The U.S. Food and Drug Administration said it is seeking additional data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs, including hand sanitizers, that are sold over-the-counter.
The regulator’s move comes more than a year after it asked for additional data to check if antiseptics used in healthcare settings were as safe and effective as they were once considered.
The action is part of a larger ongoing review by the agency after a lawsuit settlement with the environmental group Natural Resources Defense Council (NRDC) in 2013.
The group had sued the FDA, claiming the agency failed to regulate toxic chemicals found in antimicrobial soap and other personal care products. (reut.rs/292GT18)
NRDC’s senior attorney Mae Wu said the FDA action was “long overdue”. “We need to know whether these chemicals are safe and effective.”
The FDA said on Wednesday its request would help ensure that regular use of these products do not present unknown concerns, and not that these products were ineffective or unsafe. (1.usa.gov/29c72zQ)
The agency said it does not require any hand sanitizers to be removed from the shelves at this time.
“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,” the American Cleaning Institute (ACI) said 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,” the statement said.
The proposed rule, which will be available for public comment for 180 days, requires that manufacturers provide information for active ingredients: alcohol, isopropyl alcohol and benzalkonium chloride.
Since 2009, 90 percent of all consumer antiseptic rubs use ethanol or ethyl alcohol as their active ingredient, according to the agency.
The companies will get a year to submit new data after which the FDA will evaluate and publish its final determination.
(Reporting by Ankur Banerjee in Bengaluru; Editing by Shounak Dasgupta)
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