Agency Response Letter GRAS Notice No. GRN 000444

Return to inventory listing: GRAS Notice Inventory

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

CFSAN/Office of Food Additive Safety

April 12, 2013

Richard F. Mann
Keller and Heckman LLP
1001 G Street, NW
Suite 500W
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


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

Page Last Updated: 12/24/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English