FDLI - Lesson for the US from other jurisdictions - the United Kingdom -29 October 2021

Dec 9, 2021Download as PPTX, PDF0 likes477 views

Presentation on the most significant differences between US and UK/EU regulation of tobacco and vaping products. FDLI Tobacco and Nicotine Products Regulation and Policy Conference

What Can We Learn from Alternative Nicotine
Product Usage in Other Countries?
United Kingdom
Clive Bates
Counterfactual Consulting, London
FDLI Tobacco and Nicotine Products Regulation and Policy Conference
29 October 2021

Smoking and vaping 2019 – Great Britain (ONS)
ONS, E-cigarette use in Great Britain in 2019, July 2020
~3m vapers
~8m smokers
2

2030 goal “make smoking products obsolete”
5% prevalence
Two-thirds cut
3
ONS, E-cigarette use in Great Britain in 2019, July 2020

10-year adult smoking prevalence trend
4
0
5
10
15
20
25
30
%
cigarette
smokers
(3
month
moving
average)
~One-third cut
University College London, Smoking in England, Smoking Toolkit Survey, 2020 (England)

Adult e-cigarette users by smoking status, Great Britain 2014-21
“Dual use” in context
Dual use has declined over time
Source: Action on Smoking and Health (UK) and YouGov - E-cigarette Use By Adults 2021

UK compared to USA
1. Split competence / Brexit

UK compared to USA
1. Split competence / Brexit
2. Notification vs authorisation

UK compared to USA
1. Split competence / Brexit
2. Notification vs authorisation
3. Category-wide approach

UK compared to USA
1. Split competence / Brexit
2. Notification vs authorisation
3. Category-wide approach
4. Product standards

UK compared to USA
1. Split competence / Brexit
2. Notification vs authorisation
3. Category-wide approach
4. Product standards
• Notification – ingredients, toxicology,
pharmacology, production process
• Technical design restrictions and requirements
• Leaflet, packaging and warning
• Advertising, promotion, sponsorship
• Cross border sales
• Disclosure commercial data
• Market surveillance
• Public disclosure of commercial data
• Surveillance for adverse effects

UK compared to USA
1. Split competence / Brexit
2. Notification vs authorisation
3. Category-wide approach
4. Product standards
5. Nicotine cap
Max 20mg/ml (~2%)
“This concentration allows for a
delivery of nicotine that is
comparable to the permitted dose
of nicotine derived from a
standard cigarette during the time
needed to smoke such a
cigarette.”
Source: TPD 20(3)(b) TPD recital 38

UK compared to USA
1. Split competence / Brexit
2. Notification vs authorisation
3. Category-wide approach
4. Product standards
5. Nicotine cap
6. Marketing restrictions
Cross border advertising
promotion and sponsorship for all
tobacco and vaping products is
prohibited at EU level.
Source: Tobacco Advertising Directive 2002, TPD Article 20(5)

Major difference in UK
1. Split competence / Brexit
2. Notification vs authorisation
3. Category-wide approach
4. Product standards
5. Nicotine cap
6. Marketing restrictions
7. Reduced risk claims
8. Tax
9. Attitude

This document provides an introduction to tobacco harm reduction and alternative nicotine products such as e-cigarettes. It summarizes statements from public health organizations that find e-cigarettes to be much less harmful than combustible cigarettes. Research shows e-cigarettes help smokers quit at the population level and are effective cessation tools. The document argues for risk-proportionate regulation and taxation of nicotine products to incentivize smokers to switch to less harmful options and further reduce smoking rates.

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FDLI - Lesson for the US from other jurisdictions - the United Kingdom -29 October 2021

1. What Can We Learn from Alternative Nicotine Product Usage in Other Countries? United Kingdom Clive Bates Counterfactual Consulting, London FDLI Tobacco and Nicotine Products Regulation and Policy Conference 29 October 2021

2. Smoking and vaping 2019 – Great Britain (ONS) ONS, E-cigarette use in Great Britain in 2019, July 2020 ~3m vapers ~8m smokers 2

3. 2030 goal “make smoking products obsolete” 5% prevalence Two-thirds cut 3 ONS, E-cigarette use in Great Britain in 2019, July 2020

4. 10-year adult smoking prevalence trend 4 0 5 10 15 20 25 30 % cigarette smokers (3 month moving average) ~One-third cut University College London, Smoking in England, Smoking Toolkit Survey, 2020 (England)

5. Adult e-cigarette users by smoking status, Great Britain 2014-21 “Dual use” in context Dual use has declined over time Source: Action on Smoking and Health (UK) and YouGov - E-cigarette Use By Adults 2021

6. UK compared to USA 1. Split competence / Brexit

7. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation

8. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach

9. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach 4. Product standards

10. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach 4. Product standards • Notification – ingredients, toxicology, pharmacology, production process • Technical design restrictions and requirements • Leaflet, packaging and warning • Advertising, promotion, sponsorship • Cross border sales • Disclosure commercial data • Market surveillance • Public disclosure of commercial data • Surveillance for adverse effects

11. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach 4. Product standards 5. Nicotine cap Max 20mg/ml (~2%) “This concentration allows for a delivery of nicotine that is comparable to the permitted dose of nicotine derived from a standard cigarette during the time needed to smoke such a cigarette.” Source: TPD 20(3)(b) TPD recital 38

12. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach 4. Product standards 5. Nicotine cap 6. Marketing restrictions Cross border advertising promotion and sponsorship for all tobacco and vaping products is prohibited at EU level. Source: Tobacco Advertising Directive 2002, TPD Article 20(5)

13. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach 4. Product standards 5. Nicotine cap 6. Marketing restrictions  Don’t be socially irresponsible  Don’t target or feature children  Don’t confuse e-cigarettes with tobacco products  Don’t make health or safety claims  Don’t make smoking cessation claims  Don’t mislead about product ingredients  Don’t mislead about where products may be use

14. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach 4. Product standards 5. Nicotine cap 6. Marketing restrictions 7. Reduced risk claims Manufacturers must not suggest: “that a particular tobacco product is less harmful than others or aims to reduce the effect of some harmful components of smoke” Source: TPD 13(1)(b) applied to vaping products via 20(4)(b)(ii)

15. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach 4. Product standards 5. Nicotine cap 6. Marketing restrictions 7. Reduced risk claims 8. Tax 0 2 4 6 8 10 12 14 16 18 United Kingdom United States Price of 20 Marlboro USD Source: Numbeo

16. Major difference in UK 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach 4. Product standards 5. Nicotine cap 6. Marketing restrictions 7. Reduced risk claims 8. Tax 9. Attitude

17. UK compared to USA 1. Split competence / Brexit 2. Notification vs authorisation 3. Category-wide approach 4. Product standards 5. Nicotine cap 6. Marketing restrictions 7. Reduced risk claims 8. Tax 9. Attitude Thank you! Clive Bates Counterfactual clivedbates@gmail.com www.clivebates.com @clive_bates

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FDLI - Lesson for the US from other jurisdictions - the United Kingdom -29 October 2021

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FDLI - Lesson for the US from other jurisdictions - the United Kingdom -29 October 2021