5 ms·

The tone of the letter was surprising to me. I wouldn't expect the FDA to go quite so far in explaining the why behind the desist letter. I suppose that's becau

• rayiner 13y ago
  It's written for consumption by 23andMe's lawyer. This format is typical.
• jfasi 13y ago
  The most common sort of cease and desist letters we tech people are accustomed to are DMCA and patent-related. These letters are typically meant as precursors to private litigation. They are often sent out with commercial considerations in mind, and so tend to be light on details in order to be more threatening. The FDA is a regulatory agency, which implies that their mission is less about intimidation and more about protecting the public good. Hence the more open tone, I suspect.
• dragonwriter 13y ago
  > The tone of the letter was surprising to me. I wouldn't expect the FDA to go quite so far in explaining the why behind the desist letter. Its fairly typical of formal regulatory notices (or even informal notices -- much of the language is very similar to the 2010 letter in which the FDA first raised issues with the product) -- because they are typically directed at corporations with substantial legal resources and they are designed to convince them that they should voluntarily comply with the agencies direction because if they fail to do so regulatory action will be initiated which will be costly and unlikely to be reversed by subsequent litigation, so they lay out all the facts and authorities necessary for the recipient (and the recipient's counsel) to come to the desired conclusion.