FDA warning over antibacterial soaps

The Food and Drug Administration (FDA) has warned that antibacterial chemicals in soaps and body washes may pose health risks.

The FDA called for a safety review of such products.

The agency proposed a rule requiring manufacturers to prove such soaps are safe and more effective against infection than plain soap and water.

Recent studies indicate an ingredient in such products could scramble hormone levels and boost drug-proof bacteria.

Manufacturers have until the end of 2014 to submit the results of clinical trials on their products, the FDA said. The new regulations would be finalized in 2016.

“New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” Colleen Rogers, an FDA microbiologist, wrote in a statement on Monday.

Certain ingredients in such products – such as triclosan in liquid soaps and triclocarban in bar soaps – may contribute to bacterial resistance to antibiotics, the agency added.

Such products may also have “unanticipated hormonal effects that are of concern”, according to the statement.

Recent studies of such chemicals on animals have shown they may alter hormones, the FDA said, but such results have not yet been proven in humans.

“Because so many consumers use them, FDA believes that there should be clearly demonstrated benefits to balance any potential risks,” the statement added.

If the FDA’s proposed rule is finalized, companies would be required to provide data to support their product’s health claims.

If they cannot, the products would be reformulated or relabeled in order to remain on the market.

In March, a federal appeals court approved a lawsuit by the non-profit Natural Resources Defense Council, aimed at forcing the FDA to review the health impacts of triclosan.

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