FOR IMMEDIATE RELEASE
December 22, 2022
CONTACT: Susan Hepworth
susan@infanthealth.org
The bill contains a directive to FDA to regulate all donor human milk to ensure this vital nutrition for vulnerable babies is safe and of the highest quality
WASHINGTON—The non-profit National Coalition for Infant Health today released a statement applauding the U.S. Senate for passing an omnibus government spending bill that includes a directive to the U.S. Food and Drug Administration to provide much-needed regulation of donor human milk, donor human milk derived products and banks to ensure this nutrition, often provided to our most vulnerable babies, is safe and high quality.
Currently, the FDA classifies donor milk as food, meaning it is subject to no greater level of oversight than any other food product. In fact, donor human milk is regulated less stringently than infant formula or dairy milk, and not all milk banks are currently regulated.
This legislation will help address both short and long-term risks that have increased due to the rapid growth of the entities collecting, processing and selling donor human milk.
STATEMENT FROM MITCHELL GOLDSTEIN, MD, MEDICAL DIRECTOR, NATIONAL COALITION FOR INFANT HEALTH
“We applaud the Senate for including this language in the omnibus spending bill, which will help bolster the safety of donor human milk. Our most vulnerable infants, including those born preterm, must have nutrition that meets the highest quality and safety standards. We urge the House of Representatives to promptly pass this bill and send it to the President’s desk for his signature. We thank the FDA and Congress for taking this important step to ensure this critical form of infant nutrition is safe and accessible for all infants.”
The language included in the funding package states that, “the agreement directs the FDA to address regulation of donor human milk and donor human milk derived products and banks.” This builds off of several years of language from Congress urging the FDA to take a closer look at the regulation of donor human milk, a critical source of nutrition for infants.
The National Coalition for Infant Health hosted a panel discussion in August on the need to ensure donor human milk and donor human milk derived products are safe and high quality.
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About the National Coalition for Infant Health
The National Coalition for Infant Health is a collaborative of professional, clinical, community health, and family support organizations focused on education and advocacy to promote patient-centered care for infants and their families.