FDA examining antibacterial soaps, body washes
Manufacturers of antibacterial hand soap and body wash will be required to prove their products are more effective than plain soap and water in preventing illness and the spread of infection, under a proposed rule announced Monday by the Food and Drug Administration.
Those manufacturers also will be required to prove their products are safe for long-term use, the agency said.
“Millions of Americans use antibacterial hand soap and body wash products,” the agency said in a statement. “Although consumers generally view these 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.
“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 post health risks, such as bacterial resistance or hormonal effects.”
When the proposed rule is finalized, companies will have had to provide data to support their claims, or — if they do not — the products will need to be reformulated or relabeled to remain on the market.
The 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 period for rebuttal comments, according to the FDA.
“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 Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
“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 action is part of FDA’s ongoing review antibacterial active ingredients, the agency said.
Hand sanitizers, wipes and antibacterial products used in health care settings are not affected.
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