marketing with affirmative order

2017 Regulatory Plan (Deadlines for E-cigarettes)

“Freeze Date”

FDA Action Date

Public Hearing on Cessation Strategies for Youth January 26, 2018

Nicotine Reduction Information Gathering March 16, 2018

Flavored Products Information Gathering March 21, 2018

JUUL Collection of Information April 8, 2018

E-liquid Warning Letters about Specific Flavors May 1, 2018

JUUL “Blitz” September 12, 2018

FDA raids JUUL HQ October 2, 2018

242/26/2019

FDA RESPONSE

FDA Action Date

Public Hearing on Cessation Strategies for Youth January 26, 2018

Nicotine Reduction Information Gathering March 16, 2018

Flavored Products Information Gathering March 21, 2018

JUUL Collection of Information April 8, 2018

E-liquid Warning Letters about Specific Flavors May 1, 2018

JUUL “Blitz” September 12, 2018

FDA raids JUUL HQ October 2, 2018

Announcement of FDA’s Intentions November 15, 2015

252/26/2019

FDA RESPONSE

ENFORCEMENT DISCRETION

2/26/2019 26

Oh, you actually thought letting me stayup way past my usual bedtime wouldmake me sleep later in the morning?Welcome to 5:48 am . . .

ENFORCEMENT DISCRETION

2/26/2019 27

• Flavored products• Adult-only facilities• Internet sales• Nicotine salts• Limit nicotine content

to the user

STATE AND LOCAL REGULATION

282/26/2019

CONTACT THE FDA TEAM

651.290.7612

Desmond.jenson@mitchellhamline.edu

www.publichealthlawcenter.org

@DesmondJenson

facebook.com/publichealthlawcenter

292/26/2019

651.290.7666

Natalie.Hemmerich@mitchellhamline.edu

www.publichealthlawcenter.org

@publichealthlawcenter

facebook.com/publichealthlawcenter

302/26/2019

CONTACT THE FDA TEAM

651.290.7612

Desmond.jenson@mitchellhamline.edu

www.publichealthlawcenter.org

@DesmondJenson

facebook.com/publichealthlawcenter

312/26/2019

651.290.7666

Natalie.Hemmerich@mitchellhamline.edu

www.publichealthlawcenter.org

@publichealthlawcenter

facebook.com/publichealthlawcenter