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II
116TH CONGRESS
1ST SESSION
S. 3021
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 SENATE OF THE UNITED STATES
DECEMBER 11, 2019
Mr. BLUMENTHAL introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
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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•S 3021 IS
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 crossbred hybrids
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of such grains); 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 earlier
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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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