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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Bibliographic Details
Published in:International journal of environmental research and public health 2022-11, Vol.19 (21), p.14424
Main Authors: 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
Format: Article
Language:English
Subjects:
Acetaldehyde
Benzene
Child
Children
Cleaning compounds
Contamination
Coronaviruses
COVID-19
COVID-19 - epidemiology
Ethanol
Evaluation
Hand Sanitizers
Humans
Impurities
Ingestion
Manufacturing
Pandemics
Risk assessment
Sanitizers
SARS-CoV-2
Severe acute respiratory syndrome coronavirus 2
United States
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Summary: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 ( = 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.
ISSN:1660-4601
1661-7827
1660-4601
DOI:10.3390/ijerph192114424