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Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products

Regulatory frameworks on tobacco and other nicotine-containing products (TNCP) continue to evolve as novel products emerge, including electronic nicotine delivery systems (e.g., electronic cigarettes or vaping products), heated tobacco products, or certain smokeless products (e.g., nicotine pouches)...

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Detalles Bibliográficos
Autores principales: Miller-Holt, Jacqueline, Behrsing, Holger P., Clippinger, Amy J., Hirn, Carole, Stedeford, Todd J., Stucki, Andreas O.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9500230/
https://www.ncbi.nlm.nih.gov/pubmed/36157974
http://dx.doi.org/10.3389/ftox.2022.943358
Descripción
Sumario:Regulatory frameworks on tobacco and other nicotine-containing products (TNCP) continue to evolve as novel products emerge, including electronic nicotine delivery systems (e.g., electronic cigarettes or vaping products), heated tobacco products, or certain smokeless products (e.g., nicotine pouches). This article focuses on selected regulations for TNCPs that do not make health claims, and on the opportunities to use new approach methodologies (NAMs) to meet regulatory requirements for toxicological information. The manuscript presents a brief overview of regulations and examples of feedback from regulatory agencies whilst highlighting NAMs that have been successfully applied, or could be used, in a regulatory setting, either as stand-alone methods or as part of a weight-of-evidence approach to address selected endpoints. The authors highlight the need for agencies and stakeholders to collaborate and communicate on the development and application of NAMs to address specific regulatory toxicological endpoints. Collaboration across sectors and geographies will facilitate harmonized use of robust testing approaches to evaluate TNCPs without animal testing.