H.R. 3821

119th CONGRESS 1st Session

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 · Sponsor: Ms. Morrison · Committee: Committee on Energy and Commerce

Table of contents

• SEC. 1. Short title
• SEC. 2. Labeling of drugs with an ingredient that is a major food allergen or is made from a gluten-containing grain

SEC. 1. Short title

This Act may be cited as the or the "Allergen Disclosure In Non-food Articles Act" or "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.