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I
116TH CONGRESS
1ST SESSION H. R. 2074
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.
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.
Be it enacted by the Senate and House of Representa-
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tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Gluten in Medicine
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Disclosure Act of 2019’’.
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•HR 2074 IH
SEC. 2. LABELING OF DRUGS WITH AN INGREDIENT MADE
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FROM A GLUTEN-CONTAINING GRAIN.
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(a) MISBRANDING.—Section 502 of the Federal
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Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
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ed by adding at the end the following:
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‘‘(ee) If it is a drug—
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‘‘(1) that is intended for human use;
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‘‘(2) that contains an ingredient that is derived
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directly or indirectly from a gluten-containing grain
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(including wheat, barley, rye, and their crossbred hy-
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brids); and
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‘‘(3) whose label fails—
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‘‘(A) to state that the drug contains such
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an ingredient; and
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‘‘(B) to identify each such ingredient and
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the type of gluten-containing grain from which
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it is derived.’’.
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(b) APPLICABILITY.—Section 502(ee) of the Federal
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Food, Drug, and Cosmetic Act, as added by subsection
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(a) of this section, shall apply beginning on the sooner
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of—
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(1) a date to be determined by the Secretary of
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Health and Human Services; and
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(2) the date that is 2 years after the date of the
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enactment of this Act.
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