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Gluten-Drug Rule Petitioner Claims Time Has Expired For FDA Decision

This article was originally published in The Tan Sheet

Executive Summary

A lawsuit seeks to declare FDA’s failure to act on a 2008 citizen petition requesting a ban of wheat gluten in OTCs and Rx drugs in violation of the Administrative Procedure Act. The complaint alleges the agency’s delay is unreasonable and asks the court to order FDA to make a decision within 30 days.

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