Agency Response Letter GRAS Notice No. GRN 000073
CFSAN/Office of Food Additive Safety
February 4, 2002
Lee B. Dexter
Lee B. Dexter and Associates
15704 Webberville Road
Austin, TX 78724
Re: GRAS Notice No. GRN 000073
Dear Ms. Dexter:
The Food and Drug Administration (FDA) is responding to the notice, dated January 31, 2001, that you submitted on behalf of Primex Ingredients, ASA (Primex) 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 March 14, 2001, and designated it as GRAS Notice No. GRN 000073.
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 food in general for multiple technical effects.
In a letter dated January 29, 2002, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective January 31, 2002, 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).
Linda S. Kahl, Ph.D.
Division of Biotech and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition