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FDA Must Act on Citizen Petition to Eliminate Gluten from Medications or Provide Clear Labeling

March 17, 2015

FDA Must Act on Citizen Petition to Eliminate Gluten from Medications or Provide Clear Labeling

Public Citizen Represents New York State Celiac Sufferer in Suit Against Agency

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must act on a 2008 citizen petition by Michael Weber urging that prescription medications be made without wheat gluten or, if not, then labeled as containing wheat gluten, Public Citizen said in a lawsuit filed on Weber’s behalf in the U.S. District Court for the District of Columbia.

Weber, a resident of Eastchester, N.Y., filed his petition in June 2008. Weber – along with approximately 3 million other Americans – suffers from celiac disease. When individuals with celiac disease consume wheat gluten, their bodies produce an autoimmune response that attacks the small intestine. Prolonged exposure to gluten can cause intestinal cancers, autoimmune disease, increased mortality rates and other problems.

Wheat gluten is sometimes used in medications as an inactive ingredient or to bind other ingredients. Even the small amount of gluten contained in regularly consumed medications can trigger the symptoms of celiac disease.

Patients with celiac disease may have to spend significant time and effort to determine whether gluten is in the medications they take. The problem is more difficult because brand-name medications may use different binders and inactive ingredients than their generic equivalents, or one generic may use different ingredients than another generic of the same product.

On June 2, 2008, Weber petitioned the FDA, asking it to eliminate wheat gluten in medications or, if not, then at least to impose new labeling requirements on those containing wheat gluten. In his petition, he explained the difficulties that he and others with celiac disease face when taking needed medications, including time-consuming research and phone calls to manufacturers.

The FDA posted the petition online; it attracted 73 comments.

In December 2011, the FDA published a request for comments asking whether gluten should be banned from medications. The FDA received 138 comments, including several from medical and celiac disease associations supporting such a ban. The comment period closed in March 2012. The FDA has taken no further action.

“Mr. Weber and millions of others have waited far too long for the FDA to act,” said Katie Einspanier, the Public Citizen attorney handling the case. “While the FDA drags its feet, millions who suffer from celiac disease will continue to be injured or risk injury every time they take medications that contain wheat gluten. The absence of rules to address wheat gluten in prescription medications has serious and ongoing public health implications.”

Added Weber, “If gluten were to be excluded from the government’s list of safe inactive ingredients, people like me could confidently take medicine. And those who do not have the resources to research every medication would be protected as well.”

Read the complaint (PDF).

View the 2008 citizen petition (PDF).

View more information about the case.