Final to Printer_Cohen (Do Not Delete) 3/25/2019 10:14 AM Should Human Milk Be Regulated? Mathilde Cohen* 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 * Professor of Law, University of Connecticut. For helpful conversations and comments on earlier drafts, I am grateful to Naomi Bar-Yam, Bridget Crawford, Amy DiBona, Jennifer Carter-Johnson, Amy Cohen, Michael Dorf, Elizabeth Emens, Andrea Freeman, Iselin Gambert, Megan Grant, Peter Barton Hutt, Kimberly Krawiec, Brendan Maher, Ralf Michaels, Sean Pager, Sachin Pandya, Julie Smith, Julie Suk, and Hannah Ryan as well as participants in the First Annual Conference on Food Law and Policy at Harvard Law School, the Cornell Law School Faculty Workshop, the Michigan State University College of Law Faculty Workshop, and the Duke University School of Law Faculty Workshop. For research assistance, I thank Emilie Dajer-Pascal and Ciarra Minacci-Morey. For library assistance, I thank the University of Connecticut law library staff, in particular Tanya Johnson, Adam Mackie, and Anne Rajotte. My thanks also go to the editorial board of the UC Irvine Law Review for the care they brought to the editorial process. 557 Final to Printer_Cohen (Do Not Delete) 3/25/2019 10:14 AM 558 UC IRVINE LAW REVIEW [Vol. 9:557 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. Introduction ..................................................................................................................... 558 I. Who Needs Human Milk? ......................................................................................... 563 II. The Legal Status of Human Milk ............................................................................ 568 A. No National Definition ............................................................................. 568 B. Self-Regulating Milk Banks ....................................................................... 571 1. Non-Profit Banks ................................................................................ 572 2. For-Profit Banks and Companies .................................................... 574 C. Unregulated Peer-to-Peer Milk Markets ................................................ 577 III. The Multiple Identities of Human Milk ............................................................... 582 A. Food ............................................................................................................... 583 B. Medicine ......................................................................................................... 586 C. Bodily Fluid ................................................................................................... 590 D. Relationship .................................................................................................. 592 1. Corporeal Communication................................................................ 592 2. Affective Communication ................................................................. 594 3. Symbolic Communication ................................................................... 596 IV. The Impact of Categorizing Milk .......................................................................... 597 A. Supply ............................................................................................................. 597 B. Cost ................................................................................................................. 600 C. Safety .............................................................................................................. 603 V. What If Human Milk Were Liquid Gold? ............................................................. 606 A. Food and Drug Law.................................................................................... 606 B. Work Law ...................................................................................................... 608 1. Breastfeeding and Working ............................................................... 608 2. Easy Fixes and Structural Reform ................................................... 613 C. Public Health Law ....................................................................................... 618 1. A National Strategy for Donor Milk ............................................... 618 2. Accommodating Breastfeeders and Pumpers ............................... 621 D. Insurance Law .............................................................................................. 624 1. Covering the Costs of Production................................................... 624 2. Covering the Costs of Distribution ................................................ 627 3. A Cost Saving Proposition ................................................................ 630 Conclusion ........................................................................................................................ 633 INTRODUCTION Imagine that you need to buy formula to feed your baby. Easy. It’s available in any supermarket, drug store, or convenience store. It can be ordered with a few taps on your keyboard and delivered right to your doorstep in a few hours. Several Final to Printer_Cohen (Do Not Delete) 3/25/2019 10:14 AM 2019] SHOULD HUMAN MILK BE REGULATED? 559 varieties are offered. You can choose between cow’s milk-based formula, by far the most common, or plant-based formula, typically made with soy. You can also find lactose-free, organic, or goat’s milk-based formulas. Formula is convenient, easily transportable, does not need to be refrigerated, and is relatively cheap—the average price per ounce is about $0.11.1 Formula is even provided for free or at a discount by the government to low-income families who qualify for it.2 You are also assured some level of quality—formula is closely regulated by the Food and Drug Administration (FDA) and must meet federal nutrient requirements.3 Now imagine that you need to buy human milk for your baby. Why would you ever be in that situation? Suppose that your baby was born prematurely or has a medical condition calling for human milk and you cannot produce milk, or enough of it, be it because you are a man; because you are an adoptive or intended parent; because a medical condition prevents you from lactating; because the drugs you need to take could be harmful to a baby; or because social circumstances, such as your job, make it impossible for you to breastfeed. How will you obtain human milk? If your baby is hospitalized in a neonatal intensive care unit (NICU) that uses donor human milk, it will be provided by the hospital.4 But if your baby is at home or at a hospital that does not use donor human milk, you will need to procure it yourself. You will certainly not find it at your local Walmart or CVS, or on ordinary baby supplies websites. You could, however, purchase or obtain free milk directly from donors who advertise online via sites such as “Human Milk 4 Human Babies,” “Eats on Feets,” or “Only The Breast.”5 But if you are looking for medically- sanctioned milk from screened donors, your only option is to approach one of the couple dozen human milk banks and companies that exist in the United States.6 Formula is available over the counter, but a doctor’s prescription is required to procure human milk from a bank.7 Another complication lies in locating a bank near you that has human milk available. The twenty-three non-profit milk banks currently operating in the United States prioritize hospitalized infants and critically ill babies,8 leaving parents of babies requiring milk for other indications, such as formula intolerance, with no alternatives other than for-profit milk companies and 1. Breastfeeding