Regulation and Legislation

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

In depth: how e-cig associations set standards, influence policy

3rd September 2014 - Market reports , Topic market reports |

France: influence on regulation and case law • France: influence on standards adoption • French and European associations’ influence on the TPD • UK: ECITA and the BSI e-cigarette standards • UK: developing manufacturing standards • French and British approaches compared • U.S.: industry self-regulation • U.S.: association regulatory and lobbying efforts

In depth: legal challenges to the EU Tobacco Products Directive

27th August 2014 - Regulatory reports , Topic regulatory reports |

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

FDA told it should abandon deeming regs, turn to Congress

10th August 2014 - News analysis |

The U.S. Food and Drug Administration (FDA) is likely to have received a deluge of comments in the run-up to the closing of the public consultation period on its e-cigarette regulations last Friday – among them a biting critique of the agency’s approach from a U.S. vapers’ group.

In depth: little e-cig regulation in Poland, and not much likely

5th August 2014 - Country regulatory reports , Regulatory reports |

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

E-liquids: are they as dangerous as European regulators think?

29th July 2014 - News analysis |

Could handling e-liquid really be as safe as doing the dishes?

European regulations on classification, labelling and packaging (CLP) have been wrongly categorising nicotine as extremely toxic when it should be considered the equivalent of washing-up liquid, a new report claims.

Swedish pharma regulator granted control over e-cigs

23rd July 2014 - News analysis |

A Swedish court has upheld attempts by the country’s medical products regulator to treat nicotine-containing e-cigarettes as pharmaceuticals, meaning that they must go through a licensing process and cannot be sold in outlets such as groceries and convenience stores.