Regulation and Legislation

Could Republicans’ triumph mean a gentler ride for e-cigs?

6th November 2014 - Regulatory briefing |

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

Republicans’ historic victory this week in taking the U.S. mid-term elections’ big prize – control of the Senate – could have a significant impact on the e-cigarette industry’s relationship with Congress, as power shifts to a party renowned for its traditional stance against what it considers burdensome regulations on business.

In depth: Canada regulatory and legal analysis, October 2014

4th November 2014 - Market reports |

Canada
North America
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Market reports

The multi-layered regulatory framework • Tobacco regulation – the multi-layered model in action • No federal regulation of e-cigarettes • 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

In depth: France regulatory and legal update, October 2014

29th October 2014 - Regulatory reports |

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

Current regulatory framework • French courts and their precedents • Recent French regulatory initiatives • Implementation of TPD article 20 • Trade and consumer associations, case law and regulation

In depth: e-cigs in the UK – market and regulatory analysis

26th October 2014 - Regulatory reports |

EU
Europe
United Kingdom
Companies
Market Research
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

A comprehensive survey of the UK e-cigarette market and regulation, including: Market size: estimates and methodology; model assumptions; industry estimates • Consumption patterns: number of e-cigarette users in the UK; comparisons with usage data from outside UK; overview of usage data: “ever” users; tank usage; cigalike usage • Pricing and spend: online pricing; e-liquids; cigalikes; tank systems • Sales, distribution and marketing: online; offline; marketing; medical licensing for e-cigs • Brand ownership and M&A: different blends of acquisition and development; cigalikes • Raw materials and manufacturing • Current regulatory landscape • Advertising: regulatory control; advertising restrictions; the new CAP and BCAP rules; existing advertising restrictions; enforcement of advertising rules • TPD transposition: pre-transposition challenges to the TPD; transposition timeline; significant new rules for e-cigarettes: ECITA and the BSI e-cigarette standards; possible impacts of Totally Wicked’s challenge on article 20 and e-cigarette regulation; overview of ECITA proposal • Medical licensing: marketing authorisation costs for medically licensed e-cigarette product in the UK; manufacturer/import authorisation; pharmacovigilance; wholesale • Existing legislation governing manufacture, import and sale of e-cigarettes in the UK • TPD implementation: the process of implementing EU directives in the UK; the transposition process.

In depth: e-cig advertising rules in Britain and France compared

24th October 2014 - Regulatory reports |

EU
Europe
France
United Kingdom
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

Regulatory control of advertising in the UK • Existing UK advertising restrictions • The New UK Rules • Non-statutory regulation of e-cigarette advertising in France • The two regimes: few similarities

Good COP, bad COP? WHO FCTC urges ad ban, more research

19th October 2014 - Business briefing , Regulatory briefing |

World
Health
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Business briefing
Regulatory briefing

The final recommendations of the World Health Organization (WHO) on e-cigarettes allow for a wide range of regulatory regimes but single out advertising as a prime candidate for controls, as expected, as well as hinting at the need for public place usage restrictions.

In depth: why the FDA treats vitamins easier than e-cigs

15th October 2014 - Market reports |

North America
United States
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Market reports

Heavy-handed regulations for e-cigarettes • The DSHEA: a much lighter touch • Industry-friendly provisions for dietary supplements • Resisting tighter regulation for dietary supplements

NGOs say WHO should prioritise further study, not regulation

10th October 2014 - Regulatory briefing |

Africa
Asia
Australasia
Europe
North America
Russia
South America
United States
World
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

An international group of NGOs has tried to identify middle ground between the die-hard opponents and supporters of e-cigarettes in the run-up to next week’s World Health Organization (WHO) meeting on regulating e-cigs.

In depth: Spain market and regulatory update

3rd October 2014 - Regulatory reports |

EU
Europe
Spain
Market Research
Regulation and Legislation
Regulatory reports

Contents: Market size • Form factors • Individual usage • Retail channel • Major Spanish retailers • Recent upheavals • Regulation • Introduction • Regulatory landscape: from regional to uniform regulation • Current regulatory framework • Comparison with tobacco regulation • Public use restrictions • Age restrictions • Packaging and point-of-sale requirements • Advertising restrictions • Medical claims • Enforcement • Case law • The missing pieces from the TPD jigsaw • The decreto ley option

E-cigarette experts at expos unclear but upbeat

2nd October 2014 - Business briefing |

EU
Europe
France
Nevada
North America
United States
Regulation and Legislation
Business briefing

        Paris and Las Vegas: ECigIntelligence director, Tim Phillips recently chaired the E-cig Vegas: Industry Conference discussion panels where experts debated the current business climate in the sector, the upcoming Food and Drug Administration (FDA) deeming regulations and the science surrounding e-cigarettes. At Vapexpo in Paris meanwhile, Nick Wenbourne, ECigIntelligence legal and […]

In depth: Germany regulatory update September 2014

29th September 2014 - Regulatory reports |

EU
Europe
Germany
Regulation and Legislation
Regulatory reports

Current legal and regulatory framework • Legislation under consideration • Case law on medical/pharmaceutical status of e-cigs • Case law on e-cigs as tobacco products • Import restrictions • Public use and advertising restrictions • TPD implementation • Appendix: Primary lower court cases – medical/pharmaceutical status •
Appendix II: Primary lower court cases – tobacco equivalence • Appendix III: Potential e-cig restrictions

France plans public vaping ban, but goes harder on tobacco

26th September 2014 - Regulatory briefing |

EU
Europe
France
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory briefing

France’s health minister yesterday presented her long-awaited proposals on smoking and vaping to the cabinet, going easier on e-cigs than on tobacco but still introducing a public place ban and advertising restrictions.

In depth: e-cigs in the U.S. – market and regulatory analysis

24th September 2014 - Regulatory reports |

California
North America
United States
Companies
Market Research
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Regulatory reports

A comprehensive survey of the U.S. e-cigarette market and regulation, including: Market size • Consumption patterns • Online pricing • Distribution • Raw material supply • E-cigarette usage surveys • Current U.S. e-cigarette regulation • The future of e-cigarette regulation in the United States • Potential challenges to the deeming regulations • Taxation of e-cigs • State and local government regulation case study – California • Public place restrictions by state and local governments • Challenging the deeming regulations – precedents • The FDA regulatory process • The role and influence of trade and consumer associations

In depth: Spain’s national regulations – and its next steps

22nd September 2014 - Market reports , Regulatory reports |

Europe
Spain
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Market reports
Regulatory reports

Regulatory landscape: from regional to uniform regulation • Current regulatory framework • Comparison with tobacco regulation • Public use restrictions • Age restrictions • Packaging and point-of-sale requirements • Advertising restrictions • Medical claims • Enforcement • Case law • The missing pieces from the TPD jigsaw • The decreto ley option

In depth: FDA deeming regs – the problems and solutions

19th September 2014 - Market reports |

North America
United States
Companies
Policy and Politics
Regulation and Legislation
Market reports

The proposed regulations • FDA e-cigarette information requests • Analysis of SFATA submission • SFATA’s proposed alternative • Analysis of AEMSA submission and proposals • Analysis of Totally Wicked submission and proposals • Conclusions

UK pharma regulator approves cigarette-like vapour device

12th September 2014 - Business briefing , Regulatory briefing |

Europe
United Kingdom
Companies
Health
Marketing and Retailing
Regulation and Legislation
Technology and Innovation
Business briefing
Regulatory briefing

Britain’s medicines regulator has issued a product licence for the nicotine inhaler Voke, which will be sold by British American Tobacco’s subsidiary Nicoventures and looks likely to be the closest pharmaceutically-approved competitor to the e-cigarette.

Updated: the WHO’s influence on global e-cig regulation

11th September 2014 - Regulatory reports |

Africa
Asia
Australasia
EU
Europe
North America
South America
United Kingdom
United States
World
Health
Policy and Politics
Regulation and Legislation
Regulatory reports

What the FCTC is • A global treaty • Broad scope of regulation • The regulatory framework • The FCTC in practice • No enforcement powers • Enforcement by signatories • Self-reporting • Shadow reporting • Influence on European legislation • Promoting tobacco regulation in the developing world • What does the FCTC mean for e-cigarettes • Current status of e-cigs • Political will to regulate • Structural barriers • Non-binding, but influential • Exclusion of e-cig firms • Regulatory options in detail

In depth: what will the WHO decide on e-cig regulation?

8th September 2014 - Regulatory reports |

World
Health
Policy and Politics
Regulation and Legislation
Regulatory reports

WHO’s basis for regulation • Political will to regulate • Regulatory proposals in detail • Likely impact of COP6 recommendations • Industry excluded from consultation? • Russia’s political situation and COP6 • Conclusions

In depth: how e-cig associations set standards, influence policy

3rd September 2014 - Market reports |

EU
Europe
France
North America
United Kingdom
United States
Companies
Policy and Politics
Regulation and Legislation
Market reports

France: influence on regulation and case law • France: influence on standards adoption • French and European associations’ influence on the TPD • UK: ECITA and the BSI e-cigarette standards • UK: developing manufacturing standards • French and British approaches compared • U.S.: industry self-regulation • U.S.: association regulatory and lobbying efforts

