The FDA’s warning letter to 23andMe, the maker of mail-order genetic tests, highlights the challenging legal and ethical issues posed by such products.  While the FDA’s letter focuses on charges that (a) 23andMe’s DNA collection kit is an adulterated Class III medical device because it has not obtained prior regulatory clearance, and (b) the product is misbranded because 23andMe has failed to provide adequate evidence that its product provides accurate results, the situation raises additional questions.

For example, should direct-to-consumer medical genetic testing (DTCMGT) be regulated as “the practice of medicine”?  To date, DTCMGT, which takes place outside of the traditional medical setting, has not been subjected to state law regulatory requirements applicable to “the practice of medicine” imposed on medical providers.  Such requirements could assure involvement of a genetics professional in the testing, which could reduce risks of inadequate informed … Read More »