FDA Steps Back from Antibacterial Soap Products

By Jonathan Springston, Associate Managing Editor, AHC Media

The FDA on Friday issued a final rule that directs companies to no longer market over-the-counter consumer antiseptic wash products that contain one or more of 19 specific active ingredients, particularly triclosan, found in liquid soap, and triclocarban, found in bar soap.

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “In fact, some data suggest that antibacterial ingredients may do more harm than good over the long term.”

The FDA’s concerned these agents are no more effective than washing with plain soap and water and potentially lead to negative outcomes, including affecting hormones in unborn children and infants as well as potentially promoting drug-resistant bacteria.

The agency proposed a similar rule in 2013, under which manufacturers were to provide additional data on the safety and effectiveness of certain chemicals used in consumer antibacterial washes if those companies wished to continue marketing such products containing those ingredients. Some companies began removing certain chemicals of their own accord. However, for the 19 active ingredients addressed in the final rule issued Friday, the FDA says manufacturers either did not submit additional data or the data and information submitted were not sufficient for the agency to find that these ingredients are safe and effective.

In accordance with current CDC standards, the FDA recommends washing with soap and water or, failing that, with an alcohol-based hand sanitizer to prevent illness and the spread of germs. The ruling did not affect hand sanitizers and wipes, although the agency is studying the active ingredients ethanol, ethyl alcohol, isopropyl alcohol, and benzalkonium chloride.

For more on the FDA’s ruling, please be sure to read the October issue of Pharmacology Watch. And for the latest on controlling infections and ensuring the health of patients and employees alike, be sure to check out Hospital Infection Control & Prevention and Hospital Employee Health.