Triclosan typically is used in liquid antibacterial soaps, while triclocarban is used in bar soaps.
"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, said in a statement. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”
Theresa Michele, FDA's director of the division of nonprescription drug products, said in a call with reporters that the "vast majority" of the more than 2,000 antibacterial products on the market contain at least one of the banned ingredients.
She said the agency had asked manufacturers for data showing that the long-term use of the ingredients was safe, as well as evidence that the antibacterial products were more effective than soap and water in curbing the spread of illnesses and infections. But she said the companies either didn't provide the data or the material submitted wasn't convincing.
An industry group that represents makers of cleaning products disputed that, saying manufacturers had submitted the required information. "The FDA already has in its hands data that shows the safety and effectiveness of antibacterial soaps," the American Cleaning Institute said in a statement. "Manufacturers are continuing their work to provide even more science and research to fill data gaps identified by FDA."
The association added that antibacterial soaps and washes "continue to be safe and effective products for millions of people every single day."
The FDA's final rule does not affect consumer hand sanitizers, wipes or antibacterial products used in hospitals and other health-care settings. In June, the agency requested data on the safety and effectiveness of certain ingredients in those products, but emphasized it was not barring any of the items at that time.
The agency issued a proposed rule in 2013 on antibacterial soaps and washes after data suggested long-term exposure to certain ingredients could cause bacterial resistance and unanticipated hormonal effects.
Ken Cook, co-founder and president of Environmental Working Group, praised the FDA decision, saying that the group has been pressing for such action for a decade. “This decision by the FDA is a huge victory on behalf of human health and the environment,” he said.
Michele said some manufacturers, including Johnson & Johnson and Procter & Gamble, have already taken steps to phase out use of some of the banned ingredients.
The FDA also said that, in response to industry requests, it would defer for a year making a decision on three additional ingredients used in consumer wash products – benzalkonium chloride, benzethonium chloride and chloroxyleno -- to allow manufacturers to submit data to the agency.