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FDA Tells Google-Backed 23andMe To Halt DNA Test Service

samzenpus posted about 10 months ago | from the knock-it-off dept.

Businesses 371

Hugh Pickens DOT Com writes "Bloomberg reports that 23andMe Inc., the Google-backed DNA analysis company, has been told by US regulators to halt sales of its main product, the Saliva Collection Kit and Personal Genome Service, or PGS that tells users whether they carry a disease, are at risk of a disease and would respond to a drug because the kit is being sold without FDA's marketing clearance or approval. 'FDA is concerned about the public health consequences of inaccurate results from the PGS device,' says the agency. 'The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.' 23andMe was founded six years ago by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers. Most FDA-cleared genetic tests are for a single disease while 23andMe's would be the first to test for multiple conditions. 23andMe submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews but the FDA said the company failed to address 'the issues described during previous interactions'."

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Change your place of business (-1)

Anonymous Coward | about 10 months ago | (#45517503)

A new Bahamian address in 3 ... 2 ... 1 ....

Re:Change your place of business (2, Informative)

i kan reed (749298) | about 10 months ago | (#45517527)

You can market all you want to the Bahama market then. Marketing related to health in the U.S. is faced with certain proscriptions.

Re:Change your place of business (0)

Anonymous Coward | about 10 months ago | (#45517669)

Won't matter, people in the US will hear about it, send for a kit, send it back - all perfectly legal without having to bribe the FDA uphishals.

Re:Change your place of business (1)

Anonymous Coward | about 10 months ago | (#45517773)

and customs will just seize them when they enter the USA

Re:Change your place of business (1)

n30na (1525807) | about 10 months ago | (#45517979)

Unlikely - many things that are technically illegal to import/export but not particularly interesting get through customs easily. At worst they'll have to insure against the 1% seizure rate.

Re:Change your place of business (1)

i kan reed (749298) | about 10 months ago | (#45518003)

I think the black market potential of low-cost DNA kits can't really hold out where there are other legal DNA tests available.

Re:Change your place of business (3, Insightful)

TheCarp (96830) | about 10 months ago | (#45517981)

Do you have any idea how many things that are technically not legal to sell here that get through?

Have you ever bought "kinder joy" or any of the other similar chocolate candies that contain a plastic egg inside the chocolate? My wife enjoys them, so I get them for her when I see them. I know many shops I can buy them at, all over the area....yet, they are not legal products for sale in the US due to.... FDA regulations.

Hell, people have been buying mail order pot seeds and drugs and....you think customs is going to be a barrier to this?

So what exactly is so special here that means this time is going to be different?

Democracy? (-1, Flamebait)

operagost (62405) | about 10 months ago | (#45517549)

The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers

So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service? Mind you, I'm not questioning whether this is a good product or not-- just whether the FDA should be deciding what's in its jurisdiction. Where are the progressives clamoring for "checks and balances"?

Re:Democracy? (3, Insightful)

Anonymous Coward | about 10 months ago | (#45517619)

how is it not in their jurisdiction?

its a company performing a health and medical test. of course they should have research behind their you will get cancer promises

otherwise they need to put for entertainment purposes only

Re:Democracy? (1)

Anonymous Coward | about 10 months ago | (#45517693)

Not if the law doesn't clearly state they have the power to regulate said diagnostic. That puts the FDA in the same boat as a dictator - my powers are what I say they are.

And the statements are clearly labelled as "Indicators that you carry have been found in 73% of cases of X disease, you may want to get a full diagnostic from your doctor."

Nuff said.

Re:Democracy? (0)

Anonymous Coward | about 10 months ago | (#45517735)

the FDA already regulates every diagnostic test and device in the USA
that's why medicine is so expensive, everything has to be tested before you can sell it with claims about what the gizmo or test does

Re:Democracy? (0, Troll)

operagost (62405) | about 10 months ago | (#45518201)

How is this a medical device? Answer: because they say so.

Re:Democracy? (4, Insightful)

Bill_the_Engineer (772575) | about 10 months ago | (#45518303)

How is this a medical device? Answer: because they say so.

They being 23andMe. If they market it as a diagnostic service then they are providing a medical test regulated by the FDA.

Re:Democracy? (5, Informative)

Anonymous Coward | about 10 months ago | (#45517713)

Regulating this seems reasonable to me, as does the logic in the FDA letter...

"Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist. Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. For example, false genotype results for your warfarin drug response test could have significant unreasonable risk of illness, injury, or death to the patient due to thrombosis or bleeding events that occur from treatment with a drug at a dose that does not provide the appropriately calibrated anticoagulant effect. These risks are typically mitigated by International Normalized Ratio (INR) management under a physician’s care. The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported."

Fuck these government pricks (2, Insightful)

Anonymous Coward | about 10 months ago | (#45517985)

Assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment

In other words, the FDA wants to be the sole provider and arbiter of this information. The scientists are 23andme are too fucking stupid to possibly get anything right unless they have the FDA bureaucrats looking over their shoulder.

I am a 23andme member and my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more. But that doesn't matter to the FDA, because obviously 23andme, the doctor, and myself are all too stupid to utilize this information without Big Brother's help. We can't decide anything for ourselves, so we need Uncle Sam to do all our thinking for us.

The fact that people are on here making excuses and saying "they don't see anything wrong with this", is exactly why our country is so fucked. Look in the mirror: you assholes are what is wrong with this country. Every. Single. Person in the FDA, or anyone who apologizes for their fucking stupid actions, deserves to burn in the same pit of hell they are destined for.

--- shiftless (410350)

Re:Fuck these government pricks (-1)

AlphaWolf_HK (692722) | about 10 months ago | (#45518061)

Probably not good to post your name and UID if your goal is to prevent overzealous moderation - some moderators like to go looking for old posts of yours and downmod them to hit your karma score anyways. It's an asshole thing to do, but they do it anyways. Just part of how slashdot's moderation system is broken, just yesterday I had a post get moderated "redundant" because somebody disagreed with it, and I get moderated "overrated" all the time for the same reason.

