T FDA TOOLS TO TACKLE THE JUUL EPIDEMIC · 1. E-Cigarette Epidemic – No End in Sight – How Did...
Transcript of T FDA TOOLS TO TACKLE THE JUUL EPIDEMIC · 1. E-Cigarette Epidemic – No End in Sight – How Did...
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
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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
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E-CIGARETTE EPIDEMIC
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$50.00
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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
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Nielsen All-Channel Data
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$100.00
$150.00
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$250.00
$300.00
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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
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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
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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
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E-CIGARETTE EPIDEMICCDC’S CURRENT TOBACCO USE AMONG HIGH SCHOOL STUDENTS
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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?
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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?
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Deem
ing Rule
Effective Date
DEEMING RULEWHAT IS ENFORCEMENT DISCRETION?
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DEEMING RULEHOW DID WE GET HERE?
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8/8/20198/8/2016 8/8/2018 8/8/2022
Continued marketing without application Continued marketing with application
Marketing with affirmative order
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2016 Final Deeming Rule (Deadlines for E-cigarettes)
“Freeze Date” Today
FDA TOBACCO & NICOTINE REGULATORY PLAN
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FDA TOBACCO & NICOTINE REGULATORY PLAN
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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
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“Freeze Date” Today
2016 Final Deeming Rule (Deadlines for E-cigarettes)
JUUL
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JUUL
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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
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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
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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
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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
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FDA RESPONSE
ENFORCEMENT DISCRETION
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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
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• Flavored products• Adult-only facilities• Internet sales• Nicotine salts• Limit nicotine content
to the user
STATE AND LOCAL REGULATION
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CONTACT THE FDA TEAM
651.290.7612
www.publichealthlawcenter.org
@DesmondJenson
facebook.com/publichealthlawcenter
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651.290.7666
www.publichealthlawcenter.org
@publichealthlawcenter
facebook.com/publichealthlawcenter
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CONTACT THE FDA TEAM
651.290.7612
www.publichealthlawcenter.org
@DesmondJenson
facebook.com/publichealthlawcenter
312/26/2019
651.290.7666
www.publichealthlawcenter.org
@publichealthlawcenter
facebook.com/publichealthlawcenter