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FDA To Clean Up Soap: The Agency Proposes New Rule To Determine Safety And Effectiveness Of Antibacterial Soap

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Food and Drug Administration announced on Monday that they issued a proposed rule that would require manufacturers of antibacterial hand soap and body wash to prove their products are better at reducing or preventing bacterial contamination than plain soap and water, CNN reported.

In a statement, the FDA said there is currently no evidence indicating that antibacterial washes will reduce the risk of getting sick or passing on germs to others. In addition to proving they are, manufacturers will also be required to prove their products are safe for long-term use.

"Millions of Americans use antibacterial hand soap and body wash products," the agency said. "Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water."

Because so many consumers use antibacterial washes, FDA said they believed there should be clearly demonstrated benefits to balance any potential risks.

Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products' safety and effectiveness. This also includes data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.

The FDA said some data suggest that long-term exposure to certain active ingredients used in antibacterial products, such as triclosan and triclocarban, could post health risks, such as bacterial resistance or hormonal effects.

The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the agency to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as "generally recognized as safe and effective."

The proposed rule does not require the antibacterial soap products to be removed from the market at this time and does not affect hand sanitizers, wipes, or antibacterial products used in health care settings. 

According to the FDA, the proposed rule is available for public comment for 180 days, with a concurrent one-year period for companies to submit new data and information. This is followed by a 60-day period for rebuttal comments.

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