Agency Response Letter GRAS Notice No. GRN000191
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CFSAN/Office of Food Additive Safety
March 31, 2010
Scott E. Deeter
President and CEO
2120 Milestone Drive, Suite 102
Fort Collins, CO 80525
Re: GRAS Notice No. GRN 000191
Dear Mr. Deeter:
The Food and Drug Administration (FDA) is responding to the notice, dated January 20, 2006, that Ventria Bioscience (Ventria) 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 January 23, 2006, filed it on January 26, 2006, and designated it as GRAS Notice No. GRN 000191.
The subject of the notice is human lysozyme purified from rice (hLZ-r). The notice informs FDA of the view of Ventria that hLZ-r is GRAS, through scientific procedures, for use as an ingredient in term infant formulas, pre-term infant formulas, and fortifiers at levels up to 0.3 grams per liter (g/L); and in oral rehydration solutions that are medical foods intended for short-term consumption by children up to three years of age at levels up to 0.2 g/L.
In a letter dated March 5, 2010, you withdrew your notice and asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective March 12, 2010, 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 000191, 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. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition