Call to Action: Gluten in Medicine Disclosure Act of 2019

Gluten in Medicine Disclosure Act of 2019. Representatives Ryan and Cole introduced this bill on April 3, 2019. The bill currently has 8 co-sponsors.

The text of the bill is available at https://www.congress.gov/bill/116th-congress/house-bill/2074/text?fbclid=IwAR3Xr7YABCf4sFERNHO00yOkq7HCV2h1DHTnVXWL1OzKlc6znHEb9nY9n9s.

Please support this bill by contacting your representative. A state-by-state directory is available at https://www.house.gov/representatives.

You can also find your representative by zip code at https://www.house.gov/representatives/find-your-representative?fbclid=IwAR0XjoajmDCz7loMHtt2-Tx8K6-Rvf6QifiyVklSPejTw1J7A7ene0gwbUA.

I was contacted by Representative Ryan’s office and asked for my opinion regarding wording of the bill. The bill currently reads in part that a drug must state if it contains an ingredient that is derived directly or indirectly from a gluten-containing grain (including wheat, barley, rye, and their crossbred hybrids).

This language is consistent with how FDA addresses gluten in its draft guidance, “Gluten in Drug Products and Associated Labeling Recommendations Guidance for Industry.” In this document, FDA appears to interpret “ingredients derived directly or indirectly from a gluten-containing grain” to include ingredients derived from wheat starch and ingredients produced through a fermentation process if the fermentation medium is derived from wheat, barley, or rye or their crossbred hybrids.

Please let me know if you have any questions.