Back to Search
Start Over
Assessing modified risk tobacco and nicotine products: Description of the scientific framework and assessment of a closed modular electronic cigarette.
- Source :
-
Regulatory Toxicology & Pharmacology: RTP . Nov2017, Vol. 90, p342-357. 16p. - Publication Year :
- 2017
-
Abstract
- Cigarette smoking causes many human diseases including cardiovascular disease, lung disease and cancer. Novel tobacco products with reduced yields of toxicants compared to cigarettes, such as tobacco-heating products, snus and electronic cigarettes, hold great potential for reducing the harms associated with tobacco use. In the UK several public health agencies have advocated a potential role for novel products in tobacco harm reduction. Public Health England has stated that “The current best estimate is that e-cigarettes are around 95% less harmful than smoking” and the Royal College of Physicians has urged public health to “Promote e-cigarettes widely as substitute for smoking”. Health related claims on novel products such as ‘reduced exposure’ and ‘reduced risk’ should be substantiated using a weight of evidence approach based on a comprehensive scientific assessment. The US FDA, has provided draft guidance outlining a framework to assess novel products as Modified Risk Tobacco Products (MRTP). Based on this, we now propose a framework comprising pre-clinical, clinical, and population studies to assess the risk profile of novel tobacco products. Additionally, the utility of this framework is assessed through the pre-clinical and part of the clinical comparison of a commercial e-cigarette (Vype ePen) with a scientific reference cigarette (3R4F) and the results of these studies suggest that ePen has the potential to be a reduced risk product. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 02732300
- Volume :
- 90
- Database :
- Academic Search Index
- Journal :
- Regulatory Toxicology & Pharmacology: RTP
- Publication Type :
- Academic Journal
- Accession number :
- 125780541
- Full Text :
- https://doi.org/10.1016/j.yrtph.2017.09.008