Evaluation of the Tobacco Heating System 2.2. Part 1: Description of the system and the scientific assessment program

• Published in: Regulatory toxicology and pharmacology Vol. 81; pp. S17 - S26
• Main Authors: Smith, Maurice R., Clark, Bruce, Lüdicke, Frank, Schaller, Jean-Pierre, Vanscheeuwijck, Patrick, Hoeng, Julia, Peitsch, Manuel C.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 30.11.2016
• Subjects: Aerosols; Animals; Computational Biology; Consumer Product Safety; Electronic Nicotine Delivery Systems - adverse effects; Equipment Design; Gene Expression Profiling; Gene Expression Regulation - drug effects; Genetic Markers; Genomics; Harm Reduction; Heat-not-burn; Hot Temperature; Humans; Inhalation Exposure - adverse effects; Modified risk tobacco product; Program Evaluation; Risk Assessment; Scientific assessment approach; Smoke - adverse effects; Smoking - adverse effects; Smoking - genetics; Tobacco harm reduction; Tobacco Industry; Tobacco Products - toxicity; Toxicity Tests - methods; Transcriptome - drug effects; FDA; THS2.2; MRTP; FSPTCA; 3R4F; SA; CDER; OECD; miRNA; BIF; CC; HPHC; Tobacco harm reduction; THS2.2M; Scientific assessment approach; PMI; Modified risk tobacco product; HCI; Heat-not-burn; CVD; PHIM; CTP; NPA; COPD; MRC

This publication introduces a series of eight other publications describing the non-clinical assessment and initial clinical study of a candidate modified risk tobacco product (MRTP) – the Tobacco Heating System 2.2 (THS2.2). This paper presents background information on tobacco harm reduction, to c...