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THE PUBLIC HEALTH LAW CENTER 1/23/2019 2 LEGAL TECHNICAL - PowerPoint PPT Presentation

Nov 21, 2022 •157 likes •597 views

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

  1. U NANSWERED Q UESTIONS ABOUT THE FDA’ S JUUL E NFORCEMENT B LITZ 1/23/2019 1

  2. THE PUBLIC HEALTH LAW CENTER 1/23/2019 2

  3. LEGAL TECHNICAL ASSISTANCE Legal Research Policy Development, Implementation, Defense Publications Trainings Direct Representation Lobby 1/23/2019 3

  4. Photo credit: Sam Bradd https:/ / drawingchange.com/ gathering-wisdom-visuals-for-a-healthy-future/ 1/23/2019 4

  5. AGENDA • The Rise of JUUL • Background on FDA Retail Enforcement • The FDA’s Enforcement Blitz 1/23/2019 5

  6. THE RISE OF JUUL 1/23/2019 6

  7. THE RISE OF JUUL E-Cigarette Market Share 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Mar-15 Sep-15 Mar-16 Sep-16 Mar-17 Sep-17 Mar-18 Sep-18 JUUL Reynolds/BAT Altria Imperial/Fontem/Lorillard Logic/JTI NJOY 1/23/2019 7

  8. THE RISE OF JUUL Monthly E-Cigarette Sales $350.00 $300.00 $250.00 $200.00 $150.00 $100.00 $50.00 $- Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18 Nielsen All-Channel Data Market Total JUUL 1/23/2019 8

  9. THE RISE OF JUUL Monthly E-Cigarette Sales $350.00 $300.00 $250.00 $200.00 $150.00 $100.00 $50.00 $- Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18 Nielsen All-Channel Data Market Total JUUL 1/23/2019 9

  10. THE RISE OF JUUL Monthly E-Cigarette Sales $350.00 $300.00 $250.00 $200.00 $150.00 $100.00 $50.00 $- Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18 Nielsen All-Channel Data Market Total JUUL 1/23/2019 10

  11. THE RISE OF JUUL Monthly E-Cigarette Sales $350.00 $300.00 $250.00 $200.00 $150.00 $100.00 $50.00 $- Mar-15 Sep-15 Mar-16 Sep-16 Mar-17 Sep-17 Mar-18 Sep-18 Market Total JUUL Reynolds/BAT Altria Imperial/Fontem/Lorillard Logic/JTI NJOY 1/23/2019 11

  12. FDA ACTION ENFORCEMENT BLITZ 1/23/2019 12

  13. FDA RETAIL ENFORCEMENT REQUIREMENTS FOR RETAILERS Smokeless E-Cigarettes & Cigarettes Cigars Tobacco Others ✔ ✔ ✔ ✔ Minimum legal sales of 18 and age verification under 27 Prohibition on vending Allowed in adult-only Allowed in adult-only Allowed in adult-only Allowed in adult-only machine sales facilities facilities facilities facilities Prohibition on self- Allowed in adult-only Allowed in adult-only service displays facilities facilities ✔ Minimum package requirements ✔ ✔ Prohibition on breaking packages by retailers ✔ ✔ ✔ Prohibition on free Allowed in qualified samples adult-only facility Prohibition on Menthol and tobacco characterizing flavors allowed 1/23/2019 13

  14. FDA RETAIL ENFORCEMENT THE FEDERAL FISCAL YEAR October 1, 2017 September 30, 2018 Fiscal Year 1/23/2019 14

  15. FDA RETAIL ENFORCEMENT ENFORCEMENT CONTRACTS https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Retail/ucm228914.htm 1/23/2019 15

  16. FDA RETAIL ENFORCEMENT RETAIL INSPECTIONS https://www.fda.gov/downloads/TobaccoProducts/GuidanceComplianceRegulatoryInformation/UCM548353.pdf 1/23/2019 16

  17. FDA RETAIL ENFORCEMENT REPEATED VIOLATIONS Number of Timeframe Possible Enforcement Actions Violations 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 1/23/2019 17

  18. FDA RETAIL ENFORCEMENT DATA SOURCES https://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm 1/23/2019 18

  19. FDA RETAIL ENFORCEMENT DATA SOURCES https://www.accessdata.fda.gov/scripts/oce/inspections/oce_insp_searching.cfm 1/23/2019 19

  20. FDA RETAIL ENFORCEMENT DATA SOURCES https://www.fda.gov/AboutFDA/Transparency/track/default.htm 1/23/2019 20

  21. FDA ENFORCEMENT BLITZ DATA SOURCES 1/23/2019 21

  22. FDA ENFORCEMENT BLITZ BLITZ TIMING 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 1/23/2019 22

  23. FDA ENFORCEMENT BLITZ INSPECTIONS DECREASE Retail Inspections by Fiscal Year 200,000 180,000 160,000 140,000 120,000 100,000 80,000 60,000 40,000 20,000 0 FY 2011 FY 2012 FY 2013 FY 2014 FY 2015 FY 2016 FY 2017 FY 2018 1/23/2019 23

  24. FDA ENFORCEMENT BLITZ INSPECTIONS DECREASE 1/23/2019 24

  25. FDA ENFORCEMENT BLITZ INSPECTIONS DECREASE Retail Inspections by Month 16,000 15,000 14,000 13,000 12,000 11,000 10,000 9,000 8,000 1/23/2019 25

