|Submitted||Jan. 23, 2018|
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To Whom It May Concern:
This is a request under the Freedom of Information Act.
In September of 2009 I filed a Freedom of Information Act request on Lion Nutrition (request Number: 2009-8071). Although the requested documents were confirmed to exist (one investigation file), the entire request was denied on October 21, 2009, on the grounds that disclosure of the requested information could reasonably be expected to interfere with law enforcement proceedings.
In 2013, the owner of the company named in my 2009 FOIA request entered a plea of guilty, in which he admitted to operating:
"... an internet-based business called Lion Nutrition which sold drugs, purchased from China, which he knew would be taken by humans orally or through injection as bodybuilding and performance enhancing supplements...[and] knew that these drugs were misbranded and unapproved by the FDA on for human consumption."
Accordingly, as the investigation is clearly finished and my request can no longer reasonably be expected to interfere with law enforcement proceedings, I am requesting the investigation file denied in my 2009 FOIA request, plus all additional information gathered on Lion Nutrition through the April 15, 2013 guilty plea.
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.
An acknowledgement letter, stating the request is being processed.
The attached record(s) are being provided by the Office of Regulatory Affairs (ORA), Office of Criminal Investigations, in response to your request 2018-699, for records from the Food and Drug Administration pursuant to the Freedom of Information Act regarding:
LION NUTRITION DOCS
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 exemption (b)(6) and (b)(7) of the FOIA 5 U.S.C. § 552, as amended and delineated below:
Ø Exemption (b)(6) permits the withholding of information which, if released, would constitute a clearly unwarranted invasion of personal privacy. In this case, it was determined that there is no countervailing public interest qualifying under the standard set forth, under exemption (b)(6), to release the personal identifying information of certain third parties.
Ø Exemption (b)(7) protects from disclosure "records or information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information (A) could reasonably be expected to interfere with enforcement proceedings, (B) would deprive a person of a right to a fair trial or an impartial adjudication, (C) could reasonably be expected to constitute an unwarranted invasion of personal privacy, (D) could reasonably be expected to disclose the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution which furnished information on
a confidential basis, and, in the case of a record or information compiled by a criminal law enforcement authority in the course of a criminal investigation, or by an agency conducting a lawful national security intelligence investigation, information furnished by a confidential source,
(E) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law, or (F) could reasonably be expected to endanger the life or physical safety of any individual.
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
200 Independence Avenue, S.W.
Washington, DC 20201
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 Fran Seiner at Office of Criminal Investigations. You may also contact the FDA FOIA Public Liaison for assistance at:
Office of the Executive Secretariat
U.S. Food & Drug Administration
5630 Fishers Lane, Room 1050
Rockville, MD 20857
If you are unable to resolve your FOIA dispute through the releasing agency or the FOIA Public Liaison's office, the Office of Government Information Services (OGIS) - Federal FOIA Ombudsman 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
Toll free: 877-684-6448
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:
Search: $11.50; Review: $46.00: Total = $57.50
Frances M. Seiner
Thanks so much for your help with this request! I really appreciate it.