The U.S. Food and Drug Administration (FDA) has been evaluating whether to ban three common ingredients found in so-termed “antibacterial” hand soaps.
Advocates for the ban include Earthjustice, the Green Science Policy Institute, and 40 other groups, who combined to send a letter pressing the agency to act on the evidence that these chemicals do more harm than good.
The memorandum urges the FDA to finalize its decision on whether it will continue allowing the use of three antimicrobial chemicals in over-the-counter hand and body washes. The agency was due to make its decision eight years ago but deferred at the request of manufacturers and their trade associations.
During this delay Earthjustice argues there is greater evidence about the health harms—but not the effectiveness—of these chemicals.
The antimicrobials in question are two quaternary ammonium compounds (QACs) called benzalkonium chloride and benzethonium chloride and an organohalogen called chloroxylenol.
Earthjustice argues that these QACs have been linked to reproductive, respiratory, skin, and neurological harms and may also contribute to the global health threat of antimicrobial resistance.
These well-studied organohalogens have been found to be harmful to people, ecosystems, and especially to children.
With resistance, empirical data reported indicates that some bacteria can develop resistance to many types of disinfectants. The pace at which disinfectant resistance is spreading is probably a consequence of the over-use of biocides (as is the case with antibiotics).
In addition to posing health risks, these and other antimicrobials do not necessarily show any additional benefit over plain soap for handwashing. The U.S. Centers for Disease Control and Prevention (CDC) instructs the public to only use plain soap and water to wash hands, noting that “studies have not found any added health benefit from using antibacterial soap”
While alcohol hand sanitizers are available, these are not especially effective for eliminating bacterial spores. In contrast, soap washing procedures reduce the number of spores by more than 2-logs and extending the washing time increases the spore-removing efficacy.
“Adding these antimicrobials to soaps isn’t doing anything to protect us from flu or COVID,” Arlene Blum, Executive Director of the Green Science Policy Institute says in a statement to Digital Journal. “Instead, the chemicals can contribute to antimicrobial resistance, asthma, reproductive, and developmental harm. This is particularly of concern for babies and children.”
In 2016 the FDA issued a final rule banning 19 antimicrobials from consumer antiseptic washes, concluding they were neither safe nor effective. The agency said there was no data to “demonstrate that there is any additional benefit from the use of these active ingredients in consumer antiseptic wash products compared to nonantibacterial soap and water.”
However, the FDA delayed their decision on benzalkonium chloride, benzethonium chloride, and chloroxylenol. The FDA then extended the 2016 deferral several more times and has still not reached a decision.
“The FDA’s ruling on these chemicals is eight years overdue,” said Eve Gartner, Director of Crosscutting Toxics Strategies at Earthjustice. “The agency’s foot-dragging has enabled the use of these ingredients in hand soaps to skyrocket, despite manufacturers’ failure to present evidence of their safety or utility. It’s past time for the FDA to act to stop the harm.”
