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U.S. Department of Health and Human Services

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Agency Additional Correspondence Letter GRAS Notice No. GRN 000394

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

December 27, 2012

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

Re: GRAS Notice No. GRN 000394

Dear Dr. Cho:

The Food and Drug Administration (FDA) is responding to the supplement dated November 23, 2012, that you sent regarding the conditions of intended use for the subject of GRAS Notice No. GRN 000394. You initially submitted GRN 000394, 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 26, 2011, filed it on July 29, 2011, and designated it as GRN No. 000394.

The subject of the notice is the dried biomass of Arthrospira platensis, also known as Spirulina platensis (spirulina). The notice informs FDA of the view of RFI that spirulina is GRAS, through scientific procedures, for use as an ingredient in grape juice, blackberry juice, lime juice, low calorie fruit juice drinks, and low calorie vegetable juice drinks at a level of 0.3%, and in medical foods at a level of 1.25%. In a letter dated June 4, 2012, FDA informed RFI that the agency had no questions at that time regarding RFI’s conclusion that the subject of the notice is GRAS under the intended conditions of use. In the supplement dated November 23, 2012, you informed FDA that RFI intends to make a revision to the conditions of intended use described in the original notice. The revision specifically involves expanded food applications and intended use levels of spirulina. Under the revision, the intended food applications and use levels are the same as those described in GRN 000417, dried biomass of Arthrospira platensis, also known as Spirulina platensis. RFI concludes that this revision of the intended use of spirulina raises no safety concerns and concludes that spirulina, meeting the revised specifications, is GRAS for the intended use.

Based on the information provided by RFI in GRN 000394, the supplement dated November 21, 2012, and other information available to FDA, the agency has no questions at this time regarding RFI’s conclusion that spirulina is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of spirulina. As always, it is the continuing responsibility of RFI to ensure that food ingredients the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to the supplement to GRN 000394, 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