May 15–16, 2024 | Washington, DC & Virtual
CONNECT WITH FDLI #FDLIAnnual24
2024 FDLI Annual Conference
Seven reasons why the litigation will never stop
Clive Bates
Counterfactual Consulting
London, United Kingdom
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
4. Naivety about youth
5. De facto standard setting
6. Assessing products in isolation
7. Poor market surveillance
Seven reasons for trouble in the courts
1. Evidential burdens
23 vaping
products
FDA Authorized E-Cigarette Products
300,000 vaping
products
COM(2021) 249 final
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
Risks
Benefits
Adolescents Adults
Uptake of vaping by
adolescents who would
otherwise never use
nicotine.
Uptake by never-
smokers or former
smokers
Switching from
cigarettes & diversion
from smoking uptake
Smoking cessation or
reduction, better health
& wellbeing
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
0
5
10
15
20
25
30
35
40
Youth (NYTS) Adults (NHIS)
Million
Americans
Smoking and vaping in 2021
Millions of Americans
Source: National Youth Tobacco Survey (NYTS) 2021 data, National Health Interview Survey (NHIS) 2021
data. Graphic by Clive Bates. With thanks to Brad Rodu for data extraction and cross-tabulations.
Smoking
Vaping
only
Dual use
Nearly all the attention
goes here
The public
health
problem is
here
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
4. Naivety about youth
Infrequent vaping
Mostly
experimental,
or frivolous use
More
committed use
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
4. Naivety about youth
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
4. Naivety about youth
Smoking & vaping prevalence (%) Americans aged 18-24.
National Health Interview Survey, 2014-2022
Did not smoke before vaping
Vaping former smokers
Smoking & vaping
Smoking only
>70% reduction in smoking, >80%
reduction in exclusive smoking
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
4. Naivety about youth
5. De facto standard setting
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
4. Naivety about youth
5. De facto standard setting
6. Assessing products in isolation
Rest of the
market
New product
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
4. Naivety about youth
5. De facto standard setting
6. Assessing products in isolation
7. Poor market surveillance
Seven reasons for trouble in the courts
1. Evidential burdens
2. Opaque success criteria
3. Defining APPH
4. Naivety about youth
5. De facto standard setting
6. Assessing products in isolation
7. Poor market surveillance
May 15–16, 2024 | Washington, DC & Virtual
CONNECT WITH FDLI #FDLIAnnual24
2024 FDLI Annual Conference
Thank you
Clive Bates
Counterfactual Consulting
London, United Kingdom
clivedbates@gmail.com
@clive_bates
clivebates.com

FDLI Annual 2024: seven reasons why the litigation will never stop

  • 1.
    May 15–16, 2024| Washington, DC & Virtual CONNECT WITH FDLI #FDLIAnnual24 2024 FDLI Annual Conference Seven reasons why the litigation will never stop Clive Bates Counterfactual Consulting London, United Kingdom
  • 2.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH 4. Naivety about youth 5. De facto standard setting 6. Assessing products in isolation 7. Poor market surveillance
  • 3.
    Seven reasons fortrouble in the courts 1. Evidential burdens 23 vaping products FDA Authorized E-Cigarette Products 300,000 vaping products COM(2021) 249 final
  • 4.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria
  • 5.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH Risks Benefits Adolescents Adults Uptake of vaping by adolescents who would otherwise never use nicotine. Uptake by never- smokers or former smokers Switching from cigarettes & diversion from smoking uptake Smoking cessation or reduction, better health & wellbeing
  • 6.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH 0 5 10 15 20 25 30 35 40 Youth (NYTS) Adults (NHIS) Million Americans Smoking and vaping in 2021 Millions of Americans Source: National Youth Tobacco Survey (NYTS) 2021 data, National Health Interview Survey (NHIS) 2021 data. Graphic by Clive Bates. With thanks to Brad Rodu for data extraction and cross-tabulations. Smoking Vaping only Dual use Nearly all the attention goes here The public health problem is here
  • 7.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH 4. Naivety about youth Infrequent vaping Mostly experimental, or frivolous use More committed use
  • 8.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH 4. Naivety about youth
  • 9.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH 4. Naivety about youth Smoking & vaping prevalence (%) Americans aged 18-24. National Health Interview Survey, 2014-2022 Did not smoke before vaping Vaping former smokers Smoking & vaping Smoking only >70% reduction in smoking, >80% reduction in exclusive smoking
  • 10.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH 4. Naivety about youth 5. De facto standard setting
  • 11.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH 4. Naivety about youth 5. De facto standard setting 6. Assessing products in isolation Rest of the market New product
  • 12.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH 4. Naivety about youth 5. De facto standard setting 6. Assessing products in isolation 7. Poor market surveillance
  • 13.
    Seven reasons fortrouble in the courts 1. Evidential burdens 2. Opaque success criteria 3. Defining APPH 4. Naivety about youth 5. De facto standard setting 6. Assessing products in isolation 7. Poor market surveillance
  • 14.
    May 15–16, 2024| Washington, DC & Virtual CONNECT WITH FDLI #FDLIAnnual24 2024 FDLI Annual Conference Thank you Clive Bates Counterfactual Consulting London, United Kingdom [email protected] @clive_bates clivebates.com