E-cigarette flavours are causing concern again, but this time not over their purported appeal to youth. The latest study to stoke up worries about harmful substances in e-cigs is “Flavour chemicals in electronic cigarette fluids”,...
New proposals by the Danish government to transpose the European Union’s Tobacco Products Directive (TPD) into Denmark’s domestic law are the first comprehensive attempt to do so by any European...
As the e-cigarette industry gets to grips with the requirements of regulation such as the EU’s Tobacco Products Directive (TPD), ECigIntelligence takes a look at the practical implications on e-cig testing for brands and...
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...
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...
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 •...
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...
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...
E-cigarette regulation: lessons from another industry • Regulatory issues compared • Online gambling regulatory models • Lessons for the e-cigarette...
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...
FDA 9-step regulatory process • Public comment • FDA e-cigarette information requests • FDA case studies: previous FDA efforts to regulate tobacco products • Impact of public comment submissions • Extension of public comment period...
Five years after the U.S. Food and Drug Administration (FDA) finally gained the legal authority to regulate certain tobacco products, the agency is in the middle of what could be a landmark effort to extend...