The crux of their troubles comes from this paragraph in the Warning Letter:
"However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests."
The FDA, while being a pain in the rear at times, will actually work with you to meet compliance. But you have to show work and be continually in touch with them and show progress (and document everything according to your own procedures, complying to regulations of course). You can't just say you're working on compliance and then not follow through and show evidence. The issue for 23andMe is the on-label use of the product "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." They market the product this way. If you want to market your product as such, you have to show proof to the FDA and receive approval to label the medical product in this manner. It looks like 23andMe is either not working towards compliance (and is misleading the FDA) or is doing a terrible job documenting their work towards compliance and keeping the FDA abreast (my guess is this is what's happening). That in itself will get you in trouble, but then expanding your marketing for even more on-label use of the product - which hasn't been submitted to the FDA apparently - while at the same time not having FDA approval for the original use is just plain stupid.
I used to work as a state legislative aid; one of my duties was helping constituents work with state agencies on regulatory matters. I learned from that experience most regulators (at least at the state level, I imagine federal is similar) usually care much more about compliance than enforcement. As long as you aren't doing something egregious and make a good faith effort to work with them they'll often be pretty reasonable within the confines of the law. However if you ignore them, they'll come down on you like a ton of bricks.
> As long as you aren't doing something egregious and make a good faith effort to work with them they'll often be pretty reasonable within the confines of the law. However if you ignore them, they'll come down on you like a ton of bricks.
This is how all government works, in general. There will always be multiple opportunities to bring yourself into compliance, since it's in the government's interest for you to comply.
Contrary to popular belief, the government would prefer compliance over a fight.
23andMe on the other hand ... is either grossly incompetent or they're looking for a fight.
FDA's regulatory oversight over this new industry is not established. If 23andMe wanted to challenge them in court, this would be the way to do it. They need standing.
"You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider."
This is what I don't get. It's not like this is hidden. The site is completely upfront about what they are and what they do, what studies and results have more confidence and which less.
Maybe I'm just a little cynical here, but it seems the FDA would have better things to do with their time. That in mind, I wonder what spurred this...
This is much better than the other FDA story today where the FDA declared walnuts a medicine because a manufacture made the factual statement "Omega-3 Fatty Acids found in walnuts have been shown to have health benefits."
This actually makes sense. They're using marketing terminology to be say "walnuts will do this, prevent this, and help you out with this".
If you want to market your product like a drug, you should go through the regular inspection to make sure all your claims are satisfied, just like any other drug.
No, it doesn't make sense. The consequence is that no food marketing can make (even truthful and not-misleading) claims about the healthiness of the product. Carrots are healthier than Twinkies? Not unless they're a medicine.
its just a matter of knowing the game. big farma kills millions, nothing happens. small company still not pleasing the right people, huge fine/closed/etc
yes, i am implying the gov is corrupt. it is.
and this the reason everyone pays hundreds of dollars for catheters and such, and any company that tries to improve the design and price of those items are all in legislation or royalties limbo.
Not millions, and I don't want to buy into the "Big Pharma" conspiracy... but NPR's This American Life on the FDA & deaths from Tylenol was fascinating. It took the FDA 32 years to enforce warning labels for Tylenol (and other acetaminophen products) from when they were first recommended to do so:
Thalidomide, though didn't necessarily kill people, did destroy many lives. Baby formula, fire retardants, and many other products brought to market by lobbying industries have harmed consumers by varying degrees and all backed by the FDA.
"Fifty years ago, the vigilance of FDA medical officer Dr. Frances Kelsey prevented a public health tragedy of enormous proportion by ensuring that the sedative thalidomide was never approved in the United States."
> While generally safe for use at recommended doses (1,000 mg per single dose and up to 4,000 mg per day for adults), even small overdoses can be fatal. The ratio between fatal doses and therapeutic doses (the therapeutic index) is much smaller than for other over-the-counter painkillers. According to the US Food and Drug Administration as little as 25 percent above the maximum daily dose can cause liver damage when taken over several days
> In the United States, over 150 people die each year from overdoses, with up to 78,000 emergency room visits
Because drug companies aren't responsible for the actions of their customers. If you overdose on something like acetaphetamine, that's your fault, not Tylenol's. The information is out there regarding proper dosing and you've chosen to exceed that. That's really not a problem with the drug, you can overdose on practically anything, it's just chemistry. Society laughs at people (rightfully, I might add) who get busted drunk driving and try to blame Heineken for their actions. Also, taking 25% over than the recommend dosage several times may damage your liver but it certainly won't kill you. The LD50 for the drug in mice is 338 mg/kg.
yes but as I quoted, paracetamol is something you can overdose really easily, it's also a medicine everyone around me is using as a trivial thing. I might be surrounded by idiots but I think I'm the only one in my entourage who read the instructions (I've told my friends numerous amount of time "What? You're not suppose to take more than 4g per day!").
I might be surrounded by idiots but I think I'm the only one in my entourage who read the instructions (I've told my friends numerous amount of time "What? You're not suppose to take more than 4g per day!").
Seriously? If they can't even be bothered to read the instructions on medicine (or anything they put in their body) then they have problems and need more help. Or need to learn to read.
Considering the fact that we know 99.9% of people blindly click through agreements, this is the way it should be. Companies should not be able to use the lack of careful reading of TOS/T&C to their benefit.
Should a company should be able to bury a clause in their ToS such as "by accepting this contract, you agree to forfeit to The Company your first born and every cent you ever make henceforth"? Of course not.
People should be able to knowingly enter into whatever contract they want. The problem is that (as I cited elsewhere) information/effort/payoff asymmetries makes such a scenario ripe for exploitation. Therefore it follows that regulations should constrain what can reasonably appear in a contract. One should not have to parse 100 pages of legalese just to make sure they're not tacitly agreeing to indentured servitude for the rest of their lives. If this were not the case, it would be painfully easy for unscrupulous business to bury unsavory claims under mountains of incomprehensible legalese. What regulation does is balance the scales in favor of consumers.
This does in fact follow from the fact that 99.9% of the public does not read and/or cannot comprehend every instance from the set of possible legal contracts.
People should be able to knowingly enter into whatever contract they want.
Glad you agree.
Should a company should be able to...
Contract theory is far more rich a subject than you realize. In your example, a rational theory of contract wouldn't be enforced based on mere promise, but would allow contracts to be broken so long as it puts both parties more or less back to where they were before. E.g., if you promise to paint my home for $100, but then you don't paint my home, I can't then enslave you and force you to paint the home, rather, I get my $100 back.
And who is there to enforce the various tenets of contract theory? The fact is, if certain clauses of a contract are enforceable through state action then the state can and should have a say in what clauses it will enforce. Simple as that.
It's clearly not as simple as that, since there is such a thing as tyranny and perversion of justice. Now, you may be the kind of person who would approve of what his government does, whatever it does, and you may even be in the majority, but that doesn't make you right. I also imagine that, like most people with such views, you have cognitive dissonance. I.e., there are some governments that you think should change their behavior, on moral grounds.
>It's clearly not as simple as that, since there is such a thing as tyranny and perversion of justice.
It would be helpful if you tied in statements like that to the main discussion thread so that I could respond in a meaningful way. As is stands you're not really making an argument so I can't respond to anything without guessing at the logical connection.
> ... Make sure to discuss your Genetic Information ... before you act upon the Genetic Information
The problems are not about what someone might do with their "Genetic Information", but with the accuracy of the "Genetic Information" in the first place. The false positives/false negatives mentioned in the FDA's warning letter[1] are not referring to misdiagnoses based on the 23AndMe's results, but to misidentification of genes in those results (as the letter describes it, "false genotype results")
In a nutshell: 23AndMe claim that the genetic variants in their results are (to some degree of accuracy) genetic variants that you actually have; the FDA says that 23AndMe have not provided enough evidence for these claims.
The TOS is perfectly valid. It is a solid document advising people to take any results up with a medial professional. The service tells people that the product is not a medical diagnosis, however the service does provide medical information. This clearly puts said service in the realm of the FDA. Therefor compliance should be sought.
Really this goes for any company building medical services. Consulting someone on HIPAA compliance, as well as, FDA standards and practices is a must.
Is this fair in this case? Who knows. It is irrelevant. Resistance is futile.
The problem with 23andmMe is that genetics can't currently tell us much about our risk of developing common genetic diseases.
Some diseases are caused by a single gene. These are rare because people with a dominant copy of that gene are less likely to reproduce, so they are mostly deselected. Many of these monogenic diseases have a pretty major effect. You know if you have them (and probably died in childhood). Pre-natal genetic counseling is where finding these is useful.
Most of the diseases 23andMe talks about are caused by multiple genes (in combination with the environment). The interactions between these genes are often really complicated, and typically the number of genes involved is huge (and the actual contribution of each gene to risk is very small). This has made investigation a nightmare - even the most understood genetic diseases, we only know about say 10-20% of the genes that make up the genetic part of the risk, which may only be 40% of the total risk.
So 23andMe sees you have 1 of the 100 genes that we identified as contributing to a disease. That means you have 1% of 20% of 40%, which is really nothing to get excited about.
I know 23andMe tries to communicate this, but they are also trying to run a buisness. If they stood up and said 'yeah, we can do some tests, and they really won't tell you anything worth knowing', they would get no press coverage. But anything else is... carefully not lying, rather than being honest.
I read other commenters here, who say things like 'Well it's a nice compliment to getting a blood test', and get the feeling they think these tests mean shit.
Completely understandable and it's a fair point people might undergo unnecessary surgery as a result of a false positive (like having breast tissue removed preemptively after false positives for chances of contracting breast cancer). 23andMe is a nice idea, but you can't beat an old fashioned regular trip to the doctor and blood test to check for these things.
Think about the opposite, though -- most people don't get tested for anything, especially weird/uncommon conditions. Tests like 23andme aren't something your local doctor does every checkup.
For $100, people who otherwise would have been clueless know if there's something they should ask their doctor about. In this case, I think some false positives are better than ignorance.
Worst case, you think "oh no, I'm predisposed to ___!" for a few days until you make it to a doctor who can tell you for sure.
It's fair to say 23andme has saved far more lives than it's hurt.
We could write something untruthful or harmful in the newspaper (maybe about acai berry weight loss).
So why not let the government go through a process, investigate whether what we write is conducive to the public good, and once approved it can be safely published.
The idea that someone is going to get their breast tissue removed based on 23andMe alone strikes me as unbelievable. A doctor would be consulted, who would likely order more appropriate diagnostic tests first. I would imagine any doctor that jumped straight into surgery based off of a 23andMe print out would eventually be sued for negligence.
Just as there will be people who get surgery due to false positives (which happen with regulated testing too), there are lots of people who otherwise have no preferred means of testing if it's regulated away.
The FDA doesn't appear to be trying to shut down 23andMe, just trying to force them to file the appropriate documentation and follow the same rules as everyone else regarding how they advertise their services.
Has 23andMe told their side of the story yet? The FDA's press release made it sound like 23andMe was very negligent, but there has to be more to it than that. I can't imagine a company just ignoring the FDA's requests.
Hi everyone, Many of you have seen and been asking about this morning's news.
Here's the statement we've issued to the media: "We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
We'll continue to keep you updated here as we know more. Thanks for all the messages of support!
When I read the FDA press release, it states that 23andMe must cease marketing their product. I don't see where it says that they must stop selling it. If I'm right about that, they're free to continue selling the product but have to stop their public statements about it, until the FDA grants them leave to do so.
FDA as always sticking their nose into something they shouldn't. Let the people decide whether they want to use this particular service or not. People ought to be free to choose. Otherwise it's not consumer protection, it's consumer dictatorship.
This really looks like the FDA sticking their nose into something they should. 23andMe is making false claims about the efficacy of their test in their marketing material and the FDA isn't okay with that. They're not even ordering 23andMe to stop testing, just to stop marketing their service as something it isn't.
You are paying for it with your tax money, therefore you are doing it. I'm not okay with selling snake oil, but I think it is wrong to prevent other people from buying it. It's okay to inform them it's a bad idea to buy certain things - it's dictatorship to prevent them from doing so. If you can't convince somebody, it's your problem, not that person's problem. FDA doesn't convince, it just comes and shuts you down or doesn't allow you on the market.
Besides, where is FDA when charlatans sell homeopathic medicine? Show me a little consistency here.
I never said that the FDA is perfect or covers all bad cases. Just because a few bad apples can escape the law now, in letter, does not mean that we should not have regulation. Medical regulation is far from dictatorship. It is orthogonal to it.
Just because a govt. prevents from doing X, does not mean by default that the govt. is a dictatorship. X has to be something basic like the right to live or the right to free speech. The FDA is not brutishly shutting down 23andme. They seem to have reasonably tried to work with 23andme. But the startup has been stubborn.
You don't get my point. I'm questioning the existence of the FDA itself. What's your excuse for not letting each individual decide for himself what he wants to spend his money on? It's his money after all. He didn't ask you to pay for what he wants. What is your problem with that?
I get your point. I don't get anarchists who don't want regulation but want things like the Internet and technology funded almost entirely by governments.
A true anarchist would live in the wild and survive on leaves, branches, sticks and stones. Don't use roads, don't use the internet, don't use any of modern medicine (look up on how much the NSF, DARPA, DoD, NASA have contributed to modern science and technology. It is not as though Google materialized out of thin air.)
None of these companies operate in a vacuum. They stand on society's shoulders and have to operate within acceptable legal boundaries which stem from ethical standards.
Also, from an operational view, if bad companies mess up, taxpayers end up footing the bill.
(Before you delve into more predictable hyperbole: I am not advocating for complete govt. control of everything like in N. Korea.)
> A true anarchist would live in the wild and survive on leaves, branches, sticks and stones.
I think this image of anarchists was partly intentionally created by governments. Anarchists, at least those who endorse free market enterprise, believe in rules. However, they see government as an ultimate monopoly that issues rules and enforces them with unchallengeable force. If you agree with me that monopolies are not good for consumers, then it only takes a little step further to see that government is indeed a monopoly. Why does it have to say who can marry whom, who can smoke what and who can buy what? The alternative isn't living in the woods. The alternative is having a polylegal system and private protection agencies. You choose an agency and a package of rules you like and start paying. If you dislike the services - you unsubscribe and stop paying, you don't wait for the next election. Moving to a different country cannot be considered a true alternative, since it's usually complicated, expensive and you still are forced (not asked) to pay, like it or not.
> None of these companies operate in a vacuum. They stand on society's shoulders and have to operate within acceptable legal boundaries which stem from ethical standards.
Society doesn't equal government.
> Also, from an operational view, if bad companies mess up, taxpayers end up footing the bill.
That's because you have taxpayers and government can bail out companies which are in bed with it. If you didn't have taxes, people would simply let a bad actor fail and be replaced by a better one.
Massive information asymmetry means it is highly likely that people will be taken advantage of. The FDA balances the information asymmetry of the public and a product by defining a process that allows companies to make certain claims.
This doesn't answer the question of why FDA bans products and services instead of simply informing consumers of possible dangers and letting them decide for themselves. Government has the largest resources to reach out to people, so any message it would want to communicate, it could.
If the government really cared about consumers, it would go after homeopathy dealers, religious leaders and other charlatans. Never gonna happen. Why do you think that is? Why homeopathy existed for such a long time and never had any problems with authorities, but a startup that actually provides some value to people, suddenly is a threat that needs to be shut down?
>why FDA bans products and services instead of simply informing consumers of possible dangers
Because that costs money that they shouldn't have to spend. If a company is marketing a product as X, why should the FDA have to counter with marketing that says product is actually ~X, rather than simply stop the marketing as X?
I'm sure homeopathy dealers aren't allowed to make medical claims. Perhaps the FDA doesn't go after them as stringently as you might like, but lets not pretend that they have free reign.
So use force instead of convincing people, because it's easier and cheaper.
My problem with any regulatory agency is that it can't claim to work on behalf its clients. Why? Because funding comes from taxes and taxation is not voluntary. No one asks people whether they want to pay taxes or not. They still have to or they will be fined even more or will go to jail. Thus, FDA lacks basic market mechanisms that could check such a consumer protection firm in check. If a group of people feel dissatisfaction with their work - fuck them, who cares? They're still getting their funding.
Homeopathy dealers are having a great time and make tons of money. They may not make medical claims, but that doesn't stop them from hurting a lot of people by offering something those people believe is a cure. Let's not pretend government does anything to stop it, really.
Personally I feel the libertarian premise is absurd so anything that follows, however rational, is nonsense to me. I don't think we can have a productive discussion.
> This doesn't answer the question of why FDA bans products and services instead of simply informing consumers of possible dangers and letting them decide for themselves.
To the extent that it does this, it does it because the FD&C Act set standards by which they are required to. Why Congress did that is a different question.
But, it must be noted, that what they are doing here is not banning a product, they are prohibiting the marketing of a product for a particular set of advertised uses without meeting particular standards of proof that it is effective for those marketed uses.
> If the government really cared about consumers, it would go after homeopathy dealers, religious leaders and other charlatans. Never gonna happen. Why do you think that is?
In the case of homeopathy, which is regulated by the FDA, it is less regulated to less stringent standards than traditional medical products and devices largely due to public pressure.
> but a startup that actually provides some value to people, suddenly is a threat that needs to be shut down?
23andMe is "suddenly" a "threat that nees to be shut down". They were notified years ago of the requirements they needed to meet to market the product the way they do, they initiated the application process to meet those requirements in 2012, and haven't responded to FDA requests for further information necessary to move forward on those applications for over a year.
You act as if the FDA noticed the existence of 23andMe and immediately moved to destroy them. That is very much not what has happened.
The question is not whether they were notified or not. The question is whether you believe that you yourself, as a taxpayer who funds the FDA, have the right to order people what to spend their money on and how to live their lives. It doesn't matter if a person is going to hurt himself or not. Why should it be in your power to take away someone else's freedom in the name of safety this person might not even want?
Looking at this particular case of 23andme I will tell you this. It's ridiculous. The claim is that somehow consumers might act in a way that can hurt them based on the information they received from the company. That sounds a lot like censorship to me. In Russia now people are prevented to look at sites that promote suicide or drug use. It's essentially the same thing: sites are notified, if they refuse to remove the information, they are banned within Russia. Hey, we want to protect our people.
> The question is not whether they were notified or not. The question is whether you believe that you yourself, as a taxpayer who funds the FDA, have the right to order people what to spend their money on and how to live their lives.
If I didn't believe that, I couldn't believe in the existence of government at all, which is nothing but a means by which the people whom the government works for direct the people who are subject to it (largely overlapping sets) what to spend their money on and how to live their lives.
So, yes, I'll agree that that question -- which is equivalent to "do you believe government should exist at all" -- is a threshold question here. But I don't really think its the interesting question here.
> Why should it be in your power to take away someone else's freedom in the name of safety this person might not even want?
The only "freedom" even arguably being denied here is 23andMe's freedom to market their product with particular claims. The issue is not whether they can sell the product, but the manner in which they are marketing it.
The manner in which they are marketing it is entirely their own business. If american people are smart enough to choose a politician to lead the country - and political campaigns are full of lies and deceit - then how come they are not smart enough to tell whether a marketing campaign of a product that has the potential to directly affect their life - is honest enough? How come no agency oversees what a politician says during a campaign and then just suspends this politician immediately if he does anything out of line?
Also, talking about information asymmetry. Isn't it ironic how most kids are educated in public schools? Surely no information asymmetry can come out of this, it is the democratically elected government after all that takes care of the children and what and how they learn.
In other words, government with its massive resources and near monopoly on many things like police force, law and education taking advantage of people? Not possible. A startup funded by Google? No question evil.
I don't think calling names helps the argument. You can't just say "well, that's a little to extreme, so you're wrong". I simply pointed out that it happens so that most kids are educated in public schools. Would it be such a stretch to propose that those children are educated according to what government believes is important? Surely no one doubted this happened in the Soviet Union. How is the US, or for that matter, almost any other country different? Soviet children were taught to believe in communism, american children are taught to believe in democracy. Haven't you ever tried to question it at least a little bit? That maybe, only maybe, if something (and especially a political ideology) is taught in every public school as a universal good, it really may not be one?
For those protesting this decision, carefully read the following:
> However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions. In your letter dated January 9, 2013, you stated that the firm is “completing the additional analytical and clinical validations for the tests that have been submitted” and is “planning extensive labeling studies that will take several months to complete.” Thus, months after you submitted your 510(k)s and more than 5 years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now eleven months later, and you have yet to provide FDA with any new information about these tests. You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.
It appears that 23andMe is and has been aware of this situation for quite some time. In fact, the FDA has devoted significant time to aiding 23andMe in their process to compliance:
> As part of our interactions with you, including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications, we provided you with specific feedback on study protocols and clinical and analytical validation requirements, discussed potential classifications and regulatory pathways (including reasonable submission timelines), provided statistical advice, and discussed potential risk mitigation strategies.
The FDA in fact proposed a relatively simple solution, which was related to the labeling of the product.
> 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.
Please keep in mind the scenarios in which the FDA attempts to avoid, in this situation. Particularly, a layman could consider their 23andMe results to be conclusive evidence for/against particular diseases and conditions, regardless of the respective error bounds for the data, and take matters into their own hands or simply prefer their results over the advice of medical professionals. Sure, there are T&C on 23andMe which state that this product should not be used in these purposes, this labeling is exactly what the FDA wants to improve. Limitations of assurance or intended use cases for products of this nature should be clearly labeled, and in a consistent manner. A startup (although 23andMe could be considered to be well beyond that stage) should not entrusted to make these decisions alone, and in fact, we do not have one such independent entity within this space, it is a growing arena within which multiple such entities are competing. It is not their business to care about other use cases, it is their business to stay in business.
A particular paragraph on 23andMe's homepage says "Understand your genetic health risks. Change what you can, manage what you can't." I do see many individuals in the Nootropics/Quantified Self community interpreting their own results and indeed taking matters into their own hands. Okay, so perhaps these individuals may be of above average intelligence and are capable of behaving rationally, but this desire to improve oneself is not limited to our circle. Believe it or not, most of the population would love to improve in one aspect or another. We should be very careful in what 'gifts' we present to society, especially gifts of this nature.
The FDA, while being a pain in the rear at times, will actually work with you to meet compliance. But you have to show work and be continually in touch with them and show progress (and document everything according to your own procedures, complying to regulations of course). You can't just say you're working on compliance and then not follow through and show evidence. The issue for 23andMe is the on-label use of the product "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." They market the product this way. If you want to market your product as such, you have to show proof to the FDA and receive approval to label the medical product in this manner. It looks like 23andMe is either not working towards compliance (and is misleading the FDA) or is doing a terrible job documenting their work towards compliance and keeping the FDA abreast (my guess is this is what's happening). That in itself will get you in trouble, but then expanding your marketing for even more on-label use of the product - which hasn't been submitted to the FDA apparently - while at the same time not having FDA approval for the original use is just plain stupid.