The Curious Case of Trent Arsenault: Questioning FDA Regulatory Authority Over Private Sperm Donation

Abstract

In November of 2010, the FDA issued an “Order to Cease Manufacture” to a California man who offers donations of semen to women (usually partnered lesbians) on a purely uncompensated basis. Although private, noncommercial decisions about procreation typically are shielded from government interference by the right to privacy, in this case the FDA announced that an individual who provides cups of his fresh semen to women, with the understanding that artificial insemination will be performed at home, not by a medical professional, must comply with the plethora of regulations applicable to sperm banks and small medical offices that practice reproductive medicine. The FDA’s issuance of a cease-manufacture order to a private individual semen donor presents a unique opportunity for logical extension of the substantive due process doctrines developed by the courts throughout recent decades. This article examines the regulations that the FDA seeks to enforce against private sperm donors, their application in the Arsenault case, and the implications of so expanding the government’s regulatory authority over individuals’ procreative decisions.