1. Short title
This Act may be cited as the “Gluten in Medicine Disclosure Act of 2019”.
Gluten in Medicine Disclosure Act of 2019
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.
2. Labeling of drugs with an ingredient made from a gluten-containing grain
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 crossbred hybrids of such grains); 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.”
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 earlier of—
a date to be determined by the Secretary of Health and Human Services; and
the date that is 2 years after the date of the enactment of this Act.