US FDA Demands Proof of Antibacterial Soap Claims

Manufacturers of nonprescription antibacterial hand soaps and body washes will soon be required to show their products are more effective than plain soap in stopping the spread of infections.

The demand made by the US Food and Drug Administration (FDA; Silver Spring, MD, USA) does not apply to hand sanitizers and wipes, which are alcohol-based and are not used with water, or to antibacterial products used in the healthcare setting. Failing to meet these standards would mean that the antiseptic ingredients used in the products would have to be removed from over-the-counter (OTC) products, or that antibacterial claims are removed from product labeling. The FDA has been reviewing antibacterial active ingredients for the past several years, and hopes to finalize the rule by late 2016.

Over 2,200 antibacterial hand soaps and body washes are currently available for consumers in the United States alone, but there is no scientific evidence showing these products are any more effective at preventing illness than washing hands with plain soap and water. In fact, some data suggest that long-term exposure to certain active ingredients used in antibacterial products, such as triclosan and triclocarban, engender health risks such as bacterial resistance or hormonal imbalances (for example with estrogen, testosterone, and thyroid hormones).

“In order for antibacterial soaps and body washes to be considered generally recognized as effective, manufacturers would be required to conduct clinical trials demonstrating that their products are more effective than plain soap and water in preventing illness and the spread of certain infections when they're used by consumers,” said Sandra Kweder, MD, deputy director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research (CDER).

“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, MD, director of the 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.”

The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate or re-label these products in order to continue marketing.

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US Food and Drug Administration