Agency Response Letter GRAS Notice No. GRN 000241
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CFSAN/Office of Food Additive Safety
April 11, 2008
Robert S. McQuate
GRAS Associates, LLC
20482 Jacklight Lane
Bend, OR 97702-3074
Re: GRAS Notice No. GRN 000241
Dear Dr. McQuate:
The Food and Drug Administration (FDA) is responding to the notice, dated January 14, 2008, that you submitted on behalf of Cypress Systems, Inc., 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 January 28, 2008, filed it on January 30, 2008, and designated it as GRAS Notice No. GRN 000241. The subject of the notice is high-selenium yeast. The notice informs FDA of the view of Cypress Systems, Inc., that high-selenium yeast is GRAS, through scientific procedures, for use as a food ingredient in baked products, non-alcoholic beverages, breakfast cereals, grain products and pastas, milk products, processed fruits/fruit juices, processed vegetables/vegetable juices, commercial soups and soup mixes, and medical foods as a source of selenium at levels yielding 5 micrograms selenium per serving.
In a letter dated April 9, 2008, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective April 9, 2008, 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 000241, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (21 CFR 170.36(c)(1)), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition