The U.S. Food and Drug Administration (FDA) has published a review of public heath issues relating to pharmaceuticals and healthcare. Within this report is an indication of the extent of concerns raised in relation to fraudulent or dangerous hand sanitization products. Many such products were marketed by unscrupulous manufacturers during the height of the COVID-19 pandemic.
The report comes from the FDA’s Office of Compliance and it highlights key initiatives that had a direct impact on patient safety, including efforts to address the COVID-19 pandemic. Other areas of focus include addressing the opioid crisis, compounded drug quality, drug supply chain security, fraudulent and unsafe drugs, amongst others throughout 2021.
With the issue of hand sanitizers, in 2020, the FDA put more than 200 products on this list, most often for methanol and propanol contamination. In 2021, the agency added a further 46 products to the list of hand sanitizers consumers should not use. The relatively high number shows the extent of fraudulent activity, undertaken with a view to mislead or even harm consumers.
Of greatest concern were products with high levels of bacteria that can cause serious infections and with products contaminated with benzene. As a toxin, benzene causes harmful effects on the bone marrow and can cause a decrease in red blood cells, leading to anemia.
Specifically, the FDA took the necessary steps to warn consumers not to use any hand sanitizer products from artnaturals of Gardena, CA. This is because when the FDA tested certain artnaturals scent-free hand sanitizers they found unacceptable levels of benzene, acetaldehyde, and acetal contaminants.
With the bacterial contamination issue, in March 2021 the FDA took action to warn consumers about Durisan Antimicrobial Solutions Hand Sanitizer. This was due to microbial contamination with the bacteria Burkholderia cepacia complex and Ralstonia pickettii. These bacteria can cause serious infections if they enter the bloodstream through a scrape or wound, especially in people with compromised immune systems. The FDA activity led to the company involved withdrawing the affected products.
To assist with the introduction of more robust safeguards, the FDA , issued guidance outlining policies for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products.
A different type of regulatory activity arose over efforts to protect people from accidental consumption of hand sanitizer. The risk existed from a container resembling a water bottle, where some hand sanitizers were presented in 16-ounce and 20-ounce containers resembling water bottles. The design of these products posed a particular risk to children, who might mistakenly drink from the disinfectant bottles.
