Kratom FDA

Lukas Knight filed this request with the Food and Drug Administration of the United States of America.
Tracking # 2016-1838
Status
Completed

Communications

From: Lukas Knight

To Whom It May Concern:

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

Any and all documents (internal memos, emails, etc.) pertaining to the risks and public health concerns of Kratom use and possibilities and benefits of regulation. Also requested are any general procedural guidelines for regulating "herbal" supplements/medicines/drugs.

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,

Lukas Knight

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.

From: Howard, Michael

Good morning Mr. Knight,

In reviewing your subject FOIA request (see above attachment), I need a date range for the researching for possible responsive records. For example (January 1, 2015 thru January 1, 2016). I appreciate if you can provide this language to me as soon as you can. Your request was previously place on "HOLD" for clarification pertaining to the "date range" when it comes to records search. My sincere apologies for my the delay in not contacting you sooner. I do understand you would like to be notified if there are charges prior to processing. FYI, you are under requester type N (media). If responsive records does exist you will be charged for duplication only with the first 100 pages free. More than likely the information (if available) will be sent to you electronically and there is no fee for that process.
Best regards,
Michael Howard
Freedom of Information Specialist
Food and Drug Administration
Center for Food Safety & Applied Nutrition
Office of Regulations Policy and Social Sciences
Freedom of Information Office
(240-402-2120)

From: Howard, Michael

Good afternoon Mr. Knight,

Please review the email string below. The CFSAN FOI Office is still awaiting a response from you on how you would you like to proceed moving forward on your subject FOIA request under control number 2016-1838. Could you please provide an update as soon as possible?
Best regards,
Michael Howard
Freedom of Information Specialist
Food and Drug Administration
Center for Food Safety & Applied Nutrition
Office of Regulations Policy and Social Sciences
Freedom of Information Office
(240-402-2120)

From: Howard, Michael

Good afternoon Mr. Knight,

The CFSAN FOIA Office has not received any new updates from our two previous emails forwarded from us to you (see clarification below). Due to the lack in responding and no other line of communication (telephone number) is being offered and/or duly noted in your request, We will consider your FOIA case closed if no reply is met in 10 business days (Friday, April 29, 2016).
Best regards,
Michael Howard
Freedom of Information Specialist
Food and Drug Administration
Center for Food Safety & Applied Nutrition
Office of Regulations Policy and Social Sciences
Freedom of Information Office
(240-402-2120)

From: Lukas Knight

Hello Mr. Howard,

Thank you for all your help in fulfilling this request! Records from January 1st, 2010 to the date at which the search is conducted would be sufficient; however, if this results in excessive fees I may refine the search to the past 1-2 years. Thanks again!

From: Wright, Sheila

Attn: Lukas Knight

This is the Center for Food Safety and Applied Nutrition's (CFSAN) final response to Lukas Knight's February 29, 2015 Freedom of Information Act (FOIA) request seeking copies of records related to "Kratom ..."

Attached are documents responsive to your request. Your request is granted in full.

Per your request the following information is pertaining to general guidance for regulating "herbal" supplements is publicly available at the ink below:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm

CFSAN considers your request closed. 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 me directly. 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

Thank you for your interst in CFSAN's polocies and programs.

Sheila Wright
FOIA Officer
CFSAN
Office of Regulations, Policy & Social Science
Food and Drug Administration
Room 1B-006
PH (240) 402-2812
[large-telephone-phone-classic-0-15657[1]]

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