United StatesEstablishes federal regulation and inspections for donor human milk
Sets federal safety rules and funding affecting how donated human milk is produced, inspected, and supplied to infants and hospitals.
What it does
Adds a federal definition of “pasteurized donor human milk” that requires milk to be expressed by a donor and “collected, pasteurized, and dispensed without additives.”
Removes a nonprofit exemption so facilities that manufacture, process, pack, or hold certain ‘critical foods’ (including donor milk) must register as food establishments under the FD&C Act.
Requires the Secretary to inspect facilities that manufacture, process, pack, or hold pasteurized donor human milk at least annually, including unannounced inspections, using a risk-based approach.
Creates a compliance grant program for nonprofit donor-milk entities to assist with upgrades, certifications, and third-party contracts, and authorizes $8,000,000 to carry out the program.
Argument forEstablishing a clear federal definition and requiring inspections can improve the safety and consistency of pasteurized donor human milk supplied to vulnerable infants.
Argument againstRemoving the nonprofit exemption and imposing registration and inspection obligations will increase administrative and compliance costs for milk banks, possibly reducing supply.
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Where it stands
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Looking ahead
No hearings or votes scheduled.
History
- 2026
- May 21Introduced in HouseLatest
- May 21Referred to the House Committee on Energy and Commerce.Introduced
HealthcarePublic SafetyGovernment & Ethics