28 December 2018

Regulating Encapsulated Placenta

'Regulation of Encapsulated Placenta' by Greer Donley in (2019) 86 Tennessee Law Review comments
Consuming encapsulated placenta is a growing trend among post-partum mothers. 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. Though its popularity is growing, encapsulated placenta is currently unregulated. This Article examines whether the 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 the FDA’s predetermined categories, the Article explores the optimal regulatory categorization from a policy and gender perspective. It concludes that the 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.
Research and guidance about placentophagy is noted here, here and here.

'Human Placentophagy: Effects of dehydration and steaming on hormones, metals and bacteria in placental tissue' by Sophia K.Johnson, Tanja Groten, Jana Pastuschek, Jürgen Rödel, Ulrike Sammer, and Udo R. Markerta in (2018) 67 Placenta 8-14 comments
Human maternal placentophagy, the behavior of ingesting the own raw or processed placenta postpartum, is a growing trend by women of western societies. This study aims to identify the impact of dehydration and steaming on hormone and trace element concentration as well as microbial contamination of placental tissue. 
Methods: A total of nine placentas have been processed: six were studied for hormone and trace element concentrations; eight were studied for microbial contamination. The concentrations of CRH, hPL, oxytocin and ACTH in samples of raw, steamed dehydrated and raw dehydrated placental tissue were detected using ELISA. A yeast bioassay was performed in order to detect estrogen equivalent (EEQ) and gestagen equivalent (PEQ) active substances. Elements (As, Cd, Fe, Pb, Se, Hg) were analyzed using ICP-MS. Isolated colonies from tissue and placenta swab samples were identified using Vitek MS.   
Results: Following mean hormone concentrations were detected in raw placental tissue: CRH (177.88 ng/g), hPL (17.99 mg/g), oxytocin (85.10 pg/g), ACTH (2.07 ng/g), estrogen equivalent active substances (46.95 ng/g) and gestagen equivalent active substances (2.12 μg/g). All hormones were sensitive to processing with a significant concentration reduction through steaming and dehydration. Microorganisms mainly from the vaginal flora were detected on placenta swab samples and samples from raw, steamed, dehydrated and steamed dehydrated tissue and mostly disappeared after dehydration. According to regulations of the European Union the concentrations of potentially toxic elements (As, Cd, Hg, Pb) were below the toxicity threshold for foodstuffs.
The  conclusion is
 The commonly used protocols for preparation of placenta for its individual oral ingestion reduce hormone concentrations and bacterial contamination.
A different stance is adopted in 'Placentophagy and Embryophagy: An Analysis of Social Deviance within Gender, Families, or the Home (Etude 1)' by Carmen M. Cusack in (2011) 1 Journal of Law and Social Deviance 112.

Cusaack argues that
the private, eccentric acts of placentophagy and embryophagy are not illegal. Placentophagy is the eating of a placenta. Embryophagy is the eating of an embryo. This paper suggests that placentophagy and embryophagy, while not specifically legalized by statute or case law, are not acts for which a person can be charged of any crime relating to anthropophagy. Anthropophagy occurs when a human eats human tissue or blood. First, this paper proves that for the most part, anthropophagy is not illegal in the United States. Statutes and case law demonstrate that generally, the consumption of human tissue or blood is not illegal even though the possession of human blood and tissue often correlates strongly with other criminal activity. Second, this paper will argue that placentophagy and embryophagy in the home are legal anthropophagic acts; and that the policy and politics, not law, are the only obstacles for some women who question their power to possess and eat human blood and tissue.
'Human placenta processed for encapsulation contains modest concentrations of 14 trace minerals and elements' by Sharon M.Young, Laura K. Gryder, Winnie B. David, Yuanxin Teng, Shawn Gerstenberger and Daniel C. Benysheka in (2016) 36(8) Nutrition Research 872-878 comments
Maternal placentophagy has recently emerged as a rare but increasingly popular practice among women in industrialized countries who often ingest the placenta as a processed, encapsulated supplement, seeking its many purported postpartum health benefits. Little scientific research, however, has evaluated these claims, and concentrations of trace micronutrients/elements in encapsulated placenta have never been examined. Because the placenta retains beneficial micronutrients and potentially harmful toxic elements at parturition, we hypothesized that dehydrated placenta would contain detectable concentrations of these elements. To address this hypothesis, we analyzed 28 placenta samples processed for encapsulation to evaluate the concentration of 14 trace minerals/elements using inductively coupled plasma mass spectrometry. Analysis revealed detectable concentrations of arsenic, cadmium, cobalt, copper, iron, lead, manganese, mercury, molybdenum, rubidium, selenium, strontium, uranium, and zinc. Based on one recommended daily intake of placenta capsules (3300 mg/d), a daily dose of placenta supplements contains approximately 0.018 ± 0.004 mg copper, 2.19 ± 0.533 mg iron, 0.005 ± 0.000 mg selenium, and 0.180 ± 0.018 mg zinc. Based on the recommended dietary allowance (RDA) for lactating women, the recommended daily intake of placenta capsules would provide, on average, 24% RDA for iron, 7.1% RDA for selenium, 1.5% RDA for zinc, and 1.4% RDA for copper. The mean concentrations of potentially harmful elements (arsenic, cadmium, lead, mercury, uranium) were well below established toxicity thresholds. These results indicate that the recommended daily intake of encapsulated placenta may provide only a modest source of some trace micronutrients and a minimal source of toxic elements.
'A Literature Review on the Practice of Placentophagia' by Rachel Joseph, Marissa Giovinazzo and Megan Brown in (2016) 20(5) Nursing for Women's Health 476-483 comments
Placentophagia (consuming the placenta) has historically not been a common practice among humans. Over the past few decades the practice has gained attention as more women, particularly educated, middle-class, White American women, choose to partake in this practice. Purported benefits of placentophagia include pain relief, increased breast milk production, and decreased risk of postpartum depression; however, there is a lack of evidence to support these claims. The placenta can be consumed raw, cooked, or encapsulated; it can be used for keepsakes; or it can be used to make topical applications such as dermatologic creams and hair-growth products. Placentophagia has typically been viewed as a personal choice, resulting in little rigorous scientific research on the topic. More research is necessary to determine if the purported health benefits of placentophagia are proven.
'Placentophagy: therapeutic miracle or myth?' by Cynthia W. Coyle, Kathryn E. Hulse, Katherine L. Wisner, Kara E. Driscoll and Crystal T. Clark in (2015) 18(5) Archives of Women's Mental Health 673–680 similarly comments
Postpartum women are consuming their placentas encapsulated, cooked, and raw for the prevention of postpartum depression (PPD), pain relief, and other health benefits. Placentophagy is supported by health advocates who assert that the placenta retains hormones and nutrients that are beneficial to the mother. A computerized search was conducted using PubMed, Medline Ovid, and PsychINFO between January 1950 and January 2014. Keywords included placentophagy, placentophagia, maternal placentophagia, maternal placentophagy, human placentophagia, and human placentophagy. A total of 49 articles were identified. Empirical studies of human or animal consumption of human placentas were included. Editorial commentaries were excluded. Animal placentophagy studies were chosen based on their relevance to human practice. Ten articles (four human, six animal) were selected for inclusion. A minority of women in developed countries perceive placentophagy to reduce PPD risk and enhance recovery. Experimental animal research in support of pain reduction has not been applied in humans. Studies investigating placenta consumption for facilitating uterine contraction, resumption of normal cyclic estrogen cycle, and milk production are inconclusive. The health benefits and risks of placentophagy require further investigation of the retained contents of raw, cooked, and encapsulated placenta and its effects on the postpartum woman.