You may or may not know that 23andMe was sent a letter by the FDA. If you have not been following this story, I suggest you read Fooling with FDA by the Legal Genealogist, Judy G Russell.
The bottom line for genealogists, is that nothing in the FDA letter deals with the genealogical research implications of DNA testing; the focus of the letter is with regards to DNA testing for health issues and claims made by 23and Me ...
The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).
This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body .... Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.
In response to this, a petition was posted on Change.org already signed by over 4300 individuals which exhorts ...
Reverse the ban on 23andMe's saliva home-testing kit, and focus future FDA efforts on educating doctors and patients about the benefits and limitations of genetic testing — rather than simply banning personal genomics products.
Now, 23andMe has been hit with a class action suit regarding misleading advertising. You can access the class action suit via this link.
Though we are not aware of any issues at all with regards to the genealogical aspect of the autosomal testing performed by 23andMe, we thought that you should be made aware of what is occurring with regard to the company and its DNA testing.
We suggest that you check the ISOGG (International Society of Genetic Genealogy) Facebook page, the blog of the Legal Genealogist and other news outlets to learn more about these actions as they unfold.
If you have any updated information, please post a comment!
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