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


The text of the bill below is as of Apr 3, 2019 (Introduced).


I

116th CONGRESS

1st Session

H. R. 2074

IN THE HOUSE OF REPRESENTATIVES

April 3, 2019

(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.