Agency Response Letter GRAS Notice No. GRN 000234
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CFSAN/Office of Food Additive Safety
February 21, 2008
John B. Dubeck
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington D.C. 20001
Re: GRAS Notice No. GRN 000234
Dear Mr. Dubeck:
The Food and Drug Administration (FDA) is responding to the notice, dated September 6, 2007, that you submitted on behalf of Proliant Health Ingredients Inc. 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 7, 2007, filed it on September 17, 2007, and designated it as GRAS Notice No. GRN 000234.
The subject of the notice is bovine globulin. The notice informs FDA of the view of Proliant Health Ingredients Inc. that bovine globulin is GRAS, through scientific procedures, for use as an ingredient in dairy foods, juices, snack foods, beverages and meal replacements at maximum levels of 5 per cent of the finished product.
In an email message dated February 14, 2008, you withdrew your notice. Given your email, we ceased to evaluate GRN 000234, effective February 14, 2008, the date that we received your email.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000234, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (21 CFR 170.36(c)(1)), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition