The FDA has proposed a preliminary rule that will require antibacterial soap manufacturers to prove that their products are safe to use and more effective than plain soap and water for preventing infections.
The proposed rule will apply to antibacterial soaps that contain any of 22 antiseptic active ingredients, including the two most common — triclosan and triclocarban.
Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.
Those who are unable to do so will be required to reformulate or relabel the product, according to the FDA.
“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, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a press release. “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 affect hand sanitizers, wipes or antibacterial products used in health care settings, where patients are generally more susceptible to infection and the potential for spread of infection is high, the agency noted.
The announcement is part of a larger, ongoing review of antibacterial active ingredients to ensure these ingredients are proven to be safe and effective. Just last week the FDA announced plans to crack down on antibiotic use in food animals as concerns about antibiotic resistance are rising.
The proposed rule is available for public comment until June 16, 2014. Manufacturers will have a concurrent one-year period to submit new data and information.