II
116th CONGRESS
1st Session
S. 3021
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.
Short title
This Act may be cited as the Gluten in Medicine Disclosure Act of 2019
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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:
If it is a drug—
that is intended for human use;
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
whose label fails—
to state that the drug contains such an ingredient; and
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.
