My comment from the same story on reddit.

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.