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
Clive BatesDirector, Counterfactual Consulting Limited at Counterfactual: public interest consulting and analytical advocacy
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
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
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