FDA: Position on Synthetic Botanicals

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

FDA1958181

Est. Completion None
Status
No Responsive Documents

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

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Reference: FDA1958181
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From: Food and Drug Administration

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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: 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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