Agency Response Letter GRAS Notice No. GRN 000244
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CFSAN/Office of Food Additive Safety
May 30, 2008
Kohjin Co., Ltd.
1-21, Nihombashi Muromachi 4 Chome
Chou-ku, Tokyo, 103-0022
Re: GRAS Notice No. GRN 000244
Dear Mr. Uchida:
The Food and Drug Administration (FDA) is responding to the notice, dated January 31, 2008, that you submitted 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 February 12, 2008, filed it on February 14, 2008, and designated it as GRAS Notice No. GRN 000244.
The subject of the notice is glutathione. The notice informs FDA of the view of Kohjin Co., Ltd. that glutathione is GRAS, through scientific procedures, for use as a food ingredient in several food categories, including meat products, at levels ranging from 5 to 300 milligrams per serving; and in milk- and soy-based infant formula at levels up to 0.167 grams per 100 milliliters.
In a letter dated May 7, 2008, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective May 9, 2008, the date that we received your letter.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000244, 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
cc: Mr. Bill Jones
Labeling and Program Delivery Division
Office of Policy, Program Development and Evaluation
Food Safety and Inspection Service
1400 Independence Ave., S.W., Room 2925, South Building
Washington, DC 20250-3700