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

Mathilde Cohen & Tanya Cassidy*


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.