Over-the-counter consumer antiseptic wash products with active ingredients such as triclosan and triclocarban will be pulled from the market, following a final rule issued Sept. 2 by the Food and Drug Administration.
Companies will no longer be able to sell antibacterial washes with those ingredients, the FDA said, because manufacturers failed to show the ingredients are safe for long-term daily use and are better than plain soap and water at preventing illness and the spread of infections.
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The final rule targets consumer antiseptic wash products containing 1 or more of 19 active ingredients, including the 2 most commonly used ingredients, triclosan and triclocarban. Companies have 1 year to comply with the new rule.
The FDA’s rule does not apply to hand sanitizers, wipes, or antibacterial products used in health care settings.
The agency has deferred for 1 year a decision on the continued use of three other ingredients in consumer wash products: benzalkonium chloride, benzethonium chloride, and chloroxylenol.
The FDA’s decision was driven in part by concerns about the risks posed by long-term exposure to such products, including bacterial resistance or hormonal effects.
“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, MD, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “In fact, some data suggest that antibacterial ingredients may do more harm than good over the long term.”
Washing with plain soap and water remains one of the most important steps consumers can take to prevent illness and the spread of infection, the FDA advised. The agency also recommended use of alcohol-based hand sanitizer with at least 60% alcohol.
Read the full press release on the FDA website.