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.

Graphical abstract

A broad range of commercially available electronic cigarette (ecigarette) systems were tested for levels of emissions of harmful and potentially harmful constituents (HPHC), with a particular focus on the carbonyls: acetaldehyde, acrolein, and formaldehyde. The tobacco-specific nitrosamines N′-nitrosonornicotine and 4-(methylnitrosamino)-1-(3-bipyridyl)-1-butanone; the elements arsenic, cadmium, chromium, lead, and nickel; benzene; 1,3butadiene; and benzo(a)pyrene were also quantified. The results show that except for the levels of carbonyls, all types of e-cigarettes performed in a similar manner, and emission levels for HPHCs were generally not quantifiable. However, levels of carbonyls, especially formaldehyde, were highly variable. Overall, the lowest levels of formaldehyde were observed in cartridge systems, which generally achieved substantial reductions in yields in comparison with cigarette smoke. Formaldehyde levels in open tank systems were variable; however, the median formaldehyde levels across different brands were substantially lower than the formaldehyde levels in cigarette smoke. The results for variable-power devices operated at the highest voltage confirmed existing literature data regardless of orientation and differences in puffing regimes. Furthermore, our results show that many products deliver consistent HPHC yields over a broad range of testing conditions (with minimal variability from one device to another, under a range of puffing conditions). However, some products exhibit high variability in emissions of HPHCs. The use of air blanks is further highlighted to assess nonproduct-related contributions to HPHC levels to avoid misrepresentation of the data. Overall, our results highlight that some but not all electronic cigarettes deliver low levels of carbonyls consistently across the full e-liquid depletion cycle under different test conditions. The need for further research and standardization work on assessment of variable-voltage electronic cigarettes is emphasized.

Health risk associated with the use of combustible cigarettes is well characterized and numerous epidemiological studies have been published for many years. Since more than a decade, innovative non-combusted tobacco products have emerged like heated tobacco products (HTP) or electronic cigarettes (EC). Long-term effects of these new products on health remain, however, unknown and there is a need to characterize associated potential health risks. The time dedicated to epidemiological data generation (at least 20 to 40 years for cancer endpoint), though, is not compatible with innovative development. Surrogates need, therefore, to be developed. In this work, non-cancer and cancer risks were estimated in a range of HTP and commercial combustible cigarettes based upon their harmful and potentially harmful constituent yields in aerosols and smoke, respectively. It appears that mean lifetime cancer risk values were decreased by more than one order of magnitude when comparing HTPs and commercial cigarettes, and significantly higher margin of exposure for non-cancer risk was observed for HTPs when compared to commercial cigarettes. The same approach was applied to two commercial ECs. Similar results were also found for this category of products. Despite uncertainties related to the factors used for the calculations and methodological limitations, this approach is valuable to estimate health risks associated to the use of innovative products. Moreover, it acts as predictive tool in absence of long-term epidemiological data. Furthermore, both cancer and non-cancer risks estimated for HTPs and ECs highlight the potential of reduced risk for non-combusted products when compared to cigarette smoking.

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).