DNA Testing: Do You Have a Right to Test Your Own DNA? FDA Says No!


DNA testThere’s a reason your government is whittling away at your healthcare options and driving costs out of control—and not a good one.

America spends over $2.6 trillion a year (18% of our GDP) on healthcare. At the same time, government is tightening the regulatory reins on nutritional and natural methods to support health—an approach that isn’t lowering healthcare spending, but raising it!

On November 22, the FDA sent a warning letter to 23andMe.com to stop its inexpensive ($99 per test) “do-it-yourself” genetic testing service for health screening and ancestry purposes, because consumers could be “misled” and harm themselves by “self-treating.” For example, the FDA posits that an individual who learns they have a predilection for cancer would, as a result, undergo unnecessary preventive surgery, chemotherapy, and other “morbidity-inducing actions.”

The FDA’s argument is, quite clearly, a straw man: of course patients have to obtain medical advice before making major health decisions—it’s not as if consumers can go under the knife without significant medical consultation! The FDA’s true message is clear: because individuals can’t be trusted to make sound health decisions, they don’t have a right to private information on their own DNA.

It’s also worth noting that FDA action against 23andMe was sparked, in part, by a complaint by UnitedHealth Group, the largest publicly traded health insurer. UnitedHealth isn’t exactly an unbiased observer—they want access to information about your DNA. After all, if individuals were allowed to keep their DNA test data private, they wouldn’t have to share their results with insurers who, for example, could use an inherited health risk to deny insurance or charge exorbitant rates.

The FDA’s stance on DIY genetic testing could very well drive up healthcare costs. Besides premiums being raised on those forced to report DNA results to insurance companies, in-office testing is far more expensive. As tests are priced anywhere from $300 to $3,500, this could significantly add to the overall cost of healthcare.

  • Cynthia McTyre

    It is absolutely wrong, wrong, wrong to deny people the right to obtain their own DNA results! I cannot imagine how any court in the land except ones that have been “bought” could do such a thing.

  • Karla Oman

    I completed 23andme testing this past summer. I felt it very worthwhile. It confirmed some of the genetic factors that I was aware of, raised a couple of others – with very good explanations so I understood how this came to be. I can share ancestry and genetic data with a lot of others on the 23andme website, which is also invaluable.

    The FDA’s commentary? Phooey! I agree with the assessment that it was generated by UnitedHealth Group’s complaint. Of course the insurers want to have as much info as possible to either raise rates or deny coverage (I’ve worked for 2 insurance companies, one being healthcare, and the other home & auto – not as a claims adjuster, but over on the IT side of things… but I still got to hear plenty – and I don’t work for them any longer; my choice). Now knowing what I know about my risk factors, I’ll approach this with best practices regarding nutrition, exercise, life style. Fortunately, none of them are indicative of a cancer risk calling for a pre-emptive strike such as a mastectomy. Unfortunately, they are those that folks fear the most – dementia and Parkinson’s (that was the surprise; there’s no one in my family with Parkinson’s). Again – nutrition, exercise, life style…

    Bottom line: 23andme provides excellent tools for education. Allow folks to do their own genetic testing.

  • Tom

    The best way to overcome this BS is to take care of your health by eating fresh whole organic nuts, beans, seeds, fruits and veggies with maybe a little grass fed meat or dairy if need be. Do all you can to stay away from medical doctors.

  • K Thies

    “It’s also worth noting that FDA action against 23andMe was sparked, in part, by a complaint by UnitedHealth Group, the largest publicly traded health insurer. UnitedHealth isn’t exactly an unbiased observer—they want access to information about your DNA. After all, if individuals were allowed to keep their DNA test data private, they wouldn’t have to share their results with insurers who, for example, could use an inherited health risk to deny insurance or charge exorbitant rates.”

    Need I say more!!! Ecept, of course, that Obama appointed ex-VP/lobbyist of Monsanto to head the FDA. Corruption abounds.

  • Leonard Austin

    Health care providers should not be alllowed to dictate what an individual should be allowed to do
    about his personal testing. Their interest in no in a persons health but about their profit

  • Sally Jackson

    As I stated in previous comments I truly believe that the FDA is broken and needs to be closed. Re opening this department would require the removal of all bias elements (persons) before hand. This agency was originated to protect public health, at present the only thing this agency protects is itself.

  • Diana Simmons

    DNA testing will become a necessary health screening tool to help us and our doctor take action — a preventative health program that is custom tailored to our DNA and possible outcomes. More people are likely to pay attention to their health outcome if they have a better idea what they are up against.Appropriate and timely preventative care means putting less strain on our health care system. Insurance company interference withDNA testing and progress in medicine that could revolutionize preventative care usually has to do with their bottom line–not concern with your health.

  • Sherri Gillespie

    I have United Health Care through AARP and have been happy with my supplemental insurance with them until now. HOWEVER there should NEVER BE ACCESS to our DNA unless we too can also get those health care results. United Health Care’s complaint is bogus that they should also have access to our DNA but anticipated by me. I told everyone I know to wait until they are on Medicare to test their DNA to assure their health care coverage and rates are NOT INFLUENCED by the results.

  • C. Crane

    Excuse me? When did the FDA get involved with my life and health care issues?
    That really stincks. I think the FDA needs to mind his own business

  • Why shouldn’t the public have access to what is theirs? All other blood work is made available by doctors. If the medical profession had initiated the sputum sample for analysis they would make money on it and then they could release it to the insurer, but they would be obligated to release it to the patient,also. Good luck in getting past the AMA.

  • RealityBites

    FDA is nothing but corrupt morons on the payroll of big pharma. Close the agency and prosecute the drooling morons for treason. No I’m not joking, they kill Americans every day with their lies, inaction, stupidity, and gross negligence.

  • Eric Zuber

    Thats the beauty of being a government bureaucrat, you are not an elected official and are completely isolated from the public. Consequently they can say anything and it doesn’t have to be rational because the public will never get a reply to a challenge. We are simply ignored.
    This isolation allows bureaucrats to make ridiculously irrational statements and not have to back them up with facts or discussion. They have placed themselves above all that.

  • jacqueline Victor

    We don’t need anyone, but ourselves to decide things that only impact ourselves. FDA, Quit babysitting us. We are actually more interested in our health than you are, and consequentlywe need to be in charge of it- not someone else.

  • Virginia Wilber

    You have no right to stop this testing. I have every right in the world to find out what my DNA says about me. I am not stupid and would not undergo any unnecessary procedures due to the DNA results. In addition, doctors would not perform unnecessary procedures – unless forced to do so to protect themselves from you and lawyers.

  • Melodie Metje

    I feel that I have a right to purchase a genetic test if I so desire. Do not take away my freedom to get tests done that I want. It doesn’t cause anyone any harm. Why should the government prohibit me from getting this information?

  • Nancy Wainwright

    This is but another intrusion into or lives and an erosion of our rights. I hope this is contested,

  • Is there somewhere to protest this action by the FDA?

  • Ellen O’Connor

    Please do not continue to force healthcare costs to rise by your poor choice of making DNA genetic testing an expensive proposition.

  • D

    I am so disgusted by this. Since our bodies seem to belong to the government, why don’t they take better care of us? I don’t see them laying claim to sick people when they need new kidneys or hearts…or help in any way. They should let us take care of ourselves. My body belongs to me and yours to you. We should therefore be able to do whatever we want with, to, or for our bodies.

  • Steven Tupper

    23andMe is NOT “do it yourself” by any stretch of the imagination. It’s a large private corporation backed by another even larger private corporation (Google). I’m not sure why you’re distorting this so wildly, but if anybody reads this I’d like to point out that the FDA complaint has NOTHING to do with having information about your DNA and EVERYTHING to do with 23andMe making specific health claims for its DNA analysis that verge on snake oil claims. The recent FDA action was specifically brought about when 23andMe began a high-profile ad campaign making these claims in complete defiance of ongoing negotiations with the FDA over what it could and could not claim. In other words, NOTHING to do with the DNA sequencing itself.

    As for the price, you get what you pay for. The 23andMe sequencing (they did mine, so I know first hand) is very basic compared to those more expensive tests you mentioned.

    Please (again if anyone is listening) also consider the parallel to Google. Google make a ton of cash. How? By gathering your information in the form of internet searches, preferences etc. and selling it to advertisers. Is the real business plan of 23andMe perhaps similar? To gather our genetic info and then peddle it to the highest bidder? Stop and think a bit, OK?

  • Shasha

    Hi, Celiac help may help DNA to not express into cancer and other health issues. Celiac help..eating no gluten/dairy/soy/sugar…taking vitamins/good oils and LDN, Vit D3, Vit C, zinc, fish oil and more may help the immune system. Eating no gluten may help intestines absorb more nutrients…then cells are made right and work right. The whole family tree maybe Celiac..but each person may get a different health issue due to Celiac. To test genes may make a person lose hope instead of just eat healthy and take supplements with Alternative medicine care help that may prevent health issues. To me no one should cut off their breasts due to a gene…but get the Alternative help to keep them healthy. To me you could cut off breasts..but then get cancer in another location since you have not fixed the root cause…which maybe Celiac. Detoxing a person may also help the brain/body work right.

  • Rachel Tamagni

    I used the services provided by 23andme just this last summer.
    I was quite satisfied with their services and the information I obtained.
    I have been self treating since 2006. During this time period I have overcome pre-diabetes, thyroid problems and triple positive breast cancer.
    In every circumstance I was more afraid of western medicine, standard of care treatments and pharmaceuticals than I was the diseases.
    It is time for the government to accept people can and do take responsibility for themselves.
    I don’t want or need their strong arm behaviors trying to force me into treatments and drugs which have horrific side effects.
    If we choose self treatment it isn’t the governments business.

  • Durk Pearson

    Please consider this more sinister potential reason for United Healthcare’s petition to the FDA to shut down 23andme as a provider of health related genetic information:

    If someone finds that they are at a very high risk of a lethal disease because of a mutation in one or more of their genes, they are almost certain to step up their demands for diagnostic services – at United Healthcare’s expense – and may even seek proactive precautionary treatment (eg., Angela Jolie’s mastectomies) – again, at United Healthcare’s expense.

    It would be so much less expensive if these people remained ignorant and United Healthcare only had to pay for some cheap opiates to ease their pain at the end of their lives.

    23andme needs a top notch 1st Amendment attorney, such as Jonathan Emord ( http://emord.com/ ) who won the Pearson versus Shalala dietary supplement information cases against the FDA for Sandy Shaw, myself, and every other user of dietary supplements.


  • We can home test for our sugar levels and cholesterol levels, so why not our DNA? The more we know, the better we can take care of ourselves. I don’t understand why the FDA so against people knowing if they are prone to getting a disease or not. It will only help them to take measures to try and avoid any disease and they can consult with their doctors on any course they should take.

  • Kelly

    The scariest thing is, what’s next? What other of our personal rights will they take away next?

  • Julie Grant

    When the h is this all going to end? I am so fed up with this blatant manipulation of denying individual rights at the behest of the gargantuan, mega billion $$, bottomless pocketed, unscrupulous, borderline corrupt, morally bankrupt, yet “legally” operating conglomerates, I can’t stand it. Who will be left alive at the end of all of their bull? Certainly no one who heeds the advice of the FDA nor anyone unfortunate enough to be sucked in by or is otherwise unable to fight that money machine.

