FDA: We need more data on anti-microbials

FDA: We need more data on anti-microbials

The US Food and Drugs Administration is said to be looking for additional data to assess the safety of certain ingredients commonly used in OTC topical antiseptic rubs, including alcohol, isopropyl alcohol and benzalkonium chloride, according to a report published by Reuters.

The move is part of a wider review being conducted by the agency following a lawsuit settled with the Natural Resources Defense Council in 2013. The environmental group brought an action against the FDA alleging that the agency had failed to regulate toxic chemicals found in hand sanitizers and other personal care products.

“We believe that the FDA has a wealth of data on hand sanitizers in their possession to judge them as generally recognized as safe and effective,” said the American Cleaning Institute in a statement. “However, we will work to provide additional data as necessary to ensure the agency has the most complete, useful and up-to-date information on these products.”

Companies will be afforded 12 months to submit new data, before the agency evaluates the information and publishes its decision.

 

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