Cytoplasmic Transfer - Legal Status

Legal Status

In 2001, the Food and Drug Administration, worried about the long-term effects of creating genetic hybrids, asserted regulatory authority over cytoplasmic transfer, in effect banning the procedure in the U.S. until lengthy and extensive studies can be conducted. There is dispute as to the extent of the FDA's jurisdiction over reproductive technologies and federal law is inconclusive. The FDA claims that genetically manipulated embryos constitute a "biological product" and are therefore subject to regulation similar to medical implements and drugs. In any case, the withholding of federal funds and prohibitively expensive research costs needed to fulfill FDA regulations has resulted in movement of cytoplasmic transfer operations abroad. This has contributed to the development of reproductive tourism where infertile couples or individuals travel in order to obtain fertility treatments banned in their home country or state.