Import Alert 54-15

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




From: John VanOphem

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

Please provide all evidence relied upon and supporting FDA's decision to issue Import Alert 54-15.

The requested documents will be made available to the general public. 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 prefer the request be 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.

John VanOphem

From: Food and Drug Administration

Good afternoon:

FYI, our acknowledgement letter, as attached, was sent to you by mail and it was returned from the post office undelivered:

Please let us know of there is any change in your address.

Thank you.

Shera Behram
Billing Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8983<>


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From: Food and Drug Administration

Dear John VanOphem via Muckrock News,

Please find the production related to your request by FDA's Office of Enforcement and Import Operations, Division of Import Operations. Please refer to the attachments if you have any questions/concerns. Thank you!

S. Max Brewster, MBA | Division of Import Operations (OEIO) | Office of Regulatory Affairs | US Food and Drug Administration |301-796-8994|<>

From: Food and Drug Administration

Attn: Mr. VanOphem:

This is in response to your January 18, 2018 Freedom of Information Act (FOIA) request to the Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN) seeking all evidence relieved upon and supporting FDA's decision to issue Import Alert 54-15.

Attached are documents that relates to a previous final response under FOI control number 2015-2586. They are being released in part. After a thorough review of the responsive records, we have determined that portions of the documents were exempt from disclosure under exemptions (b)(5) of the FOIA 5 U.S.C. ยง 552, as delineated below. CFSAN considers this request closed.

Exemption (b)(5) permits the withholding of inter-and intra-agency records which are pre-decisional, and in this case, includes documentation of the deliberative process privilege. Disclosure of such material would inhibit the open and candid expression of such views in similar future deliberations and have a detrimental effort on our decision-making process.

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<>. 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 Michael Howard (<>) or at 240-402-2120. 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:<>.

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<>.

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

Best regards,
Michael Howard
Government Information Specialist
Center for Food Safety & Applied Nutrition
Office of Regulations & Policy
PH (240) 402-2120<>

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