Human Milk Markets Need Regulation

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Scholar says that human milk should be regulated to ensure donor milk is safe, accessible, and affordable.

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Would you feed your infant someone else’s breast milk?

Although research indicates that human milk provides nutritional, immunological, social, and emotional benefits, some mothers who are unable to produce their own milk for medical or other reasons may be hesitant to feed their child donated milk.

Currently, the human milk market is self-regulated. In a recent article, Mathilde Cohen of the University of Connecticut School of Law recommends that the federal government establish regulations to ensure that donor milk is safe, accessible, and affordable for consumers.

Cohen urges the U.S. Food and Drug Administration (FDA) to create donor milk regulations that are tailored to how the milk is distributed. Donor milk should be regulated as a drug, tissue, or food depending on what type of organization distributes the milk.

Although donor milk is fed to infants who are premature or very sick in order to increase their chance of survival, the American Academy of Pediatrics recommends that all babies be exclusively breastfed for the first six months. Human milk is recommended because it has important nutrients and immune factors that can help infants’ immune systems develop and may improve children’s long-term health outcomes.

But adoptive parents, women with medical complications, and parents who have jobs that prevent them from breastfeeding may not be able to produce their own milk, Cohn notes. These parents must decide whether to give their infants formula or find donor milk.

For-profit companies, non-profit milk banks, and peer-to-peer milk markets are the current providers of donor milk, Cohen explains. But FDA does not regulate any of these markets as food products because the agency defines milk as “the lacteal secretion obtained by the complete milking of one or more healthy cows,” excluding human milk from the definition.

Non-profit milk banks, which provide donor milk to families in need, have established their own regulations, Cohen says. The industry created the Human Milk Banking Association of North America to develop standards for non-profit milk banks that join the association. The standards require potential milk donors to undergo extensive screenings to ensure that their milk is not contaminated. The association also requires specific storage protocols and tests each donor’s milk before distributing it, Cohen explains.

Although for-profit companies claim that their milk is subject to extensive safety regulations, there is no formal organization to develop industry standards. Even if companies have their own internal regulations, there is little transparency, Cohen argues.

Peer-to-peer milk markets are the least regulated of the three suppliers, Cohen says. Donors and recipients connect using social media or other forms of advertisement. Cohen explains that consumers may screen donors independently, but there are no formal regulations to determine whether the donor milk is safe.

But consumers use peer-to-peer milk markets, or “milk sharing,” because the practice is more affordable than non-profit and for-profit milk banks. Cohen says that milk from non-profit banks can cost anywhere from $68 to $135 per day and that for-profit companies are even more expensive. Even recipients who can afford the higher costs of formal milk banks may turn to milk sharing because non-profit milk banks prioritize donations to hospitalized infants who have urgent medical needs for human milk, Cohen notes.

To protect consumers using unregulated peer-to-peer milk markets and those recipients who can access non-profit and for-profit milk banks, FDA needs to regulate human milk, Cohen argues.

But Cohen recognizes that classifying all human milk under a “one-size-fits-all” regulation would be ineffective at addressing safety, cost, and supply issues. Instead, Cohen argues that FDA should classify human milk as a food, drug, or tissue depending on which type of organization supplies the product.

Milk from peer-to-peer milk markets should be regulated as a food because this classification would impose the least stringent regulations and allow milk sharing to remain available. Since individuals run their own peer-to-peer milk markets, they would not be able to comply with the complex regulations that are imposed on drugs and tissues. Milk sharing also provides milk to healthy babies, so there are fewer safety concerns, Cohen reasons.

For-profit companies, however, often provide milk to sick or premature infants and have the financial resources to comply with stricter safety protocols. Cohen says milk from for-profit companies should be regulated as a drug––a classification that would require clinical trials, applications for approval, and standardized production procedures. Many of these companies already implement their own procedures, but Cohen acknowledges that these additional requirements could restrict supply since companies would need to comply with more formalized protocols.

Non-profit milk banks already impose their own safety standards and may not be able to comply with the extensive drug regulations, Cohen says. Instead, milk from non-profit banks should be regulated as human tissue. Tissue regulations would not require the banks to get approval before selling milk but would impose greater FDA oversight than food regulations. According to Cohen, this classification “strikes a balance between cost and safety.”

Even though classifying human milk as a food, drug, or tissue would allow FDA to regulate suppliers, Cohen recognizes that human milk cannot be regulated in isolation. She argues that federal laws need to protect women who are breastfeeding to make sure that there is an adequate supply of donor milk and that the milk is affordable for families in need.

Reform efforts should target labor laws, Cohen argues. Federal law should require employers to give all employees paid lactation time and restrict employers’ discretion to place time limits on lactation breaks. These modifications would encourage working mothers to breastfeed, creating a greater supply of donor milk and reducing the demand for the product by allowing more mothers to breastfeed.

Insurance laws should also be modified to cover the cost of obtaining donor milk, Cohen contends. The few insurance providers that currently cover the cost of donor milk typically pay only when the infant is premature or sick.

“Children deserve access to human milk regardless of their families’ socio-economic status,” Cohen concludes.