In response to concerns that widespread use of antibacterial soaps may be fueling a rise in superbugs, manufacturers will soon have to meet stricter requirements showing long-term safety, U.S. regulators said Monday.
Antibacterial soap-makers would also have to show that their products are more effective than plain soap at preventing illness and the spread of infections, said the proposed rule by the U.S. Food and Drug Administration.
The products typically contain the chemicals triclosan and triclocarban, "which may carry unnecessary risks given that their benefits are unproven," the FDA said in a statement.
Some studies have shown these soaps may affect thyroid, estrogen, and testosterone function in lab animals, and that they may be boosting people's resistance to common antibiotics.
"New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits," said Colleen Rogers, a lead microbiologist at FDA.
"There are indications that certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects that are of concern to FDA."
The FDA move would require studies that directly test the ability of an antibacterial soap to provide a clinical benefit over washing with non-antibacterial soap.
There is an 180-day comment period before the rule can take effect, and it does not mean that the products will be removed from shelves anytime soon.
Instead, companies have one year to provide the results of scientific studies that support the antibacterial claim.
Otherwise, they must either remove the antibacterial active ingredients or relabel their products to remove any antibacterial claims.
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