Except they HAVEN't done anything about the boner pills.
I really do have confidence that the commercials for boner pills have been scrutinized and approved by FDA. I haven't seen an ad for Vi[boner]ra in ages, but Ci[boner]is with that low bluesy guitar riff in the background is all over TV in the US. The pills work as advertised and are prescription-based (hahahah yeah I know). Plenty of "if you encounter symptoms such as difficulty breathing, or if you have trouble with your eyesight or hearing, stop taking [boner pills] and seek medical attention right away." And the seemingly requisite "Ask your doctor about [boner pills]."
23andme isn't offering to cure anything, they aren't offering to diagnose anything, and they aren't offering to treat anything. They're advertising a service where you spit in a cup, send it off, and get back some "okay, this shit might be going on in your family lineage" results. They're not telling you that you have sickle cell, or that you're going to die if you eat asparagus, or anything of the sort. But they are making medical-type claims regarding your DNA, such that perhaps your brain isn't receptive to flubber-baz antagonists, which might make you argue with your physician or stop taking such medication altogether, to your own detriment.
Works for me, but if your average Duck Dynasty fan picks one of these up, they might flip the fuck out at what they get back. "YOU SAYIN I GOTS NIGGER IN MAH BLOOD? ANN MAH DICK NEVER GONN' GET GOIN' AFTER AH DRINK BEERS? AHHH'MA CALL UP MY REPRASENTIVE! GET THIS SHIT BANT!"
FDA's issue is very narrow. 23andme is making marketing claims of a medical nature which have not been approved by the FDA. The advertisements do not adequately disclaim that 23andme cannot prove whatever their DNA tests might come up with. If they rebrand themselves as a novelty, or work with FDA to achieve de novo compliance (which is basically FDA saying "hey! let's start it all over and get you compliant! woo! yeah let's do it!"), they should be just fine. I hope. Because I do still want to get that shit done for my spit.