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New Law Aims To Regulate For-Profit Human Breast Milk Banks

A bill to restrict the collection of human breast milk by for-profit companies in California will be examined by the state Senate’s health committee Wednesday in a hearing that promises a lively debate on the ethics of paying cash to lactating mothers.

The debate stems from a controversy between nonprofit human breast milk banks and for-profit biomedical corporations, which are newcomers to the field.

Since the mid-1970s, a network of non-profit milk banks has asked women to donate their extra breast milk to feed preterm babies in hospital neonatal units. About 10 years ago, Prolacta Bioscience Inc., a privately held for-profit company, began to collect human breast milk and manufacture a variety of derivative products that it sells to neonatal intensive care units nationwide.

The nonprofit human breast milk banks worry that companies like Prolacta are cutting into an already scarce supply and that they deceive mothers into thinking their donations are for altruistic purposes. In the last couple of years, some of these companies began paying women for their breast milk rather than seeking free donations — a move that nonprofit advocates say targets and exploits women with low incomes.

“Paying mothers for their breast milk offers a perverse incentive for low-income women to sell their milk instead of feed it to their babies,” said Laurie True, director of the Policy Advocacy Initiative at the University of California, Berkeley. “It would be very easy for a woman to go to WIC, get her formula and continue to pump her milk and then sell it,” True said, referring to Women, Infants and Children, a federal program that supplies nutritional aid to mothers of limited means.

The bill to be considered by the Senate health committee, sponsored by Senator Lois Wolk (D-Davis), aims to regulate this emerging biomedical industry.

Wolk expressed concern that the commercialization of human milk could lead to the “predatory recruitment” of lactating mothers with low incomes, “particularly in communities of color.” Her bill, she said, would establish “thoughtful, ethical operating standards for the emerging for-profit human milk bank industry” and help ensure that “all newborns have access to breast milk during the first critical months of their life, regardless of their families’ income.”

Wolk’s bill would require for-profit milk banks to disclose to the mothers what their breast milk is used for. It would also bar for-profits from collecting milk from mothers within the first 180 days after they have given birth, to ensure they feed their infants adequately before selling any surplus.

And to ensure that mothers aren’t confused about the profit motive driving these companies, they would not be allowed to use the term “donor” to describe a participating mother, or “community benefit” to describe their business activities.

Kimberly Capwell, a Prolacta spokeswoman, said all of the company’s milk banks are “clearly branded” and that donors must sign a form stating that they understand it is a for-profit enterprise.

Prolacta, based in the City of Industry, strongly opposes Wolk’s bill. The company says it provides a vital product that has saved as many as 2,000 infants from a deadly intestinal disease that affects premature infants.

The company’s flagship product, a $180-an-ounce baby formula derived from human breast milk and fortified with added nutrients, is the only one on the market for very premature babies — infants who are born under 3 pounds and need more nutrients than standard breast milk can provide.

The product is sold by prescription only and a baby will consume on average $200-$300 worth per day, or about $10,000 for a 90-day stay in intensive care, Capwell said.

Prolacta pays mothers $1 an ounce for their breast milk or donates the money to their favorite charity.

The amount of breast milk a mother can pump in a day — and thus the amount of money she could potentially earn by selling it — varies widely.

Doctors recommend babies consume around 30 ounces a day in the early months. Many mothers produce more than that, and can store the excess in the freezer. They can also lactate for years after pregnancy, so as a child gets older and begins to eat other foods, the mom could sell or donate more of her milk.

In the most extreme case scenario — one that Wolk’s bill seeks to avoid — a mother could feed her baby only formula and store up to 40 ounces of breast milk every day for years. At that rate, she could conceivably cash in the milk for nearly $15,000 annually.

Prolacta operates a 67,000-square foot human milk processing plant that can store up to 53,000 quarts and is building two more plants in Duarte, Calif. The company processed 2.4 million ounces of milk in 2014 and was aiming for 3.4 million in 2015, according to an analysis of the Wolk bill by the Senate Committee on Health.

Prolacta’s CEO, Scott Elster, wrote a letter to Wolk complaining that her bill “is designed to unfairly target” and “penalize companies like Prolacta,” putting for-profit businesses at an “unfair disadvantage to non-profits.”

Elster argued that the proposed 180-day waiting period before a new mother can sell her milk is “inferior to the system Prolacta already has in place to protect babies.”

The company, he said, requires a mother to get a doctor’s note every four months attesting that she is healthy and her baby is getting all the milk needed for proper growth and development. “This safeguard prevents moms from donating their milk to Prolacta instead of feeding their own children,” while the proposed bill “ignores these safeguards for babies,” Elster wrote.

The National Coalition for Infant Health also opposes the bill, saying it will reduce the amount of human breast milk available for premature babies, and that the 180-day waiting period is not based on reliable data.

Also in opposition, according to the Senate health committee’s analysis, are four mothers who say it would make it harder for them to earn extra cash for their families by selling their milk. They say the for-profit milk banks they go to have always made it clear to them what their milk will be used for and have carefully screened the milk for safety.

A dozen organizations support the bill, including the American Academy of Pediatrics, California  Breastfeeding Coalition, California WIC Association and the California Conference of Local Health Department Nutritionists.

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