I used to work as a state legislative aid; one of my duties was helping constituents work with state agencies on regulatory matters. I learned from that experience most regulators (at least at the state level, I imagine federal is similar) usually care much more about compliance than enforcement. As long as you aren't doing something egregious and make a good faith effort to work with them they'll often be pretty reasonable within the confines of the law. However if you ignore them, they'll come down on you like a ton of bricks.
> As long as you aren't doing something egregious and make a good faith effort to work with them they'll often be pretty reasonable within the confines of the law. However if you ignore them, they'll come down on you like a ton of bricks.
This is how all government works, in general. There will always be multiple opportunities to bring yourself into compliance, since it's in the government's interest for you to comply.
Contrary to popular belief, the government would prefer compliance over a fight.
23andMe on the other hand ... is either grossly incompetent or they're looking for a fight.
FDA's regulatory oversight over this new industry is not established. If 23andMe wanted to challenge them in court, this would be the way to do it. They need standing.
It sounds like 23andMe has been ignoring them.