Regulation of Encapsulated Placenta
64 Pages Posted: 27 Sep 2018 Last revised: 2 Jun 2019
Date Written: September 21, 2018
The practice of placenta encapsulation is rapidly growing. It typically involves post-partum mothers consuming their placentas as pills in the months after childbirth. The perceived benefits include improved mood and energy, reduced bleeding and pain, and greater milk supply. But these effects are unproven, and consumption comes with health risks. The rise of this trend has sparked a vigorous debate in the recent medical literature, but this Article is the first to consider the legal implications of placenta encapsulation. This Article examines whether FDA should regulate encapsulated placenta, and if so, whether it should be regulated as a drug, supplement, or human tissue. Because the product does not fit neatly into any of FDA’s predetermined categories, the Article explores the optimal regulatory categorization from a policy and gender perspective. It concludes that FDA should regulate encapsulated placenta as both a supplement and particular type of low-risk human tissue. The regulations associated with these categories will sufficiently protect women without creating such high entry barriers that the product would effectively (and paternalistically) disappear from the market.
Keywords: FDA Law, Health Law, Reproductive Rights, Gender & Law, Science and Technology Law, Healthcare Innovation, Regulatory Law, Health Policy, Drug Policy
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