FDA Shuts Down 23andMe: Outrageously Banning Consumer Access to Personal Genome Information:

23andMe23andMeFor a couple of years, I have been warning all my friends and colleagues to purchase $99 personal genome testing from 23andMe before the Feds banned it. Well, now the Food and Drug Administration has banned it sending the genome testing company a warning letter:

The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act). 

This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.

The FDA says it is concerned that consumers would misunderstand genetic marker information and self treat. For example, the agency cites the company for testing for versions of the BRCA gene that confers higher risk of breast cancer worrying that women might get a false positive test leading "a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions...."

What the test results would actually lead patients to do is to get another test and to talk with their physicians. The FDA also cites the genotype results that indicate the sensitivity of patients to the blood-thinning medication warfarin. Again, such results would be used by patients to talk with their doctors about their treatment regimens should the time come that they need to take the drug. In fact, in 2010 the FDA actually updated its rules to recommend genetic testing to set the proper warfarin dosages for patients.

It is notable that the FDA cites not one example of a patient being harmed through the use of 23andMe's genotype screening test. Nevertheless the agency orders that...

...23andMe must immediately discontinue marketing the PGS (Personal Genome Service) until such time as it receives FDA marketing authorization for the device.

The FDA bureaucrats think that they know better than you how to handle your genetic information. This is outrageous.

For more background, see my 2011 Reason article on my own genetic testing experience here and go to SNPedia here for even more information on my genetic flaws.

Update: The folks at TechFreedom have just launched a petition at Change.org to FDA Adminstrator Margaret Hamburg urging her to reverse this ridiculous ban. From the petition:

The FDA seems to think that Americans can’t be trusted with more information about their potential health risks because some people might make rash decisions with it. But banning personal genomics isn’t the answer.

We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.

We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.

H/T Mike Riggs and Andrew Mayne.

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  • sarcasmic||

    Freedom means asking permission and obeying orders.

  • anon||

    Goddamnit Sarc, it was my turn to say that.

  • Mike M.||

    Anything that is not authorized is prohibited!

  • JW||

    The FDA offers the world ORDER!

  • Kuze||

    Freedom means mitigating all risk/danger and only the smartest of us can do this most effectively. Now please place Cass Sunstein's penis in your mouth, it's good for you.

  • CE||

    I must have missed the part where someone testing my saliva involved a food or a drug. At least we know now what the "A" stands for in FDA.

  • buybuydandavis||

    All sorts of names and numbers for the FDA. If you're as eager to thank them as I am, I'm sure they'll appreciate hearing from you.

    http://www.fda.gov/ICECI/Enfor.....376296.htm

    "If you have questions relating to this matter, please feel free to call Courtney Lias, Ph.D. at 301-796-5458, or log onto our web site at www.fda.gov for general information relating to FDA device requirements."

  • buybuydandavis||

    You know there's a whole page of contact information for our public "servants" at the FDA? Hooray!

    http://www.fda.gov/AboutFDA/Ce.....127854.htm

    Division of Chemistry and Toxicology Devices Courtney C. Lias, Ph.D. 301-796-5458

    Also mentioned in the warning letter:
    James Woods
    Deputy Director, Patient Safety and Product Quality
    Office of In Vitro Diagnostic Devices
    Telephone: (301) 796-6225
    Email: james.woods@fda.hhs.gov

    And the Guy in Charge:
    Director: Alberto Gutierrez, Ph.D. 301-796-5453

    I'm guessing
    Email: Alberto.Gutierrez@fda.hhs.gov
    Email: Courtney.Lias@fda.hhs.gov

  • Mercy Vetsel||

    Cool. Anyone try calling some of these assholes to express your opinion of their asserted right to decide what information about our own bodies we can be trusted with?

  • buybuydandavis||

    Oh joy! Another directory of FDA Employees.

    They must be eager to have citizens contact them.

    http://fdazilla.com/fda-employ.....h?q=Silver Spring MD 20993-0002

  • rts||

    Well, fuck, looks like I waited too long to get it done.

  • rts||

    Though, if you look at their website, it doesn't look like anything is amiss.

  • Ron Bailey||

    rts: The FDA order just stops sales of the testing kit.

  • rts||

    I took an order almost all the way to sale, and there was no hint that it wouldn't work.

  • Ron Bailey||

    Very interesting.

  • Jake||

    I just took it all the way through... actually bought one. Now let's see if it actually shows up in 6-8 days.

  • Seamus||

    I'm betting that by that time, the company will have sought protection under Chapter 11, and your money will be part of a small pool of assets that the bankruptcy court will parcel out among all the creditors, who will include suppliers as well as you and everyone else who bought kits but haven't had their orders filled.

  • Seamus||

    I've heard that a lot of people buying health insurance on the exchanges have had similar experiences.

  • anon||

    RB: What if they just give the kit away and charge a "biohazard handling fee" or something that happens to cost $99?

  • Ted S.||

    Damn you!

  • Ted S.||

    They should just give away the kit, and sell you the results. If you want to do the results yourself, go fot it. :-)

  • stuartl||

    No, you will be able to get it done, but only using FDA approved companies. According to the FDA blog they are approving two companies as "next generation sequencing," what 23andme is already doing.

    Does anyone else catch the whiff of crony capitalism here, or maybe even a flat out bribe?

    http://blogs.fda.gov/fdavoice/.....eneration/

  • Metazoan||

    I don't think 23andMe does next generation sequencing. Those runs are at least a few thousand dollars for a whole genome, and even more if you want more coverage. They also like using blood samples (or at least they did) for NGS runs. I always thought 23andMe used SNP arrays instead.

  • ||

    Regulatory capture.

  • buybuydandavis||

    So the same day that they announce two "next generation" approvals, they send a warning letter to their competition.

    No corruption to see here. Move along.

  • ||

    Jesus, I knew when I was drawn to this for funsies last time it came up I should have just done it.

  • Hugh Akston||

    That's what you said about butt-chugging.

  • Archduke von Pantsfan||

    has butt chugging been regulated by the FDA yet?

  • Lady Bertrum||

    The FDA wanted to send a cease and desist order but couldn't find Warty's current address.

  • SugarFree||

    Damn girl, your helices be lookin' fine.

  • Floridian||

    I literally mail my sample and my wife's this morning and have 3 unopened kits for family on the table. What does this mean for my order? Will I get a refund? This is infuriating! I don't need more bullshit from the government to deal with.

  • Aloysious||

    Even though there is no demand for guv bullshit, there is an endless supply of the stuff. Verily, we are awash in the foul secretion.

  • Anomalous||

    And yet, in defiance of economics, the price keeps getting higher.

  • anon||

    Even though there is no demand for guv bullshit,

    I disagree; people specifically vote for government freebies. Government bullshit is just the price they pay for those freebies.

  • Aloysious||

    Very true. I personally know people (they are NOT friends) who love their freebies, and bitch about the hoops they are expected to jump through.

    Now I have indigestion.

  • Rasilio||

    The problem here is no one voted for anything like this, they did elect politicians who promised to "make food safer" more than 70 years ago but all of the people who actually voted for those politicians (along with the politicians themselves) are dead and they had no idea how far that little regulatory agency would grow and metastasize. They basically created an unaccountable bureaucracy and it has been running on autopilot grabbing ever larger powers ever since.

  • ||

    If only they'd had 23andMe back then to warn them of the incredible genetic predisposition of regulatory agencies to turn cancerous!

  • Robert||

    There's no ban on the company's continuing to do testing, only on the specimen collection device, since FDA has no jurisdiction over services. Since you've already bought the device, you should be able to get them tested.

    Presumably in the meantime 23 & Me will have to rely on customers purchasing their own generic specimen collection devices and sending them in with money.

  • Rich||

    OK, let me get this straight. The FDA is shutting down 23andMe because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, yet the FDA allows 10,000 products to disclaim, in blatant contradiction to their advertisements, that "This product is not intended to diagnose, treat, cure, or prevent any disease"?

    Fuck the FDA.

  • Zeb||

    That's a good point. If all the "supplements" have that workaround available (which is a good thing), why not a service that does nothing at all to modify your body or its contents?

    This almost seems like a free speech thing to me. How can the FDA prevent an organization from telling people true facts about themselves?

    Would exactly the same thing be allowed if it were a scientific study and not a service provided for a fee?

  • anon||

    why not a service that does nothing at all to modify your body or its contents?

    Fuck you, that's why.

    BOOM! Nailed it.

  • Ted S.||

    More like they didn't donate to the right people.

  • Metazoan||

    Would exactly the same thing be allowed if it were a scientific study and not a service provided for a fee?

    It is allowed. My colleagues have done studies involving the use of microarrays to genotype people. But they got authorization from Top. Men.

  • ||

    How can the FDA prevent an organization from telling people true facts about themselves?

    Aw, come on, you know why!

  • anon||

    ahahaha too late!

  • buybuydandavis||

    Guns.

  • CE||

    I'm mad enough to spit. And now I can't get it analyzed.

  • sarcasmic||

    FDA kills Terminally ill father-of-three who begged drug companies to give him unapproved cancer treatment has died


    http://www.dailymail.co.uk/new.....-died.html

  • Free Society||

    Unsurprisingly free enterprise is blamed. This is why we need to give the FDA more arbitrary power, so it can force people to save other people. /derp

  • Metazoan||

    Yeah, I wonder why the drug companies wouldn't give him the drug? Hmmm...

  • Ron Bailey||

    M: Generally, because his outcome would likely have to be included in the efficacy results submitted to the FDA.

  • sarcasmic||

    And nowhere in the article does it mention that the reason the evil corporations refused to give him the drugs was because the government would treat it as a fucking crime if they did.

  • anon||

    I can't even comprehend why anyone would give a fuck if a terminally ill cancer patient died from a drug that might have actually helped him.

    Fucking FDA. Almost as bad as the EPA. Almost.

  • sarcasmic||

    Policy is policy.

  • anon||

    Doesn't it seem like the FDA should be interested in actual results from a dying patient though? I mean, isn't that their whole shindig?

    Or am I completely wrong and the FDA just exists as some kind of weird protection scheme for current drug makers?

  • sarcasmic||

    Yes.

  • Zeb||

    Yes, no, yes.

  • Zeb||

    I say worse.

  • Neoliberal Kochtopus||

    Ditto.

  • Gorilla tactics||

    I'm sure this kinda of thing happens all the time. The longer it takes and the more expensive it is for these life saving drugs to come to the market the more people die.

  • KPres||

    The author doesn't even blame the companies in the article, it's just in the headline. Then they add a couple pictures of the signs in front of their offices to imply that they refused to talk about it, like there's some conspiracy of silence. Looking at the comments they've already hooked a couple of idiots.

  • JW||

    Looking at the comments

    Well, there's your problem.

  • Free Society||

    You don't own your own genetic material. You don't possess the capability to understand or the right to seek information about your genetic material. That is, unless you do it through government approved personnel using government approved equipment and paying government approved prices.

    You're welcome, peasants.

  • Metazoan||

    Obviously the principle of this lack of self-ownership is the abomination, but it literally adds insult to injury that we are being bossed around by people who, at least by the looks of the commentariat here, are vastly our intellectual inferiors. Please note that I'm not suggesting it would be ok with Top. Men. No, it is immoral no matter who does it. But it is even more insulting that it's always these idiot bureaucrats.

  • anon||

    but it literally adds insult to injury that we are being bossed around by people who, at least by the looks of the commentariat here, are vastly our intellectual inferiors.

    You're obviously perceiving this wrong: They're so much smarter than us they just look dumb, because we couldn't possibly comprehend their brilliance.

  • Terr||

    Godfuckingdamnit!!!

  • anon||

    I'm not surprised at all that a government agency would take an action that inhibited people from paying money for a service that might empower those people to make choices for themselves.

  • hotsy totsy||

    I already did the 23&me; testing and got my results online...should I be printing it out?

    A friend of mine had to get tested for just one gene and it cost him $300. I told him I got my whole genome sequenced for $100.

  • Metazoan||

    It's not a whole genome sequence. 23andMe is awesome, but that point needs to be clear.

  • Careless||

    You should download the data

  • hotsy totsy||

    By the way, at least two of my Facebook friends have published a "Sign the petition to stop the FDA...from PERMITTING GMO Salmon, for godsakes.

    Kids are being taught in school that without the FDA we'd have human flesh in our hotdogs because it was meat packers policies years ago that if a worker fell into the processing machines, they'd never take the time to remove him, and clothes, shoes and all, he'd be ground up into the hotdogs. And that's why we should be grateful to the FDA because without them this would still be going on!

  • sarcasmic||

    Oh yeah? Well if not for the FDA, who would prevent those things from happening? Huh? Be specific! Who? Tell me! You can't! See? That's proof that the FDA is the only thing keeping Big Agriculture from marketing poison as food! It's the only thing saving us from the evils of greedy corporate profit seekers! All praise the FDA!

  • ||

    I've always wondered why it's never occurred to these people that it generally does not serve the interest of the evil corporashuns to poison their customers.

  • Smilin' Joe Fission||

    Corporations don't act in their own reality based best interest. They act in the straw man dimensions where killing their customers is best business practice.

    According to a prog that is.

  • sarcasmic||

    The only interest the evil corporation has is profit! If they can profit from poisoning their customers, then they'll poison their customers! All they care about is profit!

  • IDPNDNT||

    History books are loaded with propaganda.

    Never fails to amaze me how the narrative is always the government swooping in to the save the populace from the "evil corporations".

  • Sevo||

    "Kids are being taught in school that without the FDA we'd have human flesh in our hotdogs because it was meat packers policies years ago that if a worker fell into the processing machines, they'd never take the time to remove him, and clothes, shoes and all, he'd be ground up into the hotdogs"

    And WITH the FDA, the guy would have been inspected before he fell in and everything would be fine.

  • IDPNDNT||

    People who say just go to doctor have clearly never dealt with the frustration of having multiple doctors not know what the hell is going on.

    It's cases like this where self research or diagnosis finally got me answers.

  • Metazoan||

    That, and the fact that 23andMe offers you the raw data from the microarray iirc, something that would be difficult to get from a GP.

  • Doctor Whom||

    Choice over one's own body, how does it work?

    Oh, I remember now. Except for abortion, it doesn't.

  • sarcasmic||

    And gay sex. Don't forget gay sex.

  • Mike M.||

    "That DNA strand? You didn't build that!"

  • EDG reppin' LBC||

    Abortions and penises.

  • ||

    Of course this is great news for the CLIA labs that "play by the rules".

  • sarcasmic||

    I wonder if this could possibly have had to do with the fact that getting similar testing done by approved medical professionals costs many hundreds if not thousands of dollars.
    For example my wife's sister had a form of breast cancer caused by some gene, so my wife went and got tested to see if she was similarly predisposed. Thankfully she wasn't, but the test cost a lot more than ninety nine bucks.

  • Metazoan||

    I think it's a combination of factors. The protection racket is probably part of it, but in clinical genomics, physicians and scientists sometimes like to use certain sequencing technologies that can be very accurate and provide long reads, but are slow and expensive.

  • ||

    Nah, it's fast and cheap to run. Add in the regulatory aspect and CMS and so on, and the price climbs pretty fast.

  • ||

    It's entirely possible that the thousands of bucks fee for the tests is due to the onerous regulatory process required to get approved.

    You're basically paying for the FDA approval.

  • buybuydandavis||

    The $99 gets a million SNPs. They'd rather you paid $500 for each SNP individually, with a $300 fee from your doctor for the prescription and "consultation".

    No crony capitalism to see here. Move along.

  • hotsy totsy||

    The test my friend had done to find the ONE gene cost him $300. And I think his insurance paid for another portion of it.

    Mine was included in my 23&Me; report, because he showed me specifically what they were looking for and mine was included in my report.

  • Swiss Servator, referendiffic!||

    Fuck off, FDA slavers.

  • ||

    I believe this is already illegal in Austria and several other countries--illegal to transport bodily fluids or something. Nice to see the US keep up, all the cool socialist kids are doing it.

  • Careless||

    23andme ships to Australia

  • KPres||

    And people wonder why our healthcare costs so much.

  • Lord Humungus||

    What would Warty's Genone information look like?

  • Lord Humungus||

    or even Genome.

  • sarcasmic||

  • JW||

    It's just a repeating sequence of razor blades and anuses.

  • Enough About Palin||

    Whoa!

  • Marc F Cheney||

    The worm Ourobourus.

  • Mike M.||

    I'll bet these guys probably made the mistake of giving money to an enemy of the Community Disorganizer. This reminds me a lot of the Gibson Guitar shakedown.

  • Raston Bot||

    The FDA really is worthless.

  • buybuydandavis||

    Worthless would be an upgrade. They kill tens of thousands every year.

  • Protagoronus||

    Nutpunch for sure. Statists gonna state.

    From the TechCrunch article

    Still, if a patient receives a prognosis that indicates they’re likely to develop breast cancer, and gets a double mastectomy as a preventative measure, only to have that turn out to be a false positive, that’s a big risk and justified cause for scrutiny.

    You see! Some hypothetical person could cut off their chest because of one bad data-point! BAN IT.

  • ||

    Because it's totally normal to run out and get both tits cut off the day after you receive the results of a $99 DNA test.

  • Zeb||

    And I'm sure there are lots of doctors who are willing to do so just on that basis too. Or are they worried that people will be so alarmed that they will just cut their own breasts off as soon as they read the results.

  • ||

    Women might just strike of their breasts with a kitchen knife as soon as the get their DNA info. Which reminds me, why are kitchen knives still unregulated?

  • Smilin' Joe Fission||

    Baby, it looks like I'm pre-disposed to breast cancer according to my $99 DNA test report. The meat clever is in the second drawer down, right?
  • hotsy totsy||

    Didn't some idiot take out her own breast implants in the great Silicone Hysteria at the turn of the century?

    Nothing to do with the FDA of course, it just happened around the time that the FDA was banning silicone implants.

  • Smilin' Joe Fission||

    It really is too bad people don't have the ability choose to do things based on a risk-reward basis. We need government to make those decisions for us.

    Like fuck, this sort of stuff pisses me off. If this hypothetical situation actually did occur, that is a risk you take when making decisions using a sequence that has the potential for error. But that is your choice and you personally make the decisions based on how you value the reward against the risk. I am so sick of these people who think they must push government nanny force on everybody.

  • ||

    This is simply not acceptable. You need people to make your choices for you or you'll get screwed over by the evil corporashuns.

  • JW||

    You're making this up now, aren't you? C'mon, we're not suppose to reach Peak Retard today.

  • ||

    For the last time, there is no such thing as peak retard. See post tomorrow.

  • hotsy totsy||

    Didn't Angelina Jolie do that after receiving the genetic news from the sacred "medical professional"? Like medical professionals are never wrong, they are like gods.

  • ||

    It's a little more involved than that. Try your Google machine.

  • TexasRasta||

    Well better close down WebMD, if they are worried about people self treating, for everyday symptoms, which is much more dangerous. But WebMD does promote obamacare, so they should be safe

  • CE||

    Shhhhhhhh..... don't give them more ideas.

  • ||

    That letter is spilling over with frustration and annoyance. Those of us in the business are frankly surprised it took this long.

    (Note the absence of a value judgement in that statement.)

  • califernian||

    The FDA bureaucrats think that they know better than you how to handle your genetic information.exist This is outrageous.

