FDA Issues Rule Banning Many Antibacterial Soaps

The U.S. Food and Drug Administration (FDA) issued a final rule on September 2 establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed.

Companies will no longer be able to market antibacterial washes with triclosan, triclocarban and other similar ingredients, because 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. Some manufacturers have already started removing these ingredients from their products.

“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,” says Dr. Janet Woodcock, 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.”

The final rule applies to consumer antiseptic wash products containing one or more of 19 specific active ingredients, including the most commonly used ingredients—triclosan and triclocarban. These products are intended for use with water and are rinsed off after use. The rule does not affect consumer hand sanitizers or wipes, or antibacterial products used in healthcare settings.

In response to comments submitted by the industry, the FDA has deferred rulemaking for one year on three additional ingredients used in consumer wash products—benzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX)—to allow for the development and submission of new safety and effectiveness data for these ingredients. Consumer antibacterial washes containing these specific ingredients may be marketed during this time while data are being collected.

Manufacturers have already started phasing out the use of certain active ingredients in antibacterial washes, including triclosan and triclocarban. Manufacturers will have one year to comply with the rulemaking by removing products from the market or reformulating these products by removing the antibacterial active ingredients.

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