Regulation and Legislation

Implementing the TPD: how far to the finish line?

31st December 2015 - Market reports , Topic market reports |

As we move into 2016, nearly half of the 28 member states of the European Union (EU) have made little apparent progress in transposing its Tobacco Products Directive (TPD) into their national law – despite the May 2016 deadline. Who has achieved the most, who is lagging behind, what remains to be done, and how do the regulatory approaches of the member states differ?

Italy in-depth: preparing for the TPD

31st December 2015 - Country regulatory reports , Regulatory reports |

Contents1 Executive Summary2 Regulatory landscape3 National regulatory framework4 Age restrictions5 Product restrictions6 Labelling and packaging7 Obligation to notify8 Retail sale channels restriction9 Public usage10 Advertising and marketing11 Taxation12 Enforcement   There may be more recent ECigIntelligence reports on this territory. Please visit the home page for Italy or the advanced search page.       Executive Summary
  A draft legislative decree » Continue Reading.

Malaysia’s e-cig landscape, 2015

30th December 2015 - Country regulatory reports , Regulatory reports |

Contents1 2 Executive Summary3 Regulatory Landscape4 National regulatory framework5 Recent events6 Current applicable legislation7 Case law8 Enforcement9 Near-future regulations         Executive Summary   In Malaysia, the manufacture, distribution or sale of nicotine-containing e-cigarettes and e-liquids requires a pharmaceutical or medical license. Non-nicotine e-cigarettes and e-liquids are treated as consumer products. Lack of enforcement implies that e-cigs are » Continue Reading.

Regulatory report: France, December 2015

24th December 2015 - Country regulatory reports , Regulatory reports |

Contents1 Executive summary2 Regulatory landscape3 National regulatory framework4 Age restrictions5 Product restrictions requirements6 Labelling and packaging requirements7 Obligation to notify8 Retail channels restriction (including cross-border and distance sales)9 Public usage restrictions10 Advertising, sponsorship and promotion restrictions11 Taxation12 Enforcement13 Case law14 The missing pieces of the TPD   There may be more recent ECigIntelligence reports on this territory. Please visit the » Continue Reading.

Vapor Industry Regulation in the United States: 2016 Outlook

21st December 2015 - Regulatory reports , Topic regulatory reports |

There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United States or the advanced search page. ECigIntelligence has published its comprehensive 106-page end-of-year guidebook on the regulatory landscape for e-cigarettes and the vapor industry in the United States. Titled “Vapor Industry Regulation in the United States: 2016 Outlook” the guide is a full review of federal- and » Continue Reading.

Opinion: the fortunes of the e-cigarette industry in 2016

2nd December 2015 - News analysis |

The e-cigarette world in 2016 will be overshadowed by regulation. But the story will not just be about compliance. The market and the products themselves are rapidly evolving even without the influence of law-makers. So requirements like the TPD and the deeming regulations merely add a further twist to an already complex outlook.

Updated: Polish e-cigarette market report and data analysis

1st December 2015 - Country market reports , Market reports |

ECigIntelligence’s Dan Irwin-Brown brings ECigIntelligence subscribers an updated market report for Poland, analysing the recent drop in e-cig prices. You can also download an Excel spreadsheet with a raft of additional information, including price points for different form factors. There may be more recent ECigIntelligence reports on this territory. Please visit the home page for Poland or the advanced search page.

In depth: Slovakia’s e-cig regulatory landscape

23rd November 2015 - Country regulatory reports , Regulatory reports |

Contents1 Executive summary2 Regulatory landscape3 Current national regulatory framework4 Age restrictions5 Packaging and product restrictions6 Public usage7 Advertising and marketing restrictions8 Case law9 Taxation10 Enforcement11 The future   There may be more recent ECigIntelligence reports on this territory. Please visit the full list of regulatory reports, or the advanced search page.         Executive summary   Slovakia’s provisions are largely in » Continue Reading.

Market update + data analysis: Germany

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

There may be more recent ECigIntelligence reports on this territory. Please visit the home page for Germany or the advanced search page.   ECigIntelligence’s Nikita Dzhain and Dan Irwin-Brown bring you an up-to-date analysis of the underdeveloped German e-cig market, with an invaluable accompanying Excel document packed with data. This includes pricing across all form factors – and how that pricing has changed over time. » Continue Reading.

Update: Poland market report

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

Contents1 Executive summary2 Market size3 Form factors4 Number of e-cigarette users5 Brands6 Pricing7 Distribution8 E-liquids9 Full online pricing methodology:10 11 Full market sizing methodology     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 » 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 |

Contents1 Introduction2 Regulatory landscape3 Devolved administrations4 National regulatory framework5 Near-future situation in devolved administrations6 Product categorisation7 Information requirements8 Additional obligations in UK devolved countries9 Retail channels (cross-border sales)10 Age restrictions11 Devolved administrations12 Product and packaging restrictions13 Labelling and information requirements14 Public usage15 Advertising and marketing restrictions16 Devolved administrations17 Case law18 Taxation19 Enforcement   There may be more recent ECigIntelligence reports » Continue Reading.

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

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

Contents1 Section 1 – Relevant consumer and safety laws2 Section 2 – BCAP/CAP rules and ASA’s enforcement3 Section 3 – Relevant medical organisations’ position towards e-cigs4 Section 4 – Politics and e-cigs in Britain and the British nations5 Section 5 – Summary of consultation questions6 Section 6 – Information sought by the regulator in the UK consultation process   There » Continue Reading.