FDA: Lion Nutrition Redux

An acknowledgement letter, stating the request is being processed.

2/5/2018
Dear Requestor,
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.
Room 729H
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 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

E-mail: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>.

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
Telephone: 202-741-5770
Toll free: 877-684-6448
Facsimile: 202-741-5769
E-mail: 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:

Search: $11.50; Review: $46.00: Total = $57.50

Sincerely,

Frances M. Seiner
FOIA OFFICER