Supplier News Breaks
FDA scrutinizes antibacterial soaps
December 16th, 2013
WASHINGTON – The Food and Drug Administration has proposed a rule calling on manufacturers of antibacterial hand soaps and body washes to show that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.
The FDA said Monday that under the rule, if companies don't demonstrate such safety and effectiveness, their products would need to be reformulated or relabeled to stay on the market. The proposal doesn't affect hand sanitizers, wipes or antibacterial products used in health care settings.
According to the FDA, there's no evidence that antibacterial hand soap and body wash products are more effective at preventing illness than washing with plain soap and water. In addition, the agency said, some data suggest that long-term exposure to certain active ingredients used in antibacterial products — such as triclosan (liquid soaps) and triclocarban (bar soaps) — 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," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), 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 explained that widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the agency to re-evaluate what data are needed to classify the active ingredients in consumer antibacterial products as "generally recognized as safe and effective," or GRASE.
Under the proposed rule, manufacturers that want to continue marketing antibacterial products will be required to provide the agency with additional data on the products' safety and effectiveness, including data from clinical studies to show that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection. Almost all soaps labeled "antibacterial" or "antimicrobial" contain at least one of the antibacterial ingredients addressed in the proposed rule, the FDA said.
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"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," stated Sandra Kweder, deputy director for the 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."