  • Peggy

    We have way too much government in health care. All these mandates and controls are just ways to funnel money, force us to fund various products and services without our consent, and leave us without control over our bodies as well as our money. Thanks for the continuing efforts to educate, and to promote freedom.

  • frances martin

    It is all political with the FDA. In my opinion the only thing they are really interested in is pay-off they get from the Drug Cos. They are not to be trusted with our well-being.

  • Marsha Whipple

    Excuse me. My body, my choice. Get out of my medical choices.

  • william haegele

    This is completely and unabashedly at the expense of all Americans.
    I am truly ashamed that I live in a country like ours.
    We have the means and intelligence to solve all of the worlds problems except one. Greed.

  • Craig Tansley

    Inasmuch as it has become common knowledge that the corporations now OWN our government, our medical establishment, etc., I think it would be a very good idea for someone to ‘follow the money’ on this one, and find out just who is lobbying, in our government, to have the FDA do something so abysmally stupid as this. We cannot take action unless we see “the man behind the curtain”, and once we know which companies are behind this, I would suggest the organizing of a BOYCOTT of said companies and their products, by all concerned citizens.

  • Michael Soudant

    No, I ‘m not permitted to privately order my own DNA test. I am not permitted to determine if the food I eat, that food that is drenched in pesticides, is genetically and poisonously modified, I cannot sue the pharmaceutical company whose vaccinations clearly kill or maim my child. My government and the the corporate plutocrats who mind them long ago decided that I am a consumer not a citizen. Consumers open their mouths to gobble down more cola and chips. Citizens speak out to claim their rights as human beings. We gotta squawk and squawk loud and not stop until we are recognized as citizens.

  • Jan Miles

    The FDA doesn’t know me personally, so how could they make a decision that I don’t know my own body enough to make a sound decision. If anything, I know more than they will ever know. So, I feel that the FDA is full of hogwash and needs to stay out of our bodies and our lives. I think they just don’t want us to know of all the crap that is being put into foods that will probably show up in a DNA test.

  • joanne groshardt

    Hey United Health Care. I’m lucky that I was tested years ago. I know what to look out for. It doesn’t mean I’m going after tests and surgeries and procedures.

  • Susan Mann

    Please leave DNA screening availability alone! There are different levels and purposes for screening. The public should have different options, as the need and case may be.

  • And once again Big Brother does whatever the heck they wish to do. We can only hope that the great attorneys of the U.S, such as Jonathan Emord and Rick Jaffe, with the minor help of our totally out of control legal system, will eventually get the FDA to do ONLY what they were designed to do. I won’t take any bets but I can at least hope

  • I have used 23andme for my health and family history results. I found it very informative. My son wanted to test his dna for health reasons and now he cannot. This is downright disgusting that an administrative agency can create a new law to interfere with one’s right to choose especially when it applies to learning about the possibility of any health ailment susceptibility.

  • If people do no take over being responsible for their own healthcare, they are doomed. You cannot trust the F.D.A. or doctors because they are owned by BIG PHARMA. These doctors are afraid to defy BIG PHARMA so you will not get real care like it used to be. Be aware of what is happening in this country. BIG PHARMA and BIG FOOD are killing us every day.

  • Diana Saxon

    This is ridiculous.

    Through the NatGeo Genome project, I’ve learned I have genetic relatives around the world, including but not limited to Romania and China. I had previously thought my ancestry was limited to the United States and the British Isles. Apparently not.

    This statement by the FDA just proves that our government is headed into “Big Brother” territory.
    It’s a shame.

  • Efroim

    They want to be able to charge a high cost for the test. How dare us getting an inexpensive test…

  • Olivia Smith

    Read this!

  • Linda N

    23andme was/is an invaluable service for very reasonable funds! The FDA is out of control as usual, and kowtowing to any complaint put out by an insurance company (or drug company) whose profits might suffer if people take control of their health. And ANH is so right. Even if someone finds out they have a genetic risk for a certain cancer, they still have to go to a doctor to get part cut off, or get chemo or whatever. Darn right the FDA’s argument is a straw man!

    However people need to realize that 23andme can still do testing and give you your raw data, just not any of the interpretation they use to give like what drugs you might not metabolize or what risks you have etc. So far there are still independent places on the net that you can pay 20 bucks or less to punch in that raw data and get information on what the raw data means. So far!

  • You murdering, bought-and-owned of the FDA can go straight to . Let me know if you need directions.

  • Gary Morgan

    Health-care insurers obviously want to get between consumers and their information and squeeze another profit source for themselves.

  • Bill Little Eagle

    It is none of there business, if I want to do a DNA TEST on MY BODY I will do so, who the hell do they think they are. I know my body they do not. They can go jump in the Lake, stay out of my life, and my body. WE THE PEOPLE.

  • Walter Gillmore

    This is totally specious! Who could possibly have more right to see, and keep any results of their own medical tests. We all know that the US Government has deliberately dumbed down the Educational System to facilitate the propaganda that they feed to the masses. Consequentlly, most Civil Service bureacrats in upper echelons can feed this ridiculous garbage to the public, and expect to get away with it.

  • Laureen Sue Magyari

    I have used the 23andme.com service and it was excellent. I was not mislead or misinformed about any genetic condition. I find it outrageous and insulting that any gov’t agency thinks it knows better than I do about what I can handle in the way of personal information. I hope there is a huge outpouring against this type of government abuse!

