Regulation and Legislation

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

11th September 2014 - 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: how e-cig associations set standards, influence policy

3rd September 2014 - 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 |

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

FDA told it should abandon deeming regs, turn to Congress

10th August 2014 - News analysis |

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 |

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

Swedish pharma regulator granted control over e-cigs

23rd July 2014 - News analysis |

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.

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

3rd July 2014 - 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

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

21st June 2014 - 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