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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000396

Return to inventory listing: GRAS Notice Inventory

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


CFSAN/Office of Food Additive Safety

July 20, 2012

Susan Cho, Ph.D.
NutraSource
6309 Morning Dew Court
Clarksville, MD 21029

Re: GRAS Notice No. GRN 000396

Dear Dr. Cho:

The Food and Drug Administration (FDA) is responding to the notice, dated July 25, 2011, that you submitted on behalf of RFI, Inc. (RFI) 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 28, 2011, filed it on August 3, 2011, and designated it as GRAS Notice No. GRN 000396.

The subject of the notice is Chlorella vulgaris strain Beij. The notice informs FDA of the view of RFI that C. vulgaris strain Beij is GRAS, through scientific procedures, for use as an ingredient in food resulting in an estimated 90th percentile daily intake of 1.35 grams.

In an electronic mail message dated July 5, 2012, you withdrew your notice. Given your electronic mail message, we ceased to evaluate your GRAS notice, effective July 5, 2012, the date that we received your electronic mail message.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000396, 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 at 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