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U.S. drug regulator raises safety concerns on antibacterial soaps

English.news.cn   2013-12-17 02:54:55

WASHINGTON, Dec. 16 (Xinhua) -- Manufacturers of antibacterial hand soaps and body washes will have to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections, according to a proposed rule issued Monday by the U.S. Food and Drug Administration (FDA).

Although consumers generally view antibacterial hand soap and body wash 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, the FDA said.

Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products, for example, triclosan (liquid soaps) and triclocarban (bar soaps), could pose health risks, such as bacterial resistance or hormonal effects, it said.

"Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said in a statement. "Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk."

The proposed rule does not apply to hand sanitizers, hand wipes or antibacterial products that are used in health care settings such as hospitals. Neither does it require the antibacterial soap products to be removed from the market at this time.

When the proposed rule is finalized, either companies will have provided data to support an antibacterial claim, or if not, they will have to remove antibacterial active ingredients from the products or remove the antibacterial claim from the product's labeling in order to continue marketing, said the regulator.

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, followed by a 60-day rebuttal comment period.

Editor: Yang Yi
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