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THE PUBLIC HEALTH LAW CENTER
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THE PUBLIC HEALTH LAW CENTER 1/23/2019 2 LEGAL TECHNICAL - - PowerPoint PPT Presentation
THE PUBLIC HEALTH LAW CENTER 1/23/2019 2 LEGAL TECHNICAL - - PowerPoint PPT Presentation
U NANSWERED Q UESTIONS ABOUT THE FDA S JUUL E NFORCEMENT B LITZ 1/23/2019 1 THE PUBLIC HEALTH LAW CENTER 1/23/2019 2 LEGAL TECHNICAL ASSISTANCE Legal Research Policy Development, Implementation, Defense Publications Trainings Direct
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LEGAL TECHNICAL ASSISTANCE
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Legal Research Policy Development, Implementation, Defense Publications Trainings Direct Representation Lobby
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Photo credit: Sam Bradd https:/ / drawingchange.com/ gathering-wisdom-visuals-for-a-healthy-future/
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AGENDA
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- The Rise of JUUL
- Background on FDA Retail
Enforcement
- The FDA’s Enforcement Blitz
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THE RISE OF JUUL
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THE RISE OF JUUL
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0% 10% 20% 30% 40% 50% 60% 70% 80% 90% Mar-15 Sep-15 Mar-16 Sep-16 Mar-17 Sep-17 Mar-18 Sep-18
E-Cigarette Market Share
JUUL Reynolds/BAT Altria Imperial/Fontem/Lorillard Logic/JTI NJOY
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THE RISE OF JUUL
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Nielsen All-Channel Data
$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 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
Market Total JUUL
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THE RISE OF JUUL
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Nielsen All-Channel Data
$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 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
Market Total JUUL
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THE RISE OF JUUL
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Nielsen All-Channel Data
$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18
Monthly E-Cigarette Sales
Market Total JUUL
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THE RISE OF JUUL
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$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 Mar-15 Sep-15 Mar-16 Sep-16 Mar-17 Sep-17 Mar-18 Sep-18
Monthly E-Cigarette Sales
Market Total JUUL Reynolds/BAT Altria Imperial/Fontem/Lorillard Logic/JTI NJOY
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FDA ACTION ENFORCEMENT BLITZ
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FDA RETAIL ENFORCEMENT REQUIREMENTS FOR RETAILERS
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Cigarettes Smokeless Tobacco Cigars E-Cigarettes & Others
Minimum legal sales of 18 and age verification under 27
✔ ✔ ✔ ✔
Prohibition on vending machine sales Allowed in adult-only facilities Allowed in adult-only facilities Allowed in adult-only facilities Allowed in adult-only facilities Prohibition on self- service displays Allowed in adult-only facilities Allowed in adult-only facilities Minimum package requirements
✔
Prohibition on breaking packages by retailers
✔ ✔
Prohibition on free samples
✔
Allowed in qualified adult-only facility
✔ ✔
Prohibition on characterizing flavors Menthol and tobacco allowed
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FDA RETAIL ENFORCEMENT THE FEDERAL FISCAL YEAR
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September 30, 2018 October 1, 2017 Fiscal Year
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FDA RETAIL ENFORCEMENT ENFORCEMENT CONTRACTS
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https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Retail/ucm228914.htm
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FDA RETAIL ENFORCEMENT RETAIL INSPECTIONS
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https://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM548353.pdf
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FDA RETAIL ENFORCEMENT REPEATED VIOLATIONS
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Number of Violations Timeframe Possible Enforcement Actions 1 Warning Letter 2 Within 12 months $285 penalty 3 Within 24 months $570 penalty 4 Within 24 months $2,282 penalty 5 Within 36 months $5,705 penalty 6 Within 48 months $11,410 penalty
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FDA RETAIL ENFORCEMENT DATA SOURCES
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https://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm
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FDA RETAIL ENFORCEMENT DATA SOURCES
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https://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm
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FDA RETAIL ENFORCEMENT DATA SOURCES
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https://www.fda.gov/AboutFDA/Transparency/track/default.htm
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FDA ENFORCEMENT BLITZ DATA SOURCES
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FDA ENFORCEMENT BLITZ BLITZ TIMING
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Month Warning Letter Fines Total April 2018 43 3 46 May 2018 13 1 14 June 2018 59 11 70 July 2018 418 61 479 August 2018 616 59 675 September 2018 76 2 78 Total 1,225 137 1,362
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FDA ENFORCEMENT BLITZ INSPECTIONS DECREASE
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20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000 200,000 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 FY 2018
Retail Inspections by Fiscal Year
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FDA ENFORCEMENT BLITZ INSPECTIONS DECREASE
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FDA ENFORCEMENT BLITZ INSPECTIONS DECREASE
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8,000 9,000 10,000 11,000 12,000 13,000 14,000 15,000 16,000
Retail Inspections by Month
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1000 2000 3000 4000 5000 6000 7000
Cumulative Fines (All Products)
2017 2018
FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE
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2000 4000 6000 8000 10000 12000 14000 16000
Cumulative Warning Letters (All Products)
2017 2018
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- 500
1,000 1,500 2,000 2,500 3,000 3,500
Cumulative Warning Letters (E-Cigarettes)
2017 2018
- 50
100 150 200 250 300 350 400 450 500
Cumulative Fines (E-Cigarettes)
2017 2018
FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE
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FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE
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E-Cigarettes Cigars Cigarettes Smokeless October
- 385
40 November
- 388
21 December
- 373
32 January
- 390
51 February
- 509
49 March
- 609
60 April 1 5 509 64 May 2 4 578 66 June 7 9 564 65 July 130 216 134 14 August 75 162 312 33 September 73 129 256 29
FY 2017 M onthly Fines by Product
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- 500
1,000 1,500 2,000 2,500 3,000 3,500
Cumulative Warning Letters (E-Cigarettes)
2017 2018
- 50
100 150 200 250 300 350 400 450 500
Cumulative Fines (E-Cigarettes)
2017 2018
FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE
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893
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- 500
1,000 1,500 2,000 2,500 3,000 3,500
Cumulative Warning Letters (E-Cigarettes)
2017 2018
- 50
100 150 200 250 300 350 400 450 500
Cumulative Fines (E-Cigarettes)
2017 2018
FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE
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- 100
200 300 400 500 600 700 800 October November December January February March April May June July August September
Monthly E-Cigarette Warning Letters
Warning Letters (2017) Warning Letters (2018)
FDA ENFORCEMENT BLITZ E-CIGARETTE WARNING LETTERS
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FDA ENFORCEMENT BLITZ ENFORCEMENT SPEED
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FY 2017 Cigarettes Smokeless Cigars E-Cigarettes October 34.46 34.27 43.10 42.80 November 23.08 26.59 42.43 42.21 December 19.63 18.18 35.05 38.11 January 18.35 15.23 32.46 32.00 February 23.56 20.96 15.39 14.36 March 25.34 21.45 15.97 15.16 April 21.38 23.09 25.27 28.40 May 29.49 19.60 44.65 55.82 June 30.84 24.60 35.78 27.09 July 38.58 33.18 41.03 41.74 August 26.09 27.14 28.24 22.68 September 28.90 25.82 27.49 30.83 FY 2018 Cigarettes Smokeless Cigars E-Cigarettes October 22.58 18.73 26.05 25.84 November 27.81 17.69 32.51 26.12 December 18.94 17.31 19.62 20.51 January 21.47 22.75 22.23 20.27 February 22.28 20.14 20.58 19.82 March 33.67 30.71 37.51 33.93 April 46.84 49.42 49.51
15.49 50.57
May 57.04 56.69 56.91
8.77 57.36
June 54.49 53.95 54.95
8.56 54.71
July 53.16 56.35 52.65
14.16 53.09
August 60.87 60.07 60.75
11.37 60.52
September 56.77 57.24 55.96
10.53 93.75
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FDA ENFORCEMENT BLITZ ENFORCEMENT COMPARISON
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- 200
400 600 800 1,000 1,200 1,400 October November December January February March April May June July August September
Monthly Enforcement Actions by Product Fiscal Years 2017 & 2018
E-Cigarettes (2017) Cigars (2017) Cigarettes (2017) Smokeless (2017) E-Cigarettes (2018) Cigars (2018) Cigarettes (2018) Smokeless (2018)
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FDA ENFORCEMENT BLITZ ENFORCEMENT COMPARISON
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- 200
400 600 800 1,000 1,200 1,400 October November December January February March April May June July August September
Monthly Enforcement Actions by Product Fiscal Years 2017 & 2018
E-Cigarettes (2017) Cigars (2017) Cigarettes (2017) Smokeless (2017) E-Cigarettes (2018) Cigars (2018) Cigarettes (2018) Smokeless (2018)
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FDA ENFORCEMENT BLITZ ENFORCEMENT COMPARISON
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- 200
400 600 800 1,000 1,200 1,400 October November December January February March April May June July August September
Monthly Enforcement Actions by Product Fiscal Years 2017 & 2018
E-Cigarettes (2017) Cigars (2017) Cigarettes (2017) Smokeless (2017) E-Cigarettes (2018) Cigars (2018) Cigarettes (2018) Smokeless (2018)
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FDA ENFORCEMENT BLITZ ENFORCEMENT COMPARISON
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- 200
400 600 800 1,000 1,200 1,400 October November December January February March April May June July August September
Monthly Enforcement Actions by Product Fiscal Years 2017 & 2018
E-Cigarettes (2017) Cigars (2017) Cigarettes (2017) Smokeless (2017) E-Cigarettes (2018) Cigars (2018) Cigarettes (2018) Smokeless (2018)
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FDA ENFORCEMENT BLITZ FOCUS ON JUUL
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FDA ENFORCEMENT BLITZ FOCUS ON JUUL?
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Juul Blitz Enforcement Actions by Company 45.15% 10.15% 23.15%
17.08%
4.46% Other Vuse Blu/MyBlu
JUUL
MarkTen
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$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18
Monthly E-Cigarette Sales
Market Total JUUL
THE RISE OF JUUL NO END IN SIGHT
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Nielsen All-Channel Data
FDA raids JUUL’s HQ Class-action lawsuit filed against JUUL FDA requests marketing documents from JUUL Deeming rule takes effect (FDA begins regulating JUUL) FDA announces new regulatory plan for tobacco products and delays premarket review deadlines Altria buys a 35% stake in JUUL Surgeon General issues advisory
Retail Blitz
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$- $50.00 $100.00 $150.00 $200.00 $250.00 $300.00 $350.00 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
Market Total JUUL
THE RISE OF JUUL NO END IN SIGHT
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Nielsen All-Channel Data
13.4% 16.0% 11.3% 11.7% 20.8%
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FUTURE WEBINAR SAVE THE DATE
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The FDA’s Tools to Tackle the JUUL Epidemic February 26, 2019 12:00 pm CST
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CONTACT US
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