Agency Response Letter GRAS Notice No. GRN 000224
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CFSAN/Office of Food Additive Safety
August 30, 2007
Gregory A. Lamps
ATLA Holdings, LLC
75 Fifth Street NW, Suite 325
Atlanta, Georgia 30308
Re: GRAS Notice No. GRN 000224
Dear Mr. Lamps:
The Food and Drug Administration (FDA) is responding to the notice, dated May 15, 2007, that EAS Consulting submitted on behalf of ATLA Holdings, 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 May15, 2007, filed it on May 22, 2007, and designated it as GRAS Notice No. GRN 000224.
The subject of the notice is trans-resveratrol. The notice informs FDA of the view of ATLA Holdings, LLC, that the ingredient, trans-resveratrol, is GRAS, through scientific procedures, for use as an ingredient in bottled water at levels up to 10 milligrams per liter.
In a letter dated July 24, 2007, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective August 1, 2007, 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 000224, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (21 CFR 170.36(c)(1)), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safetyand Applied Nutrition