I
113th CONGRESS
1st Session
H. R. 2003
IN THE HOUSE OF REPRESENTATIVES
May 15, 2013
Mr. Ryan of Ohio (for himself and Mrs. Lowey) 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 drugs intended for human use to contain a parenthetical statement identifying the source of any ingredient constituting or derived from a grain or starch-containing ingredient.
Short title
This Act may be cited as the
Gluten in Medicine Disclosure Act of
2013
.
Labeling of source of human drug ingredients constituting or derived from a grain or starch-containing ingredient
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 (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient; and
whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.
.
Applicability
Section 502(bb) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a) of this section, shall apply beginning on the sooner 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.
