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Deeming regs: challenges to the sampling ban

29 July, 2016 - Regulatory reports |

Arkansas
Georgia
Iowa
Kentucky
Massachusetts
New Hampshire
New Mexico
North America
Oklahoma
Rhode Island
South Dakota
Tennessee
United States
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
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?

Will U.S. vapour taxes apply to synthetic nicotine?

29 July, 2016 - Regulatory reports |

Kansas
Louisiana
Minnesota
Missouri
North America
North Carolina
Pennsylvania
United States
West Virginia
Policy and Politics
Regulation and Legislation
Regulatory reports

Six U.S. states have enacted an excise tax on e-cigarettes and vapour products. Within these states – Kansas, Louisiana, Minnesota, North Carolina, Pennsylvania, and West Virginia – will synthetic nicotine be subject to tax?

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

1 July, 2016 - Regulatory reports |

North America
United States
Regulation and Legislation
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.

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

26 June, 2016 - Regulatory reports |

North America
United States
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory reports

        Introduction   On 10th May, the U.S. Food and Drug Administration (FDA) finalised its regulations that deemed tobacco products to be subject to the federal Food, Drug, and Cosmetic Act. This rule extended the FDA’s authority to include the regulation of electronic nicotine delivery systems (ENDS) such as e-cigarettes and vape […]

PMTA applications: how the FDA’s policy has developed

26 June, 2016 - Regulatory reports |

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

Many questions remain over how the FDA will actually interpret the requirements for authorisation: how rigid a view it will take on the evidence required to support an application, for example. Comparing a leaked earlier version of the regulations with the final published version provides some clues.

Could e-cigarettes be the next battleground for plain packaging?

10 June, 2016 - Regulatory reports |

Africa
Asia
Australasia
Australia
Belgium
Brazil
Europe
Finland
France
Hungary
Ireland
New Zealand
North America
Norway
Singapore
Slovenia
South Africa
South America
United Kingdom
United States
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory reports

As the tobacco industry braces itself for a global epidemic of plain-packaging legislation, there have been calls for the controversial measure to be applied to e-cigarettes too.

Sweden prepares for consumer regulation after court decision

6 June, 2016 - Regulatory reports |

EU
Europe
Sweden
Regulation and Legislation
Regulatory reports

Draft legislation to transpose Article 20 of the Tobacco Products Directive into Swedish national legislation will be in force by October 2016. The Swedish government is taking quite a lenient approach by allowing distance sales and omitting public place vaping provisions from their planned legislation.

Germany’s post-TPD journey begins; further rules on the way

1 June, 2016 - Regulatory reports |

EU
Europe
Germany
Regulation and Legislation
Regulatory reports

      Executive summary   On 20th May, the European Union’s (EU’s) Tobacco Products Directive (TPD) came into force in Germany, regulating e-cigarettes as tobacco-related products. A draft proposal extending the advertising ban and other restrictions to nicotine-free e-cigarettes and e-liquid was notified to the European Commission (EC) as it goes beyond the requirements […]

Deeming regulations in detail: the deadlines for initial compliance

20 May, 2016 - Regulatory reports |

North America
United States
Marketing and Retailing
Regulation and Legislation
Regulatory reports

In this ECigIntelligence report, we examine in detail the schedule for the U.S. deeming regulations’ major requirements affecting products that already exist on 8th August 2016, which will bring them into compliance with the regulations for the short term.

UK regulatory and medical bodies proffer broad views before TPD

11 May, 2016 - Regulatory reports |

England
EU
Europe
Northern Ireland
Scotland
United Kingdom
Wales
Regulation and Legislation
Regulatory reports

      Executive summary   England’s much lighter-touch approach to regulation quite different to Scotland, Wales and Northern Ireland. Unsurprisingly, many UK organisations have strong views on e-cigarette regulation; some of the industry’s strongest backers are charities including the British Heart Foundation, Tenovus, and the British Lung Foundation. The anti-e-cig lobby includes significant organisations […]

UK fragmented on regulation as TPD fast approaches

10 May, 2016 - Regulatory reports |

England
EU
Europe
Northern Ireland
Scotland
United Kingdom
Wales
Regulation and Legislation
Regulatory reports

      Introduction   As ECigIntelligence predicted, the British government has transposed the TPD with minimal additional restrictions. Distance sales will be permitted and registration will only be demanded for retailers who engage in cross border distance retail. Even though the central government implemented the minimum TPD restrictions for advertising, Scotland plans stricter regulation. […]

