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Session 24

Approaches for the assessment of next generation tobacco and nicotine products

Programme of the Session

  • An assessment strategy for candidate modified-risk tobacco products (MRTP) 
    Manuel Peitsch, Maurice Smith, Bruce Clark, Frank Luedicke, Jean-Pierre Schaller, Patrick Vanscheeuwijck, Julia Hoeng 
    Research & Development, Philip Morris International, Neuchatel, Switzerland
  • Non-clinical and clinical assessment of an e-cigarette product
    Christopher Proctor, Marianna Gaca, Frazer Lowe, Emmanuel Minet, Stacy Fiebelkorn, Krishna Prasad, Oscar Camacho, Ian Fearon, Chuan Liu, Christopher Wright, Kevin McAdam, James Murphy 
    Research & Development, British American Tobacco Limited, Southampton, United Kingdom
  • Pathway to regulatory submission: the Swedish Match story 
    Jim Solyst 
    Swedish Match, Severna Park, United States
  • Tobacco harm reduction and e-cigarettes 
    Riccardo Polosa1,2 
    1Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy; 2Institute of Internal Medicine and Clinical Immunology, University Hospital "Policlinico-V. Emanuele", Catania, Italy
  • Building pathways for regulatory acceptance of alternative methods for tobacco product assessment 
    Erin Hill, Holger Behrsing 
    Institute for In Vitro Sciences, Gaithersburg, United States

Session Abstract

A framework for the assessment of novel tobacco products with the potential to reduce health risks compared to cigarettes has been under discussion for over a decade, after the US Institute Of Medicine issued its report 'Clearing the smoke - the scientific basis for tobacco harm reduction' [1]. Currently, however, this harm reduction potential has yet to be scientifically substantiated and the US Food and Drug Administration (FDA), is the only national regulator to have provided a draft framework with which to assess novel tobacco and nicotine products for their harm reduction potential via their Modified Risk Tobacco Product directive [2]. In addition to the FDAs proposed regulatory assessment framework, the National Cancer Institute’s (NCI) Tobacco Product Assessment Consortium (TobPRAC) presented a four-stage model inclusive of pre-market evaluation; pre-claims evaluation; post-market activities; and monitoring and re-evaluation [3]. 
In April 2014, the European Union (EU) adopted the EU Tobacco Products Directive (2014/40/EU) (TPD), which regulates the manufacture, presentation and sale of tobacco products in the EU. The TPD aims to reduce the different approaches to tobacco regulation in the 28 EU Member States, laying down minimum rules for cigarettes, cigars, pipe tobacco, cigarillos (short and slim cigars), smokeless tobacco (snus), Roll-Your-Own tobacco (RYO), and E-cigarettes.
This session wishes to build on those frameworks highlighting the required science from non-clinical (a combination of chemical, in vitro toxicology, adverse outcomes pathways (AOPs) and systems biology) to clinical biomarkers and population  studies across a spectrum of tobacco and nicotine products. The presentations will describe the challenges faced in adopting standardisation of methodologies and application of these methods using integrated approaches to support product assessment and to interpret and report the data for regulatory purposes.
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