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CFSAN/Office of Food Additive Safety
July 25, 2006
James T. Heimbach, Ph.D., F.A.C.N.
4530 Broad Branch Road, N.W.
Washington, DC 20008
Re: GRAS Notice No. GRN 000164
Dear Dr. Heimbach:
The Food and Drug Administration (FDA) is providing additional information relevant to the notice dated March 2, 2005, that you submitted on behalf of Laboratorios Miret S.A. (LAMIRSA) 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 March 4, 2005, filed it on March 8, 2005, and designated it as GRAS Notice No. GRN 000164. In a letter dated September 1, 2005, FDA informed you that the agency had no questions at that time regarding the conclusion of LAMIRSA that the subject of the notice is GRAS under the intended conditions of use.
In a letter dated April 28, 2006, you informed the FDA that LAMIRSA has an interest in using lauramide arginine ethyl ester (LAE) in the form of salts of GRAS acids other than HCl. You stated that lactic acid, acetic acid, glutamic acid, citric acid, and phosphoric acid are common acids that will form salts of LAE of potential interest to your client. You noted that all are listed in our GRAS regulations with no limitations other than current good manufacturing practice. In the case of lactic acid, you appropriately noted that the regulation affirming its GRAS status excludes its use in infant foods and infant formula products. You stated that LAMIRSA does not intend to use lactic acid salts of LAE in infant foods and infant formula products. You concluded by stating that you believe that this particular use is safe and lawful, consistent with standard regulatory interpretation, and would not justify the time and effort for FDA to review a new GRAS notification.
Based on the information you have provided and other information available to the FDA, the agency has determined that it has no questions at this time regarding your conclusion that substituting lactic acid, acetic acid, glutamic acid, citric acid, or phosphoric acid for hydrochloric acid to form salts of lauramide arginine ethyl ester is safe and lawful, consistent with standard regulatory interpretation.
Edmundo Garcia Jr.
Consumer Safety Officer
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition