Agency Response Letter GRAS Notice No. GRN 000340
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CFSAN/Office of Food Additive Safety
November 17, 2010
Stanley M. Tarka, Jr., Ph.D.
The Tarka Group Inc.
210 N. Old Stonehouse Road
Carlisle, PA 17015-8517
Re: GRAS Notice No. GRN 000340
Dear Dr. Tarka:
The Food and Drug Administration (FDA) is responding to the notice, dated May 10, 2010, that you submitted on behalf of Theocorp Holding Company, LLC 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 12, 2010, filed it on May 17, 2010, and designated it as GRAS Notice No. GRN 000340.
The subject of the notice is theobromine. The notice informs FDA of the view of Theocorp Holding Company, LLC that theobromine is GRAS, through scientific procedures, for use as an ingredient in bread, ready-to-eat cereals, instant and regular oatmeal, sports and isotonic drinks, vitamin and enhanced bottled waters, chewing gums, tea, soy milk, gelatins, hard mint candy, meal replacement beverages (non-chocolate), yogurt and yogurt drinks (non-chocolate), fruit smoothies, and powdered fruit flavored drinks at levels ranging from 5-75 milligrams per serving.
In a letter dated November 10, 2010, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective November 10, 2010, 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 000340, 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