FDA Regulators Ease Just a Tiny Bit Their Stranglehold on Direct-to-Consumer Genetic Testing

Testing company 23andMe expresses its gratitude



Anne Wojcicki, the CEO of the genetic testing company 23andMe sent out an email notifying customers that the Food and Drug Administration (FDA) has relented just a little in its obnoxious over-regulation of the company. As the email explained:

Today, 23andMe was granted authorization by the U.S. Food and Drug Administration (FDA) to offer the Bloom syndrome carrier status report. This is an important first step in fulfilling our commitment to return genetic health reports to consumers.

The email added:

The FDA has been incredibly responsive throughout our review and has demonstrated its support for direct-to-consumer genetic testing.

The New York Times further reported:

Anne Wojcicki, the chief executive of 23andMe, said the approval was a first step for her company and the government.

"It shows the F.D.A. is willing and supportive of crafting the direct-to-consumer path," she said in an interview. "It's a very reasonable first step. I would go so far as saying it's a very generous first step."

I don't blame Wojcicki for her obsequious tone. After all, the FDA bureaucrats basically shut down 23andMe in 2013 on the outrageously flimsy rationale that willing customers might be too freaked out by the genetic health risk information supplied by the company. The company was allowed to offer only information concerning genetic ancestry.

How "very generous" of the FDA to allow 23andMe now to offer a single test to which i and several hundreds of thousands of early customers already have our results. In fact, the Bloom syndrome test is just one of 53 trait carrier tests that company offered regular customers as part of it $99 genomic screening test package. As it happens, I carry a recessive variant for only one of the traits: Alpha-1 Antitrypsin Deficiency.

In addition, as an early customer, 23andMe supplies me with genetic information on 122 different health risks and likely responses to 25 therapeutic drugs.

Evidently, FDA regulators are generously thinking about allowing the company to offer more carrier trait tests, but remain decorously silent on the future of direct-to-consumer genetic health risk testing.

To those interested in finding out more about their genetic risks, 23andMe does allow customers to download their uninterpreted genetic data which they can then upload into the Promethease service for a rough-and-ready analysis. To get an idea of what type of analysis Promethease provides, take a look my online genetic information at SNPedia.

NEXT: Ronald Bailey Reports that Politicians Aiming to Reduce Inequality Usually Make It Worse

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  1. I really can’t get how this falls under the FDA’s jurisdiction in the first place.

    1. Because.

      That’s why.

    2. Through Wickard-like reasoning, getting genetic info may cause you to not use some drugs or wrongly try to use others.

    3. In vitro dx. The materials used are labeled as for dx purposes & are sold in interstate commerce, hence are medical devices. Blame Congress; FDA’s doing what statute compels them to, w just a little wiggle room.

  2. It’s your genetics. You own it; you would think you have the right to know about it.

    1. “you own it” HA!

  3. Nothing

    The FDA is the posterchild of statism. Why there isn’t open rebellion over shit like this is beyond me. Politicians joke, “Can the government force you to eat broccoli?” This is 69 times worse and no one bats an eye.

    1. Because gawking at what so-and-so said about evolution or rape is a million times more important than government arbitarily stifling human progress.

      1. But we actually elect those people.

        The bureaucrats at the FDA who decide these things aren’t elected, so… I don’t know, that makes it better or not worthy of attention somehow.

    2. 69 times worse? That…that’s like 23andMe TIMES 3!

      1. Oh.



    3. Why there isn’t open rebellion over shit like this is beyond me.

      Personally, because 23andMe is so batshit stupid that they make the FDA look semi-reasonable in response.

      They stumbled into the FDA’s lair and got smug. In the process of trying to escape their bludgeoning by the FDA they came up with ideas that were neither more sensible nor more free (see their subscription model).

      Not to say their business or field is without merit and the FDA is right, just that 23andMe is the wrong hill to die on wrt the FDA.

      Especially where there are cases where the FDA is, rather demonstrably, killing people.

  4. willing customers might be too freaked out by the genetic health risk information supplied by the company.

    You can’t handle the truth!

  5. 23andMe should be free to sell their ancestry testing services. People should be smart enough and well informed enough not to take their results as any kind of a medical diagnosis.

  6. Where was the FDA when 23andme broke the news to me that I’m part Jewish? I mean, I’m cool with it, but a thing like that could leave someone verklempt.

    1. Discuss!

  7. The FDA has been incredibly responsive throughout our review and has demonstrated its support for direct-to-consumer genetic testing.

    Sometimes he gets angry and hits me, but he’s so good with the kids.

  8. OT:Here’s some news to cheer you up: Only about 1/4 of likely voters think that the president should be allowed ignore judicial rulings.

    The latest Rasmussen Reports national telephone survey finds that 26% of Likely U.S. Voters think the president should have the right to ignore federal court rulings if they are standing in the way of actions he feels are important for the country. Sixty percent (60%) disagree and say the president should not have the right to ignore the courts. Fifteen percent (15%) are undecided.

    1. And another 15% are undecided. Who needs checks and balances?

    2. Holy shit…

    3. I’m willing to bet those numbers would look radically different if you specify what policies a president might ignore.

      1. And I’ll bet that those who respond as such change depending on who’s in office.

    4. Technically the president doesn’t have a “Right” to do anything other than those rights he has in common with every other citizen of the the Republic. He does have some “Powers” granted by the constitution.

  9. I got an email earlier today from them talking about the results of their IBD study, though they’ve only gotten about half of the required volunteers so far.

  10. The FDA has been incredibly responsive throughout our review and has demonstrated its support for direct-to-consumer genetic testing.

    I seriously doubt it.

    Kiss that ring, baby!

    1. I am guessing the conversations are around how they can market their product an an “ancestry service” rather than medical testing. The new website seems to steer well away from screening for stuff like BRCA and genetic counseling.

  11. I signed myself and my whole family up for 23andMe. We just sent our samples in last week. When we had to register on the website, it had a lot of unusually convoluted caveats regarding the information they would supply.

    Now I know why!

    Far as I am concerned, we need to “burn this Mutha Fucker DOWN!” as soon as possible,

  12. Lets roll with it dude.


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