Role of testing standards in smoke-free product assessments.

Testing standards for tobacco and related products are an important basis for product science-based regulation. The recent emergence and rapid growth of products offering an alternative to continued smoking for adult smokers who would otherwise continue to smoke, urgently calls for the establishment of quality and assessment standards relevant for these products. The two main categories of products under consideration are electronic cigarettes and heated tobacco products, which both deliver nicotine in the aerosol that is not smoke, because tobacco is not burned in the process, and in particular no solid particles are generated as a result. In the case of electronic cigarettes the need for new testing and product standards is well recognized and relevant initiatives are underway, whereas no testing standards specific for heated tobacco products are currently under development. In the present manuscript, a critical review of the applicability of existing testing standards - which were mainly developed for cigarettes, is provided, and a framework approach is proposed toward developing relevant testing standards to be able to compare aerosol yields across different product categories (cigarettes, e-cigarettes, heated tobacco products).

Comparative assessment of HPHC yields in the Tobacco Heating System THS2.2 and commercial cigarettes.

There has been a sustained effort in recent years to develop products with the potential to present less risk compared with continued smoking as an alternative for adult smokers who would otherwise continue to smoke cigarettes. During the non-clinical assessment phase of such products, the chemical composition and toxicity of their aerosols are frequently compared to the chemical composition and toxicity of the smoke from a standard research cigarette - the 3R4F reference cigarette. In the present study, it is demonstrated that results of these analytical comparisons are similar when considering commercially available cigarette products worldwide. A market mean reduction of about 90% is observed on average across a broad range of harmful and potentially harmful constituents (HPHC) measured in the aerosol of a candidate modified risk tobacco product, the Tobacco Heating System 2.2 (THS2.2), compared against the levels of HPHC of cigarettes representative of selected markets; this mean reduction is well in line with the reduction observed against 3R4F smoke constituents in previous studies.