FDA Rules on Antibacterial Soap for Consumers

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The ruling applies to consumer products containing 1 or more of 19 specific active ingredients.
The ruling applies to consumer products containing 1 or more of 19 specific active ingredients.

The FDA has ruled that over-the-counter (OTC) antibacterial washes containing triclosan and triclocarban, among other ingredients, can no longer be marketed to consumers.

“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. “Some data suggest that antibacterial ingredients may do more harm than good over the long-term.”

In 2013, the FDA began to examine data that suggested long-term exposure to the active ingredients in antibacterial soaps could pose numerous health risks, including bacterial resistance and hormonal effects. Manufacturers were required to provide additional data to the FDA, including information on the safety and efficacy of certain ingredients included in OTC consumer washes, and data from clinical studies demonstrating superiority to non-antibacterial washes in preventing illness and reducing infection.

Ultimately, antibacterial hand and bodywash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients; manufacturers will have 1 year to comply with the ruling by removing or reformulating these products.

The rule does not affect consumer hand sanitizers or wipes, or antibacterial products used in health care settings.

Reference

  1. FDA issues final rule on safety and effectiveness of antibacterial soaps [news release]. Silver Springs, MD: US Food and Drug Administration. Published September 2, 2016. Accessed September 8, 2016.
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