This 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. (File photo)
SILVER SPRING, US: The US Food and Drug Administration (FDA) has issued a final rule 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 these 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.
This 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. This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
“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 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.”
Long-term exposure to certain active ingredients used in antibacterial products — for example, Triclosan (liquid soaps) and Triclocarban (bar soaps) — could pose health risks, such as bacterial resistance or hormonal effects, FDA said.
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