FDA: Exogenous Ketones, Ketone Salts, Ketone Esters
| Tracking # |
FDA1845276 |
| Submitted | July 15, 2018 |
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Communications
From: Anthony Roberts
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
All documents concerning Exogenous Ketones (also called “dietary ketones,” “ketone esters,” and/or “ketone salts”) that have been composed, created, produced, sent, or received, between the dates of January 1st, 2013 and July 15th,, 2018. This should include but not be limited to emails, both intra-agency and external, reports, trade complaints, consumer complaints, adverse reaction reports, memorandum, records, warnings, emails, papers, advertisements, evidence, depositions, interviews, case notes, schedules, enforcement actions, white papers, GRAS and/or NDI notifications, and incident reports.
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
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA1845276
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administrationpursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request. If your request is not sufficiently described,or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.
From: Food and Drug Administration
Note: Do NOT reply directly to this E-mail
Anthony Roberts Anthony Roberts
Re: Confirmation # FDA1845276
In Reply refer to: 2018-5862
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
All documents concerning Exogenous Ketones (also called dietary ketones, ketone esters, and/or ketone salts) that have been composed, created, produced, sent, or received, between the dates of January 1st, 2013 and July 15th,, 2018
Original Subject: To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: All documents concerning Exogenous Ketones (also called ?dietary ketones,? ?ketone esters,? and/or ?ketone salts?) that have been composed, created, produced, sent, or received, between the dates of January 1st, 2013 and July 15th,, 2018. This should include but not be limited to emails, both intra-agency and external, reports, trade complaints, consumer complaints, adverse reaction repo...
We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs change, and you no longer need the requested records, please contact us to cancel your request, as charges may be incurred once processing of your request has begun. For more information on processing fees, please see
http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm. If you have any questions about your request, please call Wilson M. Russ, Freedom Of Information Specialist at (301) 796-8981 or write to us at: (http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm)
Division of Freedom of Information, U.S. Food and Drug Administration
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Fax:(301)827-9267
You also have the right to seek dispute resolution services from:
FDA FOIA Public Liaison
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857
E-Mail: FDAFOIA@fda.hhs.gov and/or:
Office of Government Information Services
National Archives and 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
Fax: 202-741-5769
From: Food and Drug Administration
Hello Mr. Roberts
Please find attached final responsive letter as well as response information you requested.
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