Agency Response Letter GRAS Notice No. GRN 000225
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CFSAN/Office of Food Additive Safety
December 14, 2007
Stephen Paul Mahinka
Morgan, Lewis & Bockius LLP
1111 Pennsylvania Avenue, NW
Washington, DC 20004
Re: GRAS Notice No. GRN 000225
Dear Mr. Mahinka:
The Food and Drug Administration (FDA) is responding to the notice, dated May 17, 2007, that you submitted on behalf of Kao Corporation (Kao) 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 18, 2007, filed it on May 24, 2007, and designated it as GRN No. 000225.
The subject of the notice is catechins from green tea extract. The notice informs FDA of the view of Kao that catechins from green tea extract is GRAS, through scientific procedures, for use as an ingredient in beverages, including bottled teas, sport drinks, carbonated soft drinks and juice, at levels according to current good manufacturing practices.
In a letter dated November 26, 2007, you withdrew your notice. Given your letter, we ceased to evaluate GRN No. 000225 effective November 26, 2007, 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 000225, 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