DONOR Milk Act

The "DONOR Milk Act" seeks to significantly improve the safety and regulatory oversight of pasteurized donor human milk. It amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to explicitly define pasteurized donor human milk as a "food," thereby bringing it under the purview of federal food safety regulations. This definition specifies that the milk is expressed by a mother, donated for a recipient other than her own infant, and processed without additives. A key provision of the bill requires facilities that manufacture, process, pack, or hold pasteurized donor human milk to register as food establishments, removing a previous exemption for nonprofit entities. Furthermore, the Secretary is mandated to conduct annual, risk-based inspections , including unannounced visits, of these facilities to ensure compliance with all relevant food safety and labeling requirements. To support these entities, the bill authorizes $8,000,000 in appropriations for compliance grants , which can assist nonprofit manufacturers with equipment upgrades, certifications, and food safety quality consultations.