So Long, Antibacterial Soaps

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So Long, Antibacterial Soaps

FDA pulls 19 antiseptic ingredients from the market

By Working Nurse
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For some time now, the Food and Drug Administration (FDA) has expressed skepticism about the value of antibacterial soaps. Over the next year, new FDA rules will remove 19 of the most common antibacterial ingredients from U.S. shelves.

Clinical Evidence is Lacking

The past two decades have seen an explosion of “antibacterial” products of all kinds. Back in 2013, the FDA launched a major review of those products’ health risks and advertised benefits, about which agency officials have voiced great doubt. Now, the FDA is taking stronger action.

New rules, published September 6 in the Federal Register and effective one year from that date, will require manufacturers to cease marketing antibacterial soaps and body washes containing any of 19 common active ingredients, including triclocarban and triclosan.

FDA has not banned these 19 ingredients, but to market any of them in soap or body wash after Sep. 6, 2017, a manufacturer must submit a new drug application for FDA approval. That application must be accompanied by clinical evidence of the ingredient’s efficacy and safety, since the FDA has determined that existing evidence is insufficient.

The agency is delaying judgment on three other common antiseptic ingredients pending further research and investigation.

Advice for Nurses

The new rules do not apply to hand sanitizers, sanitizing wipes or the antiseptics used in food preparation or the healthcare industry.

However, the FDA issued proposed rules on healthcare antiseptics in April 2015 and on sanitizers and wipes in June of this year, so changes in those areas may also be forthcoming.

In the meantime, don’t throw away your hand sanitizer or skimp on washing your hands on the job. Janet Woodcock, M.D., director of the FDA Center for Drug Evaluation and Research, has called on healthcare professionals to “continue to use these [antiseptic] products consistent with infection control guidelines while additional data are gathered.”  



The 19 ingredients to be pulled from shelves include:
• Cloflucarban
• Fluorosalan
• Hexachlorophene
• Hexylresorcinol
• Iodine-containing ingredients (iodophors)
• Methylbenzethonium chloride
• Phenol
• Secondary amyltricresols
• Sodium oxychlorosene
• Tribromsalan
• Triclocarban
• Triclosan
• Triple dye
A final decision is still pending on these three ingredients:
• Benzalkonium chloride
• Benzethonium chloride
• Chloroxylenol

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