FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Soaps
September 6, 2016 03:09 PM
The U.S. Food and Drug administration issued a final rule on September 2, 2016 establishing that over-the-counter antiseptic wash products containing one or more of 19 different active ingredients may no longer be marketed to the public.
The final rule — which covers triclosan and triclocarban, the two most commonly used ingredients in antiseptic wash products — does not affect antibacterial products used in health care settings or consumer hand sanitizers or wipes.
The FDA issued a proposed rule in 2013 after evidence surfaced suggesting that long-term exposure to ingredients like triclosan in liquid soaps and triclocarban in bar soaps could lead to bacterial resistance or hormonal changes. The proposed rule required manufacturers to provide the FDA with safety and effectiveness data for some ingredients if they wanted to continue marketing products containing those ingredients. However, antibacterial hand and body wash manufacturers did not provide the necessary data establishing safety and effectiveness for the 19 different ingredients covered in the final rule.
“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
Simply washing with plain soap and running water is still critical for consumers to avoid getting sick and preventing the spread of germs. Hand sanitizer is recommended if soap and water are not available. Hand sanitizers should be alcohol-based and contain at least 60 percent alcohol, according to the U.S. Centers for Disease Control and Prevention (CDC).
Consumer antibacterial washes containing benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX) may continue to be marketed for one year while new safety and effectiveness data on those ingredients is submitted to the FDA.
Manufacturers — who began phasing out the use of some active ingredients in antibacterial washes after the FDA’s proposed rule in 2013 — have one year to comply with the rulemaking by changing the ingredients in their products or removing them from the market.