Peer-Reviewed Publications

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

    Crooks, I.; Clements, J.; Curren, R.; Guo, X.; Hollings, M.; Lloyd, M.; Smart, D.; Thorne, D.; Weber, E.; Moore, M. M.

    Published
    Dec 6, 2023
    DOI
    10.1177/02611929231219153
    PMID
    38055860
    Link to publication
    Topic
    Summary

    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 traditional tobacco and various tobacco and nicotine next-generation products (NGPs), including Heated Tobacco Products (HTPs) and Electronic Nicotine Delivery Systems (ENDS). This report was developed by a working group composed of attendees of the seventh IIVS workshop, ‘Approaches and recommendations for conducting the mouse lymphoma gene mutation assay (MLA) and introduction to in vitro disease models’, which was held virtually on 21–23 June 2022. This publication provides a background overview of the MLA, and includes the description of assay conduct and data interpretation, key challenges and recommended best practices for evaluating tobacco and nicotine products, with a focus on the evaluation of NGPs, and a summary of how the assay has been used to evaluate and compare tobacco and nicotine products.

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