Remarkably no such records exist.
Apparently the FDA engaged in this process without so much as a single sentence of documentation.
Recall the FDA made the claim at the time that e-cigs were "medical devices."
There are many interesting inferences here:
- No such records do exist.
- They are withholding them.
- They can't find them.
Of course we know that there are court filings so those must exist. But apparently not any more...
Here is part of the response: