FDA Wants To Find Out Whether Antibacterial Soap Is Safe

December 16, 2013 8:12 am0 commentsViews: 1
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Are antibacterial soaps and body washes safe and effective for long-term use? The Food and Drug Administration wants to find out.

Under a proposed rule issued Monday, Dec. 16 by the FDA, makers of antibacterial products (not including those used in health-care settings) would have to demonstrate the products are safe and effective with clinical study data.

If they’re not, the makers will have to reformulate or relabel their products in order for them to stay on store shelves.

In addition, the makers of these products would need to show that their antibacterial products are more effective at preventing illness than regular soap and water.

“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,” Dr. Janet Woodcock, M.D., the director of the Center for Drug Evaluation and Research at the FDA, 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 FDA is cracking down on consumer antibacterial products due to concerns that some ingredients in the products — such as triclosan, which is found in liquid soap, and triclocarban, which is found in bar soap — could raise the risk of bacterial resistance or affect hormones. Therefore, the FDA is reexamining the data that makes antibacterial products “generally recognized as safe and effective.”

Because this is a proposed rule, it does not mean antibacterial products have to be removed from store shelves. However, upon finalization, the makers of consumer antibacterial products will have to provide the clinical trial data showing the effectiveness and safety of their products, or will have to reformulate or relabel their products. The public is allowed to comment for 180 days on the proposed rule.

According to the Centers for Disease Control and Prevention, hand-washing with soap and water is the best way to clean hands of microbes. However, if you don’t have access to soap and water, hand sanitizer that has at least 60 percent alcohol levels is your next best bet.

Recently, a Journal of Environmental Health study showed that only 5 percent of people correctly wash their hands for 15 to 20 seconds. The average amount of time we spend scrubbing? Six seconds.