FDA: Position on Synthetic Botanicals

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Reference: FDA1846591
Dear Requester,
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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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Good morning,

Your FOIA request 2018-7324 is still pending with the Center for Food Safety and Applied Nutrition (CFSAN). You may contact them directly at CFSAN_FOI_TEAM@fda.hhs.gov<mailto:CFSAN_FOI_TEAM@fda.hhs.gov>. Please reference FOIA request #2018-7324.

Thank you,

Wilson M. Russ
Government Information Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8981
wilson.russ@fda.hhs.gov<mailto:wilson.russ@fda.hhs.gov>

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Dear Mr. Roberts,

This is in follow-up to your request 2018-7324 dated September 13, 2018. Your request is as follows:

"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."

To the extent you are seeking to better understand FDA's views on whether and when a synthetic botanical constitutes a dietary ingredient for the purposes of the Federal Food, Drug, and Cosmetic Act, we are sending you the attached August 2016 draft guidance. Although this is a draft guidance, and issued for comment purposes only and not for implementation, it has a discussion that is directly relevant to this question (in particular, see section IV.D.3, titled "Under what circumstances does FDA consider synthetically produced substances to be dietary ingredients under the FD&C Act?"). We are also sending five documents that this section of the guidance references. When the guidance is finalized, it will represent FDA's current thinking on the topic.

Please contact me directly if you have any questions at 301-796-8976 or Sarah.Kotler@fda.hhs.gov. You may also contact the FDA FOIA Public Liaison, Office of the Executive Secretariat, 5630 Fishers Lane, Room 1050, Rockville, MD 20857; email: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>.

Sincerely,

Sarah B. Kotler, J.D.
Director
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8976
Sarah.Kotler@fda.hhs.gov<mailto:Sarah.Kotler@fda.hhs.gov>

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