[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 3021 Introduced in Senate (IS)]

<DOC>






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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Gluten in Medicine Disclosure Act of 
2019''.

SEC. 2. LABELING OF DRUGS WITH AN INGREDIENT MADE FROM A GLUTEN-
              CONTAINING GRAIN.

    (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:
    ``(ee) If it is a drug--
            ``(1) that is intended for human use;
            ``(2) 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
            ``(3) whose label fails--
                    ``(A) to state that the drug contains such an 
                ingredient; and
                    ``(B) to identify each such ingredient and the type 
                of gluten-containing grain from which it is derived.''.
    (b) 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--
            (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.
                                 <all>