Re:Fuck these government pricks (0)

Anonymous Coward | about 10 months ago | (#45518227)

Perhaps he has mod points and wishes to participate in the discussion.

Re:Fuck these government pricks (1)

Impy the Impiuos Imp (442658) | about 10 months ago | (#45518283)

I would freakig love access to Slashdot's database to do data mining to discover if there are clusters of political downmodders, and call it to light. I've had a number of +5s that, after several days, suddenly go to +4.

Is this the work of a stalker? Is it some concentrated cabal? There was just that story of a company that hired a PR firm to rip up people -- could a political version of this not exist already, with paid or self-appointed dogooders?

Expect this chain to be modded offtopic (1)

Crashmarik (635988) | about 10 months ago | (#45518371)

And correctly done at that. This would be better fodder for it's own Ask Slashdot.

Re:Fuck these government pricks (4, Insightful)

Fwipp (1473271) | about 10 months ago | (#45518225)

my genetic test showed that I am sensitive to warfarin. That's something I never knew before. If I ever get into a situation where that drug is used, having informed the doctor of this potential problem just might have saved my life. There is no possibility that this information could result in any harm, because if the doctor gives a lower than normal dose and it's not effective, he can simply give more.

Weird that you think there can be no ill-effects from under-prescribing something intended to save your life. Unless you're gunning for a stroke/heart attack, that is.

You are a tyrant . . . just like the FDA. (1, Interesting)

Anonymous Coward | about 10 months ago | (#45518153)

So there just *might* be someone who electively undergoes invasive, serious, expensive medical treatment without getting a second opinion (viz. diagnosis) and that is somehow the responsibility of 23andMe? Is that what the FDA and you are claiming? Are you also claiming that FDA approved channels *never* make mistakes and therefore people obtaining those results can completely trust them and should not seek a second opinion (viz. diagnosis)?

No, this smacks of the FDA wanting to be expansive and control everything - possibly even an expensive competitor using the FDA as a way to quash competition. This also smacks of a huge number of people not understanding that *I* am responsible for my own body and get to seek information and treatment for it through any and every channel I deem useful.

You and the FDA are tyrants for trying to tell me how to treat my body and taking away useful tools for doing such.

P.S. It is quite coincidental that the capta text for submitting this is "rights". How apropos.

Re:Democracy? (-1)

Anonymous Coward | about 10 months ago | (#45518337)

such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.

Yes of course! The first step any reasonably sane person would take after a $99 test would be to spend tens of thousands of dollars on preventative procedures... The obvious step is to spend a couple of thousand on a more detailed genetic checkup that one would likely not have gotten if it were not for the $99 test. I am a 23andMe member, my test results returned a high Warafin sensitivity. I have advised my wife and my general practitioner of the result and the source of the result. I told my wife to make sure that if I am incapacitated and warafin could be of benefit that additional tests be ran. If every product and service has to account to the lowest denominator what level of product and service does that leave us?

Can the government guarantee with 100% accuracy all the FDA approved tests and procedures? No. The government does get a pretty hefty chunk of change for sticking its finger in the pie so I definitely understand the motives for this action. This is government stifling innovation. At worst I think they should make 23andMe put a disclaimer on their side saying that the procedure is not FDA approved.

Re:Democracy? (4, Interesting)

nbauman (624611) | about 10 months ago | (#45518363)

If doctors were actually using these mail-order tests to make medical decisions, that would be a concern.

I don't think it's realistic to expect that anybody would for example get a double mastectomy/ovarectomy on the basis of this test. No licensed doctor in the US would operate on a woman on that basis.

(In fact, a doctor in Australia wrote an article about that in the New England Journal of Medicine. A woman had gone to a "free screening" at a "health fair" and the "alternative medicine practitioner" told her that she had cancer, and sold her a few thousand dollars worth of "alternative medicines" to treat it. This woman went to this real doctor, an oncologist, demanding to be treated for cancer. The oncologist kept telling her, "but you don't have cancer!")

Similarly, I can't follow the FDA's argument that this test could affect a patient's use of warfarin (although I give them credit for trying to make a case).

The FDA seems to give a free hand to companies selling some dubious tests http://www.hairanalysiskit.com/glink/1a.htm?gclid=COTshpbjgLsCFQbNOgodGUMAbQ [hairanalysiskit.com] so there are some legitimate questions.

Regulators protecting us from dangerous health fraud? Or jack-booted thugs restricting our freedom? You decide.

Re:Democracy? (3, Insightful)

alexander_686 (957440) | about 10 months ago | (#45517717)

Is it a health or medical test? Or are they just an information provider? I mean they are not telling me if I have diabetes or heart disease – Just that my genes mark me at a greater risk to get those diseases – in combination with lifestyle and environmental factors.

Re:Democracy? (1, Informative)

Anonymous Coward | about 10 months ago | (#45518261)

It's neither.

It's a genetic test that tells you which markers you have, that have been linked (by healthcare professionals and researchers) to illnesses and conditions.

They aren't making a diagnosis, they aren't telling you that you have anything, they just tell you what markers you have, and what the potential links are.

This is just the FDA trying to protect their wallets.

Re:Democracy? (2, Funny)

Anonymous Coward | about 10 months ago | (#45517829)

It definitely isn't a food or medicine. I don't think this is a health test (phenotype versus genotype) unless you think that genes are unhealthy. (I recall some fascists once thought like that.) It is arguably a medical test -- but so is measuring weight, BP, temperature, pulse, and examining an individual for albinism, eye color, and gender. I guess all companies who state, "You have high BP and you are male; you are at higher risk of cardiovascular disease" and back it up with research should be shut down too.

Re:Democracy? (1)

ColdWetDog (752185) | about 10 months ago | (#45517665)

This is what regulatory agencies do. They 'decide' if the product or service or what not falls under their jurisdiction. They are typically (and in this case, the FDA specifically) given legal powers to compel companies to follow rules and regulations.

Of course, the companies are not without recourse. There are detailed rules on how the regulations are enforced (go ahead, read them, that should keep you occupied for some time, be sure to stock up on adequate quantities of Doritos and Diet Dr. Pepper). The last letter in the summary is quite interesting. The FDA details an entire page of attempts to work with 23&me at various times and venues. Apparently, the company's response has been pretty minimal. If you read between the diplomatic legalese, the FDA sounds pretty annoyed at the company.

Don't get all bunched up about how we 'didn't elect' the FDA / FAA and even the NSA. We elect the people that write the enabling legislation and believe me, Congress is forever trying to meddle into details they really shouldn't (cf, the 10 million exceptions to everything in Medicare / Medicaid regulations and the horrid legislative quagmire that the ACA* is trying to create). Further, the involved companies can directly petition the regulatory agencies and even sue them.

There are plenty of checks and balances. Hardly perfect and always subject to argument about where the various lines should be drawn, but it is never a regulatory free fall, despite what Limbag wants you believe.

* ACA - Affordable Care Act - aka Obamacare

Re:Democracy? (1)

operagost (62405) | about 10 months ago | (#45518239)

be sure to stock up on adequate quantities of Doritos and Diet Dr. Pepper

Nope, the FDA banned them this morning.

Re:Democracy? (1)

Anonymous Coward | about 10 months ago | (#45517687)

Most of us Progressives understand that Congress created the FDA (Food and Drug Administration), and gave it power to regulate the safety of foods, and the effectiveness of drugs and medicines.
When a person thinks the FDA should not regulate a given item, they can sue, and that court case might expand or limit the FDA's overall authority.

For the FDA to decide that a DNA test, which claims to tell a person what risk they have for diseases, without a physician's help or expertise, needs to be checked to make sure it isn't providing bad information, seems to be right in their purview.

Note: the FDA has been successfully limited in the past; if an item is a 'Nutritional supplement' then it's not regulated as a drug, and only needs to be safe to eat. If it's a 'vitamin' or 'treatment', then the seller must prove it does help / cure what it says it cures.

This is the way it's supposed to work.

Re:Democracy? (0)

i kan reed (749298) | about 10 months ago | (#45517689)

It can come to court as soon as they actually make the decision to include it in their purview. If the courts find the law disagrees, the manufacturer would be free to continue.

In fact, if the review of powers itself were enough of a problem, it would grant standing for taking it to court before the decision had been made. The 3 step process in the US of "legislation, executive action, court review" is pretty good, except for all those hundreds of times that all 3 steps fail in their duty.

Re:Democracy? (-1)

Anonymous Coward | about 10 months ago | (#45517697)

If they decided that and weren't instantly shut down by a court, then it would mean that it was already within the scope of their Congress-granted authority to exercise that power, even if there was a time that they where not exercising it. Right?

As much as you may suggest it, the FDA deciding this isn't using some magic powers to override congress and the courts.

Re:Democracy? (-1)

Anonymous Coward | about 10 months ago | (#45517715)

The Republicans are just protecting the medical cartel. So instead of an OTC test, we now have to get the permission of a member of the cartel to get the test done.

Re:Democracy? (4, Insightful)

tgd (2822) | about 10 months ago | (#45517775)

The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers

So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service? Mind you, I'm not questioning whether this is a good product or not-- just whether the FDA should be deciding what's in its jurisdiction. Where are the progressives clamoring for "checks and balances"?

I think you have a badly misguided understanding of how government in the US operates... and was explicitly designed.

There's a reason the "founding fathers" intended that your voice carried no weight at the national level -- or even largely at the state level. The "public" doesn't have the knowledge to have their opinions really matter on most topics. The US form of government was explicitly set up so that you'd elect local officials -- on the basis of local matters that you, presumably, have some understanding of -- up to the level of Governor of your state or commonwealth, but beyond that *those* officials voted on national matters.

And its a DAMN good thing that the dimwit "will of the masses" is not involved in the vast majority of things the government does, because the will of the masses is both ignorant and easily controlled. In fact, IMO, the majority of the problem we've got with the federal government today stems from the fact that the separation between the will of the people and the federal government has eroded over time. Instead of good people being elected, the slime balls who can most effectively sway the opinion of the ignorant masses gets elected -- and then has to spend their time playing politics to keep that position.

Re:Democracy? (2)

Minwee (522556) | about 10 months ago | (#45517997)

And its a DAMN good thing that the dimwit "will of the masses" is not involved in the vast majority of things the government does, because the will of the masses is both ignorant and easily controlled. In fact, IMO, the majority of the problem we've got with the federal government today stems from the fact that the separation between the will of the people and the federal government has eroded over time. Instead of good people being elected, the slime balls who can most effectively sway the opinion of the ignorant masses gets elected -- and then has to spend their time playing politics to keep that position.

So the only problem with democracy is that the people are allowed to vote. Take that away and you can accomplish anything -- even making the trains run on time.

Re:Democracy? (0)

Anonymous Coward | about 10 months ago | (#45518059)

You brought up the founding fathers, so riddle me this.
Amendment 10 (paraphrase from memory) All powers not listed within the Constitution are to be handled by the states.
Now please point to me where the "founding fathers" put in the FDA in the Constitution, or which amendment it was added in.

If you want to argue individual states have this power, I can agree. What state is the FDA under?

Seems to me most of the issues with the Federal Government could easily be cleared up by Congress, Executive Branch, Supreme Court, being forced to READ the 10th amendment and the 14th amendments every day out loud and if what they are proposing does not fit, toss it out.

Re:Democracy? (1)

Anonymous Coward | about 10 months ago | (#45518127)

Interstate commerce. If you think 23andme selling a product over the internet, which is then mailed to consumers, typically in different states, and then mailed back, typically to a different state, and then the results are transmitted via the internet, across all sorts of state lines, isn't interstate commerce, I'm not sure what is.

