FDA: All Kratom New Dietary Ingredient Notifications

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




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 New Dietary Ingredient Notifications filed for kratom (Mitragyna speciosa Korth aka ketum) and kratom-related (i.e. extracts, concentrates, etc...) products, the FDA's responses, and all documents included in the notification, plus response letters from the FDA, between January 1st, 2015 through the present date (Monday, March 20th, 2017).

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.


anthony roberts

From: Food and Drug Administration

An acknowledgement letter, stating the request is being processed.

From: Wright, Sheila


These have already been reviewed by you as they have been provided to Mr. Roberts before for other request.

Dear Mr. Roberts,

This is in response to your March 21, 2017 Freedom of Information Act (FOIA) request to the Center for Food Safety and Applied Nutrition (CFSAN) seeking copies of records related to:


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) and (b)(4) of the FOIA 5 U.S.C. ยง 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.

> Exemption (b)(4) permits the withholding of "trade secrets" (TS) and "commercial confidential information" (CCI). Disclosure of this information would impair the government's ability to obtain necessary information in the future and cause substantial harm to the competitive position of the person from whom the information was obtained. Under the balancing test of this exemption, we are withholding all proprietary information identified as TS and CCI.

CFSAN considers your request closed.

If you have reason to believe that the information withheld should not be exempt from disclosure, 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:
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 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:

Office of Government Information Services
National Archives and Records Administration
8601 Adelphi Road-OGIS College Park, MD 20740-6001

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


Sheila Wright
FOIA Officer
Center for Food Safety & Applied Nutrition
Office of Regulations, Policy & Social Science
Tel: 240-402-2812

From: anthony roberts


Thanks so much for your help with this request! I really appreciate it.

anthony roberts