[hacker789]

It all depends on what is meant by "regulate". If the FDA just wants 23andMe to make it clearer to their customers that:

1. Like any screening, their results could be inaccurate.

2. Before making any changes based on their results—aside from eating more healthfully, exercising more, and sleeping better—they really need to talk to a doctor.

... then few people would have a problem with it. And maybe that's all the FDA is trying to do! I don't really know.

Sadly, when an activity or product could result in a bad outcome, certain types of people are incredibly eager to ban (or heavily regulate) it.

Those people don't realize that by doing so, they themselves are actively harming the people who benefit from that activity or product by preventing or heavily limiting their access to it.

Just like we shouldn't ban health discussion boards (and we shouldn't make it illegal to participate in health-related discussions without government-mandated credentials), we shouldn't limit people's freedom to choose services like these. It's wrong.

We just need to make sure the services aren't lying about what they're offering.

[tptacek]

That in fact appears to be what the FDA is interested in; their letter references attempts to clarify 23AM's "labeling". Presumably, the FDA would like 23AM to stop overtly mentioning health conditions in their marketing; they could write copy that refers to the importance of genetic testing in health management while explicitly stating that their consumer service is not intended as a medical diagnostic.

It seems clear that FDA does not in fact want to shut 23AM down, but that they do want 23AM to radically change their marketing. Which seems fair, because 23AM's marketing is disquietingly clinical.

[dragonwriter]

> It seems clear that FDA does not in fact want to shut 23AM down, but that they do want 23AM to radically change their marketing.

I don't think that's accurate either. I think that the FDA views that 23andMe must do one of the following:

1) Provide necessary evidence to support their current marketing claims, or

2) Change the way they are marketing their product, or

3) Cease marketing their product altogether.

I don't see that the FDA necessary has a strong preference as to which manner of complying with the law 23andMe takes.

[tptacek]

Sorry, you're right, I was being imprecise. Obviously, I think (2) is the only viable option here; 23AM doesn't appear to be set up for clinical genomics. But that bias was built into my comment implicitly, not stated directly like it should have been.