The FDA has proposed a rule requiring the manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term use and more effective than plain soap and water.
The rule is part of a larger, ongoing FDA review of antibacterial ingredients. The rule does not affect hand sanitizers, wipes or antibacterial products used in health care settings.
“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.”
According to the press release, nearly all soaps labeled as antibacterial or antimicrobial contain an antibacterial ingredient addressed in the proposed rule, such as triclosan in liquid soaps and triclocarban in bar soaps. Recent data have suggested that long-term exposure to these ingredients could pose health risks such as bacterial resistance or hormonal effects. Furthermore, there is no evidence that these products are any more effective at preventing illness than washing with plain soap and water.
The proposed rule does not require that antibacterial soaps be removed from the market at this time. When the rule is finalized, companies will be required to provide data to support the antibacterial label. If this data is not provided, they will need to reformulate the product by removing antibacterial active ingredients or re-label the product to remove the antibacterial claim.
“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,” Sandra Kweder, MD, deputy director of the Office of New Drugs at CDER, said in the press release. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and prevent spreading germs to others.”