July 6, 2020

The Niche

Knoepfler lab stem cell blog

Deja you: human cloning generally legal in the US

sheep cloning, human cloning
Deja You (or ewe in this case).

One of the great areas of confusion over the human cloning development this week is whether human cloning is legal or illegal.

With few exceptions, human cloning in general is legal in the US. Update: in 2020 it still appears that reproductive human cloning is legal in the US. It just hasn’t gotten that much attention surprisingly.

More specifically, therapeutic cloning of the type done in Oregon to produce embryonic stem cells (ESC) is legal in most states in the US including California. Just a handful of states ban therapeutic cloning.

At the federal level therapeutic cloning is legal.

How about reproductive Star Wars kind of cloning? The type of cloning that makes actual people? About a dozen ban reproductive cloning, but by far most do not.

There is also no federal law prohibiting reproductive cloning.

The FDA has stated that it believes it has jurisdiction over the process, but that does not make the process illegal. In fact, someone could clone a human being in the US without the FDA’s permission and it still would not be necessarily illegal.

We have seen from the FDA’s frustratingly circumspect behavior with dubious, non-compliant stem cell clinics as well as IVF clinics that just because the FDA says it has regulatory oversight power over a given process does not mean that those who go ahead and do that process without FDA permission will get into legal trouble or even any trouble at all. In fact, to the contrary, most of the time the FDA takes months if not years to react to non-compliant biologics-related activities and does so very cautiously.

What this means is that if a lab cloned a human being, the FDA could first of all do nothing to prevent it and second of all would probably not take dramatic action against the cloner.

Instead, I predict the FDA would visit the lab (assuming they could find it) and the FDA may after the fact tell the people they could not clone again, but by then it is kind of too late, right?

Also of relevance, but indirectly, is the fact that states vary substantially in their laws regarding compensation for egg donation by women, but my hunch would be that human cloners would not care much about complying with state laws in this area.

The bottom line is that generally in most of the US, there is no legal or insurmountable regulatory obstacle to human cloning. 

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