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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000139

CFSAN/Office of Food Additive Safety

May 7, 2004

Melvin S. Drozen
Keller and Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001

Re: GRAS Notice No. GRN 000139

Dear Mr. Drozen:

The Food and Drug Administration (FDA) has received the notice, dated November 14, 2003, that you submitted on behalf of Noveon, Inc. (Noveon) 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 this notice on November 17, 2003, filed it on November 21, 2003, and designated it as GRN No. 000139.

The subject of the notice is cassia gum. The notice informs FDA of the view of Noveon that cassia gum is GRAS, through scientific procedures, for use as a thickening agent, texturizer, and water retention aid in cheese-créme filling in pastries and other cheese-créme desserts, dry soup mixes, oil-free salad dressings, and meat and poultry products (sausages, corned beef, and canned poultry) at varying levels up to 5,000 parts per million (ppm).

In a letter dated May 3, 2004, you asked that FDA cease to evaluate Noveon's notice in light of the technical requirements discussed at our most recent meeting of January 26, 2004, with the understanding that Noveon may, in the future, submit another GRAS notification or make another appropriate submission for cassia gum. Given your request, we ceased to evaluate GRN No. GRN 000139 effective May 3, the date we received your letter.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in 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).

Sincerely,


George H. Pauli, Ph.D.
Acting Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

 

cc: Dr. Robert Post, Director
     Labeling and Consumer Protection Staff
     Office of Policy, Program Development and Evaluation
     Food Safety and Inspection Service
     1400 Independence Ave., SW, Suite 602, Annex
     Washington, DC 20250-3700