In vitro toxicological evaluation of pouched portioned oral nicotine products

IntroductionModern oral nicotine pouch products (ONPs) are a category of oral nicotine products which contain pharmaceutical-grade nicotine, flavors, and other food-grade ingredients but no tobacco leaf. Recent reports indicate that ONPs in general do not contain (or only at minimal levels) the harm...

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Main Authors: Brian M. Keyser, Robert Leverette, Reagan McRae, John Wertman, Tom Shutsky, Ken Szeliga, Patrudu Makena, Kristen G. Jordan
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-11-01
Series:Frontiers in Toxicology
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Online Access:https://www.frontiersin.org/articles/10.3389/ftox.2024.1452274/full
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author Brian M. Keyser
Robert Leverette
Reagan McRae
John Wertman
Tom Shutsky
Ken Szeliga
Patrudu Makena
Kristen G. Jordan
author_facet Brian M. Keyser
Robert Leverette
Reagan McRae
John Wertman
Tom Shutsky
Ken Szeliga
Patrudu Makena
Kristen G. Jordan
author_sort Brian M. Keyser
collection DOAJ
description IntroductionModern oral nicotine pouch products (ONPs) are a category of oral nicotine products which contain pharmaceutical-grade nicotine, flavors, and other food-grade ingredients but no tobacco leaf. Recent reports indicate that ONPs in general do not contain (or only at minimal levels) the harmful and potentially harmful constituents (HPHCs) identified in cigarette smoke, suggesting their potential as alternative products for reducing harm from cigarette smoking.MethodsWe assessed in vitro toxicological effects of eight ONPs, designated as modern oral (MO) 1 to 8 along with an ONP, an oral tobacco (snus), and a combustible cigarette market comparator using established regulatory toxicological assays including Ames, in vitro micronucleus (ivMN), and neutral red uptake (NRU) assays.ResultsThe MO test products 1-7 ZYN wintergreen, and General Snus white mint were negative for mutagenicity (Ames assay), genotoxicity (ivMN), and cytotoxicity (NRU). The combustible cigarette was positive in all three assays. The MO-8 test product was negative for mutagenicity; however, it was positive in the ivMN and NRU assays at concentrations either 42 to 135-fold based on the ivMN i to iv treatment schedule or 60-fold higher, respectively, when compared to combustible cigarettes.DiscussionThus, the MO test products are likely to be less harmful than combustible cigarettes and are alternatives to cigarettes. However, understanding of long-term effects of ONPs in general requires additional research.
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spelling doaj-art-c8167f896357405889fcb97b312160712025-08-20T02:07:20ZengFrontiers Media S.A.Frontiers in Toxicology2673-30802024-11-01610.3389/ftox.2024.14522741452274In vitro toxicological evaluation of pouched portioned oral nicotine productsBrian M. KeyserRobert LeveretteReagan McRaeJohn WertmanTom ShutskyKen SzeligaPatrudu MakenaKristen G. JordanIntroductionModern oral nicotine pouch products (ONPs) are a category of oral nicotine products which contain pharmaceutical-grade nicotine, flavors, and other food-grade ingredients but no tobacco leaf. Recent reports indicate that ONPs in general do not contain (or only at minimal levels) the harmful and potentially harmful constituents (HPHCs) identified in cigarette smoke, suggesting their potential as alternative products for reducing harm from cigarette smoking.MethodsWe assessed in vitro toxicological effects of eight ONPs, designated as modern oral (MO) 1 to 8 along with an ONP, an oral tobacco (snus), and a combustible cigarette market comparator using established regulatory toxicological assays including Ames, in vitro micronucleus (ivMN), and neutral red uptake (NRU) assays.ResultsThe MO test products 1-7 ZYN wintergreen, and General Snus white mint were negative for mutagenicity (Ames assay), genotoxicity (ivMN), and cytotoxicity (NRU). The combustible cigarette was positive in all three assays. The MO-8 test product was negative for mutagenicity; however, it was positive in the ivMN and NRU assays at concentrations either 42 to 135-fold based on the ivMN i to iv treatment schedule or 60-fold higher, respectively, when compared to combustible cigarettes.DiscussionThus, the MO test products are likely to be less harmful than combustible cigarettes and are alternatives to cigarettes. However, understanding of long-term effects of ONPs in general requires additional research.https://www.frontiersin.org/articles/10.3389/ftox.2024.1452274/fullmodern oral nicotine pouchesin vitro toxicity assaysmutagenicitygenotoxicitycytotoxicity
spellingShingle Brian M. Keyser
Robert Leverette
Reagan McRae
John Wertman
Tom Shutsky
Ken Szeliga
Patrudu Makena
Kristen G. Jordan
In vitro toxicological evaluation of pouched portioned oral nicotine products
Frontiers in Toxicology
modern oral nicotine pouches
in vitro toxicity assays
mutagenicity
genotoxicity
cytotoxicity
title In vitro toxicological evaluation of pouched portioned oral nicotine products
title_full In vitro toxicological evaluation of pouched portioned oral nicotine products
title_fullStr In vitro toxicological evaluation of pouched portioned oral nicotine products
title_full_unstemmed In vitro toxicological evaluation of pouched portioned oral nicotine products
title_short In vitro toxicological evaluation of pouched portioned oral nicotine products
title_sort in vitro toxicological evaluation of pouched portioned oral nicotine products
topic modern oral nicotine pouches
in vitro toxicity assays
mutagenicity
genotoxicity
cytotoxicity
url https://www.frontiersin.org/articles/10.3389/ftox.2024.1452274/full
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