On Monday, the FDA issued a proposed rule to require manufacturers of nonprescription antibacterial hand soaps and body washes to demonstrate that these products are safe for long-term daily use and that they are more effective than plain soap and water in preventing illness and the spread of certain infections.
If finalized, the rule would require manufacturers to provide the FDA with clinical study data demonstrating that products labeled as antibacterials are more effective than non-antibacterial soaps in preventing human illness or reducing infection. In addition to effectiveness data, manufacturers also would be required to provide safety and efficacy data to support their claims or to reformulate their products by removing the antibacterial active ingredients and relabeling them by removing the antibacterial claim from the product’s labeling.
“There is widespread and frequent use of antibacterial hand soap and body wash products in the United States. More than 2,200 products are currently available for consumers. While consumers generally view these products as effective tools in preventing the spread of germs, there is no scientific evidence demonstrating that these products are any more effective at preventing illness than simply washing hands with plain soap and water. Further, the risk of infection in everyday settings such as home, work, school and public settings is relatively low,” According to Janet Woodcock, MD, director, Center for Drug Evaluation and Research at the FDA.
“Moreover,” she continues, “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. These ingredients include triclosan (used in liquid soaps) and triclocarban (used in bar soaps). The extensive exposure to these ingredients by consumers, along with scientific information and concerns raised by health care and consumer groups, have prompted FDA to reevaluate what data are needed to classify these active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE. The Agency believes there should be a clearly demonstrated clinical benefit from using antibacterial soaps to balance any potential risk.”
In the interim, FDA will continue its larger, ongoing review of antibacterial active ingredients to ensure that these ingredients are proven to be safe and effective.