Health and science

Hungary regulatory report: an end to mandatory pharma licensing

13th November 2015 - Country market reports , Country regulatory reports , Market reports , Regulatory reports |

Hungary’s transposition of the EU Tobacco Products Directive will do away with the current mandatory pharmaceutical licensing requirement for e-cigarettes – which has resulted in no nicotine-containing products being legal in the country – and allow them to be sold as consumer products. As this great change approaches, our in-depth report on Hungary includes: Regulatory landscape • Current national regulatory framework • Age restrictions • Packaging and product restrictions • Notification requirements • Retailing restrictions (including cross-border and distance sales) • Public usage • Advertising and marketing restrictions • Taxation • Case law • Enforcement • The missing pieces of the TPD jigsaw • Graphic: how Hungarian e-cigarette regulation will change

PMTAs: the road to FDA approval for e-cigarette products

12th November 2015 - Regulatory reports , Topic regulatory reports |

Executive summary • Introduction • Why an electronic nicotine delivery system (ENDS) product requires a PMTA: distinction among ENDS products, components/parts, and accessories; three pathways to market approval; concerns about the grandfather date • Guidance for industry: information on premarket tobacco product applications (PMTA) and the submission process • Public health considerations: scientific evidence, comparative analysis, voluntary restrictions on sale and distribution, nicotine exposure warnings, child-resistant packaging, alternatives to new scientific studies, government-sponsored databases, non-U.S. randomised controlled clinical trials, literature reviews or reports • FDA enforcement for manufacturers and retailers: enforcement limited to finished tobacco products; independent vapour shops considered as tobacco product manufacturers • Appendix 1: definitions • Appendix 2: submitting a PMTA

Regulatory report: UK gears up for fragmented TPD transposition

3rd November 2015 - Country regulatory reports , Regulatory reports |

  There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United Kingdom or the advanced search page.     Introduction The central government has started to transpose the Tobacco Products Directive (TPD). At the same time, the regional government of Wales wants to impose a smoking-style public place usage restriction while Scotland plans to ban the » Continue Reading.

E-cigarettes in the UK: regulations, politics, and consultations

2nd November 2015 - Regulatory reports , Topic regulatory reports |

  There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United Kingdom or the advanced search page.       To provide further insight on the developing UK regulatory scene for e-cigarettes, we have collated this in-depth companion to Regulatory report: UK gears up for fragmented TPD transposition for ECigIntelligence readers. Section 1 – Relevant consumer » Continue Reading.

E-cigarette regulation in Germany: the draft TPD plans and beyond

14th October 2015 - Country regulatory reports , Regulatory reports |

Introduction • Regulatory landscape • Current national regulatory framework • National regulatory framework post-TPD • Age restrictions • Product restrictions • Ingredients • Labelling and packaging • Product notification • Annual reporting • Vigilance • Retailing • Public usage • North Rhine-Westphalia • Bavaria • Baden-Württemberg • Lower Saxony • Hesse • Public usage: an inconsistent future? • Advertising and marketing • Taxation • Enforcement • Case law: e-cigarettes as medical products • Case law: e-cigarettes as tobacco products • Case law: tobacco advertising restrictions • The missing pieces from the TPD jigsaw • Graphic: how German e-cigarette regulation will change

Farsalinos: e-cigs need a fresh legal approach

2nd October 2015 - News analysis |

Two of vaping’s most eminent scientific advocates have called for bespoke regulatory regimes that follow neither the tobacco nor the pharmaceutical model, but they acknowledge that formulating appropriate rules can be a “very challenging process”.

Opinion: public health, magical thinking and monsters under the bed

24th September 2015 - News analysis |

Counterblasts against Public Health England’s nearly unequivocal support for e-cigarettes were only to be expected, and their trajectory has been laid out by two of Britain’s most eminent general medical journals, The Lancet and The BMJ. But their arguments are neither nuanced nor practical, and are muddled by dislike of the tobacco industry.

E-cigs and dental health: a field wide open for study

22nd September 2015 - News analysis |

There has been little study or comment on e-cigs so far from professional bodies in dental health, or from dental researchers.
But that may now be changing, with increased interest from some corners of the dental profession in e-cigs’ role as potential reducers of harm to oral health.

Praise and criticism for Public Health England’s e-cig stance

11th September 2015 - News analysis |

British politicians this week heard praise from e-cigarette advocates for the recent endorsement of e-cigs by Public Health England (PHE), but some proponents argued that PHE’s backing was too little too late and failed to address serious short-term problems that they believe the industry faces in the UK.

E-cigarette regulation in Portugal: TPD plans become clear

6th September 2015 - Country regulatory reports , Regulatory reports |

Introduction • Regulatory landscape • Current regulatory framework • Product categorisation • Age restrictions • Product restrictions • Notification procedure • Public usage • Advertising and marketing restrictions • Cross-border sales • Taxation • Case law • Enforcement • Conclusions • Graphic: how Portuguese e-cigarette regulation will change

Developing nations advised to adopt pharma model

21st August 2015 - News analysis |

Governments of poorer countries need to regulate e-cigarettes just as much as their wealthier counterparts, and ought to opt for a pharmaceutical model – but they may find it difficult, according to a new paper by two U.S. academics.