FDA Regulation of Sperm Donation

 

An article in the February 13, 2012 Issue of New York Magazine titled “The Virgin Father” by Benjamin Wallace brings to light several legal and ethical issues surrounding proper regulation of “Do It Yourself” sperm donations. Trent Arsenault has been labeled The Virgin Father.[1] Although Trent never had sex with a woman, he has fathered 15 children to date. Trent is “part of a growing movement of peer-to-peer sperm donation that bypassed regulated banks”, by conducting his own sperm donation business through a website. [2] Trent is very pragmatic in his daily regime to keep his body healthy in order to produce the healthiest and most fertile sperm possible.

The FDA learned about Trent and his private sperm donation business, and launched an investigation against him, filing a “cease manufacture” order. “Although sperm is neither a food nor a drug, the FDA’s Center for Biologics Evaluation and Research has the power to  regulate those who traffic items that can possibly spread communicable diseases and genetic disorders.”[3] Historically, the FDA has only regulated traditional sperm banks, not private donors. However, because Trent was so public about his actions, the FDA contacted him and Trent signed a document confirming he was “an establishment”.[4] The FDA used this as a means to issue a cease-manufacture order that Trent wasn’t screening for diseases enough. Trent responded by claiming his celibacy, unusually healthily diet, and disease free lifestyle was enough to safeguard his DNA. A public interest group, Cause of Action, took Trent’s case, appealing the FDA’s order, claiming that they were overreaching into Trent’s “intimate” relationships with people, (for which he is receiving no compensation).… <Read More>