Review of Safety of Antibacterial Soaps is Needed Says US

As many as 2,000 such soap products containing triclosan are for sale on the US market, an FDA spokeswoman said.

The chemical has been on the market for 40 years and is also present in toothpastes, household cleaning products, plastics and cosmetics.

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Some studies have shown triclosan may affect thyroid, estrogen, and testosterone function in lab animals, and that it may boost 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.

Sandra Kweder, deputy director of the FDA's Office of New Drugs, told reporters that some laboratory studies have shown that bacteria exposed to these products change their resistance pattern.

"What we don't understand is how that -- specifically related to these products -- is operative in the real world, or say in the home of a family that uses these products regularly," she said.

"We are hopeful that there are researchers out there who have actually looked at some of these questions."

Manufacturers have until the end of 2014 to submit the results of clinical trials on their products, and the rule will be finalized in 2016, the FDA said.

The new requirements do not affect hand sanitizers, which are alcohol-based and do not require the use of water, or antibacterial products used in hospitals.

The FDA changes also do not mean antibacterial soaps products would vanish from the store shelves.

Instead, manufacturers that fail to meet the stricter safety requirement may either remove the antibacterial active ingredients or relabel their products to remove any antibacterial claims.

Asked for comment, a spokeswoman for Henkel, the maker of Dial soap, told AFP that the company was not yet aware of the FDA decision.

A spokesman for the American Cleaning Institute told AFP a statement was being prepared and would be released to the media soon.

Senator Edward Markey, a Democrat from Massachusetts who has called for a ban on products containing triclosan, hailed the FDA move.

"Chemicals like triclosan existed in a regulatory black hole, despite serious concerns about its impact on public health, especially that of developing children," he said in a statement.

"I applaud the FDA for taking a step to restrict the use of this harmful and ineffective chemical that continues to pollute our bodies."

Triclosan is a source of controversy in Europe as well.

A committee of European Union scientists issued a paper in 2009 that said concentrations higher than 0.3 percent in soaps and cosmetics are "not safe for the consumer because of the magnitude of the aggregate exposure."

The group also said questions remain about its impact on microbial resistance, and recommended "prudent" use. It has not been banned from consumer care products in Europe.

In the United States, some toothpastes and mouthwashes also contain triclosan, as it has been shown to help prevent the gum disease gingivitis, the FDA said.

Last week, the FDA issued voluntary guidelines to help cut back on antibiotics routinely fed to farm animals, a practice that has also fueled concerns about drug-resistant bugs.

Kweder said the two issues were not directly related but were "part of a larger framework of assuring that there is a well established benefit and risk assessment that can be conducted before these products can be just put out there widely for general use."

Source: AFP