    FTFY

  • ||

    Somehow, I can't help but connect this to the recent SCOTUS ruling on the patentability of the BRAC4 breast cancer gene, which held that the gene could not be patented, which means that other people could develop tests for the gene.

    Is it possible that 23andMe is being shut down as a means of restricting cheap competitors to medical genetics testing companies? IIRC, the company involved was selling it's tests for thousands of bucks a pop.

    If one company could sell you a suite of genetic tests for $100, including the BRAC4 gene, wouldn't that threaten the interests of established genomics companies?

    Regulatory capture anyone?

  • ||

    I'm fairly confident that's exactly what's going on here. 23andMe kind of seems like a social network for genomic information. You pay for the service of having your genome partially-analyzed and you get access to tons of studies and can connect with other users to share your results or other information. This can't be a good thing for other companies that would charge the same price for a single test.

  • Enough About Palin||

    Just file a Freedom of Information request with the NSA. No doubt they have a copy.

  • Jose Chung||

    The FDA bureaucrats think that they know better than you how to handle your genetic information.

    FTFY

  • James Anderson Merritt||

    The FDA was so cuuuute, back in the early 20th century when its only charge was to be sure that foods and drugs were pure and properly labeled, that medical and nutritional claims made for them were accurate and verified.

    Now look at the monster, and remember this the next time someone is forcing some kind of labeling scheme on the market -- any market. Labeling schemes seem innocent and fair, but they are inevitably stepping stones to 1) greater government power to micromanage business and individual lives; 2) abuse of said power, such as we see today in the FDA.

    I'm with those who think that the FDA is stepping into First Amendment-land here. All 23AndMe should have to do is to make it clear in the user agreement that the results are intended for entertainment and social introduction purposes only, and should not be relied upon as a diagnostic tool. If that doesn't satisfy the feds, then indeed, screw the FDA, and hard, in the Supreme Court, if possible. I say this after ten years of working for an FDA-regulated company. You know they assert regulatory power over iPods, don't you, because the earbuds can cause hearing damage (if turned up too loud), and certain Apps have claimed therapeutic effects (through binaural beats or certain tonal or rhythmic qualities of the sounds they generate)? That was outrageous when I first heard it, and today's news only stokes my outrage at the FDA's overreach.

  • Marc F Cheney||

    Did you think you could just give mankind a $99 personal genome test and GET AWAY WITH IT?

  • Robert||

    The problem 23 & Me is dealing with is that since their specimen collection kit (instructions & explanations, mostly) has been classified by FDA as an unlicensed home diagnostic (medical) device, in the states where diagnostic labs are regulated by requiring a doctor's prescription from the state where the specimen is collected, people will have to get a prescription to have a specimen collected & sent in. FDA is only a part of the problem here, and not the major part, although it can be part of the solution, because they can license 23 & Me's specimen collection device as a home testing kit, which exempts them from the state laws. What 23 & Me should probably do is file a 510(k) notification as a class 2 medical device, showing their product to be the equivalent of an already licensed one.

  • Robert||

    Well, now that I've read the letter...

    FDA has spent significant time evaluating the intended uses of the PGS to determine whether certain uses might be appropriately classified into class II, thus requiring only 510(k) clearance or de novo classification and not PMA approval, and we have proposed modifications to the device’s labeling that could mitigate risks and render certain intended uses appropriate for de novo classification. Further, we provided ample detailed feedback to 23andMe regarding the types of data it needs to submit for the intended uses of the PGS.


    ...it appears they're already under way, and it's just a matter of getting those results in and arriving at a compromise on labeling. There's money to be made here, so I'm sure they'll be able to work something out with FDA. They may have to withdraw the kits for a time while they work out these details, but I'm sure they'll be back.

  • Atlas Slugged||

    Does this mean they will also ban genealogists? They could discover mutiple relatives had Alzheimers, Huntingtons, or cancer. Why that would be just like making a diagnosis! How dare they!!!

