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CFSAN/Office of Premarket Approval
March 19, 1999
Nancy A. Higley, Ph.D.
Vice President, Product Safety & Regulatory Assurance
Givaudan Roure Flavors Corporation
1199 Edison Drive
Cincinnati, OH 45216
Re: GRAS Notice No. GRN 000012
Dear Dr. Higley:
The Food and Drug Administration (FDA) is responding to your letter dated March 8, 1999, concerning the notice 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)). Your notice informed FDA of the view of Givaudan Roure that mesquite wood alcoholic extract is GRAS for use as a flavoring ingredient in several food categories, including alcoholic beverages. FDA received your notice on December 30,1998, and designated it as GRAS Notice No. GRN 000012.
Your March 8, 1999, letter states that Givaudan Roure Flavors Corporation requests the withdrawal of GRN 000012 from consideration in accordance with proposed 21 CFR 170.36. Given your letter, FDA ceased to evaluate GRAS Notice No. GRN 000012, effective March 11, 1999, the date on which we received your letter.
In accordance with proposed 21 CFR 170.36(f), we have placed a copy of this letter, as well as a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1), in a file that is available for public review and copying in the public reading room of the agency's Freedom of Information Staff.
Linda S. Kahl, Ph.D.
Regulatory Policy Branch (HFS-206)
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition