FDA: Two Specific Kratom Studies

anthony roberts filed this request with the Food and Drug Administration of the United States of America.

It is a clone of this request.

Tracking # 2017-334
Est. Completion None
Status
No Responsive Documents

Communications

From: anthony roberts

To Whom It May Concern:

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

I am seeking all communications with or within the FDA that references either of the following studies:

Monitoring of kratom or Krypton intake in urine using GC-MS in clinical and forensic toxicology. Anal Bioanal Chem. 2011 Apr;400(1):127-35. doi: 10.1007/s00216-010-4464-3. Epub 2010 Dec 12. Philipp AA, Meyer MR, Wissenbach DK, Weber AA, Zoerntlein SW, Zweipfenning PG, Maurer HH. Department of Experimental and Clinical Toxicology, Institute of Experimental and Clinical Pharmacology and Toxicology, Saarland University, 66421 Homburg, Saar, Germany.

Forensic Sci Int. 2011 May 20;208(1-3):47-52. doi: 10.1016/j.forsciint.2010.10.025. Epub 2010 Nov 26. Kratom alkaloids and O-desmethyltramadol in urine of a "Krypton" herbal mixture consumer. Arndt T, Claussen U, Güssregen B, Schröfel S, Stürzer B, Werle A, Wolf G. Bioscientia, Institut für Medizinische Diagnostik GmbH, Ingelheim, Germany. torsten.arndt@bioscientia.de

This should include newsletters, emails, internal memorandum, and any other documents or communications that indicate that either of these studies, or both, are in possession by the agency, and when the agency came into said possession.

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

An acknowledgement letter, stating the request is being processed.

From: Wilde, Samantha

Dear Anthony Roberts,

This is in response to your January 11, 2017 Freedom of Information Act (FOIA) request for records pertaining to:

* KRATOM OR KRYPTON INTAKE IN URINE USING GC-MS IN CLNCL & FORENSIC TOXICOLOGY

The Center for Food Safety and Applied Nutrition (CFSAN) conducted a search and is unable to locate any records responsive to your request. CFSAN considers this request closed.

While we believe that an adequate search of appropriate files was conducted for the records you requested, you have a 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:

Ms. Catherine Teti
Deputy 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

Please clearly mark both the envelope and your letter "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 HHS FOIA Public Liaison for assistance at:

Michael Bell
HHS FOIA Public Liaison
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
Telephone: (202) 260-0793
E-mail: HHS_FOIA_Public_Liaison@hhs.gov<mailto:HHS_FOIA_Public_Liaison@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:

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>
Fax: 202-741-5769

Sincerely,
Samantha Wilde
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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