FDA: Position on Synthetic Botanicals

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

2018-1551
Submitted Aug. 5, 2017
Est. Completion None
Status
Fix Required

Communications

From: anthony roberts

Subject: Freedom of Information Request: FDA: Position on Synthetic Botanicals

Email

To Whom It May Concern:

This is a request under 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 deliberative process through which the FDA came to 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: Muckrock Staff

Subject: RE: Freedom of Information Request: FDA: Position on Synthetic Botanicals

Email

To Whom It May Concern:
I wanted to follow up on the following request, copied below. Please let me know when I can expect to receive a response.
Thanks for your help, and let me know if further clarification is needed.

From: Food and Drug Administration

Subject: None

Mail (Postmarked March 1, 2018)

An interim response, stating the request is being processed.

From: Food and Drug Administration

Subject: RE: Freedom of Information Request: FDA: Position on Synthetic Botanicals

Email

Good afternoon,

Please provide the request number if you want status updates. Also, please submit these by fax or through the FOIA request page, not through email.

Thank you,

Wilson M. Russ
Program Support 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>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Anthony Roberts

Subject: RE: Freedom of Information Act Request: FDA: Position on Synthetic Botanicals

Email

Sir-

I can’t provide a request number because FDA hasn’t replied to my initial request (from August of 2017) with a number (or at all).

You can view the request here, but as I say, there has been no response, so I can’t cite a number:

https://www.muckrock.com/foi/united-states-of-america-10/fda-position-on-synthetic-botanicals-41485/

From: Food and Drug Administration

Subject: RE: Freedom of Information Act Request: FDA: Position on Synthetic Botanicals

Email

Good afternoon,

In the future, if you do not receive an acknowledgement letter within a week or week and a half you need to notify us. We get so many requests from Muckrock that it is hard to determine which request you are referring to. Also, in the future please submit your request by fax or through the online portal at FDA.gov.

Thank you,

Wilson M. Russ
Program Support 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>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Food and Drug Administration

Subject: FW: Freedom of Information Act Request: FDA: Position on Synthetic Botanicals

Email

Good morning, Mr. Roberts. This request was logged as 18-1551 when you emailed it to us a few weeks ago. If you didn’t get the acknowledgement letter, you should check with Muckrock, as the letter was sent to their mailing address that was in your request. You may want to consider submitting your requests electronically to our online portal, or using your own mailing address, so that you can get your acknowledgement letters and control numbers in the future, since you are not getting this information from Muckrock.

Thanks,

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>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA>[cid:image003.jpg@01D1C57E.DFA022A0]<https://twitter.com/US_FDA>[cid:image004.jpg@01D1C57E.DFA022A0]<http://www.youtube.com/user/USFoodandDrugAdmin>[cid:image005.jpg@01D1C57E.DFA022A0]<http://www.flickr.com/photos/fdaphotos/>[cid:image006.jpg@01D1C57E.DFA022A0]<http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

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From: Food and Drug Administration

Subject: Your FOI Request ref: 2018-1552

Email

Attn: Anthony Roberts

In regards to the subject request seeking records

"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 deliberative process through which the FDA came to 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."

I am requesting clarification on you seeking " . . .deliberative process ..." documents. As a frequent FOI requester I am sure you are aware that certain deliberative documents are exempt from public disclosure pursuant to FOIA exemption b5. Can you please explain what you mean or intent as it pertains to deliberative. Clarification is needed in order to process your request and avoid further delay.

Feel free to contact me directly.

Sheila Wright
FOIA Officer
Center for Food Safety & Applied Nutrition
Office of Regulations and Policy
Tel: 240-402-2812
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Food and Drug Administration

Subject: CORRECTION RE: Your FOI Request ref: 2018-1551

Email

FOI reference number typo. Correction to 2018-1551.

Sheila Wright
FOIA Officer
Center for Food Safety & Applied Nutrition
Office of Regulations and Policy
Tel: 240-402-2812
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: Food and Drug Administration

Subject: RE: CORRECTION RE: Your FOI Request ref: 2018-1551

Email

Good afternoon!

As it has now been more than 3 weeks since I sought clarification from you pertaining to the subject FOIA request, please be advised that if I do not hear from you by June 29th I will presume you are no longer interested in pursuing this request and we will close it. If that occurs and you respond late or change your mind, you will have to submit a new request.

I appreciate your attention to this matter.

Sheila Wright
FOIA Officer
Center for Food Safety & Applied Nutrition
Office of Regulations and Policy
Tel: 240-402-2812
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/US_FDA> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

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