Agency Response Letter GRAS Notice No. GRN 000444
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CFSAN/Office of Food Additive Safety
April 12, 2013
Richard F. Mann
Keller and Heckman LLP
1001 G Street, NW
Washington, DC 20001
Re: GRAS Notice No. GRN 000444
Dear Mr. Mann:
The Food and Drug Administration (FDA) is responding to the notice, dated September 21, 2012, that you submitted on behalf of the American Dairy Products Institute (ADPI) and the U.S. Dairy Export Council (USDEC) 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 September 21, 2012, filed it on September 25, 2012, and designated it as GRAS Notice No. GRN 000444.
The subjects of the notice are milk protein concentrate and milk protein isolate. The notice informs FDA of the view of ADPI and USDEC that milk protein concentrate and milk protein isolate are GRAS, through scientific procedures, for use as ingredients in meal replacements and bars, term infant formula, milk products, non-standardized cheese products, confections and frosting, puddings and fillings, and dressings, soups, sauces, and snack foods.
In a letter dated, March 18, 2013, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective March 18, 2013, 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 000444, 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