Agency Response Letter GRAS Notice No. GRN 000347
CFSAN/Office of Food Additive Safety
November 30, 2010
George Burdock, Ph.D.
801 N. Orange Ave., Suite 710
Orlando, FL 32801
Re: GRAS Notice No. GRN 000347
Dear Dr. Burdock:
The Food and Drug Administration (FDA) is responding to the notice, dated June 25, 2010, that you submitted on behalf of Phusion Projects, 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 June 29, 2010, filed it on June 30, 2010, and designated it as GRAS Notice No. GRN 000347.
The subject of the notice is caffeine. The notice informs FDA of the view of Phusion Projects, LLC that caffeine is GRAS, through scientific procedures, for use as a flavoring ingredient in alcoholic beverages at a level of up to 200 parts per million.
In a letter dated November 24, 2010, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective November 24, 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 000347, 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