Milk from Mars. The Challenges of Regulating Lab-Produced (Human) Milk

Food and Drug Law Journal, Vol. 77, pp.6-50, 2022

45 Pages Posted: 26 Aug 2022

See all articles by Mathilde Cohen

Mathilde Cohen

University of Connecticut - School of Law

Tanya Cassidy

Maynooth University

Date Written: 2022


For over a century, pediatricians, scientists, and industry players have sought to create an infant formula that would be as close as possible to human milk. Until recently, their efforts focused on “humanizing” cow’s milk by making its composition more similar to human milk. But in the past few years, new technologies have led some companies to culture mammary cells or yeast in the lab. The resulting lab-produced components have been claimed to be identical to those found in human milk. One goal behind this new technology is to manufacture an infant formula that is more nutritionally adapted for newborns than conventional breastmilk substitutes. What impact might this new lab-produced milk have on infant feeding and regulation? Will it benefit parents and their children or represent a threat for lactation and donor human milk support? Could it precipitate a new regulatory regime for human milk itself? Given the many unknowns in this area, this Article hypothesizes various outcomes, examining their potential costs and benefits. What is certain, however, is that the legal regime eventually accorded to lab-produced milk will shape not only the products on the market, but also who will get access to them and at what cost.

Keywords: Lab-Grown Milk, Fermented Milk, Cultured Milk, Cultured Milk, Cell-Based Milk, Infant Formula, Breastmilk Substitute, Lactation Law, Breastfeeding, Cellular Agriculture, Donor Human Milk, Human Milk Bank, FDA, USDA

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

Suggested Citation

Cohen, Mathilde and Cassidy, Tanya, Milk from Mars. The Challenges of Regulating Lab-Produced (Human) Milk (2022). Food and Drug Law Journal, Vol. 77, pp.6-50, 2022, Available at SSRN:

Mathilde Cohen (Contact Author)

University of Connecticut - School of Law ( email )

65 Elizabeth Street
Hartford, CT 06105
United States

Tanya Cassidy

Maynooth University ( email )

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