FDA Seeks More Data on OTC Hand Sanitizers

FDA Seeks More Data on OTC Hand Sanitizers

The United States Food and Drug Administration (FDA) wants more time, and is asking for specific information on three main ingredients in hand sanitizers, before determining whether or not their use is “safe or effective.” Although this information was expected to be forthcoming, a lawsuit has delayed the release of the FDA’s decision. The FDA’s public statement explained that the request for additional time does not imply inefficacy or danger on the part of hand sanitizers but is needed to determine if other factors may be caused by their use as well. The FDA’s decision will not be released for at least one more year, during which the manufacturers of hand sanitizer will be submitting new information for analysis. The lawsuit was initiated by “an environmental group” and not by manufacturers of hand sanitizer.

Key Points:

  • 1FDA is looking into over the counter hand sanitizers after lawsuit over effectiveness by the Natural Resources Defense Council (NRDC) in 2013.
  • 2FDA’s response to current data is the proposition of a new rule requiring the provision of ingredient information on contents to consumers.
  • 3When all data have been received the FDA will evaluate and publish its findings.


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.

Read the full article at: http://www.medpagetoday.com/HospitalBasedMedicine/InfectionControl/58846

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