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Public Citizen Attempts To Force FDA Decision On Benzocaine Petition

 
• By Eileen Francis

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.

old chronometer

Public Citizen has filed litigation to force FDA to issue a decision within 30 days on a citizen petition it submitted more than three years ago questioning the safety of OTC benzocaine's use for teething pain.

The agency is “unlawfully withholding or unreasonably delaying action” which is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law” under the Administrative Procedure Act, Public Citizen says in its complaint filed Sept

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