119-hr3821

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3821 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 3821

To amend the Federal Food, Drug, and Cosmetic Act to require the label 
 of a drug intended for human use to identify each ingredient in such 
 drug that is, or is derived directly or indirectly from, a major food 
 allergen or a gluten-containing grain, and for other purposes.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 June 6, 2025

 Ms. Morrison (for herself, Mr. Lawler, Ms. Matsui, Mr. Cline, Mr. 
 Fitzpatrick, and Mr. Bacon) 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 a drug intended for human use to identify each ingredient in such 
 drug that is, or is derived directly or indirectly from, a major food 
 allergen or a gluten-containing grain, 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 ``Allergen Disclosure In Non-food 
Articles Act'' or the ``ADINA Act''.

SEC. 2. LABELING OF DRUGS WITH AN INGREDIENT THAT IS A MAJOR FOOD 
 ALLERGEN OR IS 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:
 ``

    (hh) If it is a drug--
 ``

    (1) that is intended for human use;
 ``

    (2) that contains an ingredient that is, or is derived 
 directly or indirectly from--
 ``
        (A) a major food allergen; or
 ``
        (B) a gluten-containing grain (including wheat, 
 barley, rye, and their crossbred hybrids); and
 ``

    (3) whose label fails--
 ``
        (A) to state that the drug contains such an 
 ingredient; and
 ``
        (B) to identify each such ingredient and, as 
 applicable, the type of gluten-containing grain.''.

    (b) Applicability.--

Section 502

    (hh) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection

    (a) , shall apply beginning on the 
earlier of--

    (1) a date to be determined by the Secretary of Health and 
 Human Services; or

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