It is a clone of this request.
|Submitted||Sept. 7, 2018|
|Due||Oct. 5, 2018|
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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.
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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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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)
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