  • I BELIEVE THAT PATIENTS ARE MORE TRUSTWORTHY TO MAKE DECISIONS ON THEIR OWN HEALTH THAN FDA AND THEY HAVE THE RIGHT TO HAVE ALL INFO ON THEIR OWN DNA. The central point is that of FREEDOM TO KNOW ABOUT THYSELF to best plan your short life. FDA can be biased, based on bureaucratic, political, or other influences without direct or severe penalties on wrong decisions, but an individual’s decision is directly influencing the outcome of the most precious thing in their possession: THEIR OWN HEALTH or THEIR LIFE.

  • Dale LaCognata

    I have an inherent right to have my DNA tested and and to keep the results private.

  • I believe the FDA is thoroughly corrupt and evil.
    Any clear thinking American can see this.

    I wish to know if we the people have any avenues open to us, in order that we may make the correction
    We need to be allowed to use current and emerging technologies which are legally afforded our brothers and sisters in European countries and elsewhere!

    Why must we accept the leftovers like dogs under the table?

    We need to create a movement or a petition or something! America deserves better!

  • Mark

    This is an outrage! Please give us a petition to sign to stop this nonesense.

  • Patients should be free to test themselves.

  • Bonnie Johnston

    If you are going to stop people from receiving their own dna sequence for fear of self-treatment, it would only be consistent to also ban pharmaceutical commercials, for fear that people will persuade their doctor to give them antidepressants and statins they don’t need and to ban websites containing information about all medical conditions, for fear they will decide they have a cold and accidentally overdose on cold medicine. Maybe doctors should be forbidden from telling patients their own diagnosis, for fear that the patient will try to influence their own treatment in any way at all.

  • I am working on a Ph.D. in Holistic Healing and have discovered that the basis of all disease is digestive failure. In cluldren born with medical problems is because mom’s digestive system was compromised. Medicines are nothing more then a band-aid on the symptoms they do not correct the problem. What is causing the excessive amount of disease is the over contamination of the water with toxins, antibiotics, pollutants, etc. that are destroying the probiotics. I have subsequently created a program that teaches how to restore the digestive and immune systems and then the body heals itself. Why does the medical community have to have it all? Let me know if you are interested, I have research and documentation that supporrts my work.

  • Oreste Lombardi

    I consider knowing my own DNA as a fundamental right. Also I should have the right to keep it private and what I do with it should not be any body’s business. This should be a private matter between me and the test provider. To take any action on such information would be a matter between me and my doctor..
    I submit that government intrusion in this area serves no useful governmental purpose.
    I note that this issue came up as a result of a complaint lodged by United Health Care. So I ask the question what they have to gain by stopping 23 and Me.
    Oreste Lombardi

  • Lisa Read

    Please allow U.S. citizens to test their own DNA. I have important concerns related to my family history related to my liking to have it done for me someday.

  • Lisa Read

    Please allow U.S. citizens to test their own DNA. I have important concerns related to my fmily history related to my liking to have it done for me someday.

  • Trixie

    I would refute the author’s reasoning that United Health Group “could use an inherited health risk to deny insurance or charge exorbitant rates.” I believe the ACA (Obamacare) prohibits the denial of enrollment in a health care plan due to illness and also cannot charge an individual more than anyone else in a particular group due to health. They can only charge more for age. With that said, I do believe individuals should have the right to have their DNA tested. I personally know of several people who have availed themselves of 23andMe’s services and the information received was spot-on for problems big and small.

  • Henry Sarbiewski

    Funding for the FDA should be reduced and their penchant for abusing their authority should be curtailed.

  • Kathleen Bobb

    DNA is part of MY body – not a corporations.

  • The 23&me website states they can still provide the test kit and raw data, just not provide the interpretation.
    Although I may agree with you about the value of one’s genome to discriminate health risk by insurers and risk of it being in the wrong hands, so to speak, the shut-down appears to be in assisting interpretation of the raw data which you can still obtain (which to the untrained eye is not very useful and more likely to be misunderstood with a little bit of information and zero context). I suppose the FDA thinks only your doctor should have access and explain it to you. What a laugh. No doctor who takes $ from insurance companies for a living has time for that.

  • Mike Neill

    Let me make my own choose, of what test is best for me .

  • wendy frederick

    This is absurd! The government has no business deciding people cannot get DNA testing. It’s really stepping over the line. Enough is enough!

  • Jim

    FDA, go to h! You don’t own me, your not God.

  • Sherry Henderson

    Human beings should be able to know everything about themselves without an intermediary. It should be a basic right.

  • Sherry Henderson

    Human beings should be able to have all the information that is obtainable about their own body. This is a basic right.

  • Lenore Lyons

    I want the right to have info my DNA. This is part my right to the pursuit of happiness and there is no rational reason to deny individuals this information.

  • edgar gillham

    our government has proven over and over that they are NOT more moral or more intelligent than the rest of us, I rest my case

  • Dawit

    We have a right to know everything about ourselves on our own… Let us!!!

  • Prudence Brooks

    I double dare the FDA or anybody else to stop me from finding out about my DNA. Remember that Mexico is an option, should that fail in this new prison called America..

  • Bruce Stewart

    I have no desire to get genetic testing done but the FDA has once again overstepped their bounds by denying one the right to test. It is similar to the Texas medical board, they do not allow me to breath oxygen without a prescription. They do not allow me to get a blood test without a prescription.

    I say leave me alone!!! If I want to test let me test, big brother!

    Could individual states allow DNA testing as they do blood tests?

  • John Christensen

    The FDA has gone from being an organization to protect consumers, if it ever was, to being a group that is bought and paid for by special interests that use its dictatorial powers to get what they want, regardless of how much harm they do to the people they are supposed to protect.
    They should be abolished or reorganized back to their original purpose.

  • Charlotte LaRoux

    The FDA has nothing better to do? What about GMO potatoes and meat safety inspections? What about fish farmed in China and shipped to the U.S. consumers?

