The agency announced a proposed rule and comment period calling on manufacturers of antibacterial soaps and body washes to provide evidence their products actually kill bacteria. Evidence from animal studies show these products are no more effective than soap and water and might actually affect estrogen, testosterone and thyroid hormonal levels, officials said.
“While the use of antibacterial soaps and body washes has become part of many consumers’ routines, we at the FDA have not been provided with data to demonstrate that these products are any more effective at preventing people from getting sick than washing with plain soap and water,” said Dr. Sandra Kweder, deputy director of the Office of New Drugs in the Center for Drug Evaluation and Research at FDA. “To put it simply, we need to collect additional information from the companies that make these products so that consumers can be confident about their effectiveness and their safety.”
There is also evidence that these products might be aiding antibiotic resistance among bacteria, she said.
“There are laboratory data that show that bacteria exposed to these products do change their resistance patterns,” Kweder said.
Most of those products contain an ingredient called triclosan or another called triclocarban. The FDA is aware of 2,000 such products, about 93 percent of which are labeled antibacterial, Kweder said. Companies that could not provide evidence of effectiveness would have to reformulate the products or relabel them to remove the antibacterial claim, she said. The FDA is taking comments on the proposed rule for 180 days and the industry would have until December 2014 to submit data and studies. FDA would expect to finalize the rule around September 2016.
The FDA has been talking about the issue since at least 2005 so it should not be unexpected, Kweder said.
“The industry has long been aware of our concerns,” she said.
The proposed rule would not affect hand sanitizers and other sanitizers that are alcohol-based because those have been shown to be effective, Kweder said.