In depth: legal challenges to the EU Tobacco Products Directive

27th August 2014 - Regulatory reports |

EU
Europe
Regulation and Legislation
Regulatory reports

The law governing adoption of the TPD • Significant new rules for tobacco and e-cigs • Challenges before transposition • Pre-transposition challenges by member states • Poland’s TPD challenge • Pre-transposition challenges before the UK high court • PMI’s TPD challenge • Totally Wicked’s TPD challenge • Possible post-transposition challenges • Possible impacts on article 20 and e-cig regulation • Potential challenges by other e-cig stakeholders

North Carolina allows prison inmates to buy e-cigarettes

13th August 2014 - Business briefing , Regulatory briefing |

Alabama
Canada
Illinois
Nebraska
North America
North Carolina
Tennessee
United States
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Business briefing
Regulatory briefing

Prison inmates in North Carolina are to be allowed e-cigarettes, following an unusual law-making decision which implicitly gives official recognition to the products as substitutes for tobacco smoking.

FDA told it should abandon deeming regs, turn to Congress

10th August 2014 - Business briefing , Regulatory briefing |

North America
United States
Marketing and Retailing
Policy and Politics
Regulation and Legislation
Business briefing
Regulatory briefing

The U.S. Food and Drug Administration (FDA) is likely to have received a deluge of comments in the run-up to the closing of the public consultation period on its e-cigarette regulations last Friday – among them a biting critique of the agency’s approach from a U.S. vapers’ group.

In depth: little e-cig regulation in Poland, and not much likely

5th August 2014 - Regulatory reports |

EU
Europe
Poland
Policy and Politics
Regulation and Legislation
Regulatory reports

E-cigs are not tobacco products • E-cigs are relatively unregulated • Standard consumer protection law applies • No product standards or requirements • Public use restrictions in significant cities • Limits on local government power • No tobacco taxes, or other special taxes – yet • Implementation of the TPD: scope • Implementation of the TPD: timeline and process • Implementation of the TPD: industry and NGO input • Implementation of the TPD: regulatory authority • Tobacco regulation in Poland

In depth: GMPs – are standards coming for e-cig manufacture?

4th August 2014 - Market reports , Regulatory reports |

EU
Europe
North America
United States
Regulation and Legislation
Technology and Innovation
Market reports
Regulatory reports

GMPs defined • Core principles: control and documentation • Enforcement • Evolution of GMPs: “current GMPs” and international harmonisation • The application of GMPs to tobacco and e-cigarettes • Industry groups and NGOs fill the regulatory void • How might the FDA formulate e-cig GMPs? • Conclusions

No basis for tobacco-style rules, says review of e-cig science

3rd August 2014 - Regulatory briefing |

Europe
North America
Health
Policy and Politics
Regulation and Legislation
Regulatory briefing

A new review of medical and public health research on e-cigarettes concludes that tobacco-style regulation is unjustifiably strict, but also suggests that further research is needed on health effects and the relationship of e-cigs to smoking.

E-liquids: are they as dangerous as European regulators think?

29th July 2014 - Regulatory briefing |

EU
Europe
Regulation and Legislation
Regulatory briefing

Could handling e-liquid really be as safe as doing the dishes?

European regulations on classification, labelling and packaging (CLP) have been wrongly categorising nicotine as extremely toxic when it should be considered the equivalent of washing-up liquid, a new report claims.

City’s health director weighs in on Canadian e-cig confusion

24th July 2014 - Regulatory briefing |

Canada
North America
Policy and Politics
Regulation and Legislation
Regulatory briefing

The director of public health for Canada’s second-largest city has called for national regulation specifically covering e-cigarettes, which would clarify the country’s confusing mixture of proclaimed prohibition and actual tolerance.

Pressure still mounting on FDA over child safety requirements

24th July 2014 - Regulatory briefing |

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

An influential member of the U.S. Congress has urged the Food and Drug Administration (FDA) to mandate child-proofing for e-liquid containers, as the wrangling over whether e-cigarettes pose a threat to young people rumbles on.

Swedish pharma regulator granted control over e-cigs

23rd July 2014 - Regulatory briefing |

Europe
Sweden
Regulation and Legislation
Regulatory briefing

A Swedish court has upheld attempts by the country’s medical products regulator to treat nicotine-containing e-cigarettes as pharmaceuticals, meaning that they must go through a licensing process and cannot be sold in outlets such as groceries and convenience stores.

Crowd-funded appeal against ban on “lookalike” e-cigs

11th July 2014 - Regulatory briefing |

Australasia
Australia
Regulation and Legislation
Regulatory briefing

An Australian e-cigarette retailer is attempting to crowd-fund an appeal after a court ruled that the e-cigarettes the company sold resembled conventional cigarettes – violating Australia’s Tobacco Products Control Act of 2006.