FDA: Unsent Warning Letters

Anthony Roberts filed this request with the Food and Drug Administration of the United States of America.
Tracking #

FDA1844877

Status
Completed

Communications

From: Anthony Roberts


To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

I am seeking emails, memorandum, and correspondence that reference FDA warning letters, withheld from being sent to government witnesses and informants, from January 1st, 2014 to June 15th, 2018.

I have obtained court documents (USA v. Patel. 1:16-cr-00034-JPJ-PMS Document 132)
revealing that the FDA failed to send a warning letter to the owner of Serious Nutrition Solutions, as a benefit of his cooperating with the government. I specifically request all communications regarding this unsent letter, and generally all similar instances regarding other dietary supplement companies, through the aforementioned dates.

My request is therefore, for all such withheld warning letters and documents, plus all discussions/communications that reference the withholding of those letters.

I also hereby request all communications with the dietary supplement firms in question, who received the benefit of an unsent warning letter.

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

*** This is an automated message. Please do not reply to this email. ***

Reference: FDA1844877
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administrationpursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request. If your request is not sufficiently described,or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.

From: Food and Drug Administration

Note: Do NOT reply directly to this E-mail
Anthony Roberts Anthony Roberts
Re: Confirmation # FDA1844877
In Reply refer to: 2018-5530
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
SERIOUS NUTRITION SOLUTIONS - RECS RE WARNING LETTER; RECS RE UNSENT WARNING LETTERS DIETARY SUPPLEMENTS
Original Subject: I am seeking emails, memorandum, and correspondence that reference FDA warning letters, withheld from being sent to government witnesses and informants, from January 1st, 2014 to June 15th, 2018. I have obtained court documents (USA v. Patel. 1:16-cr-00034-JPJ-PMS Document 132) revealing that the FDA failed to send a warning letter to the owner of Serious Nutrition Solutions, as a benefit of his cooperating with the government. I specifically request all communications regarding this unsent let...
We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see
http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm. If you have any questions about your request, please call Wilson M. Russ, Freedom Of Information Specialist at (301) 796-8981 or write to us at: (http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm)
Division of Freedom of Information, U.S. Food and Drug Administration
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Fax:(301)827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov and/or:
Office of Government Information Services
National Archives and Administration
8601 Adelphi Road ? OGIS
College Park, MD 20740-6001
Telephone: 202-741-5770
Toll-Free: 1-877-684-6448
E-mail: ogis@nara.gov
Fax: 202-741-5769

From: Food and Drug Administration

Dear Mr. Roberts,

This is in response to your July 9, 2018, Freedom of Information Act (FOIA) request for records pertaining to SERIOUS NUTRITION SOLUTIONS - RECS RE WARNING LETTER; RECS RE UNSENT WARNING LETTERS DIETARY SUPPLEMENTS.

The Center Food Safety and Applied Nutrition (CFSAN) conducted a search and did not locate any records responsive to your request. Therefore, we are closing our file on this case.

While we believe that an adequate search of appropriate files was conducted for the records you requested in CFSAN, you have the right to appeal this determination. By filing an appeal, you preserve your rights under FOIA and give the agency a chance to review and reconsider your request and the agency's decision. Your appeal must be mailed within 90 days from the date of this response, to: Agency Chief FOIA Officer, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Public Affairs, Room 729H, 200 Independence Avenue, S.W., Washington, DC 20201; e-mail FOIARequest@PSC.hhs.gov<mailto:FOIARequest@PSC.hhs.gov>. Please clearly mark both the envelope and your letter or e-mail "FDA Freedom of Information Act Appeal."

If you would like to discuss our response before filing an appeal to attempt to resolve your dispute without going through the appeals process, please contact Melissa.McIntosh-Ball@fda.hhs.gov<mailto:Melissa.McIntosh-Ball@fda.hhs.gov> or 240-402-9215. You may also contact the FDA FOIA Public Liaison for assistance at: Office of the Executive Secretariat, US Food & Drug Administration, 5630 Fishers Lane, Room 1050, Rockville, MD 20857, E-mail: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>.

If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information Services (OGIS), the Federal FOIA Ombudsman's office, offers mediation services to help resolve disputes between FOIA requesters and Federal agencies. The contact information for OGIS is as follows: Office of Government Information Services, National Archives and Records Administration, 8601 Adelphi Road-OGIS, College Park, MD 20740-6001; telephone at 202-741-5770; toll free at 1-877-684-6448; or facsimile at 202-741-5769; e-mail at ogis@nara.gov<mailto:ogis@nara.gov>.

Kimberly Jones

for

Melissa McIntosh-Ball
Government Information Specialist
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulations and Policy (ORP)
U.S. Food and Drug Administration
Tel: 240-402-9215
Melissa.McIntosh-Ball@fda.hhs.gov<mailto:Melissa.McIntosh-Ball@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>

From: Anthony Roberts

As I am in possession of court documents (referenced in my original correspondence) that directly reference the documents I am seeking, we will need to figure out where they are.

From: Food and Drug Administration

*** This is an automated message. Please do not reply to this email. ***

Reference: FDA1952314
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administrationpursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.

From: Food and Drug Administration

Note: Do NOT reply directly to this E-mail

MUCKROCK Anthony Roberts

Re: Confirmation # FDA1952314
In Reply refer to: 2019-3671

The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:

I am seeking emails, memorandum, and correspondence that reference FDA warning letters, withheld from being sent to government witnesses and informants, from January 1st, 2014 to June 15th, 2018

Original Subject: To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: I am seeking emails, memorandum, and correspondence that reference FDA warning letters, withheld from being sent to government witnesses and informants, from January 1st, 2014 to June 15th, 2018. I have obtained court documents (USA v. Patel. 1:16-cr-00034-JPJ-PMS Document 132) revealing that the FDA failed to send a warning letter to the owner of Serious Nutrition Solutions, as a benef...

We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm. If you have any questions about your request, please call Rochelle A. Coleman, Information Technician at (301) 796-8982 or write to us at: (http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm)

Division of Freedom of Information, U.S. Food and Drug Administration
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Fax:(301)827-9267

You also have the right to seek dispute resolution services from:

FDA FOIA Public Liaison
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857

E-Mail: FDAFOIA@fda.hhs.gov and/or:

Office of Government Information Services
National Archives and Administration
8601 Adelphi Road ? OGIS
College Park, MD 20740-6001

Telephone: 202-741-5770
Toll-Free: 1-877-684-6448
E-mail: ogis@nara.gov
Fax: 202-741-5769

From: Anthony Roberts

Per my original email, I know these records exist. I’ve provided proof in the form of referencing court records that they exist. Can I please have an estimate on when I should expect to receive them?

From: Food and Drug Administration

A fix is required to perfect the request.

From: Anthony Roberts

I am still waiting on this request. I timely replied to your last communication and it is now approaching two years since filing this request. Should you wonder if I sill want these documents, you needn’t send another communication to that’s effect, as the answer is yes, as it was last time (and the dozen other communication s before that, plus the multiple phone calls and conversations), and the numerous times I rearticulated, with particularity, the documents being requested, and the reasons for the request and why the public ought to know the details of a government informant being allowed to sell dietary supplements that have been deemed unsafe by FDA.

From: Food and Drug Administration

Records were sent for this request in March and April 2020. The file is closed. Update your system.

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