    I had my DNA tested by 23andme and found the information both correct on disease prediction (I’m 66 years old – I’ve been getting some of their predicted illnesses) and family connections. I have met a cousin I did not know existed and have been able to prove to my family that I have Native American ancestors, later confirmed by Ancestry.com.

    I have a right to my personal information, thank you very much.

  • jbjb

    I already really dislike the FDA. This piles it on. What a bunch of jerks

  • Annette Gerhardt

    There is a petition on peitions.whitehouse.gov asking for the FDA’s action against 23andme to be overturned. There are only 4269 signatures on it as of 12-10-13. A total of 100,000 signatures is required by 12-25-13. If you care about the ability to find out your own genetic information and keep it private, you can find the petition here https://petitions.whitehouse.gov/petition/overrule-fdas-decision-bar-23andme-selling-their-potentially-life-saving-diagnostic-kits/96BRCYNB

  • mary mcanerney

    This is an outrage to deny people their own information BUT INSURANCE COMPANY WANTS OUR INFO TO CHARGE YOU MORE FOR COVERAGE.

  • T. W

    For the Love of God! This unrelenting totalitarian goal of claiming ownership by the Government & the Conglomerates of Everything on God’s green earth!. This Slave Master mentality, that people are not “allowed” to do get their own DNA tests? The FDA doesn’t “approve” of anything that isn’t manufactured and controlled by their “Master” The Pharma Drug Cartel, The GMO Cartel,…etc. $$$$$

    Well, I Dont Approve of them. How about that? How about we the people of the United States dont approve of you, FDA. WE are not your property, WE do not work for you, WE do not look for you to have Dominion over Us the people. You have shown yourself to be a destructive, anti-liberty organization whose goal is to suppress, steal, rob, deceive, manipulate, murder the God given freedoms of a people.

    My DNA test revealed that I never had a chance of avoiding the destruction I endured from FDA approved “Fluoroquinolone” antibiotics. This I learned after the damage was done. This I learned after wheelchair, and damage to my CNS, Peripheral Nervous System, Tendons, Ligaments, Liver, Eyesight, Neurotransmitters. Learning that I was given a drug that has been maiming the public, fooling the public for 20years….and that I only had a 17% capability of detoxing from this chemical..therefore rendering an “Overdose ” after 3 tablets. This is the FDA’s idea of Good for the public . Withholding the facts, the truth and peddling corrosive drugs & poison as food. Causing 3 years of horrific pain, and severe disability. Regardless of that dismal trajectory, had it never occurred, I would still vehemently abhor the unscrupulous practices of this corrupt agency named the FDA.

  • Let me start by saying I am not a defender of the FDA or our disease management system.
    The problem 23andme has according to the FDA is – false marketing information. The percentage of scientist that would agree with their claims for disease detection or prevention is about the same number that still denies man-made global warming.
    Except in a very few purely genetic diseases a persons environment has a 3-fold or greater impact on future health. These epigenetic risks are not identified by a genetic test.
    The comment made about privacy is strange to me. The reason 23andme charges $99 for a test costing several thousand dollars is their desire to gain genetic data that can be marked to drug companies. For the data to be valuable they need to have as many client as possible. Therefore they subsidize the tests using the millions in investment capital. This will enable them to produce statistics the drug companies will pay for. At some point they will comply with the FDA. For now they are getting as many samples as possible. This for them has been a business decision. I see no reason for ANH-USA to turn it into either apolitical or health decision.

  • eileen miller

    As a health advocate and someone involved in the business of nutrition & supplementation for 30+ years, I do extensive research (peer-review studies, tests, background from credited sources) on any problems with my body and I also do this for my clients. Over the years, I always partner with my doctors and discuss options. I could not do this if I were denied the right to study my own body through available testing, etc. It behoves ANH-USA to trace to the source those who oppose a patient’s right to know to determine why that corporation wants something suppressed. It is rarely in the patient’s interest to suppress information and usually only benefits the corporation who want to control some substance, test, procedure, etc.

  • EmEmBee

    How and when can we take action against this?


    This is unbelievable!!! Now the FDA thinks they can tell me what to do with my body, what tests I can have or not. These people need to get a life and get out of mine.




    I am shouting!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

  • diane

    Too many of our rights are being taken away. This includes the right to privacy and the right to the control of our own bodies. When our rights are taken, control is given in equal measure to whoever ithen has the power to deny our rights. The ones who profit from this, and who ultimately have the power unless many of us together oppose them, are the corprations and those who control them. They are the silent oligarchy of which we need to be aware, unless we no longer want a democracy.

  • Maria Vicareo

    This is outrageous and against our rights and the free market!

  • Mary

    This is outrageous! Its the same with trying to get our own blood or fluids tested without a medical request. How can this happen? We are millions of people… How can we get together for the greatest momentum to effect a change on this? They’re treating us like herd. Next they’ ll be branding us and what better than to use our DNA? We must have our voices heard, you, we are… The People!! WE, YOU, are the owners of our, your, bodies! For millennia hominid man has survived unfathomable environmental conditions – and we are here…the supposedly more advanced creatures and civilization…and he physically made it without science, doctors, nor synthetics! WHO are the real experts on health? Hominid man experimented with his environment and body for millennia and that’s why there’s botany and countless other natural modalities that brought us to this date. How do we just give all that up? Dis- information. That’s how.

    We must stand up and repossess our birth right…our plants…our agriculture…our Earth…and now our very own DNA and that of our planet!!! Enough! with letting the few decide for most of us!

