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FDA Reviews Antibacterial Soaps and Washes

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The Food and Drug Administration (FDA) has started a review of the safety and effectiveness of antibacterial products across a range of industries.

The first stage of the process will focus on antibacterial soaps and body washes. Despite some heavy marketing, FDA officials say very little is known about the long-term effects of these products.

In December, the Administration gave manufacturers a year to prove their antibacterial soaps and washes are safe for long term daily use, and are more effective than regular soap and water in preventing illness.

Sandra Kweder, deputy director for the office of new drugs at the FDA, says there’s no data to show whether or not these products do what they claim to.

And, she says, it’s unclear whether long term exposure to some ingredients may result in hormone disruption for users, or an increased risk that targeted bacteria will become resistant to available antibiotics.

Kweder says there’ll be opportunities for public comment, but the end of the year could see a new regulation in place that would mean big changes for companies that can’t scientifically prove their products are effective.

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“Companies would be required to reformulate their products, which would basically mean taking the antibacterial ingredients out. Or, removing the claim from the products label that it’s antibacterial in order to continue marketing, or the product would have to come out of the market,” she says.

The full review will be carried out over the next few years. Future stages will include reviews of items such as antiseptic products used in the health care industry, hand wipes, and hand sanitizing gels.

While antibacterial products are under review, Kweder says consumers are very capable of making their own decisions about the products.

But, she says there are a few things that people should keep in mind.

“What we’re saying is, we don’t have evidence that these products are effective and really do what you expect them to do. And, we also aren’t entirely certain of the risks, both to you as an individual and to the environment and the greater public health. So take those into account when making a decision about whether the benefits you think you might get from the product are worth the potential risks.”

Results of the FDA review of antibacterial soaps and washes will be finalized early next year.