  26. FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE Cumulative Warning Letters (All Products) Cumulative Fines (All Products) 16000 7000 14000 6000 12000 5000 10000 4000 8000 3000 6000 2000 4000 1000 2000 0 0 2017 2018 2017 2018 1/23/2019 26

  27. FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE Cumulative Warning Letters (E-Cigarettes) Cumulative Fines (E-Cigarettes) 3,500 500 450 3,000 400 2,500 350 300 2,000 250 1,500 200 150 1,000 100 500 50 - - 2017 2018 2017 2018 1/23/2019 27

  28. FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE FY 2017 M onthly Fines by Product 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 1/23/2019 28

  29. FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE Cumulative Warning Letters (E-Cigarettes) Cumulative Fines (E-Cigarettes) 3,500 500 450 3,000 400 2,500 350 300 2,000 893 250 1,500 200 150 1,000 100 500 50 - - 2017 2018 2017 2018 1/23/2019 29

  30. FDA ENFORCEMENT BLITZ ENFORCEMENT ACTIONS DECREASE Cumulative Warning Letters (E-Cigarettes) Cumulative Fines (E-Cigarettes) 3,500 500 450 3,000 400 2,500 350 300 2,000 250 1,500 200 150 1,000 100 500 50 - - 2017 2018 2017 2018 1/23/2019 30

  31. FDA ENFORCEMENT BLITZ E-CIGARETTE WARNING LETTERS Monthly E-Cigarette Warning Letters 800 700 600 500 400 300 200 100 - October November December January February March April May June July August September Warning Letters (2017) Warning Letters (2018) 1/23/2019 31

  32. FDA ENFORCEMENT BLITZ ENFORCEMENT SPEED FY 2017 Cigarettes Smokeless Cigars E-Cigarettes FY 2018 Cigarettes Smokeless Cigars E-Cigarettes October 34.46 34.27 43.10 42.80 October 22.58 18.73 26.05 25.84 November 23.08 26.59 42.43 42.21 November 27.81 17.69 32.51 26.12 December 19.63 18.18 35.05 38.11 December 18.94 17.31 19.62 20.51 January 18.35 15.23 32.46 32.00 January 21.47 22.75 22.23 20.27 February 23.56 20.96 15.39 14.36 February 22.28 20.14 20.58 19.82 March 25.34 21.45 15.97 15.16 March 33.67 30.71 37.51 33.93 April 21.38 23.09 25.27 28.40 April 46.84 49.42 49.51 15.49 50.57 May 29.49 19.60 44.65 55.82 May 57.04 56.69 56.91 8.77 57.36 June 30.84 24.60 35.78 27.09 June 54.49 53.95 54.95 8.56 54.71 July 38.58 33.18 41.03 41.74 July 53.16 56.35 52.65 14.16 53.09 August 26.09 27.14 28.24 22.68 August 60.87 60.07 60.75 11.37 60.52 September 28.90 25.82 27.49 30.83 September 56.77 57.24 55.96 10.53 93.75 1/23/2019 32

  33. FDA ENFORCEMENT BLITZ ENFORCEMENT COMPARISON Monthly Enforcement Actions by Product Fiscal Years 2017 & 2018 1,400 1,200 1,000 800 600 400 200 - October November December January February March April May June July August September E-Cigarettes (2017) Cigars (2017) Cigarettes (2017) Smokeless (2017) E-Cigarettes (2018) Cigars (2018) Cigarettes (2018) Smokeless (2018) 1/23/2019 33

  34. FDA ENFORCEMENT BLITZ ENFORCEMENT COMPARISON Monthly Enforcement Actions by Product Fiscal Years 2017 & 2018 1,400 1,200 1,000 800 600 400 200 - October November December January February March April May June July August September E-Cigarettes (2017) Cigars (2017) Cigarettes (2017) Smokeless (2017) E-Cigarettes (2018) Cigars (2018) Cigarettes (2018) Smokeless (2018) 1/23/2019 34

  35. FDA ENFORCEMENT BLITZ ENFORCEMENT COMPARISON Monthly Enforcement Actions by Product Fiscal Years 2017 & 2018 1,400 1,200 1,000 800 600 400 200 - October November December January February March April May June July August September E-Cigarettes (2017) Cigars (2017) Cigarettes (2017) Smokeless (2017) E-Cigarettes (2018) Cigars (2018) Cigarettes (2018) Smokeless (2018) 1/23/2019 35

  36. FDA ENFORCEMENT BLITZ ENFORCEMENT COMPARISON Monthly Enforcement Actions by Product Fiscal Years 2017 & 2018 1,400 1,200 1,000 800 600 400 200 - October November December January February March April May June July August September E-Cigarettes (2017) Cigars (2017) Cigarettes (2017) Smokeless (2017) E-Cigarettes (2018) Cigars (2018) Cigarettes (2018) Smokeless (2018) 1/23/2019 36

  37. FDA ENFORCEMENT BLITZ FOCUS ON JUUL 1/23/2019 37

  38. FDA ENFORCEMENT BLITZ FOCUS ON JUUL? Juul Blitz Enforcement Actions by Company Other 10.15% Blu/MyBlu 23.15% Vuse 45.15 % 17.08% JUUL MarkTen 4.46% 1/23/2019 38

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