  • Angela Brown

    This is supposed to be America and I strongly oppose any restriction on my right to pursue information or freedom to pursue health and happiness as I determine is best for me.
    There are many reasons for genetic testing such as desiring to best parent my adopted child while lacking adequate heritage information. I will be responsible for paying health care and other costs for my child and as a parent should have the right to access any related information.
    The government cannot know our individual situations and has no role in restricting our access to information as we see fit to pursue it.
    Unfortunately our government has a long history of inappropriate interference in the area of the health of it’s citizenry.. And from what I see that has not been working out very well to date. There are programs in other countries that do a far better job proteciting humans than the ones in this country which are far too influenced by commercial interests which do not correlate to health.

  • Angela Brown

    This is supposed to be America and I strongly oppose any restriction on my right to pursue information or freedom to pursue health and happiness as I determine is best for me.
    There are many reasons for genetic testing such as desiring to best parent my adopted child while lacking adequate heritage information. I will be responsible for paying health care and other costs for my child and as a parent should have the right to access any related information.
    The government cannot know our individual situations and has no role in restricting our access to information as we see fit to pursue it.
    Unfortunately our government has a long history of inappropriate interference in the area of the health of it’s citizenry.. And from what I see that has not been working out very well to date. There are programs in other countries that do a far better job protecting humans than the ones in this country which are far too influenced by commercial interests which do not correlate to health.

  • Since when do law abiding sociopaths, get to control other persons [email protected]–so that the sociopaths can criminally “”profit”” from someone else’s health habits, superior nutrition,and commerically valuable biological molecules.American capitalism stands for one thing,…..sociopath- it alism.Sociopaths feel that everything valuable, magically belongs to them, when it actualy belongs to the rightful owner.

    • Christie Clark

      Law abiding sociopaths get to control other persons bodies? Okay, man. Let’s see…there’s prostitution? That’s generally a *law abiding sociopath* paying cash dollars for a wet hole…that belongs, and is attached to, a (generally speaking) living, breathing human being. Men pay large cash amounts for escort services. Escort services are, again (generally speaking) run by living, breathing human beings. Part of their cash dollars in turn go to the person(s) who own or operate the escort service. The owner operator, therefore, capitalizes (turns a profit) off of the health, nutrition and biological molecules of said prostitute. Almost like ownership. Which in turn, creates a proprietorship. GLOBAL SOCIOPATHS (Ahem…) in every nation contribute to prostitution and often unwilling marketing participants are beaten to death or die from disease or other reasons. Unfortunately, the members of the PROPRIETORSHIPS are not always willing to participate. Therefore, the contract is obsolete, or non-existent., although the act continues. Thousands of young women are forced into sexual slavery every year all around the world. Capitalism, false “ownership”, making a dollar off human beings (intellectual – physical – or otherwise) is not exclusive to Americans. There is a global blanket of corruption that has blinded those attuned to it.

  • Greta Wanyik

    There is nothing wrong to check your DNA to find out your ancestries , however to use it so the insurances can benefit from it , is questionable. It is important to know if you carry a gene for breast cancer so you can be proactive and may save your life. Or the possibility that you carry a gene for other debilitating diseases that you can pass on to your children with all the miseries that it can bring. I is better to know and be proactive.

  • janice palma-glennie


    The FDA’s stance on genetic testing could drive up healthcare costs and, most important, infringe upon my personal freedom and privacy. Besides premiums being raised on those forced to report DNA results to insurance companies, in-office testing is far more expensive. As tests are priced anywhere from $300 to $3,500, this could significantly add to the overall cost of healthcare.

    It’s also worth noting that FDA action against 23andMe was sparked, in part, by a complaint by UnitedHealth Group, the largest publicly traded health insurer. UnitedHealth isn’t exactly an unbiased observer—they want access to information about your DNA. After all, if individuals were allowed to keep their DNA test data private, they wouldn’t have to share their results with insurers who, for example, could use an inherited health risk to deny insurance or charge exorbitant rates.

    My DNA is mine. If anyone is going to know the complexities of its messages, let it be me– not insurers.

  • James

    What right does government have to restrict the information a citizen can obtain about his own body? What right does government have to control how or even whether a citizen treats his own body to repair his health? And when did it become illegal to treat oneself with whatever remedy one decides is appropriate for oneself? They are still our own bodies, aren’t they? And if that’s still true, then when did Americans begin to accept that Big Brother should have his say in how we care for them?

    The idea that government should have any control at all in how individuals use and maintain their bodies, an idea expressed with vague negative connotations in the term “self-treating,” goes well beyond the overreaching of a paternalistic nanny state and steps squarely into tyranny: for an external authority to control what a person does with his own body and what goes on inside it is the very definition of slavery. Right?

    FDA should have NO input whatsoever regarding the range of information that market sources may make available to persons seeking to learn more about their own bodies.

    Government officials who advocate such restrictions on the ability of citizens to obtain information about themselves and choose treatments on their own authority should be removed from office immediately; for they have no business occupying positions of responsibility in a government ostensibly constituted to serve the needs and protect the liberties of people in a free society.

  • Norma Wiliams

    We have the right to manage our own health needs without interference from government or insurers

  • What in the world gives YOU the right to forbid ME from testing MY own DNA? Quit doing the bidding of Insurance companies (even though you make billions from big Pharma).

  • Trudi Trevara

    I’m left speachless and appalled, what has happened to our democracy?? Come on folks, we have got to join together, unite to re-establish our rights, from chemicals being dumped into our drinking water, our food supply being contaminated and genetically modified or exposed to radiation and pesticides, hormones, and antibiotics, and forced vaccinations and we can’t seem to see ourselves clear of mercury loaded dental fillings. The FDA, major agricultural, & big Pharmaciticals have become meaner, nastier and more hateful to humanity than Adolf Hitler in the human experiments he conducted without concent or even the kindness of anesthia. We have been anesthetized by the propaganda of being the greatest nation and the promise of prosperity, neither of which are any longer truly in evidence. Shut off your TV’s!! Throw away your FrankinFoods, educate yourselves, and become activists to save democracy and the United States for our people! ThankU, Namaste

  • philip schings

    dear sir

    the FDA can go to h if i want to test my DNA i will do so. who give then the right to tell me i can’t get my DNA tested. i don’t trust the FDA because they take kick back from the drug company. Than
    the FDA tell me that natures things are not go.

