Agency Response Letter GRAS Notice No. GRN 000190
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CFSAN/Office of Food Additive Safety
May 4, 2006
Mr. Melvin S. Drozen
Mr. Devon Wm. Hill
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001
Re: GRAS Notice No. GRN 000190
Dear Mr. Drozen and Mr. Hill:
The Food and Drug Administration (FDA) is responding to the notice, dated January 11, 2006, that you submitted on behalf of The Dow Chemical Company (Dow Chemical) 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)). FDA received the notice on January 11, 2006, filed it on January 17, 2006, and designated it as GRAS Notice No. GRN 000190.
The subject of the notice is hydroxypropyl methylcellulose (HPMC). The notice informs FDA of the view of Dow Chemical that HPMC is GRAS, through scientific procedures, as an ingredient for use in food in general, including meat products.
In an e-mail dated April 6, 2006, you withdrew the notice. Given your request, we ceased to evaluate the GRAS notice, effective April 6, 2006, the date that we received your e-mail.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000190, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (proposed 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