H.R. 3821

119 HR 3821 IH: Allergen Disclosure In Non-food Articles Act
 U.S. House of Representatives
 2025-06-06
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 I  119th CONGRESS  1st Session  H. R. 3821  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.
1.
Short title
This Act may be cited as the   Allergen Disclosure In Non-food Articles Act   or the   ADINA Act  .
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.