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Old November 27th 13, 01:36 PM posted to
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Default FDA Bans Genetic Testing by 23andme

The United States Food and Drug Administration has gone way over the top by banning genetic testing by 23andme.

The letter from the FDA is posted online at

However, the FDA has far exceeded its legal authority. The letter from the FDA says, "23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”

However, 23andme does not market a "device". It is a simple test tube commonly available at any medical supply or high school science supply store. One simply spits in the tube, seals it with a stopper and mails it in. The mailing box with a bar code on it simply prevents it from getting mixed up with the many thousands of other similar test tubes mailed being in. There is no possible health risk to the procedure. I do not see how the FDA has jurisdiction to ban it.

The FDA claims that it has jurisdiction to do so because it has the authority to ban any device used in the "diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease". However, 23andme does not diagnose or treat any disease. What it does instead is test millions of people who have sent in their saliva samples and then tries to find which DNA types are more likely to get which diseases. It does not tell you weather you have the disease or not. It just tells you to be on the lookout if your particular DNA type makes you more likely than average to get this disease.

It has long been known that certain racial or ethnic groups are more likely than others to get certain diseases. Anybody can think of examples of this.. Does the FDA propose to ban all racial profiling for certain kinds of diseases?

More than that, the FDA says that there needs to be more research before linking certain DNA types to certain diseases. However, 23andme is doing that very research in the only way it can be done. 23andme is in the process of collecting DNA samples from millions of people. Only by sequencing their DNA can it be determined which DNA types are more prone to which diseases. Does the FDA propose to ban all genetic testing?

Most subscribers to 23andme including myself use the test results for an entirely different purpose, which is to find out who their relatives and ancestors are.

A letter to Scientific American says "a few techno-libertarians are up in arms over the FDA’s letter warning the genetics company 23andMe to stop selling its personalized genome services kit." However, the Libertarian Party has not taken up this issue. It should do so.

Sam Sloan
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