This report examines the regulation of heat-not-burn (HnB) or heated tobacco products in Europe, as well as some of the broader regulatory issues that they raise. It considers their treatment under the TPD; the question of whether they are smoking or smokeless products; and issues such as labelling, advertising and taxation. A detailed case study focuses on Italy.
The EU’s Tobacco Products Directive (TPD) demands that manufacturers supply information on the ingredients and components of e-cig products, as well as testing ingredients and carrying out toxicological assessments – but it is vague on the detail of what to test and how. More clarity has been forthcoming from the European Commission (EC), however, with guidance on its expectations for testing.
Executive summary • Introduction • Why an electronic nicotine delivery system (ENDS) product requires a PMTA: distinction among ENDS products, components/parts, and accessories; three pathways to market approval; concerns about the grandfather date • Guidance for industry: information on premarket tobacco product applications (PMTA) and the submission process • Public health considerations: scientific evidence, comparative analysis, voluntary restrictions on sale and distribution, nicotine exposure warnings, child-resistant packaging, alternatives to new scientific studies, government-sponsored databases, non-U.S. randomised controlled clinical trials, literature reviews or reports • FDA enforcement for manufacturers and retailers: enforcement limited to finished tobacco products; independent vapour shops considered as tobacco product manufacturers • Appendix 1: definitions • Appendix 2: submitting a PMTA
ECigIntelligence breaks down the minimum cost it is likely to require for a company to meet the recommendations laid out in the British Standards Institution (BSI) publicly available specification (PAS).
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 manufacturers.
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
Market intelligence • Market structure • Regulatory landscape