ADINA Act

Bill Number

H.R. 3821

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Health

Status

Introduced

Latest Action

2025-06-06: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-07-10T08:06:30Z

AI-Generated Summary

Summary of H.R. 3821: Allergen Disclosure In Non-food Articles Act (ADINA Act)

Purpose

The legislation aims to improve safety for people with allergies by requiring drug labels to clearly disclose ingredients derived from major food allergens (such as peanuts, tree nuts, milk, eggs, fish, shellfish, soy, and wheat) or gluten-containing grains (like wheat, barley, rye, and their hybrids). This helps users identify potential risks in medications not typically thought of as food.

Key Provisions

• Labeling Requirement: Drugs intended for human use must have labels that state if they contain ingredients from major food allergens or gluten-containing grains. The label must identify each such ingredient and, if applicable, specify the type of gluten-containing grain.
• Misbranding Definition: Failure to include this information on the label makes the drug "misbranded" under federal law, which can lead to enforcement actions like recalls or fines.
• Effective Date: The new rule applies starting on the earlier of a date set by the Secretary of Health and Human Services (HHS) or 2 years after the bill's enactment.

Significant Changes to Existing Law

• Amends Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which defines what makes a product misbranded.
• Adds a new subsection (hh) specifically for drugs, expanding labeling rules beyond current requirements that focus mainly on food products. Previously, drug labels did not have to explicitly call out allergen-derived ingredients unless they were active components.

Potential Impacts

• On Citizens: Enhances public health by reducing accidental exposure to allergens in medications, benefiting those with severe allergies or conditions like celiac disease (an intolerance to gluten that damages the gut).
• On Government Agencies: The Food and Drug Administration (FDA), part of HHS, will need to update guidance, inspect labels, and enforce compliance, potentially increasing workload but aligning with its role in drug safety.
• On International Relations: Minimal direct impact, though it could influence global pharmaceutical standards if U.S. companies exporting drugs adopt similar labeling for consistency.
• Broader Effects: Drug manufacturers may face higher costs for label redesigns and testing, but this could lead to fewer allergic reactions and related healthcare expenses.

Main Stakeholders Affected

• Individuals with Allergies: Primary beneficiaries, including the estimated 32 million Americans with food allergies and those with gluten sensitivities.
• Pharmaceutical Companies: Must revise product labels and supply chains to comply, affecting both large and small drug makers.
• Healthcare Providers: Gain clearer information to advise patients, improving prescribing and dispensing safety.
• Regulatory Bodies: FDA and HHS, responsible for implementation and oversight.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens consumer protection under the FD&C Act without creating new agencies or major penalties beyond existing misbranding tools (e.g., seizures or injunctions). It promotes transparency but may require courts to interpret "derived directly or indirectly" in disputes.
• Constitutional: No significant issues; aligns with Congress's authority to regulate interstate commerce and public health under the Commerce Clause.
• Political: Supports bipartisan health initiatives (introduced by a mix of Democrats and Republicans), potentially appealing to voters concerned with food safety extensions to drugs. It could set a precedent for broader allergen disclosures in non-food items like cosmetics.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Morrison, Kelly [D-MN-3]

Cosponsors (20)

Rep. Lawler, Michael [R-NY-17], Rep. Matsui, Doris O. [D-CA-7], Rep. Cline, Ben [R-VA-6], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Bacon, Don [R-NE-2], Rep. Craig, Angie [D-MN-2], Rep. Davids, Sharice [D-KS-3], Rep. Quigley, Mike [D-IL-5], Rep. Grothman, Glenn [R-WI-6], Rep. Pingree, Chellie [D-ME-1], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Carson, André [D-IN-7], Rep. McDowell, Addison P. [R-NC-6], Rep. Thanedar, Shri [D-MI-13], Rep. Frost, Maxwell [D-FL-10], Rep. Van Drew, Jefferson [R-NJ-2], Rep. Gottheimer, Josh [D-NJ-5], Rep. Bice, Stephanie I. [R-OK-5], Rep. Sorensen, Eric [D-IL-17], Rep. Riley, Josh [D-NY-19]

Recent Actions

• 2025-06-06: Referred to the House Committee on Energy and Commerce.
• 2025-06-06: Sponsor introductory remarks on measure. (CR H2516)
• 2025-06-06: Introduced in House
• 2025-06-06: Introduced in House

Bill Versions

• Allergen Disclosure In Non-food Articles Act — issued 2025-06-06 — PDF (3 pages)