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Regulation and Legislation

France regulatory report: public spaces relaxed, ads banned

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

One of the world’s largest e-cig markets, France has transposed the Tobacco Products Directive (TPD) in several pieces of legislation, starting with the Health Law plus decrees and ordinances with more detailed product specific regulation for e-cigarettes.

The most stringent provision has been an almost complete ban on any type of advertising and sponsorship, which equalises the e-cig regime with that of tobacco.

Report: Netherlands market shrinks but promises stability

1st September 2016 - Country market reports , Market reports |

Contents1 Executive summary2 Market background and development3 Market size and growth prospects4 Vaper population5 Form factors and future trends6 Distribution7 Big Tobacco8 Online and offline companies9 E-liquids10 Pricing11 Associations12 Methodologies   There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the Netherlands or the advanced search page.         Executive summary   Market size is » Continue Reading.

The EU’s TPD: latest news, reports and trackers

31st August 2016 - News analysis |

Contents1 News articles2 In-depth reports3 Key facts This page provides an updated repository for all major ECigIntelligence articles, reports and database trackers concerning the EU Tobacco Products Directive (TPD) going back to 4th July 2016. Older articles dating to the start of the year can be found on this summary page. Information preceding that can be located through the search facility or » Continue Reading.

Exclusive Platinum subscriber download: the TPD era guide

18th August 2016 - Regulatory reports , Topic regulatory reports |

ECigIntelligence recently published a new guide to Europe’s post-Tobacco Products Directive era, a 152-page book packed with information every e-cig business needs to conduct business in the world’s largest economic area. ECigIntelligence Platinum subscribers can download a complimentary copy of The TPD era: e-cigarette regulation in Europe – 2016 and beyond. Non-Platinum subscribers can download a free excerpt preview of the » Continue Reading.

TPD compliance: what to test and how to test it

17th August 2016 - Regulatory reports , Topic regulatory reports |

The EU’s Tobacco Products Directive (TPD) demands that manufacturers supply information on the ingredients and components of e-cig products, as well as testing ingredients and carrying out toxicological assessments – but it is vague on the detail of what to test and how. More clarity has been forthcoming from the European Commission (EC), however, with guidance on its expectations for testing.

E-cig supporters file amicus briefs in deeming regulations case

12th August 2016 - News analysis |

A series of three amicus briefs have been submitted to an ongoing case against the U.S. Food and Drug Administration (FDA) deeming regulations on e-cigarettes. These briefs – documents of unsolicited information submitted to the court by third parties in order to assist it in judging the case – have been presented to the U.S. District Court for the District of » Continue Reading.

Irish regulatory report: TPD law includes unusual packaging rule

12th August 2016 - Country regulatory reports , Regulatory reports |

Contents1 Executive summary2 Regulatory landscape3 National regulatory framework4 Product restrictions5 Labelling and packaging6 Information obligations7 Retail channels restriction (including cross-border and distance sales)8 Public usage9 Advertising and marketing10 Taxation11 Enforcement   There may be more recent ECigIntelligence reports on this territory. Please visit the home page for Ireland or the advanced search page.       Executive summary   Ireland’s transposition of the TPD » Continue Reading.

Russia: regulations expected by 2017

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

Contents1 Executive summary2 Regulatory landscape3 National regulatory framework4 Age restrictions5 Labelling and packaging6 Retail channel restrictions (including cross-border and distance sales)7 Public usage8 Advertising and marketing9 Taxation10 Enforcement11 Case law12 Future developments   There may be more recent ECigIntelligence reports on this territory. Please visit the home page for Russia or the advanced search page.         Executive summary   • E-cigarette » Continue Reading.

Regulatory report: Estonia, Latvia, Lithuania

3rd August 2016 - Country regulatory reports , Regulatory reports |

Contents1 Executive summary2 TPD common rules3 Legal framework in the Baltic nations4 Estonia (Eesti)5 Latvia (Latvija)6 Lithuania (Lietuva)   There may be more recent ECigIntelligence reports on these territories. Please visit the full list of regulatory reports, or the advanced search page.       Executive summary   Estonia, Latvia and Lithuania are often collectively known as the Baltic states; these adjacent countries » Continue Reading.

Deeming regs: challenges to the sampling ban

29th July 2016 - Regulatory reports , Topic regulatory reports |

When the U.S. deeming regulations come into effect on 8th of August, the distribution of free e-liquid samples will be prohibited in the U.S. The U.S. Food and Drug Administration (FDA) justifies this ban as necessary for the protection of the public health but retailers believe it will undermine their profits without having a noticeable public health benefit. What challenges follow?

Challenging the U.S. deeming rule: the legal options and their chances

1st July 2016 - Regulatory reports , Topic regulatory reports |

The U.S. FDA’s final deeming rule is likely to be the subject of a number of legal challenges if finalised in its current form. This could delay the application of any final regulations by several years, and could ultimately lead to a court setting the deeming rule aside – at least with regard to e-cigs.

This report examines the “next steps” for industry, the current and potential challenges, as well as the possibility of congressional relief.

Video presentation: disharmony and the EU TPD

30th June 2016 - News analysis |

At June’s Global Forum on Nicotine in Warsaw, ECigIntelligence editorial director Barnaby Page took a look at some of the inconsistencies that are emerging in European regulation of e-cigarettes despite the standardisation imposed by the EU Tobacco Products Directive (TPD). Here is his presentation.

The deeming rule and PMTAs: what it all means for manufacturers

26th June 2016 - Regulatory reports , Topic regulatory reports |

Contents1 Introduction2 Why an ENDS product requires FDA approval3 Pathways to approval4 The FDA guidance on PMTAs5 PMTAs, public health, and scientific studies     There may be more recent ECigIntelligence reports on this territory. Please visit the home page for the United States or the advanced search page.       Introduction   On 10th May, the U.S. Food and Drug Administration (FDA) » Continue Reading.

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