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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000295

CFSAN/Office of Food Additive Safety

December 8, 2009

Robert S. McQuate
GRAS Associates, LLC
20482 Jacklight Lane
Bend, Oregon 97702-3074

Re: GRAS Notice No. GRN 000295

Dear Dr. McQuate:

The Food and Drug Administration (FDA) is responding to the notice, dated June 29, 2009, that you submitted on behalf of Natreon, Inc. (Natreon) in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on July 02, 2009, filed it on July 10, 2009, and designated it as GRAS Notice No. GRN 000295.

The subject of the notice is Emblica officinalis extract. The notice informs FDA of the view of Natreon that Emblica officinalis extract is GRAS, through experience based on common use in food, for use as an ingredient in nonalcoholic beverages and processed fruits and fruit juices at levels ranging from 100 to 150 milligrams per serving.

In a letter dated November 23, 2009, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective November 23, 2009, the date that we received your letter.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000295, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the "Food" topic to the "Food Ingredients and Packaging" section to the "Generally Recognized as Safe (GRAS)" page where the GRAS Inventory is listed.

 

Sincerely,

Antonia Mattia, Ph.D.
Director
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition