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Indonesia: ban looks possible – when government makes its mind up

15 December, 2016 - Regulatory Reports |

Asia
Indonesia
Marketing and Retailing
Public Health and Medicine
Regulation and Legislation
Regulatory Reports

The legal classification of e-cigarettes in Indonesia is far from clear – whether they come under regulations relating to tobacco, pharmaceutical or consumer products.
What does seem clear is that e-cigs continue to be legal for now, despite some reports last year to the contrary. It is possible they may become illegal in future. Our in-depth regulatory report looks at every aspect of e-cigarette regulation in Indonesia.

Belgium: end of medical regulation, new consumer regime imminent

6 December, 2016 - Regulatory Reports |

Belgium
Europe
Regulation and Legislation
Regulatory Reports

The new Belgian law, transposing the TPD, comes into force in January 2017. It will end the classification of e-cigarettes as medical devices and impose severe restrictions, including an online sales ban as well as product, packaging, labelling and advertising restrictions.

Taiwan

Taiwan: likely to end pharma regime for nicotine-containing products

1 December, 2016 - Regulatory Reports |

Asia
Taiwan
Regulation and Legislation
Regulatory Reports

In this report, ECigIntelligence looks in detail at the situation in Taiwan, where the legal situation may possibly be set to change. It is likely that nicotine-containing products will become legal while nicotine-free liquid will be banned, leading unusual situation of nicotine-containing e-cigarettes being available as consumer products while nicotine-free products were treated as pharmaceutical products.

Israel looks set to follow EU or U.S. lead on e-cig legislation

16 November, 2016 - Regulatory Reports |

Asia
Israel
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory Reports

In this report, ECigIntelligence looks at a country with a complex past and slightly complicated present as the Supreme Court recently overturned a five-year ban on e-cigs. ECigIntelligence expects Israel to follow the European or American lead in future legislative decisions.

Bulgaria brings in TPD regulation with the lightest of touches

15 November, 2016 - Regulatory Reports |

Bulgaria
EU
Europe
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory Reports

Bulgaria has taken a gentle approach to adopting Europe’s TPD regulations. E-cigarettes are regarded as “tobacco-related” rather than tobacco products as such, and are treated more benignly than tobacco, with public usage allowed.

Regulation in Norway: ban on nicotine products likely to end

3 November, 2016 - Regulatory Reports |

Europe
Norway
Scandinavia
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory Reports

We strongly expect nicotine-containing e-cigarettes to be legalised in Norway, where their sale has been banned until now. The anticipated move will come as a boost to the Norwegian vaping market, which has already grown by 18% since 2014.

Heat-not-burn in Europe: emerging regulation for a new category

26 October, 2016 - Regulatory Reports |

EU
Europe
Italy
Companies
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Technology and Innovation
Regulatory Reports

This report examines the regulation of heat-not-burn (HnB) or heated tobacco products in Europe, as well as some of the broader regulatory issues that they raise. It considers their treatment under the TPD; the question of whether they are smoking or smokeless products; and issues such as labelling, advertising and taxation. A detailed case study focuses on Italy.

Italy: light-touch TPD transposition with minimal restrictions

21 October, 2016 - Regulatory Reports |

EU
Europe
Italy
Marketing and Retailing
Public Health and Medicine
Regulation and Legislation
Regulatory Reports

Italy has adopted a light touch approach to implementing the European TPD regulations, with only minimum restrictions on the e-cigarette industry. There is only a limited ban on advertising, and no restriction on public use of e-cigs. Cross-border sales are prohibited, but domestic distance sales are allowed. Our report provides a full examination of all aspects of post-TPD e-cigarette regulation in Italy.

Netherlands: TPD followed closely, but some issues remain unresolved

20 October, 2016 - Regulatory Reports |

Europe
Netherlands
Marketing and Retailing
Public Health and Medicine
Regulation and Legislation
Regulatory Reports

Regulation of vape products in the Netherlands follows closely the provisions of the European Tobacco Products Directive (TPD). But although the vaping industry is highly regulated, a few issues remain to be resolved, such as what laboratories will be accredited for product testing. This complete regulatory report examines in detail every aspect of e-cigarette regulation in the Netherlands.

FDA demands health documents from U.S. makers and importers

18 October, 2016 - Regulatory Reports |

North America
United States
Public Health and Medicine
Regulation and Legislation
Regulatory Reports

Following the introduction this summer of the deeming regulations by the U.S. Food and Drug Administration (FDA), each vapour product manufacturer or importer is required to submit health documents describing the physiological, behavioural and toxicological effects of their tobacco products, current or future.

