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What I Live By...
http://www.nydailynews.com/life-sty...lt-faces-legal-challenge-fda-article-1.989055
The Food and Drug Administration wants to shut down a do-it-yourself sperm bank of one.
Trent Arsenault, 36, says he donates semen to low-income and same-sex couples who face hurdles acquiring it at licensed sperm banks.
"It is helping people in need," the Fremont, California, resident told CBS San Francisco. "I don't make any money, I don't charge people anything. And it's just helping childless couples have children."
The FDA disagrees. In a Cease Manufacturing letter delivered on Nov. 1 of last year, the FDA classified Arsenault's setup as a "firm" that "recovers and distributes semen and therefore is a manufacturer of human cells, tissues and cellular and tissue-based products." An inspection of Arsenault's house carried out between August and September 2010 found, among other alleged health violations, that he did not take the legally required precautions to prevent the spread of disease or provide sufficient documentation.
The agency ordered Arsenault to shut down the renegade semen-distribution operation until he demonstrated compliance. Arsenault, on the other hand, contends that as a sole donor he should not have to comply with laws established for sperm banks that operate as businesses.
The dispute lingered on for over a year before CBS San Francisco broke the story for the national media this week. Arsenault says he continues to donate sperm while he waits for his hearing.
Arsenault certainly seems to be meeting a demand. He told CBS he has received some 20,000 email inquiries and he has fathered 14 children since his first sperm donation to a teacher in 2004.
The FDA estimated that Arsenault dealt out 328 semen donations to 46 recipients between 2006 and 2010.
The Food and Drug Administration wants to shut down a do-it-yourself sperm bank of one.
Trent Arsenault, 36, says he donates semen to low-income and same-sex couples who face hurdles acquiring it at licensed sperm banks.
"It is helping people in need," the Fremont, California, resident told CBS San Francisco. "I don't make any money, I don't charge people anything. And it's just helping childless couples have children."
The FDA disagrees. In a Cease Manufacturing letter delivered on Nov. 1 of last year, the FDA classified Arsenault's setup as a "firm" that "recovers and distributes semen and therefore is a manufacturer of human cells, tissues and cellular and tissue-based products." An inspection of Arsenault's house carried out between August and September 2010 found, among other alleged health violations, that he did not take the legally required precautions to prevent the spread of disease or provide sufficient documentation.
The agency ordered Arsenault to shut down the renegade semen-distribution operation until he demonstrated compliance. Arsenault, on the other hand, contends that as a sole donor he should not have to comply with laws established for sperm banks that operate as businesses.
The dispute lingered on for over a year before CBS San Francisco broke the story for the national media this week. Arsenault says he continues to donate sperm while he waits for his hearing.
Arsenault certainly seems to be meeting a demand. He told CBS he has received some 20,000 email inquiries and he has fathered 14 children since his first sperm donation to a teacher in 2004.
The FDA estimated that Arsenault dealt out 328 semen donations to 46 recipients between 2006 and 2010.