  • Ossie Sharon, M.S.

    With all due respect, the type of information provided by “23andMe” should be addressed by healthcare professionals, just as some blood tests are addressed with physicians. It can be powerful information that can make or break someone’s health, and if the company does not believe that, they have no business being in business. The model of their competitor, Nutrigenomix, is based on licensed guidance, and is simply more effective.

  • k

    Not allowing people to have access to their own DNA is a crime. Stop micro managing our health for the sole purpose of financial gain through control, and let us have the freedom to acquire our personal information .

  • FDA is way out-of-line with that stance! Time to write their Mission Statement anew, and clean house in their managerial ranks.

  • Bettina Herbert

    While I agree with your premise, the facts are that as of January 1, 21014, thanks to the Affordable Care Act, pre-existing conditions will no longer be a basis for denying insurance. Please correct this in your email, as the error will lessen your other good argument.

  • Bettina Herbert

    While I agree with your premise, the facts are that as of January 1, 21014, thanks to the Affordable Care Act, pre-existing conditions will no longer be a basis for denying insurance. Please correct this in your email, as the error will weaken your other good argument.

    • Jennie R.

      I agree with Bettina,

      I am absolutely against the FDA trying to control DNA testing, but that part of your argument that healthcare agencies will use DNA info to deny health coverage or raise rates does not make sense now that one can get coverage regardless of pre-existing conditions.

      thanks, Jennie

      • wvhillbilly

        Yes, you can get coverage for pre-existing conditions—IF you can afford four figure premiums and five figure deductibles…

    • Sam

      while that may be true, it is still true that insurance companies will do anything possible to raise the costs of the premiums to the person and they will also do anything possible to deny a claim and keep the money. they will allow you to “dispute” the refusal to pay, however all this is is a stalling tactic to keep the money in their bank account longer. if they keep it longer, it earns more interest/money for them longer, blah blah blah. Insurance and “health care” are big business. Don’t be delusional enough to believe other wise.

      • Sophystra

        Sam is right. My family and I are both involved in the healthcare system, and mostly it’s about saving money. It’s a twisted circle that begins with the patient seeking help and unwittingly being taken advantage of every step of the way. I’ve seen pill mills, Dr. shopping, and of course insurances, who on a dime will tell a transplant patient they’re no longer covering their medicine. The leaders of the healthcare system want people to have health problems and they want the people to have to pay through the nose to cure their ailments. Of course, to top it all off, there is not one drug without possibility of severe reactions, so there you go.

    • Amy

      Yes thanks to the Affordable Care Act, pre-existing conditions will no longer be a basis for denying insurance. However, you may not be able to afford the insurance rate that is exorbitant due to your pre-existing conditions!

    • Hi all–Thank you so much for your comments! It is true that under the Affordable Care Act, health insurance companies will no longer be allowed to deny coverage or charge more for those with preexisting health conditions, EXCEPT in the case of grandfathered individual insurance plans. Many Americans are still covered under this type of plan.

      Best, ANH-USA


      • Trixie

        Under the link you provided, the term Grandfathered is said to mean individual plans that have been in effect since 2010 and have not made any significant (a rather subjective term) changes that reduces benefits or increases costs. I believe that charging a participant more for faulty DNA would result in losing Grandfathered status. Still, the personal right to DNA testing as well as the acceptance or rejection of what allopathic medicine has to offer, should be preserved. I dread the day that I cannot treat my own body by supplementation rather than by drugs. The prevailing medical ideology that I cannot take responsibility for my own health but must trust it to pharmaceutical companies makes no sense to me….except: Follow the Money.

  • Carol

    This is the biggest load of rubbish that I have ever heard of! Again, It’s all about government control, not concern for our health!

    • wvhillbilly

      It’s also all about greed, and greed is an insatiable monster that is never satisfied. The more a greedy entity gets, the more it wants, and there’s no end to its efforts to that end.

    • Jose_X

      It seems the issue is about misleading the public (what the FDA wants to stop) and not about having the tests done (which is still possible) without misleading interpretation. I agree with the FDA if that is the case.

  • 23andme will still do the testing, but will only provide raw data without interpretation. This is still extremely valuable, but you have to use a third party site to parse the data. Links to some of those sites on my blog.

  • John v K

    The FDA’s blatant conflicts of interest and demand for control is out of control. It is obvious that actual advances in healthcare treatment, true affordability, and privacy of information is even less than undesirable, perhaps disdainful to the FDA. The agency which was created to protect people and protects only the interests of corporations has lost its credibility and doesn’t care about that or anything other than its funding sources. What recourse is available to the “subjects” of an agency that has no accountability? For those who pay attention to the actions of the FDA there is little faith and even less trust. It has become a tyrannical entity, with no regard for its true purpose, ignoring scientific advances and crushing progress in general with unreasonable restrictions. This is no surprise given that the FDA is run by former high level Big Pharma executives, but to make matters worse, Big Phrama and Big Agri make campaign contributions to politicians, essentially buying their support. What can be said about this except that the FDA is corrupt and no one is going to do anything about it, least of all the Federal government or the FDA itself? Between the FDA and the “Affordable” Care Act, there is no hope for any progress in healthcare whatsoever.

