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
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.
This Act may be cited as the
Gluten in Medicine Disclosure Act of 2019.
Labeling of drugs with an ingredient made from a gluten-containing grain
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.
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.