Which isn't to say interstate commerce isn't abused, but 23andme is certainly engaging in it.

Re:Democracy? (0)

Anonymous Coward | about 10 months ago | (#45518159)

Fortunately for the rest of us, you're one of the dimwits without a voice.

Re:Democracy? (3, Interesting)

ShaunC (203807) | about 10 months ago | (#45517789)

I figure that a product which makes claims about its ability to predict (note that they won't say diagnose) your potential for developing certain diseases later in life should fall under the FDA's purview. I've been interested in 23andme for a long time. The first time I heard about them, the test and resulting reports ran something like $500. I added it to my "wish list" way back then and nobody bit. It's apparently down to the $99 mark now and is being marketed on television in time for the holiday season.

I'm a fairly intelligent individual and I'd be absolutely sure to take anything they reported about my genetic profile with a grain of salt. However, the FDA exists to protect your average Joe out there, who believes those TV commercials that say taking Penalis will give you a raging boner, and that lady who was on "Las Vegas" really does have an amazing non-surgical facelift procedure that will remove 20 years from your face.

A lot of these products get away with using a very blatant disclaimer that "these statements have not been evaluated by the FDA" etc. I'm not entirely sure why 23andme can't just put that disclaimer in there as well, and be all good. But the fact is, FDA has been trying to work with them for several years to get them into whatever is considered to be FDA marketing compliance, and the company apparently hasn't cooperated.

If they'd not put commercials on TV, they probably wouldn't be in any trouble. I just checked their site and can't immediately find the old list of stuff that they said they'd test your DNA for (and there was a big list). Not saying they've taken it down, but I didn't see it with a quick glance.

All of that said, the 23andme spit-and-get-results thingy is still on my wish list.

Re:Democracy? (2)

Okian Warrior (537106) | about 10 months ago | (#45517799)

So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service? Mind you, I'm not questioning whether this is a good product or not-- just whether the FDA should be deciding what's in its jurisdiction. Where are the progressives clamoring for "checks and balances"?

The FDA bears the brunt of all public outrage of anything even tangentially related to medicine. They are bureaucrats who want to avoid responsibility at any cost. The FDA also bears none of the costs of testing new products.

What outcome did you expect?

A different model might take the utility of public safety into account. Instead of "safety at any cost", it might be "more good than harm".

The current diagnosis model is probabilistic fitting, where a self-confessed list of symptoms is matched against a list of possible conditions. The doctor starts with "try this, see if it clears up" and moves to the next condition if it doesn't. (And heaven help you if you get a rare condition.)

I don't see how a diagnostic test, even an inaccurate one, could be worse than what we have now. A false positive would have to be confirmed by more accurate testing, and a false negative wouldn't be any different from not taking the test (ie - you'd wait for symptoms to appear). Maybe instead of the FDA requiring companies to prove perfection, it should be up to the FDA to prove that something *doesn't* work. They would eliminate all the obvious scams and swindles, and allow companies to try new things(*).

(*) With normal legal protections - companies would still be liable for damages.

A brief history of the FDA (1)

westlake (615356) | about 10 months ago | (#45517855)

So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service?

Science based legislation is enforced through science based administrative law and procedures.

The history of the FDA can be traced to the latter part of the 19th century and the U.S. Department of Agriculture's Division of Chemistry. Under Harvey Washington Wiley, appointed chief chemist in 1883, the Division began conducting research into the adulteration and misbranding of food and drugs on the American market. Wiley's advocacy came at a time when the public had become aroused to hazards in the marketplace by muckraking journalists like Upton Sinclair, and became part of a general trend for increased federal regulations in matters pertinent to public safety during the Progressive Era.

The 1902 Biologics Control Act was put in place after diphtheria antitoxin was collected from a horse named Jim who contracted tetanus, resulting in several deaths.

In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate.] The Act prohibited, under penalty of seizure of goods, the interstate transport of food that had been "adulterated". The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopoeia or the National Formulary.

The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry. Wiley used these new regulatory powers to pursue an aggressive campaign against the manufacturers of foods with chemical additives, but the Chemistry Bureau's authority was soon checked by judicial decisions, which narrowly defined the bureau's powers and set high standards for proof of fraudulent intent.

In 1927, the Bureau of Chemistry's regulatory powers were reorganized under a new USDA body, the Food, Drug, and Insecticide organization. This name was shortened to the Food and Drug Administration (FDA) three years later.

By the 1930s, muckraking journalists, consumer protection organizations, and federal regulators began mounting a campaign for stronger regulatory authority by publicizing a list of injurious products that had been ruled permissible under the 1906 law, including radioactive beverages, the mascara Lash lure, which caused blindness, and worthless "cures" for diabetes and tuberculosis.

The resulting proposed law was unable to get through the Congress of the United States for five years, but was rapidly enacted into law following the public outcry over the 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent.

President Franklin Delano Roosevelt signed the new Food, Drug, and Cosmetic Act (FD&C Act) into law on June 24, 1938. The new law significantly increased federal regulatory authority over drugs by mandating a pre-market review of the safety of all new drugs, as well as banning false therapeutic claims in drug labeling without requiring that the FDA prove fraudulent intent. Soon after passage of the 1938 Act, the FDA began to designate certain drugs as safe for use only under the supervision of a medical professional, and the category of "prescription-only" drugs was securely codified into law by the 1951 Durham-Humphrey Amendment.

Food and Drug Administration [wikipedia.org]

Re:Democracy? (0)

Archangel Michael (180766) | about 10 months ago | (#45517899)

Well, considering that the FDA told the Walnut Marketing Association, that any marketing of "health benefits" regarding walnuts would classify them as "drugs" and thus they are not allowed to even promote Proven benefits of Walnuts, this makes perfect sense. They are, after all, protecting us from the boogie man of health.

We need a government approved, ObamaCare Certified doctor our plan approves of, in order to tell us anything medical. "We are from the Government, we are here to help."

Of course they are a bunch of un-elected bureaucrats. THAT is why we keep voting for (R) and (D)s who keep giving us more Bureaucracy, never less. And queue the Republicrat response of "Somalia is a Libertarian dream" in 3 - 2 - 1 .... (And by the same measure North Korea is a Bureaucrat dream!)

Re: Democracy? (1)

Bill, Shooter of Bul (629286) | about 10 months ago | (#45517901)

Its not a democracy, it's a republic. If, we, the people, don't like what they are doing we simply need to elect people who will change the law. The check on the fda, is congess and the courts. In this case, I think it's actually good policy.

Re:Democracy? (2)

nbauman (624611) | about 10 months ago | (#45518131)

The FDA jurisdiction over medical tests (as opposed to therapeutic drugs) is interesting.

I once researched this. The manufacturer has to give the FDA enough information that the FDA has to certify that tests used for medical purposes are accurate.

Question: Exactly what do they accurately measure?

Take this test, for example: http://www.walgreens.com/store/c/at-home-drug-test,-marijuana/ID=prod375983-product [walgreens.com]

Is it enough to measure the presence of marijuana (with 99.9% accuracy)?*

Or is the medical question whether the person being tested has marijuana abuse, which means that marijuana use is interfering with education, recreation, social functioning, or some important life function?

Suppose a parent tests his teenager for marijuana, and beats her if she fails the test. Does the FDA have to consider those broader results of testing?

The FDA had a bit of trouble with these tests, and finally decided that their responsibility ended at certifying that it accurately indicated the presence of marijuana.

In 23andme, the FDA seems to be saying that it's not enough to report the results accurately (or within the stated accuracy), but they have to consider the consequences of finding out the results.

__________
*Slashdot readers will immediately recognize that if the false positive rate is 0.1%, it will falsely accuse a 1 out of 1,000 subjects, which is a lot.

Re:Democracy? (5, Informative)

hairyfeet (841228) | about 10 months ago | (#45518149)

Uhhh..you might want to look up the history of the FDA friend as its one of the government services that has a DAMN good reason for existing!

You see back in the 1920s, soon after the discovery of Radium and X-Rays...and you just KNOW when a sentence starts like that its gonna end badly..a bunch of companies started selling "Health restoring radium water" which of course not only had zero oversight since there wasn't an FDA but also had zero standards when it came to doses. Needless to say several people died most horribly, including on industrialist whose jaw literally rotted off and who ended up so damned radioactive that they had to bury him in a lead casket to keep him from contaminating the entire area, and THAT is the event that caused the birth of the FDA.

Now if you want to argue that this shouldn't be under their jurisdiction? Fine and dandy although I would argue that a bad test result could cause folks to die as they might ignore symptoms because "The test says I'm not at risk for X", not to mention we have ZERO proof that their labs are even monitored in any way. Don't forget that there was a gal at a state crime lab recently that got busted for just tossing samples and telling cops what they wanted to hear and who knows whether or not they have any bad apples at this place so...yeah I kinda want their to be oversight when it comes to DNA testing, especially since more and more things like insurance and jobs could very well be affected by bad results.

Good! (0)

Anonymous Coward | about 10 months ago | (#45517591)

Where's that damn "Good!" cat when you need him?

cue Eric Cartmen: (0)

Anonymous Coward | about 10 months ago | (#45517629)

_Respect_ _Ma_ _A-Tor-A-Tay_!!!

Sorry, you bribed the wrong people... (0)

Anonymous Coward | about 10 months ago | (#45517633)

Grease my palms and we'll let you proceed.

Sorry 'bout that.

Obama Super-Liar (-1, Offtopic)

Anonymous Coward | about 10 months ago | (#45517645)

How many of you believe this crap? Real question, are you fooled or not? If so why>

http://news.yahoo.com/obama-im-not-particularly-ideological-person-050844120.html

"I'm not a particularly ideological person," he said, saying pragmatism was necessary to advance the values that were important to him."

This guy is the most openly partisan far left plitical person the country has seen ever, and certaily the most radical statist ever to have achieved the executive office. And he just keeps piling on the bullshit knowing that the media will cover for him at every level, by claiming to be a moderate "regular guy" who isn't pushing an agenda.

Socialized medicine has been the dream of the statist class in this country for generations, this legislation (Obamacare) will effectively place all economic power in the hands of the federal government, resulting in total control over the individual by the government, and has been what Obama and the radical Democrats have put their everything into accomplishing, and it's undeniable that this program is big government socialism from top to bottom.

And yet this genius, who can barely put words to together to form a coherent sentence without a teleprompter, tries to pull yet another lie on the people, that he is a moderate.

And I am betting a whole lot of you are going to believe it.

Am I wrong? If so I am curious, how do you justify this? How can you possibly support this assertion that Obama is not a radical - and highly partisan statist?

Troll Food (1)

rakslice (90330) | about 10 months ago | (#45518069)

The original article, which is talking about the FDA pulling the plug on a medical service due to its operator not addressing some red tape with respect to safety standards, is a good illustration of the interventionist form of "statism". Subsidized health care doesn't necessarily dictate what the medical industry can do in the same way, but taxing people and spending the money on certain kinds of health programs is definitely an economic intervention that pushes the medical industry in a certain direction. What do you think, Mr. Anon.? Did you have this similarity in mind when you wrote your post?

Re:Troll Food (0)

Anonymous Coward | about 10 months ago | (#45518235)

Sorry man I honestly do not understand what question it is you are asking, can you restate it?

And yet, what I am asking is pretty simple and clear, this man claims to be non partisan while, of all things, he is out on a fundraising whirlwind tour of Democrat venues including the homes of rich Democrat donors and Hollywood idiots.

I'm just asking if you really buy this crap, and if you do, how do you justify it? I mean the guy is lying right at your face! Really?

