FDA removes 'more harm than good' antibacterial soaps from market
Manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections, the FDA said in its final rule.
The ban applies to products containing one or more of 19 specific active ingredients, including the most commonly used ingredients - triclosan and triclocarban, but it does not affect consumer hand sanitizers or wipes, or antibacterial products used in health care settings, the agency said.
"Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
"In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term," Woodcock said.
According to the FDA, long-term exposure to certain active ingredients used in antibacterial products, for example, triclosan and triclocarban, could pose health risks such as bacterial resistance or hormonal effects.
But the agency has deferred rulemaking for one year on three additional ingredients used in consumer wash products - benzalkonium chloride, benzethonium chloride and chloroxylenol - to allow for the development and submission of new safety and effectiveness data for them.
The FDA noted that washing with plain soap and running water remains one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.
If soap and water are not available and a consumer uses hand sanitizer instead, the U.S. Centers for Disease Control and Prevention (CDC) recommended that it be an alcohol-based hand sanitizer that contains at least 60 percent alcohol. ■