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CFSAN/Office of Food Additive Safety
November 17, 2005
Lee B. Dexter
Dexter and Associates
15704 Webberville Road
Austin, Texas 78724
Re: GRAS Notice No. GRN 000170
Dear Ms. Dexter:
The Food and Drug Administration (FDA) is responding to the notice, dated April 25, 2005, that you submitted on behalf of Primex ehf 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 May 31, 2005, filed it on June 3, 2005, and designated it as GRAS Notice No. GRN 000170.
The subject of the notice is shrimp-derived chitosan. The notice informs FDA of the view of Primex that shrimp-derived chitosan is GRAS, through scientific procedures for use in foods in general, including meat and poultry, for multiple technical effects.
In a letter dated October 31, 2005, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective October 31, 2005, the date that 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).
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
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