As a community based, nonprofit milk bank, The Milk Bank wants to ensure our constituents are kept up to date on federal advocacy, legislation, and policy that may impact milk banking or infant health.
Here are three important federal advocacy updates to be aware of going into the last quarter of 2025.
Health Equity and Infant Nutrition Leaders Release Letter of Opposition on Bill H.R. 2300
Nonprofit donor milk banks continue to be of interest to federal policymakers, and the Human Milk Banking Association of North America (HMBANA) continues to be active in the advocacy space. A primary federal policy focus right now is to slow momentum on H.R. 2300, a deeply problematic piece of legislation that would make it more difficult for consumers to litigate against formula companies in Necrotizing Enterocolitis (NEC) cases.
NEC is an incredibly harmful intestinal disease that primarily affects premature and low birth weight infants, which weigh than 2,500 grams (5.5 pounds) at birth. NEC can also affect term babies, especially those with existing medical conditions. NEC causes severe inflammation of the intestine, leading to a bacterial infection causing necrosis (tissue death).
HMBANA has drafted a letter of opposition to the bill and was joined in the effort by several other organizations in the health equity and infant nutrition space, including MomsRising and the US Breastfeeding Committee. The letter was shared with Members of Congress and their staff on September 11, 2025. HMBANA is collaborating on advocacy with other organizations in the legal protection space, including the lawyers representing families whose babies were harmed by NEC.
FDA Issues Request for Information (RFI) on Infant Formula; HMBANA Responds
HMBANA also continues to be in touch with the federal agencies that are relevant to our work. The organization has submitted a public comment to the US Department of Health and Human Services Request for Information (RFI) on infant nutrition safety and formula. Through the RFI, the FDA is seeking public input to help determine whether existing nutrient requirements for formula should be revised based on the latest scientific data.
The comment will provide the opportunity for HMBANA’s technical expertise and perspective to be included as the federal government considers policies related to infant feeding.
The HMBANA RFI requests the agency adjust its guidance to reflect the scientific consensus that mother’s milk is the healthiest food for babies, and pasteurized donor human milk is the most appropriate option when mother’s milk is unavailable.
Access to Donor Milk Act (ADMA) and Donor Milk Safety Act (DMSA)
Federal legislation related to the regulation of donor milk is still being discussed by policymakers. HMBANA is in close touch with the champions of the Access to Donor Milk Act (ADMA) to discuss its potential reintroduction. As dynamics continue to shift, the offices are considering adjusting either the ADMA language itself or its timeline.
And finally, HMBANA has continued to engage with Representative Rosa DeLauro’s office regarding the Donor Milk Safety Act (DMSA) and the most appropriate ways to regulate donor milk. HMBANA has established itself as a key stakeholder and resource on these topics.
Representative DeLauro, in the wake of the recent recall, continues to be interested in introducing legislation related to donor milk regulation, but it will not propose donor milk be regulated as infant formula as was the case in the original version of the Donor Milk Safety Act. Representative DeLauro released a statement calling attention to the recall, saying: “Though this milk bank seemed to have solid safety practices in place, the FDA should regularly inspect these facilities to ensure the highest standards of safety for our most vulnerable – our babies – who depend on this vital nutrition.”
Advocating for Access to Safe Donor Milk
As a part of the HMBANA network, The Milk Bank continues to advocate for legislation that will support and expand access to pasteurized donor human milk. If you’d like to stay up-to-date on recent federal advocacy efforts and legislation updates, consider subscribing to The Drop, The Milk Bank’s bi-monthly newsletter.
About the Author: Sarah Bolton
Sarah Bolton is a managing principal in Raben’s Government Affairs practice and brings more than a decade of federal- and state-level domestic and international policy experience. Her work has focused on racial and socioeconomic equity and policies that improve the well-being of families and children. Sarah helps clients create advocacy agendas that drive progress for historically marginalized populations. Sarah is a proud public school graduate with degrees from Appalachian State University and the University of South Carolina. She’s an avid reader and international traveler (50 countries and counting).
