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FDA suspends trading of some antibacterial over-the-counter hand and body wash products

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Linus Unah – Fourth Estate Contributor

Silver Spring, MD, United States (4E) – The U.S. Food and Drug Administration Friday issued a final ruling banning the sale of some over-the-counter antibacterial hand and body wash products because it indicated the ingredients are neither safe for long-term daily use nor better than plain soap and water in fending off illnesses and minimizing the spread of infections.

The FDA says the ruling doesn’t affect consumer hand sanitizers, wipes and antibacterial products used in healthcare settings but applies to products containing one or more of 19 ingredients, including triclosan and triclocarban , which are the most commonly used.

The agency added that some manufacturers have already started removing these ingredients from their products.

“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, director of the FDA’s Center for Drug Evaluation and Research. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The agency is urging consumers to wash with plain soap and running water because they would help them to avoid getting sick and to prevent spreading germs to others.

It says consumers can use hand sanitizer if soap and water are not available. The U.S. Centers for Disease Control and Prevention (CDC) suggests the use of alcohol-based hand sanitizer that contains at least 60 percent alcohol.

The FDA had issued a proposed rule in 2013 following available data which indicated that long-term exposure to certain active ingredients used in antibacterial products including triclosan (liquid soaps) and triclocarban (bar soaps) could pose health risks, such as bacterial resistance or hormonal effects.

The proposed rule asked manufacturers that wanted to continue marketing antibacterial products containing some ingredients to provide the FDA with additional facts on the safety and effectiveness of those ingredients used in over-the-counter consumer antibacterial washes.

The agency warns manufacturers to remove these products from the market or remove antibacterial active ingredients from these products within one year.

The 19 ingredients the FDA banned for consumer antibacterial washes are cloflucarban , fluorosalan , hexachlorophene, hexylresorcinol , iodophors (iodine-containing ingredients), iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate ), iodine complex (phosphate ester of alkylaryloxy polyethylene glycol), nonylphenoxypoly ( ethyleneoxy ) and ethanoliodine .

Others are poloxamer–iodine complex o povidone-iodine 5 to 10 percent, undecoylium chloride iodine complex, methylbenzethonium chloride, phenol (greater than 1.5 percent), phenol (less than 1.5 percent) 16, secondary amyltricresols , sodium oxychlorosene , tribromsalan , triclocarban , triclosan , and triple dye.


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