FDA Tells Consumers To Skip Antibacterial Soap

On August 14, 2024, the US Food & Drug Administration (FDA) advised consumers that there is a lack of evidence to show that over-the-counter (OTC) antibacterial soaps are better at preventing illness than washing with plain soap and water.  The information was shared in a consumer update titled:  “Skip the Antibacterial Soap; Use Plain Soap and Water,” which was posted online.

The Agency stated that data also suggests that “antibacterial ingredients could do more harm than good over the long-term.”

“Following simple handwashing practices is one of the most effective ways to prevent the spread of many types of infection and illness at home, at school and elsewhere,” said Theresa M. Michele, M.D., of the FDA. “We can’t advise this enough. It’s simple, and it works.”

The American Cleaning Institute Isn’t Happy

Following FDA’s announcement, the American Cleaning Institute said it was disappointed at the recent consumer guidance. ACI and a group of member company manufacturers of antibacterial soaps and ingredients continue to comply with stringent safety and efficacy requirements set by FDA in the 2016 final rule for consumer antiseptic hand washes, through a multi-year, multi-million-dollar research effort.

“The timing of this consumer update is mysterious, given that there haven’t been any new advisories or findings by FDA that would prompt such a random piece of advice,” said James Kim PhD, SVP-science & regulatory affairs, ACI. “The agency’s public statements could sow consumer confusion about the amount of scientific data and research that manufacturers have submitted over the years on product safety and effectiveness.”

According to Kim, while FDA’s final rule is requiring human clinical efficacy trials to demonstrate that antibacterial soaps reduce the incidence of infectious disease (demonstrating prevention), a lot of research such as in vitro efficacy assays and smaller clinical studies have already been completed and/or published. 

“If these products were actually unsafe, companies would take them off the market,” Kim added.

Kim pointed out that that antibacterial soaps are used in healthcare and institutional settings for a reason.

“What FDA ignores that much of today’s healthcare has moved out of hospital medical facilities and into homecare settings, where there are indeed individuals who are immuno-comprised and/or otherwise ill and may need beneficial over-the-counter antiseptic products,” he explained.

The ACI executive said manufacturers stand behind the product science, research and data submitted over several decades to FDA.

“We urge the agency to refrain from issuing further prejudicial statements as we continue to conduct and share research on these beneficial products,” concluded Kim.

2016 Final Rule

FDA issued a final rule in 2016 under which most antibacterial active ingredients, including triclosan and triclocarban, can no longer be marketed in nonprescription consumer antiseptic wash products. Those products include liquid, foam and gel hand soaps; bar soaps; and body washes.

In the consumer update issued in this week, FDA noted that the 2016 rule didn’t apply to benzalkonium chloride, benzethonium chloride and chloroxylenol. “Manufacturers are developing and planning to submit new safety and effectiveness data for these ingredients,” FDA shared in the update.

The Agency also included the following statement about other products:

“The FDA’s final rule covers only consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers, hand wipes or antibacterial soaps used in health care settings, such as hospitals and nursing homes.”

The agency directed consumers to learn about the difference between consumer hand sanitizers and consumer antibacterial soaps at its own webpage on the topic.