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Representatives Tim Ryan (OH-13) and Nita Lowey (NY-17) Raise Awareness By Sponsoring the Gluten in Medicine Disclosure Act

Washington, D.C. – In honor of Celiac Disease Awareness Month, Representatives Tim Ryan and Nita Lowey introduced the Gluten in Medicine Disclosure Act in order to make it easier to identify gluten in drug products. This legislation requires that drugs intended for human use have a label containing an identification of ingredients constituting or derived from a grain or starch.

This legislation is crucial for the millions of Americans affected by this life-long digestive disorder triggered by the ingestion of gluten or wheat grain products. According to the Mayo Clinic, celiac disease has increased by as much as four times in the last decade and affects three million Americans. The standard treatment for celiac disease is the elimination of gluten-containing products; and for some individuals, failure to avoid these can cause life-threatening complications.

“Celiac disease is a growing issue for our country and as elected officials it is our duty to give those affected all the resources they need to treat their disease. The United States already mandates that food products containing wheat are adequately labeled and there is no reason why we shouldn’t do the same for our medications. I am proud to introduce legislation that can help avert the serious health risk millions of Americans are forced to endure every day while taking unlabeled, potentially harmful medications,” said Congressman Ryan (OH-13).

“For millions of Americans, avoiding gluten is a medical necessity. Just as consumers deserve to know if their food contains gluten, it is critical that consumers know if medications contain gluten,” said Congresswoman Nita Lowey (D-NY), the Ranking Member on the House Appropriations Committee. “This legislation would help protect Americans’ health by giving them information on the label to ensure their medications help — not hurt – them,” said Congresswoman Lowey (NY-17)

“This legislation would provide individuals with celiac disease and food allergies with vitally important information to manage their health. It is a simple, cost-effective measure that will ensure prescription medications are, in fact, safe for millions of Americans,” noted Beth Hillson, President of the American Celiac Disease Alliance.  “We applaud Representatives Ryan and Lowey for their leadership in sponsoring the Gluten in Medicine Disclosure Act.”

The Gluten in Medicine Disclosure Act has been endorsed by: American Celiac Disease Alliance, National Foundation for Celiac Awareness, Celiac Disease Foundation, Celiac Sprue Association, Gluten Intolerance Group, North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, and the American College of Gastroenterology.

Now, its our turn, tweet your thanks to @RepTimRyan and @NitaLowey.  Take one more minute, and send a letter asking your representative to cosponsor H.R. 2003, the Gluten in Medicine Disclosure Act.

Celebrating National Celiac Awareness Month

Not many years ago, the autoimmune condition celiac disease was considered rare, affecting perhaps 1 in 10,000 or maybe 1 in 5,000 Americans.  Over the past decade knowledge about its associated genes, scientific underpinnings, and treatment has expanded dramatically.

During the month of May, we build upon those efforts by engaging in a range of activities to raise awareness in communities across the U.S. and around the world.  This year we take pride in knowing those actions have resonated in the nation’s Capitol with the introduction of the Gluten in Medications Disclosure Act. It would require labeling for gluten specific ingredients in prescription medications.  We applaud Rep. Tim Ryan (D-OH) and Rep. Nita Lowey (D-NY) for their leadership and introducing this important legislation.

On a related front, news from Alvine Pharmaceuticals reveals that interest in celiac disease has reached a new level. The biopharmaceutical, focused on autoimmune and inflammatory diseases, entered into a global collaboration with AbbVie to develop a novel treatment for patients with celiac disease. This the first time a mainstream pharmaceutical company has entered into such a partnership. Read more about their promising project.

Gluten-Free Labeling Proposal in Final Stage of Review

On February 25, the celiac community received exciting, positive, news out of Washington DC.  The FDA’s gluten-free labeling rule was sent to the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget at the White House.  This is expected to be the last step in the regulatory approval process.  After nearly a decade, the gluten-free labeling standard mandated by the Food Allergen Labeling and Consumer Protection Act of 2004 is truly on the verge of completion.  OIRA endeavors to complete action on pending matters within 90 days. That window should close in late May or June (calendar vs. business days).

At the time the gluten-free proposal was forwarded to OIRA, there were 143 other rules and proposals in its queue of items to be reviewed.

Department of Justice Settlement Reignites Call for Gluten-Free School Meals

The U. S. Department of Justice reached a settlement agreement with Lesley University in Cambridge, MA, to ensure that current and prospective students with celiac disease and food allergies have full and equal access to the university’s meal plan and food services. A student filed complaint alleging the university was not in compliance with Title III of the Americans with Disabilities Act (ADA) triggered the Department of Justice to investigate and resolve the case without litigation.