Agency Response Letter GRAS Notice No. GRN 000423

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

CFSAN/Office of Food Additive Safety

June 8, 2012

Claire L. Kruger, Ph.D.
Spherix Consulting, Inc.
6430 Rockledge Drive
Westmoreland Bldg. #503
Bethesda, MD 20817

Re: GRAS Notice No. GRN 000423

Dear Dr. Kruger:

The Food and Drug Administration (FDA) is responding to the notice, dated February 22, 2012, that you submitted on behalf of Morinaga Milk Industry Co., Ltd.(Morinaga) 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 this notice on February 29, 2012, filed it on March 7, 2012, and designated it as GRN No. 000423.

The subject of the notice is cow’s milk-derived lactoferrin. The notice informs FDA of the view of Morinaga that cow’s milk-derived lactoferrin is GRAS, through scientific procedures for use as an ingredient in cow’s milk-based term infant formulas at a level of 13 milligrams per 100 milliliter (mg/mL) formula (ready-to-feed or prepared from powder or concentrate) and in other cow's milk-based products including yogurts (100 mg per 100 gram (g)), powdered milk (400 mg/100 g), and milk-based frozen desserts (200 mg/100 g), and in chewing gum (30 mg/g).

In a letter dated May 2, 2012, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective May 2, 2012, 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 000423, 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)), are available for public review and copying at


Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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