The Gluten in Medicine Disclosure Act of 2019

April 22, 2019

On April 3, 2019, Representative Tim Ryan [D-OH] introduced H.R. 2074, the Gluten in Medicine Disclosure Act of 2019 to the congressional floor. If passed, the bill would amend the Federal Food, Drug, and Cosmetic Act to require gluten be labeled in all medications.

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

Providing Transparency for Consumers

Why Should I Care about Gluten in Medications?

  • According to the Mayo Clinic, the rate of celiac disease (CD) has almost quadrupled over the past 50 years-3 million Americans currently have CD.
  • Research estimates that 18 million Americans have non-celiac gluten sensitivity (NCGS).

What is Celiac Disease?

  • CD is a serious, genetic autoimmune disorder.
  • Ingesting gluten causes damage to the villi of the small intestine.
  • 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 medicine.

Current Law:

  • Packaged foods require labeling of wheat and 7 other allergens
    • This doesn’t include rye and barley nor does it cover medications.
  • Not knowing if gluten in present in medications leads to fear and anxiety as well as potential avoidance of treatment.
  • Accidental ingestion of gluten sets off an autoimmune response and could lead to malabsorption of the medication itself.

What Will This Act Do?

  • Will make it easier to identify gluten in prescription drugs.
  • It 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; that small distinction is an important one.

Beyond Celiac encourages you to support the Gluten in Medicine Disclosure Act of 2019 by contacting your representatives and encouraging them to cosponsor this bill. 

A list of those currently cosponsoring this bill can be found here.

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