Introduction • The deeming regulations: express pre-emption of state laws • Where pre-emption does not apply • Pre-emption in practice: California’s Prop 65 • How pre-emption can prevent state-level litigation • Appendix: the...
Legislative solution: giving the FDA discretion • Legislative solution: changing the grandfathering date • Legislative solution: amending the Tobacco Control Act • Judicial challenge: the Tobacco Control Act’s purpose • Judicial challenge: scientific evidence •...
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”,...
Introduction • The matrix of authority • State government regulation • Local government regulation • Regulation by quasi-governmental institutions • Regulatory trends • Appendix: state law – health and safety codes and consumer protection...
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 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 •...
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...