Agency Response Letter GRAS Notice No. GRN 000391
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CFSAN/Office of Food Additive Safety
October 20, 2011
John R. Endres, ND
Chief Scientific Officer
AIBMR Life Sciences, Inc.
4117 S. Meridian
Puyallup, WA 98373
Re: GRAS Notice No. GRN 000391
Dear Dr. John R. Endres:
The Food and Drug Administration (FDA) is responding to the notice, dated July 12, 2011, that you submitted on behalf of E.I.D. Parry (India) Limited, Parry Nutraceuticals Division (Parry Nutraceuticals) 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 this notice on July 22, 2011, filed it on July 27, 2011, and designated it as GRN Notice No. 000391.
The subject of the notice is Spirulina (Arthrospira platensis). The notice informs FDA of the view of Parry Nutraceuticals that Spirulina (Arthrospira platensis) is GRAS, through scientific procedures, for use as an ingredient in a variety of food categories at levels of 0.5 grams per serving (g/s) to 3 g/s.
In a letter dated October 6, 2011, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective October 6, 2011, 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 000391, as well as a copy of the information in this notice that conforms to the information described in the proposed GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), are available for public review and copying at www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology
and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition