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
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.
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.