The Food and Drug Administration issued a proposed rule on Monday that would require makers of antibacterial hand soaps and body washes to demonstrate their products are safe and more effective than regular soap and water in preventing infection and the spread of bacteria, after they found no evidence that the antibacterial chemicals used in liquid soaps and washes help prevent the spread of germs, and there is some evidence they may actually pose health risks. If companies cannot demonstrate the safety and effectiveness of their products, they would have to be reformulated, relabeled or possibly removed from the market.
In an official statement, the FDA said that millions of Americans use antibacterial hand soap and body wash products. However, some data suggest that long-term exposure to certain active ingredients used in antibacterial products-for example, triclosan in liquid soaps, and triclocarban in bar soaps could pose health risks, such as bacterial resistance or hormonal effects. Almost all soaps labeled "antibacterial" or "antimicrobial" contain at least one of the antibacterial ingredients addressed in the proposed rule. Some soaps labeled "deodorant" may also contain these ingredients.
"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." Sandra Kweder, M.D., deputy director of the Office of New Drugs at CDER, also weighed in. "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."
She added, "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." The proposed rule would not affect hand sanitizers, wipes, or antimicrobial products used in health care settings, the agency said, and it does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate or relabel these products in order to continue marketing.
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