FDA issues final rule on safety and effectiveness of antibacterial soaps

Three years after the agency asked manufacturers of over-the-counter antibacterial soaps to provide proof of safety and effectiveness, the FDA has chose to ban those marketed as "antibacterial" that contain any of 19 specific active ingredients.

Dial's "All Day Freshness" antibacterial soap still lists triclocarban as an active ingredient.

But now, the FDA says there is no proof that antibacterial agents in soap are more effective at preventing the spread of germs, and they may even be harmful in the long run. "It's a great step for getting triclosan and triclocarban out of these products".

"Some manufacturers have already started removing these ingredients from their products".

In 2013 FDA gave soapmakers a year to show that adding antibacterial chemicals did anything at all to help them kill germs. In its final ruling, issued Friday, the FDA seemed to agree.

The FDA has discussed the safety of triclosan and similar ingredients since at least 2005. Ultimately, the government agreed to publish its findings only after a three-year legal battle with an environmental group, the Natural Resources Defense Council, which accused the FDA of delaying a decision on the safety of triclosan.

Specifically, the agency said, there's data from animal studies that suggests long-term exposure to chemicals like triclosan can interrupt hormone function in the body. Or take the easy way out and choose hand soap that isn't marketed as "antibacterial" at all.

Consumer antibacterial washes containing these specific ingredients may be sold during this time, the FDA said. We don't need those other ingredients to get clean.

It does not apply to hand sanitizers or hand wipes, although those are now under review, nor soaps used in health-care settings such as hospitals or nursing homes.

The ACI also disputed the FDA's statements about the efficacy of antibacterial soaps, saying they're safe for consumers to use, and "critical to public health because of the importance hand hygiene plays in the prevention of infection". Manufacturers plan to provide additional science and research to fill any data gaps, according to the statement. A 2007 paper published in the journal Clinical Infectious Diseases found that using triclosan-containing consumer soaps seemed to not offer an additional health benefit over using regular soap and water.

The agency also recently called for safety and effectiveness data from makers of hand sanitizer and other such products used without soap and water.

Companies can no longer market hand soaps containing several common antibacterial compounds, the Food and Drug Administration announced today.

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