FDA to Take a Closer Look at Antibacterial Soaps
The U.S. Food and Drug Administration (FDA) today announced that it will be taking a closer look into the safety of antibacterial soaps.
Under a new rule proposed by the agency, antibacterial soap and body wash manufacturers would have to provide evidence showing that their products are safe for long-term daily use and that their products are more effective than regular soap. Manufacturers unable to provide such evidence, which includes clinical trial data, would have to relabel their product for sale in the U.S. or reformulate their products to remove certain active ingredients.
“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 Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CEDR) at the FDA. “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 FDA there is currently no evidence products marketed as antibacterial are any more effective at preventing the spread of illnesses than normal soap and water. The FDA also feels there is evidence that some active ingredients in antibacterial soaps (the most common being triclosan and triclocarban) could “pose health risks” with long-term exposure, iincluding “bacterial resistance or hormonal effects.”
The FDA’s new rule would not affect hand sanitizers or wipes. Also, manufacturers will not have to scramble right away to provide the FDA with the data it is looking for. The new rule will go into effect after 180 days and manufacturers will then have one year to submit their evidence to the agency.
“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 Dr. Sandra Kweder, deputy director for 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.”