FDA: Position on Synthetic Botanicals

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 #

FDA1846591

Due Oct. 5, 2018
Est. Completion None
Status
Awaiting Response

Communications

From: Anthony Roberts


To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

The FDA has repeatedly expressed the opinion that a synthetic botanical, or indeed anything synthetic that has not been grandfathered in as a legitimate dietary supplement prior to the passage of the Dietary Supplement Health and Education Act of 1994, constitutes a wholly new substance and therefore requires a New Dietary Ingredient Notification. However, nowhere in DSHEA is this expressly stated, nor in any of the germane federal regulations. I am requesting documents related to the which the FDA relies upon for the determination of this opinion.

This should include scientific references, studies, white papers, memorandums, emails, intra and outer office communications, and all related documents that might provide insight the FDA's position on synthetic botanicals constituting new dietary ingredients.

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

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Reference: FDA1846591
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
MUCKROCK Anthony Roberts
Re: Confirmation # FDA1846591
In Reply refer to: 2018-7324
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
RECS RE FDA OPINION THAT A SYNTHETIC BOTANICAL REQUIRES A NEW NDI NOTIFICATION
Original Subject: Pursuant to the Freedom of Information Act, I hereby request the following records: The FDA has repeatedly expressed the opinion that a synthetic botanical, or indeed anything synthetic that has not been grandfathered in as a legitimate dietary supplement prior to the passage of the Dietary Supplement Health and Education Act of 1994, constitutes a wholly new substance and therefore requires a New Dietary Ingredient Notification. However, nowhere in DSHEA is this expressly stated, nor in any of...
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