DONOR Milk Act

Bill Number

H.R. 8964

Origin Chamber

House

Congress

119th Congress, Session 2

Policy Area

Health

Status

Introduced

Latest Action

2026-05-21: Referred to the House Committee on Energy and Commerce.

Last Updated

2026-06-26T08:07:34Z

AI-Generated Summary

Purpose This legislation aims to enhance the safety and regulatory oversight of pasteurized donor human milk by treating it as a regulated food product under federal law, requiring inspections, and providing support for compliance.

Key Provisions

• Definitions: Amends the Federal Food, Drug, and Cosmetic Act to classify pasteurized donor human milk as "food" and defines it as human milk expressed by a donor mother, intended for a recipient other than her own infant, and processed through collection, pasteurization, and dispensing without additives.
• Registration Requirement: Clarifies that facilities manufacturing, processing, packing, or holding pasteurized donor human milk (as a critical food) must register with the FDA and are no longer exempt as nonprofit establishments preparing food for direct consumer service.
• Annual Inspections: Mandates FDA inspections (including unannounced ones) of these facilities at least once per year, using a risk-based approach to verify compliance with food safety and labeling rules.
• Compliance Grants: Authorizes the FDA to award grants to nonprofit entities handling pasteurized donor human milk for upgrades, certifications, and third-party consultations; $8 million is authorized for this purpose.

Significant Changes to Existing Law

• Expands the scope of the Federal Food, Drug, and Cosmetic Act to explicitly cover pasteurized donor human milk, removing prior exemptions from registration for certain nonprofit operations.
• Introduces mandatory annual inspections specifically for these manufacturers, which were not previously required under Section 412.
• Creates a new grant program to assist with regulatory compliance, representing an addition to existing food safety authorities.

Potential Impacts

• Government Agencies: Increases FDA workload through more frequent inspections and grant administration, potentially requiring additional resources for oversight of this specialized product.
• Citizens: May improve safety for infants receiving donor milk by ensuring consistent standards, though it could raise operational costs for providers that are passed on to recipients.
• International Relations: Limited direct effects, as the focus is domestic regulation, though it could influence standards for imported or exported human milk products.

Main Stakeholders Affected

• FDA (as the primary regulator).
• Nonprofit milk banks and processing facilities that handle donor human milk.
• Donors, recipients (primarily infants and families), and healthcare providers using this milk.
• Equipment suppliers and third-party food safety consultants.

Notable Legal, Constitutional, or Political Implications

• Reinforces federal authority over food safety under the Commerce Clause by extending oversight to a previously less-regulated product category.
• No apparent constitutional conflicts, as it builds on established FDA powers without creating new enforcement mechanisms beyond inspections and grants.
• Politically, the bill reflects a bipartisan effort to address infant nutrition safety through targeted regulation and financial assistance for compliance.

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

Sponsor

Rep. DeLauro, Rosa L. [D-CT-3]

Cosponsors (8)

Rep. Trahan, Lori [D-MA-3], Rep. Van Drew, Jefferson [R-NJ-2], Rep. Pappas, Chris [D-NH-1], Rep. Dean, Madeleine [D-PA-4], Rep. McGarvey, Morgan [D-KY-3], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Lawler, Michael [R-NY-17], Rep. Bonamici, Suzanne [D-OR-1]

Recent Actions

• 2026-05-21: Referred to the House Committee on Energy and Commerce.
• 2026-05-21: Introduced in House
• 2026-05-21: Introduced in House

Bill Versions

• Developing Oversight for Nutrition through the Official Regulation of Milk Act — issued 2026-05-21 — PDF (4 pages)