Agency Response Letter GRAS Notice No. GRN 000431
CFSAN/Office of Food Additive Safety
November 21, 2012
Dilip Patel, Ph.D.
133 32nd Ave.
Brookings, SD 57006
Re: GRAS Notice No. GRN 000431
Dear Dr. Patel:
The Food and Drug Administration (FDA) is responding to the notice, dated May 2, 2012, 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 May 7, 2012, filed it on May 21, 2012, and designated it as GRAS Notice No. GRN 000431.
The subject of the notice is colostral whey protein concentrate (CWPC). The notice informs FDA of the view of Sterling Technology that CWPC is GRAS, through scientific procedures, for use as an ingredient in multiple food categories at a level of either 1 gram or 100 milligrams of CWPC per serving of food, depending on which of two product formulations of CWPC is used.
In an email dated October 12, 2012, your authorized agent asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective October 12, 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 000431, 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/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition