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Agency Response Letter GRAS Notice No. GRN 000658

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See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

September 30, 2016

Thomas R. Wright
Chemie Research & Manufacturing Co., Inc.
160 Concord Drive
Casselberry, FL 32707

Re: GRAS Notice No. GRN 000658

Dear Mr. Wright:

The Food and Drug Administration (FDA) is responding to the notice, dated June 7, 2016, 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 July 1, 2016, filed it on July 27, 2016, and designated it as GRAS Notice No. GRN 000658.

The subject of the notice is grapefruit extract. The notice informs FDA of the view of Chemie Research & Manufacturing Co., Inc. that grapefruit extract is GRAS, through scientific procedures and common use in food, for a variety of uses including as an antimicrobial in all food categories except infant formulas and food products regulated by the United States Department of Agriculture, at a level of up to125 mL/L per serving.

In an email dated September 28, 2016, you asked that FDA cease to evaluate your notice to collect information regarding the subjects FDA raised in a phone conversation on September 12, 2016 and an email sent on September 19, 2016. Given your request, we ceased to evaluate your GRAS notice, effective September 28, 2016, the date that we received your request.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000658, 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.

Sincerely,

Antonia Mattia, Ph.D.
Director
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition