Background: Hand sanitizers are an important preventive measure to halt the spread of pathogens, which has become a huge demand during the coronavirus disease (COVID-19). Consequently, their safety and quality are top priorities for regulatory organizations. Methods: Saudi Food & Drug Authority laboratories have analyzed numerous samples of hand sanitizers in order to ensure their safety and efficacy. Active ingredients, as well as hazardous impurities, have been checked according to the pharmacopeia. Results: In this study, we report the results of the analysis of 1409 samples, which represent the majority of products available in the Saudi Arabian market. The results showed that 196 samples (13.9%) did not meet international standards. Specifically, out of 196 failed samples, 75, 12, and 4 products contained hazardous substances such as methanol, 1-propanol, and acetaldehyde, respectively. Additionally, some failed samples contained foreign particles, were improperly labeled, or contained an inadequate concentration of alcohol. Conclusion: The substandard hand sanitizers possess a risk to the community, particularly during pandemics, and hence stringent yet dynamic regulations should be implemented.
(2020) Covid-19 Updates: One in 10 Worldwide May Have Had Virus, WHO Says. https://www.bbc.com/news/world-54422023
(2020) How COVID-19 Spreads. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/how-covid-spreads.html
European Centre for Disease Prevention and Control (2020) Transmission of COVID-19. https://www.ecdc.europa.eu/en/covid-19/latest-evidence/transmission
WHO (2020) Coronavirus Disease (COVID-19). Q&A. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and-answers-hub/q-a-detail/coronavirus-disease-covid-19
Nussbaumer-Streit, B., Mayr, V., Dobrescu, A.I., Chapman, A., Persad, E., Klerings, I., Wagner, G., Siebert, U., Christof, C., Zachariah, C. and Gartlehner, G. (2020) Quarantine Alone or in Combination with Other Public Health Measures to Control COVID-19: A Rapid Review. The Cochrane Database of Systematic Reviews, 4, CD013574. https://doi.org/10.1002/14651858.CD013574
US FDA (2021) Emergency Use Authorization for Vaccines to Prevent COVID-19, Guidance for Industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-vaccines-prevent-covid-19
Todd, E.C., Michaels, B.S., Holah, J., Smith, D., Greig, J.D. and Bartleson, C.A. (2010) Outbreaks Where Food Workers Have Been Implicated in the Spread of Foodborne Disease. Part 10. Alcohol-Based Antiseptics for Hand Disinfection and a Comparison of Their Effectiveness with Soaps. Journal of Food Protection, 73, 2128-2140. https://doi.org/10.4315/0362-028X-73.11.2128
Dyer, D.L., Gerenratch, K.B. and Wadhams, P.S. (1998) Testing a New Alcohol-Free Hand Sanitizer to Combat Infection. AORN Journal, 68, 239-251. https://doi.org/10.1016/S0001-2092(06)62517-9
Moadab, A., Rupley, K.F. and Wadhams, P. (2001) Effectiveness of a Nonrinse, Alcohol-Free Antiseptic Hand Wash. Journal of the American Podiatric Medical Association, 91, 288-293. https://doi.org/10.7547/87507315-91-6-288
WHO (2010) Guide to Local Production: WHO-Recommended Handrub Formulations. https://www.who.int/publications/i/item/WHO-IER-PSP-2010.5
FDA (2020) Updates on Hand Sanitizers Consumers Should Not Use. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use
Tse, T.J., Nelson, F.B. and Reaney, M.J.T. (2021) Analyses of Commercially Available Alcohol-Based Hand Rubs Formulated with Compliant and Non-Compliant Ethanol. International Journal of Environmental Research and Public Health, 18, 3766. https://doi.org/10.3390/ijerph18073766
Myers, T.P.M. (2020) A Recommendation for Acceptability of Limited Acetaldehyde Content in Ethanol used for Hand Sanitizers. Altiras Chemicals, LLC, Houston.
SFDA (2020) “SFDA” Warns Consumers against 5 Hand Sanitizer Products. https://www.sfda.gov.sa/en/warnings/66202
Yoon, H.-K., et al. (2020) Survey on the Use of Hand Sanitizer and Component Analysis. Journal of Environmental Health Sciences, 46, 702-706. https://doi.org/10.1208/s12249-020-01818-6
Berardi, A., Cenci-Goga, B., Grispoldi, L., Cossignani, L. and Perinelli, D.R. (2020) Analysis of Commercial Hand Sanitisers amid CoViD-19: Are We Getting the Products that We Need? AAPS PharmSciTech, 21, 286.
León, J.A. and Fontalvo, J. (2020) Analysis of a Hybrid Distillation-Pervaporation Column in a Single Unit: Intermediate Membrane Section in the Rectifying and Stripping Section. The Canadian Journal of Chemical Engineering, 98, 2227-2237. https://doi.org/10.1002/cjce.23765
Emami, A., Javanmardi, F., Keshavarzi, A. and Pirbonyeh, N. (2020) Hidden Threat Lurking behind the Alcohol Sanitizers in COVID-19 Outbreak. Dermatologic Therapy, 33, e13627. https://doi.org/10.1111/dth.13627
Methanol Poisoning Overview. Not Specified. https://web.archive.org/web/20111005043548/ http:/www.antizol.com/mpoisono.htm
Jing, J.L.J., Pei, Y.T., Bose, R.J.C., McCarthy, J.R., Tharmalingam, N. and Madheswaran, T. (2020) Hand Sanitizers: A Review on Formulation Aspects, Adverse Effects, and Regulations. International Journal of Environmental Research and Public Health, 17, 3326. https://doi.org/10.3390/ijerph17093326
Tse, T.J., Purdy, S.K., Shen, J., Nelson, F.B., Mustafa, R., Wiens, D.J. and Reaney, M.J.T. (2021) Toxicology of Alcohol-Based Hand Rubs Formulated with Technical-Grade Ethanol. Toxicology Reports, 8, 785-792. https://doi.org/10.1016/j.toxrep.2021.03.034
Methanol Safe Handling Manual. Methanol Institute, Not Specified. https://www.methanol.org/wp-content/uploads/2020/03/Safe-Handling-Manual_5th-Edition_Final.pdf
Cleaning and Disinfection for Households: Interim Recommendations for U.S. Households with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19). 2020.
WHO (2020) IARC Monographs on the Identification of Carcinogenic Hazards to Humans. https://monographs.iarc.who.int/list-of-classifications
USP (2020) Excerpted USP-NF and FCC Standards: A Hand Sanitizer Resource. https://www.usp.org/sites/default/files/usp/document/health-quality-safety/usp-hand-sanitizer-ingredients.pdf
FDA (2020) Temporary Policy for Manufacture of Alcohol for Incorporation into Alcohol-Based Hand Sanitizer Products during the Public Health Emergency (COVID-19). https://www.fda.gov/media/136390/download
Health Canada (2020) Technical-Grade Ethanol for the Manufacture of Hand Sanitizers and Hard-Surface Disinfectants during the COVID-19 Pandemic: Risk Assessment Summary Report. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/covid19-technical-grade-ethanol-hand-sanitizer/risk-assessment-summary-report.html
(2020) Show Me the Science—When & How to Use Hand Sanitizer in Community Settings. https://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html
SFDA (2019) Guidelines and Documents. https://old.sfda.gov.sa/ar/drug/resources/Pages/GuidesPages.aspx
Fendler, E. and Groziak, P. (2015) Efficacy of Alcohol-Based Hand Sanitizers against Fungi and Viruses. Infection Control & Hospital Epidemiology, 23, 61-62. https://doi.org/10.1086/503455
Ionidis, G., Hübscher, J., Jack, T., Becker, B., Bischoff, B., Todt, D., Hodasa, V., Brill, F.H.H., Steinmann, E. and Steinmann, J. (2016) Development and Virucidal Activity of a Novel Alcohol-Based Hand Disinfectant Supplemented with Urea and Citric Acid. BMC Infectious Diseases, 16, Article No. 77. https://doi.org/10.1186/s12879-016-1410-9
Jain, V.M., Karibasappa, G., Dodamani, A.S., Prashanth, V.K. and Mali, G.V. (2016) Comparative Assessment of Antimicrobial Efficacy of Different Hand Sanitizers: An in Vitro Study. Dental Research Journal (Isfahan), 13, 424-431. https://doi.org/10.4103/1735-3327.192283