Agency Response Letter GRAS Notice No. GRN 000162
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CFSAN/Office of Food Additive Safety
November 20, 2006
Delia Bethell, Ph.D.
4110 N. Freeway Blvd.
Sacramento, CA 95834
Re: GRAS Notice No. GRN 000162
Dear Dr. Bethell:
The Food and Drug Administration (FDA) is responding to the notice, dated December 16, 2004, 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 December 21, 2004, filed it on December 22, 2004, and designated it as GRAS Notice No. GRN 000162.
The subject of the notice is lactoferrin (LF) (human) purified from rice (hLF-r). The notice informs FDA of the view of Ventria Bioscience (Ventria) that hLF-r is GRAS, through scientific procedures, for use as an ingredient in foods and beverages at levels not to exceed 1000 milligrams (mg)/serving and in medical foods at levels not to exceed 1 mg/milliliter.
In a letter dated November 16, 2006, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective November 16, 2006, the date that we received your letter. Although you have withdrawn your notice and FDA has ceased to evaluate the notice, FDA, nevertheless, plans to engage the wider scientific community for further consideration of the complex scientific issues in your notice.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000162, 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