H.R. 2003 (113th): Gluten in Medicine Disclosure Act of 2013

The text of the bill below is as of May 15, 2013 (Introduced).

I

113th CONGRESS

1st Session

H. R. 2003

IN THE HOUSE OF REPRESENTATIVES

May 15, 2013

(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.

1.

Short title

This Act may be cited as the Gluten in Medicine Disclosure Act of 2013 .

2.

Labeling of source of human drug ingredients constituting or derived from a grain or starch-containing ingredient

(a)

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:

(bb)

If it is a drug—

(1)

that is intended for human use;

(2)

that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient; and

(3)

whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.

.

(b)

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—

(1)

a date to be determined by the Secretary of Health and Human Services; and

(2)

the date that is 2 years after the date of the enactment of this Act.