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Classified in: Health
Subjects: LEG, POL

Prolacta Bioscience Applauds House Appropriations Committee for Directing FDA to Address the Regulation of Donor Human Milk in Appropriations Bill

DUARTE, Calif., June 15, 2023 /PRNewswire/ -- Prolacta Bioscience®, the world's leading hospital provider of 100% human milk-based nutritional products for critically ill, premature infants, today applauded the House Appropriations Committee for advancing a Fiscal Year 2024 (FY24) Agriculture and Rural Development and Food and Drug Administration spending bill that includes directive report language instructing the Food and Drug Administration (FDA) to address safety standards of human donor milk:

"The recent infant formula crisis continues to create supply shortages for families, and has laid bare the dangerous vulnerabilities that exist for infant health nutrition.  At Prolacta Bioscience, we are deeply concerned about the lack of federal oversight and safety regulations for human donor milk, which is routinely provided to premature infants in the Neonatal intensive care unit (NICU) as a primary food source during the first days of life.  We applaud the House Appropriations Committee for demonstrating a sense of urgency by directing the FDA to address the regulation of donor human milk and other donor human milk derived products.  Our most vulnerable population cannot wait any longer for federal regulators to take action and introduce uniform safety guidelines for milk banks that are releasing an increasing amount of product into the market to NICUs and households in need of this critical food source. We urge Congress to pass this bill and continue to spotlight this important safety issue for the sake of premature infants and families across the nation. The time to act is now."

About Prolacta Bioscience
Prolacta Bioscience® Inc. is a privately held, global life sciences company dedicated to Advancing the Science of Human Milk® to improve the health of critically ill, premature infants. Prolacta's 100% human milk-based nutritional products have been evaluated in more than 20 clinical studies published in peer-reviewed journals. More than 90,000 premature infants have benefited from Prolacta's nutritional products worldwide to date. 1 Established in 1999, Prolacta is the world's leading provider of human milk-based nutritional products for hospital use and is also exploring the therapeutic potential of human milk across a wide spectrum of diseases. Prolacta maintains the industry's strictest quality and safety standards for screening, testing, and processing donor human milk. Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta uses vat pasteurization and a patented, FDA-reviewed manufacturing process to ensure pathogen inactivation while protecting the nutritional composition and bioactivity of its human milk-based products. Prolacta is a global company with headquarters in Duarte, California, and can be found online at www.prolacta.com, on Twitter, Instagram, Facebook, and LinkedIn.

Media Contact:
Loren Kosmont
[email protected]


  1. Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to December 2022.

SOURCE Prolacta Bioscience

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