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
• ISSN: 0273-2300; 1096-0295; 1096-0295
• DOI: 10.1016/j.yrtph.2016.07.006

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 complement the approaches aimed at increasing smoking cessation and reducing smoking initiation to reduce the morbidity and mortality caused by cigarette smoking. THS2.2 heats tobacco without combustion, and the resulting formation of harmful and potentially harmful constituents (HPHC) is greatly reduced compared with cigarette smoke. Assessment of the THS2.2 aerosol in vitro and in vivo reveals reduced toxicity and no new hazards. Additional mechanistic endpoints, measured as part of in vivo studies, confirmed reduced impact on smoking-related disease networks. The clinical study confirmed the reduced exposure to HPHCs in smokers switching to THS2.2, and the associated transcriptomic study confirmed the utility of a gene expression signature, consisting of only 11 genes tested in the blood transcriptome of subjects enrolled in the clinical study, as a complementary measure of exposure response. The potential of THS2.2 as an MRTP is demonstrated by the assessment and additional publications cited in this series. •Tobacco harm reduction as an approach to reduce individual and population risk of smoking.•Scientific assessment process for Modified risk tobacco products is described.•The heat-not-burn tobacco product, Tobacco Heating System 2.2. is described.•Results reported confirm the potential for THS2.2 to be a reduced risk product.