Slovenia’s tough post-TPD regime: no advertising, no online sales

28 April, 2016 - Regulatory reports |

EU
Europe
Slovenia
Regulation and Legislation
Regulatory reports

      Executive summary   E-cigarettes are not currently regulated in Slovenia. However, a strict regime will apply from May onwards, when nearly all forms of advertising will be forbidden and online sales banned under the Tobacco Products Directive (TPD). A public place smoking ban has been extended to vaping by the official draft proposal […]

Austria poised to enter stricter post-TPD regulatory landscape

27 April, 2016 - Regulatory reports |

Austria
EU
Europe
Regulation and Legislation
Regulatory reports

      Executive summary   E-cigarette products are currently unregulated in Austria, so they are sold freely. But this is set to change from May when the European Union’s (EU’s) Tobacco Products Directive (TPD) comes into effect. The official draft proposal will transpose the TPD into Austrian national legislation and regulates e-cigarettes as tobacco-related […]

Belgium: e-cigs become consumer products, but tough rules likely

15 April, 2016 - Regulatory reports |

Belgium
EU
Europe
Policy and Politics
Regulation and Legislation
Regulatory reports

    Executive summary   Nicotine-containing products will become legal for the first time in Belgium, in contrast with the previous situation where a medical regime required a licence. Distance sales will not be allowed. However, the regulator has chosen not to prohibit some product characteristics and activities. Flavours will be allowed, for example. So far […]

Canada’s e-cig regulation a three-tiered tangle

29 March, 2016 - Regulatory reports |

Canada
North America
Regulation and Legislation
Regulatory reports

      Executive summary   The federal government’s regulatory stance on e-cigs is unclear, which is causing confusion in the industry and among regulatory bodies. The federal Health Canada agency has issued an advisory regulating the sale and marketing of e-cigarettes, but it lacks the authority to do so. Nevertheless, the advisory has impacted […]

Denmark: draft TPD law will end licensing requirement

17 March, 2016 - Regulatory reports |

Denmark
EU
Europe
Regulation and Legislation
Regulatory reports

      Executive summary   Nicotine-containing e-cigarettes can’t be sold or advertised without a medical licence in Denmark. Selling nicotine-containing e-cigs and e-liquids as consumer products without a pharmaceutical licence will be legal after 20th May, when the draft proposal to transpose the EU Tobacco Products Directive (TPD) comes into force (on 7 June […]

E-cig advertising in the United States: defining the boundaries

16 March, 2016 - Regulatory reports |

North America
United States
Marketing and Retailing
Regulation and Legislation
Regulatory reports

      Executive Summary   In the U.S., there are laws in place to regulate misleading marketing claims, which apply to e-cigarettes. However, the advertising requirements related to tobacco products are much broader in scope – several laws and regulations prohibit broadcast advertisement, limit print advertising, and require health warnings on labels. Anti-nicotine advocates […]

Romania regulatory report: tax regime in place, TPD on the way

14 February, 2016 - Regulatory reports |

EU
Europe
Romania
Policy and Politics
Regulatory reports

    Executive summary   Tax is levied on e-cigs and e-liquid from 1st January 2016. Apart from taxation, e-cigarettes are mainly unregulated in Romania. From May 2016 onward, new legislation comes into place transposing the Tobacco Products Directive (TPD) and introducing strict restrictions on advertising and distance sales.     Regulatory landscape   Romania […]

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

10 February, 2016 - Regulatory reports |

North America
United States
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
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.

Finland regulatory report: pharma regime ending, new rules arriving

9 February, 2016 - Regulatory reports |

Europe
Finland
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

      Introduction   Nicotine-containing e-cigarettes, currently illegal in Finland unless a medical licence has been obtained, will become legal from May 2016 and be treated as tobacco-related products. Despite this liberalisation, however, prohibitions that threaten the development of the e-cig industry will be introduced. Most importantly, flavours will be banned as well as […]

Netherlands TPD report

5 February, 2016 - Regulatory reports |

Europe
Netherlands
Policy and Politics
Regulation and Legislation
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.

