FDA: Commissioner Gottlieb Kratom Communications

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

2017-9719

Status
Completed

Communications

From: Anthony Roberts

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request all communications made to, from, or by, FDA commissioner Scott Gottlieb, in regards to kratom. This should include but not be limited to emails, memorandum, and records of same (i.e. meetings held, seminars attended , etc...)

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,

I have received the records for your request. I will conduct my review of the upon my return to the office in early January.

You may contact me directly with any further concerns regarding your request.

Sincerely,

Celeste Smith
Government Information Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8991
celeste.smith@fda.hhs.gov<mailto:celeste.smith@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

From: Anthony Roberts

Thanks, I appreciate your attention and promptness on this request. As you're likely aware, this is a matter that concerns millions of Americans, many of whom have expressed a desire to see these documents, as they relate to potential scheduling that would have a direct effect on them.

From: Food and Drug Administration

Mr. Roberts, the records are currently being reviewing. You should check with me again in a few weeks.

From: Anthony Roberts

Thank you. I'll check back next month.

From: Anthony Roberts

Hello-

I'm just checking in on the records being reviewed for FOIA 2017-9719 (a MuckRock freedom of Information Request on Commissioner Gottlieb's Kratom Communications) per your last email. Are they out of review and are you able to send them to us?

~Anthony Roberts

From: Food and Drug Administration

Good morning. I have completed my review of the records. The records have been forwarded on for a second review prior to release. I apologize, I cannot provide an estimate of time for how long it will take for the reviewer to complete their review. As soon as the review is complete, you will receive our response.

Celeste

From: Food and Drug Administration

Good morning. We are currently reviewing these records for release.

Thanks,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Food and Drug Administration

Good morning. Your request is still under review.
Thanks,

Celeste Smith
Government Information Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8991
celeste.smith@fda.hhs.gov<mailto:celeste.smith@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

From: Food and Drug Administration

Mr. Roberts, based on your latest clarification, agency employees revised their search criteria and are currently searching for responsive records to your request. Once I have received them, they will be reviewed and provided to you.
Thanks,

Celeste

From: Food and Drug Administration

Mr. Roberts, Agency employees are currently searching for responsive records to your request. Once the search has been completed, any records located will be reviewed and a release determination will be provided to you.
Thanks,

Celeste

From: Food and Drug Administration

Good morning. Ms. Smith will update you when she returns to the office next week.

Thanks,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Anthony Roberts

Thanks. I’ll be waiting for that update.

From: Food and Drug Administration

Hi, Ms. Smith is going to be away from our office for a few months starting tomorrow. I will be your contact for the time being. There are approximately 20 requests pending in the Office of the Commissioner that were received prior to yours. We are required to process requests on a first-in-first-out basis. We expect several of these 20 requests to be completed in the next 4-6 weeks. Please check back with me at that time, and we can give you an updated estimate on where you are in the queue.

Thanks,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Anthony Roberts

Could I please have an update on the request I made for “...all communications made to, from, or by, FDA commissioner Scott Gottlieb, in regards to kratom.” It was filed in mid-November of last year, in mid-February I was told that the initial review had been completed, shortly after which I agreed to have the records released on a rolling basis to get documents more quickly, but I’ve still received nothing at all.

These documents are obviously important to the public’s understanding of this issue, and since my initial request, FDA has made numerous public statements on Kratom, as has Mr. Gottlieb.

Would it be possible to send me whatever documents have been completed to this point, in keeping with the idea of expediting the process through a rolling release?

As always, thank you for your time and consideration.

From: Food and Drug Administration

Good morning,

In response to your status inquiry, we are reviewing the records. There are a few older requests ahead of yours.

Thank you,

Meredith J. Schlaifer, M.S., J.D.
U.S. Food and Drug Administration
Tel: 301-796-0583
meredith.schlaifer@fda.hhs.gov<mailto:meredith.schlaifer@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/>

From: Food and Drug Administration

Good morning,

We are reviewing the records. There are a few older requests ahead of yours. We are required to process requests on a first in, first out basis.

Thank you.

From: Food and Drug Administration

Good morning,

We are reviewing the records. There are a few older requests ahead of yours. We are required to process requests on a first in, first out basis.

Thank you.

From: Muckrock Staff

To Whom It May Concern:
I wanted to follow up on the following request, copied below. Please let me know when I can expect to receive a response.
Thanks for your help, and let me know if further clarification is needed.

From: Food and Drug Administration

Good afternoon,

Your request is in our complex queue. We are required to process requests on a first in, first out basis (FIFO). There are a number of requests ahead of yours in the queue. The expected wait time is usually 12-18 months.

Please feel free to contact me if you have any questions.

Thank you,

Meredith J. Schlaifer, M.S., J.D.

Office of the Executive Secretariat

Division of Freedom of Information
U.S. Food and Drug Administration

meredith.schlaifer@fda.hhs.gov<mailto:meredith.schlaifer@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/>

From: Food and Drug Administration

Good morning,

Your request is in our complex queue. We are required to process requests on a first in, first out basis (FIFO). There are a few requests ahead of yours in the queue. The expected wait time is usually 12-18 months. I hope to have this out in the next two to three months.

Please feel free to contact me if you have any questions.
Thank you,

Meredith J. Schlaifer, M.S., J.D.

Office of the Executive Secretariat

Division of Freedom of Information
U.S. Food and Drug Administration
meredith.schlaifer@fda.hhs.gov<mailto:meredith.schlaifer@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/>

From: Food and Drug Administration

Good morning,

Your request is in our complex queue. We are required to process requests on a first in, first out basis (FIFO). There are a few requests ahead of yours in the queue. The expected wait time is usually 12-18 months. I hope to have this out in the next two months.

Please feel free to contact me if you have any questions.
Thank you,

Meredith J. Schlaifer, M.S., J.D.

FOIA Officer, Office of the Commissioner

Division of Freedom of Information
U.S. Food and Drug Administration
meredith.schlaifer@fda.hhs.gov<mailto:meredith.schlaifer@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/>

From: Food and Drug Administration

Dear Requester,

The records you are seeking are attached.

Certain information has been redacted from the records under Exemption 6 of the FOIA (personal privacy information).

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 me at 301-796-8976 or Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>. 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

Telephone: 202-741-5770

Toll-Free: 1-877-684-6448

E-mail: ogis@nara.gov<mailto:ogis@nara.gov>

Fax: 202-741-5769

Sincerely,

Sarah Kotler

From: Anthony Roberts

Hi,

Thanks so much for your help with this request. It’s been a long time and I really appreciate your work and help here.

Sincerely,
Anthony Roberts

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