Re:Obama Super-Liar (0)

Anonymous Coward | about 10 months ago | (#45518365)

Once again, what the hell does this have to do with Obama? Man, these anti-Obama people are fucking dillusional.

You insens17ive clod?! (-1, Offtopic)

Anonymous Coward | about 10 months ago | (#45517651)

abysmal sales and The failure ofW 0perating systems,

Re: You insens17ive clod?! (0)

Anonymous Coward | about 10 months ago | (#45517875)

I am intrigued by your ideas and wish to subscribe to your news mailings, kind Sir!

Yeah Right, (0)

CheezburgerBrown . (3417019) | about 10 months ago | (#45517677)

I read that as "The FDA wants money from these people before letting them sell their product"

Entirely Reasonable (4, Insightful)

PvtVoid (1252388) | about 10 months ago | (#45517681)

Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective? The FDA would be on me like shit on stink, and rightly so. Same here: suppose they incorrectly tell someone they have Huntington's Disease, or carry BRCA?

Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

Re:Entirely Reasonable (3, Insightful)

0123456 (636235) | about 10 months ago | (#45517737)

Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective?

Is anyone claiming these tests aren't effective? I don't see it in TFS, only claims that they don't have the right paperwork from the government.

Re:Entirely Reasonable (5, Interesting)

Anonymous Coward | about 10 months ago | (#45517819)

I believe that's exactly what the problem is. 23&Me is selling the test but never submitted evidence to the FDA that it works. Why should they just assume it's good because they said so?

I think likely the test is fine, but they haven't shown it to be so, so why should the FDA approve?

Re:Entirely Reasonable (4, Insightful)

timeOday (582209) | about 10 months ago | (#45518101)

And if 23&Me does work, then it is in their own best interest for the FDA to enforce these requirements. Otherwise they will be driven out of the market by somebody who makes similar claims at a lower cost, by providing a shoddy and unreliable product. This isn't an area where consumers are able to judge quality for themselves.

Re:Entirely Reasonable (1)

BradMajors (995624) | about 10 months ago | (#45517831)

Is anyone claiming these tests aren't effective?

Yes. I am claiming these tests aren't effective.

Re:Entirely Reasonable (1)

NoNonAlphaCharsHere (2201864) | about 10 months ago | (#45517847)

This New Year's Eve noisemaker I have in my hand scares away elephants - there aren't any elephants in MILES of my location.

Re:Entirely Reasonable (0)

Anonymous Coward | about 10 months ago | (#45517881)

if you RTFA, they tested the tests and found a lot of problems with them. they aren't that accurate and issues in the lab

Re:Entirely Reasonable (0)

Anonymous Coward | about 10 months ago | (#45518123)

The FDA is claiming that they have a mandate to determine if these tests are effective. Which is similar, but not quite the same.

Re:Entirely Reasonable (2)

TheSync (5291) | about 10 months ago | (#45517771)

Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

I own my DNA!

Re:Entirely Reasonable (3, Interesting)

Anonymous Coward | about 10 months ago | (#45517791)

My brother is working for a company that is in the prototype stage for something similar, but for use in non-developed countries.

Their test you first create a cartridge that has the dna sample doped with a radioactive substance you want to match against. You insert the patients test sample, it gets treated by different chemicals in the cartridge, and if the dna is a match the radioactive substance is released and a faint glow occurs which the machine reads giving you a nearly instant result to let you know if that dna sequence shows up in the patients sample.

It is not ready for use at this time, but you can be damned sure they will cross every single t and dot every i when they are ready to get approval for their system.

Re:Entirely Reasonable (1)

Anonymous Coward | about 10 months ago | (#45517983)

I doubt it's a radioactive substance, it's probably just chemicals like those used in glowsticks.

Re:Entirely Reasonable (0)

Anonymous Coward | about 10 months ago | (#45518029)

No, it is a radioactive substance. You couldn't attach part of the chemical used in glow sticks to a single sample of dna in such a manner.

Re:Entirely Reasonable (2)

mindwhip (894744) | about 10 months ago | (#45518009)

There is a distinct difference between a test for a specific disease and a test that tells you if you have DNA that may make you susceptible to possibly, maybe getting a disease compared to someone else's.

Also it isn't Food or a Drug or Medicine that involves ingesting/injecting/inhaling and can't cause physical harm if misused. It is a non diagnostic test that as at no point will it say 'you have disease x' or 'you don't have disease y'.

Its only a super advanced version of taking blood pressure and pulse... If someone chooses not to consult a doctor because they think their own pulse is normal should the FDA ban everyone from putting a finger on an artery and counting the beats in 30 seconds?

If it doesn't show a genetic tendency for say breast cancer someone who finds a lump will still likely go to their doctor and is unlikely to check less often than before.
If it does show a tendency then that same person may check more often or even go sooner to get a suspect lump checked.
If someone that shows a genetic tendency overreacts and decides they need their breasts removed now to prevent any possibility of cancer in the future they have to go to their doctor who should at the very least do more tests, arrange counselling and only proceed if in his professional opinion it is warranted.

Re:Entirely Reasonable (0)

Anonymous Coward | about 10 months ago | (#45518139)

Isn't it stink on shit? Unless shit is somehow attracted to your armpits if you forget to put on deodorant.

Re:Entirely Reasonable (0)

Anonymous Coward | about 10 months ago | (#45518187)

Now cue all the Slashbertarians ranting about how restricting unproven medical testing is an assault on freedom...

Look, if this whole "being alive and well" thing is important to YOU, then YOU should take a little responsibility and EARN a doctorate in all practices of medicine and keep track of every health-related product released on the FREE MARKET (hallowed be its name, which should never ever ever ever never ever be subject to any regulation unless it suddenly affects me) to make sure they won't kill YOU. I'M not about to do it for you. In unrelated news, wanna help me move apartments this weekend? What?!? What sort of self-centered asshole ARE you?

