Workshop series to identify, discuss, and develop recommendations for the optimal generation and use of in vitro assay data for tobacco product evaluation: Phase 1 genotoxicity assays

Introduction: The Institute for In Vitro Sciences is sponsoring a workshop series to identify, discuss, and develop recommendations for optimal scientific and technical approaches for conducting in vitro assays—focusing first on genotoxicity assays—used for assessing potential toxicity within and across tobacco and electronic nicotine delivery product categories (hereafter referred to as tobacco products). Materials and Methods: Workshops provide a unique opportunity for invited expert stakeholders to share experiences and to develop recommendations that may serve as a resource for developing optimal testing approaches and data interpretation. It is envisioned that some recommendations would form the basis for the generation of guidance documents and/or serve as authoritative reference publications to support regulatory submissions. Results and Discussion: During the first workshop (November 27–28, 2018), workgroup members identified important issues for using in vitro genotoxicity assays for evaluating tobacco products. These issues were triaged into three priority categories that will provide the basis for selecting high-priority topics for subsequent workshops. To provide background for future workshops and to serve as a scientific community resource, the workgroup developed a tabulated referenced summary of the types of tobacco product test samples that have been evaluated using the regulatory genotoxicity assays and the types of regulatory questions that have been addressed. A touch-base meeting was held March 7, 2019, and a second workshop June 4–5, 2019 to discuss ongoing issues and to further organize workgroup activities. Conclusion: The current publication lists priority topics and background summary information for using regulatory genotoxicity assays to evaluate tobacco products