FDA issues final rule on antibacterial soaps

 

The Food and Drug Administration has forbidden the use of marketing soaps with ingredients such as triclosan and triclocarban in over-the-counter consumer antiseptic wash products.

The rule does not impact consumer hand sanitizer or antibacterial products used in healthcare. However, the FDA found the ingredients in “antibacterial soap” were not demonstrably safe for long-term daily use or more effective than plain soap and water.

“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, M.D., 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 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.