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FDA to require companies to prove safety & effectiveness of antibacterial soaps

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Although millions of people in this country regularly use antibacterial hand soap and body wash products, there has been no real evidence that they are any more effective at preventing illness than washing with plain soap and water. In fact, the FDA notes that some studies actually indicate that “long-term exposure to certain active ingredients used in antibacterial products, such as triclosan used in liquid soaps and triclocarban in bar soaps may actually pose health risks, such as bacterial resistance or hormonal effects.”

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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “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.”

As a result, the agency is now proposing a rule to requiring manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use. If not, companies would be forced to either reformulate or relabel products for them to stay in the marketplace. Hand sanitizers, wipes, or antibacterial products used in health care settings will not be affected by the action.

“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” added Dr. Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”

In the meantime, the CDC encourages the public to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60% alcohol should be used.

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