|Submitted||Nov. 14, 2017|
|Due||Dec. 13, 2017|
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To Whom It May Concern:
This is a request under the Freedom of Information Act. I hereby request copies of all evidence and all validating documents, plus related proof, that the FDA relied upon when making all of the claims about kratom found in this press announcement:
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:
"some marketers touting it as a “safe” treatment with broad healing properties"
What marketers? What are their claims? Where can these claims be found? Please provide documents.
"Proponents argue that it’s a safe substance largely because it’s a plant-based product."
What proponents are claiming that kratom is safe? What proponents are making this argument largely because it is plant-based? Again, please provide documentation.
"The FDA knows people are using kratom to treat conditions like pain, anxiety and depression..."
How does the FDA know this? What people, specifically, are doing this? I am seeking the documentation used by the FDA in acquiring this knowledge.
"We also know that this substance is being actively marketed and distributed for these purposes."
How does the FDA know this? Please provide all documents relied upon as support for this claim.
"...evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death."
What evidence? Please provide said evidence. Again, I am seeking the documents the FDA has relied upon, or experts consulted, to come to these conclusions. Additionally, 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). 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 press release.
Here, I am also seeking to answer, with specificity, which opioids kratom resembles in terms of risk of death. Here, as "similar risk" has been mentioned, I am seeking the documentation and statistical analysis, used by the FDA, that articulates or provides evidence of the "similar risk" of kratom viz a viz other opioids.
"...often kratom is taken recreationally by users for its euphoric effects."
Please provide validation and documentation the FDA relied upon for this claim.
"...patients believe they can use kratom to treat opioid withdrawal symptoms. "
What patients believe this? Please provide evidence that the FDA has identified patients and moreover that the FDA has knowledge of what these specific patients believe, and furthermore, how the FDA acquired this information.
"Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs."
Please provide evidence that opioid-addicted patients are using kratom and doing so without dependable instructions for use. Include the designated criteria for "dependable instructions" as it was used to apply in this press release.
"There’s clear data on the increasing harms associated with kratom. "
Please provide the "clear data" in full.
"Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year."
Please provide details and records of these calls and statistics.
"The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products."
How is the FDA aware of these deaths? Please provide correspondence with any outside agencies or agents, whether governmental, private, or otherwise concerning these deaths. Additionally, please provide all evidence and documentation of these deaths, and further that they were associated with kratom.
"There have been reports of kratom being laced with other opioids like hydrocodone."
Provide the reports referenced.
"The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms."
Please provide evidence of kratom being associated with "seizures, liver damage and withdrawal symptoms."
"...FDA has evidence to show that there are significant safety issues associated with its use. "
Again, please provide the evidence FDA utilized and/or analyzed in the composition of this press announcement to come to this conclusion.
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.
An interim response, stating the request is being processed.
Dear Mr. Roberts,
This is in response to your November 17, 2017, Freedom of Information Act (FOIA) request for records pertaining to "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."
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 email@example.com<mailto:firstname.lastname@example.org>.
Center for Food Safety & Applied Nutrition
Office of Regulations, Policy & Social Science
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