FDA proposes tighter rules on antibacterial soaps
The U.S. Food and Drug Administration is giving manufacturers of antibacterial hand soaps one year to prove their products are any more safe and effective than soap and water—when it comes to preventing infection and the spread of bacteria.
Under a proposed rule, manufacturers of the more than 2,000 antibacterial hand soap and body wash products currently on the market would be required to conduct clinical trials and submit data to the FDA to remain on store shelves.
In a conference call with reporters, Dr. Sandra Kweder, deputy director, Office of New Drugs, Center for Drug Evaluation and Research at the FDA said:
"We at the FDA have not been provided with data to convince us they're clearly any more effective than washing with soap and water. An antibacterial soap will not prevent the common cold...we think companies ought to have data before they make those claims."
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The FDA is primarily concerned about two of the chemicals—triclosan and triclocarban. Tests of these chemicals with laboratory animals may adversely effect estrogen, testosterone, and thyroid hormones.
However, the FDA said the proposed rule does not effect toothpaste with triclosan, used to prevent gum disease.
Manufacturers will have lots of time to make their case to the FDA. There will be a six-month public comment period from now until June 2014, and manufactures will have until December of next year to submit data to government regulators.
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The target for a final rule is September 2016.
Today's proposed rule would not affect hand sanitizers or wipes.
—By CNBC's Hampton Pearson