FDA: Super DMZ Warning Letter
| Tracking # |
2018-759 |
| Submitted | Jan. 25, 2018 |
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Communications
From: Anthony Roberts
To Whom It May Concern:
This is a request under the Freedom of Information Act.
I am seeking all documents (including emails, memorandum, files, trade complaints, consumer complaints, and anything) related to the FDA Warning Letter sent to Ironmag Labs, dated October 23, 2017 (unique identifier 494623):
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm582464.htm
These documents are being requested in an effort to ascertain why FDA sent a warning letter on a product that hadn't been sold in years. The product in question is the subject of ongoing civil litigation (Nutrition Distribution v. Ironmag Labs). I would therefore like to examine the provenance of this warning letter, specifically to know whether it was influenced by the litigation, and more specifically if FDA sent the letter as a result of being aware (or being made aware of) or in direct response to being provided information about the lawsuit or product, by Nutrition Distribution or their legal representation, and/or at the direct request of Nutrition Distribution (who subsequently relied on the letter in a successful appeal to the Ninth Circuit Court).
The requested documents will be made available to the general public, and this request is not being made for commercial purposes.
In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.
Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.
Sincerely,
Anthony Roberts
From: Food and Drug Administration
An acknowledgement letter, stating the request is being processed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information request, copied below, and originally submitted on Jan. 25, 2018. Please let me know when I can expect to receive a response, or if further clarification is needed. You had assigned it reference number #2018-759.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Dear Requester,
Attached, please find documents in read to your request.
Respectfully,
Tracey D. Taylor
Legal Instruments Examiner
FOIA West
Division of Information Disclosure Policy
Office of Strategic Planning and Operational Policy
Office of Regulatory Affairs
U.S. Food and Drug Administration
4040 N. Central Expressway, Suite 300
Dallas, TX 75204
T: 214-253-5294
Traceyd.taylor@fda.hhs.gov<mailto:Traceyd.taylor@fda.hhs.gov>
[cid:image001.png@01D20E70.82D77510]<http://www.fda.gov/>
[cid:image002.jpg@01D20E70.82D77510]<https://www.facebook.com/FDA> [cid:image003.jpg@01D20E70.82D77510] <https://twitter.com/US_FDA> [cid:image004.jpg@01D20E70.82D77510] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D20E70.82D77510] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D20E70.82D77510] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Anthony Roberts
Thank you for your help with this request, and I appreciate the documents you’ve sent, but I specifically asked to see the provenance of this warning letter. In other words, I’m asking to see it’s lineage, specifically what catalyzed the letter, i.e. since it was no longer being sold for a couple of years, I want to seeexactly what prompted the warning letter. I’m looking for communications on this topic to and from the field office who issued the letter, as well as any communications that mention this compound from all of the FDA employees named on the letter.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following request, copied below. Please let me know when I can expect to receive a response.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Jan. 25, 2018. Please let me know when I can expect to receive a response. You had assigned it reference number #2018-759.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good afternoon,
Attached are the responsive records for FOIA Request 2018-759.
Thank you,
Wilson M. Russ
Government Information Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8981
wilson.russ@fda.hhs.gov<mailto:wilson.russ@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>
[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
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