  • SQRLSY One||

    Hey Y’all, Please help me out here by suggesting an OUT to 23andMe: Email help@23andme.com and / or bd@23andme.com as follows: I read in the newspaper that the FDA wants to regulate your genetics testing services, which will doubtlessly inflate the costs to us consumers. Please accept my sympathies.
    Meanwhile, PLEASE consider my worthy suggestions here! The SHORT version is simply this: Set up a “Feng Shui Molecular Fortune-Telling Analysis” branch in China. Tell you USA customers how to run a Q-Tip across the insides of their cheek linings, and where to send it in China. Your Chinese subsidiary can then email or snail-mail the results back to the USA consumer, who is anxiously awaiting the results of the (obviously non-medical) analysis of the Feng Shui sooth-sayers in China. They will examine the arrangements of the molecules on the Q-Tip, to say what they might tell of the fortunes of the USA consumer. FDA problems solved!

  • SQRLSY One||

    SURELY it is no crime for me to mail a dirty Q-Tip to China! SURELY it is no crime for someone in China to email or snail-mail me about my fortunes! So here is your possible, proposed verbiage to put on your flyers, web site, advertisements, etc.: “Our company regrets to inform you that the FDA has inflated the costs of our USA-based genetics testing services. If you appreciate the services of the FDA, you may purchase our well-regulated services in the USA for $700.have meditated deeply about matters concerning the proper Feng Shui, and Chinese Buddhist, principles as they relate to the arrangements of molecules and atoms in your cheek linings. Keep in mind that our Chinese brothers and sisters are NOT addressing matters of medicine, here, they are addressing spiritual principles. So, regardless of your other spiritual beliefs, or lack thereof, if you are willing to sufficiently believe enough in Chinese Buddhism to send some of your cheek linings to China, then they will mail or email you your fortune predictions, for $400 (not $700). We do not promise any scientific or medical accuracy here; this is simply a spiritual fortune-telling operation. However, we do challenge anyone to see if they can put in two identical source samples, under different names and addresses, and get significantly different results. We DO stand by the integrity of our spiritual fortune-telling operations. Follow these instructions: …. Blah-blah-blah.”

  • SQRLSY One||

    However, we do challenge anyone to see if they can put in two identical source samples, under different names and addresses, and get significantly different results. We DO stand by the integrity of our spiritual fortune-telling operations. Follow these instructions: …. Blah-blah-blah.”
    Actually, I am NOT a follower of Chinese or Eastern Mysticism of any sort, I am a follower of Scienfoology, and I would like for you to tell my effigy, at an affordable price, what its genetic fortune is. But since lame-stream society might consider me a “whack job” for saying and believing such things, I am NOT going to tell you that!

  • SQRLSY One||

    In other words, WTF?!?! I can see the foam-at-the-mouth religious prophet or the Gypsy fortune-telling lady & learn about my future & that’s RELIGIOUS freedom or freedom in general, but as soon as someone follows SCIENCE or technology to ANY extent, then all my moral superiors in Guv-Mint fuckin’ Almighty have to get between me and who I might want to talk to?!?! WTF gives here, WHO appointed the FDA to be God?

  • Giulio Prisco||

    One more example of the idiotic zealotry of the regulators.

    This can only result in pushing a key technology abroad, or underground.

    The dumb regulators don't seem to understand that, if we-the-people want something, we will find ways to get access to it, and somebody will find ways to provide it to us via black markets.

  • plusafdotcom||

    Rewrite the website to eliminate the words offensive to the FDA, then tell them to shove their fucking letter up their ass...

  • JFA in Montreal||

    " doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin."

    And do you think that it will make Obamacare look good, or help cut down coosts?

    They much prefer give you the mushroom treatment: keep you in the dark, feed you on manure... A rancher does not like it's cattle to make too many demands.

    Cheers,

    JFA in Montreal, Kollektive Komradship of Kanada, a.k.a. "Kanuck-istan"

  • K23||

    Why is the FDA wrong for enforcing the law? All medical tests are to be examined for their accuracy and safety BEFORE marketing. They are regulated as devices. I'm sorry the public is not aware of this. The company clearly violated the law, why should they get special treatment?

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