Sperm Banking as a Strategy to Reduce Harms Associated with Advancing Paternal Age.

Medical studies increasingly link paternal age with disorders in offspring. Associated disorders include autism, bipolar disorder, schizophrenia, and ADHD. Banking one's sperm earlier in life, thereby reducing the effective paternal age at conception, would therefore seem to be a successful strategy for reducing risk to one's eventual offspring. But could a cryopreservation equipment manufacturer or a sperm bank lawfully claim that cryopreservation does more than preserve fertility--that it also prevents disease? This article considers arguments for and against FDA's jurisdiction over such claims, and then makes recommendations for how the agency and Congress should respond.