Agency Response Letter GRAS Notice No. GRN 000663
CFSAN/Office of Food Additive Safety
October 6, 2016
Melvin S. Drozen
Keller and Heckman LLP
1001 G. Street, NW, Suite 500W
Washington, DC 20001
Re: GRAS Notice No. GRN 000663
Dear Mr. Drozen:
The Food and Drug Administration (FDA) is responding to the notice, dated August 10, 2016, that you submitted on behalf of Ingredion, Inc. 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 11, 2016, filed it on August 22, 2016, and designated it as GRAS Notice No. GRN 000663.
The subject of the notice is distarch phosphate. The notice informs FDA of the view of Ingredion, Inc. that distarch phosphate is GRAS, through scientific procedures, for use as a source of dietary fiber and as a thickener or texturizing agent in a variety of food categories as listed in the notice at a level of 3.5 to 7.0 grams per serving.
In an email dated September 30, 2016, you asked that FDA cease to evaluate the notice to collect information regarding the subjects FDA raised in a phone conversation on September 21, 2016 and emails sent on September 23 and 29, 2016. Given your request, we ceased to evaluate the GRAS notice, effective September 30, 2016, 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 000663, 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 www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition