FDA Sued for Inaction to a Citizen Petition for Wheat Gluten

Michael Weber v. Food and Drug Administration (FDA) (Gluten)

Michael Weber is suing the FDA.  

In 2008, Michael Weber submitted a citizen petition to the Food and Drug Administration requesting that the FDA exclude the use of wheat gluten as an inactive ingredient in both prescription and over-the-counter drugs or, in the alternative, that the FDA require that drugs containing gluten be labeled to disclose that fact. In March 2015, the FDA had yet to grant or deny the petition. Representing Mr. Weber, Public Citizen brought an action against the FDA for its unreasonable delay in responding to his petition. 

In his Complaint, he is requesting the Court to declare unlawful the FDA’s failure to act on Mr. Weber’s citizen petition and order the FDA to issue a decision on Mr. Weber’s petition within 30 days of the Court’s order, etc. 

In August 5, 2013, FDA issued a final rule, establishing a regulatory definition of the term "gluten-free" for voluntary use and implementing part of the Food Allergen Labeling and Consumer Protection Act of 2004, Title II of Public Law 108-282, enacted on August 2, 2004. 

In June, 2014, FDA issued a guidance for industry entitled "Gluten-Free Labeling of Food." The final rule states "Firms are not required to label their foods “gluten-free,” but if firms whose foods are regulated by FDA voluntarily choose to make this labeling claim, those products must conform to our definition for a “gluten-free” food."

Living with Celiac Disease

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