Agency Response Letter GRAS Notice No. GRN 000362
CFSAN/Office of Food Additive Safety
March 10, 2011
Northeast Pharmaceutical Group Co., Ltd.
No. 37, Zhonggong Bei Street
Tiexi District, Shenyang City, Liaoning Province
Re: GRAS Notice No. GRN 000362
Dear Xie Dan:
The Food and Drug Administration (FDA) is responding to the notice, dated November 15, 2010, 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 this notice on November 29, 2010, filed it on December 8, 2010, and designated it as GRN No. 000362.
The subject of the notice is levocarnitine. The notice informs FDA of the view of Northeast Pharmaceutical Group Co., Ltd. that levocarnitine is GRAS, through scientific procedures, for use as an ingredient in several food categories, which do not include meat or poultry products.
In an electronic mail message dated March 8, 2011, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective March 9, 2011, the date 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 000362, 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 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