Topics: Regulation and Legislation

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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.

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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
Marketing and Retailing
Public Health and Medicine
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
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World
Policy and Politics
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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
Policy and Politics
Public Health and Medicine
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
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North America
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Tennessee
United States
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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

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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
Policy and Politics
Public Health and Medicine
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.

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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.

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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.

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In depth: the complexity of U.S. e-cigarette regulation

3rd July 2014 - Regulatory reports |

California
Louisiana
North America
United States
Regulation and Legislation
Regulatory reports

The multi-layered, multi-jurisdictional regulatory landscape • The structure of federal and state e-cig regulation • Trends in state government regulation • Trends in local government regulation • Case study: regulation of e-cigarettes in California • Deep dive: restriction of e-cig use in “public places” by state and local governments

Poison risk to kids prompts proposal for NY e-liquid ban

3rd July 2014 - Regulatory briefing |

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

Campaigners have accused two New York state senators of failing to see the wood for the trees after they introduced a bill that could prevent businesses from selling, offering to sell or giving away e-liquids.

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In depth: e-gaming’s lessons for e-cigarettes

2nd July 2014 - Regulatory reports |

Africa
Asia
Australasia
EU
Europe
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South America
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World
Regulation and Legislation
Regulatory reports

E-cigarette regulation: lessons from another industry • Regulatory issues compared • Online gambling regulatory models • Lessons for the e-cigarette sector

FDA, WHO petitioners advised to focus on public health

2nd July 2014 - Regulatory briefing |

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

Comments to the U.S. Food and Drug Administration (FDA) on its proposed e-cigarette regulations should focus on public health and skip business issues, an industry organisation has advised.

In depth: potential legal challenges to FDA e-cig rules

21st June 2014 - Regulatory reports |

North America
United States
Regulation and Legislation
Regulatory reports

Tobacco: precedents for challenge • Potential challenges to the deeming regulations • Challenges to scientific foundation • Challenges to pre-market approval and substantial equivalence • Challenges to health warning labels • Challenges to the deeming of e-cigs as tobacco products • Challenges on the grounds that the regulations constitute a ban • Temporary suspension of the rules via injunctive relief • Potential loophole: nicotine not derived from tobacco

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Call for swift action on child safety, but FDA faces delays

19th June 2014 - Regulatory briefing |

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

Ten U.S. public health organisations have today asked the Food and Drug Administration (FDA) to move quickly on child-proofing of e-liquid containers, and extend its proposed e-cigarette regulations to cover flavourings and advertising.

WHO told to remember links with tobacco, make tough policy

18th June 2014 - Regulatory briefing |

Africa
Asia
Australasia
EU
Europe
North America
South America
United States
Policy and Politics
Public Health and Medicine
Regulation and Legislation
Regulatory briefing

Battle lines are drawing up around the World Health Organization (WHO) as it prepares to formulate policy on e-cigarettes which will powerfully influence most countries’ domestic regulation.