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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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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
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author Miller-Holt, Jacqueline
Behrsing, Holger P.
Clippinger, Amy J.
Hirn, Carole
Stedeford, Todd J.
Stucki, Andreas O.
author_facet Miller-Holt, Jacqueline
Behrsing, Holger P.
Clippinger, Amy J.
Hirn, Carole
Stedeford, Todd J.
Stucki, Andreas O.
author_sort Miller-Holt, Jacqueline
collection PubMed
description 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.
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spelling pubmed-95002302022-09-24 Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products Miller-Holt, Jacqueline Behrsing, Holger P. Clippinger, Amy J. Hirn, Carole Stedeford, Todd J. Stucki, Andreas O. Front Toxicol Toxicology 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. Frontiers Media S.A. 2022-09-09 /pmc/articles/PMC9500230/ /pubmed/36157974 http://dx.doi.org/10.3389/ftox.2022.943358 Text en Copyright © 2022 Miller-Holt, Behrsing, Clippinger, Hirn, Stedeford and Stucki. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Toxicology
Miller-Holt, Jacqueline
Behrsing, Holger P.
Clippinger, Amy J.
Hirn, Carole
Stedeford, Todd J.
Stucki, Andreas O.
Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products
title Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products
title_full Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products
title_fullStr Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products
title_full_unstemmed Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products
title_short Use of new approach methodologies (NAMs) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products
title_sort use of new approach methodologies (nams) to meet regulatory requirements for the assessment of tobacco and other nicotine-containing products
topic Toxicology
url 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
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