Policy and Politics

U.S. state and federal regulation: what to expect in 2016

10th February 2016 - Regulatory reports , Topic regulatory reports |

More vapour-related bills were introduced during the 2015 state legislative sessions than ever before, and ECigIntelligence expects even more vapour regulation to be proposed during the 2016 regular session. This report looks at the current regulatory situation across the U.S. in key areas such as manufacturing, labelling, advertising and marketing, public place usage, youth access and taxation, and forecasts the regulatory trends for 2016.

U.S. manufacturing standards: increasing costs and confidence?

9th February 2016 - Market reports , Topic market reports |

Contents1 Executive summary2 Introduction3 Current good manufacturing practices4 Adulteration and misbranding5 Quality control at state level6 The bottom line7 Appendix I: examples of cGMP for vapour companies8 Appendix II: FD&C Act chapter IX: tobacco products   There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United States or the advanced search page.       Executive » Continue Reading.

Finland regulatory report: pharma regime ending, new rules arriving

9th February 2016 - Country regulatory reports , Regulatory reports |

Contents1 Introduction2 Regulatory landscape3 Current national regulatory framework4 Upcoming regulatory changes5 Age restrictions6 Product restrictions7 Labelling and packaging: current8 Labelling and packaging: near future9 Sale restrictions10 Retail licensing11 Public usage12 Exceptions to the public vaping ban13 14 Advertising and marketing15 Notification and surveillance obligations16 17 Taxation18 Enforcement19 Next steps   There may be more recent ECigIntelligence reports on this territory. » Continue Reading.

Netherlands TPD report

5th February 2016 - Country regulatory reports , Regulatory reports |

E-cigarettes are legal in the Netherlands, and are currently regulated as consumer products. But from May 2016, new regulations transposing the EU Tobacco Products Directive will enter into force. Our report examines current and future regulation of e-cigarettes in the Netherlands in detail.

E-cigarette regulation in Japan: the future is still pharma

26th January 2016 - Country regulatory reports , Regulatory reports |

E-cigarette products containing nicotine cannot be sold in Japan without a pharmaceutical licence, and there appears to be little immediate likelihood of that changing. However, imports are tolerated and nicotine-free products can be sold. Our in-depth report on Japanese regulation examines the legal framework and specific legislation that constrains the e-cig market there.

Denmark scales down plans for public vaping restrictions

22nd January 2016 - News analysis |

Denmark’s government has had second thoughts about imposing a strict, tobacco-style regime on vaping in public places. A new draft of wide-ranging legislation which will make e-cigarettes available as consumer products, transpose the European Union’s Tobacco Products Directive (TPD), and set a minimum purchase age of 18 as well as regulating public usage of e-cigs was put before the Danish » Continue Reading.

Updated: Germany’s draft TPD plans and beyond

19th January 2016 - 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

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?

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.

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.

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.

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