Should Human Milk Be Regulated?

UC Irvine Law Review, Vol. 9, pp.557-634 (2019)

78 Pages Posted: 11 Mar 2019 Last revised: 20 Mar 2019

See all articles by Mathilde Cohen

Mathilde Cohen

University of Connecticut - School of Law

Date Written: March 2, 2018


Markets in human milk are booming. They take two main forms: informal markets—women giving or selling their milk peer-to-peer—, and formal markets—for-profit or non-profit organizations collecting, processing, and distributing donor milk to neonatal intensive care units and a few outpatients for a fee. The legal regime applicable to these human milk transactions is fragmented and unstable. The federal government does not define human milk as anything. The Food and Drug Administration has declined to regulate milk banks even though it oversees blood, cord, oocytes, semen, and stool banks. Only a handful of states have laws on the books pertaining to human milk.

In light of the growing demand for human milk and public health professionals’ calls for government oversight due to fears of pathogen contamination, this Article asks whether human milk should be regulated more tightly and, if so, what types of legal reforms would be most desirable. It concludes that human milk should not be treated as a disembodied product under a food, drug, and tissue law paradigm, but rather as the product of a relationship between breastfeeders and breastfed babies. It is this relationship that is in urgent need of legal protections so that more parents can breastfeed their children and make extra milk available for others. Though the risks of contamination are real, they can be, and are, mitigated by milk banks, as well as by peer-to-peer donors and recipients. But many children who need donor milk do not obtain it either because it is unavailable or too expensive. Legal reforms should therefore focus on increasing the supply via robust breastfeeding and donor milk support, which in turn will make human milk accessible to all those who need it regardless of their socioeconomic status. This approach entails shifting from a single-minded focus on health and safety to considering the conditions of people who produce and donate milk and the health insurance market that often fails to cover it.

Keywords: Breastfeeding, Human Milk, Commodification, Donor Milk, Infant Feeding, Food Drug and Tissue Law, Lactation Law, Milk Banks, Peer-to-Peer Markets, Law and Gender

JEL Classification: K1, K20, K32, K36, I1, I3

Suggested Citation

Cohen, Mathilde, Should Human Milk Be Regulated? (March 2, 2018). UC Irvine Law Review, Vol. 9, pp.557-634 (2019), Available at SSRN:

Mathilde Cohen (Contact Author)

University of Connecticut - School of Law ( email )

65 Elizabeth Street
Hartford, CT 06105
United States

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