Determining How to Regulate Encapsulated Placenta

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Scholar argues that FDA should use a narrowly tailored framework to regulate encapsulated placenta pills.

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What do Katherine Heigl, Kourtney Kardashian, and January Jones have in common? They are part of a growing list of celebrities who have reportedly eaten their placentas after giving birth.

Celebrity proponents and other advocates have shared stories of hiring manufacturers to make their placentas—the organ that develops during pregnancy to remove waste—into encapsulated pills to eat in the months after giving birth. Although proponents of eating encapsulated placenta pills claim they deliver supposed health benefits, opponents warn of safety concerns.

In a recent article, legal scholar Greer Donley argues that encapsulated placenta pills should remain available to those women who choose to eat them, but the U.S. Food and Drug Administration (FDA) needs to begin regulating them.

Donley, a professor at the University of Pittsburgh School of Law, favors keeping encapsulated placenta available because women seeking to avoid medications while breastfeeding claim the pills reduce their symptoms of postpartum depression, a type of depression that occurs after a woman gives birth. Women also claim that eating the placenta reduces bleeding, increases breast milk supply, and replaces nutrients and hormones.

Although women have reportedly said that they experienced health benefits from eating their placenta, studies have not supported these claims. Researchers have found that eating the placenta does not affect hormone levels or improve postpartum depression, Donley says.

Even though Donley recognizes these findings, she references studies that show women perceive the pills to improve their health, even if the benefits are only due to the belief that the treatment is working—the placebo effect. Donley argues that because the benefits are “unclear” and the practice continues to grow, FDA needs to regulate encapsulated placenta to ensure that manufacturers use safe processing methods and do not make unproven health claims.

FDA oversight could prevent manufacturers from making claims about the pill’s ability to cure or prevent diseases. To date, Donley says, manufacturers have stated that the pills can treat postpartum depression. But Donley warns that allowing manufacturers to make health claims may lead women to use the pills instead of seeking clinically substantiated treatment for depression. If FDA were to regulate, manufacturers would not be able to make disease claims without going through an extensive clinical trial process to demonstrate the pill’s ability to treat the disease, Donley explains.

Donley also cautions that if the placenta is not properly processed, bacteria can grow inside the pills, leading to the spread of disease. Furthermore, since the placenta filters waste during pregnancy, some researchers have thought that if the tissue is not properly processed, toxins could potentially remain in the pills. She argues that if FDA were to oversee how encapsulated placenta are processed, the agency could monitor manufacturers to ensure the pills are safe for women to eat.

Although Donley argues that FDA oversight could make encapsulated placenta safer, she acknowledges that women’s rights advocates may resist such federal regulation. She explains that advocates worry that the manufacturers, often small businesses, will not be able to afford to comply with costly regulations and encapsulated placenta will disappear from the market.

Indeed, many consumers who take the pills already feel that “women’s autonomy over their reproductive decisions is curtailed by governmental and institutional forces,” according to Donley. Eliminating the option to take these pills after childbirth would further restrict women’s ability to make decisions about their reproductive health.

Even though women’s rights advocates might resist regulation, Donley argues that “women cannot make informed, autonomous decisions when providers, manufacturers, or institutions are not held to a minimum floor of honesty and competence.”

Using a combination of regulations that are traditionally used for supplements and human tissue will help FDA monitor manufacturers health claims and ensure that the encapsulated placenta is safe to consume, Donley says.

Supplements are not required to undergo extensive premarket studies before entering the market. But, because supplements are not extensively studied, manufacturers are prohibited from making claims that supplements can prevent or treat diseases such as depression, Donley explains.

In addition, regulating placenta as a supplement would mean that manufacturers do not have to comply with costly requirements to get the product on the market. Instead, Donley suggests that manufacturers could complete an application that would allow the pills to be approved in less than three months.

Even though supplement regulations would prevent manufacturers from making unproven health claims, Donley explains that these restrictions would do nothing to promote safe manufacturing processes—for this, FDA must also use human tissue regulations.

Some human tissue regulations establish stringent standards that would make it difficult for companies to bring encapsulated placenta on the market. But Donley says that if FDA used its discretion to tailor the regulations, the agency could select specific regulations to monitor the manufacturing process. This would allow FDA to establish manufacturing standards to make sure the placenta is properly handled to “prevent spoliation, contamination, and the spread of communicable diseases,” Donley explains. The regulations would also require manufacturers to register with FDA, so that the agency could inspect the facilities to ensure the processing methods are safe.

By combining the regulations traditionally used for supplements and human tissues, Donley concludes that FDA can “provide the regulatory floor necessary to protect women without over-protecting them.”