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HR 3821
Introduced Re-checks Congress.gov for new actions and updates the bill's status, and fills in any sponsors, committees, or related bills that are missing. It does not re-pull sponsors/cosponsors/committees/related — those rarely change — and it skips all work if nothing has changed upstream, so it's cheap to click.

ADINA Act

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.

Introduced Jun 6, 2025

Latest action (Jun 6, 2025) Referred to the House Committee on Energy and Commerce.

Referred to
Energy and Commerce Committee
Policy area
Health

Summary

This bill would amend the Federal Food, Drug, and Cosmetic Act to require drug labels to identify all ingredients that are major food allergens or derived from gluten-containing grains such as wheat, barley, and rye. Drug manufacturers would be required to clearly state on the label that the drug contains such an ingredient and identify each allergen or gluten-containing grain present. The new labeling requirement would take effect either on a date chosen by the Secretary of Health and Human Services or two years after the bill's enactment, whichever comes first. Drugs that fail to comply with the new labeling requirements would be considered misbranded.

AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.

Sponsor (1)
20 cosponsors

Actions (3)
  1. Jun 6, 2025 Referred to the House Committee on Energy and Commerce. · house
  2. Jun 6, 2025 Sponsor introductory remarks on measure. (CR H2516)
  3. Jun 6, 2025 Introduced in House

Similar bills (6)

Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.

  • HR 843 — Prompt Approval of Safe Generic Drugs Act · Introduced Jan 31, 2025 · Cong. 119 68%
  • HR 1051 — To amend the Federal Food, Drug, and Cosmetic Act to allow for the approval of an abbreviated new drug application submitted by a subsequent applicant in the case of a failure by a first applicant to commence commercial marketing within a certain period, and for other purposes. · Introduced Feb 6, 2025 · Cong. 119 64%
  • HR 4525 — Right to FDA-Approved Medicines Act · Introduced Jul 17, 2025 · Cong. 119 63%
  • HR 7366 — Dietary Supplement Regulatory Uniformity Act · Introduced Feb 4, 2026 · Cong. 119 63%
  • HR 3162 — Affordable and Safe Prescription Drug Importation Act of 2025 · Introduced May 1, 2025 · Cong. 119 62%
  • HR 5969 — LABEL Act · Introduced Nov 7, 2025 · Cong. 119 61%

Text versions (1)
  • Introduced in House · Jun 6, 2025

Only one text version is on file, so there’s no earlier version to compare against yet.

Full text

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. <all>

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