Agency Response Letter GRAS Notice No. GRN 000276
CFSAN/Office of Food Additive Safety
March 17, 2009
Phoenix Regulatory Associates, Ltd.
21525 Ridgetop Circle
Sterling, VA 20166
Re: GRAS Notice No. GRN 000276
Dear Dr. Gund:
The Food and Drug Administration (FDA) is responding to the notice, dated December 31, 2008, that you submitted on behalf of Nikken Sohonsha Corporation 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 December 31, 2008, filed it on January 2, 2009, and designated it as GRAS Notice No. GRN 000276.
The subject of the notice is Dunaliella bardawil alga. The notice informs FDA of the view of Nikken Sohonsha Corporation that D. bardawil alga is GRAS, through scientific procedures, for use as an ingredient in the following foods: dairy products, cakes, mayonnaise and salad oils, pudding and custards, crackers and cookies, wheat noodles, bread/rolls, tofu, Kimchi and fermented soybean products.
In a letter dated March 5, 2009, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective March 6, 2009, 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 000276, 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