117 HR 2435 IH: Gluten in Medicine Disclosure Act of 2021 U.S. House of Representatives 2021-04-08 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I117th CONGRESS1st SessionH. R. 2435IN THE HOUSE OF REPRESENTATIVESApril 8, 2021Mr. Ryan (for himself and Mr. Stivers) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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 2021.

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:(gg)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(gg) 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.