So in February, as I wrote here, I made a FOIA request (Freedom of Information Act) to the FDA for
“All
FDA scientific records, evidence, emails, and expert data related to the decision to block NJOY
(April 15, 2009) and other e-cigarette importers as detailed in SOTTERRA INC NJOY V. FOOD
DRUG Administration.”
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:
Of course we know that there are court filings so those must exist. But apparently not any more...
Here is part of the response:
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:
You filed the FOIA with CTP -- but that office didn't have anything to do with the 2009/10 seizures. In fact, it didn't even exist yet. The Sottera actions were taken by the Center for Drug Evaluation and Research (CDER).
ReplyDeleteRefile your FOIA with that FDA office.