Regulation and Legislation

Welsh government U-turns on proposed public vaping ban

14th December 2015 - Regulatory briefing |

Europe
United Kingdom
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

The Welsh Labour party has backed down on a proposal to enact a wide-ranging ban on vaping in public spaces. However, it would still like to see some areas marked as off-limits to vapers.

Updated infographic: the TPD and European e-cigarette regulation

3rd December 2015 - Regulatory briefing |

Austria
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Regulatory briefing

This new infographic from ECigIntelligence examines the state of e-cigarette regulation and transposition of the EU Tobacco Products Directive (TPD) throughout the European Union.

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

2nd December 2015 - Business briefing |

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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 - Market reports |

Europe
Poland
Market Research
Regulation and Legislation
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 […]

In depth: Slovakia’s e-cig regulatory landscape

23rd November 2015 - Regulatory reports |

Europe
Slovakia
Market Research
Policy and Politics
Regulation and Legislation
Regulatory reports

  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 line with the Tobacco Products Directive (TPD), which categorises e-cigs as tobacco-related products. There is no existing tax proposal for e-cigs in […]

Califf survives Senate hearing on FDA job, seemingly unscathed

22nd November 2015 - Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing

Robert Califf, president Barack Obama’s pick to lead the U.S. Food and Drug Administration (FDA), has expressed his support for the agency’s approach to reviewing innovative tobacco products such as e-cigarettes.

Market update + data analysis: Germany

20th November 2015 - Market reports |

Europe
Germany
Market Research
Marketing and Retailing
Regulation and Legislation
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 […]

Update: Poland market report

20th November 2015 - Market reports |

Europe
Poland
Marketing and Retailing
Regulation and Legislation
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 […]

Hungary regulatory report: an end to mandatory pharma licensing

13th November 2015 - Market reports , Regulatory reports |

EU
Europe
Hungary
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
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 |

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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 - Regulatory briefing |

North America
United States
Regulation and Legislation
Regulatory briefing

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 - Regulatory reports |

England
EU
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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 […]

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

2nd November 2015 - Regulatory reports |

Europe
Scotland
United Kingdom
Wales
Health
Market Research
Marketing and Retailing
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Regulation and Legislation
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. […]

“Leaked deeming regulations” raise questions, offer few answers

29th October 2015 - Regulatory briefing |

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United States
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Regulatory briefing

An e-cigarette industry association this week claimed to be in possession of the U.S. Food and Drug Administration’s forthcoming deeming regulations, but the provenance and authenticity of the brief excerpts that it published remain unclear.

Washington state prosecutes e-cig firms over “organic” claims

29th October 2015 - Regulatory briefing |

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Washington
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The state of Washington has brought charges against e-cigarette firms for wrongly claiming organic status on their products. This move is part of a wider trend by state attorneys general to crack down on marketing of e-cigarette products without e-cig specific legislation in place.

The UK e-cigarette market, October 2015

29th October 2015 - Market reports |

Europe
Scotland
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Wales
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The UK market in 2015 is estimated to be worth around £445million (€619m/$682m), with projected growth of 15% over the next two years. There has been a significant shift to tank, with usage of tanks now at 68% of the vaping population.

Presentation: the state of the e-cigarette industry

27th October 2015 - Business briefing |

Europe
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Exclusive insight for ECigIntelligence readers – download a detailed, data-rich presentation on the current state and future of the e-cig industry.

Video: municipal e-cig taxation in the United States

27th October 2015 - Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing

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.

Deeming regulations reach their final hurdle: the White House

21st October 2015 - Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing

Federal control has come a step closer for the U.S. e-cigarette market this week, with the Food and Drug Administration (FDA) sending its proposed deeming regulations to the White House office responsible for their final review.

Opinion: why zoning is the next big threat to America’s vape stores

16th October 2015 - Regulatory briefing |

California
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The gravest threat to the U.S. vapour industry comes from local government. While state-level attempts to regulate the industry have been largely unsuccessful, hundreds of local laws have come into force.

Italy opts for minimal regulation in draft TPD law

16th October 2015 - Regulatory briefing |

EU
Europe
Italy
Marketing and Retailing
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Regulatory briefing

The e-cigarette industry in Italy appears likely to receive gentle regulatory treatment from the government’s forthcoming implementation of the European Union Tobacco Products Directive (EU TPD).

Washington conferences to consider deeming regs, harm reduction

16th October 2015 - Regulatory briefing |

North America
United States
Virginia
Washington D.C.
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

As the U.S. e-cig industry and policy-makers alike await the final version of the Food and Drug Administration’s deeming regulations, two conferences will be held in the Washington area next week to discuss a spectrum of issues related to tobacco and nicotine policies.

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

14th October 2015 - Regulatory reports |

EU
Europe
Germany
Health
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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 - Regulatory briefing |

EU
Europe
North America
United States
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

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”.

Tobacco product or medical? FDA spells out the difference

24th September 2015 - Regulatory briefing |

North America
United States
Health
Marketing and Retailing
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Technology and Innovation
Regulatory briefing

The U.S. Food and Drug Administration (FDA) is this week proposing a new rule that will make it clearer when tobacco products should be considered as drugs or medical devices, and regulated accordingly.

FDA enforcement on e-cigarette suppliers: risks and strategies

23rd September 2015 - Market reports |

North America
United States
Companies
Health
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Technology and Innovation
Market reports

Executive summary • Introduction • FDA enforcement authority • Development of FDA e-cigarette enforcement • Compliance strategies for the industry • Risk posed by patents

Ireland allows vaping in workplaces, but tightens ad rules

23rd September 2015 - Regulatory briefing |

EU
Europe
Ireland
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

The Irish government has decided not to extend the country’s smoking ban to e-cigarettes, citing the lack of evidence for harm – but the advertising self-regulatory body in Ireland has taken a slightly harder line.

Obama names deputy commissioner Califf to head FDA

16th September 2015 - Regulatory briefing |

United States
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

U.S. president Barack Obama has chosen Rob Califf, currently the deputy commissioner for medical products and tobacco at the Food and Drug Administration (FDA), to head up the agency.

Podcast: state regulation of public vaping in the U.S.

16th September 2015 - Regulatory briefing |

North America
United States
Policy and Politics
Regulation and Legislation
Regulatory briefing

In this exclusive 20-minute podcast for ECigIntelligence, our U.S. regulatory analyst Carly Souther explores the current situation with state regulation of public vaping, and examines its potential implications.

Regulation key to success of tobacco alternatives, say PMI and Altria

11th September 2015 - Regulatory briefing |

Europe
Italy
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Tobacco giant Philip Morris International (PMI) wants to see alternative products take a large share of the nicotine market away from combustible cigarettes as soon as possible – with the help of appropriate regulation.

Portugal adds public vaping ban to new TPD law

7th September 2015 - Regulatory briefing |

Europe
Portugal
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

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 - Regulatory reports |

EU
Europe
Portugal
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
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 - Regulatory briefing |

United States
Marketing and Retailing
Regulation and Legislation
Regulatory briefing

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 […]