Agency Response Letter GRAS Notice No. GRN 000590
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
January 16, 2016
David H. Bechtel, Ph.D., D.A.B.T.
100 Davidson Avenue
Somerset, NJ 08873
Re: GRAS Notice No. GRN 000590
Dear Dr. Bechtel:
The Food and Drug Administration (FDA) is responding to the notice, dated July 6, 2015, that you submitted on behalf of Nascent Health Sciences, 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 July 15, 2015, filed it on July 29, 2015, and designated it as GRAS Notice No. GRN 000590.
The subject of the notice is pyrroloquinoline quinine. The notice informs FDA of the view of Nascent Health Sciences, LLC that pyrroloquinoline quinine is GRAS, through scientific procedures, for use as an ingredient in energy, sport, and isotonic drinks; non-milk based meal replacement beverages; water (bottled, enhanced, fortified); milk-based meal replacement beverages; cereal and granola bars; and energy, meal replacement, and fortified bars at levels ranging from 0.008 to 0.05 percent.
In a telephone conversation on January 14, 2016, we discussed with you questions regarding the interpretation of toxicology studies cited in the GRAS notice. In an email dated January 18, 2016, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective January 16, 2016, the date that we received your letter. We note that we have received a revised submission from you on February 6, 2016.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 00, 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