FDA Warns Against Human Cloning Attempt

The Food and Drug Administration has decided it has the authority to regulate human cloning, and agency officials warned Monday that it would be a violation of federal law to try the procedure without its approval.

“Through the Food, Drug and Cosmetic Act, we do have the authority to regulate human cloning, and we are prepared to assert that authority,” acting FDA Commissioner Michael A. Friedman said.

The announcement by a Chicago-area physicist, G. Richard Seed, that he plans to try to clone a person has sparked a public outcry and a race by Congress and more than a dozen states to ban cloning.

Scientists have widely discounted Seed’s statements, however, saying that the current state of technology is far too primitive for him to accomplish what he says he wants to try.

Seed has said he plans to clone a person within 18 months. However, he has no medical degree, no laboratory backing and little money. The team that last year succeeded in cloning a sheep, named Dolly, experienced 277 failures before it was successful.

After reviewing the issue for several weeks, Friedman said the FDA had determined that the kinds of manipulations involved in human cloning presented “serious health and safety issues” for the fetus and the mother.

Should Seed actually move forward, the FDA’s new statement would require him to first file a formal application with the agency. The FDA would then undertake a lengthy review, Friedman said. The review would be similar to those undertaken for proposed new drugs or medical devices--a process that can often take years.

The FDA will initiate legal action against anyone who fails to file that application, Friedman added.