FDA to Make Manufacturers Validate Effectiveness of Antibacterial Soaps
The U.S. Food and Drug Administration proposed a rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are more effective in preventing illness and the spread of infection than regular soap and safe for long-term daily use. Hand sanitizers, wipes or other products used in health care settings are not included in this rule.
“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, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER), said. “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.”
Some data has suggested long-term exposure to ingredients, such as triclosan and triclocarban, could pose health risks that may include bacterial resistance or hormonal effects while there is not evidence that they work better than regular soap and water, according to the FDA. These points along with widespread consumer use prompted the FDA to reevaluate what is "generally recognized as safe and effective" (GRASE).
Companies who want to continue to market their products as "antibacterial" will have to submit data on their safety and effectiveness, as well as clinical data showing they are more effective than their non-antibacterial counterparts, over the course of the next year. Otherwise they must reformulate or relabel their items, according to the FDA. This process will take more than a year, and the soaps will not be required to be removed from the market during that time.
“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,” said Sandra Kweder, M.D., deputy director, 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.”