FDA: Consumer Complaints on Selective Androgen Receptor Modulators

An acknowledgement letter, stating the request is being processed.

Dear Mr. Roberts,

This is in response to your November 3, 2017 Freedom of Information Act (FOIA) request to the Center for Food Safety and Applied Nutrition (CFSAN) seeking copies of records related to:

* CMPLTS FILED BY CONSUMERS OF DIETARY SUPPLEMENTS AGAINST ANY OTHER COMPANY FOR SELLING SELECTIVE ANDROGEN RECEPTOR MODULATORS 1/15 TO 10/2017

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 exemption (b)(6) of the FOIA 5 U.S.C. § 552, as amended and delineated below:

> 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.

Please be advised that your request may have been submitted to one or more component offices within FDA. These offices will reply to you directly. CFSAN considers your request closed.

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 samantha.wilde@fda.hhs.gov<mailto:samantha.wilde@fda.hhs.gov> or call 240-402-0003.

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,

Samantha Wilde
for

Sheila Wright
Government Information Specialist
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulations, Policy and Social Sciences (ORPSS)
U.S. Food and Drug Administration (FDA)
Tel: 240-402-0003
samantha.wilde@fda.hhs.gov<mailto:samantha.wilde@fda.hhs.gov>
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Dear Requestor,

The attached record(s) are being provided by the Office of Regulatory Affairs (ORA) Division of Information Disclosure Policy in response to your request 2017-9371 for record(s) from the Food and Drug Administration pursuant to the Freedom of Information Act regarding:

CMPLNTS FILED BY CONSUMERS OF DIETARY SUPPLEMENTS AGAINST ANY OTHER COMPANY FOR SELLING SELECTIVE ANDROGEN RECEPTOR MODULATORS 1/15 TO 10/17

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) and (b)(6) 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.

 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.

ORA considers your request closed. If you have any questions about this response, you may contact Andrew Miller at 301-796-5313.

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 person that worked on request. You may also contact the FDA 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 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: 202-741-5770
Toll-Free: 1-877-684-6448
E-mail: ogis@nara.gov<mailto:ogis@nara.gov>

Andrew R. Miller | Program Analyst | ORA Division of Information Disclosure Policy | U.S. Food and Drug Administration