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.
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
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.
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
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.
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.
Britain’s advertising standards-setters today published their new guidelines for e-cigarette ads, welcomed by the industry, imposing no unexpected restrictions, and allowing e-cigs to be shown in TV commercials for the first time.
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
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 […]
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’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.
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
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
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
The U.S. state of Missouri is to legally distinguish between e-cigarettes and tobacco products, following disagreement among law-makers which saw legislation passed, then vetoed, and finally reinstated.
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.
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
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
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
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
A British e-cigarette supplier is the sector’s first independent to launch a legal challenge against the Tobacco Products Directive (TPD), the EU rules published this year that will regulate the e-cig market in European member states.
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.
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.
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
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
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.
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.
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.
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.
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.
Divisions among British pharmacists over whether to sell e-cigarettes, and who to, have been further highlighted this week by a survey showing that a substantial minority would support making the products available to under-18s.
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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