Policies/procedures re: GRAS substances.

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

2015-5235
Submitted June 25, 2015
Status
Completed

Communications

From: Beryl Lipton

Subject: None

Fax

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

Policies, procedures, and preparatory strategic materials regarding the verification and submission to the FDA of ingredients "generally recognized as safe" (GRAS). Please include, but do not limit, responsive materials to records regarding the following topics:

• acquisition of relevant information on any ingredient determined to be GRAS by any firm (independent or otherwise)
• use of advisory committees in GRAS determinations
• audits and requests for additional information regarding notification and/or determination of GRAS status
• reconsideration of the safety of GRAS substances
• citizen petitions regarding GRAS substances
• the safety of engineered nanomaterials marketed as GRAS
• guidance provided to developers of food applications of nanotechnology regarding application of the GRAS concept

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 fees cannot be waived, 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,

Beryl C.D. Lipton

From: Food and Drug Administration

Subject: None

Mail (Postmarked June 30, 2015)

An acknowledgement letter, stating the request is being processed.

From: Food and Drug Administration

Subject: None

Mail (Postmarked June 30, 2015)

A copy of documents responsive to the request.

From: Food and Drug Administration

Subject: None

Mail (Postmarked June 30, 2015)

A cover letter granting the request and outlining any exempted materials, if any.

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