Agency Response Letter GRAS Notice No. GRN 000322
CFSAN/Office of Food Additive Safety
June 17, 2010
Robert S. McQuate, Ph.D.
GRAS Associates, LLC
20482 Jacklight Lane
Bend, OR 97702-3074
Re: GRAS Notice No. GRN 000322
Dear Dr. McQuate:
The Food and Drug Administration (FDA) is responding to the notice, dated February 1, 2010, 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 February 5, 2010, filed it on February 18, 2010, and designated it as GRAS Notice No. GRN 000322.
The subject of the notice is aqueous extract of Emblica officinalis (E. officinalis extract). The notice informs FDA of the view of Natreon that E. officinalis extract is GRAS, through 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 June 16, 2010, you asked, on behalf of Natreon, that FDA cease to evaluate GRN 000322. Given your request, we ceased to evaluate Natreon’s GRAS notice, effective June 16, 2010, 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 000322, 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.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition