I 116th CONGRESS 1st Session H. R. 2074 IN THE HOUSE OF REPRESENTATIVES April 3, 2019 Mr. Ryan (for himself and Mr. Cole ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act to require the label of a drug that is intended for human use and contains an ingredient that is derived directly or indirectly from a gluten-containing grain to identify each such ingredient, and for other purposes.

1. Short title This Act may be cited as the Gluten in Medicine Disclosure Act of 2019 . 2. Labeling of drugs with an ingredient made from a gluten-containing grain (a) Misbranding Section 502 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352 ) is amended by adding at the end the following: (ee) If it is a drug— (1) that is intended for human use; (2) that contains an ingredient that is derived directly or indirectly from a gluten-containing grain (including wheat, barley, rye, and their crossbred hybrids); and (3) whose label fails— (A) to state that the drug contains such an ingredient; and (B) to identify each such ingredient and the type of gluten-containing grain from which it is derived. . (b) Applicability Section 502(ee) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section, shall apply beginning on the sooner of— (1) a date to be determined by the Secretary of Health and Human Services; and (2) the date that is 2 years after the date of the enactment of this Act.