Gloekler L, Bincewski N, De Gandiaga E, Gibbs K, Kozal J, Massarsky A, Vincent M, et al. Evaluation of the safety and efficacy of children’s hand sanitizers available during the COVID-19 pandemic. Poster presentation P664 at the Society of Toxicology (SOT) Annual Meeting & ToxExpo, San Diego, CA. Toxicologist 186(S1):287. Abstract 3973. March 2022.
Usage of hand sanitizers in the United States (US) increased dramatically after the emergence of SARS-CoV-2 and ensuing global pandemic. The US Food and Drug Administration (FDA) released temporary guidance for manufacturers during the pandemic, which changed requirements for impurity levels allowed in alcoholbased hand sanitizers and guidance for the preparation of such products. The FDA’s method for determination of interim limits is not clearly reported, and therefore it is not understood whether these limits are protective of sensitive populations (e.g., children). Since the temporary guidance took effect, the FDA has recalled numerous hand sanitizers from newly registered foreign and domestic companies due to concerns over safety, efficacy, and/or risk of incidental ingestion in children. To address current gaps in exposure characterization, this study describes a market survey of children’s hand sanitizers available for purchase in the US during the pandemic, as defined by the inclusion criteria (e.g., cartoon characters on packaging, scented liquid, etc.). A subset of products (n=31) that fit the study inclusion criteria were evaluated for alcohol content and the presence of organic impurities using a modified version of the FDA’s Direct Injection Gas Chromatography Mass Spectrometry (GC/MS) method. Products with detectable levels of impurities were compared to the interim limits established by the FDA for the preparation of hand sanitizers during the COVID-19 pandemic. Four children’s products had levels of impurities that exceeded the recommended FDA interim limits, including benzene (6.9-9.1 ppm), acetaldehyde (59.9-104.1 ppm), and acetal (41.8-63.0 ppm). The total measured alcohol content ranged from 52-98% in all hand sanitizers tested, which ranged from 39% below and up to 31% above than the labeled concentration. A risk assessment is needed to determine if dermal application, or incidental ingestion of hand sanitizers with impurities found at levels reported in this study pose potential risks to children. Future studies are also needed to confirm source of impurity contamination, whether the issue is related to product batches alone or represent a systemic issue related to manufacturing processes