Poland regulatory report: e-cigs regulated as tobacco

30 September, 2016 - Regulatory Reports |

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

Recent legislation transposes the EU’s Tobacco Products Directive into Polish law and regulates e-cigarettes in the same way as tobacco.

This means advertising and vaping are banned in public places are banned, in line with the restrictions on combustible tobacco products.

Required warning statements on U.S. advertisements

23 September, 2016 - Regulatory Reports |

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

The U.S. Final Deeming Rule requires that the advertisements of all covered tobacco products, including e-cigarettes, bear an addictiveness warning label statement. For tobacco products that do not contain nicotine, there is an alternative warning label statement for packages and advertisements.

Croatia regulatory report: TPD finally being transposed

23 September, 2016 - Regulatory Reports |

Croatia
Europe
Marketing and Retailing
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory Reports

E-cigarette products are in the process of being regulated in Croatia, by transposing the Tobacco Product Directive (TPD), once the government is established. We expect the Draft Act on Restriction of the Use of Tobacco Products to be passed by the end of 2016, or early 2017. The delay in transposition led the European Commission (EC) to take an infringement decision against Croatia.

European retailers face complex rules on in-store marketing

20 September, 2016 - Regulatory Reports |

England
EU
Europe
France
Germany
Italy
Netherlands
Northern Ireland
Poland
Scotland
United Kingdom
Wales
Marketing and Retailing
Regulation and Legislation
Regulatory Reports

ECigIntelligence has taken an in-depth look at the current situation for e-cigarette point of sale advertising in six of the biggest e-cig markets in Europe, offering guidance on what can and can’t be done in-store. It is important to take into account that regulation is still developing in many countries, and enforcement and interpretation by authorities is still to be seen.

Advertising, promotion and sponsorship in post-TPD Europe

9 September, 2016 - Regulatory Reports |

EU
Europe
Marketing and Retailing
Regulation and Legislation
Regulatory Reports

The transposition of the European Union’s (EU’s) Tobacco Products Directive (TPD) has introduced changes that have strong implications for the future of the emerging e-cig industry – particularly advertising, promotion and sponsorship. We run through the implications.

Deeming regulations and product packaging: key questions answered

9 September, 2016 - Regulatory Reports |

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

New vapour products have been barred from entry to the U.S. market – but what impact will this have on those already on sale? How will the FDA’s final deeming rule impact the packaging of e-cig products considered “safe”?

France regulatory report: public spaces relaxed, ads banned

5 September, 2016 - Regulatory Reports |

Europe
France
Regulation and Legislation
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.

ECigIntelligence TPD logo - what next

The TPD’s impact on product design explained

1 September, 2016 - Regulatory Reports |

EU
Europe
Regulation and Legislation
Regulatory Reports

The Tobacco Products Directive (TPD) has important implications for the products that are allowed on the e-cig market, because it prescribes their characteristics, such as the permitted concentration of nicotine or the size of bottles.

Exclusive Platinum subscriber download: the TPD era guide

18 August, 2016 - Regulatory Reports |

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czech Republic
Denmark
Estonia
EU
Europe
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxemburg
Malta
Netherlands
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Regulation and Legislation
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 […]

TPD compliance: what to test and how to test it

17 August, 2016 - Regulatory Reports |

EU
Europe
Regulation and Legislation
Technology and Innovation
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.

Irish regulatory report: TPD law includes unusual packaging rule

12 August, 2016 - Regulatory Reports |

EU
Europe
Ireland
Regulation and Legislation
Regulatory Reports

    Executive summary   Ireland’s transposition of the TPD has been quite straightforward, with no tax on e-cigs, and advertising restricted as per the TPD. There is one unique restriction in Ireland’s law, however. The product presentation – the packaging – for electronic cigarettes cannot include any feature that makes reference to the taste […]

Russia: regulations expected by 2017

5 August, 2016 - Regulatory Reports |

Asia
Europe
Russia
Marketing and Retailing
Public Health and Medicine
Regulation and Legislation
Regulatory Reports

        Executive summary   • E-cigarette products are mainly unregulated in Russia, aside from general consumer and safety regulation. • Several initiatives to regulate policy are currently being discussed at the State Duma. These cover areas such as age restriction, advertising, labelling and public place use. • There is currently no excise […]

Regulatory report: Estonia, Latvia, Lithuania

3 August, 2016 - Regulatory Reports |

Estonia
EU
Europe
Latvia
Lithuania
Regulation and Legislation
Regulatory Reports

      Executive summary   Estonia, Latvia and Lithuania are often collectively known as the Baltic states; these adjacent countries are located in north-eastern Europe at the easternmost edge of the European Union (EU), bordering Poland, and the non-EU countries of Russia and Belarus. These three countries are not homogeneous at all, but they […]

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 […]