FDA Update 19, Dec 2011

FDA cracks down on DIY sperm donor in California.

The Food and Drug administration is working to put an end to a California' man's free sperm donation operation. Trent Arsenault, who has provided more than 350 donations and fathered 14 children through them, he's just "helping people in need."

A California man is vowing to continue his do-it-yourself sperm donor operation, despite efforts of federal health officials to crack down on the free service.

Trent C. Arsenault, 36, of Fremont, Calif., has fathered 14 children -- with four more on the way and donated sperm to between 60 and 75 families since he started the online operation in 2006.

Last year, federal Food and Drug Administration officials delivered a letter ordering Arsenault to “cease manufacturing,” or halt his service, because the computer security expert had not followed regulations governing safety precautions for transmission of human cells or tissues through donor clinics.

But Arsenault was allowed to continue the operation while the agency decided whether to grant him a hearing on the matter, according to his lawyers.

The lawyers, who work for the nonprofit legal firm Cause of Action in Washington, D.C., argue that Arsenault shouldn’t be held to clinic sperm donor standards because his contracts with recipients are individual intimate partner arrangements allowed under the law.

No hearing has yet been scheduled, Burgess said. Arsenault could face penalties including court action if the agency concludes that his acts were a violation of federal regulations.

Any questions on this FDA update please email us at info@mdiconsultants.comand Ref: FDA crackdown on Sperm Donor.

For more information on this FDA Updates you can go to the following link: http://vitals.msnbc.msn.com/_news/2011/12/14/9445757-fda-cracks-down-on-diy-sperm-donor-in-calif