FDA Regulates Spitting

Should you have wanted to pick up a DNA testing kit down at Walgreens this weekend, well, you'll just have to change your plans.

Walgreens said late Wednesday that it would postpone selling a personal genetic test through its drugstores after the Food and Drug Administration challenged the legality of the test.
Wha…? Willing buyers, willing seller: what excuse does the FDA have to block this?

The "Genetic Health Report" kits were to have been provided by Pathway Genomics. The FDA sent Pathway Founder/CEO James Plante a nastygram.

The Genetic Health Report appears to meet the definition of a device as that term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act.
Oh oh. That was apparently enough to get Walgreens to back off its plans; if your primary business is "drugstore", you don't want the FDA on your case for selling unapproved "devices". And, indeed, section 201(h) does define "device" very widely ("an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory…")

But what is this "device", really? We're not talking about a magnetic resonance cholangiopancreatography machine here, friends. Here's a small picture from the the Pathway site:

[Kit Box Photo]

As near as I can make out the primary "device" components are:

  1. one (1) container;
  2. one (1) container lid.

And in case there's any doubt, here's a helpful picture, also from the Pathway site, that gives you an accurate idea of the complex operating instructions for the "device":

[What You Do 2]

I think you don't actually have to say "Ptoo". But you provide an adequate amount of saliva, box it up, send it off to Pathway, and a couple months (and a few hundred dollars) later, you have your DNA analysis.

Now, I'm a soft-core libertarian, so you would expect me to find this sort of FDA intrusion odious. But—c'mon—wouldn't even non-libertarians find a pretty blatant signal that FDA bureaucrats have way, way too much time on their hands? That they've run out of things to do that might (arguably) protect the public against ingesting dangerous products, and instead are looking for things to do on otherwise boring May afternoons?

The good news (at least for now): you don't have to go to Walgreens. Unless you live in New York (whose nanny-statists are apparently ahead of the curve when it comes to preventing their residents from obtaining information about their own genetic makeup), you can do the whole thing via the Internet and mail.

I'm willing to bet, however, that this is just the onset of a wave of innovation-stifling regulation.

(Original link via Lore Sjöberg's quiz we linked to yesterday.)


Last Modified 2012-10-03 1:57 PM EDT