  • Niels

    Consumer abuse, exploitation, & pure piracy plain & simple. This whole business model & concept is purely a human rights violation – nothing less. Why this business model is even permitted to exist at all in any market is beyond me. Our whole global business paradigm in every aspect imaginable could prosper exponentially – in reverse as a model for public benefit instead of personal gain for the few.

    • I think it should be a personal decision

    • growltigerkat

      Does this mean these tests are no longer being performed or can one still get a test. If how how can I contact them? Thanks.

      • Jackie

        Yes, you can still order the test from 23andMe. Go to their website. At this time you will only receive raw health data. But that’s fine. Once you receive the raw data, you can find a free or paid app to interpret your results.

  • TessaC

    We are Human capital. (Executive Order 13037). You don’t have the right to your DNA.

  • It seems to be all about the money. Deny insurance, save money. Office tests charge more. Of course, homeland security/FBI/NSA would love to get their grubby little hands on all information at the drop of a search warrent, or NOT!


  • shelly

    Oigionally the FDA got involved was because the results inaccurate. I know mine had very little correlation to my health issues. 99 % of my obvious health issues, such as asthma, were not found by 23&me. I’ve had it since age 5! other than for hobby 23&me was pretty useless. the only thing they got right on mine was eye color and blood type. On the other hand there were hundreds of things listed that, even at age 60, I have never had nor is there any sign I ever will have.

    We learned in school that America was a free country but the government would prevent monopoly. If you recall, in the board game there was 4 players. There was also ALWAYS 3 loosers.

    • Pot Luck

      Interesting reaction; mine is 180 degrees the opposite. Not only pegged exotic ancestry correctly, it managed to pick out not the diseases I would have been most likely to think of as dangerous to me but in fact what killed my father (I’m male) and which I had considered to be just a one-off event.

      I have been very impressed with it and have found it to be AT LEAST as capable of providing useful health information as my doctor has been. As an example, I went in to test for fatigue and even though I insisted my sleep pattern was fine–I NEVER have insomnia and can drop off–or stay awake–whenever I want–I had to fight my way out of the office to avoid being enrolled in a “sleep study.” More like a “wallet study” to find out what was available for picking.

      Note to the FDA: No matter what you do to try to drive me to the conventional medical model that is killing/bankrupting us, I WILL NOT comply past my own level of interest. If I have to live off of roots and grubs to avoid kowtowing to you and the medical monopoly, I will.

      In short: FDA, GO TO H!

    • Dorothy

      DNA testing will not show every medical diagnosis that you have. It only shows the ones that are “in your genes”. Most of the illnesses we have today are not actually inherited in the true sense of the word. They are from lifestyle. Before you get all bent out of shape thinking I am slamming your lifestyle hear me out.

      Anything that goes into our bodies either helps it or hurts it. Eating is not the only way to that things get into the body. The air we breath carries pollutants into our bodies. The fabric softener we use on our laundry gets into our bodies through our skin and through breathing the scent. The water we shower in can carry pollutants into our bodies through our skin. The bubble we live in, our personal space, has pollutants from nearly all areas of the earth.

      Then we get to what we eat. The additives (artificial sweeteners, colors, fragrances, preservatives, etc) and processing that are foods are subject to are a factor in our illnesses. Think you only eat organic so your food is safe? What about the GMO pollen that floats around and lands on your food plants then settle to earth to ruin your soil?

      Your DNA may become altered because of some of the environmental influences on your body but it cannot, at this time, show every illness that you have simply because they are not all inherited.

  • Gengis O’Toole

    the only thing you need to get FDA on our side is to get private industry (read here: Monsanto and the like) employees s out of the senior positions at the FDA. neither the Republicans or the Democrate have the _____ to say no to private industry.

  • brad

    DNA is over-rated. The expression of your genetics will vary tremendously depending upon what is available for your body to metabolize and process. The same genes will express differently if you have or are missing various amino acids, have or lack minerals, have or lack enzymes, etc.

    A geneticist studying stem cells at Stanford believes that your health is dictated only about 2% from your genetics, but the rest is determined by our subconscious attitudes. Positive people literally make healthier chemical pH which is more conducive to increased health. Personally this seems to trivialize biochemistry and nutrition more than it should.

    In the book EXPLODING THE GENE MYTH” the authors point out that MOST of what we are told are genetic breakthroughs are really not. You never get to see the retractions, just like when they insult of lie about people. So many times we read or hear that gene X on chromosome 24 or whatever, seems to indicate . . . . alcoholism, or macular degeneration, or X type of cancer, or whatever. i’ve heard claims to show depression and other mental issues. These are pretty much ALL LIES.

    When (as in Texas) many people near a town shared some of the same genetic code it was claimed that with many of the people having the same symptoms it proved that the genetic link was proven for that disease. Wrong. There were people with the exact gene sequence that never developed a hint of that disease. That invalidates the gene as the cause.

    Similarly, when people share the same disease, but do not share the same genetic strand to blame that disease on, they have just proven that the genes do not cause that illness.

    There is a political component here. Control issues regarding your health and your decisions over what you do and don’t do regarding YOUR body. There is an attempt to find stigma in all people due to genetic coding so that we can be divided and conquered. There are already (for over a dozen years) people denied insurance because of some genetic markers. The old eugenics programs are making a comeback as genetics. It is being used in fake science to manipulate, scare, define, limit, and pigeonhole everyone to the whims of the powers that be, but if you look at the rich people making all these damaging decisions against the defined genetic “problems”, you will find that THEY will also have “bad genetic” segments too. But YOURS will damage your lives. Theirs will never be witnessed.

  • Robert Wolfe

    A more likely reason to limit DNA testing is to keep us from finding the DNA of stuff they’ve put in us, like SV40, which was put in me. They don’t want me to live to be 101 like my great-great grandmother. Tough luck, I already found it and what kills it!