As the e-cigarette industry gets to grips with the requirements of regulation such as the EU’s Tobacco Products Directive (TPD), ECigIntelligence takes a look at the practical implications on e-cig testing for brands and manufacturers.
A comprehensive survey of the UK e-cigarette market and regulation, including: Market size: estimates and methodology; model assumptions; industry estimates • Consumption patterns: number of e-cigarette users in the UK; comparisons with usage data from outside UK; overview of usage data: “ever” users; tank usage; cigalike usage • Pricing and spend: online pricing; e-liquids; cigalikes; tank systems • Sales, distribution and marketing: online; offline; marketing; medical licensing for e-cigs • Brand ownership and M&A: different blends of acquisition and development; cigalikes • Raw materials and manufacturing • Current regulatory landscape • Advertising: regulatory control; advertising restrictions; the new CAP and BCAP rules; existing advertising restrictions; enforcement of advertising rules • TPD transposition: pre-transposition challenges to the TPD; transposition timeline; significant new rules for e-cigarettes: ECITA and the BSI e-cigarette standards; possible impacts of Totally Wicked’s challenge on article 20 and e-cigarette regulation; overview of ECITA proposal • Medical licensing: marketing authorisation costs for medically licensed e-cigarette product in the UK; manufacturer/import authorisation; pharmacovigilance; wholesale • Existing legislation governing manufacture, import and sale of e-cigarettes in the UK • TPD implementation: the process of implementing EU directives in the UK; the transposition process.
Regulatory control of advertising in the UK • Existing UK advertising restrictions • The New UK Rules • Non-statutory regulation of e-cigarette advertising in France • The two regimes: few similarities
Contents: Market size • Form factors • Individual usage • Retail channel • Major Spanish retailers • Recent upheavals • Regulation • Introduction • Regulatory landscape: from regional to uniform regulation • Current regulatory framework • Comparison with tobacco regulation • Public use restrictions • Age restrictions • Packaging and point-of-sale requirements • Advertising restrictions • Medical claims • Enforcement • Case law • The missing pieces from the TPD jigsaw • The decreto ley option
Current legal and regulatory framework • Legislation under consideration • Case law on medical/pharmaceutical status of e-cigs • Case law on e-cigs as tobacco products • Import restrictions • Public use and advertising restrictions • TPD implementation • Appendix: Primary lower court cases – medical/pharmaceutical status •
Appendix II: Primary lower court cases – tobacco equivalence • Appendix III: Potential e-cig restrictions
Regulatory landscape: from regional to uniform regulation • Current regulatory framework • Comparison with tobacco regulation • Public use restrictions • Age restrictions • Packaging and point-of-sale requirements • Advertising restrictions • Medical claims • Enforcement • Case law • The missing pieces from the TPD jigsaw • The decreto ley option
What the FCTC is • A global treaty • Broad scope of regulation • The regulatory framework • The FCTC in practice • No enforcement powers • Enforcement by signatories • Self-reporting • Shadow reporting • Influence on European legislation • Promoting tobacco regulation in the developing world • What does the FCTC mean for e-cigarettes • Current status of e-cigs • Political will to regulate • Structural barriers • Non-binding, but influential • Exclusion of e-cig firms • Regulatory options in detail
The law governing adoption of the TPD • Significant new rules for tobacco and e-cigs • Challenges before transposition • Pre-transposition challenges by member states • Poland’s TPD challenge • Pre-transposition challenges before the UK high court • PMI’s TPD challenge • Totally Wicked’s TPD challenge • Possible post-transposition challenges • Possible impacts on article 20 and e-cig regulation • Potential challenges by other e-cig stakeholders
E-cigs are not tobacco products • E-cigs are relatively unregulated • Standard consumer protection law applies • No product standards or requirements • Public use restrictions in significant cities • Limits on local government power • No tobacco taxes, or other special taxes – yet • Implementation of the TPD: scope • Implementation of the TPD: timeline and process • Implementation of the TPD: industry and NGO input • Implementation of the TPD: regulatory authority • Tobacco regulation in Poland
GMPs defined • Core principles: control and documentation • Enforcement • Evolution of GMPs: “current GMPs” and international harmonisation • The application of GMPs to tobacco and e-cigarettes • Industry groups and NGOs fill the regulatory void • How might the FDA formulate e-cig GMPs? • Conclusions