The U.S. Food and Drug Administration (FDA) has issued a final rule prohibiting the marketing of over-the-counter consumer antiseptic wash products that contain certain ingredients. Nineteen banned ingredients are specified in the final rule, including triclosan and triclocarbon, the most commonly used ingredients in antiseptic wash products.
In 2013, FDA proposed a rule requiring manufacturers to prove that the ingredients were safe for long-term daily use and more effective at preventing illness and infections than soap and water. FDA found that insufficient data was submitted to support a finding that the ingredients are Generally Recognized as Safe and Effective.
“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, director of FDA’s Center for Drug Evaluation and Research. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
The agency is still considering prohibiting the use of banzalkonium chloride, benzethonium chloride and chloroxylenol (PCMX). Manufacturers have one year to submit new safety and effectiveness information to FDA before a decision is made.
The recent ban applies to products intended for rinsing off with water. Of note, the rule does not apply to consumer hand sanitizers and wipes or antibacterial products employed in health care-related settings. Manufacturers of products with one or more of the 19 banned ingredients have until September 6, 2017, to remove their products from the market. See FDA Press Release, Sept. 2, 2016.