Final FDA rules on antibacterial hand soaps

11/13/18 - Industry News

On Friday, September 2nd 2016, FDA issued the long expected final rule for over-the-counter (OTC) consumer antiseptic wash products. As a result, the FDA will exclude 19 active ingredients, including Triclosan, that have been listed on the previous 1994 tentative final monograph for over-the-counter antiseptic wash products. Manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.

Manufacturers have until September 2nd 2017 to meet compliance.

It’s important to note that this ruling only applies to product intended to be used with water and rinsed off. Hand sanitizers, wipes, and products intended to be used in health care settings are unaffected.

—we have no scientific evidence that they are any better than plain soap and water—

“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.”

Concerns center around antibacterial resistance and possible hormone effects. This is the final outcome of a 2013 proposal, and in anticipation many companies have already begun reformulating their product or phasing out these ingredients. Manufacturers have until September 2nd 2017 to meet compliance.