Regulation and Legislation

In depth: e-cig market and law in Australia and New Zealand

18th December 2014 - Country market reports , Market reports |

Market analysis • Market size • Consumption patterns • Pricing and spend • Sales, distribution and marketing • Brands • Regulatory analysis • Australia: national regulation • Australia: the Therapeutic Goods Administration • Australia: personal imports • Australia: state and territory regulation • Australia: taxation • Australia: the future of e-cig regulation • New Zealand: national regulation • New Zealand: medical regulation • New Zealand: regulatory forecast • Appendix 1: importation into Australia • Appendix 2: New Zealand Medicines Act 1981

In depth: New York state e-cig regulation, December 2014

1st December 2014 - News analysis |

Introduction • The matrix of authority • State government regulation • Local government regulation • Regulation by quasi-governmental institutions • Regulatory trends • Appendix 1: state law and New York City law • Appendix 2: notable lawsuit – The Citizens Lobbying Against Smoker Harassment vs New York City

In depth: California e-cig regulation, November 2014

15th November 2014 - News analysis |

The matrix of authority • State government regulation • Local government regulation • Regulation by quasi-governmental institutions • Regulatory trends • Appendix 1: state law, consumer protection law and licensing law • Appendix 2: notable lawsuits – Smoking Everywhere and Sottera

Could Republicans’ triumph mean a gentler ride for e-cigs?

6th November 2014 - News analysis |

Republicans’ historic victory this week in taking the U.S. mid-term elections’ big prize – control of the Senate – could have a significant impact on the e-cigarette industry’s relationship with Congress, as power shifts to a party renowned for its traditional stance against what it considers burdensome regulations on business.

In depth: Canada regulatory and legal analysis, October 2014

4th November 2014 - Country market reports , Market reports |

The multi-layered regulatory framework • Tobacco regulation – the multi-layered model in action • No federal regulation of e-cigarettes • The role of Health Canada • Provincial regulation • Municipal regulation • Trade associations and industry standards • Appendix 1: provincial and territorial tobacco regulation in Canada • Appendix 2: market authorisation in Canada

In depth: e-cigs in the UK – market and regulatory analysis

26th October 2014 - Country market reports , Country regulatory reports , Market reports , Regulatory reports |

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.

Good COP, bad COP? WHO FCTC urges ad ban, more research

19th October 2014 - News analysis |

The final recommendations of the World Health Organization (WHO) on e-cigarettes allow for a wide range of regulatory regimes but single out advertising as a prime candidate for controls, as expected, as well as hinting at the need for public place usage restrictions.

In depth: Spain market and regulatory update

3rd October 2014 - Country regulatory reports , Regulatory reports |

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

E-cigarette experts at expos unclear but upbeat

2nd October 2014 - News analysis |

        Paris and Las Vegas: ECigIntelligence director, Tim Phillips recently chaired the E-cig Vegas: Industry Conference discussion panels where experts debated the current business climate in the sector, the upcoming Food and Drug Administration (FDA) deeming regulations and the science surrounding e-cigarettes. At Vapexpo in Paris meanwhile, Nick Wenbourne, ECigIntelligence legal and regulatory director, discussed the EU’s » Continue Reading.

In depth: Germany regulatory update September 2014

29th September 2014 - Country regulatory reports , Regulatory reports |

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

In depth: e-cigs in the U.S. – market and regulatory analysis

24th September 2014 - Country market reports , Country regulatory reports , Market reports , Regulatory reports |

A comprehensive survey of the U.S. e-cigarette market and regulation, including: Market size • Consumption patterns • Online pricing • Distribution • Raw material supply • E-cigarette usage surveys • Current U.S. e-cigarette regulation • The future of e-cigarette regulation in the United States • Potential challenges to the deeming regulations • Taxation of e-cigs • State and local government regulation case study – California • Public place restrictions by state and local governments • Challenging the deeming regulations – precedents • The FDA regulatory process • The role and influence of trade and consumer associations

In depth: Spain’s national regulations – and its next steps

22nd September 2014 - Country regulatory reports , Regulatory reports |

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

UK pharma regulator approves cigarette-like vapour device

12th September 2014 - News analysis |

Britain’s medicines regulator has issued a product licence for the nicotine inhaler Voke, which will be sold by British American Tobacco’s subsidiary Nicoventures and looks likely to be the closest pharmaceutically-approved competitor to the e-cigarette.

Updated: the WHO’s influence on global e-cig regulation

11th September 2014 - Regulatory reports , Topic regulatory reports |

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