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FDA turning the spotlight on antibacterial hand soaps and body washes

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Millions of Americans have bought into the notion that antibacterial hand soaps and body washes are more effective at preventing the spread of infections than plain soap and water, but now the FDA has proposed a new rule requiring manufacturers of over 2000 individual products to prove their safety for long term use as well as their efficacy.

The FDA’s concern is that long-term exposure to certain active ingredients such as triclosan in liquid soaps and triclocarban in bar soaps could actually pose health risks by blocking hormones and/or creating resistance to bacteria. Up to now, companies have been allowed to make effectiveness claims without producing any supportive evidence.

According to Dr. Sandra Kweder, deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and Research, studies in rats have demonstrated a decreased in thyroid hormones with long-term exposure.

The proposed rule states that if manufacturers can not provide data to support their claims, the products will need to be reformulated or relabeled in order to remain on the market.

The rule is available for public comment until June 2014, while manufacturers have until December 2014 to submit new data. After that there will be a 60-day period for rebuttal comments.

The FDA hopes to determine the safety and efficacy of these products by September 2016.

Hand sanitizers, wipes and antibacterial products used in health care settings are not affected.

Bottom line: Whether antibacterial hand soaps and body washes turn out to be completely safe, the fact is that washing your hands with good old soap and water is is probably still the best method for preventing the spread of germs.



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