FDA: Evidence of Claims in 2/6/2018 Kratom Press Announcement

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 #

2018-1126

Est. Completion None
Status
Fix Required

Communications

From: Anthony Roberts

To Whom It May Concern:

Under the Freedom of Information Act, I hereby request copies of all evidence, validating documents, white papers, analysis, lab tests, and related proof, that the FDA relied upon when making all claims about kratom found in this press announcement:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm595622.htm

Therefore, I seek all evidence and documentation relied upon in the drafting and publication of the aforementioned press release, to support the following statements, made by the FDA:

"....we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence...”

I would like to see the “computational model,” i.e. the code, script, software, or algorithms FDA used here. I also want to see the raw evidence it generated plus the methodology used to interpret it.

FDA has identified the aforementioned model as “Public Health Assessment via Structural Evaluation (PHASE) methodology” - and claimed that “... 3-D computer technology” was used to determine, with regards to Kratom “... how the chemical constituents... are structured at a molecular level, how they may behave inside the body, and how they can potentially affect the brain.”

Under the Freedom of Information Act, I hereby request copies of the 3D models of Kratom, including their structures, and the resulting data on how they behave inside the body/affect the brain.”

I am also requesting the results obtained by FDA that predict Kratom’s “biological function in the body,” and how it “...will affect various receptors in the brain based on...chemical structure and its similarity to controlled substances for which data are already available.”

I am further requesting the analysis, steps, methodology, lab tests, notes, memorandum, and computations that led FDA to this conclusion:

“From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.”

I would like copies of all data referenced and used to provide the evidence mentioned here:

“The new data provides even stronger evidence of kratom compounds’ opioid properties.”

I would like a copy of the model of receptor binding referenced, plus the references relied upon or cited to draw the conclusions and predictions made in the following statement:

“The computational model also predicted that some of the kratom compounds may bind to the receptors in the brain that may contribute to stress responses that impact neurologic and cardiovascular function.”

I further request all of the FDA’s data on Kratom and respiratory depression and seizures per this claim:

“The agency has previously warned of the serious side effects associated with kratom including seizures and respiratory depression.”
In addition, regarding the following statement:

“We also have learned more about deaths that involved kratom use, and have identified additional adverse events related to this product. This new data adds to our body of substantial scientific evidence...”

Please provide documentation. What has been learned about “deaths that involved Kratom?” What evidence was relied upon and how were these conclusions drawn?

What additional adverse events have been identified? Also, please provide both the “new data” as well as FDA’s “body of substantial scientific evidence (which although presumably preexisting, was not provided after the last press release).

Moreover, I seek validation for this claim:

“...we now have 44 reported deaths...”

I hereby request these 44 reports.

Finally, and most broadly, I am seeking all documents the FDA has relied upon to make the determinations and come to the conclusions in the 2/6/2018 press release on Kratom.

I am also seeking any emails (whether sent to the FDA or any employee or director of the FDA, by a lobbying group, PAC, or any other outside source, as well as internally composed/generated emails) that led or contributed to this press announcement.

I additionally seek internal documents, including but not limited to memorandum of interviews and white papers, that offer the opinions or facts used to support the preceding, quoted, claims found in the preceding press release.

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: Food and Drug Administration

Dear Mr. Roberts,

This is in response to your February 12, 2018, Freedom of Information Act (FOIA) request for records pertaining to KRATOM - WHITE PAPERS, ANALYSIS, LAB TESTS, ETC.

The Center Food Safety and Applied Nutrition (CFSAN) conducted a search and did not locate any records responsive to your request.

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

While we believe that an adequate search of appropriate files was conducted for the records you requested in CFSAN, 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 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>.

Kimberly Jones

for

Samantha Wilde
Government Information Specialist
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulations and Policy
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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Kimberly Jones
Administrative Support Specialist (CNI Technical Services Contractor)
Government Information Staff
Freedom of Information Act (FOIA)
Center for Food Safety & Applied Nutrition (CFSAN)
Office of Regulations and Policy (ORP)
PH (240) 402-1825
Kimberly.jones@fda.hh<mailto:Kimberly.jones@fda.hh>s.gov

[cid:image001.png@01D29CBA.FA769050]<http://www.fda.gov/>

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From: Food and Drug Administration

Mr. Roberts,

CFSAN responded to your request on February 16, 2018 with the response listed below.

Thanks

Kimberly Jones
Administrative Support Specialist (CNI Technical Services Contractor)
Government Information Staff
Freedom of Information Act (FOIA)
Center for Food Safety & Applied Nutrition (CFSAN)
Office of Regulations and Policy (ORP)
PH (240) 402-1825
Kimberly.jones@fda.hh<mailto:Kimberly.jones@fda.hh>s.gov

[cid:image001.png@01D29CBA.FA769050]<http://www.fda.gov/>

[cid:image002.jpg@01D29CBA.FA769050]<https://www.facebook.com/FDA> [cid:image003.jpg@01D29CBA.FA769050] <https://twitter.com/US_FDA> [cid:image004.jpg@01D29CBA.FA769050] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D29CBA.FA769050] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D29CBA.FA769050] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

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