Agency Response Letter GRAS Notice No. GRN 000474
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See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory
October 30, 2013
Madu G. Soni, Ph.D.
Soni and Associates, Inc.
749 46th Square
Vero Beach, FL 32968
Re: GRAS Notice No. GRN 000
Dear Dr. Soni:
The Food and Drug Administration (FDA) is responding to the notice, dated May 20, 2013, 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 4, 2013, filed it on June 17, 2013, and designated it as GRAS Notice No. GRN 000474.
The subject of the notice is piperine derived from the fruits of Piper nigrum L (black pepper) or P. longum L (long pepper). The notice informs FDA of the view of Sabinsa Corporation that piperine derived from the fruits of Piper nigrum L or P. longum L is GRAS, through scientific procedures, for use as a flavoring agent in a variety of food categories at use levels up to 15 parts per million.
In an electronic mail message dated September 19, 2013, you asked that FDA cease to evaluate the notice. You noted in your message that the notifier no longer intends to use P. longum as a source material for piperine and that extracts of P. nigrum are already considered to be GRAS. Given your request, we ceased to evaluate the GRAS notice, effective September 19, 2013, the date that we received your electronic mail message.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000474, 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