Food

Agency Response Letter GRAS Notice No. GRN 000513

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See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory


CFSAN/Office of Food Additive Safety

July 10, 2014

John A. Kassebaum, Ph.D.
Algaeon, Inc.
8440 West 82nd St.
Indianpolis, IN 46278

Re: GRAS Notice No. GRN 000513

Dear Dr. Kassebaum:

The Food and Drug Administration (FDA) is responding to the notice, dated February 13, 2014, that you submitted  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 April 17, 2014, filed it on April 30, 2014, and designated it as GRAS Notice No. GRN 000513.

The subject of the notice is dried biomass of Euglena gracilis and beta-1,3-glucan from E. gracilis. The notice informs FDA of the view of Algaeon, Inc. that dried biomass of E. gracilis and beta-1,3-glucan from E. gracilis are GRAS, through scientific procedures, for use as ingredients in food.

In an electronic message dated July 9, 2014, you withdrew your notice. Given your request, we ceased to evaluate your GRAS notice, effective July 9, 2014, the date that we received your request.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000513, 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/grasnoticeinventory.

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

 

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