FDA Demands Man Stop Giving Away Sperm - Spokane, North Idaho News & Weather KHQ.com

FDA Demands Man Stop Giving Away Sperm

HUFFINGTONPOST.COM - Last fall, the Food and Drug Administration hand-delivered an order to cease manufacturing to a seemingly unremarkable recipient, a soft-spoken, 36-year-old man from Fremont, Calif., who works in computer security. The contents of that letter, however, were anything but ordinary. The agency was demanding that Trent Arsenault comply with federal regulations or stop giving away his fresh semen to women hoping to have a baby.

Since Arsenault made his first free sperm donation in 2006, answering a Listserv request from a Bay Area teacher who is now mother to a 4-year-old boy, he claims to have fathered 13 children, with four more on the way. Arsenault posts this information, as well as details about his appearance (blonde hair, brown eyes), hobbies (bird watching, Native American history) and what he calls his "sperm donor friendly diet" (twice daily fruit-and-raw-milk smoothies) on his website, Trentdonor.org. The site provides his latest physicals and tests for sexually transmitted diseases, and explains how women wanting to use his sperm can contact him.

The real trouble for Arsenault began in 2010, when the FDA's Center for Biologics Evaluation and Research inspected his home and found him in violation of numerous regulations, including failing to properly protect himself against communicable diseases. A year earlier, an FDA investigator had emailed Arsenault, requesting an opportunity to discuss the activities advertised on his website. During the meeting, Arsenault completed what is known as a human cells and tissues establishment registration form, indicating he was a "directed" or known donor and, as such, subject to federal regulation. Arsenault admits he filled out the form not because he fully understood its meaning and implications, but because he was eager to comply with the FDA's wishes.

Since that time, Arsenault has been fighting the agency's efforts to shut him down -- in particular, disputing the notion that he is a "manufacturer" of sperm, given that he packages his semen and distributes it in a cup. He has petitioned for a hearing to prove that even though he does not have sex with his recipients, he is a sexually intimate partner to them (a term the FDA currently does not define) and therefore is exempt from regulatory requirements that apply to manufacturers.

So far, Arsenault's requests have been denied, and he now faces potential financial penalties and jail time. What the FDA decides to do with the case, however, has consequences beyond Arsenault's fate, for it has stirred debate within a small pocket of the world of assisted reproduction about what sexual intimacy is and whether the government really wants any part of that discussion.

"Trent believes he is a sexually intimate partner with these women," said Daniel Epstein, executive director of Cause of Action, the Washington, D.C.-based public interest nonprofit representing him. "And it shouldn't be up to the FDA to define how private individuals define intimacy." click here to read more

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