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...