Key challenges for in vitro testing of tobacco products for regulatory applications: Recommendations for dosimetry

Abstract

The Institute for In Vitro Sciences (IIVS) is sponsoring a series of workshops to develop recommendations for optimal scientific and technical approaches for conducting in vitro assays to assess potential toxicity within and across tobacco and various next‐generation products (NGPs) including heated tobacco products (HTPs) and electronic nicotine delivery systems (ENDSs). This publication was developed by a working group of the workshop members in conjunction with the sixth workshop in that series entitled “Dosimetry for conducting in vitro evaluations” and focuses on aerosol dosimetry for aerosol exposure to combustible cigarettes, HTP, and ENDS aerosolized tobacco products and summarizes the key challenges as well as documenting areas for future research.

Characterisation of a smoke/ aerosol exposure in vitro system (SAEIVS) for delivery of complex mixtures directly to cells at the air‐liquid interface

“…However, this is currently the only machine of this type; therefore, standardisation across multiple different systems is important to ensure that outcomes can be compared both within and between laboratories. For example, characterisation of systems using a reference product and aligned dosimetry measures have been used for this purpose (Miller‐Holt et al, 2022; Thorne, Adamson, et al, 2021). There are working groups who carry out such studies, for example, those of the Institute of In Vitro Sciences (Miller‐Holt et al, 2022).…”

“…For example, characterisation of systems using a reference product and aligned dosimetry measures have been used for this purpose (Miller‐Holt et al, 2022; Thorne, Adamson, et al, 2021). There are working groups who carry out such studies, for example, those of the Institute of In Vitro Sciences (Miller‐Holt et al, 2022).…”

“…for this purpose (Miller-Holt et al, 2022;Thorne, Adamson, et al, 2021). There are working groups who carry out such studies, for example, those of the Institute of In Vitro Sciences (Miller-Holt et al, 2022).…”

Key Challenges for In Vitro Testing of Tobacco Products for Regulatory Applications: Recommendations for the In Vitro Mouse Lymphoma Assay

“…11 The importance of dosimetry and considerations for conducting dosimetry evaluations has also been discussed. 12 Other workshops are in preparation to address the issues, challenges and recommendations identified in the first workshop. 10…”

The science behind vaping

“…Together, these studies help to substantiate the reduced risk nature of e‐cigarettes compared with traditional cigarettes. Lastly, Miller‐Holt et al 13 report the findings of a workshop facilitated by the Institute for In Vitro Sciences (iivs.org), summarising progress in the harmonisation of protocols and provide recommendations for dosimetry, key challenges and areas for future research as an outcome of a working group. Standardising testing methodologies is very important from a regulatory perspective – it is critical for all stakeholders to be using the same methods for testing products.…”