Re:Entirely Reasonable (1)

operagost (62405) | about 10 months ago | (#45518223)

Suppose I started marketing an HIV test, or a Hepatitis C test, or a tuberculosis test without demonstrating the test was effective? The FDA would be on me like shit on stink, and rightly so

Please cite me the part of the federal food, drug, and cosmetic act which says they have the authority. They have jurisdiction over the following: food, drugs, medical devices, food additives, and dietary supplements.
Naturally, the kneejerk progressives already modded down my post... so thanks for responding, instead.

Re:Entirely Reasonable (0)

Anonymous Coward | about 10 months ago | (#45518377)

Maybe they modded you down because you are turning this into a political discussion with your radical tea party agenda views.

Re:Entirely Reasonable (1, Insightful)

Charliemopps (1157495) | about 10 months ago | (#45518285)

It's pretty simple. This is a screening test. It's supposed to be inaccurate as silly as that sounds. The point of it is, if there are ANY markers for the disease it's supposed to easily test positive. Then the user is supposed to go to a DOCTOR and verify the results. Even the initial tests they do in hospitals can sometimes give false positives as high as 80 to 90% of the time. So even if you do test positive, you still only have a 10% chance of actually having the disease.

Government regulation should be used to inform the public of the choices they are making to help prevent deception in the marketplace. It should not be used to prevent products the government dislikes from being made available to the public. In this case, the FDA should ask them to place clear and obvious statistics on the results of test. i.e. "You have flagged positive for suchandasuch disease. This is not a definitive diagnoses, and on average only 40% of people that get flagged on this test actually end up having the disease. Please seek a medical professional for a more definitive test and treatment if necessary"

Requiring disclosure is usually easy to comply with, welcome by nearly everyone and a non-controversial topic. If the company does not want to provide those statistics or even worse doesn't even have them yet, then I think the FDA would be in the right in telling them to stop production.

Can't be true (1)

0123456 (636235) | about 10 months ago | (#45517705)

Someone in another story was just telling us how wonderful the FDA are.

Upsetting the Apple Cart (5, Insightful)

ponraul (1233704) | about 10 months ago | (#45517785)

I can see why cheap and reliable genetic testing you can do without the intervention of medical industry is frightening. For one hundred dollars you can find out if you have markers that put you at elevated odds of hundreds of conditions. If this came from the traditional medical, you would have to go to a doctor who would release the results to your insurance company, it would cost about $1000, and you wouldn't even get to see the results yourself unless the doctor wanted to show you something.

I've done the 23andMe testing and it has been of value. I'm not in close contact with much of my extended family and have almost no contact with the family on my father's side. It doesn't claim to diagnose or treat diseases or traits. What it does do is tell you if you're at elevated odds for a few select conditions, along with heritable traits. This is can be invaluable if you don't know that much about the medical history of your family.

Re:Upsetting the Apple Cart (4, Insightful)

Jeng (926980) | about 10 months ago | (#45517869)

And you are apparently perfectly ok with the possibility that they could be completely wrong.

Nobody is saying that inexpensive dna testing is bad, just that the process needs to be verified that it works before it should be sold to the individual.

Re:Upsetting the Apple Cart (-1)

Anonymous Coward | about 10 months ago | (#45518041)

And you think that filling out the right paperwork for the FDA (read bribe the right people) makes those tests effective?

Me thinkest that word doesn't mean what you think it means.

Re:Upsetting the Apple Cart (1)

Jeng (926980) | about 10 months ago | (#45518091)

Trust, but verify.

Re:Upsetting the Apple Cart (1)

OverlordQ (264228) | about 10 months ago | (#45518221)

> And you are apparently perfectly ok with the possibility that they could be completely wrong.

Yes. It's not a diagnostic tool. It's a "Hey 5 out of 7 people wearing red shirts die in star trek. You're wearing a red shirt, you've got good odds you might die"

Any test can be wrong (1)

mveloso (325617) | about 10 months ago | (#45518271)

Any diagnostic test can be wrong, and the public and medical community is OK with that.

The problem isn't the test, it's that there's no way to verify that the recipient of the results has any idea what the results mean. If a human being is involved, at least you can pretend that someone attempted to make sure the person in question understood the results.

Personally, I think 23 and me is fine as it was. OTOH, the FDA has to deal with "the public", who is invariably stupid.

Re:Upsetting the Apple Cart (0)

Anonymous Coward | about 10 months ago | (#45517957)

I've done the 23andMe testing and it has been of value. I'm not in close contact with much of my extended family and have almost no contact with the family on my father's side. It doesn't claim to diagnose or treat diseases or traits. What it does do is tell you if you're at elevated odds for a few select conditions, along with heritable traits. This is can be invaluable if you don't know that much about the medical history of your family.

Has it been of value? How do you know that?
What reliable source has shown that this testing is accurate?
I agree, it could provide invaluable information.
It is upon the manufacturer to demonstrate to the regulatory agency that the test does what it says on the tin.
Until then, relying on the information provided by the test is at best foolish, and quite possibly very dangerous.

Re:Upsetting the Apple Cart (1)

ponraul (1233704) | about 10 months ago | (#45518011)

It confirmed things I knew about my health and ancestry. It's not like they're running a faith healing operation here. All they had to go on was a vial of spit and a barcode.

Re:Upsetting the Apple Cart (3, Insightful)

Quince alPillan (677281) | about 10 months ago | (#45517967)

The FDA has a point, though. If the test isn't accurate and gives false negatives or isn't clear about what the results really mean, it can lure people into overconfidence and that can be dangerous if they really are at risk for one of the diseases.

Granted, they probably wouldn't have known about these conditions in the first place, but if, as an example, the rest of their family is known for heart disease due to a genetic defect and they get a false negative, they might be overconfident in their chances for heart disease, leading to possible death because they didn't go to a doctor to get checked out.

Re:Upsetting the Apple Cart (1)

ponraul (1233704) | about 10 months ago | (#45518047)

Yeah, you will run into the case where a condition is so rare that an imprecise test will give you more false positives that the population size of what you're testing for. I don't see that as a failure of the test, just a consequence of probability.

