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Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic

Hand sanitizer use in the United States (U.S.) increased after the SARS-CoV-2 outbreak. The U.S. Food and Drug Administration (FDA) released temporary manufacturer guidance, changing impurity level limits for alcohol-based hand sanitizers (ABHSs). Since the guidance took effect, the FDA has recommen...

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Autores principales: Gloekler, Lauren E., de Gandiaga, Elise J., Binczewski, Natalie R., Steimel, Katie G., Massarsky, Andrey, Kozal, Jordan, Vincent, Melissa, Zisook, Rachel, LaGuardia, Mark J., Dotson, Scott, Gaffney, Shannon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9655340/
https://www.ncbi.nlm.nih.gov/pubmed/36361303
http://dx.doi.org/10.3390/ijerph192114424
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author Gloekler, Lauren E.
de Gandiaga, Elise J.
Binczewski, Natalie R.
Steimel, Katie G.
Massarsky, Andrey
Kozal, Jordan
Vincent, Melissa
Zisook, Rachel
LaGuardia, Mark J.
Dotson, Scott
Gaffney, Shannon
author_facet Gloekler, Lauren E.
de Gandiaga, Elise J.
Binczewski, Natalie R.
Steimel, Katie G.
Massarsky, Andrey
Kozal, Jordan
Vincent, Melissa
Zisook, Rachel
LaGuardia, Mark J.
Dotson, Scott
Gaffney, Shannon
author_sort Gloekler, Lauren E.
collection PubMed
description Hand sanitizer use in the United States (U.S.) increased after the SARS-CoV-2 outbreak. The U.S. Food and Drug Administration (FDA) released temporary manufacturer guidance, changing impurity level limits for alcohol-based hand sanitizers (ABHSs). Since the guidance took effect, the FDA has recommended against using these hand sanitizers due to concerns over safety, efficacy, and/or risk of incidental ingestion. To address current gaps in exposure characterization, this study describes a survey of ABHSs marketed to children available in the U.S., as defined by several inclusion criteria. A subset of ABHSs (n = 31) were evaluated for ethanol and organic impurities using a modified FDA method. Products with detectable impurity levels were compared to the FDA’s established interim limits. Seven children’s products had impurity levels exceeding the FDA’s recommended interim limits, including benzene (up to 9.14 ppm), acetaldehyde (up to 134.12 ppm), and acetal (up to 75.60 ppm). The total measured alcohol content ranged from 52% to 98% in all hand sanitizers tested, ranging from 39% below, and up to 31% above, the labeled concentration. Future studies should confirm impurity contamination sources. A risk assessment could determine whether dermal application or incidental ingestion of impurity-containing hand sanitizers pose any consumer risk.
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spelling pubmed-96553402022-11-15 Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic Gloekler, Lauren E. de Gandiaga, Elise J. Binczewski, Natalie R. Steimel, Katie G. Massarsky, Andrey Kozal, Jordan Vincent, Melissa Zisook, Rachel LaGuardia, Mark J. Dotson, Scott Gaffney, Shannon Int J Environ Res Public Health Article Hand sanitizer use in the United States (U.S.) increased after the SARS-CoV-2 outbreak. The U.S. Food and Drug Administration (FDA) released temporary manufacturer guidance, changing impurity level limits for alcohol-based hand sanitizers (ABHSs). Since the guidance took effect, the FDA has recommended against using these hand sanitizers due to concerns over safety, efficacy, and/or risk of incidental ingestion. To address current gaps in exposure characterization, this study describes a survey of ABHSs marketed to children available in the U.S., as defined by several inclusion criteria. A subset of ABHSs (n = 31) were evaluated for ethanol and organic impurities using a modified FDA method. Products with detectable impurity levels were compared to the FDA’s established interim limits. Seven children’s products had impurity levels exceeding the FDA’s recommended interim limits, including benzene (up to 9.14 ppm), acetaldehyde (up to 134.12 ppm), and acetal (up to 75.60 ppm). The total measured alcohol content ranged from 52% to 98% in all hand sanitizers tested, ranging from 39% below, and up to 31% above, the labeled concentration. Future studies should confirm impurity contamination sources. A risk assessment could determine whether dermal application or incidental ingestion of impurity-containing hand sanitizers pose any consumer risk. MDPI 2022-11-03 /pmc/articles/PMC9655340/ /pubmed/36361303 http://dx.doi.org/10.3390/ijerph192114424 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Gloekler, Lauren E.
de Gandiaga, Elise J.
Binczewski, Natalie R.
Steimel, Katie G.
Massarsky, Andrey
Kozal, Jordan
Vincent, Melissa
Zisook, Rachel
LaGuardia, Mark J.
Dotson, Scott
Gaffney, Shannon
Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic
title Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic
title_full Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic
title_fullStr Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic
title_full_unstemmed Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic
title_short Evaluation of the Safety and Efficacy of Hand Sanitizer Products Marketed to Children Available during the COVID-19 Pandemic
title_sort evaluation of the safety and efficacy of hand sanitizer products marketed to children available during the covid-19 pandemic
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9655340/
https://www.ncbi.nlm.nih.gov/pubmed/36361303
http://dx.doi.org/10.3390/ijerph192114424
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