Is That Hand Soap a Drug? The FDA Says It May Be
Some ingredients in antibacterial hand soaps are just not safe, says the U.S. Food and Drug Administration (FDA). The agency just finalized a rule first proposed in 2015 to label triclosan and 23 other active ingredients commonly found in the soaps as not “generally recognized as safe and effective.”
As a result of this ruling, over-the-counter antiseptic products containing one or more of these unsafe ingredients are considered new drugs for which approved new drug applications are required. Makers of these products are prohibited from marketing them without additional review by the FDA. Manufacturers have one year to comply by revising or changing the formulas in these products or removing them from the market.
Of the 24 non-safe and effective ingredients, triclosan is the only one currently used in antiseptic products, according to the FDA. Products impacted by this ruling include health care personnel hand washes and rubs, surgical hand scrubs and rubs, and patient antiseptic skin preparations – used prior to surgery, for example.