Agency Response Letter GRAS Notice No. GRN 000259
CFSAN/Office of Food Additive Safety
August 26, 2009
Stephen Paul Mahinka
Morgan, Lewis and Bockius
1111 Pennsylvania Avenue, N.W.
Washington, DC 20004
Re: GRAS Notice No. GRN 000259
Dear Mr. Mahinka:
The Food and Drug Administration (FDA) is responding to the notice, dated August 14, 2008, 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 August 15, 2008, filed it on September 8, 2008, and designated it as GRAS Notice No. GRN 000259.
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 are GRAS, through scientific procedures, for use as an ingredient in bottled teas, sports drinks, carbonated soft drinks, and juices at levels up to 540 milligrams per serving.
In a letter dated August 21, 2009, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective August 21, 2009, the date that we received your letter. Although you have withdrawn your notice, and FDA has ceased to evaluate the notice, FDA, nevertheless, plans to continue to monitor publications as well as other publicly available data and information related to catechins from green tea extract.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000259, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition