FDA Consumer Antiseptic Wash Products Final Rule (September 2016)

The U.S. Food and Drug Administration (FDA) issued a final rule to address certain active ingredients found in over-the-counter (OTC) consumer antiseptic wash products including hand and body soaps. After learning information about the potential risks of ingredients found in antiseptic wash products, FDA requested studies be done to reassess the claim that antibacterial washes are “generally recognized as effective” (GRAE) at providing benefits to consumers including reducing infection and preventing illness compared to normal soaps. The data collected suggests that these products can have adverse effects with long term exposure and hold no advantage in effectiveness compared to normal soaps. As a result, FDA is establishing that 19 active ingredients used in consumer antibacterial washes are not “generally recognized as safe” (GRAS) and GRAE, and therefore can no longer be offered for sale. This final rule excludes three additional active ingredients, which have been deferred for action until further reviews can be done.

This final rule only applies to consumer antiseptic body and hand washes. It does not pertain to consumer antiseptic rubs, health care antiseptics, first aid antiseptics, or antiseptics used in the food industry. The final rule goes into effect September 6, 2017. This gives companies one year to phase out recently unapproved active ingredients and reformulate their products if necessary.