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The Breast Milk Market and the Need for Clearer Rules

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Source: CDC

A study published in Pediatrics by researchers at Nationwide Children’s Hospital in Columbus, OH has been in the news (ABC News; Wall Street Journal; New York Times) after they found that 72% of the breast milk samples they purchased online contained infection-causing bacteria. This comes after increased awareness and promotion of the benefits of breastfeeding, including World Health Organization (WHO) recommendations that infants be exclusively breastfed for the first six months of life and countless numbers of domestic public health officials promoting breastfeeding to improve infant health, which has led to “mommy wars” about breastfeeding versus infant formula. It’s no surprise that the increased pressure to breastfeed has resulted in a market for the sale of breast milk.

The sale and donation of breast milk over the Internet raises concerns over how human milk is currently regulated, whether it should be regulated on the federal level, and if so, by which agency. The marketplace for breast milk also raises questions in regards to the commodification of body parts and tissues, which generally is illegal. Should breast milk be considered similar to eggs, sperm, and plasma, which may be “donated” for compensation for the inconvenience, or like organs, which may only be donated without compensation?  This blog post focuses primarily on the current regulations out there, though the questions surrounding the commodification of human body parts is one to keep in consideration.

Current Regulations for Breast Milk

Currently, the Food and Drug Administration (FDA) has issued a warning about the health hazards due to improper collection, storage and shipping involving the use of human milk from a source other than the baby’s mother, but has not issued any formal regulations on suppliers or sales. An essay by Karleen Gribble and Bernice Hausman explores why public health officials are warning against the use of human milk from other sources, but also providing parents with information to assist them in mitigating the risks associated with using donated human milk, and comparing the risks of donated milk with those of infant formula.

Four states regulate milk banks (California, Maryland, New York, and Texas) and most states regulate the storage of breast milk under licensing for child care standards. New York regulates milk banks from the donation (voluntary and without remuneration, 1- NYCRR 52-9.1(b)), through administrative responsibilities of the bank (including the “appointment of a medical director and a medical advisory committee composed of physicians with experience in pediatrics, neonatology, blood banking, nutrition and/or other appropriate field, including at least one member with expertise in infectious diseases”, 1- NYCRR 52-9.3), that donors be periodically screened (1- NYCRR 52-9.4), and specific rules for the collection and storage of the milk in the bank (1-NYCRR 52-9.6). Maryland regulates milk banks under regulations for tissue banks (COMAR 10.50.01), and requires that banks acquire necessary permits and meet standards in regards to inspections, personnel, and testing to minimize disease transmission. California defines a “mothers’ milk bank” as “any person, firm, or corporation which engages in the not-for-profit procurement, processing, storage, distribution, or use of human milk, contributed by volunteer donors, in compliance with standards prescribed by the Human Milk Banking Association of North America” (CA WEL & INST § 14132.34). Additional California declares that the procurement, processing, distribution or use of human milk for the purpose of human consumption is considered to be a rendition of a service rather than a sale of human milk (1999 Cal. Stats., Chap. 87; AB 532). Texas’ has adopted that Human Milk Banking Association of North America’s “Guidelines for the Establishment and Operation of a Donor Human Milk Bank,” Ninth Edition, 2000, as amended as their minimum guidelines.

Which Federal Agency? is a website compiling food safety information provided by government agencies, including the White House, U.S. Department of Health and Human Services, U.S Department of Agriculture (USDA), FDA, Centers for Disease Control (CDC), and the National Institutes of Health (NIH). This highlights the fragmentation of agency regulation regarding the food safety puzzle as a whole.

FDA currently regulates milk and cream (21 C.F.R. § 131.110) and infant formula and is generally charged with protecting consumers against impure, unsafe, and fraudulently labeled products. Additionally, the FDA, through its Center for Food Safety and Applied Nutrition (CFSAN), regulates foods other than those regulated by the USDA’s Food Safety and Inspection Service (FSIS).

CDC leads federal efforts to gather data on foodborne illnesses, investigate foodborne illnesses and outbreaks, and monitor the effectiveness of prevention and control efforts in reducing foodborne illnesses and works with states and local health departments on foodborne disease surveillance and outbreak response. CDC currently has a webpage dedicated to the risks of mistaken use of another woman’s expressed breast milk

Finally, the Health Resources and Services Administration (HRSA) runs the Organ Procurement and Transplantation Network (OPTN). The FDA’s Center for Biologics Evaluation and Research (CBER) is a center responsible for regulating the many types of human tissue and cells used in transplantation. Should these departments also have a piece of the regulation pie when it comes to donor human milk regulations? 

Regulating the donation and sale of breast milk will not be an easy task, but with the growing market it makes sense to consider how best to do so in an effort to protect consumers from the purchase of tainted milk. It may take passing a law by Congress to truly set the stage for such regulation, and to help guide the agencies in how far regulations should reach the growing market for breast milk in the US. 

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The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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