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Priority Setting of Harmful and Potentially Harmful Constituents (HPHCs) in Tobacco Smoke Products with Bioinformatics

Principal Investigator: Weida Tong/Michael Orr

Funding Mechanism: JV

ID number: C12038/E0750901

Award Date: 9/20/2012

Institution: National Center for Toxicological Research


Based on available information, FDA established a list of 93 HPHCs found in tobacco products and/or tobacco smoke and identified a representative subset of 20 HPHCs to be reported by tobacco product manufacturers. Well-established testing methods are available for these 20 HPHCs; however, tobacco and tobacco smoke include approximately 8,400 constituents. New scientific information about constituents may prompt FDA to add to or remove HPHCs from the current list.  Unfortunately, health-related data regarding most tobacco constituents is not readily available to support informed decision-making.  Some data can be extracted using bioinformatics from public domains such as PubMed.  NCTR has established several bioinformatics approaches to analyze data from published literature and public databases for drug safety; investigators have successfully applied these methodologies to set drug analysis priorities based on toxicity profiles. These methodologies can be refined and modified to inform prioritization of HPHCs by health risk. The goal of this project is to identify and predict the major health endpoints associated with tobacco constituents; specific aims are: (1) to develop and apply the bioinformatics methods to prioritize the HPHCs using data from the literature and public databases, and (2) to extend the application of these methods to the entire list of tobacco and tobacco smoke constituents for priority setting.  This project will facilitate an understanding of the risks of tobacco products to users and non-users, and may inform regulatory activities.

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