FDA: Position on Synthetic Botanicals
It is a clone of this request.
| Tracking # |
FDA1958181 |
| Submitted | Sept. 12, 2019 |
| Est. Completion | None |
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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:
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. Now, a recent decision in the 11th Circuit has expressly confirmed FDA to have been incorrectly interpreting the law.
I am requesting documents related to the deliberative process through which the FDA came to this incorrect 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
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA1958181
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant 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 # FDA1958181
In Reply refer to: 2019-8762
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, 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.
Original Subject: 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 expres...
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From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Sept. 12, 2019. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1958181.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on Sept. 12, 2019. Please let me know when I can expect to receive a response. You had assigned it reference number #FDA1958181.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Attn: Anthony Roberts
This is notice regarding your subject FOIA request (attached). In your request you state, "I am requesting documents related to the deliberative process. . . " Please be advised that certain documents that are part of the deliberative process are protected from disclosure under FOIA exemption (b)(5). Consequently we would not be providing any responsive documents to your request as written. You did not respond to previous notice, it is CFSAN's intention to withdraw your request in 10 days unless you select to modify it.
Thank you,
Sheila Wright
FOIA Officer
Center for Food Safety & Applied Nutrition
Office of Regulations and Policy
Tel: 240-402-2812
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