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.