WASHINGTON (CBSDC) – On Monday, officials with the Food and Drug Administration proposed a rule that would require manufacturers of antibacterial hand soaps to prove that their products are safe to use on a daily basis over an extended period of time.

Makers of such soaps would have to be able to demonstrate that the active ingredients in their products are safe as well as effective, according to a release posted to the official FDA website. Officials stated that no evidence presently exists regarding the superiority of antibacterial soaps, and that “some data suggest that long-term exposure to certain active ingredients used in antibacterial products … could 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,” Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, was quoted as saying. “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 proposal would not, however, mandate the removal of existing products from the market. When it is finalized, however, future products would have to comply with standards set forth in the rule.

One of the requirements set forth by the proposal involves providing the FDA with clinical studies that show the superiority of a product labeled as anti-bacterial in comparison to a soap that does not make such claims.

FDA officials additionally urged Americans to continue washing their hands frequently to protect from the transmission of certain illnesses.

“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,” Dr. Sandra Kweder, deputy director, Office of New Drugs at CDER, noted in the release. “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.”


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