Regulation and Legislation

Update: Poland market report

20th November 2015 - Country market reports , Market reports |

    There may be more recent ECigIntelligence reports on this territory. Please visit the home page for Poland or the advanced search page.  
  Executive summary   The Polish e-cigarette market for 2015 is expected to be worth PLN541m (Polish zloty) (€126m, $144m). The small growth (7%) in the market from 2014 to 2015 can be attributed to the » Continue Reading.

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

Q&A: what happens next with the deeming regulations?

6th November 2015 - News analysis |

Introduction • Why is the OIRA required to review the final deeming rule before publication? • How many regulatory actions does the OIRA review at any given time? • When is the deadline for the OIRA to complete its review of the deeming regulations? • When will the OIRA most likely hand the regulations back to the FDA? • Why does ECigIntelligence believe the earliest date the final deeming rule will be published is in the spring of 2016? • What does the senators’ letter to the OIRA mean?

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.

Video: municipal e-cig taxation in the United States

27th October 2015 - News analysis |

Why are local governments in the U.S. approving new taxes on e-cigarettes? ECigIntelligence’s regulatory analyst Carly Souther uncovers the reasons, identifies the trendsetters and discusses the outlook for municipal taxation of the vaping industry in our exclusive video presentation.

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”.

Portugal adds public vaping ban to new TPD law

7th September 2015 - News analysis |

Portugal has become the latest European Union member state to implement the EU’s Tobacco Products Directive (TPD), hewing closely to its requirements but also introducing a public vaping ban with limited exceptions.

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

“Most online e-cig vendors make false claims,” says watchdog

4th September 2015 - News analysis |

The majority of U.S. e-cig vendors make unsupported claims on their Websites, a watchdog group has charged after surveying the online presence of 159 companies. Truth in Advertising (TINA), a nonprofit based in Connecticut, examined the firms’ online content including “social media, testimonials, [and] links to studies or media reports” – not just advertising in the conventional sense – to » Continue Reading.

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.