FDA: Pieter Cohen on red Yeast Rice

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

2018-1419

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 emails and email attachments sent and received by the FDA to and from Dr. Pieter Cohen between January 1st, 2016 and February 1st, 2018 that mention Red Yeast Rice, red fermented rice, lovastatin, Lovastatin, and/or monacolin K.

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

Good morning,

I'm writing concerning your FOIA request described above to request clarification. Specifically, it would be helpful if Muckrock would provide context to enable CDER to conduct a search for responsive records. We're aware that Dr. Cohen conducted a study, referenced at http://journals.sagepub.com/stoken/default+domain/NUGtGPuIjd9k77UwkpU7/full. Please confirm that you seek communications and attachments concerning this study.

Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
HILL-3138
Silver Spring, MD 20993-0002
301-796-2697

This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>

From: Anthony Roberts

Please accept this email as confirmation that I seek communications and attachments concerning the study/link foud in your last email to me.

From: Food and Drug Administration

Thank you for the clarification.

Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
HILL-3138
Silver Spring, MD 20993-0002
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>>

From: Anthony Roberts

I’m looking for January 1st, 2013 through the date I filed the request.

From: Food and Drug Administration

Thank you for clarifying the timeframe.

Eli Landy
Lead Regulatory Counsel
Food and Drug Administration
Center for Drug Evaluation and Research
10001 New Hampshire Avenue
HILL-3138
Silver Spring, MD 20993-0002
301-796-2697
This e-mail message may contain information that is protected, privileged, or confidential, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution or copying is strictly prohibited. If you think you have received this e-mail message in error, please e-mail the sender immediately at eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov<mailto:eli.landy@fda.hhs.gov>

From: Food and Drug Administration

A no responsive documents response.

From: Food and Drug Administration

Attn: Mr. Roberts,

This is in response to your February 12, 2018 request for information from the Food and Drug Administration (FDA), Center for Food Safety & Applied Nutrition (CFSAN) pursuant to the Freedom of Information Act seeking all email attachments (date range 01/01/2016 thru 02/01/2018) sent and received by the FDA to and from Dr. Pieter Cohen that mention red yeast rice, red fermented rice, lovastatin, and/or monacolin K.

Attached is a document responsive to your request. Your request is granted in full. CFSAN considers your request closed. Your request has been assigned to one or more other FDA components that may have or will reply to you directly under separate cover.

If you are not satisfied with any aspect of the processing and handling of this request, please contact michael.howard@fda.hhs.gov<mailto:michael.howard@fda.hhs.gov> or call 240-402-2120. You also have the right to contact:

Office of the Executive Secretariat
FDA FOIA Public Liaison
U.S. Food & Drug Administration
5630 Fishers Lane
Room 1050
Rockville, MD 20857
E-mail: FDAFOIA@fda.hhs,gov<mailto:FDAFOIA@fda.hhs,gov>

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

My sincere apologies for this delayed response. Your patience and consideration is greatly appreciated.

Best regards,
Michael Howard
Government Information Specialist
Center for Food Safety & Applied Nutrition
Office of Regulations, Policy & Social Science
PH (240) 402-2120
Michael.Howard@fda.hhs.gov<mailto:Michael.Howard@fda.hhs.gov>
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