In depth update: e-cigarette regulation in Croatia, 2016

28 January, 2016 - Regulatory reports |

Croatia
EU
Europe
Policy and Politics
Regulation and Legislation
Regulatory reports

Regulatory landscape • Current national regulatory framework • Age restrictions • Packaging and product restrictions • Public usage • Advertising and marketing restrictions • Case law • Taxation • Enforcement • The missing pieces from the TPD jigsaw

Manila skyline

Philippines unregulated but local laws on horizon

28 January, 2016 - Regulatory reports |

Asia
Philippines
Market Research
Policy and Politics
Regulation and Legislation
Regulatory reports

In the Philippines e-cigs are regulated as any other consumer product, therefore, the e-cig industry is largely unrestricted; in other words, very few product limitations apply, public usage and advertising is permitted, and e-cigs can be sold in any retail outlet.

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

26 January, 2016 - Regulatory reports |

Asia
Japan
Marketing and Retailing
Policy and Politics
Regulation and Legislation
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.

Updated: Germany’s draft TPD plans and beyond

19 January, 2016 - Regulatory reports |

EU
Europe
Germany
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
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

Spanish regulation: TPD looms, regions react

15 January, 2016 - Regulatory reports |

Europe
Spain
Regulation and Legislation
Regulatory reports

    Executive Summary     The Spanish regulator has initiated the process to transpose the TPD and regulate e-cigs: Advertising, promotion and sponsorship will mainly be restricted in line with the TPD Harsher public usage restrictions are not envisaged, therefore, e-cigs continue to be treated more favourably than tobacco products Cross-border and distance sales […]

Italy in-depth: preparing for the TPD

31 December, 2015 - Regulatory reports |

Europe
Italy
Regulation and Legislation
Regulatory reports

    Executive Summary   A draft legislative decree fully transposing the TPD is currently in the process of being enacted in the Italian Parliament. According to the draft, only the minimum restrictions required by the TPD will be imposed on the e-cig industry (e.g. no full advertising ban). No public usage restrictions are envisaged […]

Malaysia’s e-cig landscape, 2015

30 December, 2015 - Regulatory reports |

Asia
Malaysia
Singapore
Policy and Politics
Regulation and Legislation
Regulatory reports

    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 widely available. Five Malaysian states (Terengganu, Penang, Kedah, Johor, Kelantan) have banned the sale of any […]

Regulatory report: France, December 2015

24 December, 2015 - Regulatory reports |

Europe
France
Regulation and Legislation
Regulatory reports

Executive summary   One of the largest e-cig markets, France has enacted regulations specific to e-cigarettes (inter alia, nicotine concentration, labelling and advertising); these regulations do not place an excessive burden on the industry and are not compliant with the Tobacco Products Directive (TPD). The French government is committed to transpose the TPD and further […]

Vapor Industry Regulation in the United States: 2016 Outlook

21 December, 2015 - Regulatory reports |

North America
United States
Regulation and Legislation
Regulatory reports

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 state-level regulatory development for the sector in 2015, and what can be learnt from this […]

In depth: Slovakia’s e-cig regulatory landscape

23 November, 2015 - Regulatory reports |

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

    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 Slovakia, they are currently subject only to VAT. A grandfathering clause for products not TPD compliant allows e-cig manufacturers a window to commercialise […]

Hungary regulatory report: an end to mandatory pharma licensing

13 November, 2015 - Market reports , Regulatory reports |

EU
Europe
Hungary
Marketing and Retailing
Policy and Politics
Public Health and Medicine
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

12 November, 2015 - Regulatory reports |

North America
United States
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Technology and Innovation
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

Regulatory report: UK gears up for fragmented TPD transposition

3 November, 2015 - Regulatory reports |

England
EU
Europe
Scotland
United Kingdom
Wales
Market Research
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory reports

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 advertising and promotion of e-cigarettes. As ECigIntelligence predicted, the British government plans to transpose the TPD with minimal […]

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

2 November, 2015 - Regulatory reports |

Europe
Scotland
United Kingdom
Wales
Market Research
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory reports

  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 and safety laws 1. General Product Safety Regulations 2005 (an implementation of Directive 2001/95/EC) The General Product Safety […]

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

14 October, 2015 - Regulatory reports |

EU
Europe
Germany
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
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

E-cigarette regulation in Portugal: TPD plans become clear

6 September, 2015 - Regulatory reports |

EU
Europe
Portugal
Marketing and Retailing
Policy and Politics
Public Health and Medicine
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

E-cigarette regulation in Poland: the road ahead

2 September, 2015 - Regulatory reports |

EU
Europe
Poland
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

Executive summary • Introduction • Current national regulatory framework • Age restrictions • Product and packaging restrictions • Retail channels • Notification procedure • Public place usage • Advertising restrictions • Taxation • Case law • Enforcement • The missing pieces from the TPD jigsaw

Watch out, there’s a state attorney general about

24 August, 2015 - Regulatory reports |

California
Indiana
Kentucky
Maine
New York
North Carolina
Ohio
United States
Washington
Policy and Politics
Regulation and Legislation
Regulatory reports

Executive summary • Introduction • The powers of attorneys general • AG attitudes to the e-cigarette industry • Advertising and marketing • Child-proof packaging • Age verification systems • Consumer protection • Attorney general co-operation

E-cigarette regulation and outlook for Bulgaria, August 2015

18 August, 2015 - Regulatory reports |

Bulgaria
EU
Europe
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory reports

Regulatory landscape • Current national regulatory framework • Age restrictions • Packaging and product restrictions • Public usage • Advertising and marketing restrictions • Case law • Taxation • Enforcement • The future • Graphic: how Bulgarian e-cigarette regulation will change

E-cigarette regulatory outlook for Switzerland, August 2015

13 August, 2015 - Regulatory reports |

Europe
Switzerland
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

Introduction • Regulatory landscape • National regulatory framework • Regulatory change • Timeline for the revised Federal Tobacco Products Act • Age restrictions • Packaging restrictions: current • Packaging restrictions: future • Product restrictions • Public usage • Advertising and marketing restrictions • Taxation • Enforcement • Looking ahead

The costs and challenges of the BSI PAS

31 July, 2015 - Regulatory reports |

EU
Europe
United Kingdom
Companies
Regulation and Legislation
Technology and Innovation
Regulatory reports

ECigIntelligence breaks down the minimum cost it is likely to require for a company to meet the recommendations laid out in the British Standards Institution (BSI) publicly available specification (PAS).

In-depth: e-cigarette legislation in Cyprus, July 2015

30 July, 2015 - Regulatory reports |

Cyprus
EU
Europe
Policy and Politics
Regulation and Legislation
Regulatory reports

    Executive summary   E-cigarettes are not currently regulated in Cyprus but they are subject to general consumer protection and safety regulations unless they are deemed a medicine “by presentation”.   ECigIntelligence has learned that the Medical and Public Health Services (MPHS) at the Ministry of Health is drafting a bill for the transposition […]

E-cigarette regulation in Canada, July 2015

24 July, 2015 - Regulatory reports |

Canada
North America
Policy and Politics
Regulation and Legislation
Regulatory reports

Executive summary • Introduction • The multi-layered regulatory framework • Tobacco regulation – the multi-layered model in action • No federal regulation of e-cigs • The role of Health Canada • Provincial regulation • Municipal regulation • Trade associations and industry standards • Appendix 1: provincial and territorial tobacco regulation in Canada • Appendix 2: market authorisation in Canada

Implementing the TPD: what Europe will do next

23 July, 2015 - Regulatory reports |

EU
Europe
Policy and Politics
Regulation and Legislation
Regulatory reports

Executive summary • Background • Implementing acts and reports • Implementing act: reporting format • Implementing act: refill mechanisms • Report: potential public-health risks • The regulation-makers • External contractors and the expert group • What lies ahead? • A European excise tax on e-cigs? • Timeline

Deeming regulations vs state law: who wins?

17 July, 2015 - Regulatory reports |

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

Introduction • The deeming regulations: express pre-emption of state laws • Where pre-emption does not apply • Pre-emption in practice: California’s Prop 65 • How pre-emption can prevent state-level litigation • Appendix: the doctrine of pre-emption • Appendix: Tobacco Control Act provisions

E-cigarette regulation and outlook in Hungary, July 2015

17 July, 2015 - Regulatory reports |

Europe
Hungary
Policy and Politics
Regulation and Legislation
Regulatory reports

Regulatory landscape • Current national regulatory framework • Product categorisation • Age restrictions • Packaging and product restrictions • Public usage • Advertising and marketing restrictions • Taxation • Case law • Enforcement • The missing pieces from the TPD jigsaw • Graphic: how Hungarian e-cigarette regulation will change