Re:Upsetting the Apple Cart (0)

Anonymous Coward | about 10 months ago | (#45518169)

All the FDA personnel want is their bribe, that's all they're whining about.

Does the kit consist of food or drugs? (0)

Anonymous Coward | about 10 months ago | (#45517837)

No, and no.

So then how exactly does the FDA justify a claim to jurisdiction here?

Perhaps this should instead fall under the aegis of the CDC?

Re:Does the kit consist of food or drugs? (1)

Jeng (926980) | about 10 months ago | (#45517939)

A doctor does more than just prescribe drugs, they also diagnose illnesses. People could die from a misdiagnoses.

If I tell you that you have prostate cancer and you have your prostate removed and then you find out I was wrong, wouldn't you be a bit upset?

Re:Does the kit consist of food or drugs? (1)

Richy_T (111409) | about 10 months ago | (#45518269)

Perhaps. But you miss his point.

Old boys' network (-1, Flamebait)

EmperorOfCanada (1332175) | about 10 months ago | (#45517871)

I am 100% sure that this is because 23 and me are cutting out layer upon layer of the traditional health network. Cable would shut down Netflix if they could claim "It's for the children" like the health industry can.

Off the top of my head the layers cut out would include: Doctors, HMOs, Lab techs, companies that distribute the tests, the companies that make the tests, and most importantly the various government departments that deal with all these people. It is not like 23 and me are going to destroy traditional medicine but the last thing that the health industry wants are for their "customers" to grow comfortable going to cheap efficient companies for their medical needs.

Re:Old boys' network (1)

Jeng (926980) | about 10 months ago | (#45517973)

Wow, so if you got the test results back and it said you had dick cancer, would you just be hacking it off yourself or would you be going to a doctor to have your dick removed?

Re:Old boys' network (1)

stdarg (456557) | about 10 months ago | (#45518263)

How did you deduce that, considering OP said "It is not like 23 and me are going to destroy traditional medicine?"

Re:Old boys' network (1)

Manfre (631065) | about 10 months ago | (#45518333)

You clearly don't understand what the service provides, but I'm glad that doesn't inhibit you from responding as if you do!

Using your example, they don't test you for dick cancer. They check your DNA for indicators that you might be more likely to get dick cancer. The appropriate response to the results is to keep that in mind and every so often have a doctor check to make sure you don't have dick cancer.

Unlisted subtext (2, Insightful)

phayes (202222) | about 10 months ago | (#45517873)

The FDA states that false positives & false negatives are a major part of the reason that they are outlawing direct sales of these tests to consumers. Because a false positive on the breast cancer gene could lead to "prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions". Yeah, because Physicians using the existing tests never have false positives & even were there to be one, malpractice suits always punish doctors guilty of errors of interpretation...

Because you see, people would be performing surgery, chemo, etc all by themselves without the assistance of healthcare professionals alerted to the possible presence of a problem by one of these simple tests...

To my eyes, outlawing these tests is above all a defense of the existing expensive testing industry. We cannot have people having simple inexpensive tests. That would undercut profit margins.

Genetic testing (0)

Anonymous Coward | about 10 months ago | (#45517897)

Well, it's not the first time that a genetic test led to a divorce ...

FDA is doing you a favor (3, Informative)

EmagGeek (574360) | about 10 months ago | (#45517935)

Turning over your DNA to Google is just plain stupid. Believing you have some semblance of privacy with them is even more stupid.

Stupid, stupid, stupid.

Medical claims (4, Informative)

Animats (122034) | about 10 months ago | (#45518017)

The problem is that 23andMe started making medical claims. As the FDA says, "your company's website at www.23andme.com/health ... 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." Those are health claims. Those have to be clinically tested.

The history of their web site shows the health claims becoming more blatant over time.

  • From 2008: [archive.org] "Find out what current research can tell you about your genes."
  • From 2013: [23andme.com] "Living well starts with knowing your DNA. Our genes make us who we are, so naturally they impact our health. By knowing your DNA, you can take steps toward living a healthier life. Find out if your children are at risk for inherited conditions, so you can plan for the health of your family. Order now."

Their advertising thus shows a progression from marketing to the technically curious to marketing to parents worried about their kids. That's what properly concerns the FDA.

"We're from the government.. (0)

h8sg8s (559966) | about 10 months ago | (#45518075)

..and want to help" Frequently the last words a great idea ever hears.

SHIT HEADS AT THE FDA (0)

Anonymous Coward | about 10 months ago | (#45518147)

They need to justify their billions and billions of dollars budget.
Just who is damaged by 23 and Me.

Yes, but... (0)

Anonymous Coward | about 10 months ago | (#45518255)

You have to realize that there is an entire industry running on "press releases". The mere fact that they meet with, and "negotiated" with, the FDA created buzz and made eager investors pump up money in the company. In the end, when they close shop, they will say: "It's not our fault. We have a great product. Unfortunately, the FDA decided not to approve it for [some technicality/political reasons/you name it]." -- and then pocket a few extra million dollars to start up a new company. "It’s a dream, a frightful dream life is"

Can anyone say "Shakedown"? (0)

Anonymous Coward | about 10 months ago | (#45518317)

Government agencies love their power, it seems you need permission to do just about anything now days. Unless there is a danger to the testing, I am not sure I get why the FDA would be involved in analysis like this. Times have changed.

Texasification (0)

Anonymous Coward | about 10 months ago | (#45518369)

Based on a "hold-on" request at an ethics conference a few years ago, and a "sorry, we go where the money is" response from 23addme, I don't expect this FDA request will do too much. 23andme will probably find a way around this, perhaps initially by not offering their DNA marker analysis to people in the US, and then eventually working out some way to skirt around the rules. Maybe their US kit won't actually include the swab stuff, and you'll have to go to informed consent showrooms to get the swabs.

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