Tim Ryan

From the office of:

Tim Ryan

Sending Office: Honorable Tim Ryan
Sent By:

        Request for Cosponsor(s)

Cosponsor H.R. 2074: The Gluten in Medicine Disclosure Act of 2019

Providing Consistency and Transparency for Consumers

Endorsed By: Beyond Celiac, Celiac Disease Foundation,
National Celiac Association

Cosponsors (47): Allred, Axne, Blumenauer, Blunt Rochester, Bonamici, Brownley, Cohen,
Cole, Cooper, Dean, Doggett, Engel, Evans, Fitzpatrick, Foster, Gottheimer, Hastings, Heck, Higgins, Holmes Norton, Kind, Khanna, Kuster, Lamb, Lipinski, Lieu, Lofgren, Lowey, Luria, McCollum, McGovern, Murphy, Neguse, Pappas, Pingree, Pressley,
Raskin, Ruppersberger, Rush, Scanlon, Schneider, Soto, Stivers, Trahan, Trone, Van Drew, Wild

Dear Colleague:

According to the Mayo Clinic, the rate of celiac disease has almost quadrupled over the past 50 years. Celiac disease is a serious, genetic autoimmune disorder in which ingesting gluten causes damage to the villi of the small intestine. The only treatment
is the total elimination of gluten-containing products, including wheat, barley, and rye sources. For some, failure to avoid these can lead to life-threatening complications. Currently, this is nearly impossible to determine the presence of gluten in prescription

In 2004, the Food Allergen Labeling Consumer Protection Act required packaged food labels to identify all ingredients containing wheat and other allergens. This requirement does not extend to prescription drugs. After repeated efforts to shed light on this
issue, the FDA released draft guidance in 2017 encouraging drug manufacturers to disclose the presence of gluten. While some manufacturers have taken this step, it has not been implemented consistently. This leads to anxiety of not knowing whether or not your
medicine is causing more harm than good.

That is why we introduced the Gluten in Medicine Disclosure Act, which will make it easier to identify gluten in prescription drugs. This legislation would require drug manufacturers to label medications intended for human use with the list of ingredients,
their source, and whether gluten is present. A gluten-containing drug that does not meet these requirements would be considered misbranded under Section 502 of the Federal Food, Drug, and Cosmetic Act. This labeling will allow concerned consumers to know,
for example, if the starch in their prescription drugs comes from wheat or corn. For the nearly 3 million Americans living with celiac disease, that small distinction is an important one.

Please join us in cosponsoring this important piece of legislation to make it easier and safer for individuals with celiac disease or gluten sensitivity to make informed purchases of needed medications. For more information or to cosponsor, please contact
Rachel Jenkins ( in Congressman Ryan’s Office or Shane Hand ( in Congressman Cole’s Office.



Tim Ryan                                                                                   Tom Cole

Member of Congress                                                                 Member of Congress

Related Legislative Issues

Selected legislative information: Consumer Affairs, HealthCare

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