Agency Response Letter GRAS Notice No. GRN 000257
CFSAN/Office of Food Additive Safety
January 8, 2009
Yoshiaki Yoshikuni, Ph.D.
Pharma Foods International Co., Ltd.
1-49 Goryo-Ohara, Nishikyo-Ku
Re: GRAS Notice No. GRN 000257
Dear Dr. Yoshikuni:
The Food and Drug Administration (FDA) is responding to the notice, dated July 22, 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 August 7, 2008, filed it on August 11, 2008, and designated it as GRAS Notice No. GRN 000257.
The subject of the notice is gamma-Amino butyric acid. The notice informs FDA of the view of Pharma Foods International Co., Ltd. that gamma-Amino butyric acid is GRAS, through scientific procedures, for use as an ingredient in beverages and beverage bases, chewing gum, ready-to-drink coffee and tea products, and candy at levels ranging from 0.04% to 4%.
In a letter dated December 15, 2008, Pharma Foods International Co., Inc. withdrew its notice. Given the letter, we ceased to evaluate the GRAS notice, effective December 22, 2008, the date that we received the letter.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000257, 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