September 30, 2015

Washington, DC – Representatives Tim Ryan (OH-13) and Nita Lowey (NY-17) introduce the Gluten in Medicine Identification Act, which makes it easier to identify gluten in pharmaceutical products. This legislation requires drugs intended for humans use labels contain a statement identifying the source of any ingredient constituting or derived from a grain or starch-containing ingredient.

“People need to be able to trust that the medicine they are prescribed will improve their health, not worsen it,” said Representative Ryan. “Celiac disease is a growing issue in our country and those suffering have the right to know if their medicine contains ingredients that are adverse to their health. I am proud to introduce legislation that will help prevent the serious health risks and frustrations that Americans suffering from this disease are forced to deal with on a daily basis. These men and women are simply asking for the information they need to protect their health and wellbeing, and as Members of Congress we owe them this clarity.”

“Americans deserve to know what is in their food and drugs.  Providing uniform standards for food and drug labeling will make a world of difference to the quality of life for people with celiac disease. I wrote the Food Allergen Labeling and Consumer Protection Act because I wanted to help millions of people coping with food allergies and related health challenges. We now need clear labels on drugs that contain gluten, so millions of Americans can have peace of mind that the positive effect of their medicine isn’t counteracted by ingredients harmful to them,” said Representative Lowey.

“With FDA labeling requirements for gluten-free foods now secured, Celiac Disease Foundation (CDF) is pleased to support Representative Tim Ryan and Congresswoman Lowey’s Gluten in Medicine Disclosure Act,” said Marilyn G. Geller, Chief Executive Officer of Celiac Disease Foundation (CDF). “The celiac disease community should be able to take both prescription and non-prescription medicines with as much confidence as possible that it will improve our quality of life. Without this legislation, that confidence is missing.”

According to the Mayo Clinic, celiac disease has increased as much as four times in the last decade. Celiac disease is an immune-mediated chronic inflammatory disorder triggered by the ingestion of gluten or wheat grain products, affecting primarily the small intestine. The Food Allergen Labeling Consumer Protection Act of 2004 required packaged food labels to identify all ingredients containing wheat and other allergens, but this important distinction is missing from medicine labels. The lack of information regarding gluten in medicine is troubling for people who suffer from this disease.

The standard treatment for celiac disease is the elimination of gluten-containing products, including wheat, barley, or rye sources. For some individuals, failure to avoid these sources can cause life-threatening complications. Unfortunately, this can be nearly impossible when it comes to the presence of gluten in medicine. The lack of proper labeling to inform the average consumer or pharmacist about the presence of gluten can cause confusion, delay in taking the medicine, and unintentional digestion of gluten.

H.R. 3648: Gluten in Medicine Disclosure Act of 2015

Original Press Release