The Legal Status of Placenta
The Legal Status of Placenta
By Eric Brand
Human placenta, known in Chinese medicine as Zi He Che, is not permitted for use as a dietary supplement in the United States. The official FDA position on Zi He Che is that human placenta is not a food or a dietary ingredient. They say that it can transmit disease and thus cannot be included in dietary supplement products. The disease transmission theme aside, it appears that the FDA actually has a very bizarre interpretation of why placenta can't be considered as a dietary substance.
In the somewhat comical letter quoted below, it appears that the crux of the FDA's argument revolves around the fact that human tissue cannot be considered to be a substance that humans consume as a normal dietary substance. In other words, cannibalism is not a normal human behavior so human tissue cannot be considered to be a customary item in the human diet. However, while we all can agree that cannibalism is obviously not the norm, I really question the FDA's wisdom in stating that human placenta is not a substance that humans consume. Many animals consume their placenta after giving birth, and the practice of a human mother consuming her placenta is a tradition that exists worldwide. The use of Zi He Che has been documented since at least 1590 CE, when human placenta first was first recorded in Chinese materia medica works by Li Shi-Zhen. Given the long history of human consumption of placenta as a nutritional supplement and medicinal product, I really have to question the scientific validity of the FDA's position that it is not a traditional addition to the human diet. Furthermore, the commercial product is tested, cleaned, and cooked before consumption, so I am curious as to whether or not there is any intrinsic scientific validity in the FDA's statement that (properly processed) human placenta is a potential vector of disease.
In the FDA's own words:
"Human placenta is not a dietary ingredient under section201 (f~(l ) of the Act. It is not a vitamin, a mineral, an herb or botanical, or an amino acid [section 201 (ff)(l )(A-E) of the Act]. It is not a “dietary substance for use by man to supplement the diet by increasing the total dietary intake” [section 201 (fl)( l)(E) of the Act]. While the term “dietary substance” is not defined in either the Act itself or the statute’s legislative history, the term must be interpreted in accordance with its common, usual meaning. The term “dietary” means “of or relating to diet” and the term ‘“diet” means “an organism’s usual food and drink,” and the term “substance” generically refers to “that which has mass, occupies space, and can be perceived.” “Dietary substance,” therefore, under a common-sense understanding of the term, means simply substances customarily used as human food or drink Human tissue is not a dietary ingredient under this definition. Nor is it a concentrate, metabolize, constituent, extract, or combination of any ingredient above [section 201 (f~( 1)(F) of the Act]. Human tissue also is not a food under section 201 (f) of the Act in that it is not “an article used for food or drink for man.” Given that human tissue is not “food” or a dietary ingredient, and that it may transmit human disease, a dietary supplement that contains it is adulterated. [sections 402(a)(l), 402(f)(l)(A), and 402(a)(3)of the Act]."