Redcon1 Arimistane (ANDROSTA-3,5-DIENE-7,17-DIONE) (Food and Drug Administration)
| Tracking # |
2022-3955 FDA22083757 |
| Multi Request | Redcon1 Arimistane (ANDROSTA-3,5-DIENE-7,17-DIONE) |
| Submitted | May 17, 2022 |
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Communications
From: Anthony Roberts
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
All documents concerning Arimistane (also called “ANDROSTA-3,5-DIENE-7,17-DIONE”) that have been composed, created, produced, sent, or received, between the dates of May 10th, 2016, and May 17th, 2022. This is a general request and should be construed as such, but should be construed with additional specificity to include the Redcon1 products known as "Shield" and "Aftermath." (See Attached photos/files which show Redcon1 labels listing the aforementioned as an ingredient). This should include but not be limited to emails, both intra-agency and external, reports, trade complaints, consumer complaints, adverse reaction reports, prosecutions, warning letters, memorandum, records, warnings, emails, papers, advertisements, evidence, recalls, depositions, interviews, case notes, schedules, enforcement actions, white papers, GRAS and/or NDI Notifications, accompanying support to the NDIN documents, responses to those NDINs, and incident reports.
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: FDA22083757
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant 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
Control number: 2022-3955
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail
From: Food and Drug Administration
Good morning Ms. Roberts
Please find attached final responsive letter for FOIA request 2022-3956 as well as final responsive letter as well as responsive documents for FOIA request 2022-3955. I apologize for the inconvenience
Please confirm upon receipt, if you have any question please don't hesitate to contact me.
Thank you and have a great day.
From: Food and Drug Administration
Good morning Mr. Roberts
Please find attached responsive final letters as well as responsive documents for 2022-3398.
If you have any questions please don't hesitate to contact me. I apologize for any inconvenience that may have been caused during the delay in you receiving the responsive files.
Please also confirm upon receipt of this email.
Thank you
From: Food and Drug Administration
requests@muckrock.com<mailto:requests@muckrock.com>
Attention: Anthony Roberts
This is in response to your June 1, 2022, Freedom of Information Act (FOIA) request to the Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN) seeking,
"All documents concerning Arimistane (also called "ANDROSTA-3,5-DIENE-7,17-DIONE") that have been composed, created, produced, sent, or received, between the dates of May 10th, 2016, and May 17th, 2022."
Attached are documents responsive to your request. Your request is granted in part. After a thorough review of the responsive records, we have determined that portions of the documents are exempt from disclosure under FOIA exemptions (b)(5) of the FOIA 5 U.S.C. § 552, as amended and delineated below.
* Exemption (b)(5) permits the withholding of inter-agency or intra-agency communications records which are part of the deliberative process and pre-decisional. Disclosure of such material could inhibit the open and candid expression of opinions and diminish the quality of the decision-making process.
In determining to withhold such information, FDA considered 5 USC 552(a)(8)(i), when applicable, and whether FDA reasonably foresees that disclosure of such information would harm an interest protected by the relevant exemption(s) and whether disclosure is prohibited by law.
CFSAN considers your request closed. You have the right to appeal this determination. Your appeal should clearly identify the agency determination that is being appealed. It would be helpful if you provide specific reasons explaining why you believe the agency's adverse determination should be reconsidered. 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: Director, Office of the Executive Secretariat, U.S. Food & Drug Administration, 5630 Fishers Lane, Room 1050, Rockville, MD 20857, or emailed within 90 days from the date of this response to FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>. Please clearly mark both the envelope and your letter "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 Dillon.Ainsworth@fda.hhs.gov<mailto:Dillon.Ainsworth@fda.hhs.gov> or by telephone 240-402-1947. 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>.
Please do not submit payment until you receive an invoice. The following charges for this request to date may be included in a monthly invoice:
Reproduction $0.00 Search $0.00 Review $0.00 Other $0.00 Total $0.00
Sincerely,
Sheila Wright
FOI Officer
Office of Regulations and Policy
Center for Food Safety and Applied Nutrition
Tel: 240-402-2812
[cid:image001.png@01D9C461.D7726310]<http://www.fda.gov/>
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