Public Citizen Attempts To Force FDA Decision On Benzocaine Petition
This article was originally published in The Pink Sheet
FDA is sued by Public Citizen after failing to make a decision on a 2014 citizen petition urging the agency to remove an infant teething indication for OTC benzocaine products. The complaint asks a federal court to order a response from the agency within 30 days.
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In a citizen petition the group asks FDA to remove teething for children 2 years and older as an indication for some benzocaine products and require a label warning for OTC monograph benzocaine products concerning the risk of methemoglobinemia.