Agency Response Letter GRAS Notice No. GRN 000434
CFSAN/Office of Food Additive Safety
November 21, 2012
Pharmachem Laboratories, Inc.
265 Harrison Avenue
Kearny, NJ 07032
Re: GRAS Notice No. GRN 000434
Dear Mr. Irizarry:
The Food and Drug Administration (FDA) is responding to the notice, dated June 12, 2012, 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 June 18, 2012, filed it on June 21, 2012, and designated it as GRAS Notice No. GRN 000434.
The subject of the notice is dried aqueous extract derived from white kidney bean (Phaseolus vulgaris). The notice informs FDA of the view of Pharmachem Laboratories, Inc. that white kidney bean extract is GRAS, through scientific procedures, for use as an ingredient in food providing an aggregate intake of up to 10 grams per person per day.
In an email dated October 10, 2012, your authorized agent asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective October 10, 2012, 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 000434, 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/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition