23andMe Suspends Genome Service Under FDA Orders—But You Can Still Annoy the Regulators



In late November, the Food and Drug Administration sent the genotype testing company 23andMe a warning letter outrageously ordering it to stop marketing its Personal Genome Service. As a justification for its high-handed demand, the FDA missive suggested some highly implausible ways in which 23andMe customers might harm themselves through misunderstanding the data supplied by the company.

The FDA letter gave the company 15 days in which to respond, advising that if the agency didn't like what it heard it might initiate regulatory actions that could "include, but are not limited to, seizure, injunction, and civil money penalties." To avoid further regulator ire, 23andMe has announced that it is suspending its Personal Genome Service to new customers:

At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration's directive to discontinue new consumer access during our regulatory review process.

We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe's interpretation.

If you are an existing customer please click the button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results.

We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.

The fact that the company will still supply new customers with their raw genetic data provides a bit of a loophole for those of you who would like to annoy FDA bureaucrats.

That data can be uploaded into the online genotype interpretation service Promethease. It's a bit clunkier than 23andMe's well-designed interface, but it does provide a good deal of interesting information. It takes 10 minutes and costs $5.

To get some idea if Promethease is for you, you might want to take a look at my Promethease generated open-access genetic profile at SNPedia. Of course, your report will be private, although genetic privacy is way overrated.

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  1. Looks like an opportunity for Prometheus to join forces with 23andMe, improving both businesses and the consumer experience too.

  2. Statist asshole says 23andme not good enough for everyone else:
    “Let the buyer beware of commercial genetic tests”
    “Giving people tools to manage their health is a good idea – but only solid tools.”

  3. Progress! Forward, comrades! Only a few dozen more rogue and unaccountable bureaucracies wielding draconian and tyrannical powers and we can finally reach peak utopia!

    1. A bit surprised that the statists have not seized on this technology to make The New Soviet Man.

      1. Soon. It all starts with mandatory Headstart, complete with Chairman Obama pin on the little uniforms, and then after the 2nd year of indoctrination, the little tykes get their progresso-chip implanted directly into the brain.

  4. Okay, America…

    What lessons have we learned about allowing Congress to delegate legislative authority to unelected government regulators?

    Some cute little saying about absolute power?


    I think the term slippery slope needs a new label. Fallacy doesn’t quite seem to always fit.

    If regulators don’t regulate, someone might get the impression they’re not doing their job and ask that their positions be eliminated.

    Perhaps the FDA should close down fortune tellers, as people might act on bad information? Or religion? Or the media? Or, god forbid, the government!

    1. Logical fallacies are only that. They are only fallacies in a logical sense, that doesnt make them invalid arguments.

    2. The inner anarchist is alive and well, within you!

      1. Last post directed at Francisco.

      2. I haven’t violated my minarchist philosophy in any way in that paragraph.

        2. The ONLY legitimate function of government is to protect the rights of the individual.

        1. Your life would be so much better off if the FDA shut down the government.

          1. Right up to the point where someone else tries to take my shit.

    3. Okay, America…

      What lessons have we learned about allowing Congress to delegate legislative authority to unelected government regulators?

      I think that depends on which Americans you are asking, the ones here at Reason, the ones calling for Obama to take dictatorial powers, or the 99% in the middle of that who know everything about Miley Cyrus or Jay Z, but who can’t name even one elected representative from their own state?

      The USA as it has existed, is doomed, toast, over. The question is, what comes after?

      1. I hope you’re wrong, but I’m pretty sure you are right.

        The world has yet to invent government that can be prevented from offering the the ignorant something for nothing.

      2. but who can’t name even one elected representative from their own state?

        When I worked for a congressman people from other districts would call out office all the time because they had no idea SC had more than one member in the House.

    4. Perhaps the FDA should close down fortune tellers, as people might act on bad information?

      Sounds like a job for the FTC to me!

  5. Whats the current price on complete genome data?

    Is it under $1k yet?

    I may consider doing that in 2014.

    1. Why bother knowing, until you can actually fix anything?

      We are primitives, our medical techniques are barely more advanced than blood letting, and governments can keep us there for a very long time, if not forever, through over regulation, or just blow us all up in a nuclear holocaust. Not to mention, Obamacare, which will probably kill most of us through limiting resources.

      I’m so cheerful today.

      1. H: Why bother? Because it’s fun!

        1. Can’t I just get on Ancestry.com for fun? I mean, that doesn’t cost $1000.

          1. Ancestry.com sells their genetic service for the same price as 23andMe, but the focus is not on health markers. National Geographic’s genetic test is similar to Ancestry.com’s, but regularly costs $199. Last time I looked it was on sale for $149.

        2. So’s doing coke, which your Promethease profile suggests you can do with reduced risk of addiction. Next ski party is at Bailey’s place.

        1. It’s the new Dark Ages, otherwise known as the Progressives Utopia.

        2. Oh, I’d give a lot to see the hospital. Probably needles and sutures. All the pain. They used to hand-cut and sew people like garments. Needles and sutures. Oh, the terrible pain!

  6. So, I mailed back my results earlier this week. Will give the Prometheus thing a try when I get them. Thanks for the updates, Ron.

    1. Well, I mailed back my spit, which was a result of spitting for a very long time. I’m not a prolific generator of spit.

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